Background

Medicines constitute an essential part of healthcare delivery, and help to prevent or treat illness, influence quality of life, and generally increase life expectancy. However, medications can cause harm if prescribed irrationally, dispensed or used incorrectly, and monitored or followed up insufficiently (Ofori-Asenso & Agyeman, 2016). Furthermore, medication harm can be a result of errors, accidents, or communication problems (World Health Organization (WHO), 2017). Unsafe medication management and practices have consequences on both the patient and healthcare system level in the form of injuries, failure of therapy, worsening of illness, increased use of healthcare services, and large financial expenditures (Donaldson et al., 2017; Elliot et al., 2020; Panagioti et al., 2019).

We understand medication safety as freedom from avoidable harm while using medicines, or those actions that avoid, prevent, or correct harm caused by medicines. Since 2017, WHO has focused on medication safety in the global patient safety challenge, “Medication Without Harm”, where the goal is to reduce severe, avoidable medication-related harm (Donaldson et al., 2017). Furthermore, medication safety is central in WHOs Global Patient Safety Action Plan 2021–2030, where the goal is to achieve the maximum possible reduction in avoidable harm due to unsafe healthcare (WHO, 2021).

Rational use of medicines and safe medication management have been important focus areas in patient safety initiatives both in Norway (The Norwegian Directorate of Health, 2020) and internationally (Bates & Singh, 2018). Generally, the past 20 years have witnessed a positive development in solutions for patient safety measures, however there remains some inconsequence in clinical practice implementation (Bates & Singh, 2018). Most of the documentation relating to preventable patient harm and medication errors in healthcare originates from studies conducted in general hospitals or in advanced speciality care (Panagioti et al., 2019; WHO, 2016). However, the risks present in primary care may differ from the hospital setting, since there are differences in the type of clinical problems, medicine use, and the organization and systems of medication practices (Bates & Singh, 2018; WHO, 2016). Therefore, there is still a need to seek more knowledge, and focus on the prevention of medication harm in primary care settings, that is, municipal health and care services, which encompass a high patient volume.

The Scope of the Anthology

In this anthology, we want to showcase the challenges of medication management and the rational use of medicines in municipal health and care services, and present various strategies and measures related to medication safety. The anthology hopes to raise awareness, engage, and enable discussion of initiatives and strategies to improve patient safety related to medications in municipal health and care services. Furthermore, this is a scientific anthology, which can create a basis for further research to promote safe medication management and rational use of medicines.

The anthology will be of interest primarily to healthcare professionals, academic staff, researchers, policymakers, and managers in healthcare services. Furthermore, anyone involved in, or concerned with, medication safety will hopefully benefit from reading the anthology.

Structure, Chapters, and the Contributors

The anthology is structured according to the four domains of WHOs strategic framework of the third global patient safety challenge, “Medication Without Harm”, wherein medications are described as able to cause inadvertent harm: 1) patients and the public, 2) medicines, 3) healthcare professionals, and 4) systems and practices of medication (Donaldson et al., 2017).

This anthology includes 17 chapters compiled through contributions from 35 researchers who represent a wide range of disciplines, and who have experience from different levels of healthcare services, and from different parts of the research and education sectors. Thereby, the anthology provides valuable insights based on expertise in the field of medication safety. The material investigates different aspects of medication safety in municipal health and care services, and highlights a wide range of on­going initiatives and practices.

Acknowledgements

We would like to extend our sincere gratitude to all the authors for their unique scientific contributions and for collaborating throughout the project, making this anthology possible. We thank the anonymous peer reviewers for their careful reading of our manuscripts, and for providing insightful comments and suggestions. Furthermore, we greatly appreciate the support and commitment of the publisher. The anthology is financially supported through shared contributions from the universities with which the authors are affiliated.

References

• Bates, D. W. & Singh, H. (2018). Two decades since “To Err Is Human”: An assessment of progress and emerging priorities in patient safety. Health Affairs (Millwood), 37(11), 1736–1743. https://doi.org/10.1377/hlthaff.2018.0738
• Donaldson, L. J., Kelley, E. T., Dhingra-Kumar, N., Kieny, M. P. & Sheikh, A. (2017). Medication without harm: WHO’s third global patient safety challenge. Lancet, 389(10080), 1680–1681. https://doi.org/10.1016/S0140-6736(17)31047-4
• Elliot, R. A., Camacho, E., Jankovic, D., Sculpher, M. J. & Faria, R. (2021). Economic analysis of the prevalence and clinical and economic burden of medication error in England. BMJ Quality & Safety, 30(2), 96–105. https://doi.org/10.1136/bmjqs-2019-010206
• Ofori-Asenso, R. & Agyeman, A. A. (2016). Irrational use of medicines: A summary of key concepts. Pharmacy (Basel), 4(4). https://doi.org/10.3390/pharmacy4040035
• Panagioti, M., Khan, K., Keers, R. N., Abuzour, A., Phipps, D., Kontopantelis, E., Bower, P., Campbell, S., Haneef, R., Avery, A. J. & Ashcroft, D. M. (2019). Prevalence, severity, and nature of preventable patient harm across medical care settings: Systematic review and meta-analysis. BMJ, 366, l4185. https://doi.org/10.1136/bmj.l4185
• The Norwegian Directorate of Health (2020). In safe hands 24-7. Accessed from https://www.itryggehender24-7.no/om-i-trygge-hender-24-7/english/the-norwegian-patient-safety-programme-in-safe-hands
• World Health Organization. (2016). Medication errors: Technical series on safer primary care. Accessed from https://www.who.int/publications/i/item/9789241511643
• World Health Organization. (2017). Medication without harm: Global patient safety challenge on medication safety. Accessed from https://www.who.int/initiatives/medication-without-harm
• World Health Organization. (2019). Medication Safety in Transitions of Care. https://www.who.int/publications/i/item/WHO-UHC-SDS-2019.9
• World Health Organization. (2021). Global patient safety action plan 2021–2030: Towards eliminating avoidable harm in health care. Accessed from https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan

Methods

Results

An adapted PRISMA flow diagram in Figure 1 shows the information through the different phases of the review. The search strategy identified 850 studies, of which 170 were duplicates. After screening titles and abstracts for relevance, 65 studies were identified requiring full-text review for eligibility. Following review, a total of five studies were included for analysis and form the basis of the findings.

Risk of Bias and Quality of Studies

The overall quality of evidence in this systematic review is illustrated in Figure 2. In total, a low RoB was observed in 54% of the dimensions, and across all studies in reporting bias and selection bias by random sequence generation. A high or unclear RoB was observed in 23% of the dimensions.

The RoB analysis shows a high risk of other bias in four of the included studies (Figure 3). This was mainly due to small sample size or unbalanced groups of study subjects in the interventions groups versus control groups, in relation to characteristics at baseline, which would likely affect the study outcome. Performance bias was considered a high risk in two studies, since neither participants nor study personnel were blinded, and unclear RoB was considered when only personnel were blinded (n = 2). Differential attrition >9% combined with overall attrition above 10% were observed in two studies and considered a high RoB, while differential attrition of 8.7% was observed in one study and considered unclear. No information on blinding of outcome assessments in the studies was considered as unclear detection bias (n = 3).

Discussion

This systematic review identified five RCTs describing patient engagement interventions that affect medication safety in long-term care. Involvement and partnership/shared leadership interventions were used in three and two studies, respectively, according to the framework for patient engagement in patient safety of own care (Corman et al., 2013; NHS England, 2016). Involvement characterization means that interventions entailed patients having an active role in medication safety measures, but power remains with the healthcare professional. Partnership or shared leadership interventions entailed patients sharing power with healthcare professionals. Patient engagement interventions reported statistically significant effects on medication safety in three of the studies (Goeman et al., 2013; Graumlich et al., 2016; Wang et al., 2021), within several outcome measures: medication adherence (Goeman et al., 2013); self-reported knowledge of medicines (Graumlich et al., 2016); medication errors (Wang et al., 2021); and self-efficacy for appropriate medication use (Wang et al., 2021). However, due to the limited evidence base in five studies, and their extensive heterogeneity in relation to intervention designs, population, settings, and outcome measures, we are not able to draw further conclusions on patient engagement effects on medication safety among patients in long-term care settings. Nor can we attribute changes in medication safety outcomes to a particular level of patient engagement (cf. the framework of Carman et al., 2013). We know from previous research that interventions to improve medication safety remain on a low level of patient engagement, typically involving informing patients about engagement, encouraging patients to engage, to ask questions, and communicate with their healthcare professionals (Kim et al., 2018). Other systematic reviews of patient engagement interventions affecting patient or medication safety are scarce and have not limited the setting to long-term care or to RCT study designs (Kim et al., 2018; Newman et al., 2021). Hence, they are not readily comparable. However, this study aligns with previous studies in describing heterogeneity between studies in for example, design, population, setting, outcome measurements, and quality (Kim et al., 2018; Newman et al., 2021).

A systematic review of interventions can guide decision makers and the practice field in choosing approaches to improve medication safety. Due to the evidence base of the five studies in this chapter, the implications for practice are limited. However, the result of this systematic review aligns with previous research describing the importance of including patients in their own care and management of medicines, and empowering patients may enhance medication safety (Lee et al., 2018, Kangovi et al., 2014, Kim et al., 2018). This study expands our knowledge of interventions to engage patients, and typically involve several behavioural or knowledge components. Examples were medicine reconciliation, medication review, medication information in written or digital formats, individual follow-up and/or counselling by healthcare professionals, and various eHealth components (e.g., digital tools to provide information or communicate with health providers). This result is partly in line with previous research. Kim et al. (2018) found in their review that key strategies for engaging patients in medication safety included education and medication reconciliation, often involving information technology or patient portal use.

In recent years, the global health community has focused on measures to increase patient engagement to ensure safe medicine practices, anchored by WHOs global patient safety challenge on medication safety (Donaldson et al., 2017; WHO, 2017). However, the results of this review show that effect studies testing patient engagement interventions in long-term care are limited, but achievable. Further research on patient engagement interventions in community settings are needed, and should include a greater amount of patient engagement, and patient-centred approaches to assess medication safety (Lee, 2018). Furthermore, there is a need for international consensus and guidelines for medication safety outcome measurements, which is necessary to perform meta-analyses and provide the practice field and stakeholders with reliable evidence and trustworthy effect estimates.

Strengths and Limitations

The strength of this chapter is the rigorous, systematic approach in reviewing studies, following the PRISMA 2020 statement for reporting (Moher et al., 2009). The method used to identify all relevant information was comprehensive and feasible for the scope of the review. In addition, the eligibility screening, quality assessment, data extraction and knowledge synthesis were performed by researchers with professional healthcare education, as a registered nurse (first author) and a pharmacist (second author). This interdisciplinary approach with relevant areas of expertise, strengthens the study.

The main limitation of this systematic review is the small number of studies included, limiting the evidence base available to create new knowledge and draw conclusions. This could be due to the scope of the review and the selection criteria, and limitations used in the search process. For example, we selected patients in community settings, and the safety of their own level of care according to the patient engagement framework, including only RCTs. Furthermore, a more comprehensive search strategy including grey literature could have provided a larger evidence base. However, we strongly believe that the five included studies reveal a knowledge gap in the literature, and highlight the need to perform medication safety effect studies using patient engagement interventions with a high amount of engagement in community settings.

Conclusion

This chapter provides a systematic review of patient engagement interventions and how they affect medication safety among patients in long-term care. A limited body of evidence suggests that key strategies for patient engagement to ensure medication safety in long-term care should include several components to increase medication knowledge and change behaviour. A knowledge gap in the literature has been detected, and additional effect studies are needed. Preferably, future RCTs should include comparable medication safety outcomes, to guide the practice field and stakeholders utilizing reliable evidence.

Acknowledgements

The authors wish to thank Linda Amundstuen for her valuable support and helpful discussions during the assessment of the studies’ eligibility.

References

• Assiri, G. A., Shebl, N. A., Mahmoud, M. A., Aloudah, N., Grant, E., Aljadhey, H. & Sheikh, A. (2018). What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of the international literature. BMJ Open, 8(5), e019101. https://doi.org/10.1136/bmjopen-2017-019101
• Carman, K. L., Dardess, P., Maurer, M., Sofaer, S., Adams, K., Bechtel, C. & Sweeney, J. (2013). Patient and family engagement: A framework for understanding the elements and developing interventions and policies. Health Affairs, 32(2), 223–231. https://doi.org/10.1377/hlthaff.2012.1133
• Donaldson, L. J., Kelley, E. T., Dhingra-Kumar, N., Kieny, M. P. & Sheikh, A. (2017). Medication without harm: WHO’s third global patient safety challenge. Lancet, 389(10080), 1680–1681. https://doi.org/10.1016/S0140-6736(17)31047-4
• Goeman, D., Jenkins, C., Crane, M., Paul, E. & Douglass, J. (2013). Educational intervention for older people with asthma: A randomised, controlled trial. Patient Education and Counseling, 93(3), 586–595. https://doi.org/10.1016/j.pec.2013.08.014
• Graumlich, J. F., Wang, H., Madison, A., Wolf, M. S., Kaiser, D., Dahal, K. & Morrow, D. G. (2016). Effects of a patient-provider, collaborative, medication-planning tool: A randomized, controlled trial. Journal of Diabetes Research, 2129838–16. https://doi.org/10.1155/2016/2129838
• Heisler, M., Choi, H., Palmisano, G., Mase, R., Richardson, C., Fagerlin, A., Montori, V. M., Spencer, M. & An, L. C. (2014). Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using eHealth tools versus print materials: A randomized, controlled trial. Annals of Internal Medicine, 161(10 Suppl), 13–S22. https://doi.org/10.7326/M13-3012
• Higgins, J. P. T, Thomas, J., Chandler, J., Cumpston, M., Li, T., Page, M. J. & Welch, V. A. (2021). Cochrane handbook for systematic reviews of interventions version 6.2 (updated February 2021). Retrieved November 11, 2021, from www.training.cochrane.org/handbook.
• Higgins, J. P., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., & Sterne, J. A. (2011). The Cochrane collaboration tool for assessing risk of bias in randomised trials. British Medical Journal, 343(7829), 1–9. https://doi.org/10.1136/bmj.d5928
• Insani, W. N., Whittlesea, C., Alwafi, H., Man, K., Chapman, S. & Wei, L. (2021). Prevalence of adverse drug reactions in the primary care setting: A systematic review and meta-analysis. PLOS One, 16(5), e0252161. https://doi.org/10.1371/journal.pone.0252161
• Kangovi, S., Mitra, N., Grande, D., White, M. L., McCollum, S., Sellman, J., Shannon, R. P. & Long, J. A. (2014). Patient-centered community health worker intervention to improve post-hospital outcomes: A randomized clinical trial. JAMA Internal Medicine, 174(4), 535–543. https://doi.org/10.1001/jamainternmed.2013.14327
• Kim, J. M., Suarez-Cuervo, C., Berger, Z., Lee, J., Gayleard, J., Rosenberg, C., Nagy, N., Weeks, K. & Dy, S. (2018). Evaluation of patient and family engagement strategies to improve medication safety. The Patient, 11(2), 193–206. https://doi.org/10.1007/s40271-017-0270-8
• Lee, J. L., Dy, S. M., Gurses, A. P., Kim, J. M., Suarez-Cuervo, C., Berger, Z. D., Brown, R. & Xiao, Y. (2018). Towards a more patient-centered approach to medication safety. Journal of Patient Experience, 5(2), 83–87. https://doi.org/10.1177/2374373517727532
• Moher, D., Liberati, A., Tetzlaff, J. & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. British Medical Journal, 339, b2535. https://doi.org/10.1136/bmj.b2535
• Morin, L., Laroche, M. L., Texier, G. & Johnell, K. (2016). Prevalence of potentially inappropriate medication use in older adults living in nursing homes: A systematic review. Journal of the American Medical Directors Association, 17(9), 862.e1–862.e8629. https://doi.org/10.1016/j.jamda.2016.06.011
• Newman, B., Joseph, K., Chauhan, A., Seale, H., Li, J., Manias, E., Walton, M., Mears, S., Jones, B. & Harrison, R. (2021). Do patient engagement interventions work for all patients? A systematic review and realist synthesis of interventions to enhance patient safety. Health Expectations, 24(6), 1905–1923. https://doi.org/10.1111/hex.13343
• NHS England. (2016). Patient engagement in patient safety: A framework for the NHS. https://www.england.nhs.uk/signuptosafety/wp-content/uploads/sites/16/2016/05/pe-ps-framwrk-apr-16.pdf
• Plácido, A. I., Herdeiro, M. T., Morgado, M., Figueiras, A. & Roque, F. (2020). Drug-related problems in home-dwelling older adults: A systematic review. Clinical Therapeutics, 42(4), 559–572.e14. https://doi.org/10.1016/j.clinthera.2020.02.005
• Sit, J. W., Chair, S. Y., Choi, K. C., Chan, C. W., Lee, D. T., Chan, A. W., Cheung, J. L., Tang, S. W., Chan, P. S. & Taylor-Piliae, R. E. (2016). Do empowered stroke patients perform better at self-management and functional recovery after a stroke? A randomized controlled trial. Clinical Interventions in Aging, 11, 1441–1450. https://doi.org/10.2147/CIA.S109560
• Wang, W., Zhang, H., Lin, B. & Zhang, Z. (2021). Feasibility of a patient engagement and medication safety management program for older adults suffering cardiovascular disease in community settings. Medicine (Baltimore), 100(21):e26125. https://doi.org/10.1097/MD.0000000000026125
• World Health Organization. (2016). Patient engagement: Technical series on safer primary care. (Licence: CC BY-NC-SA 3.0 IGO). Retrieved from https://www.who.int/publications/i/item/9789241511629
• World Health Organization. (2017). Medication without harm: Global patient safety challenge on medication safety (Licence: CC BY-NC-SA 3.0 IGO.). Retrieved from https://www.who.int/initiatives/medication-without-harm

Methodology and Research Ethics

This chapter is a synthesis of knowledge based on the findings of two PhD studies and an updated literature search (Whittemore et al., 2014). We have interpreted and summarized the results from these studies in the context of medication safety to provide new knowledge on how to operationalize the perspectives of patient and next of kin involvement, in order to inform best practice in mitigating adverse events related to systemic anticancer treatment (Bergerød, 2021; Haukland, 2020).

The chapter is based on previously published healthcare research and quality assurance work done by the authors. According to the Regional Committee for Medical and Health Research Ethics in Norway, healthcare research and quality assurance work does not require approval by the committee, compare The Health Research Act §9 and The Research Ethics Act § 4.

The Norwegian Cancer System

Norway has a nationalized healthcare system that is semi-decentralized, meaning that the central government is responsible for secondary healthcare services. The service is delivered through four regional health authorities, which own and operate 20 hospital trusts (Saunes et al., 2020). The municipalities are responsible for primary care, including nursing homes, homecare, general practitioners, casualty clinics and rehabilitation services. The Norwegian Board of Health Supervision is the independent supervisory authority in Norway. All service providers are by law responsible for providing sound professional practice and for establishing safety management systems. Documentation and follow-up of adverse events should be done internally in the healthcare organizations. It is mandatory to report the most severe adverse events to the Norwegian Board of Health Supervision and the Norwegian Healthcare Investigation Board. In 2020, more than 1,000 severe events were reported (Saunes et al., 2020).

Cancer Care in Norway

In Norway nearly 300,000 people have a cancer diagnosis, and the numbers are increasing. There are approximately 35,000 new cases per year, and patients are also living longer (Cancer Registry of Norway, 2020). A typical course for a cancer patient in Norway is to first consult their general practitioner (GP). If the patient has suspicious cancer symptoms, the GP refers the patient to the hospital in line with national guidelines and care pathways. The patient is then integrated into care pathways, and goes through a rapid schedule of essential tests and requirements for the suspected diagnosis. A multidisciplinary team along with the patient reach a decision on diagnosis and treatment options. Cancer treatment and care are in general paid for by the public sector, and the patient is followed up by the hospital and the GP. The municipalities appoint a cancer coordinator for the individual patient after diagnosis. At first glance this seems like a seamless system with an appropriate distribution of responsibility and division of work. However, the cancer patient will alternate back and forth between service levels, as well as several actors in and between hospitals and services in the municipalities during the care trajectory, causing challenges related to care transitions and involvement (Aase et al., 2017; Aase & Waring, 2020; Bergerød & Braut et al., 2020; Saunes et al., 2020).

Patient Safety and Adverse Events

There are many definitions of patient safety. This chapter uses the well-known definition provided by Vincent: “The avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare” (Vincent, 2010, p. 14).

This definition links patient safety to adverse outcomes or injuries, caused, for example, by medication harm. An adverse event is defined by the World Health Organization as “an injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care. Adverse events may be preventable or non-preventable” (World Health Organization, 2005).

This means that an adverse event is not caused by the disease itself, but is rather harm inflicted in or by the process of treatment or care. This is highly relevant for the cancer care field because systemic anticancer treatment not only cures or postpones the development of the disease, but could potentially cause harmful acute or subsequent effects, such as fatigue, pain and psychological harm. The harmful side effects of anticancer treatment can perhaps be regarded as poorly managed safety, however for the cancer field this is often considered to be unavoidable, justified by the argument that the patient will be able to live longer with their cancer or be cured. These potentially harmful effects may cause challenges for how the patient copes with treatment and care, but consequences and interventions seldom integrate the next of kin perspective, in terms of involvement, to mitigate these adverse events (Barlow et al., 2021; Moghli et al., 2021).

Adverse Events in Cancer Treatment in Norway

In Norway, the Patient Safety Campaign, In Safe Hands 24-7, was launched in 2011 aiming to reduce the number of patient injuries by 25%. This campaign has continued within a patient safety program, and is now integrated into an action plan for quality and patient safety at the national level (Norwegian Directorate of Health, 2020a). None of the program initiatives focus specifically on improving patient safety in cancer care. In general, serious adverse events in the Norwegian healthcare system continue to be a big problem, and the numbers remain stable. In 2020 adverse events occurred in 13.1% of all hospital stays in Norway (Norwegian Directorate of Health, 2021b). In comparison, hospitalized cancer patients experienced an adverse event in 24.2% of admissions.

During the last decade there have been multiple studies indicating that cancer patients experience higher rates of adverse events than the general population, with an average of nearly 40% of admissions having at least one event (Cihangir et al., 2013; Hébert et al., 2015; Lipczak et al., 2015; Lipitz-Snyderman et al., 2017; Mattsson et al., 2013). Hospitalized cancer patients have a 39% higher risk of adverse events compared to other hospitalized patients. This is not due to the cancer diagnosis itself, but is associated with older age, longer hospital stays, and surgical complications (Haukland et al., 2017). By examining deceased hospitalized patients, one finds that for cancer patients dying in hospitals, the rate of severe adverse events is as much as seven times higher than for the general population (Haukland et al., 2020). The potential risks for hospitalized cancer patients are most often related to medication harm and infection (Haukland, 2020).

Several risk analyses conducted by the Norwegian Board of Health Supervision have also found that the risk for adverse events in cancer care is high in Norway (Hannisdal et al., 2013; Haukland et al., 2017) There is also a lack of national overview relating to how large the problem is within the cancer care field (Hannisdal et al., 2013).

However, the national compensatory systems and many good quality registries provide measures for surveillance. In Norway we have a national system for patient compensation after patient injuries caused by the healthcare services. Numbers from this system show that cancer is the second largest medical area with reported cases in Norway. Common reasons for compensation reported in the cancer field are failures in treatment or diagnosis (The Norwegian System of Patient Injury Compensation, 2020). Nevertheless, even if Norway has a mandatory reporting system for the most severe adverse events, underreporting in documentation and disclosure of adverse events in hospitals remains a problem. Studies show that only one in four adverse events causing injury or death are reported through incident reporting systems in hospitals (Smeby et al., 2015).

Measuring Adverse Events

It is no surprise that cancer patients experience treatment-related toxicities, but accurate and reliable measurements of adverse events remain a major challenge for the patient safety field (Jha & Pronovost, 2016; Shojania & Thomas, 2013). Measuring adverse events is more difficult than measuring many other healthcare processes or outcomes, because adverse events need to be understood in the context of the complex systems within which they occur.

Many methods have been developed to detect adverse events, and reporting them in oncology has evolved in response to new treatments and modalities. Patient-reported outcomes (PROs) are considered the gold standard for data collection in research. Based on this, the National Cancer Institute has also developed a patient-reported outcome assessment system (PRO-CTCAE) used to evaluate symptomatic toxicity reported by the patients themselves (Basch et al., 2014; Dueck et al., 2015). The patient-reported assessment consists of 78 symptom-related questions relevant to oncology, grading common adverse events in relation to anticancer treatment. By involving cancer patients in reporting symptoms electronically themselves at an early stage, there is a potential to mitigate harm before it develops into a severe adverse event. Implementing a follow-up with PRO-CTCAE as standard clinical practice could be part of a safety surveillance system to prevent adverse events related to systemic anticancer treatment.

Next of kin are often excluded from evaluation measures (patient surveys) in healthcare services, despite the fact that healthcare professionals describe the next of kin within the cancer field as collaborative partners in quality and safety efforts (Bergerød & Dalen, et al., 2020; Stenberg et al., 2014; Stolz-Baskett et al., 2021).We suggest a change in the evaluation of cancer care services to include measurement from the next of kin perspective. Surveys of next of kin satisfaction with care and other experiences can be useful at the department level, and could provide meaningful information as a compass and a guide in co-creating and collaborative learning, with the next of kin as an equal and natural collaborative partner in hospital cancer care (Bergerød & Dalen, et al., 2020).

Medication Harm in Cancer Care

Medication harm is reported as the most common type of adverse event in cancer patients, and is related to both systemic anticancer treatment and other medications (Haukland et al., 2017; Lipczak et al., 2011; Schwappach & Wernli, 2010; Weingart et al., 2018). Adverse drug events related to systemic anticancer treatment are of serious concern for patient safety, and in many cases cause extra unnecessary burdens to already vulnerable cancer patients (World Health Organization, 2019a).

Figure 1 compares the number of adverse events per patient for general patients, deceased patients and deceased cancer patients at a Norwegian hospital. Deceased patients experienced significantly more adverse events than general patients, and for deceased cancer patients medication harm, often related to systemic anticancer treatment, such as chemotherapy and immune-checkpoint inhibitors, is by far the most common cause of adverse events (Haukland, 2020).

Chemotherapy-Related Adverse Events

Chemotherapy is classified as high-risk medication, since it has a low therapeutic index, which increases the risk of harm. Having a low therapeutic index means that the ratio of the maximally tolerable dose of the medicine to the minimal effective dose is low (Habet, 2021). In clinical practice this means that even a minimal increase in the chemotherapy dose, due to for example: drug interactions, weight changes, concomitant clinical conditions or individual variation to eliminate the medication, may cause a significant increase in effect, and potentially result in harm to the patient. For chemotherapy even doses within the recommended range often cause adverse drug reactions. Short-term toxicities such as nausea, vomiting and diarrhea are well-known adverse events related to chemotherapy treatment. For most patients, current procedures to control these are reasonably effective, preventing such side effects from developing into severe adverse events (Nurgali et al., 2018). On the other hand, neutropenia infection is a feared dose-related complication connected with chemotherapy. In the worst cases such a reaction can led to sepsis and septic shock, which is a leading cause of intensive care unit admission and mortality in cancer patients undergoing intensive cytotoxic chemotherapy (Kochanek et al., 2019). Neutropenia is itself an independent risk factor for infection. Cancer patients more often experience adverse events related to healthcare-associated infections than general patients. Chemotherapy, contributing to a reduced immune system, makes cancer patients more vulnerable to severe infections, and contributed to death in 58% of deceased cancer patients in a retrospective study from 2011–2012 (Haukland et al., 2020). The adverse events were mainly lower respiratory infections, and occurred nearly three times more frequently in cancer patients, and were the most common cause of death for cancer patients not receiving anticancer treatment during the last 30 days of life. This high incidence of hospital-acquired infections in cancer patients can be explained by the severity of the illness, age, underlying conditions, and use of immunosuppressive medications such as chemotherapy and steroids. In addition, cancer patients often spend more time being hospitalized, contributing to a susceptibility to infections.

More than 70% of medication-related adverse events contributing to death occur in cancer patients, and most of these adverse events were related to lethal complications after chemotherapy. Patients receiving anticancer treatment during the last 30 days of life had the highest rate of medication-related adverse events, more than twice the rate of cancer patients not receiving such treatments. Anticancer treatment related adverse events contributing to death occurred only in patients who received such treatment during the last 30 days of life (Haukland, 2020). This accentuates the increased risk of severe adverse events when systemic anticancer treatment is given during the last 30 days of life, and should encourage caution when consideration providing systemic cancer treatment to patients near the end of life.

Immunotherapy-Related Adverse Events

New systemic anticancer treatments, such as targeted therapies and immunotherapy are now well-established treatments for many cancer types, and their indication for use is continuously expanding across malignancies and disease situations. The introduction of these new treatments has improved outcomes for many patients with advanced cancer. However, their introduction is also associated with a whole range of new medication-related adverse events. Unlike conventional chemotherapy, immune-checkpoint inhibitors boost the immune system and can lead to a unique constellation of inflammatory toxicities known as immune-related adverse events that are distinctly different from classic chemotherapy-related toxicities. Symptoms occur as inflammation, and can affect every organ system in the body, thus being sometimes challenging to identify. Many of the adverse events caused by targeted therapies are short-lived or reversible when therapy stops, and are often not associated with long-term adverse events (Shahrokni et al., 2016). However, if symptoms are not recognized and treated at an early stage, immune-related adverse events can be life threatening. The rate of severe immune-related adverse events requiring immunosuppression and withdrawal of immunotherapy varies between the different immune-checkpoint inhibitors. For ipililumab (anti-CTLA-4 inhibitor), immune-related adverse events of any grade occur in up to 60% of patients, of which 10–30% are considered serious (defined as grade 3–4) (Martins et al., 2019). In comparison, anti-PD-1 inhibitors, such as nivolumab and pembrolizumab, cause severe immune-related adverse events in approximately 16% of patients (Magee et al., 2020). The combination of these two immune-checkpoint inhibitors (anti-CTLA-4 and anti-PD1) increases the incidence of severe adverse events in more than 50% of patients (Martins et al., 2019; Xing et al., 2019). Another challenge is that unlike chemotherapy-related toxicities, immune-related adverse events are not related to cumulative doses or organ reserve function, and occur more unpredictably during the course of treatment. Most often, adverse events occur during an early stage of treatment, but late-onset immune-related adverse events may also be severe. The fact that the incidence of immune-related adverse events is so high, and the outcome may be so serious and even fatal for some patients, intensifies the need for using personalized surveillance strategies that involve the patients to a greater extent.

Other Medication-Related Adverse Events

Most cancer patients are over 65 years old, and many of them often have other chronic conditions in addition to their cancer diagnosis. This adds complexity to the treatment, and is associated with polypharmacy, use of potentially inappropriate medications, and risk of adverse drug reactions. Systemic anticancer treatment potentially increases the risk of interaction with other medications and can pose a threat of increased or decreased efficacy of the cancer treatment or medication, thus causing an unintended adverse event. Thirty percent of overall cancer patients are at risk of drug-drug interactions related both to systemic anticancer treatment and supportive care treatment (Riechelmann & Girardi, 2016). Medications such as warfarin, antihypertensive medications, corticosteroids, and anticonvulsants especially have the potential for interactions resulting in adverse events (Riechelmann & Girardi, 2016). This emphasizes the importance of medication reconciliation and close collaboration among all stakeholders involved during a course of treatment, especially the patients and their next of kin, who are often the “keepers of the story”.

Narcotic agents such as opioids, sedatives and steroids are other high-risk medications often used as supportive care for many cancer patients. Patients in need of palliative care and near the end of life are also more likely to be vulnerable to medication-related adverse events. A study done in a specialist palliative care service found that 62% of the patients suffered from symptomatic adverse events (Currow et al., 2011). In palliative care the meaning of a medication-related adverse event may be considered in a broader perspective. The main fundamental goal of palliative care is the best possible symptom control with a focus on quality of life, instead of maximum prolongation of life. Not achieving these goals by, for example, omission of the administration of needed palliative medications, such as opioids, to relieve pain may also be considered an adverse event.

Mitigating Adverse Events by Involving Patients and Next of Kin

Personalized Follow-Up

To achieve a personalized follow-up of cancer patients and their next of kin we need to meet their individual needs, and the first step in doing so is to involve them more actively. Empirical evidence demonstrates that clinicians underreport the incidence and severity of symptoms compared to when patients themselves report how they feel (Basch et al., 2006; Lammers et al., 2019; Pakhomov et al., 2008). More importantly, most cancer patients are willing and able to self-report their own symptoms without substantial attrition. This is the case even among cancer patients with end-stage disease and poor performance status (Basch, 2010; Quinten et al., 2011).

“It feels safe to know that my care team monitors how I am doing while at home.” (Quote from a patient)

Patient-Reported Outcomes (PRO) and Outcome Measures (PROM) have shown to better describe patients’ symptoms compared to reporting by health care professionals (Pakhomov et al., 2008). A recent systematic review of 22 studies including PROMs in daily cancer care found that follow-ups by PROMs had a positive effect on survival, symptoms, health-related quality of life and patient satisfaction (Graupner et al., 2021). Studies have demonstrated that electronic PROs (e-PROs) as follow-ups for cancer patients given chemotherapy treatment can reduce acute admissions to hospitals, improve quality of life and prolong overall survival by up to five months compared to standard care follow-ups (Basch et al., 2016; Jordan et al., 2018). Consequently, PROMs are seen as the preferred method and gold standard to gather information from patients in studies and in real life, as they more often give a more convincing picture of patients’ wellbeing and side effects from interventions and treatments (Graupner et al., 2021).

“It is good to sit in peace and quiet and fill in the questions when it suits me. Then it is easier to answer what I really feel.” (Quote from a patient)

If cancer patients report symptoms electronically to a healthcare professional at an early stage, there is a potential to mitigate harm before it becomes severe and results in an adverse event for the patient. As the first hospital in Norway to do so, the cancer department in Nordland Hospital Trust implemented electronic patient-reported outcomes (e-PRO) follow-ups through digital monitoring as the standard of care for all patients receiving immunotherapy from June 2021, by using Kaiku Health (Kaiku Health LTD, 2020). The immunotherapy module in the Kaiku Health program is based upon the National Cancer Institute’s reporting of adverse events in clinical trials of immunotherapy (Iivanainen et al., 2019). This is a web-based program for smartphones, I-pads, and home computers, and by using machine learning algorithms the software screens, grades, and alerts potential harm. Based on received treatment, each patient gets their own personalized follow-up symptom and quality of life questionnaire sent out regularly in the software. If the patients have a high symptom burden at the start of the treatment or if the risk for adverse events is high, for example when combinations of immune-checkpoint inhibitors are given, the symptom questionnaire can be sent out every week to follow the patients closely. If the patient, on the other hand, has no symptoms the questionnaire can be sent out every second, third or even forth week, individualized to meet the specific needs of the patient. If symptoms should appear between the requested reports the patient can always fill in an extra questionnaire, measurement value or quality of life report to alert the care team of changes in his or her condition.

“I simply feel freer, because I can fill out the form and use the app whenever and wherever I want.” (Quote from a patient)

Filled-out questionnaires are submitted to the patient’s care team in the cancer department, and they can see the patient’s status in real time, and directly identify grades of the possible symptoms. This makes it easier to respond immediately to potentially serious immune-related adverse events and prevent further impairment of the patient, as many of the immune-related toxicities can be reversed with early intervention and use of steroids (Martins et al., 2019).

“I was afraid it would be impersonal, but that did not happen. Now I get answers to my worries right away, if not immediately.” (Quote from a patient)

At the same time as the health care professionals are alerted, the patient gets feedback on how their symptoms have evolved over time, how they should react and what they themselves can do at home to relieve the complaints. The feedback given to patients is based on international guidelines and is meant to support them in their everyday lives. Particularly mild symptoms, such as lack of appetite, feeling tired or sleeplessness, can affect quality of life for patients, but these rarely result in severe adverse events. In a busy clinical practice with limited time to talk to the patient, mild symptoms and advice on how to cope with them are often not prioritized. Providing standardized feedback to everyday symptoms encourages empowerment and safety for the patient and their family, and has proved to reduce symptoms such as pain, depression and fatigue and increase the patient’s quality of life (Aapro et al., 2020). Importantly, patients are more active in their own patient journey, with more knowledge about their own symptoms and how to react to them. Figure 2 illustrates how an e-PRO follow-up with Kaiku Health works in clinical practice.

“Like when I got a rash, I got feedback to treat it with a specific ointment. But then I got quite severe itching, and my doctor called me right away after I reported this on the app.” (Quote from a patient)

The use of e-PROs can provide personalized follow-ups of patients and give healthcare professionals the opportunity to mitigate and prevent harm before it results in a severe adverse event. It could also decrease the need for emergency admissions or unplanned visits/phone calls to the outpatient clinic, which can be a burden for the patient, their family and the healthcare system (Aapro et al., 2020; Basch et al., 2016). Knowledge about real-time follow-ups and adverse events can be clinically relevant in order to better inform patients before starting new treatments. Consequently, it may also provide information about when to end potentially harmful and high-cost anticancer treatment, as it gives healthcare personnel the opportunity to monitor and compare symptoms over time. This makes it easier to discover changes in the patient’s clinical condition that might signal changing or ending a systemic anticancer treatment because of toxicities or progressive disease. For some anticancer treatments the clinical effects may occur before the response can be verified radiologically on CT or MRI scans. On radiological images we may, in such cases, see a pseudo-progression before a later response to the treatment with regression of the disease. In such cases the clinician must rely on clinical judgment, and therefore an overview of symptom development or changes in quality of life over a period are invaluable in making the right decision. If the symptom burden and quality of life of the patient have improved, this supports continuing the anticancer treatment, closely monitoring if there is a delayed radiological response.

The Challenging Transitions

Transitions of care occur when a patient moves between facilities, sectors and staff members, for example: a transfer from the emergency room to the cancer unit; from a nursing home to a hospital; from a primary care doctor to a specialist; or from one nurse to another during a shift change. As part of their treatment cancer patients receiving systemic anticancer treatment often have numerous transitions between the outpatient clinic or cancer unit back and forth to their own home. Shifting between so many care providers and being left to yourself at home can create insecurity for patients and their next of kin. Such transitions of care increase the chances of communication errors, which can lead to serious medication harm (Aase et al., 2017; Aase & Waring, 2020).

Essential components in making the transition process safer include: medication reconciliation, structured facilitation and discharge communication, patient and next of kin education, and timely follow-up after discharge. All of these processes are unique to each cancer patient and their family and may change over time, so they need to be actively and consistently involved on all occasions. It is important to recognize that healthcare personnel always have the responsibility to facilitate the transition of care and provide safe care regardless of the service level in the healthcare system.

For post-discharge communication through new technologies, such as smartphones and applications, provide new opportunities to follow the patients closer when at home. A systematic review of studies using various technologies concluded that these technology-based interventions did not compromise safety or patient satisfaction when they measured symptoms, quality of life or psychological distress (Dickinson et al., 2014). The consequences for cancer patients in anticancer treatment can have potentially fatal outcomes in cases of missing responses to changes in the patient’s condition (e.g., sepsis, bleeding). The next of kin’s ability to observe the patient and to respond quickly to changes in their condition is therefore crucial, especially when the patient is between care levels. Next of kins living with the cancer patient are described as quality and safety resources, just as important as professional actors, and thus have a key role in safe transitions across care levels. Nevertheless, proper next of kin involvement is often lacking:

“As a next of kin, you really get little information that is aimed at you on how to help and ease the treatment even if a lot happens at home.” (Quote from a next of kin)

Healthcare service is a public responsibility in the Norwegian welfare state, and the formal expectations for next of kin participation are low. There are, nevertheless, strong indications that healthcare services do depend on support from next of kin to ensure high quality care for the patients (Bergerød & Braut, et al., 2020; Norwegian Ministry of Health and Care Services, 2020a; O’Hara et al., 2019). Healthcare professionals within cancer care in hospitals report that they depend on support from the next of kin to provide care quality and safety in the cancer field in hospitals. The next of kin role is often referred to as a “key piece of the puzzle”, as a resource to cope with tasks they are unable to cope with because of internal (e.g., inadequate staffing, deteriorating patients) or external factors (e.g., culture, demands, economy) (Bergerød & Braut, et al., 2020).

They often help to transport the patient, follow the patient to take blood samples, check the medicine list, and also ensure that the patient takes the medication at the right time, especially if the patient doesn’t want homecare. They inject medication, measure temperature, and contact the hospital if the patient is experiencing fever. They have a huge sense of responsibility to the patient and are resource persons for the patient, us (hospital) and the municipalities. (Quote from a nurse)

Currently no recommendations exist on how to make safe transitions from hospitals to home for cancer patients or their next of kin. However, the Norwegian Directorate of Health is working on a care package process ensuring predictability for patients and their families, both in the specialist health service and in the municipal health and care services (Norwegian Directorate of Health, 2021c). Involvement is therefore crucial to strengthen the goal of creating an alliance between the family of the patient, healthcare services and voluntary organizations (Norwegian Ministry of Health and Care Services, 2020a). Next of kin involvement is more prominent than ever, and in 2021 the Norwegian government launched the first national strategy on next of kin involvement. The strategy is a clear acknowledgement of the next of kin role as a valuable societal and care contributor. The strategy has three overarching goals: 1) to acknowledge the next of kin role as a resource; 2) attention and support so that next of kin can live good lives and combine the role of next of kin with education and work; 3) no child should have to take care of their family or others (Norwegian Ministry of Health and Care Services, 2020b). This strategy strives to have sound next of kin involvement, however there is also a long way to go before we reach these goals. Even if strategies, plans and sound involvement measures are slowly appearing, there is a great potential for translating these into clinical practice with a multi-stakeholder approach (Petkovic et al., 2020).

The development of the next of kin involvement guide for hospitals constitutes a good and promising tool (Figure 4) in terms of multiple stakeholders’ engagement and sound involvement measures (Bergerød & Braut et al. 2021). The guide is built through a collective sharing of the experiences of 20 stakeholders including hospitals, healthcare professionals (nurses/doctors), patients and next of kin representatives, and researchers. The nominal group consensus method utilized in the development of the guide promoted a collaborative learning arena that resulted in mutual consensus. The guide is co-created and provides a requested tool that has the potential to support managers’ and healthcare professionals’ systematic work on next of kin involvement in hospitals. The next of kin involvement guide can be used either as a reflective tool to create a dialogue on how it can be refined to meet the context where involvement takes place, or as a guide with practical examples of relevant next of kin involvement measures (Bergerød & Braut et al. 2021). We argue that even if the guide is developed with the specialist healthcare system in mind, it could be pilot tested for other contexts (Bergerød et al. 2022).

Summary

This chapter has demonstrated that medication safety in cancer care is complex, with a high risk of adverse events related to systemic cancer treatment. It is no surprise that cancer patients experience treatment-related toxicities, since traditional systemic treatment, such as chemotherapy, have a low therapeutic index. This means that even a minimal increase in the chemotherapy dose due to, for example: drug interactions, weight changes, or concomitant clinical conditions, may cause a significant increase in effect and potentially result in an adverse event for the patient. Due to this, adverse events related to systemic anticancer treatment will always occur to some extent, but we argue that, by sound involvement of patients and next of kin throughout the whole cancer care continuum, severe adverse events can be reduced. Essential components in making the systemic anticancer treatment process safer include: medication reconciliation; structured facilitation and discharge communication; and sound patient and next of kin involvement focusing on individual education and timely follow-ups in the challenging transitions. The goal of measuring adverse events is to provide real-time feedback to healthcare professionals, and thereby offer hospitals state-of-the-art quality improvement and learning opportunities to prevent such events from happening. New technology and innovations create new opportunities to engage the patient more actively in their own treatment and follow them more closely when they are at home. Personalized patient follow-ups using e-PROs give healthcare personnel a better opportunity to observe patients during treatment even when they are at home, and facilitates proactive interventions so severe adverse events can be mitigated. It also improves symptoms and quality of life, empowers patients in everyday living, and provides safety for patients and their next of kin. Next of kin play an essential role within the cancer field as collaborative partners in quality and safety efforts, and should be acknowledged as equal and natural partners in the same way as patients. The development of the next of kin involvement guide for hospitals provides a promising tool in terms of multiple stakeholders’ engagement and sound involvement measures relevant for healthcare professionals and mangers throughout the health­care system.

References

• Aapro, M., Bossi, P., Dasari, A., Fallowfield, L., Gascón, P., Geller, M., Jordan, K., Kim, J., Martin, K., & Porzig, S. (2020). Digital health for optimal supportive care in oncology: Benefits, limits, and future perspectives. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 28(10), 4589–4612. https://doi.org/10.1007/S00520-020-05539-1
• Aase, K., Schibevaag, L., & Waring, J. (2017). Researching quality in care transitions: International perspectives. Researching Quality in Care Transitions: International Perspectives, 1–301. https://doi.org/10.1007/978-3-319-62346-7
• Aase, K., & Waring, J. (2020). Crossing boundaries: Establishing a framework for researching quality and safety in care transitions. Applied Ergonomics, 89. https://doi.org/10.1016/J.APERGO.2020.103228
• Barlow, A., Prusak, E. S., Barlow, B., & Nightingale, G. (2021). Interventions to reduce polypharmacy and optimize medication use in older adults with cancer. Journal of Geriatric Oncology, 12(6), 863–871. https://doi.org/10.1016/J.JGO.2020.12.007
• Basch, E. (2010). The missing voice of patients in drug-safety reporting. New England Journal of Medicine, 362(10), 865–869. https://doi.org/10.1056/NEJMp0911494
• Basch, E., Deal, A. M., Kris, M. G., Scher, H. I., Hudis, C. A., Sabbatini, P., Rogak, L., Bennett, A. v, Dueck, A. C., Atkinson, T. M., Chou, J. F., Dulko, D., Sit, L., Barz, A., Novotny, P., Fruscione, M., Sloan, J. A., & Schrag, D. (2016). Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 34(6), 557–565. https://doi.org/10.1200/JCO.2015.63.0830
• Basch, E., Iasonos, A., Mcdonough, T. A., Barz, A., Culkin, A., Kris, M. G., Scher, H. I., & Schrag, D. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncology, 7, 903–909. https://doi.org/10.1016/S1470-2045(06)70910-X
• Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Dueck, A. C., Mendoza, T. R., Hay, J., Atkinson, T. M., Abernethy, A. P., Bruner, D. W., Cleeland, C. S., Sloan, J. A., Chilukuri, R., Baumgartner, P., Denicoff, A., st. Germain, D., O’Mara, A. M., Chen, A., Schrag, D. (2014). Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). In Journal of the National Cancer Institute (Vol. 106, Issue 9). Oxford University Press. https://doi.org/10.1093/jnci/dju244
• Bergerød, I. J. (2021). Quality and safety in hospital cancer care: A mixed methods study of next of kin involvement. [Doctoral dissertation, University of Stavanger, Norway]. Brage, UIS. https://uis.brage.unit.no/uis-xmlui/handle/11250/2753635
• Bergerød, I. J., Braut, G. S., & Wiig, S. (2020). Resilience from a stakeholder perspective: The role of next of kin in cancer care. Journal of Patient Safety, 16(3), E205–E210. https://doi.org/10.1097/PTS.0000000000000532
• Bergerød, I. J., Dalen, I., Braut, G. S., Gilje, B., & Wiig, S. (2020). Measuring next of kin satisfaction with hospital cancer care: Using a mixed-method approach as basis for improving quality and safety. Journal of Advanced Nursing, 76(5), 1232–1246. https://doi.org/10.1111/jan.14315
• Bergerød IJ, Braut GS, Fagerdal B, Gilje B, Wiig S. (2021). Developing a next-of-kin involvement guide in cancer care: Results from a consensus process. Cancer Nursing, Nov-Dec 01, 44(6):E447-E457. https://doi.org/10.1097/NCC.0000000000000869
• Bergerød, I. J., Clay-Williams, R., Wiig S. (2022, January 21). Developing methods to support collaborative learning and co-creation of resilience in healthcare: Tips for success and lessons learnt from a Norwegian hospital cancer care study. Journal of Patient Safety. https://doi.org/10.1097/PTS.0000000000000958
• Cancer Registry of Norway. Cancer in Norway 2019. (2020). https://www.kreftregisteret.no/en/General/Publications/Cancer-in-Norway/cancer-in-norway-2019/
• Currow, D. C., Agar, M. R., To, T. H. M., Rowett, D., Greene, A., & Abernethy, A. P. (2011). Adverse events in hospice and palliative care: A pilot study to determine feasibility of collection and baseline rates. Journal of Palliative Medicine, 14(3), 309–314. https://doi.org/10.1089/jpm.2010.0392
• Dickinson, R., Hall, S., Sinclair, J. E., Bond, C., & Murchie, P. (2014). Using technology to deliver cancer follow-up: A systematic review. BMC Cancer, 14(1), 311. https://doi.org/10.1186/1471-2407-14-311
• Dueck, A. C., Mendoza, T. R., Mitchell, S. A., Reeve, B. B., Castro, K. M., Rogak, L. J., Atkinson, T. M., Bennett, A. v, Denicoff, A. M., O’Mara, A. M., Li, Y., Clauser, S. B., Bryant, D. M., Bearden, J. D., Gillis, T. A., Harness, J. K., Siegel, R. D., Paul, D. B., Cleeland, C. S., Basch, E. (2015). Validity and reliability of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncology, 1(8), 1051–1059. https://doi.org/10.1001/jamaoncol.2015.2639
• Graupner, C., Kimman, M. L., Mul, S., Slok, A. H. M., Claessens, D., Kleijnen, J., Dirksen, C. D., & Breukink, S. O. (2021). Patient outcomes, patient experiences and process indicators associated with the routine use of patient-reported outcome measures (PROMs) in cancer care: A systematic review. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 29(2), 573–593. https://doi.org/10.1007/S00520-020-05695-4
• Habet, S. (2021). Narrow therapeutic index drugs: Clinical pharmacology perspective. Journal of Pharmacy and Pharmacology, 73(10), 1285–1291. https://doi.org/10.1093/JPP/RGAB102
• Hannisdal, E., Arianson, H., Braut, G. S., Schlichting, E., & Vinnem, J. E. (2013). A risk analysis of cancer care in Norway: The top 16 patient safety hazards. Joint Commission Journal on Quality and Patient Safety/Joint Commission Resources, 39(11), 511–516. https://doi.org/10.1016/S1553-7250(13)39067-9
• Haukland, E. C. (2020). Adverse events as a measure of patient safety in cancer care: A study of patient safety in cancer patients using the Global Trigger Tool review method to identify adverse events. [Doctoral dissertation, The Arctic University of Norway]. UiT Munin. https://hdl.handle.net/10037/18677
• Haukland, E. C., von Plessen, C., Nieder, C., & Vonen, B. (2017). Adverse events in hospitalised cancer patients: A comparison to a general hospital population. Acta Oncologica, 56(9), 1218–1223. https://doi.org/10.1080/0284186X.2017.1309063
• Haukland, E. C., von Plessen, C., Nieder, C., & Vonen, B. (2020). Adverse events in deceased hospitalised cancer patients as a measure of quality and safety in end-of-life cancer care. BMC Palliative Care, 19(1), 76. https://doi.org/10.1186/s12904-020-00579-0
• Herledan, C., Baudouin, A., Larbre, V., Gahbiche, A., Dufay, E., Alquier, I., Ranchon, F., & Rioufol, C. (2020). Clinical and economic impact of medication reconciliation in cancer patients: A systematic review. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 28(8), 3557–3569. https://doi.org/10.1007/S00520-020-05400-5
• Iivanainen, S., Alanko, T., Vihinen, P., Konkola, T., Ekstrom, J., Virtanen, H., & Koivunen, J. (2020). Follow-up of cancer patients receiving anti-PD-(L)1 therapy using an electronic patient-reported outcomes tool (KISS): Prospective feasibility cohort study. JMIR Formative Research, 4(10), e17898. https://doi.org/10.2196/17898
• Jha A, Pronovost P. (2016). Toward a safer health care system: The critical need to improve measurement. JAMA, 315(17), 1831–1832. https://doi.org.10.1001/jama.2016.3448
• Jordan, K., Aapro, M., Kaasa, S., Ripamonti, C. I., Scotté, F., Strasser, F., Young, A., Bruera, E., Herrstedt, J., Keefe, D., Laird, B., Walsh, D., Douillard, J. Y., & Cervantes, A. (2018). European Society for Medical Oncology (ESMO): Position paper on supportive and palliative care. Annals of Oncology, 29(1), 36–43. https://doi.org/10.1093/annonc/mdx757
• Kaiku Health LTD. (2020). Personalised digital health interventions for cancer patients. [Medical device]. https://kaikuhealth.com/
• Kochanek, M., Schalk, E., von Bergwelt-Baildon, M., Beutel, G., Buchheidt, D., Hentrich, M., Henze, L., Kiehl, M., Liebregts, T., von Lilienfeld-Toal, M., Classen, A., Mellinghoff, S., Penack, O., Piepel, C., & Böll, B. (2019). Management of sepsis in neutropenic cancer patients: 2018 guidelines from the Infectious Diseases Working Party (AGIHO) and Intensive Care Working Party (iCHOP) of the German Society of Hematology and Medical Oncology (DGHO). Annals of Hematology, 98(5), 1051–1069. https://doi.org/10.1007/s00277-019-03622-0
• Lambert, S. D., Ould Brahim, L., Morrison, M., Girgis, A., Yaffe, M., Belzile, E., Clayberg, K., Robinson, J., Thorne, S., Bottorff, J. L., Duggleby, W., Campbell-Enns, H., Kim, Y., & Loiselle, C. G. (2019). Priorities for caregiver research in cancer care: An international Delphi survey of caregivers, clinicians, managers, and researchers. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 27(3), 805–817. https://doi.org/10.1007/S00520-018-4314-Y
• Lammers, A., Slatore, C. G., Fromme, E. K., Vranas, K. C., & Sullivan, D. R. (2019). Association of early palliative care with chemotherapy intensity in patients with advanced stage lung cancer: A national cohort study. Journal of Thoracic Oncology, 14(2), 176–183. https://doi.org/10.1016/j.jtho.2018.09.029
• Lipczak, H., Knudsen, J. L., & Nissen, A. (2011). Safety hazards in cancer care: Findings using three different methods. BMJ Quality & Safety, 20(12), 1052–1056. https://doi.org/10.1136/bmjqs.2010.050856
• Magee, D. E., Hird, A. E., Klaassen, Z., Sridhar, S. S., Nam, R. K., Wallis, C. J. D., & Kulkarni, G. S. (2020). Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: A systematic review and meta-analysis of randomized clinical trials. Annals of Oncology, 31(1), 50–60. https://doi.org/10.1016/j.annonc.2019.10.008
• Martins, F., Sofiya, L., Sykiotis, G. P., Lamine, F., Maillard, M., Fraga, M., Shabafrouz, K., Ribi, C., Cairoli, A., Guex-Crosier, Y., Kuntzer, T., Michielin, O., Peters, S., Coukos, G., Spertini, F., Thompson, J. A., & Obeid, M. (2019). Adverse effects of immune-checkpoint inhibitors: Epidemiology, management and surveillance. Nature Reviews Clinical Oncology, 16(9), 563–580. https://doi.org/10.1038/s41571-019-0218-0
• Moghli, M. A., Farha, R. A., & Hammour, K. A. (2021). Medication discrepancies in hospitalized cancer patients: Do we need medication reconciliation? Journal of Oncology Pharmacy Practice: Official Publication of the International Society of Oncology Pharmacy Practitioners, 27(5), 1139–1146. https://doi.org/10.1177/1078155220946388
• National Cancer Institute (2017). Common terminology criteria for adverse events (CTCAE) v5.0. https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm
• Nayak, M. G., & George, A. (2021). Effectiveness of multicomponent intervention on quality of life of family caregivers of cancer patients. Asian Pacific Journal of Cancer Prevention: APJCP, 22(9), 2789–2795. https://doi.org/10.31557/APJCP.2021.22.9.2789
• Norwegian Ministry of Health and Care Services (2017–2018). Meld. St. 15. A full life – all your life. A quality reform for older persons. [White paper]. https://www.regjeringen.no/en/dokumenter/meld.-st.-15-20172018/id2599850/
• Norwegian Ministry of Health and Care Services. (2020a). Care plan 2020. The Norwegian government`s plan for care services field for 2015–2020. https://www.regjeringen.no/contentassets/af2a24858c8340edaf78a77e2fbe9cb7/careplan2020_eng.pdf
• Norwegian Ministry of Health and Care Services. (2020b). Vi – de pårørende. Regjeringens pårørendestrategi og handlingsplan. [Us – The next of kin. The Government’s strategy and action plan.] https://www.regjeringen.no/contentassets/08948819b8244ec893d90a66deb1aa4a/vi-de-parorende.pdf
• Nurgali, K., Jagoe, R. T., & Abalo, R. (2018). Adverse effects of cancer chemotherapy: Anything new to improve tolerance and reduce sequelae? [Editorial]. Frontiers in Pharmacology, 9, 245. https://doi.org/10.3389/fphar.2018.00245
• O’Hara, J. K., Aase, K., & Waring, J. (2019). Scaffolding our systems? Patients and families “reaching in” as a source of healthcare resilience. BMJ Quality & Safety, 28(1), 3–6. https://doi.org/10.1136/BMJQS-2018-008216
• Pakhomov, S. V, Jacobsen, S. J., Chute, C. G., & Roger, V. L. (2008). Agreement between patient-reported symptoms and their documentation in the medical record. The American Journal of Managed Care, 14(8), 530–539. http://www.ncbi.nlm.nih.gov/pubmed/18690769
• Petkovic, J., Riddle, A., Akl, E. A., Khabsa, J., Lytvyn, L., Atwere, P., Campbell, P., Chalkidou, K., Chang, S. M., Crowe, S., Dans, L., Jardali, F. el, Ghersi, D., Graham, I. D., Grant, S., Greer-Smith, R., Guise, J. M., Hazlewood, G., Jull, J., Tugwell, P. (2020). Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation. Systematic Reviews, 9(1). https://doi.org/10.1186/S13643-020-1272-5
• Quinten, C., Maringwa, J., Gotay, C. C., Martinelli, F., Coens, C., Reeve, B. B., Flechtner, H., Greimel, E., King, M., Osoba, D., Cleeland, C., Ringash, J., Schmucker-Von Koch, J., Taphoorn, M. J. B., Weis, J., & Bottomley, A. (2011). Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. Journal of the National Cancer Institute, 103(24), 1851–1858. https://doi.org/10.1093/jnci/djr485
• Riechelmann, R., & Girardi, D. (2016). Drug interactions in cancer patients: A hidden risk? Journal of Research in Pharmacy Practice, 5(2), 77. https://doi.org/10.4103/2279-042x.179560
• Saunes, S., Karanikolos, I., & Sagan, A. (2020). Norway: Health system review. World Health Organization. Regional Office for Europe, European Observatory on Health Systems and Policies. https://apps.who.int/iris/handle/10665/331786
• Schwappach, D. L. B., & Wernli, M. (2010). Medication errors in chemotherapy: Incidence, types and involvement of patients in prevention. A review of the literature. European Journal of Cancer Care, 19(3), 285–292. https://doi.org/10.1111/j.1365-2354.2009.01127.x
• Shahrokni, A., Wu, A. J., Carter, J., & Lichtman, S. M. (2016). Long-term toxicity of cancer treatment in older patients. Clinics in Geriatric Medicine, 32(1), 63–80. https://doi.org/10.1016/j.cger.2015.08.005
• Smeby, S. S., Johnsen, R., & Marhaug, G. (2015). Documentation and disclosure of adverse events that led to compensated patient injury in a Norwegian university hospital. International Journal for Quality in Health Care: Journal of the International Society for Quality in Health Care, 27(6), 486–491. https://doi.org/10.1093/INTQHC/MZV084
• Shojania K. G., Thomas E. J. (2013). Trends in adverse events over time: Why are we not improving? BMJ Quality & Safety 22, 273–277. http://dx.doi.org/10.1136/bmjqs-2013-001935
• Stenberg, U., Cvancarova, M., Ekstedt, M., Olsson, M., & Ruland, C. (2014). Family caregivers of cancer patients: Perceived burden and symptoms during the early phases of cancer treatment. Social Work in Health Care, 53(3), 289–309. https://doi.org/10.1080/00981389.2013.873518
• Stolz-Baskett, P., Taylor, C., Glaus, A., & Ream, E. (2021). Supporting older adults with chemotherapy treatment: A mixed methods exploration of cancer caregivers’ experiences and outcomes. European Journal of Oncology Nursing: The Official Journal of European Oncology Nursing Society, 50. https://doi.org/10.1016/J.EJON.2020.101877
• The Norwegian Directorate of Health. (2021a). I trygge hender. [In safe hands]. https://www.itryggehender24-7.no/om-i-trygge-hender-24-7/english
• The Norwegian Directorate of Health. (2021b). Pasientskader i Norge 2020: Målt med Global Trigger Tool. [Patient injuries in Norway 2020: Measured with the Global Trigger Tool] Report. https://www.helsedirektoratet.no/rapporter/pasientskader-i-norge-2020-malt-med-global-trigger-tool/
• The Norwegian Directorate of Health. (2021c). Pakkeforløp hjem for kreftpasienter [Care pathway home for cancer patients]. [National recommendations]. https://www.helsedirektoratet.no/pakkeforlop/hjem-for-pasienter-med-kreft
• The Norwegian System of Patient Injury Compensation. (2020). Undersøkelse av samsvar mellom NPE-saker og saker i sykehusenes meldesystemer. [Investigation of correlation between NPE cases and cases in hospital reporting systems]. [Report]. https://www.npe.no/en/Health-care-provider/pasientsikkerhet/rapporter/undersokelse-av-samsvar-mellom-npe-saker-og-saker-i-sykehusenes-meldesystemer/
• Ugalde, A., Gaskin, C. J., Rankin, N. M., Schofield, P., Boltong, A., Aranda, S., Chambers, S., Krishnasamy, M., & Livingston, P. M. (2019). A systematic review of cancer caregiver interventions: Appraising the potential for implementation of evidence into practice. Psycho-Oncology, 28(4), 687–701. https://doi.org/10.1002/PON.5018
• Vincent, C. (2010). Patient safety. (2nd Ed.) https://doi.org/10.1002/9781444323856
• Weingart, S. N., Zhang, L., Sweeney, M., & Hassett, M. (2018). Chemotherapy medication errors. The Lancet Oncology, 19(4), e191–e199. https://doi.org/10.1016/S1470-2045(18)30094-9
• Whittemore, R., Chao, A., Jang, M., Minges, K. E., & Park, C. (2014). Methods for knowledge synthesis: An overview. Heart & Lung: The Journal of Critical Care, 43(5), 453–461. https://doi.org/10.1016/j.hrtlng.2014.05.014
• Wiig, S., Rutz, S., Boyd, A., Churruca, K., Kleefstra, S., Haraldseid-Driftland, C., Braithwaite, J., O’Hara, J., & van de Bovenkamp, H. (2020). What methods are used to promote patient and family involvement in healthcare regulation? A multiple case study across four countries. BMC Health Services Research, 20(1). https://doi.org/10.1186/S12913-020-05471-4
• World Health Organization. (2005). World alliance for patient safety: WHO draft guidelines for adverse event reporting and learning systems: From information to action. https://apps.who.int/iris/handle/10665/69797
• World Health Organization. (2019a). Medication safety in high-risk situations. https://www.who.int/publications/i/item/WHO-UHC-SDS-2019.10
• World Health Organization. (2019b). Patient safety fact file. Patient safety and risk management service delivery and safety. https://www.who.int/news-room/fact-sheets/detail/patient-safety
• Xing, P., Zhang, F., Wang, G., Xu, Y., Li, C., Wang, S., Guo, Y., Cai, S., Wang, Y., & Li, J. (2019). Incidence rates of immune-related adverse events and their correlation with response in advanced solid tumours treated with NIVO or NIVO+IPI: A systematic review and meta-analysis. Journal for Immunotherapy of Cancer, 7(1). https://doi.org/10.1186/s40425-019-0779-6

Background

In Norway, national health reforms in the last two decades focus on quality improvements, coordination, continuity in care, and decentralization of services (Ministry of Health and Care Services, 2006, 2009, 2013, 2018). These national health reforms within healthcare services highlight health-promotion efforts, expecting the elderly to live longer in their own homes and, if needed, to receive home care services. Norwegian municipalities are obliged to provide health and care services for older adults, where institutional care, home care, and general practitioners are defined as core services (Skinner, Veenstra et al., 2020). Home care services typically consist of help for activities of daily living (ADL), for example, personal hygiene and meals, or medication administration (Ministry of Health and Care Services, 2011). In total, almost 200,000 persons receive home care services in Norway (Statistics Norway, 2021). Out of these, 110,000 persons are 67 years or older. Further, 28.9% of the population 80 years and older receive home care services (Statistics Norway, 2021).

In general, elderly persons are multimorbid, consequently causing a complex polypharmacy situation. Moreover, medication-related events occur most frequently among the elderly (Olsen & Andreassen, 2016; Romskaug & Bakken, 2020). These events will typically appear as an increased risk of adverse effects from treatment, always considering the balance between benefit and harm. Given the situation and frailty of the elderly person, this demands a thorough clinical assessment in which the patient’s preferences must be emphasized. This is crucial to ensure elderly patients safe and reasonable medication prescriptions (Romskaug & Bakken, 2020). Moreover, event is the preferred term according to the International Classification for Patient Safety (ICPS) conceptual framework, meaning “something that happens to or involves a patient” (WHO, 2009), and we have chosen to use this term in our study.

However, the particular characteristics of elderly patients is not the only factor associated with medication-related problems. How the healthcare services are organized is also of importance, since collaboration between different healthcare services and professionals has an impact and can affect the quality of outcomes (Skinner, Veenstra et al., 2020). Recent research has revealed a situation, as a result of the national healthcare reforms, where the decentralization of tasks from specialist health services¹ to the municipality and primary care service has led to a greater need for information exchange and collaboration between different healthcare providers within municipal health service organizations (Gautun & Syse, 2017; Skinner, Veenstra et al., 2020). To preserve the older person’s need for continuity of care, better collaboration between nurses and general practitioners (GP) is needed (Skinner, Veenstra et al., 2020). Moreover, features of the municipality, such as number of inhabitants, socioeconomic factors, and limited resources in the healthcare sector, may also affect the situation (Gautun & Syse, 2017; Skinner, Veenstra et al., 2020).

Of special interest is the use of psychotropic medication among elderly people receiving home care services, and especially whether the patients are informed about what medications they are prescribed. Lack of information about what drugs they are prescribed and why, may influence their compliance. Psychotropic drugs are antipsychotics, antidepressants, anxiolytics, sedatives, and anti-dementia drugs (Lornstad et al., 2019). Side and adverse effects like sedation, weakened muscle tone, hypotension, and orthostatism from these types of medications are of particular concern to the elderly, because they can lead to falls and trigger delirium (Romskaug & Bakken, 2020). Beyond individual consequences, adverse drug reactions are also a source of economic burdens for the healthcare systems through increased hospitalization, prolongation of hospital stay, and additional clinical investigations in more serious cases (Sultana et al., 2013). A review study reveals that approximately 10–20% of geriatric hospital admissions are drug-related, moreover 32–65% of adverse drug reactions occur in nursing homes (Sultana et al., 2013). Unfortunately, there is a lack of similar statistics and registers for Norwegian municipal healthcare services (Odberg, 2020).

We know that the prescription of psychotropic medication among elderly people is high. In a group of 1,001 people aged 70 years or more, 40.3% used psychotropic drugs, and the prescription of psychotropic drugs was higher in those admitted to a nursing home than in those living at home (Lornstad et al., 2019). Additionally, the combined use of alcohol and medication among the elderly has been given attention, showing both a potentially serious alcohol-medication interaction when using central nervous system agents (Holton et al., 2020), and inadequate knowledge about these interactions. The first causes potentially harmful orthostatism and sedation, and the latter indicates a need for information to older adults about prescription drug safety via a variety of formats (Zanjani et al., 2013).

In summary, the high prevalence of multimorbidity and polypharmacy in the elderly population, psychotropic medications’ risk of adverse effects, and the possible lack of information about what medication patients are taking, are all of concern. The aims of the study underlying this chapter were to describe the use of psychotropic drugs in a group of older persons receiving home care service, and to study the relationship between which psychotropic drugs the patients were prescribed, and which medications they were told they were prescribed.

Method

Results

Demographic and clinical data are presented in table 1. For the whole cohort, the mean age was 80.7 (SD 8.8) years, 67.3% were women, and 74.0% had fair or poor physical health according to the General Medical Health Rating scale (GMHR).

Table 1. Demographic and Clinical Variables for the Whole Cohort, and for the Groups of Participants “Informed About Their Medication” and “Not Informed About Their Medication”

SD = standard deviation, GMHR = General Medical Heath Rating scale.

Table 2 describes the proportion of participants informed about what medication they were prescribed, and the proportion of participants prescribed different classes of medication. Twenty-three participants (11.1%) were prescribed anxiolytics, 63 participants (30.3%) were prescribed hypnotics/sedatives, and 63 participants (30.3%) were prescribed analgesics.

Table 2. Reported and Prescribed Medication Use in the Sample

Tables 3, 4, and 5 present the relationship between the proportions of participants prescribed anxiolytics, sedatives, and analgesics, respectively, and the proportion of participants confirming use of the same classes of drugs (answering “yes” to the questions about use of drugs).

Table 3. Cross-Table for Prescribed and Reported Use of Anxiolytics

Chi-square test for categorial data.

Of the 23 participants prescribed anxiolytics (Table 3), four participants (17.4%) answered “no” to the question, “Do you use drugs for agitation or anxiety?”, while of the 183 participants not prescribed anxiolytics, 34 participants (18.6%) answer “yes” to the question, “Do you use drugs for agitation or anxiety?” (p<0.001).

Of the 63 participants prescribed sedatives (Table 4), zero participants answered “no” to the question, “Do you use sleeping pills?”, while of the 145 participants not prescribed sedatives, 40 participants (27.6%) answered “yes” to the question, “Do you use sleeping pills?” (p<0.001).

Table 4. Cross-Table for Prescribed and Reported Use of Sedatives

Chi-square test for categorial data.

Of the 63 participants prescribed analgesics (Table 5), three participants (4.8%) answered “no” to the question, “Do you use painkillers?”, while of the 145 participants not prescribed analgesics, 92 participants (63.4%) answered “yes” to the question, “Do you use painkillers?” (p<0.001).

Table 5. Cross-Table for Prescribed and Reported Use of Analgesics

Chi-square test for categorial data.

In a logistic regression (Table 6) where “informed about the medication prescribed” was the dependent variable, females had higher odds (OR = 2.35) for being in the group of participants not informed about their medication, and participants with higher scores on the MoCA (better cognitive function) had higher odds (OR = 1.05) for being in the group of participants not informed about their medication.

Table 6. Logistic Regression with Informed About Medication as Dependent Variable, and Sex, Age, Years of Education, Marital Status, Physical Health, Cognition, Anxiety Symptoms, and Depressive Symptoms as Independent Variables

B = unstandardized regression weight, SE = standard error, GMHR = General Medical Health Rating scale, MoCA = Montreal Cognitive Assessment scale, RAID = Rating Anxiety in Depression, GDS = Geriatric Depression scale.

The main findings in our study show that most of the participants prescribed sedatives or analgesics were informed about their prescription, and for which condition the medications were prescribed, while 17.4% of participants prescribed anxiolytics were not informed about the reason for the prescription.

Discussion

The fact that almost one out of five patients prescribed anxiolytics are not aware that they were prescribed medication usually used for agitation and anxiety is of concern, particularly since there are few other indications for the use of it. If you use anxiolytics, and are not aware of it, this may be because of lack of information from the GP and the health care staff, misunderstanding between the GP and the patients due to wording and use of phrases not familiar to the patients, and/or the stigma of psychiatric diseases. Some participants in our study had cognitive decline (mean MoCA score 21.5, SD 6.6), and it is reasonable to believe that some of them may have had home care service to help them remember to take their prescribed medications. Therefore, asking them questions about what medication they are prescribed may give unreliable answers. This may explain some of the discrepancy between the information about one’s own medication through asking the participants, and the information from medical records about their prescriptions. Our results indicate that information to the patients about what medications they are prescribed and why, must be repeated. The GPs and healthcare staff must also use common everyday language that the patients understand, and make sure that the information is understood, as pinpointed by authors referred to in this chapter (Olsen & Andreassen, 2016; Romskaug & Bakken, 2020).

As highlighted by the WHO in their safety action plan for 2021–2030, good quality care should include patient and family engagement, for example, information to and education of patients and families. Moreover, this insures patient safety in clinical processes in primary care and transition of care (WHO, 2021, pp. 13–14). The use of informal care is high in Norwegian municipalities (Skinner, Lorentzen et al., 2020), and education and information relating to prescribed medication must be shared with relatives of patients. This is even more important when the patient has a cognitive impairment. A high proportion (80%) of the participants were either unmarried, widow/widower, or divorced, indicating that they lived alone. However, we do not know this for sure since we did not ask them if they lived alone. In any case, it is highly relevant and important to involve and empower patients and families in relation to prescribed medications since the consequences for all parties are multiple and severe (Romskaug & Bakken, 2020). In addition, where and how information about the patient’s medications and prescriptions are stored (i.e., a list of medicines) is important. Is this information only available on a digital medium (e.g., Helse Norge²), and/or is it available as a written version in the patient’s home? However, since the participants in this study received home care services, the information is stored primarily where the medication is administered. Depending on the locale, the possibility for the health personnel to show and/or remind the patient/the relatives/informal caregivers, or for the parties themselves to obtain this information, is more or less good. This is also an important issue when there are changes to be made in the medication, and a need for medication reconciliation, which is a featured goal for patient safety work in Norway (National Directorate of Health, 2022).

Among the participants not prescribed anxiolytics, sedatives, or analgesics, a high proportion answered “yes” to the questions on whether they used these kinds of medication or not. This can be explained by the fact that we included only medication in the ATC group N05B (anxiolytics), N05C (hypnotics/sedatives), and N02 + M01A (analgesics) in our study, and participants may have been prescribed other medication groups for their anxiety, insomnia, or pain, such as antiepileptics, antihistamines, or antidepressants. Moreover, analgesics are available in stores without a prescription. The latter fact may also contribute to the understanding of why females had higher odds (OR = 2.35) for being in the group of participants not informed about their medications, since 72 out of 93 answers of “not informed about analgesics” came from females.

But it could also be the other way around. Some psychotropic drugs that are usually prescribed for anxiety, insomnia, and/or pain may have other indications. Participants answering “no” to questions about the conditions for which they were prescribed medication, may have been correct. In our opinion, our results, showing that participants that were prescribed medication but answered “no” to questions about taking medication for these conditions, are more reliable than the results showing that participants not prescribed medications but answered “yes” about taking medication for these conditions.

Also mentioned earlier, stigma may be a reason for answering “no” to the question, “Do you use drugs for agitation or anxiety?”. Persons with mental illness experience stigma from both inside and outside the health services (Hoel, 2020). Stigma is a barrier to recovery, and stigma is described to be a larger problem for the person with mental illness than the disorder itself (Hoel, 2020). The answer “no” to the questions in our study, may indicate a denial of one’s own problems or a fear of being stigmatized. The solution to stigma like this would be more openness. Consequently, contributing to more openness surrounding mental health issues is an important patient safety task and a follow-up for health personnel. If they recognize or suspect this to be a problem for their patients, they must manage it in a responsible and professional way. What the right solution is must rely on individual considerations based on the patient’s needs and condition. Whether the next of kin and/or informal caregiver should be included, is also an individual consideration.

We find it counterintuitive that participants with better cognitive function had higher odds for being in the group of participants not informed about their medications. We expected that participants with cognitive decline would have more trouble remembering what medications they were prescribed. But one possible explanation may be that participants with cognitive decline, because of their cognitive decline had been better informed about the medication they were prescribed.

A key point in this study is not mainly the fear of adverse effects from medication, but that events in administering the medication might lead to adverse effects. Considering persons who might live alone, suffering from cognitive decline in addition to limited knowledge about their own medication, this is not an optimal situation. Hence, more research is needed to map out this complex situation.

An interesting issue is that we can recognize WHO’s definition of patient safety as less strict than the one used in Norway. Where WHO refers to “lower risk, reduce the occurrence of avoidable harm, etc.” (WHO, 2021), the Norwegian definition specifies “without harm, for every patient and user, always and everywhere” (National Directorate of Health, 2022). This might be a theoretical issue, but worth noting. What are we aiming for in this important work?

Our study has some limitations and some strengths. One limitation is that all participants were recruited from the same municipality, and more than 50% of the invited eligible participants were excluded from the study. This may challenge the generalization of the results. One other limitation is the complexity of indications for medication prescriptions and diseases for which one medication may be prescribed. This has been elaborated earlier in the discussion. We are also aware that persons suffering from psychiatric problems and diseases still experience stigma related to their situation (Gulslett et al., 2014). This might have prevented our participants from sharing information about their own situation, including what medications they were prescribed, affecting our results.

One strength of the study is that all persons receiving home care service in the included municipality were invited to the study. On the other hand, they were invited to a study with the aim of describing psychiatric symptoms, prescribed medication, and the use of alcohol and illegal drugs. Therefore, persons in the municipality may have declined to take part in the study due to stigma. Another strength of the study was that information about the prescribed medications was collected from the participants’ medical records, which is a reliable source of information. We also used internationally recognized assessment tools to collect information about clinical variables, and the two study nurses had received a two-day training period before the data collection, which should result in reliable data for the study.

Closing Reflections

A high proportion of persons receiving home care service are prescribed psychotropic drugs. Although most of them are aware of what medications they are prescribed, our study shows that a significant proportion of persons receiving home care service are not fully aware of the medications they are prescribed. This is a concern regarding patient safety, and it shows that health care personnel should inform their patients more thoroughly, and moreover, repeat information about the medications prescribed. Better knowledge about prescribed medications, will help patients better understand their own diseases and make informed decisions about their own health.

References

• Bergh, S., Michaelsen, E., Andfossen, N. B., Lichtwarck, B., Selbæk, G., & Kirkevold, Ø. (2021). Use of alcohol and pharmacological agents in elderly patients receiving home care service in Norway, and association with psychiatric symptoms and cognition. [Bruk av alkohol og vanedannende legemidler hos eldre norske hjemmetjenestemottakere. Sammenheng med psykiske lidelser og kognisjon]. Tidsskrift for Omsorgsforskning, 7(3).
• Gautun, H., & Syse, A. (2017). Earlier hospital discharge: A challenge for Norwegian municipalities. Nordic Journal of Social Research, 8. https://doi.org/10.7577/njsr.2204
• Gulslett, M. K., Kim, H. S., & Borg, M. (2014). Service users’ experiences of the impact of mental health crises on social identity and social relations. Scandinavian Psychologist 1(2). https://doi.org/10.15714/scandpsychol.1.e2
• Hoel, T. L. (2020). Stigma fører til diskriminering. [Stigma leads to discrimination]. https://erfaringskompetanse.no/nyheter/stigma-forer-til-diskriminering/
• Holton, A. E., Keeney, C., Ryan, B., & Cousins, G. (2020). Prevalence of potentially serious alcohol–medication interactions in older adults in a community pharmacy setting: A cross-sectional study. BMJ Open, 10(8). https://doi.org/10.1136/bmjopen-2019-035212
• Lornstad, M. T., Aarøen, M., Bergh, S., Benth, J. Š., & Helvik, A.-S. (2019). Prevalence and persistent use of psychotropic drugs in older adults receiving domiciliary care at baseline. BMC Geriatrics, 19(1), 119. https://doi.org/10.1186/s12877-019-1126-y
• Lyketsos, C. G., Galik, E., Steele, C., Steinberg, M., Rosenblatt, A., Warren, A., Sheppard, J.-M., Baker, A., & Brandt, J. (1999). The general medical health rating: A bedside global rating of medical comorbidity in patients with dementia. Journal of the American Geriatrics Society, 47(4), 487–491. https://doi.org/10.1111/j.1532-5415.1999.tb07245.x
• Ministry of Health and Care Services. (2006). St.meld. 25 (2005–2006) Mestring, muligheter og mening – framtidas omsorgsutfordringer [White paper] [Coping, possibilities and meaning – the Future’s Care Challenges]. https://www.regjeringen.no/no/dokumenter/stmeld-nr-25-2005-2006-/id200879/
• Ministry of Health and Care Services. (2009). St.meld. nr. 47 (2008–2009). Samhandlingsreformen: Rett behandling – på rett sted – til rett tid [White Paper] [The Coordination Reform: Right treatment – in the right place – at the right time]. https://www.regjeringen.no/no/dokumenter/stmeld-nr-47-2008-2009-/id567201/
• Ministry of Health and Care Services. (2011). Health and care services act. https://lovdata.no/dokument/NL/lov/2011-06-24-30
• Ministry of Health and Care Services. (2013). St.meld. 29 (2012–2013) Morgendagens omsorg [White paper] [Care of tomorrow]. https://www.regjeringen.no/no/dokumenter/meld-st-29-20122013/id723252/
• Ministry of Health and Care Services. (2017). Lov om Statens undersøkelseskommisjon for helse- og omsorgstjenesten [Act on the Norwegian Commission of Inquiry into the Health and Care Services]. https://lovdata.no/dokument/NL/lov/2017-06-16-56
• Ministry Of Health and Care Services. (2018). St. meld. 15 (2017–2018) Leve hele livet: En kvalitetsreform for eldre [White paper] [Live life: A quality reform for older people]. https://www.regjeringen.no/no/dokumenter/meld.-st.-15-20172018/id2599850/
• Nasreddine, Z. S., Phillips, N. A., Bédirian, V., Charbonneau, S., Whitehead, V., Collin, I., Cummings, J. L., & Chertkow, H. (2005). The Montreal cognitive assessment, MoCA: A brief screening tool for mild cognitive impairment. Journal of the American Geriatrics Society, 53(4), 695–699. https://doi.org/10.1111/j.1532-5415.2005.53221.x
• National Directorate of Health. (2022). I trygge hender 24-7 [In safe hands 24-7]. https://www.itryggehender24-7.no/om-i-trygge-hender-24-7
• Norwegain Commision of Inquiry in Health and Care Services. (2021). Legemiddel. Saksnummer: Sak 20-00689 [Drug. Case number: Case 20-00689]. https://ukom.no/nyheter/gir-ikke-ut-rapport-om-legemiddelhandtering
• Odberg, K. R. (2020). A human factors approach to medication administration in nursing homes. [PhD dissertation, University of Stavanger]. https://doi.org/10.31265/usps.48
• Olsen, R. M., & Andreassen, S. D. (2016). Legemiddelbruk og pasientsikkerhet. En oppsummering av kunnskap [Drug use and patient safety. A summary of knowledge]. Senter for omsorgsforskning. https://www.helsebiblioteket.no/omsorgsbiblioteket/pasientsikkerhet/legemiddelbruk-og-pasientsikkerhet
• Romskaug, R., & Bakken, M. S. (2020). G10 Eldre og legemidler [G10 Elderly and medicines]. https://www.legemiddelhandboka.no/G10/Eldre_og_legemidler
• Shankar, K. K., Walker, M., Frost, D., & Orrell, M. W. (1999). The development of a valid and reliable scale for rating anxiety in dementia (RAID). Aging & Mental Health, 3(1), 39–49. https://doi.org/10.1080/13607869956424
• Skinner, M. S., Lorentzen, H., Tingvold, L., Sortland, O., Andfossen, N. B., & Jegermalm, M. (2020). Volunteers and informal caregivers’ contributions and collaboration with formal caregivers in Norwegian long-term care. Journal of Aging & Social Policy, 1–26. https://doi.org/10.1080/08959420.2020.1745988
• Skinner, M. S., Veenstra, M., & Sogstad, M. (2020). Nurses’ assessments of horizontal collaboration in municipal health and care services for older adults: A cross-sectional study. Research in Nursing & Health, 1–11. https://doi.org/10.1002/nur.22144
• Statistics Norway. (2021). Sjukeheimar, heimetenester og andre omsorgstenester [Nursing homes, home care services and other care services]. https://www.ssb.no/helse/helsetjenester/statistikk/sjukeheimar-heimetenester-og-andre-omsorgstenester
• Sultana, J., Cutroneo, P., & Trifirò, G. (2013). Clinical and economic burden of adverse drug reactions. Journal of Pharmacology and Pharmacotherapeutics, 4(1), S73-S77. https://pubmed.ncbi.nlm.nih.gov/24347988/
• WHO. (2009, January). More than words. Conceptual framework for the international classification for patient safety. Version 1.1. [Final Technical Report. World Health Organization. https://apps.who.int/iris/handle/10665/70882
• WHO. (2021). Global patient safety action plan 2021–2030: Towards eliminating avoidable harm in health care. World Health Organization. Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan
• Yesavage, J. A. (1988). Geriatric depression scale. Psychopharmacology Bulletin, 24(4), 709–711. https://hdl.handle.net/2027/mdp.39015020992684?urlappend=%3Bseq=1%3Bownerid=39098586-0
• Zanjani, F., Hoogland, A. I., & Downer, B. G. (2013). Alcohol and prescription drug safety in older adults. Drugs, Healthcare and Patient Safety, 5, 13–27. https://doi.org/10.2147/DHPS.S38666

The Extent of and Reasons for Manipulation of Oral Solid Dosage Forms

Manipulation of solid oral dosage forms is common and occurs in different settings and for different reasons. Schiele et al. (2013) reported that 59% of patients in a German general practice population, taking at least one OSDF for a period of four weeks or more, reported having modified their drugs to facilitate swallowing. A self-reported study done in Australian hospitals, found that modifications occurred at the bedside for 79% of responding hospitals (Nissen et al., 2009). Modification occurred for both adults and children, and the most common reason for modification was the inability to swallow the OSDF (82%). Other reasons were lack of the correct dose in commercially available products and the need for drug administration through, for example, nasogastric tubes. Furthermore, a Norwegian cross-sectional study carried out in hospital paediatric wards, found that 17% of administrations of oral medicines involved manipulation. Unacceptable dosage form, inappropriate strength, or a combination of these, were the most frequent reasons for manipulations (Bjerknes et al., 2017). A study performed in 19 Norwegian nursing homes, showed that crushing tablets occurred in all nursing homes. Difficulty swallowing was the most common reason for crushing tablets. Others were preventing tablets from being spat out, kept or hidden in the mouth, and the need to administer the drug through a probe (Wannebo, 2009). Solberg et al. (2021) recently reported that modifications were done in 56 (21%) of 273 dispensing episodes. In addition to swallowing difficulties, lack of understanding by the patient, routines, and the patient’s own wishes were the most common reasons reported for modification. For a specific patient, both the formulation, size, shape, and surface characteristics of the tablet/capsule, may contribute to swallowing difficulties. Fear of patients choking on medication may also contribute to modifying oral medicines (Mc Gillicuddy et al., 2019).

Potential Consequences of Modification

The consequences of modifying OSDFs depend on the pharmaceutical design of the specific medicine (Anonymous, 2014; Logrippo et al., 2017). Most worrying are cases of modifying extended-release solid dosage forms, which might lead to the release of the total amount of the drug, possibly causing severe adverse effects depending on the nature of the drug itself (Cleary et al., 1999). The consequences of manipulating gastro-resistant dosage forms depend on the reason for formulating a gastro-resistant dosage form in the first place. For chemically susceptible drugs, drug loss through degradation may occur, resulting in a lower amount of the drug being absorbed, reducing the pharmacological response (e.g., proton pump inhibitors). For drugs showing gastrointestinal side effects due to, among other things, local irritation, like NSAIDs, these effects might be more pronounced (Anonymous, 2014).

Manipulating immediate-release solid dosage forms by means of crushing or chewing, might not necessarily have an impact on their intended release profile. Such dosage forms are supposed to disintegrate rapidly, releasing the drug immediately in the stomach, and one could argue that crushing or chewing such dosage forms would accelerate the disintegrating process, resulting in earlier onset. Lippert et al. (2005) revealed no significant differences in the area under the curve (AUC) and the maximum concentration (C_max) of immediate-release telithromycin tablets, administered as either intact or crushed tablets, and thereby assessed both administrations as bioequivalent. Nonetheless, manipulating immediate-release solid dosage forms might be unacceptable due to drug properties rather than release profile, like unpleasant taste or safety issues handling the medicine (e.g., chemotherapeutic agents).

The appearance of OSDFs do not in general reveal the purpose of their design, but since the intake of certain dosage forms in an unaltered way is crucial for their intended mode of action, so is comprehensible written information on how to handle and administer such dosage forms for the success of the medical treatment.

The aim of the study underlying this chapter is to describe the extent and content of information and advice given relating to manipulation (e.g., crushing and dividing) of OSDFs in the Felleskatalogen®. The research questions were: To what extent is information on manipulation given in the monographs? What information concerning manipulation is given for immediate-release and modified-release preparations, respectively? Based on specific examples, what could be the implications of (not) following the advice concerning manipulation of oral solid medicines given in the monographs?

In this study, OSDFs include all different types of tablets, capsules, granules, powder, gums, pastilles/lozenges as well as powder and granules intended to be dissolved or dispersed in water by the patient before administration.

Methods

We exported trade names of all pharmaceutical preparations available in Felleskatalogen® (www.felleskatalogen.no) on 4 March 2021, n = 2,555 monographs. Written consent was given by Felleskatalogen® to store and use the data for the purpose of this study. Data were further handled and analyzed using IBM SPSS version 27.0. and 28.0.

The monographs were screened to identify the total number of individual pharmaceutical preparations. Medicines available as two different dosage forms, for example both tablets and capsules, were counted as two preparations. Medicines containing the same active substances having different names, (e.g., Cozaar Comp® and Cozaar Comp Forte® by Organon, both containing hydrochlorothiazide and losartan), were registered as two different preparations. A total of 2,915 individual pharmaceutical preparations were identified, representing 41 different oral dosage forms, in addition to preparations not intended for oral administration.

As shown in Figure 1, we excluded oral liquid preparations, and preparations not intended for oral administration. Thus, a total of 1,387 monographs relating to OSDFs were included in the study. From 4 March until 22 July 2021, we reviewed the monographs of these OSDFs on www.felleskatalogen.no. The following variables were registered: the dosage form; whether the preparation had its “own” monograph in Felleskatalogen®, and if not, which monograph the reader was referred to; the recommendations given under “Administration” for the manipulation of drugs (e.g., advice on crushing, dividing, and chewing the drugs); and whether the reasons for the recommendations were given. Dosage forms were registered based on the descriptions in Felleskatalogen®. In the analysis, we categorized extended-release, delayed-release and gastro-resistant tablets, capsules, and granules as drugs with modified-release characteristics. All other drugs were categorized as immediate-release drugs.

We categorized the recommendations for medicines that “shall not”, “should not” and “cannot be divided” as “cannot be divided”. Medicines that “can be divided”, “can be divided in two similar doses”, “should only be divided once”, “cannot be divided in two similar doses” and medicines for which different recommendations were given for different doses were categorized as “can be divided”. For capsules, medicines were categorized in “shall not be opened”, and “can be opened”. For recommendations concerning crushing, medicines that “should not”, “shall not” and “must not be crushed” were categorized as “cannot be crushed”, whereas medicines that “should be” and “may (if necessary) be crushed” were categorized as “can be crushed”. For chewing, medicines that “should not”, “shall not” and “must not” be chewed were categorized as “cannot be chewed”, whereas medicines that “can be” or “should be” chewed, were categorized as “can be chewed”.

Results

Table 1 shows the frequency of different OSDFs in Felleskatalogen®, representing 33 different types of dosage forms. 1,200 (86,5%) of the preparations had dosage forms with immediate-release-characteristics, whereas 187 (13,5%) had modified-release characteristics. Of the 187 modified-release preparations 122 (65,2%) were tablets, 56 (29,9%) were capsules, and 9 (4,8%) were granules.

Table 1. Frequency of Different Oral Solid Dosage Forms in Felleskatalogen® (www.felleskatalogen.no)

*Soluble tablets (n = 3), chewing gums (n = 2), powders (n = 4), granules in capsules to be opened (n = 1), pastils (n = 1), and dispersible/soluble tablet (n = 1).
**Gastro-resistant granules for liquid preparation (n = 3), gastro-resistant modified-release tablets (n = 2), modified-release granules for liquid preparation (n = 1).

Information and recommendations concerning administration varied largely between dosage forms and within similar dosage forms. We will further focus on information concerning modified-release tablets and capsules, and conventional immediate-release dosage forms. Table 2 shows the information and recommendations given on whether to swallow these drugs whole.

Table 2. Information and Recommendations in Monographs in Felleskatalogen® This relates to whether oral solid modified-release (tablets and capsules) and the conventional immediate-release dosage forms should be swallowed whole. Soft capsules are not included in the table

Of the 11 OSDFs with modified-release characteristics lacking information on whether to be swallowed whole, all had other specific recommendations on how to handle the drug. Recommendations were, for example:

• Should be swallowed with a glass of water. Shall not be chewed. Shall not be divided or crushed (Cortiment® modified-release tablets (budesonide, Ferring Legemidler AS))
• One gastro-resistant capsule is to be taken with cold or lukewarm water (not over 37°C) on an empty stomach, and at least one hour before the next meal. Shall not be chewed, and is to be swallowed as soon as possible after being put in the mouth (Vivotif® gastro-resistant capsules (typhoid vaccine, Emergent)).

Six of the 11 medicines with modified-release characteristics lacking recommendations to be swallowed whole, could, however, be divided, (e.g., Tegretol Retard®, carbamazepine, Novartis). Selo-Zok® modified-release tablets (metoprolol, Recordati) could also be divided. Yet, for 50, 100 and 200mg doses, dividing should only take place to make them easier to swallow. In comparison, dividing 25mg tablets results in two similar doses.

Information on whether the medicine should be swallowed whole, could be divided, crushed, chewed, dispersed in water, or sucked was lacking for all variables for 143 coated tablets (23,6%), 45 (15,3%) conventional tablets, and 11 (8,3%) capsules. This does not necessarily mean that no information was given on how to administer these medicines, as some mentioned that the drug was to be swallowed (but not, specifically, whole) and gave other recommendations which did not fit into these pre-defined categories. No OSDFs with modified-release characteristics were among these.

Table 3 shows information and recommendations on dividing, crushing and chewing oral solid dosage forms with modified-release characteristics and the conventional immediate-release dosage forms.

Only a few monographs explained the reasons for recommendations relating to modifying the medicine. One explicit reason given for the recommendation on why one should swallow the drug whole, was that the taste of the drug was bitter or bad. Another stated reason to swallow the drug whole, was an increased risk of side effects if the drug was divided, crushed, or chewed. Side effects could occur due to local effects, such as irritation of the gastric mucosa (e.g., Albyl-E® gastro-resistant tablets (acetylsalicylic acid, Takeda)), and discoloration of the teeth and mouth cavity (e.g., Vanquin® tablets (pyrvin, MEDA)), or due to increased systemic effects of the drug, such as an increased risk of bleeding caused by Pradaxa® capsules (dabigatran, Boehringer Ingelheim). For some drugs, dividing, chewing, or crushing tablets may result in rapid release and absorption of potentially lethal doses of the drugs, such as for Reltebon Depot® (Actavis) and OxyContin® (Mundipharma), both containing the opioid analgesic drug oxycodone in a modified-release dosage form. Furthermore, some cytostatic drugs, such as Sprycel® tablets (dasatinib, Bristol-Myers Squibb), were recommended to be swallowed whole to ensure correct dosing and minimize the risk of skin exposure. Similarly, Valganciclovir® tablets (valganciclovir, Accord; Sandoz), an antiviral drug, should not be divided or crushed as it is potentially teratogenic and carcinogenic.

Table 3. Information and Recommendations. This relates to dividing, crushing, and chewing oral solid modified-release (tablets and capsules), and the conventional immediate-release dosage forms. Soft capsules are not included in the table

*For capsules, the presented data concerns opening the capsules.
**Includes preparations for which different recommendations are given for different strengths of the drug.

Discussion

Conclusion

Information on modification of OSDFs is commonly available in Felleskatalogen®. As expected, information was more common for medicines with modified-release than immediate-release characteristics. However, recommendations regarding the modification of immediate-release dosage forms were surprisingly numerous. Moreover, the information was not unambiguous, and the reasons for the given recommendations, as well as the possible consequences of modifications, were rarely included. This may result in medication errors and possible harm to the patient.

References

• Alderborn, G., & Frenning, G. (2018). Tablets and compaction. In M. E. Aulton & K. M. G. Taylor (Eds.), Aulton’s pharmaceutics: The design and manufacture of medicines (pp. 533–540). Elsevier.
• Anonymous. (2014). Crushing tablets or opening capsules: Many uncertainties, some established dangers. Prescrire International, 23(152), 209–211, 213–204.
• Bjerknes, K., Bøyum, S., Kristensen, S., Brustugun, J., & Wang, S. (2017). Manipulating tablets and capsules given to hospitalised children in Norway is common practice. Acta Paediatrica, 106(3), 503–508. https://doi.org/10.1111/apa.13700
• Cleary, J. D., Evans, P. C., Hikal, A. H., & Chapman, S. W. (1999). Administration of crushed extended-release pentoxifylline tablets: Bioavailability and adverse effects. American Journal of Health System Pharmacy, 56(15), 1529–1534. https://doi.org/10.1093/ajhp/56.15.1529
• Felleskatalogen. (2021a). Information to the pharmaceutical companies. FELLESKATALOGEN AS. Retrieved 12.11.2021 from https://www.felleskatalogen.no/medisin/info-companies
• Felleskatalogen. (2021b). Monograph and SPC: Lanzo Melt. FELLESKATALOGEN AS. Retrieved 09.12.2021 from https://www.felleskatalogen.no/medisin/lanzo-melt-pfizer-560834
• Felleskatalogen. (2021c). Om Felleskatalogen. [About Felleskatalogen]. FELLESKATALOGEN AS. Retrieved 12.11.2021 from https://www.felleskatalogen.no/medisin/om-felleskatalogen
• Fuchs, J. (2009). The amount of liquid patients use to take tablets or capsules. Pharmacy Practice, 7(3), 170–174. https://doi.org/10.4321/s1886-36552009000300007
• Gharaibeh, S. F., & Tahaineh, L. (2020). Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan. Pharmacy Practice, 18(2), 1776. https://doi.org/10.18549/PharmPract.2020.2.1776
• Johansen, R. (2019). Sykepleieres kunnskap og oppfatninger om generisk bytte. [Nurses’ knowledge and perceptions on generic substitution]. Sykepleien Forskning 14(79517). https://doi.org/10.4220/Sykepleienf.2019.79517
• Karttunen, M., Sneck, S., Jokelainen, J., & Elo, S. (2020). Nurses’ self-assessments of adherence to guidelines on safe medication preparation and administration in long-term elderly care. Scandinavian Journal of Caring Sciences, 34(1), 108–117. https://doi.org/10.1111/scs.12712
• Kirkevold, Ø., & Engedal, K. (2010). Legemiddelhåndtering i norske sykehjem med fokus på knusing av medikamenter. [Drug management in Norwegian nursing homes focusing on the crushing of drugs]. Sykepleien Forskning (5), 16–25. https://doi.org/10.4220/sykepleienf.2010.0014
• Lau, E. T., Steadman, K. J., Cichero, J. A., & Nissen, L. M. (2018). Dosage form modification and oral drug delivery in older people. Advanced Drug Delivery Reviews, 135, 75–84. https://doi.org/10.1016/j.addr.2018.04.012
• Lippert, C., Gbenado, S., Qiu, C., Lavin, B., & Kovacs, S. J. (2005). The bioequivalence of telithromycin administered orally as crushed tablets versus tablets swallowed whole. Journal of Clinical Pharmacology, 45(9), 1025–1031. https://doi.org/10.1177/0091270005279273
• Logrippo, S., Ricci, G., Sestili, M., Cespi, M., Ferrara, L., Palmieri, G. F., Ganzetti, R., Bonacucina, G., & Blasi, P. (2017). Oral drug therapy in elderly with dysphagia: Between a rock and a hard place! Clinical Interventions in Aging, 12, 241–251. https://doi.org/10.2147/cia.S121905
• Manrique-Torres, Y. J., Lee, D. J., Islam, F., Nissen, L. M., Cichero, J. A., Stokes, J. R., & Steadman, K. J. (2014). Crushed tablets: Does the administration of food vehicles and thickened fluids to aid medication swallowing alter drug release? Journal of Pharmacy & Pharmaceutical Sciences, 17(2), 207–219. https://doi.org/10.18433/j39w3v
• Mc Gillicuddy, A., Crean, A. M., Kelly, M., & Sahm, L. (2017a). Oral medicine modification for older adults: A qualitative study of nurses. BMJ Open, 7(12), e018151. https://doi.org/10.1136/bmjopen-2017-018151
• Mc Gillicuddy, A., Kelly, M., Crean, A. M., & Sahm, L. J. (2017b). The knowledge, attitudes and beliefs of patients and their healthcare professionals around oral dosage form modification: A systematic review of the qualitative literature. Research in Social and Adminiatrative Pharmacy, 13(4), 717–726. https://doi.org/10.1016/j.sapharm.2016.09.004
• Mc Gillicuddy, A., Kelly, M., Crean, A. M., & Sahm, L. J. (2019). Understanding the knowledge, attitudes and beliefs of community-dwelling older adults and their carers about the modification of oral medicines: A qualitative interview study to inform healthcare professional practice. Research in Social and Administrative Pharmacy, 15(12), 1425–1435. https://doi.org/10.1016/j.sapharm.2019.01.004
• McConell, E. L., & Basit, A. W. (2018). Modified-release oral drug delivery. In M. E. Aulton & K. M. G. Taylor (Eds.), Aulton’s pharmaceutics: The design and manufacture of medicines (pp. 565–573). Elsevier.
• Mullen, R. J., Duhig, J., Russell, A., Scarazzini, L., Lievano, F., & Wolf, M. S. (2018). Best-practices for the design and development of prescription medication information: A systematic review. Patient Education and Counseling, 101(8), 1351–1367. https://doi.org/10.1016/j.pec.2018.03.012
• Nissen, L. M., Haywood, A., & Steadman, K. J. (2009). Solid medication dosage form modification at the bedside and in the pharmacy of Queensland hospitals. Journal of Pharmacy Practice and Research, 39(2), 129–134. https://doi.org/10.1002/j.2055-2335.2009.tb00436.x
• Oslo Universitetssykehus. (2021). Tabletter og kapsler – knuse-/åpne-/løselisten [Tablets and capsules – the crushing/opening/dissolving list]. https://ehandboken.ous-hf.no/api/File/GetFileDocument?entityId=209634
• Schiele, J. T., Quinzler, R., Klimm, H.-D., Pruszydlo, M. G., & Haefeli, W. E. (2013). Difficulties swallowing solid oral dosage forms in a general practice population: Prevalence, causes, and relationship to dosage forms. European Journal of Clinical Pharmacology, 69(4), 937–948. https://doi.org/10.1007/s00228-012-1417-0
• The Society of Hospital Pharmacists of Australia (SHPA). (2021). Do not rush to crush (4th ed.). https://www.shpa.org.au/drtc3
• Solberg, H., Devik, S. A., Bell, H. T., Zeiss, D. H., & Olsen, R. M. (2021). Drug modification by nurses in Norwegian nursing homes: A cross-sectional study. Geriatric Nursing, 42(2), 351–357. https://doi.org/10.1016/j.gerinurse.2021.01.005
• Thong, M. Y., Manrique, Y. J., & Steadman, K. J. (2018). Drug loss while crushing tablets: Comparison of 24 tablet crushing devices [Comparative Study]. PLOS ONE [Electronic Resource], 13(3), e0193683. https://doi.org/10.1371/journal.pone.0193683
• Wannebo, W. (2009). Tablettknusing i sykehjem – en sikkerhetsrisiko for pasienten? [Crushing tablets in nursing homes – a risk to the patient?] Sykepleien Forskning (1), 6–15. https://doi.org/10.4220/sykepleienf.2009.0016
• Wannebo, W., & Sagmo, L. (2013). Stort behov for mer kunnskap om legemidler blant sykepleiere i sykehjem. [Great need for more knowledge of drugs among nurses in nursing homes]. Sykepleien Forskning (8), 26–34. https://doi.org/10.4220/sykepleienf.2013.0006
• World Health Organisation (2017). Medication without harm: Global patient safety challenge on medication safety. https://www.who.int/initiatives/medication-without-harm

Material and Methods

This is a cross-sectional study among Norwegian women born between 1943 and 1957. Data were collected from 2002 to 2006 as a part of NOWAC.

Identifying Interactions

The registered content/substances from all reported, decipherable DS were checked for interaction potential in combination with medication, using the Natural Medicines database (Natural Medicines, accessed 2020) professional monographs. Natural Medicines is a not-for-profit database, primarily focused on the safety and effectiveness of natural products of all kinds. It is systematically updated, and potential literature sources are critically evaluated for relevance and validity. Interactions are classified according to a stop-light rating system, combining severity and likelihood of occurrence (Natural Medicines). In addition, the interactions are classified according to level of evidence: A) high-quality RCT/meta-analysis; B) non-randomized/observational studies; C) consensus/expert opinion; and D) anecdotal/animal/in vitro/theoretical evidence.

In our study, we defined clinically significant interactions as interactions of moderate to high severity and of possible, probable, or likely occurrence (Figure 1). These were labelled “potential” interactions, as they were based on self-reported use and the data material did not provide information about clinical evidence of an actual interaction occurring. In addition, classification C or D in level of evidence was considered low-grade documentation.

We created a variable for each DS-medication or medication category combination with interaction potential identified by Natural Medicines. Interactions were further classified as potentially clinically significant or not (Figure 1). We counted the number of interactions and calculated the proportion of participants with a potential interaction. We also categorized the participants according to number of interactions identified (1, 2 and >2). One DS-medication combination may give rise to more than one interaction: a DS may interact through several interaction mechanisms due to mixed content, and a medication may belong to more than one medication group, it may for instance be both an OATP and a CYP3A4 substrate.

Results

The study population comprised 3,970 women, of whom 2,577 (65%) used medication, 1,824 (71%) used DS and 1,885 (47%) combined medication and DS use. Most of the women were postmenopausal (Table 1). The women reported a total of 463 different DS products. The content of 22 of these were not decipherable, and 64 participants used one (n = 59) or two such DS (n = 5).

Irrespective of documentation grade, the prevalence of potentially clinically significant DS-medication interactions was 44% (n = 823), that is the proportion of DS-medication users with at least one interaction identified (Table 2). When excluding interactions with low-grade documentation, the proportion was 33% (n = 630), which represents 16% of the total study population. Among these, 132 women (7%) used herb-medication combinations, and 63 (3%) used combination(s) that represented more than two interactions.

Altogether, 1,857 DS-medication interactions were identified, 591 of these were herb-medication interactions. The corresponding number of interactions after exclusion of those with low-grade documentation was 960 and 173 respectively. As shown in Table 3, herb-medication interactions are more often specifically related to liver metabolism and membrane transport than non-herb-medication interactions. Four of the herb-medication interactions, representing three of the participants (0.02% of 1,885 DS-medication combination users), were classified as major risk of adverse outcome according to the Natural Medicines database (Figure 1) and involved grapefruit and St. John’s wort. One participant combined St. John’s wort with clarithromycin, which represents a risk of reduced plasma concentration of clarithromycin due to induction of the liver enzyme CYP3A4. She also used a tomato extract, cod liver oil and a soy supplement. Two participants used a herbal mixture which included grapefruit, combined with levothyroxine, an OATP1B1 substrate. Due to the many herbs present in the herbal product as well as use of some other DS products, both women had several additional potentially clinically significant interactions identified, but these were all classified as low-grade documentation.

Table 1. Characteristics of the Study Population Overall and According to Use of Medication and Dietary Supplements (DS)*

*Missing information was defined as non-use. 18 did not answer the question about medication use and 16 did not answer the questions about dietary supplement use.

Table 2. Number (%)* of Participants with Identified Potentially Clinically Significant Iinteractions Related to Dietary Supplements (DS) Use Among Participants Combining Medication and DS (n = 1885)

*The percentages represent the proportion of participants who combine DS and medication, (i.e., 1,885).
^#The overall numbers are not the sum (vertically) of participants with herb-medication and other DS-medication interactions. Some participants have both interaction types, and some have one interaction of one type and several interactions of another.

Table 3. Frequency of Potential Dietary Supplements-Medication Interactions, Excluding Interactions with Low-Grade Documentation

*Major risk of adverse outcome.
OATP: Organic Anion Transporting Polypeptides; CYP: Cytochrome P450.

A complete list of identified DS-medication interactions is available on request.

Discussion

The main study findings are that among a middle-aged population of Norwegian women, 71% used DS and 47% combined DS and medication use. The prevalence of potentially clinically significant DS-medication interactions was 33% among the DS-medication users, 16% in the total study population. DS-medication combinations with a potentially serious interaction outcome were identified, but the prevalence was very low.

Other studies that have reported prevalence of DS-medication interactions, have found a variation from 5% to 40% (Bush et al., 2007; Dergal et al., 2002; Firkins et al., 2018; Peng et al., 2004; Risvoll et al., 2017). There are several plausible reasons for this variation: 1) varying study populations (elderly, particular patient groups (cancer, kidney, dementia)); 2) various countries/geographical regions with differing legislation and culture for DS use; and 3) varying methods and tools used to define DS or herbal use and DS-medication interactions.

The Norwegian study by Risvoll et al. (2017) is particularly interesting as it includes persons with dementia, a patient group who may be excluded from surveys either intentionally, or indirectly due to their cognitive status. Among 151 participants, 46% used DS and 11% had a potentially clinically significant DS-medication interaction. A similar Canadian study conducted at a memory clinic detected potential herb-medication interactions in 5% of the patients (Dergal et al., 2002). A survey among patients attending American outpatient clinics detected a substantial number of potentially adverse herb-medication (prescription) interactions (40% of the herb users), but did not uncover any serious adverse interactions after reviewing the patients’ charts (Bush et al., 2007). Another American survey in primary care identified potential DS-medication interactions among 17% of the participants, while 1% had potentially severe interactions (Peng et al., 2004). A German study in oncology clinics found that 16% of the patients risked interaction due to combined use of conventional medication and so-called biologically based CAM (complementary and alternative medicine) (Firkins et al., 2018), but severity was not assessed.

The results from these studies, ours included, may be summed up as follows. There is a noteworthy potential for clinically significant interactions to occur between DS and medications, and the prevalence may be high or low depending on the type and number of medications used in the study population. Also, although there is a risk of seriously compromised health through combining DS-medication, the prevalence of interactions representing a major health risk is generally low.

Conclusion

Pharmacological interaction with medications is one of several ways in which dietary supplements can adversely affect patients’ health. There is considerable potential for clinically significant dietary supplement–medication interactions in a general population of middle-aged women. Whether this poses a serious health threat, could not be unequivocally established by the data material from NOWAC, though the probability of serious health risks seems low in this population segment. However, our findings indicate that health personnel should take supplements into account when assessing health risk and medication use among their patients.

Acknowledgement

Open Access funding was provided by UiT The Arctic University of Norway. We thank the women who participated in the NOWAC study.

References

• Abe, A., Kaye, A. D., Gritsenko, K., Urman, R. D., & Kaye, A. M. (2014). Perioperative analgesia and the effects of dietary supplements. Best Practice & Research Clinical Anaesthesiology, 28(2), 183–189. https://doi.org/10.1016/j.bpa.2014.04.002
• Anwar-Mohamed, A., Elbekai, R. H., & El-Kadi, A. O. S. (2009). Regulation of CYP1A1 by heavy metals and consequences for drug metabolism. Expert Opinion in Drug Metabolism & Toxicology, 5(5), 501–521. https://doi.org/10.1517/17425250902918302
• Arab, L. (2000). Epidemiologic challenges in the study of the efficacy and safety of medicinal herbs. Public Health Nutrition, 3(4a), 453–457. https://doi.org/10.1017/S1368980000000537
• Astin, J. A. (1998). Why patients use alternative medicine: Results of a national study. JAMA, 279(19), 1548–1553. https://doi.org/10.1001/jama.279.19.1548
• Bailey, R. L., Gahche, J. J., Miller, P. E., Thomas, P. R., & Dwyer, J. T. (2013). Why US adults use dietary supplements. JAMA Internal Medicine, 173(5), 355–361. https://doi.org/10.1001/jamainternmed.2013.2299
• Bergli, T. L. (2020). NAFKAM-undersøkelsen 2012–2018 [Infografikk] [The NAFKAM survey 2012–2018]. NAFKAM.Available from: https://nafkam.no/nafkam-undersokelsen-2012–2018-infografikk
• Björnsson, E. S. (2016). Hepatotoxicity by drugs: The most common implicated agents. International Journal of Molecular Sciences, 17(2), 224. https://doi.org/10.3390/ijms17020224
• Boullata, J. (2005). Natural health product interactions with medication. Nutrition in Clinical Practice, 20(1), 33–51. https://doi.org/10.1177/011542650502000133
• Brustad, M., Alsaker, E., Engelsen, O., Aksnes, L., & Lund, E. (2004). Vitamin D status of middle-aged women at 65–71°N in relation to dietary intake and exposure to ultraviolet radiation. Public Health Nutrition, 7(2), 327–335. https://doi.org/10.1079/PHN2003536
• Buchanan, N. (2001). Medications which may lower seizure threshold. Australian Prescriber, 24(1), 8–9. https://doi.org/10.18773/austprescr.2001.006
• Bush, T. M., Rayburn, K. S., Holloway, S. W., Sanchez-Yamamoto, D. S., Allen, B. L., Lam, T., So, B. K., Tran de, H., Greyber, E. R., Kantor, S., & Roth, L. W. (2007). Adverse interactions between herbal and dietary substances and prescription medications: A clinical survey. Alternative Therapies in Health and Medicine, 13(2), 30–35.
• Clinical Pharmacology, Department of Medicine, Indiana University. Drug Interactions Flockhart Table™. Retrieved June 2018. Available from: https://drug-interactions.medicine.iu.edu/MainTable.aspx
• CredibleMeds®. QTdrug lists. Retrieved June 2018. Available from: www.crediblemeds.org
• Dergal, J. M., Gold, J. L., Laxer, D. A., Lee, M. S., Binns, M. A., Lanctôt, K. L., Freedman, M., & Rochon, P. A. (2002). Potential interactions between herbal medicines and conventional drug therapies used by older adults attending a memory clinic. Drugs & Aging, 19(11), 879–886. https://doi.org/10.2165/00002512-200219110-00005
• DrugFacts. Prescription CNS depressants. Retrieved June 2018. Available from: https://www.drugabuse.gov/publications/drugfacts/prescription-cns-depressants
• Drugs.com. List of CNS stimulants. Retrieved June 2018. Available from: https://www.drugs.com/drug-class/cns-stimulants.html?condition_id=0&generic=1&sort=drug&order=asc#filterSection
• Drugs.com. List of narcotic analgesics. Retrieved June 2018. Available from: https://www.drugs.com/drug-class/narcotic-analgesics.html
• Firkins, R., Eisfeld, H., Keinki, C., Buentzel, J., Hochhaus, A., Schmidt, T., & Huebner, J. (2018). The use of complementary and alternative medicine by patients in routine care and the risk of interactions. Journal of Cancer Research and Clinical Oncology, 144(3), 551–557. https://doi.org/10.1007/s00432-018-2587-7
• Gardiner, P., Sadikova, E., Filippelli, A. C., White, L. F., & Jack, B. W. (2015). Medical reconciliation of dietary supplements: Don’t ask, don’t tell. Patient Education and Counseling, 98(4), 512–517. https://doi.org/10.1016/j.pec.2014.12.010
• Gurley, B. J. (2014). Clinically relevant herb-drug interactions: Past, present, and future. [Online lecture] National Institutes of Health, National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/training/videolectures/clinically-relevant-herb-drug-interactions
• Guzman, J. R., Paterniti, D. A., Liu, Y., & Tarn, D. M. (2019). Factors related to disclosure and nondisclosure of dietary supplements in primary care, integrative medicine, and naturopathic medicine. Journal of Family Medicine and Disease Prevention, 5(4). https://doi.org/10.23937/2469-5793/1510109
• Hitchings, A. W. (2016). Drugs that lower the seizure threshold. Adverse Drug Reaction Bulletin, 298(1). https://doi.org/10.1097/FAD.0000000000000016, Available from: https://journals.lww.com/adversedrugreactbull/Fulltext/2016/06000/Drugs_that_lower_the_seizure_threshold.1.aspx
• Kiang, T. K. L., Ensom, M. H. H., & Chang, T. K. H. (2005). UDP-glucuronosyltransferases and clinical drug-drug interactions. Pharmacology & Therapeutics, 106(1), 97–132. https://doi.org/10.1016/j.pharmthera.2004.10.013
• Kofoed, C. L. F., Christensen, J., Dragsted, L. O., Tjønneland, A., & Roswall, N. (2015). Determinants of dietary supplement use: Healthy individuals use dietary supplements. British Journal of Nutrition, 113(12), 1993–2000. https://doi.org/10.1017/S0007114515001440
• Li, K., Kaaks, R., Linseisen, J., & Rohrmann, S. (2010). Consistency of vitamin and/or mineral supplement use and demographic, lifestyle and health-status predictors: Findings from the European prospective investigation into cancer and nutrition (EPIC) Heidelberg cohort. British Journal of Nutrition, 104(7), 1058–1064. https://doi.org/10.1017/S0007114510001728
• Lovdata [Norwegian statutes in force] (2004). Forskrift om kosttilskudd. [Regulation of dietary supplements], Available from: https://lovdata.no/dokument/SF/forskrift/2004-05-20-755?q=kosttilskudd
• Lund, E., Dumeaux, V., Braaten, T., Hjartaker, A., Engeset, D., Skeie, G., & Kumle, M. (2007). Cohort profile: The Norwegian women and cancer study (NOWAC). [Kvinner og kreft]. International Journal of Epidemiology, 37(1), 36–41. https://doi.org/10.1093/ije/dym137
• Lund, E., Kumle, M., Braaten, T., Hjartaker, A., Bakken, K., Eggen, E., & Gram, T. I. (2003). External validity in a population-based national prospective study: The Norwegian women and cancer study (NOWAC). Cancer Causes & Control, 14(10), 1001–1008. https://doi-org.mime.uit.no/10.1023/B:CACO.0000007982.18311.2e
• Mouly, S., Lloret-Linares, C., Sellier, P.-O., Sene, D., & Bergmann, J. F. (2017). Is the clinical relevance of drug-food and drug-herb interactions limited to grapefruit juice and Saint-John’s wort? Pharmacological Research, 118, 82–92. https://doi.org/10.1016/j.phrs.2016.09.038
• Natural Medicines. Level of significance: Stop-light rating system occurrence/severity. Therapeutic Research Center. Available from: https://naturalmedicines-therapeuticresearch-com.mime.uit.no/tools/stop-light-rating-system.aspx#Occurrence
• Natural Medicines. Database. Therapeutic Research Center. Available from: https://naturalmedicines-therapeuticresearch-com.mime.uit.no/ (Subscription required to view), accessed 2020.
• Nestor, M. A., Ryan, M., & Cook, A. M. (2010). Catching the seizure culprit: Drugs on the differential. Orthopedics, 33(9), 679. https://doi.org/10.3928/01477447-20100722-16
• Niemi, M. (2007). Role of OATP transporters in the disposition of drugs. Pharmacogenomics, 8(7), 787–802. https://doi.org/10.2217/14622416.8.7.787
• Owens, C., Baergen, R., & Puckett, D. (2014). Online sources of herbal product information. The American Journal of Medicine, 127(2), 109–115. https://doi.org/10.1016/j.amjmed.2013.09.016
• Park, K., Harnack, L., & Jacobs, D. R. (2009). Trends in dietary supplement use in a cohort of postmenopausal women from Iowa. American Journal of Epidemiology, 169(7), 887–892. https://doi.org/10.1093/aje/kwn410
• Peng, C. C., Glassman, P. A., Trilli, L. E., Hayes-Hunter, J., & Good, C. B. (2004). Incidence and severity of potential drug-dietary supplement interactions in primary care patients: An exploratory study of two outpatient practices. Archives of Internal Medicine, 164(6), 630–636. https://doi.org/10.1001/archinte.164.6.630
• Reddy, V. P., Jo, H., & Neuhoff, S. (2021). Food constituent and herb-drug interactions in oncology: Influence of quantitative modelling on drug labelling. British Journal of Clinical Pharmacology, 87(10), 3988–4000. https://doi.org/10.1111/bcp.14822
• Risvoll, H., Giverhaug, T., Halvorsen, K. H., Waaseth, M., & Musial, F. (2017). Direct and indirect risk associated with the use of dietary supplements among persons with dementia in a Norwegian memory clinic. BMC Complementary and Alternative Medicine, 17(1), 261(pp.212). https://doi.org/10.1186/s12906-017-1765-5
• Risvoll, H., Musial, F., Halvorsen, K. H., Giverhaug, T., & Waaseth, M. (2019). Pharmacy employees’ involvement in safeguarding persons with dementia who use dietary supplements: Results from a survey of Norwegian pharmacies. BMC Complementary and Alternative Medicine, 19(1), 179. https://doi.org/10.1186/s12906-019-2587-4
• Risvoll, H., Musial, F., Waaseth, M., Giverhaug, T., & Halvorsen, K. (2021). Home care service employees’ contribution to patient safety in clients with dementia who use dietary supplements: A Norwegian survey. Scandinavian Journal of Primary Health Care, 1–10. https://doi.org/10.1080/02813432.2021.1970944
• Ronis, M. J. J., Pedersen, K. B., & Watt, J. (2018). Adverse effects of nutraceuticals and dietary supplements. Annual Review of Pharmacology and Toxicology, 58(1), 583–601. https://doi.org/10.1146/annurev-pharmtox-010617-052844
• Salamonsen, A. (2013). Doctor-patient communication and cancer patients’ choice of alternative therapies as supplement or alternative to conventional care. Scandinavian Journal of Caring Sciences, 27(1), 70–76. https://doi.org/10.1111/j.1471-6712.2012.01002.x
• Scullin, C., Scott, M. G., Hogg, A., & McElnay, J. C. (2007). An innovative approach to integrated medicines management. Journal of Evaluation in Clinical Practice, 13(5), 781–788. https://doi-org.mime.uit.no/10.1111/j.1365-2753.2006.00753.x
• Shitara, Y., Maeda, K., Ikejiri, K., Yoshida, K., Horie, T., & Sugiyama, Y. (2013). Clinical significance of organic anion transporting polypeptides (OATPs) in drug disposition: Their roles in hepatic clearance and intestinal absorption. Biopharmaceutics & Drug Disposition, 34(1), 45–78. https://doi-org.mime.uit.no/10.1002/bdd.1823
• Skalli, S., & Soulaymani Bencheikh, R. (2012). Safety monitoring of herb-drug interactions: A component of pharmacovigilance. Drug Safety, 35(10), 785–791. https://doi.org/10.1007/bf03261975
• Stieger, B., & Hagenbuch, B. (2014). Organic anion transporting polypeptides. Current Topics in Membranes, 73, 205–232. https://doi.org/10.1016/B978-0-12-800223-0.00005-0
• Straight Healthcare. P-glycoprotein. Retrieved June 2018. Available from: https://www.straighthealthcare.com/p-glycoprotein.html
• Tarirai, C., Viljoen, A. M., & Hamman, J. H. (2010). Herb–drug pharmacokinetic interactions reviewed. Expert Opinion on Drug Metabolism & Toxicology, 6(12), 1515–1538. https://doi.org/10.1517/17425255.2010.529129
• The European Parliament and the Council (2002, June 10). Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, 51–57 L 183/51. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002L0046
• The European Parliament and the Council (2004, March 31). Directive 2004/24/EC amending as regards traditional herbal medicinal products, Directive 2001/83/EC on the community code relating to medicinal products for human use, 85–90 L 136. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF
• The WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD index. Norwegian Institute of Public Health. Retrieved June 2018. Available from: http://www.whocc.no/atcddd/
• Touvier, M., Kesse, E., Volatier, J. L., Clavel-Chapelon, F., & Boutron-Ruault, M. C. (2006). Dietary and cancer-related behaviors of vitamin/mineral dietary supplement users in a large cohort of French women. European Journal of Nutrition, 45(4), 205–214. https://doi.org/10.1007/s00394-006-0587-x
• Wang, Y.-H., Li, Y., Yang, S.-L., & Yang, L. (2005). Classification of substrates and inhibitors of P-glycoprotein using unsupervised machine learning approach. Journal of Chemical Information and Modeling, 45(3), 750–757. https://doi.org/10.1021/ci050041k
• Waaseth, M., Bakken, K., Dumeaux, V., Olsen, K., Rylander, C., Figenschau, Y., & Lund, E. (2008). Hormone replacement therapy use and plasma levels of sex hormones in the Norwegian women and cancer postgenome cohort: A cross-sectional analysis. BMC Women’s Health, 8(1), 1. https://doi.org/10.1186/1472-6874-8-1
• Waaseth, M., Eggen, A. E., & Grimsgaard, S. (2007). Natural remedies in Scandinavia: Authorization and sales. Pharmacy World & Science, 29(3), 137–145. https://doi.org/10.1007/s11096-006-9033-7
• Waaseth, M., Havelkova, M., Forsdahl, G., Lund, E., & Log, T. (2020). Validity of self-reported antidepressants use: The norwegian women and cancer study, in ICPE [all access conference abstracts]. Pharmacoepidemiol & Drug Safety, 29(S3), 3–634. https://doi.org/10.1002/pds.5114
• Waaseth, M., Larsen, H. N., Thoresen, M.-B. S., & Skeie, G. (2019). Bruk av kosttilskudd blant middelaldrende norske kvinner. Norsk Tidsskrift for Ernæring, 17(1), 8–16. [Dietary supplement user pattern among Norwegian middle-aged women] available from: https://munin.uit.no/bitstream/handle/10037/16831/article.pdf?sequence=8&isAllowed=y
• Zanger, U. M., & Schwab, M. (2013). Cytochrome P450 enzymes in drug metabolism: Regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacology & Therapeutics, 138(1), 103–141. https://doi.org/10.1016/j.pharmthera.2012.12.007
• Zhang, A. Y., & Elmets, C. A. (2020). Drug-induced photosensitivity. Medscape. Available from: https://emedicine.medscape.com/article/1049648-overview
• Ziemann, J., Lendeckel, A., Müller, S., Horneber, M., & Ritter, C. A. (2019). Herb-drug interactions: A novel algorithm-assisted information system for pharmacokinetic drug interactions with herbal supplements in cancer treatment. European Journal of Clinical Pharmacology, 75(9), 1237–1248. https://doi.org/10.1007/s00228-019-02700-6

Background

A variety of tools and methods are utilized to measure the extent of ADEs. Depending on what is being measured, some methods are better suited for certain types of events than others. For example, some methods detect events regardless of harm, while others detect only harmful events – ADEs (Institute of Medicine 2007). Different approaches are needed to detect errors in research versus clinical practice. Different methods, or a variation of the same method, are utilized in inpatient versus outpatient care (Hanlon et al., 2001).

Aim

The aim of this chapter is to examine methodologies for detecting adverse drug events and medication errors, analyze what type of events they detect, and discuss their advantages and limitations.

Methods

Terminology and Definitions

Box 1 Definitions of an adverse drug event and a medication error

An adverse drug event is defined as any harm caused by medication use (Nebeker et al., 2004).

Medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm (NCC MERP, 2001).

In this review, we use the terms “incident”, “event”, “medication error” and “adverse drug event” (ADE) to describe medication safety events. These events vary in their preventability and harm. ADEs can be potential, meaning an event that has the potential to cause patient harm. Actual ADEs have reached the patient and caused some grade of harm (Bates, Boyle, et al., 1995). All potential ADEs are preventable, while actual ADEs can be preventable or non-preventable. Actual ADEs were considered preventable if they resulted from a medication error (e.g., liver damage caused by administering the wrong dose of paracetamol), or non-preventable if they did not result from a medication error (and were thus attributable to adverse drug reactions e.g., harm occurred at doses normally used in patients).

The correlation between medication errors and adverse drug events is somewhat tricky to separate, but important to distinguish. Figure 1 illustrates the terms “medication errors”, “actual ADEs” (preventable/non-preventable) and “potential ADEs”. Essentially, medication error does not necessarily imply harm. Only a small number of medication errors are actual ADEs, while all potential ADEs are medication errors. Which also means that, fortunately, only a small number of medication errors reach the patient and cause some grade of harm.

Results

Discussion

A comparison of different methods reveals that they vary in the number and type of events they can detect. This is best illustrated in a study performed in 36 hospitals and skilled-nursing facilities that compared three methods for medication error detection, and found that direct observation was more efficient and accurate than reviewing charts and incident reports. It is a well-established fact that chart reviews and incident reporting underestimate the true rates of medication errors (Meyer-Massetti et al., 2011; Westbrook et al., 2015), while the method that detects the highest number of medication errors is direct observation (Barker & Allan, 1995). Nevertheless, observation was least effective for detecting ADEs (Maaskant et al., 2018) when compared to other methods.

While known as a low-cost method that provides rich data within or across healthcare systems or nationwide, incident reporting detected the least number of ADEs, and is thus not suited to establish ADE rates.

Chart review has been the most effective method for ADE detection in the majority of studies, however, this requires a trained and experienced reviewer, and is resource intensive. The role of computerized surveillance in detecting ADEs is important, since it integrates comprehensive information sources, and it can identify ADEs missed by clinicians more quickly and inexpensively than other methods. More importantly, there was a poor overlap between ADEs detected with record reviews, computerized surveillance, and incident reporting. The results of our literature review are consistent with prior studies, and confirm the need for complementary detection methods as a standard for measuring ADEs and medication errors.

Conclusion

This review of the pros and cons of current ADEs and medication error detection methodologies can assist and inspire stakeholders to choose the most appropriate methods relevant to their local, regional or national setting. We have discussed how the detection methods vary in their detection rates, cost, time, and resources required. We have exemplified the event types the different methods detect, the ability to detect preventable events, and their ability to limit harm.The low number of studies from the outpatient setting highlights the research and knowledge gaps of detecting methods for adverse drug events in municipal health and care services.

Few medication errors and adverse events are detected using any one method alone, that means that none of the methods can serve as a gold standard, and each method described has its place in monitoring medication safety. The literature supports a combination of methods to be used to detect the diversity of ADEs and medication errors.

One single method cannot detect and measure all medication errors and adverse events. Our discussion of how the current methodologies can detect and measure medication errors – their advantages and limitations – will hopefully expand the toolbox of stakeholders when they set out to learn from the past, and prevent future adverse drug events and medication errors.

References

• Arksey, H., & O’Malley, L. (2005). Scoping studies: towards a methodological framework. International Journal of Social Research Methodology, 8(1), 19–32. https://doi.org/10.1080/1364557032000119616
• Barker, K. N., & Allan, E. L. (1995). Research on drug-use-system errors. American Journal of Health-System Pharmacy, 52(4), 400–403. https://doi.org/10.1093/ajhp/52.4.400
• Bates, D. W., Boyle, D. L., Vander Vliet, M. B., Schneider, J., & Leape, L. (1995). Relationship between medication errors and adverse drug events. Journal of General Internal Medicine. 10(4), 199–205. https://doi.org/10.1007/bf02600255
• Bates, D. W., Cullen, D. J., Laird, N., Petersen, L. A., Small, S. D., Servi, D., Laffel, G., Sweitzer, B. J., Shea, B. F., Hallisey, R., & et al. (1995). Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. Journal of the American Medical Association, 274(1), 29–34. https://doi.org/10.1001/jama.1995.03530010043033
• Bates, D. W., Evans, R. S., Murff, H., Stetson, P. D., Pizziferri, L., & Hripcsak, G. (2003). Detecting adverse events using information technology. Journal of the American Medical Informatics Association, 10(2), 115–128. https://doi.org/10.1197/jamia.m1074
• Bates, D. W., & Singh, H. (2018). Two Decades Since To Err Is Human: An Assessment Of Progress And Emerging Priorities In Patient Safety. Health Affairs (Millwood), 37(11), 1736–1743. https://doi.org/10.1377/hlthaff.2018.0738
• Bengtsson, M., Ekedahl, A.-B. I., & Sjöström, K. (2021). Errors linked to medication management in nursing homes: an interview study. BMC Nursing, 20(1), 69. https://doi.org/10.1186/s12912-021-00587-2
• Boyce, R. D., Perera, S., Nace, D. A., Culley, C. M., & Handler, S. M. (2014). A survey of nursing home physicians to determine laboratory monitoring adverse drug event alert preferences. Applied Clinical Informatics, 5(4), 895–906. https://doi.org/10.4338/aci-2014-06-ra-0053
• Christiansen, A. B., Simonsen, S., & Nielsen, G. A. (2021). Patients Own Safety Incidents Reports to the Danish Patient Safety Database Possess a Unique but Underused Learning Potential in Patient Safety. Journal of Patient Safety, 17(8), e1480-e1487. https://doi.org/10.1097/pts.0000000000000604
• Classen, D. C., Resar, R., Griffin, F., Federico, F., Frankel, T., Kimmel, N., Whittington, J. C., Frankel, A., Seger, A., & James, B. C. (2011). ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Affairs (Millwood), 30(4), 581–589. https://doi.org/10.1377/hlthaff.2011.0190
• Dabba, K., Elswood, M., Ameer, A., Gerrett, D., & Maidment, I. (2019). A mixed methods analysis of clozapine errors reported to the National Reporting and Learning System. Pharmacoepidemiology and Drug Safety, 28(5), 657–664. https://doi.org/10.1002/pds.4727
• Donaldson, L. J., Kelley, E. T., Dhingra-Kumar, N., Kieny, M. P., & Sheikh, A. (2017). Medication Without Harm: WHO’s Third Global Patient Safety Challenge. Lancet, 389(10080), 1680–1681. https://doi.org/10.1016/s0140-6736(17)31047-4
• Doupi, P., Svaar, H., Bjørn, B., Deilkås, E., Nylén, U., & Rutberg, H. (2015). Use of the Global Trigger Tool in patient safety improvement efforts: Nordic experiences. Cognition, Technology & Work, 17(1), 45–54. https://doi.org/10.1007/s10111-014-0302-2
• Erstad, B. L., Patanwala, A. E., & Theodorou, A. A. (2012). Comparison of methods for the detection of medication safety events in the critically ill. Current Drug Safety, 7(3), 238–246. https://doi.org/10.2174/157488612803251270
• Ferranti, J., Horvath, M. M., Cozart, H., Whitehurst, J., & Eckstrand, J. (2008). Reevaluating the safety profile of pediatrics: a comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment. Pediatrics, 121(5), e1201–1207. https://doi.org/10.1542/peds.2007-2609
• Fialová, D., & Onder, G. (2009). Medication errors in elderly people: contributing factors and future perspectives. British Journal of Clinical Pharmacology, 67(6), 641–645. https://doi.org/10.1111/j.1365-2125.2009.03419.x
• Field, T. S., Gurwitz, J. H., Harrold, L. R., Rothschild, J. M., Debellis, K., Seger, A. C., Fish, L. S., Garber, L., Kelleher, M., & Bates, D. W. (2004). Strategies for Detecting Adverse Drug Events among Older Persons in the Ambulatory Setting. Journal of the American Medical Informatics Association, 11(6), 492–498. https://doi.org/10.1197/jamia.M1586
• Flynn, E. A., Barker, K. N., Pepper, G. A., Bates, D. W., & Mikeal, R. L. (2002). Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. American Journal of Health-System Pharmacy 59(5), 436–446. https://doi.org/10.1093/ajhp/59.5.436
• Franklin, B. D., Birch, S., Savage, I., Wong, I., Woloshynowych, M., Jacklin, A., & Barber, N. (2009). Methodological variability in detecting prescribing errors and consequences for the evaluation of interventions. Pharmacoepidemiology and Drug Safety, 18(11), 992–999. https://doi.org/10.1002/pds.1811
• Franklin, B. D., Birch, S., Schachter, M., & Barber, N. (2010). Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: a pilot study. International Journal of Pharmacy Practice, 18(5), 305–311. https://doi.org/10.1111/j.2042-7174.2010.00058.x
• Govindan, M., Van Citters, A. D., Nelson, E. C., Kelly-Cummings, J., & Suresh, G. (2010). Automated detection of harm in healthcare with information technology: a systematic review. Quality & Safety in Health Care, 19(5), e11. https://doi.org/10.1136/qshc.2009.033027
• Griffin, F. A., & Resar, R. K. IHI Global Trigger Tool for Measuring Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement. 2009. Avaliable: http://www.ihi.org/resources/Pages/IHIWhitePapers/IHIGlobalTriggerToolWhitePaper.aspx [Accessed 05 Nov 2021].
• Handler, S. M., & Hanlon, J. T. (2010). Detecting Adverse Drug Events Using a Nursing Home Specific Trigger Tool. Annals of Long-term Care, 18(5), 17–22.
• Hanlon, J. T., Maher, R. L., Lindblad, C. I., Ruby, C. M., Twersky, J., Cohen, H. J., & Schmader, K. E. (2001). Comparison of methods for detecting potential adverse drug events in frail elderly inpatients and outpatients. American Journal of Health-System Pharmacy, 58(17), 1622–1626. https://doi.org/10.1093/ajhp/58.17.1622
• Hanskamp-Sebregts, M., Zegers, M., Vincent, C., van Gurp, P. J., de Vet, H. C., & Wollersheim, H. (2016). Measurement of patient safety: a systematic review of the reliability and validity of adverse event detection with record review. BMJ Open, 6(8), e011078. https://doi.org/10.1136/bmjopen-2016-011078
• Hibbert, P. D., Molloy, C. J., Hooper, T. D., Wiles, L. K., Runciman, W. B., Lachman, P., Muething, S. E., & Braithwaite, J. (2017). The application of the Global Trigger Tool: a systematic review. International Journal for Quality in Health Care, 28(6), 640–649. https://doi.org/10.1093/intqhc/mzw115
• Honigman, B., Lee, J., Rothschild, J., Light, P., Pulling, R. M., Yu, T., & Bates, D. W. (2001). Using computerized data to identify adverse drug events in outpatients. Journal of the American Medical Informatics Association, 8(3), 254–266. https://doi.org/10.1136/jamia.2001.0080254
• Hwang, J. I., Chin, H. J., & Chang, Y. S. (2014). Characteristics associated with the occurrence of adverse events: a retrospective medical record review using the Global Trigger Tool in a fully digitalized tertiary teaching hospital in Korea. Journal of Evaluation in Clinical Practice, 20(1), 27–35. https://doi.org/10.1111/jep.12075
• Institute of Medicine (2007). Preventing Medication Errors. The National Academies Press. https://doi.org/10.17226/11623
• Jha, A. K., Kuperman, G. J., Teich, J. M., Leape, L., Shea, B., Rittenberg, E., Burdick, E., Seger, D. L., Vander Vliet, M., & Bates, D. W. (1998). Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. Journal of the American Medical Informatics Association, 5(3), 305–314. https://doi.org/10.1136/jamia.1998.0050305
• Kapoor, A., Field, T., Handler, S., Fisher, K., Saphirak, C., Crawford, S., Fouayzi, H., Johnson, F., Spenard, A., Zhang, N., & Gurwitz, J. H. (2019). Adverse Events in Long-term Care Residents Transitioning From Hospital Back to Nursing Home. JAMA Internal Medicine, 179(9), 1254–1261. https://doi.org/10.1001/jamainternmed.2019.2005
• Kennerly, D. A., Saldaña, M., Kudyakov, R., da Graca, B., Nicewander, D., & Compton, J. (2013). Description and evaluation of adaptations to the global trigger tool to enhance value to adverse event reduction efforts. Journal of Patient Safety, 9(2), 87–95. https://doi.org/10.1097/PTS.0b013e31827cdc3b
• Kilbridge, P. M., Campbell, U. C., Cozart, H. B., & Mojarrad, M. G. (2006). Automated surveillance for adverse drug events at a community hospital and an academic medical center. Journal of the American Medical Informatics Association, 13(4), 372–377. https://doi.org/10.1197/jamia.M2069
• Kinnunen‐Luovi, K., Saarnio, R., & Isola, A. (2014). Safety incidents involving confused and forgetful older patients in a specialised care setting–analysis of the safety incidents reported to the HaiPro reporting system. Journal of Clinical Nursing, 23(17–18), 2442–2450.
• Larson, C. M., & Saine, D. (2013). Medication Safety Officer’s Handbook. American Society of Health-System Pharmacists, Bethesda, MD.
• Leape, L. L. (2002). Reporting of adverse events. New England Journal of Medicine, 347(20), 1633–1638. https://doi.org/10.1056/NEJMNEJMhpr011493
• Levac, D., Colquhoun, H., & O’Brien, K. K. (2010). Scoping studies: advancing the methodology. Implementation Science, 5(1), 69. https://doi.org/10.1186/1748-5908-5-69
• McCambridge, J., Witton, J., & Elbourne, D. R. (2014). Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. Journal of clinical epidemiology, 67(3), 267–277. https://doi.org/10.1016/j.jclinepi.2013.08.015
• Melton, G. B., & Hripcsak, G. (2005). Automated detection of adverse events using natural language processing of discharge summaries. Journal of the American Medical Informatics Association, 12(4), 448–457. https://doi.org/10.1197/jamia.M1794
• Meyer-Massetti, C., Cheng, C. M., Schwappach, D. L. B., Paulsen, L., Ide, B., Meier, C. R., & Guglielmo, B. J. (2011). Systematic review of medication safety assessment methods. American Journal of Health-System Pharmacy, 68(3), 227–240. https://doi.org/10.2146/ajhp100019
• Mulac, A. (2022). Medication errors in hospitals: Exploring medication safety through incident reports and observation of practice. Chapter 1.3–1.4. 5–14. [Doctoral thesis, University of Oslo]. https://www.duo.uio.no/handle/10852/93260
• Mulac, A., Mathiesen, L., Taxis, K., & Granas, A. G. (2021). Barcode medication administration technology use in hospital practice: a mixed-methods observational study of policy deviations. BMJ Quality & Safety, 30(12), 1021–1030. https://doi.org/10.1136/bmjqs-2021-013223
• Mulac, A., Taxis, K., Hagesaether, E., & Gerd Granas, A. (2021). Severe and fatal medication errors in hospitals: findings from the Norwegian Incident Reporting System. Eur J Hosp Pharm, 28(Suppl 2), e56–e61. https://doi.org/10.1136/ejhpharm-2020-002298
• Mulac, A., Taxis, K., Hagesaether, E., & Granas, A. G. (2020). Severe and fatal medication errors in hospitals: findings from the Norwegian Incident Reporting System. European Journal of Hospital Pharmacy, 28(Suppl 2), e56–e61. https://doi.org/10.1136/ejhpharm-2020-002298
• Maaskant, J. M., Smeulers, M., Bosman, D., Busink, A., van Rijn-Bikker, P., van Aalderen, W., & Vermeulen, H. (2018). The Trigger Tool as a Method to Measure Harmful Medication Errors in Children. Journal of Patient Safety, 14(2), 95–100. https://doi.org/10.1097/pts.0000000000000177
• NCC MERP. (2001). National Coordinating Council for Medication Error Reporting and Prevention. Index for Categorizing Medication Errors. https://www.nccmerp.org/about-medication-errors
• Nebeker, J. R., Barach, P., & Samore, M. H. (2004). Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Annals of Internal Medicine, 140(10), 795–801. https://doi.org/10.7326/0003-4819-140-10-200405180-00009
• Nwulu, U., Nirantharakumar, K., Odesanya, R., McDowell, S. E., & Coleman, J. J. (2013). Improvement in the detection of adverse drug events by the use of electronic health and prescription records: an evaluation of two trigger tools. European Journal of Clinical Pharmacology, 69(2), 255–259. https://doi.org/10.1007/s00228-012-1327-1
• O’Leary, K. J., Devisetty, V. K., Patel, A. R., Malkenson, D., Sama, P., Thompson, W. K., Landler, M. P., Barnard, C., & Williams, M. V. (2013). Comparison of traditional trigger tool to data warehouse based screening for identifying hospital adverse events. BMJ Quality & Safety, 22(2), 130–138. https://doi.org/10.1136/bmjqs-2012-001102
• Olsen, S., Neale, G., Schwab, K., Psaila, B., Patel, T., Chapman, E. J., & Vincent, C. (2007). Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real-time record review may all have a place. Quality & Safety in Health Care, 16(1), 40–44. https://doi.org/10.1136/qshc.2005.017616
• Rochefort, C. M., Buckeridge, D. L., & Forster, A. J. (2015a). Accuracy of using automated methods for detecting adverse events from electronic health record data: a research protocol. Implementation Science, 10, 5. https://doi.org/10.1186/s13012-014-0197-6
• Rochefort, C. M., Buckeridge, D. L., & Forster, A. J. (2015b). Accuracy of using automated methods for detecting adverse events from electronic health record data: a research protocol. Implementation Science, 10, 5. https://doi.org/10.1186/s13012-014-0197-6
• Schildmeijer, K. G., Nilsson, L., Arestedt, K., & Perk, J. (2013). The assessment of adverse events in medical care; lack of consistency between experienced teams using the Global Trigger Tool. BMJ Quality & Safety, 22(3), 271–272. https://doi.org/10.1136/bmjqs-2012-001587
• Stockwell, D. C., & Kane-Gill, S. L. (2010). Developing a patient safety surveillance system to identify adverse events in the intensive care unit. Critical Care Medicine, 38(6 Suppl), S117–125. https://doi.org/10.1097/CCM.0b013e3181dde2d9
• Tinoco, A., Evans, R. S., Staes, C. J., Lloyd, J. F., Rothschild, J. M., & Haug, P. J. (2011). Comparison of computerized surveillance and manual chart review for adverse events. Journal of the American Medical Informatics Association, 18(4), 491–497. https://doi.org/10.1136/amiajnl-2011-000187
• von Plessen, C., Kodal, A. M., & Anhøj, J. (2012). Experiences with global trigger tool reviews in five Danish hospitals: an implementation study. BMJ Open, 2(5). https://doi.org/10.1136/bmjopen-2012-001324
• Weissman, J. S., Schneider, E. C., Weingart, S. N., Epstein, A. M., David-Kasdan, J., Feibelmann, S., Annas, C. L., Ridley, N., Kirle, L., & Gatsonis, C. (2008). Comparing patient-reported hospital adverse events with medical record review: do patients know something that hospitals do not? Annals of Internal Medicine, 149(2), 100–108. https://doi.org/10.7326/0003-4819-149-2-200807150-00006
• Westbrook, J. I., Li, L., Lehnbom, E. C., Baysari, M. T., Braithwaite, J., Burke, R., Conn, C., & Day, R. O. (2015). What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system. International Journal for Quality in Health Care, 27(1), 1–9. https://doi.org/10.1093/intqhc/mzu098
• Yun, I. S., Koo, M. J., Park, E. H., Kim, S. E., Lee, J. H., Park, J. W., & Hong, C. S. (2012). A comparison of active surveillance programs including a spontaneous reporting model for phamacovigilance of adverse drug events in a hospital. Korean Journal of Internal Medicine, 27(4), 443–450. https://doi.org/10.3904/kjim.2012.27.4.443

Method

Results

Figure 1 shows the study flow diagram. The search strategy yielded 715 studies, of which 108 were duplicates. In total, 550 studies were excluded based on their title or abstract, and 39 studies were excluded following full-text review for eligibility. In total, 18 studies were included for analysis in this review.

Characteristics of Studies

Table 2 shows the characteristics of the included studies and the study sample. Two studies presented results from the same RCT (Blank et al., 2011; Blank et al., 2014), resulting in 17 RCTs to analyze. Study designs included two-armed (n = 14), three-armed (n = 3), cluster (n = 3), and pilot RCTs (n = 4). Clusters were determined by geographical location or health center (Amado Guirado et al., 2011; Lewis et al., 2016; Persell et al., 2018; Shen et al., 2021). The studies were conducted in 13 different countries, predominantly the USA (n = 5), and China (n = 4). Total study sample was 4,654 participants, with an average of 274 study subjects (standard deviation, SD 295) randomized to intervention or control groups. Overall loss to follow-up was 686 study subjects (14.7%), ranging from 0 to 154 subjects. The mean age of the study subjects at baseline was 56.2 years (SD 14.4), and varied from 28.7 years (Chien et al., 2015) to 80.7 (Liang et al., 2021). The study sample was diverse in terms of health conditions, with hypertension most frequently represented (n = 8), followed by HIV (n = 3). Other health conditions were “mental illness”, schizophrenia, inflammatory bowel disease, long-term diseases in general, coronary heart disease, diabetes mellitus, and upper extremity fragility fracture.

Table 2. Characteristics of the Included Studies and Participants

Abbreviations: RCT, randomized controlled trial; NA, not available; HIV, human immunodeficiency virus.
^aMean age of study participants at baseline in intervention and comparison groups combined.
^bHealth condition of study participants that was an inclusion criterion.
^cTwo articles published on the same intervention.

Characteristics of Nurse-Led Interventions

Table 3 shows an overview of the nurse-led interventions in the included studies. Overall, the nurse-led interventions were complex, with a variety of components that typically included personalized health or medication information (oral, written and/or digital), education, consultation, counseling and/or motivational interviewing performed by nurses in primary health clinics or home visits. eHealth components, that is information and communication technology in support of health education and/or health and medication management, were used in seven studies (Cicolini et al., 2014; Del Hoyo et al., 2018; Liang et al., 2021; Persell et al., 2018; Shen et al., 2021; Still et al., 2020; Wakefield et al., 2011). The eHealth intervention elements ranged in complexity, from relatively simple e-mail alerts (Cicolini et al., 2014) and apps (Del Hoyo et al., 2018), to a complex integrated tele-homecare program including a smartphone, blood pressure monitor, medication dispenser, glucometer and a necklace emergency call button (Liang et al., 2021). Adherence aids were used in six interventions (Blank et al., 2014; Del Hoyo et al., 2018; Kolcu & Ergun, 2020; Liang et al., 2021; Simoni et al., 2011; Still et al., 2020).

The interventions in 14 of the RCTs included strategies to change behavior, like motivational interviewing (n = 3), counseling sessions (n = 5), habit-based interventions comprising digital alerts and tools (n = 6), or adherence tools like pillbox organizers or reminder alarms (n = 6), and different combinations of these. Additionally, strategies to increase knowledge were used, like patient education on health and medicines, and psychoeducation (n = 13). In two studies, knowledge increasing strategies were the main intervetion components (Adeyemo et al., 2013; Amado Guirado et al., 2011), and one study used a knowledge strategy involving monitoring key clinical symptoms combined with education and advice (Wakefield et al., 2011).

Table 3. Characteristics of the Nurse-Led Interventions and Synthesis of Intervention Effects on Adherence and Clinical Outcomes

Abbreviations: ART, antiretroviral therapy; BMI, body mass index; BP, blood pressure; C, control; ED, emergency department; EDM, electronic drug monitoring; HbA1c, haemoglobin A1c; HIV, human immunodeficiency virus; I, intervention; LDL, low density lipoprotein; MMAS, the Morisky medication adherence scale; RCT, randomized controlled trial; QoL, quality of life.
^aPrimary (1^o) and secondary (2^o) outcomes are specified, if defined by the study authors.
^bTwo articles published on the same intervention.

Interventions appeared to be time-consuming, but time was not reported, and no economic analyses were located.

Effect on Medication Adherence

Table 2 shows an overview of adherence measurements used and the interventions’ effects on adherence. Adherence was the primary outcome measure in 13 out of the 17 RCTs (72.2%). Both subjective and objective measures were used, including self-reported adherence scales or questionnaires, pill counts, plasma/urine levels of medication/tracer, medication event monitoring systems (MEMS), and electronic pharmacy refill records. The most commonly used measure was subjective self-reported adherence (n = 14, 82.3%). Two or more adherence measures were used in six studies out of the 17 (35.3%) (Adeyemo et al., 2013; Amado Guirado et al., 2011; Mayer et al., 2017; McAlister et al., 2019; Simoni et al., 2011; Still et al., 2020).

Of the 17 included RCTs, four (23.5%) reported a statistically significant effect of nurse-led interventions on adherence (Chien et al., 2015; Kolcu & Ergun, 2020; Ma et al., 2014; Shen et al., 2021). These interventions targeted behavior and knowledge. The intervention components in these RCTs were: motivational interviewing, pillbox organizers, patient education, and eHealth. Duration of the intervention ranged from 3 to 6 months, and involved antipsychotics, antihypertensive agents, and unspecified agents for treatment of coronary heart disease. A common feature of these four studies was that the nurses’ contribution to the intervention was substantial, in terms of scope and time used on repetitive educational and/or behavioral intervention elements. For example, in the study by Shen and co-workers, the nurses provided six sessions over 12 weeks including health education and behavioral/skills, combined with participant interaction onsite (quizzes, seminars, simulation), regular telephone interaction, and continual online interaction via a social media platform (Shen et al., 2021). In the adherence therapy program described in Chien et al. (2015), nurses provided two hours of in-home motivational interview-based adherence therapy every two weeks for four months.

None of the included RCTs had a negative impact on adherence measures.

Effects on Clinical Outcomes

Seven (41.2%) of the included RCTs reported a statistically significant effect of the intervention on clinical outcomes when compared with control arms (Chien et al., 2015; Cicolini et al., 2014; Kolcu & Ergun, 2020; Liang et al., 2021; Ma et al., 2014; Shen et al., 2021; Wakefield et al., 2011). Table 3 presents an overview of clinical measurements and outcomes of the included studies. The nurse-led interventions on patients living in the community reduced systolic blood pressure (BP) (n = 5) (Cicolini et al., 2014; Kolcu & Ergun, 2020; Ma et al., 2014; Shen et al., 2021; Wakefield et al., 2011), reduced body mass index (BMI) and/or cholesterol concentrations (Cicolini et al., 2014; Shen et al., 2021), and increased quality of life (QoL) (Kolcu & Ergun, 2020), among hypertensive patients. Statistically significant positive effects on symptom severity and reduced numbers of readmissions among outpatients with schizophrenia (Chien et al., 2015), reduction in emergency department (ED) visits among patients with multiple long-term conditions (Liang et al., 2021), and reduction in haemoglobin A1c (HbA1c) among patients with diabetes (Wakefield et al., 2011), were also reported.

Risk of Bias and Quality of Studies

Figure 2 shows the risk of bias (RoB) analysis results of the individual studies. All studies have a high RoB in at least one dimension, most commonly in blinding of participants and/or researchers (15 studies), since the nature of interventions rarely allowed for blinding. Of note, 12 studies gave no information on blinding of outcome assessment and were assessed as unclear RoB. All included studies are defined by the study authors to have an RCT design, however, in one study the randomization was insufficiently described and was assessed to have a high RoB (Amado Guirado et al., 2011). Additionally, the randomization procedure was described vaguely in five studies (Adeyemo et al., 2013; Liang et al., 2021; Persell et al., 2018; Shen et al., 2021; Usher et al., 2013), which were therefore assessed to have an unclear RoB. A high risk of attrition bias was detected in four studies (Blank et al., 2011; Mayer et al., 2017; Simoni et al., 2011; Wakefield et al., 2011), mainly due to high attrition (>20%) in combination with unbalanced attrition between intervention and comparison groups. A medium or lower overall attrition (<20%), but unbalanced between groups, was classified as an unknown RoB, concerning two studies (Liang et al., 2021; Shen et al., 2021). Most studies had a low risk of reporting bias (n = 11), and four studies had an unclear risk of reporting bias due to for example, not showing a study flow diagram or not giving detailed data on adherence (Blank et al., 2011; Mayer et al., 2017; Simoni et al., 2011; Still et al., 2020). Two studies had a high risk of reporting bias due to missing data on adherence outcomes, and/or study flow diagrams, and/or study participants’ health characteristics (Usher et al., 2013; Wakefield et al., 2011). A high risk of other bias was detected in nine studies, due to low statistical power (small sample sizes, pilot studies), or unbalanced study participant groups likely influencing outcomes.

Figure 3 shows the cumulative risk of bias in the included studies, illustrating the overall quality of evidence in this systematic review. In total, a low RoB was observed in 45% of the dimensions, whereas a high RoB was observed in 30% of the dimensions.

Discussion

In this systematic review, we identified and assessed 17 RCTs describing nurses’ involvement in aiding adherence and clinical outcomes. Interventions typically targeted adherence through behavior and/or knowledge of health and medicines, with components and combinations of motivational interviewing, counseling, education, adherence tools, and eHealth. Four (23.5%) and seven (41.2%) out of the 17 RCTs reported statistically significant effects on adherence and clinical outcomes, respectively, when compared with control arms. The interventions that improved adherence entailed substantial contributions from nurses, in terms of using several interventional components and the time used in the intervention. Diversity in design and conduct of the RCTs precluded any meta-analysis of the reported nurse-led interventions.

The extent to which patients adhere to the recommendations for prescribed medications, greatly impacts health and healthcare expenditure (Cutler et al., 2018; Sabaté, 2003). Hence, adherence served as a natural primary outcome measure for this review. Additionally, we synthesized nurse-led intervention effects on clinical outcomes, which might serve as an indirect measure of whether patients adhere to treatment. Furthermore, it is important to review existing research evidence on nurses’ contributions to patients’ health in a community setting, to pinpoint measures that have been shown to be useful, and to highlight areas of interest and make recommendations for further research.

Of the 17 RCTs in this review, only four (23.5%) reported significant effect estimates on adherence, and concomitantly they reported significant effects on clinical outcomes. However, seven (41.2%) of the RCTs showed significant positive effects on clinical outcomes or surrogate endpoints, such as BP, BMI, HbA1c, and cholesterol-levels. One trial (Liang et al., 2021) demonstrated a reduction in ED visits, and one a reduction in re-hospitalization (Chien et al., 2015). The lack of statistically significant intervention effects might be attributed to insufficient sample sizes in some studies: five had fewer than 100 participants (Del Hoyo et al., 2018; Kolcu & Ergun, 2020; Mayer et al., 2017; Simoni et al., 2011; Still et al., 2020). However, some studies used continuous outcome measures, which can indicate a statistically significant difference with relatively small sample sizes. Adherence was a secondary outcome in four RCTs, hence the interventions were not primarily designed to enhance adherence. Furthermore, there are challenges in measuring adherence as there is no single gold standard measure, and a mixed-method approach is recommended (Lam & Fresco, 2015; Nguyen et al., 2014). Among the RCTs in this review, only six (35.3%) used a mixed-method approach, as recommended (Lam & Fresco, 2015). However, none of these studies detected statistically significant effects. Crucial in detecting intervention effects is quality in study design. This may have affected outcome measures in the RCTs in this review, as all studies had issues regarding risk of bias. Consequently, results should be interpreted with caution.

Two previous systematic reviews have investigated nurse-led interventions on improving adherence, focusing on discharged older adults (Verloo et al., 2017), and long-term medications (Van Camp et al., 2013). The latter review identified ten studies published from 2006 to 2011, where five studies reported significant effects on short and/or long-term adherence to long-term medications. In contrast to our review, Van Camp and co-authors reported odds ratios and pooled mean differences in adherence between intervention and control arms, revealing that nurses can enhance adherence in this population. However, the generalizability is limited, since seven of the ten studies involved only HIV-positive patients (Van Camp et al., 2013). Furthermore, the review states that nursing interventions for tackling non-adherence must be multifaceted and tailored, with continuous efforts and follow-up of patients (Van Camp et al., 2013), a conclusion that is supported by the results of this review. This review endorses these conclusions: to ensure the correct and safe use of medicines, several strategies – multifaceted and multitargeted – are needed (Cross et al., 2020; Jordan et al., 2021; Khalil et al., 2017; Ryan et al., 2014; World Health Organization (WHO), 2017).

Verloo and co-authors reviewed 14 studies published between 1989–2015 that included nurse-led (n = 7) or nurse-collaborative (n = 7) interventions. The population primarily consisted of discharged older inpatients with cardiovascular diseases (n = 8), and post-surgical patients from hospital geriatric and internal medicine units (n = 4) (Verloo et al., 2017). Hence, the patients and contexts differed from this review. In further contrast, Verloo et al. detected a relatively high proportion of interventions that significantly increased adherence (57.1%, 8 of 14 studies) (Verloo et al., 2017). In line with our results, Verloo et al. describes heterogeneity between studies regarding design and type of intervention, and relative low quality of evidence (Verloo et al., 2017). Low quality of evidence in studies investigating adherence interventions has been described previously in several reviews, due to heterogeneity and the methodological limitations of the studies (Conn & Ruppar, 2017; Cross et al., 2020; Sletvold et al., 2020).

The overall effect of nursing on health outcomes in the community is of interest, and this review found that nurses can play an important role in patients’ clinical outcomes, particularly surrogate markers, such as BP. To make an impact on patient-focused outcomes of pharmacotherapy, increased engagement among healthcare professionals, including nurses, is necessary, and may be facilitated by nurse-led approaches (Jordan et al., 2021). An overview of research evidence by Coster et al., indicates moderate evidence for nurses being able to produce health outcomes that are equivalent to those of doctors, for patients with long-term conditions, particularly in primary care (Coster et al., 2018). Furthermore, a meta-analysis found that modest but significant improvements in patient-centered outcomes (knowledge of medications, QoL, physical functioning and symptoms) followed adherence interventions (Conn et al., 2016). This review adds to this evidence: in some trials, nursing-led adherence interventions contributed to improvement in patients’ BP, BMI, HbA1c, and cholesterol-levels, when compared with controls in the community. In two trials, adherence interventions in primary care reduced the demands on secondary healthcare (Chien et al., 2015; Liang et al., 2021). Both these interventions were high intensity. Further research might consider investigating if intensity of interventions is associated with effectiveness of outcomes.

Strengths and Limitations

The major strength of this review is the systematic approach in all parts of the study, from search strategy, study selection, results extraction, to assessment of quality. Furthermore, we included studies covering adult patients with a wide age range, a variety of health conditions, and studies were performed in diverse community settings. Both adherence and clinical outcomes are reported, which might enhance the transferability of findings.

The main limitation of this review is publication bias, since we did not search for grey literature or unpublished reports. Furthermore, the evidence is limited to articles published between 2011 and 2021 and includes only adults (≥18 years old). This review is solely based on the results presented in the published articles, hence there was no contact with corresponding authors to provide additional information that could have improved the result synthesis.

In the study selection process, the exclusion of irrelevant studies through perusal of the titles and abstracts was done by one researcher only, which may have resulted in missing studies. However, the reviewer has substantial experience in relevance screening for systematic reviews (three peer-reviewed systematic reviews published in scientific journals the last four years), which is suggested to be an acceptable approach (Waffenschmidt et al., 2019). Single researcher evaluation of study quality may pose a risk of misclassification, and is a study limitation.

The diverse nature of the studies precluded a numerical analysis, and studies are reported narratively. The time spent on these interventions was not costed, and no economic analysis could be attempted. No studies indicated whether any nursing tasks were delegated or omitted to allow nurses to complete these interventions. Given the global shortages in the nursing workforce, the impact of interventions on all aspects of nursing care warrants attention.

Conclusion

This systematic review provides updated and expanded knowledge on the impact of nurses on the correct use of medications among community-based patients. Low-quality evidence, as assessed in line with GRADE criteria (Schünemann, 2013), suggests that nurse-led interventions may improve medication adherence and clinical outcomes in community care. Interventions are typically multifaceted, targeting adherence through behavior and knowledge strategies, and nurses may play a significant role. However, to increase confidence in the effectiveness of these interventions, further high-quality studies reporting clinical outcomes and cost-effectiveness are needed.

References

• Adeyemo, A., Tayo, B. O., Luke, A., Ogedegbe, O., Durazo-Arvizu, R., Cooper, R. S., Adeyemo, A., Tayo, B. O., Luke, A., Ogedegbe, O., Durazo-Arvizu, R., & Cooper, R. S. (2013). The Nigerian antihypertensive adherence trial: A community-based randomized trial. Journal of Hypertension, 31(1), 201–207. https://doi.org/10.1097/HJH.0b013e32835b0842
• Amado Guirado, E., Pujol Ribera, E., Pacheco Huergo, V., & Borras, J. M. (2011). Knowledge and adherence to antihypertensive therapy in primary care: Results of a randomized trial. Gaceta Sanitaria, 25(1), 62–67. https://doi.org/10.1016/j.gaceta.2010.09.015
• Assiri, G. A., Shebl, N. A., Mahmoud, M. A., Aloudah, N., Grant, E., Aljadhey, H., & Sheikh, A. (2018). What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of the international literature. BMJ Open, 8(5), e019101. https://doi.org/10.1136/bmjopen-2017-019101
• Blank, M. B., Hanrahan, N. P., Fishbein, M., Wu, E. S., Tennille, J. A., Ten Have, T. R., Kutney-Lee, A. M., Gross, R., Hines, J. M., Coyne, J. C., & Aiken, L. H. (2011). A randomized trial of a nursing intervention for HIV disease management among persons with serious mental illness. Psychiatric Services (Washington, D.C.), 62(11), 1318–1324. https://dx.doi.org/10.1176/ps.62.11.pss6211_1318
• Blank, M. B., Hennessy, M., & Eisenberg, M. M. (2014). Increasing quality of life and reducing HIV burden: The PATH+ intervention [Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural]. AIDS and behavior, 18(4), 716‐725. https://doi.org/10.1007/s10461-013-0606-x
• Celio, J., Ninane, F., Bugnon, O., & Schneider, M. P. (2018). Pharmacist-nurse collaborations in medication adherence-enhancing interventions: A review. Patient Education and Counseling, 101(7), 1175–1192. https://doi.org/10.1016/j.pec.2018.01.022
• Chien, W. T., Mui, J. H. C., Cheung, E. F. C., & Gray, R. (2015). Effects of motivational interviewing-based adherence therapy for schizophrenia spectrum disorders: A randomized controlled trial. Trials, 16(1), 270. http://dx.doi.org/10.1186/s13063-015-0785-z
• Cicolini, G., Simonetti, V., Comparcini, D., Celiberti, I., Di Nicola, M., Capasso, L. M., Flacco, M. E., Bucci, M., Mezzetti, A., & Manzoli, L. (2014). Efficacy of a nurse-led email reminder program for cardiovascular prevention risk reduction in hypertensive patients: A randomized controlled trial. International Journal of Nursing Studies, 51(6), 833–843. https://doi.org/10.1016/j.ijnurstu.2013.10.010
• Conn, V. S., & Ruppar, T. M. (2017). Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Preventive Medicine, 99, 269–276. https://doi.org/10.1016/j.ypmed.2017.03.008
• Conn, V. S., Ruppar, T. M., Enriquez, M., & Cooper, P. S. (2016). Patient-centered outcomes of medication adherence interventions: Systematic review and meta-analysis. Value Health, 19(2), 277–285. https://doi.org/10.1016/j.jval.2015.12.001
• Coster, S., Watkins, M., & Norman, I. J. (2018). What is the impact of professional nursing on patients’ outcomes globally? An overview of research evidence. International Journal of Nursing Studies, 78, 76–83. https://doi.org/10.1016/j.ijnurstu.2017.10.009
• Cross, A. J., Elliott, R. A., Petrie, K., Kuruvilla, L., & George, J. (2020). Interventions for improving medication-taking ability and adherence in older adults prescribed multiple medications. Cochrane Database of Systematic Reviews, 5(5), Cd012419. https://doi.org/10.1002/14651858.CD012419.pub2
• Cutler, R. L., Fernandez-Llimos, F., Frommer, M., Benrimoj, C., & Garcia-Cardenas, V. (2018). Economic impact of medication non-adherence by disease groups: A systematic review. BMJ Open, 8(1), e016982. https://doi.org/10.1136/bmjopen-2017-016982
• Del Hoyo, J., Nos, P., Faubel, R., Muñoz, D., Domínguez, D., Bastida, G., Valdivieso, B., Correcher, M., & Aguas, M. (2018). A web-based telemanagement system for improving disease activity and quality of life in patients with complex inflammatory bowel disease: Pilot randomized controlled trial. Journal of Medical Internet Research, 20(11), e11602. https://doi.org/10.2196/11602
• Haynes, R. B., McDonald, H., Garg, A. X., & Montague, P. (2002). Interventions for helping patients to follow prescriptions for medications. Cochrane Database of Systematic Reviews (2), Cd000011. https://doi.org/10.1002/14651858.Cd000011
• Haynes, R. B., Yao, X., Degani, A., Kripalani, S., Garg, A., & McDonald, H. P. (2005). Interventions to enhance medication adherence. Cochrane Database of Systematic Reviews (4), Cd000011. https://doi.org/10.1002/14651858.CD000011.pub2
• Higgins, J., Thomas, J., Chandler, J., Cumpston, M., T, L., MJ, P., & VA, W. (2021). Cochrane handbook for systematic reviews of interventions. (version 6.2, updated February 2021). Retrieved November 11, 2021, from www.training.cochrane.org/handbook.
• Higgins, J. P., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., & Sterne, J. A. (2011). The Cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ, 343, d5928. https://doi.org/10.1136/bmj.d5928
• Jordan, S., Logan, V., Turner, A., & Hughes, D. (2021). Using nurse-led patient monitoring to avoid medicines-related harm. Nursing Standard, 36(7), 61–66. https://doi.org/10.7748/ns.2021.e11770
• Kardas, P., Lewek, P., & Matyjaszczyk, M. (2013). Determinants of patient adherence: A review of systematic reviews. Frontiers in Pharmacology, 4, 91. https://doi.org/10.3389/fphar.2013.00091
• Khalil, H., Bell, B., Chambers, H., Sheikh, A., & Avery, A. J. (2017). Professional, structural and organisational interventions in primary care for reducing medication errors. Cochrane Database of Systematic Reviews, 10(10), Cd003942. https://doi.org/10.1002/14651858.CD003942.pub3
• Kolcu, M., & Ergun, A. (2020). Effect of a nurse‐led hypertension management program on quality of life, medication adherence and hypertension management in older adults: A randomized controlled trial. Geriatrics & Gerontology International, 20(12), 1182–1189. https://doi.org/10.1111/ggi.14068
• Lam, W. Y., & Fresco, P. (2015). Medication adherence measures: An overview. Biomed Research International, 2015, 217047. https://doi.org/10.1155/2015/217047
• Lewis, H., Kunkel, J., Axten, D., Dalton, J., Gardner, H., Tippett, A., Wynne, S., Wilkinson, M., & Foster, G. R. (2016). Community nurse-led initiation of antiviral therapy for chronic hepatitis C in people who inject drugs does not increase uptake of or adherence to treatment. European Journal of Gastroenterology & Hepatology, 28(11), 1258‐1263. https://doi.org/10.1097/MEG.0000000000000711
• Liang, H. Y., Hann Lin, L., Yu Chang, C., Mei Wu, F., & Yu, S. (2021). Effectiveness of a nurse‐led tele‐homecare program for patients with multiple chronic illnesses and a high risk for readmission: A randomized controlled trial. Journal of Nursing Scholarship, 53(2), 161–170. https://doi.org/10.1111/jnu.12622
• Ma, C., Zhou, Y., Zhou, W., & Huang, C. (2014). Evaluation of the effect of motivational interviewing counselling on hypertension care. Patient Education and Counseling, 95(2), 231–237. https://doi.org/10.1016/j.pec.2014.01.011
• Mayer, K. H., Safren, S. A., Elsesser, S. A., Psaros, C., Tinsley, J. P., Marzinke, M., Clarke, W., Hendrix, C., Wade Taylor, S., Haberer, J., & Mimiaga, M. J. (2017). Optimizing pre-exposure antiretroviral prophylaxis adherence in men who have sex with men: Results of a pilot randomized controlled trial of “Life-steps for PrEP”. AIDS and Behavior, 21(5), 1350–1360. https://doi.org/10.1007/s10461-016-1606-4
• McAlister, F. A., Ye, C., Beaupre, L. A., Rowe, B. H., Johnson, J. A., Bellerose, D., Hassan, I., & Majumdar, S. R. (2019). Adherence to osteoporosis therapy after an upper extremity fracture: A pre-specified substudy of the C-STOP randomized controlled trial. Osteoporosis International, 30(1), 127–134. https://doi.org/10.1007/s00198-018-4702-7
• Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. BMJ, 339, b2535. https://doi.org/10.1136/bmj.b2535
• National Library of Medicine. (2021). The medical subject headings (MeSH) thesaurus. Retrieved October, 2021, from https://www.nlm.nih.gov/mesh/meshhome.html
• Nguyen, T. M., La Caze, A., & Cottrell, N. (2014). What are validated self-report adherence scales really measuring? A systematic review. British Journal of Clinical Pharmacology, 77(3), 427–445. https://doi.org/10.1111/bcp.12194
• Nieuwlaat, R., Wilczynski, N., Navarro, T., Hobson, N., Jeffery, R., Keepanasseril, A., Agoritsas, T., Mistry, N., Iorio, A., Jack, S., Sivaramalingam, B., Iserman, E., Mustafa, R. A., Jedraszewski, D., Cotoi, C., & Haynes, R. B. (2014). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews, 2014(11), Cd000011. https://doi.org/10.1002/14651858.CD000011.pub4
• Persell, S. D., Karmali, K. N., Lazar, D., Friesema, E. M., Lee, J. Y., Rademaker, A., Kaiser, D., Eder, M., French, D. D., Brown, T., & Wolf, M. S. (2018). Effect of electronic health record-based medication support and nurse-led medication therapy management on hypertension and medication self-management: A randomized clinical trial. JAMA Internal Medicine, 178(8), 1069–1077. https://doi.org/10.1001/jamainternmed.2018.2372
• Ruppar, T. M., Conn, V. S., & Russell, C. L. (2008). Medication adherence interventions for older adults: Literature review. Research and Theory for Nursing Practice, 22(2), 114–147.
• Ryan, R., Santesso, N., Lowe, D., Hill, S., Grimshaw, J., Prictor, M., Kaufman, C., Cowie, G., & Taylor, M. (2014). Interventions to improve safe and effective medicines use by consumers: An overview of systematic reviews. Cochrane Database of Systematic Reviews, 2014(4), Cd007768. https://doi.org/10.1002/14651858.CD007768.pub3
• Sabaté, E. (2003). Adherence to long-term therapies:Evidence for action. (ISBN 92 4 154599 2). World Health Organization (WHO). https://apps.who.int/iris/bitstream/handle/10665/42682/9241545992.pdf
• Schünemann, H. B., Jan; Guyatt, Gordon; Oxman, Andrew (2013). The GRADE handbook. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. Updated October 2013. https://gdt.gradepro.org/app/handbook/handbook.html#h.fzuoa9x107cu
• Shen, Q., He, P., Wen, M., Chen, Y., Li, J., Ouyang, X., & Yu, J. (2021). Secondary prevention of coronary heart disease: The effect of a nursing intervention using Cox’s interaction model of client health behaviour. Journal of Advanced Nursing. http://dx.doi.org/10.1111/jan.14930
• Simoni, J. M., Chen, W.-T., Huh, D., Fredriksen-Goldsen, K. I., Pearson, C., Zhao, H., Shiu, C.-S., Wang, X., & Zhang, F. (2011). A preliminary randomized controlled trial of a nurse-delivered medication adherence intervention among HIV-positive outpatients initiating antiretroviral therapy in Beijing, China. AIDS and Behavior, 15(5), 919–929. https://dx.doi.org/10.1007/s10461-010-9828-3
• Singh, P., LeBlanc, P., & King-Shier, K. (2021). Interventions to improve medication adherence in ethnically diverse patients: A narrative systematic review. Journal of Transcultural Nursing, 32(5), 600–613. https://doi.org/10.1177/10436596211017971
• Sletvold, H., Sagmo, L. A. B., & Torheim, E. A. (2020). Impact of pictograms on medication adherence: A systematic literature review. Patient Education and Counseling, 103(6), 1095–1103. https://doi.org/10.1016/j.pec.2019.12.018
• Still, C. H., Margevicius, S., Harwell, C., Huang, M. C., Martin, L., Dang, P. B., & Wright Jnr, J. T. (2020). A community and technology-based approach for hypertension self-management (COACHMAN) to improve blood pressure control in African Americans: Results from a pilot study. Patient Preference and Adherence, 14, 2301–2313. https://doi.org/10.2147/ppa.S283086
• Tan, J. P., Cheng, K. K. F., & Siah, R. C. (2019). A systematic review and meta-analysis on the effectiveness of education on medication adherence for patients with hypertension, hyperlipidaemia and diabetes. Journal of Advanced Nursing, 75(11), 2478–2494. https://doi.org/10.1111/jan.14025
• Usher, K., Park, T., Foster, K., & Buettner, P. (2013). A randomized controlled trial undertaken to test a nurse-led weight management and exercise intervention designed for people with serious mental illness who take second generation antipsychotics. Journal of Advanced Nursing, 69(7), 1539–1548. https://doi.org/10.1111/jan.12012
• Van Camp, Y. P., Van Rompaey, B., & Elseviers, M. M. (2013). Nurse-led interventions to enhance adherence to chronic medication: Systematic review and meta-analysis of randomised controlled trials. European Journal of Clinical Pharmacology, 69(4), 761–770. https://doi.org/10.1007/s00228-012-1419-y
• Verloo, H., Chiolero, A., Kiszio, B., Kampel, T., & Santschi, V. (2017). Nurse interventions to improve medication adherence among discharged older adults: A systematic review. Age Ageing, 46(5), 747–754. https://doi.org/10.1093/ageing/afx076
• Waffenschmidt, S., Knelangen, M., Sieben, W. et al. (2019). Single screening versus conventional double screening for study selection in systematic reviews: A methodological systematic review. BMC Medical Research Methodology, 19, 132. https://doi.org/10.1186/s12874-019-0782-0
• Wakefield, B. J., Holman, J. E., Ray, A., Scherubel, M., Adams, M. R., Hillis, S. L., & Rosenthal, G. E. (2011). Effectiveness of home telehealth in comorbid diabetes and hypertension: A randomized, controlled trial. Telemedicine Journal and E-Health, 17(4), 254–261. https://doi.org/10.1089/tmj.2010.0176
• Williams, A., Manias, E., & Walker, R. (2008). Interventions to improve medication adherence in people with multiple chronic conditions: A systematic review. Journal of Advanced Nursing, 63(2), 132–143. https://doi.org/10.1111/j.1365-2648.2008.04656.x
• World Health Organization (WHO). (2017). Medication without harm: Global patient safety challenge on medication safety (Licence: CC BY-NC-SA 3.0 IGO.). Accessed from https://www.who.int/initiatives/medication-without-harm
• Zomahoun, H. T. V., Guénette, L., Grégoire, J. P., Lauzier, S., Lawani, A. M., Ferdynus, C., Huiart, L., & Moisan, J. (2017). Effectiveness of motivational interviewing interventions on medication adherence in adults with chronic diseases: A systematic review and meta-analysis. International Journal of Epidemiology, 46(2), 589–602. https://doi.org/10.1093/ije/dyw273

Method

This literature review provided an examination of published articles on Norwegian nursing homes, and a selection of recently published international articles, identifying the nature and extent of pharmacists’ involvement with nursing home patients. The literature review method is appropriate because it allows consolidation and summation, it finds omissions or gaps in the literature, and it builds knowledge from previous work (Grant & Booth, 2009). The review was based on a search in PubMed, using both medical subject headings (MESH) and free-text search. The two MESH terms “pharmacist” and “nursing home” combined retrieved 222 results. These 222 results were filtered using “article type review”, resulting in 16 papers. From these 16 papers, it was decided to include two recently published papers (Lee et al., 2019; Spinewine et al., 2021), since they mirror how pharmacists work in Norway. Subsequently, the free-text search using the terms “pharmacist”, “nursing home” and “Norway” resulted in 17 studies. Of these 17 studies, 12 were included in the review, based on their relevance to the Norwegian setting and the author’s knowledge from working for more than fifteen years with medication therapy in older nursing home residents, either as an advisor or clinical pharmacist.

The knowledge synthesis, describing where pharmacists can play an active role to optimize medication use in nursing home residents, was conducted by applying a conceptual framework (Institute of Medicine, 2005) of four (three, see Figure 1) different levels: A) the resident (patient) level; B) the care team level; C) the system (nursing home) level; and D) the environment level. However, the fourth level (D) was considered to be beyond the scope of this study.

Results and Discussions

The results are based on 12 articles from the Norwegian nursing home setting, and two international articles mirroring how the author perceives how pharmacists work to improve the quality of medication therapy in Norwegian nursing homes at the individual, healthcare and system level.

Conclusion

Pharmacists contribute on different levels to optimize medication use in nursing home residents. Although pharmacists, as healthcare providers, seem to be expanding their role, municipalities and the healthcare system seem to lack a strategy in terms of how this resource can be used most effectively. Developing job descriptions for pharmacists, which prepare the primary healthcare setting and nursing homes for future challenges should be prioritized.

References

• Abelsen, B., Gaski, M., Nødland, S. I., & Stephansen, A. (2014). Samhandlings­reformens konsekvenser for det kommunale pleie- og omsorgstilbudet. [The consequences of the coordination reform for home care and nursing home services]. http://hdl.handle.net/11250/2631346
• American Geriatrics Society. (2019). Updated AGS Beers criteria® for potentially inappropriate medication use in older adults. (2019). Journal of the American Geriatric Society, 67(4), 674–694. https://doi.org/10.1111/jgs.15767
• Bakken, M. S., Ranhoff, A. H., Engeland, A., & Ruths, S. (2012). Inappropriate prescribing for older people admitted to an intermediate-care nursing home unit and hospital wards. Scandinavian Journal of Primary Health Care, 30(3), 169–175. https://doi.org/10.3109/02813432.2012.704813
• Davidsson, M., Vibe, O. E., Ruths, S., & Blix, H. S. (2011). A multidisciplinary approach to improve drug therapy in nursing homes. Journal of Multidisciplinary Healthcare, 4, 9–13. https://doi.org/10.2147/JMDH.S15773
• Deprescribing.org. (2021). Reducing medications safely to meet life’s changes. https://deprescribing.org/
• Devik, S. A., Olsen, R. M., Fiskvik, I. L., Halbostad, T., Lassen, T., Kuzina, N., & Enmarker, I. (2018). Variations in drug-related problems detected by multidisciplinary teams in Norwegian nursing homes and home nursing care. Scandinavian Journal of Primary Health Care, 36(3), 291–299. https://doi.org/10.1080/02813432.2018.1499581
• Fog, A. F., Kvalvaag, G., Engedal, K., & Straand, J. (2017). Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway. Scandinavian Journal of Primary Health Care, 35(4), 329–335. https://doi.org/10.1080/02813432.2017.1397246
• Grant, M. J., & Booth, A. (2009). A typology of reviews: An analysis of 14 review types and associated methodologies. Health Information & Libraries Journal, 26(2), 91–108. https://doi.org/10.1111/j.1471-1842.2009.00848.x
• Halvorsen, K. H., Granas, A. G., Engeland, A., & Ruths, S. (2012). Prescribing quality for older people in Norwegian nursing homes and home nursing services using multidose dispensed drugs. Pharmacoepidemiology and Drug Safety, 21(9), 929–936. https://doi.org/10.1002/pds.2232
• Halvorsen, K. H., Ruths, S., Granas, A. G., & Viktil, K. K. (2010). Multidisciplinary intervention to identify and resolve drug-related problems in Norwegian nursing homes. Scandinavian Journal of Primary Health Care, 28(2), 82–88. https://doi.org/10.3109/02813431003765455
• Halvorsen, K. H., Selbaek, G., & Ruths, S. (2017). Trends in potentially inappropriate medication prescribing to nursing home patients: Comparison of three cross-sectional studies. Pharmacoepidemiology and Drug Safety, 26(2), 192–200. https://doi.org/10.1002/pds.4142
• Halvorsen, K. H., Stadeløkken, T., & Garcia, B. H. (2019). A stepwise pharmacist-led medication review service in interdisciplinary teams in rural nursing homes. Pharmacy (Basel), 7(4). https://doi.org/10.3390/pharmacy7040148
• Halvorsen, K. H., Stensland, P., & Granas, A. G. (2011). A qualitative study of physicians’ and nurses’ experiences of multidisciplinary collaboration with pharmacists participating at case conferences. International Journal of Clinical Pharmacy, 19(5), 350–357. https://doi.org/10.1111/j.2042-7174.2011.00129.x
• Helsedirektoratet. (2017). Botid i sykehjem og varighet av tjenester til hjemmeboende [Residents in nursing homes and duration of home care services]. https://www.helsedirektoratet.no/rapporter/botid-i-sykehjem-og-varighet-av-tjenester-til-hjemmeboende/2017-02%20Botid%20i%20sykehjem%20og%20varighet%20av%20tjenester%20til%20hjemmeboende.pdf/_/attachment/inline/9f8fa68c-5969-4147-95d1-2177464084de:8a6b1b6e741b917894778a5ef81610764635ea4c/2017-02%20Botid%20i%20sykehjem%20og%20varighet%20av%20tjenester%20til%20hjemmeboende.pdf#:~:text=De%20fleste%20som%20flytter%20inn,26%20%C3%A5r%20botid%20i%20sykehjem.
• Helse- og omsorgsdepartementet. (2014–2015). Legemiddelmeldingen – Riktig bruk – bedre helse. Meld. St. 28.
• Hermann, M., Eikemo, H., Heimro, L. S., Høyvik, E., & Kjome, R. (2021). Legemiddelgjennomgang ved innkomst i sykehjem [Medication reviews in nursing homes at admittance]. Sykepleien Forskning (Oslo)(86715), e-86715. https://doi.org/10.4220/Sykepleienf.2021.86715
• Institute of Medicine. (2005). Building a better delivery system: A new engineering/health care partnership. https://doi.org/10.17226/11378
• Lee, S. W. H., Mak, V. S. L., & Tang, Y. W. (2019). Pharmacist services in nursing homes: A systematic review and meta-analysis. British Journal of Clinical Pharmacology, 85(12), 2668–2688. https://doi.org/10.1111/bcp.14101
• Lovdata. (2021). Forskrift om legemiddelhåndtering for virksomheter og helsepersonell som yter helsehjelp [Regulations of medication management for organizations and health care professionals who provide health care]. https://lovdata.no/dokument/SF/forskrift/2008-04-03-320
• Nyborg, G., Straand, J., Klovning, A., & Brekke, M. (2015). The Norwegian general practice: Nursing home criteria (NORGEP-NH) for potentially inappropriate medication use: A web-based Delphi study. Scandinavian Journal of Primary Health Care, 33(2), 134–141. https://doi.org/10.3109/02813432.2015.1041833
• O’Mahony, D., O’Sullivan, D., Byrne, S., O’Connor, M. N., Ryan, C., & Gallagher, P. (2015). STOPP/START criteria for potentially inappropriate prescribing in older people, version 2. Age Ageing, 44(2), 213–218. https://doi.org/10.1093/ageing/afu145
• Pagès, A., Rouch, L., Costa, N., Cestac, P., De Souto Barreto, P., Rolland, Y., Vellas, B., Molinier, L., Juillard-Condat, B., & Group, M. D. (2021). Potentially inappropriate medication prescribing detected by computer algorithm among older patients: Results from the MAPT study. Pharmacy, 9(4). https://doi.org/10.3390/pharmacy9040189
• Pharmaceutical Care Network Europe (PCNE. (2021). Online international validation second round coding of upgraded PCNE DRP cases using PCNE DRP Classification V9.1 [Report]. https://www.pcne.org/upload/files/449_2021-01-27_Report_online_validation_PCNE_classification_v9.1.pdf
• Services, A. H. P., & Conolly, G. (2016). Effective medicines management is vital to improving patient safety. https://www.ashtonshospitalpharmacy.com/blog/2016/07/effective-medicines-management-is-vital-to-improving-patient-safety/
• Soraas, I. A., Staurset, H. B., Slordal, L., & Spigset, O. (2014). Legemiddelinteraksjoner hos pasienter i sykehjem [Drug-drug interactions in nursing home patients]. Tidsskrift for Den Norske Legeforening [Journal of the Norwegian Medical Association], 134(10), 1041–1046. https://doi.org/10.4045/tidsskr.13.1550
• Spinewine, A., Evrard, P., & Hughes, C. (2021). Interventions to optimize medication use in nursing homes: A narrative review. European Geriatric Medicine, 12(3), 551–567. https://doi.org/10.1007/s41999-021-00477-5
• Statistics-Norway (SSB). (2021). Care services. Retrieved April 3, 2022, from https://www.ssb.no/en/helse/helsetjenester/statistikk/sjukeheimar-heimetenester-og-andre-omsorgstenester
• Thomson, M. S., Gruneir, A., Lee, M., Baril, J., Field, T. S., Gurwitz, J. H., & Rochon, P. A. (2009). Nursing time devoted to medication administration in long-term care: Clinical, safety, and resource implications. Journal of the American Geriatric Society, 57(2), 266–272. https://doi.org/10.1111/j.1532-5415.2008.02101.x
• Toverud, E. L., & Håkonsen, H. (2019). Kommunefarmasi i Norge. En studie over hva farmasøyter bidrar med og hva de mener det er behov for av farmasøytiske tjenester i kommunehelsetjenesten [Pharmacists in Norwegian municipalities. A study of pharmacists’ contributions and what they think is needed for pharmaceutical services in the primary health care service]. [Pharmacists in Norwegian Municipalities. A study of pharmacists’ contributions and their perceived need for pharmaceutical services at the municipal health service level.]. Norsk Farmaceutisk Tidsskrift, 7, 11. https://www.farmaceutene.no/sites/default/files/atoms/files/rapport_kommunefarmasoyter_27._september.pdf

Method

This study is based on the authors’ experiences from their practice in pharmacies and the specialist healthcare services from the past several years to the present. A literature review was performed according to Grant and Booth (2009). The authors’ experiences have been valuable for recognizing the challenges in this area, and also for selecting keywords for the literature searches, which were not exhaustive but filtered through the following criteria. Articles from the last 15 years, with an emphasis on the last five years, have been included. Articles in English, published in international peer-reviewed journals, were chosen. Among the selection criteria, we included the following search terms: patient safety, communication, pharmacy, hospital pharmacy, health literacy, OTC. The literature search was performed from July to November 2021, including open searches on Google and Google Scholar, and more specific searches in Pubmed. We also included articles from the authors’ own archives related to the topic. Articles written in Norwegian, or from non peer-reviewed journals, or older published studies were excluded.

The included articles covered the main experiences and challenges, relevant to patient-centered communication and counseling, defined by the authors. To describe Norwegian conditions primarily, it was necessary to include reports and documents from the authorities. A total of 57 studies were included.

Results and Discussion

Communication

The included studies show that many of the challenges presented in the introduction can be avoided if the communication, or more precisely counseling, is more focused. Counseling is, in Brown et al. (2016), defined as an “individualized process involving guidance and collaborative problem solving to help the patient better manage their health problems” (Brown et al., 2016).

Communicate originates from communicare, which is latin and means “to share”. Interpersonal health communication deals with imbalanced and complex power positions between the patient and healthcare personnel. In past times, this relationship, especially the doctor-patient relationship, was authoritarian and often about biomedical issues. Now, communication is more individualized and focused on each patient (Higgs et al., 2014).

The communication process between a patient and a provider is well illustrated in Figure 1 in Fieldman-Steward et al. (2005).

This model focuses on the individual’s goals in the communication and discussion process, and describes which factors are important for how the communication process proceeds (Feldman-Stewart et al., 2005). The framework includes four key components, with a focus on elements that can be modified. The first component is the focus of the interaction: each participant’s communication goals. The second component consists of the participants themselves: each with five key attributes that determine, in part, how they address their goals. The third component is the communication process: each person both conveys and receives messages, and the messages themselves can be verbal, non-verbal, or silent. The communication process is iterative and extended in time, with one act having an impact on following acts. Finally, the fourth component is the environment in which the communication occurs, both the immediate physical setting and the context beyond. Important aspects of the environment, identified as external factors, affect the communication process through their impact on the participants’ attributes. The framework builds on classic communication frameworks to which it adds unique elements. Some of these unique elements include the prominent role of the participants’ goals and the distinct recognition that messages are conveyed through silence.

There are many models for assessing patient/healthcare provider interaction. One of them is the four habits model (FHM) (Frankel & Stein, 2001; Stein et al., 2005). This model is a relationship-centered framework for assessing healthcare provider communication skills with patients during medical interviews and encounters. The key concept in this model is: Patients don’t care how much you know until they know how much you care. The four habits of clinical communication are: 1) invest in the beginning; 2) elicit the patient’s perspective; 3) demonstrate empathy; and 4) invest in the end. The goals of the FHM are to: 1) establish rapport and build trust rapidly; 2) facilitate the effective exchange of information; 3) demonstrate care and concern; and 4) increase the likelihood of adherence and positive health outcomes (Frankel & Stein, 2001; Stein et al., 2005).

Ensuring Patient Safety After Discharge From Hospital: Experiences From Specialist Healthcare

At discharge from hospital, insufficient transfer of medication information is a common challenge (Cochrane et al., 1992; Coleman, 2003; Glintborg et al., 2007; Kripalani et al., 2007). After discharge, home-dwelling patients are expected to manage their medicines themselves, and adequate counseling is important for self-efficacy in relation to medication management (Náfrádi et al., 2017). In a study performed in Australia, pharmacists and patients were asked what made the pharmacist–patient conversations effective. The overarching theme or shared goal resonating from the participants’ interviews was that patients need to be confident in managing their medications at home. To facilitate this, patients focused mainly on pharmacists’ delivery of medication information and interpersonal behavior. For the pharmacists, building rapport was important, but they also emphasized patients’ understanding of their medications, and their level of engagement, as indicators of patients’ confidence in self-managing their therapy (Chevalier et al., 2018).

A Norwegian study from 2017 looked into patients’ needs for medication information after discharge from hospital, including the patients’ perception and appraisal of the information they received at discharge. The results from interviewing 12 patients showed that information should focus on empowering the patients throughout the hospital stay, and not only at discharge. The informants used various strategies for coping with their use of medicines, influencing their self-efficacy in relation to medicine management. They gained information in several ways: by receiving information from healthcare professionals, through observation, and by seeking it themselves. Some thought they could have been better informed about adverse reactions and how to manage life as a user of medicines. Others felt they did not want or need more information (Svensberg et al., 2021). This is also shown in other studies (Borgsteede et al., 2011; Kusch et al., 2018).

The National Center for Epilepsy, Oslo University Hospital, serves the most refractory patients with epilepsy from the whole country. Over the years, different approaches to improving patient-centered communication have been utilized. As part of the service, a close follow-up of pharmacological treatment is a cornerstone. Therapeutic drug monitoring of all antiseizure medications is a tool to optimize treatment for the individual patient (Johannessen Landmark, Fløgstad, Baftiu, et al., 2019; Johannessen Landmark et al., 2020). It relies on close collaboration between the clinicians, nurses and pharmacists at the hospital, and pharmacologists at the laboratory for clinical pharmacology. The use of therapeutic drug monitoring in a clinical setting serves as a tool for improved understanding of drug exposure, and factors contributing to variability between and within patients: adherence, withdrawal, and interactions (Johannessen Landmark, Fløgstad, Syvertsen, et al., 2019; Syvertsen et al., 2019). This tool has also been used in direct communication with patients and their treating clinicians for improved health literacy and understanding of the importance of routines for drug intake and possible consequences (Johannessen Landmark, Fløgstad, Baftiu, et al., 2019).

Some years ago, a multi-professional pharmacology team was established, with the primary aim of optimal treatment with antiseizure medications for the individual patient: education of colleagues; information to patients and relatives; focusing on patient safety issues. Another practical task has been the participation of a pharmacist, attending the out-patient clinic along with the neurologist, for improved communication about medications. Furthermore, a digital e-learning course on the use of antiseizure medications, and written information on the website of all the different drugs available, have been developed and implemented. These are among the most popular sites within Oslo University Hospital.

In several studies the patients’ perspectives on challenges in epilepsy and their treatment were elucidated. Patients were interviewed with a focus on their perspective regarding adverse effects and adherence to medications, first as a project in clinical pharmacy (Mevaag et al., 2017), then as a larger-scale questionnaire (Henning, Johannessen Landmark, et al., 2019; Henning, Lossius, et al., 2019). Finally, the questionnaires were utilized in routine screening for adverse effects, adherence issues and other factors related to living with epilepsy.

These studies demonstrate that, through various interventions and focusing on different aspects of the treatment of refractory epilepsy, a patient-centered emphasis as well as a multi-disciplinary approach will hopefully continue to achieve improved treatment and care of this vulnerable patient group.

Ensuring Patient Safety at Community Pharmacies: Experiences of Communication About Prescribed Medicines

In general, Norwegian pharmacies have a monopoly on distributing prescription medicines to the public. Even though community pharmacies are private, they are part of the Norwegian healthcare system, and cooperate with other healthcare personnel to ensure patient safety and the correct use of medicines, and to help patients take care of their own health. The three main goals are to:

• Ensure that patients receive medicines of high quality in the correct form, dosage, and quantum
• Ensure that medicines are available throughout the whole country
• Ensure that patients receive high quality information and guidance that ensures correct use of medicines

In the report to Stortinget (Norwegian Parliament) No. 28 (2014–2015) (HOD, 2015) White paper on medicines correct use – better health, it is stated that pharmacies have an important role in providing advice on the correct use of medicines. The pharmacy is a low-threshold healthcare service. Pharmacists or pharmacy technicians provide advice on how to use prescription or OTC medicines. The quality of the counseling is of great importance to safeguard patient safety. Thus, being up-to-date and having good communication skills are of great importance to ensure the correct use of medicines and thus, ensure patient safety.

Since 2000, the number of pharmacies has more than doubled, they have longer opening hours, and sell a wider range of health-related products. The general public also seek advice for treating a range of minor illnesses.

The law specifies requirements as to how the pharmacy should be designed. A number of pharmacies are small, which is challenging when personal conversations take place between staff and customers seeking advice. Discretion and lack of privacy is a challenge when delivering professional pharmacy services, especially regarding elderly patients (Mamen et al., 2015). Studies from Australia and Denmark have revealed that a lack of discretion is one of the main reasons that pharmacists do not offer these services and patients do not receive them (Latif et al., 2013; Patwardhan & Chewning, 2009). Our experiences indicate a need to improve these factors. It is important to examine the culture of the pharmacy and the pharmacy manager’s interest in communication. Studies have revealed that this may explain the variation among pharmacies in terms of their degree of communication (Kaae et al., 2014).

Employees in pharmacies are authorized as healthcare personnel: pharmacists (holding a bachelor’s or master’s degree in pharmacy), and pharmacy technicians (three-year high school specialty). They have combined theoretical and practical training on how to advise customers on when and how to handle minor ailments, and can adjust their advice to each particular customer based on symptoms, age, gender, and health condition.

Patient counseling is important on all levels of the healthcare services, and this requires good communication skills. What kind of communication skills are important in patient counseling? Several researchers have looked into this and found that they can be divided into content skills, process skills, and perceptual skills. All are important. Table 1 exemplifies the skills for the pharmacist role within each of these three categories (Hargie et al., 2000; Hyvärinen et al., 2010).

Table 1. Communication Skills for the Role of the Pharmacist (Hargie et al., 2000; Hyvärinen et al., 2010)

As mentioned before, information on the patient’s medicines is of great importance to patient safety. Because pharmacists possess extensive knowledge about medicines (administration, dosage, effects, side-effects, storage, interactions, and important factors for correct use), the pharmacist is in a position to play an important role in patient counseling (Hämmerlein et al., 2007). In addition to being a medicine expert, the pharmacists see patients with a chronic disease probably more often than their physician does. These patients often see their physician just once a year, while the pharmacist meets the patient at least four times a year, when they pick up their prescribed medicines.

However, from our own experiences, we believe that pharmacists, as well as other healthcare personnel, should be more conscious of and focus on dialogic patient-centered communication. Several studies have examined this issue. A review of counseling practices, in relation to prescription medicines in community pharmacies, revealed a variation in counseling rates from 8% to 100%, depending on the research methods used. The type of prescription also influenced the rate. Higher rates were found in counseling consumers with new compared to regular prescriptions. Information on directions for use, dosage, medicine name, and indications was given more frequently than information on side effects, precautions, interactions, contraindications, and storage (Puspitasari et al., 2009). A newer study from the Netherlands described the information exchanged between pharmacy staff and patients on prescribed medication at the community pharmacy counter. When dispensing first prescriptions, pharmacy staff provided most information on instructions of how to use the medication (83.3%), the form of the medication (71.4%), and treatment duration (42.9%). Topics for repeat prescriptions (such as the effects of the medication and the incidence of observed adverse effects) were rarely discussed. Pharmacy staff rarely encouraged patients to ask questions. In only 10% of the new prescriptions and in 5% of the repeat prescriptions did the pharmacist try to involve the patient (van Dijk et al., 2016). A Norwegian study among elderly patients showed that the general practitioner (GP) was the main source of drug information. As many as 50% of them were not informed about the medicines when picking them up at the pharmacy. However, 56% wanted to know more about their medications (Mamen et al., 2015). In a Danish observation study, 26% of the encounters had no communication about medicines (Kaae et al., 2013). The aim of a Swedish study was to determine the content and time disposition of patient–pharmacist communication during the dispensing of prescribed medicines. They found that 11 seconds (median) was spent on medical issues like user instructions, 72 seconds (median) on non-medical issues like availability of the medicine, and 88 seconds was spent in silence (Olsson et al., 2014).

Some studies have revealed that pharmacists use patient-centered communication to a low degree, for example low patient involvement, and low exploration of the patients’ needs (Greenhill et al., 2011; Kaae et al., 2012; Latif et al., 2011). One review has shown that a patient-centered focus was found in eight of 32 studies (Murad et al., 2014). Some of these studies indicate that the pharmacists forget or do not think, to explore the patients’ needs, understanding and knowledge of their medicines, while another review reveals patient-centered focus in several studies. For patient safety reasons, it is important to inform patients about administration, side-effects, interactions, and important factors for correct use. However, just as important is motivating the patients to adhere to their medicines to promote good health. Thus, the patient’s preferences have to be explored, in order to provide the patient with medical information to help them make the right decisions. Patients have to be honest about their needs and concerns. A patient-centered encounter contributes to the patients’ trust in healthcare personnel, not only the pharmacy personnel, which in turn will increase adherence and patient safety.

To improve patient-healthcare personnel communication, teaching and training is of great importance. A study performed with hospital doctors demonstrated that a 20 hour course using the four habits model showed an improvement in communication skills among these doctors (Fossli Jensen et al., 2010). A review from 2021 has also looked into how pharmacists can develop patient-pharmacist communication skills (Kerr et al., 2021). They conclude that educational interventions that promote reflection are particularly useful.

Ensuring Patient Safety for Self-Caring Patients

WHO defines self-care as “the ability of individuals, families, and communities to promote health, prevent disease, maintain health, and to cope with illness and disability with or without the support of a healthcare provider” (WHO, 2021).

There is a growing global trend for consumers to self-medicate with non-prescription medications, also called over the counter (OTC) medications, for common ailments (Benrimoj et al., 2008). Shifts in consumer preferences towards self-care and self-responsibility for health (Benrimoj et al., 2008), and the emerging trend towards ‘‘down-scheduling’’ of prescription medicines to non-prescription status (Global Self-Care Federation, 2004) are two factors associated with this development. Community pharmacists are the most accessible healthcare professionals to the public, and their competence is important to ensure the correct use of OTC.

When a member of the general public experiences symptoms of disease or illness, their response on how to treat the symptoms is often based on personal experience and advice from family or friends. A very common source of advice is to seek information on the internet, in these days referred to as “Dr. Google” or on the vast variety of public and private websites with health information. Depending on the severity of the symptoms, people also seek help at the emergency ward, or from a family doctor, or, if the symptoms are minor, they treat the symptoms through self-care or seeking advice at a community pharmacy.

Risks Associated With the Top Selling OTCs

Total OTC sales in 2020 were ca. NOK 3.5 billion (FHI, 2021b), and the leading indications were pain, fever and common cold. Use of nasal spray to treat nasal congestion has been rising steadily, and two thirds are sold outside pharmacies (FHI, 2020). The number of people addicted to these types of nasal spray is, according to otolaryngologists, increasing (Hauge & Nordahl, 2019), and many healthcare professionals support restrictions to availability. It is hard to communicate information about safety concerns, and that continuous use beyond the recommended maximum 10 days leads to addiction and a constantly blocked nose.

Sales of paracetamol are second on the OTC list. A Norwegian study showed that 30% of female and 13% of male adolescents aged 13–19 use OTC analgesics weekly (Jonassen et al., 2021). Daily use of paracetamol, even in small doses, can give rebound headaches (Fischer & Jan, 2021). There has also been an increase in paracetamol intoxication, especially among young females (Soldal, 2017). In Sweden, non-prescription paracetamol tablets are, since 2015, no longer sold outside pharmacies due to the high increase in paracetamol intoxications (Sandstedt, 2015).

Remedies for smoking cessation (nicotine replacement therapy, NRT) are also high on the OTC sales list. The percentage of daily smokers in Norway has, however, decreased considerably from over 40% in the 1970s to 12% in 2016 (WHO, 2020). For some people, addiction to nicotine in cigarettes has been replaced by NRT addiction (Borup et al., 2015).

Supplements and Herbal Remedies in Self-Care

Many people use supplements and/or herbal remedies, instead of, or in addition to medicines as self-care. A Norwegian study from 2013 showed that among the 381 patients who participated, 44% used herbs (e.g., blueberry, green tea, garlic, aloe vera, echinacea) and among those using conventional drugs regularly, 45% used herbs concomitantly (Djuv et al., 2013).

It is a safety concern that herbal remedies often lack documentation of quality, efficacy, and safety, for example drug interactions. However, some interactions are known, for example NOMA recommends patients to refrain from herbal remedies containing ginkgo-biloba, ginseng, ginger and St. John’s wart one to two weeks before surgery, as these could have an effect on bleeding during an operation (SLV, 2016).

Norwegian Governmental Strategies on Self-Care

Conclusion

The included articles, in addition to our own multi-disciplinary experiences, indicate that incorrect use of medicines endangers patient safety and may have serious consequences for both the patient and society. The common theme of most barriers connected to incorrect use of medicines seems to be communication. It is therefore essential for healthcare providers to have good communication skills, and to be able to provide patient-centered communication and counseling of high quality. This may be the path towards optimizing use of medicines and ensuring patient safety. To improve patient-centered communication and counseling, teaching communication, as well as training courses, should be included in the curricula for healthcare providers in addition to postgraduate training.

References

• Aitken, M., Gorokhovich, L. (2012). Advancing the responsible use of medicines: Applying levers for change. IMS Institute for Healthcare Informatics. Retrieved March 2, 2022, from https://ssrn.com/abstract=2222541, accessed 2 March 2022
• Aronson, J. K. (2009). Medication errors: definitions and classification [https://doi.org/10.1111/j.1365-2125.2009.03415.x]. British Journal of Clinical Pharmacology, 67(6), 599–604. https://doi.org/10.1111/j.1365-2125.2009.03415.x
• Benrimoj, S. I., Werner, J. B., Raffaele, C., & Roberts, A. S. (2008). A system for monitoring quality standards in the provision of non-prescription medicines from Australian community pharmacies. Pharmacy World & Science, 30(2), 147–153. http://dx.doi.org/10.1007/s11096-007-9162-7
• Blix, H. S., Viktil, K. K., Reikvam, A., Moger, T. A., Hjemaas, B. J., Pretsch, P., Vraalsen, T. F., & Walseth, E. K. (2004). The majority of hospitalised patients have drug-related problems: Results from a prospective study in general hospitals. European Journal of Clinical Pharmacology, 60(9), 651–658. https://doi.org/10.1007/s00228-004-0830-4
• Borgsteede, S. D., Karapinar-Çarkit, F., Hoffmann, E., Zoer, J., & van den Bemt, P. M. (2011). Information needs about medication according to patients discharged from a general hospital. Patient Education and Counseling, 83(1), 22–28. https://doi.org/10.1016/j.pec.2010.05.020
• Borup, G., Mikkelsen, K. L., Tønnesen, P., & Christrup, L. L. (2015). Exploratory survey study of long-term users of nicotine replacement therapy in Danish consumers. Harm Reduction Journal, 12(1), 2. https://doi.org/10.1186/1477-7517-12-2
• Brown, T. J., Todd, A., O’Malley, C., Moore, H. J., Husband, A. K., Bambra, C., Kasim, A., Sniehotta, F. F., Steed, L., Smith, S., Nield, L., & Summerbell, C. D. (2016). Community pharmacy-delivered interventions for public health priorities: A systematic review of interventions for alcohol reduction, smoking cessation and weight management, including meta-analysis for smoking cessation. BMJ Open, 6(2), e009828. https://doi.org/10.1136/bmjopen-2015-009828
• Burton, J. (2020). List of countries by literacy rate. WorldAtlas. Retrieved November 29, 2021, from https://www.worldatlas.com/articles/the-highest-literacy-rates-in-the-world.html
• CDC. (2021). What is health literacy? Centers for Disease Control and Prevention. https://www.cdc.gov/healthliteracy/learn/index.html
• Chang, E., Tsang, B., & Thornley, S. (2011). Language barriers in the community pharmacy: A survey of northern and western Auckland. Journal of Primary Health Care, 3(2), 102–106. https://doi.org/10.1071/HC11102
• Chevalier, B. A. M., Watson, B. M., Barras, M. A., & Cottrell, W. N. (2018). Hospital pharmacists’ and patients’ views about what constitutes effective communication between pharmacists and patients. International Journal of Pharmacy Practice, 26(5), 450–457. https://doi.org/10.1111/ijpp.12423
• Cleland, J. A., Watson, M. C., Walker, L., Denison, A., Vanes, N., & Moffat, M. (2011). Community pharmacists’ perceptions of barriers to communication with migrants. International Journal of Pharmacy Practice, 20(3), 148–154. https://doi.org/10.1111/j.2042-7174.2011.00172.x
• Cochrane, R. A., Mandal, A. R., Ledger-Scott, M., & Walker, R. (1992). Changes in drug treatment after discharge from hospital in geriatric patients. British Medical Journal, 305(6855), 694–696. https://doi.org/10.1136/bmj.305.6855.694
• Coleman, E. A. (2003). Falling through the cracks: Challenges and opportunities for improving transitional care for persons with continuous complex care needs. Journal of the American Geriatriatric Society, 51(4), 549–555. https://doi.org/10.1046/j.1532-5415.2003.51185.x
• Djuv, A., Nilsen, O. G., & Steinsbekk, A. (2013). The co-use of conventional drugs and herbs among patients in Norwegian general practice: A cross-sectional study. BMC Complementary and Alternative Medicine, 13, 295. https://doi.org/10.1186/1472-6882-13-295
• Feldman-Stewart, D., Brundage, M. D., & Tishelman, C. (2005). A conceptual framework for patient-professional communication: An application to the cancer context. Psychooncology, 14(10), 801–809; discussion 810–801. https://doi.org/10.1002/pon.950
• FHI. (2020). Reseptfrie legemiddel selt i både daglegvare og apotek i 2019. https://www.fhi.no/hn/legemiddelbruk/omsetning-utenom-apotek/Reseptfrie-legemiddel-selt-i-baade-daglegvare-og-apotek-i-2019/
• FHI. (2021a). Drug consumption in Norway 2016–2020. Data from Norwegian drug wholesales statistics and Norwegian prescription database. https://www.fhi.no/en/publ/2021/drug-consumption-in-norway-2016-2020/
• FHI. (2021b). Reseptfritt salg av legemidler i 2020. https://www.fhi.no/hn/legemiddelbruk/omsetning-utenom-apotek/reseptfritt-salg-av-legemidler-i-2020/
• Fischer, M. A., & Jan, A. (2021). Medication-overuse headache. StatPearls Publishing.
• Fossli Jensen, B., Gulbrandsen, P., Dahl, F. A., Krupat E., Frankel, R. M. & Finset, A. (2010). Effectiveness of a short course in clinical communication skills for hospital doctors: Results of a crossover randomized controlled trial (ISRCTN22153332). Patient Education and Counseling, 84(2), 163–169
• Frankel, R. M., & Stein, T. (2001). Getting the most out of the clinical encounter: The four habits model. Journal of Medical Practice Management, 16(4), 184–191.
• From, J. (2013). Det medisinske pakningsvedlegget – begripelig for lekperson? [Master’s thesis] https://www.duo.uio.no/bitstream/handle/10852/38997/1/JULIE-HILLE-FROM_MASTEROPPGAVE.pdf
• Glintborg, B., Andersen, S. E., & Dalhoff, K. (2007). Insufficient communication about medication use at the interface between hospital and primary care. Quality and Safety in Health Care, 16, 34–39.
• Global Self-Care Federation. (2004). Legal status of selected ingredients worldwide. https://www.selfcarefederation.org/
• Grant, M. J. & Booth, A. (2009). A typology of reviews: An analysis of 14 review types and associated methodologies. Health Information and Libraries Journal, 26(2),91–108. https://doi.org/10.1111/j.1471-1842.2009.00848.x
• Greenhill, N., Anderson, C., Avery, A., & Pilnick, A. (2011). Analysis of pharmacist-patient communication using the Calgary-Cambridge guide. Patient Education and Counseling, 83(3), 423–431. https://doi.org/10.1016/j.pec.2011.04.036
• Halvorsen, I. S. (2011). Yngre personers meninger om pakningsvedlegg for reseptfrie analgetika. [Master’s thesis] https://www.duo.uio.no/bitstream/handle/10852/11964/Ingvild_Halvorsen_Masteroppgave.pdf?sequence=5&isAllowed=y
• Halvorsen, K. H., Ruths, S., Granas, A. G., & Viktil, K. K. (2010). Multidisciplinary intervention to identify and resolve drug-related problems in Norwegian nursing homes. Scandinavian Journal of Primary Health Care, 28(2), 82–88. https://doi.org/10.3109/02813431003765455
• Hargie, O. D., Morrow, N. C., & Woodman, C. (2000). Pharmacists’ evaluation of key communication skills in practice. Patient Education and Counseling, 39(1), 61–70. https://doi.org/10.1016/s0738-3991(99)00091-9
• Hauge, C. B., & Nordahl, A. M. (2019). Folk bruker både tre og fire flasker daglig. https://www.nrk.no/osloogviken/bruker-fire-flasker-nesespray-om-dagen-1.14716344
• Helsedirektoratet. (2010). LEON-prinsippet. https://www.forebygging.no/Ordbok/L-P/LEON-prinsippet/
• Helsedirektoratet. (2016). Helse-, omsorgs- og rehabiliteringsstatistikk. Eldres helse og bruk av kommunale helse- og omsorgstjenester. https://www.helsedirektoratet.no/rapporter/helse-omsorgs-og-rehabiliteringsstatistikk-eldres-helse-og-bruk-av-kommunale-helse-og-omsorgstjenester/Helse,-omsorgs,-%20og%20rehabiliteringsstatistikk%20%E2%80%93%20Eldres%20helse%20og%20bruk%20av%20kommunale%20helse-%20og%20omsorgstjenester.pdf/_/attachment/inline/9fd0b64f-1c63-41c9-b06b-240a8f92d60e:2ff83cff46b33ba9aa9e2b4be590080526cb3d6e/Helse,-omsorgs,-%20og%20rehabiliteringsstatistikk%20%E2%80%93%20Eldres%20helse%20og%20bruk%20av%20kommunale%20helse-%20og%20omsorgstjenester.pdf
• Henning, O., Johannessen Landmark, C., Henning, D., Nakken, K. O., & Lossius, M. I. (2019). Challenges in epilepsy: The perspective of Norwegian epilepsy patients. Acta Neurologica Scandinavica, 140(1), 40–47. https://doi.org/10.1111/ane.13098
• Henning, O., Lossius, M. I., Lima, M., Mevåg, M., Villagran, A., Nakken, K. O., & Johannessen Landmark, C. (2019). Refractory epilepsy and nonadherence to drug treatment. Epilepsia Open, 4(4), 618–623. https://doi.org/10.1002/epi4.12367
• Higgs, J., Croker, A., Tasker, D., Hummell, J., & Patton, N. (2014). Health practice relationships. SensePublishers.
• HOD (2014). Pasientens helsetjeneste. Helse og omsorgsdepartementet, regjeringen Solberg.
• HOD (2015). Medicinal Products: Correct use – better health. Report to the Storting No. 28 [White paper] Helse og omsorgsdepartementet. Oslo
• Horwitz, A., Reuther, L., & Andersen, S. E. (2009). [Patient information leaflets seen through the eyes of patients in a general practice]. (Patienters vurdering af medicinpakningernes indlaegssedler.) Ugeskr Laeger, 171(8), 599–602.
• Hyvärinen, M.-L., Tanskanen, P., Katajavuori, N., & Isotalus, P. (2010). A method for teaching communication in pharmacy in authentic work situations. Communication Education, 59(2), 124–145. https://doi.org/10.1080/03634520903576184
• Hämmerlein, A., Griese, N., & Schulz, M. (2007). Survey of drug-related problems identified by community pharmacies. Annals of Pharmacotherapy, 41(11), 1825–1832. https://doi.org/10.1345/aph.1K207
• Håkonsen, H., Lees, K., & Toverud, E. L. (2014). Cultural barriers encountered by Norwegian community pharmacists in providing service to non-Western immigrant patients. International Journal of Clinical Pharmacology, 36(6), 1144–1151. https://doi.org/10.1007/s11096-014-0005-z
• Jha, A. K. (2018, October 18). Patient safety: A grand challenge for healthcare professionals and policymakers alike. A roundtable at the Grand Challenges Meeting of the Bill & Melinda Gates Foundation. [Conference presentation] Retrieved March 2, 2022, from https://globalhealth.harvard.edu/qualitypowerpoint
• Johannessen Landmark, C., Fløgstad, I., Baftiu, A., Syvertsen, M., Enger, U., Koht, J., & Johannessen, S. I. (2019). Long-term follow-up with therapeutic drug monitoring of antiepileptic drugs in patients with juvenile myoclonic epilepsy. Epilepsy Research, 155, 106148. https://doi.org/10.1016/j.eplepsyres.2019.05.016
• Johannessen Landmark, C., Fløgstad, I., Syvertsen, M., Baftiu, A., Enger, U., Koht, J., & Johannessen, S. I. (2019). Treatment and challenges with antiepileptic drugs in patients with juvenile myoclonic epilepsy. Epilepsy & Behavior, 98, 110–116. https://doi.org/10.1016/j.yebeh.2019.05.021
• Johannessen Landmark, C., Johannessen, S. I., & Patsalos, P. N. (2020). Therapeutic drug monitoring of antiepileptic drugs: Current status and future prospects. Expert Opinion on Drug Metabolism & Toxicology, 16(3), 227–238. https://doi.org/10.1080/17425255.2020.1724956
• Jonassen, R., Hilland, E., Harmer, C. J., Abebe, D. S., Bergem, A. K., & Skarstein, S. (2021). Over-the-counter analgesics use is associated with pain and psychological distress among adolescents: A mixed effects approach in cross-sectional survey data from Norway. BMC Public Health, 21(1), 2030. https://doi.org/10.1186/s12889-021-12054-3
• Kerr, A., Kelleher, C., Pawlikowska, T. & Strawbridge, J. (2021). How can pharmacists develop patient-pharmacist communication skills? A realist synthesis. Patient Education and Counseling, 104, 2467–2479
• Kripalani, S., LeFevre, F., Phillips, C. O., Williams, M. V., Basaviah, P., & Baker, D. W. (2007). Deficits in communication and information transfer between hospital-based and primary care physicians: Implications for patient safety and continuity of care. JAMA, 297(8), 831–841. https://doi.org/10.1001/jama.297.8.831
• Kusch, M. K., Haefeli, W. E., & Seidling, H. M. (2018). How to meet patients’ individual needs for drug information: A scoping review. Patient Preference and Adherence, 12, 2339–2355. https://doi.org/10.2147/ppa.S173651
• Kaae, S., Mygind, A., & Saleem, S. (2013). A characterization of the current communication patterns in Danish community pharmacies: An observational study. Research in Social and Administrative Pharmacy, 9(6), 958–964. https://doi.org/10.1016/j.sapharm.2012.10.003
• Kaae, S., Saleem, S., & Kristiansen, M. (2014). How do Danish community pharmacies vary in engaging customers in medicine dialogues at the counter: An observational study. Pharmacy Practice, 12(3), 422–422. https://doi.org/10.4321/s1886-36552014000300006
• Kaae, S., Traulsen, J. M., & Nørgaard, L. S. (2012). Challenges to counseling customers at the pharmacy counter: Why do they exist? Research in Social and Administrative Pharmacy, 8(3), 253–257. https://doi.org/10.1016/j.sapharm.2011.05.002
• Latif, A., Boardman, H. F., & Pollock, K. (2013). A qualitative study exploring the impact and consequence of the medicines use review service on pharmacy support staff. Pharmacy Practice, 11(2), 118–124. https://doi.org/10.4321/s1886-36552013000200009
• Latif, A., Pollock, K., & Boardman, H. F. (2011). The contribution of the medicines use review (MUR) consultation to counseling practice in community pharmacies. Patient Education and Counseling, 83(3), 336–344. https://doi.org/10.1016/j.pec.2011.05.007
• Le, C., Finsbråten, H. S., Pettersen, K. S., & Guttersrud, Ø. (2021a). Befolkningens helsekompetanse del I. The international health literacy population survey 2019–2021. https://www.helsedirektoratet.no/rapporter/befolkningens-helsekompetanse/Befolkningens%20helsekompetanse%20-%20del%20I.pdf/_/attachment/inline/e256f137-3799-446d-afef-24e57de16f2d:646b6f5ddafac96eef5f5ad602aeb1bc518eabc3/Befolkningens%20helsekompetanse%20-%20del%20I.pdf
• Le, C., Finsbråten, H. S., Pettersen, K. S., & Guttersrud, Ø. (2021b). Helsekompetansen i fem utvalgte innvandrerpopulasjoner i Norge: Pakistan, Polen, Somalia, Tyrkia og Vietnam. [Report]. ODA Oslo Met.
• LMI. (2021). Offentlige utgifter, finansiering og tilgang. https://www.lmi.no/tall-og-fakta-2021-kapittel-5/#5.2
• Mamen, A. V., Håkonsen, H., Kjome, R. L., Gustavsen-Krabbesund, B., & Toverud, E. L. (2015). Norwegian elderly patients’ need for drug information and attitudes towards medication use reviews in community pharmacies. International Journal of Pharmacy Practice, 23(6), 423–428. https://doi.org/10.1111/ijpp.12184
• Mevaag, M., Henning, O., Baftiu, A., Granas, A. G., Johannessen, S. I., Nakken, K. O., & Johannessen Landmark, C. (2017). Discrepancies between physicians’ prescriptions and patients’ use of antiepileptic drugs. Acta Neurologica Scandinavica, 135(1), 80–87. https://doi.org/10.1111/ane.12578
• Murad, M. S., Chatterley, T., & Guirguis, L. M. (2014). A meta-narrative review of recorded patient-pharmacist interactions: Exploring biomedical or patient-centered communication? Research in Social and Administrative Pharmacy, 10(1), 1–20. https://doi.org/10.1016/j.sapharm.2013.03.002
• Náfrádi, L., Nakamoto, K., & Schulz, P. J. (2017). Is patient empowerment the key to promote adherence? A systematic review of the relationship between self-efficacy, health locus of control and medication adherence. PLOS One, 12(10), e0186458. https://doi.org/10.1371/journal.pone.0186458
• Olsson, E., Ingman, P., Ahmed, B., & Kälvemark Sporrong, S. (2014). Pharmacist-patient communication in Swedish community pharmacies. Research in Social and Administrative Pharmacy, 10(1), 149–155. https://doi.org/10.1016/j.sapharm.2013.03.001
• Patwardhan, P. D., & Chewning, B. A. (2009). Ask, advise and refer: Hypothesis generation to promote a brief tobacco-cessation intervention in community pharmacies. International Journal of Pharmacy Practice, 17(4), 221–229. https://doi.org/10.1211/ijpp/17.04.0005
• Puspitasari, H. P., Aslani, P., & Krass, I. (2009). A review of counseling practices on prescription medicines in community pharmacies. Research in Social and Administrative Pharmacy, 5(3), 197–210. https://doi.org/10.1016/j.sapharm.2008.08.006
• Ryan, R. (2014). Interventions to improve safe and effective medicines use by consumers: An overview of systematic reviews. Cochrane Database Syst Rev. 4: CD007768
• Sandstedt, J. (2015). Paracetamoltabletter får bara säljas på apotek. Läkemedelsvärlden. https://www.lakemedelsvarlden.se/paracetamoltabletter-far-bara-saljas-pa-apotek/
• Schneider, E. C., Shah, A., Doty, M. M., Tikkanen, R., Fields, K., & Williams II, R. D. (2021). Mirror, mirror 2021: Reflecting poorly. Health care in the U.S. compared to other high-income countries. https://www.commonwealthfund.org/publications/fund-reports/2021/aug/mirror-mirror-2021-reflecting-poorly
• Schwappach, D. L., Meyer Massetti, C., & Gehring, K. (2012). Communication barriers in counselling foreign-language patients in public pharmacies: Threats to patient safety? International Journal of Clinical Pharmacy, 34(5), 765–772. https://doi.org/10.1007/s11096-012-9674-7
• Sletvold, H., & Nguyen, T. (2021). Experiences and perceptions of foreign-language customers on medication information received in the pharmacy: A focus group study. International Journal of Pharmacy Practice, 29(4), 330–335. https://doi.org/10.1093/ijpp/riab021
• SLV. (2016). Biverknader og råd om bruk av plantebaserte legemiddel. https://legemiddelverket.no/bivirkninger-og-sikkerhet/rad-til-helsepersonell/plantebaserte-legemidler/biverknader-og-rad-om-bruk-av-plantebaserte-legemiddel
• SLV. (2021). Medicinal products to be distributed without medical prescription. https://legemiddelverket.no/english/regulatory-affairs/otc-status
• Soldal, J. (2017). Alarmerende økning i paracetamol-forgiftninger blant unge jenter. Apotekforeningen. https://www.apotek.no/nyhetsarkiv/helsepolitikk/alarmerende-%C3%B8kning-i-paracetamol-forgiftninger-blant-unge-jenter
• SSB. (2021). Immigrants and Norwegians born to immigrant parents, by country background. 1 January. Retrieved November 29, 2021, from https://www.ssb.no/en/befolkning/innvandrere/statistikk/innvandrere-og-norskfodte-med-innvandrerforeldre
• Stein, T., Frankel, R. M., & Krupat, E. (2005). Enhancing clinician communication skills in a large healthcare organization: A longitudinal case study. Patient Education and Counseling, 58(1), 4–12. https://doi.org/10.1016/j.pec.2005.01.014
• Svensberg, K., Trapnes, E., Nguyen, D., Hasan, R. A., Sund, J. K., & Mathiesen, L. (2021). Patients’ perceptions of medicines information received at hospital discharge in Norway: A qualitative interview study. International Journal of Clinical Pharmacy, 43(1), 144–153. https://doi.org/10.1007/s11096-020-01122-0
• Syvertsen, M., Fløgstad, I., Enger, U., Landmark, C. J., & Koht, J. (2019). Antiepileptic drug withdrawal in juvenile myoclonic epilepsy. Acta Neurologica Scandinavica, 139(2), 192–198. https://doi.org/10.1111/ane.13042
• van Dijk, M., Blom, L., Koopman, L., Philbert, D., Koster, E., Bouvy, M., & van Dijk, L. (2016). Patient-provider communication about medication use at the community pharmacy counter. International Journal of Pharmay Practice, 24(1), 13–21. https://doi.org/10.1111/ijpp.12198
• Viktil, K. K., Blix, H. S., Moger, T. A., & Reikvam, A. (2006). Interview of patients by pharmacists contributes significantly to the identification of drug-related problems (DRPs). Pharmacoepidemiology and Drug Safety, 15(9), 667–674. https://doi.org/10.1002/pds.1238
• WHO. (2019). Patient safety. Retrieved November 28, 2021, from https://www.who.int/news-room/fact-sheets/detail/patient-safety
• WHO. (2020). Norway: Health system review. https://www.who.int/publications/i/item/HiT-22-1-2020
• WHO. (2021). What do we mean by self-care? Retrieved November 29, 2021, from https://www.who.int/reproductivehealth/self-care-interventions/definitions/en/
• Yeheskel, A., & Rawal, S. (2019). Exploring the ‘patient experience’ of individuals with limited English proficiency: A scoping review. Journal of Immigrant and Minority Health, 21(4), 853–878. https://doi.org/10.1007/s10903-018-0816-4

Methods

This chapter is based on a secondary analysis of qualitative data (Heaton, 2008; Ruggiano & Perry, 2019). Data were collected from two studies focusing on pro re nata decision making, by using focus groups or individual in-depth interviews, respectively (Nilsen et al., 2020, 2021). The first author conducted the two primary studies, and is well acquainted with the data material and the data gathering context.

The focus group study aimed to describe factors affecting PRNM management in sheltered housing, while the individual in-depth study aimed to expand knowledge on healthcare providers’ experiences relating to decision making for PRNMs. All interviewees were licensed to administer PRNMs. The sample is described in Table 1.

A secondary analysis used existing data collected for a previous study, analyzed to explore new questions (Heaton, 2008; Ruggiano & Perry, 2019). The approach used in this article was to analyze data from the parent study that appeared crucial, and which were not sufficiently focused on in the original articles (Ruggiano & Perry, 2019). An amplified analysis in which the two datasets were combined for purposes of secondary analysis was used (Heaton, 2008). The focus of the secondary analysis was to explore healthcare providers’ experiences related to the residents’ medication lists.

The secondary analysis was performed by using systematic text condensation (Malterud, 2012). This is an iterative four-step process, searching for similarities and differences in the data material. In the first step, both authors read the transcripts, and preliminary themes were identified and discussed. Secondly, the transcripts were coded according to these themes by identifying units of meaning, and the main themes were adjusted. In the third step, the units of meaning were arranged into subthemes, and a condensate was made of each theme and subtheme. In the last step, an analytic text was synthesized based on the condensates of each theme and subtheme.

Table 1. The Sample: Interviewees’ Characteristics

Both authors frequently discussed the steps to ensure the interpretation of our findings. Disagreements were discussed until agreement was reached. Throughout the whole process the authors returned to the transcripts to make sure their analysis was in line with the whole. The authors are pharmacists with supplementary experience. Both have experience with qualitative methods, and work experience from pharmacies and universities. Additionally, the second author is presently working as a municipal pharmacist. The authors have no clinical experience from sheltered housing.

Ethical Considerations

Ethical issues have been raised surrounding the use of secondary analysis (Heaton, 2008; Ruggiano & Perry, 2019). These issues relate particularly to obtaining informed consent from interviewees for retaining data, sharing data, and re-using data for another purpose than the original one. Written consent and approval from the Norwegian Centre for Research Data (NSD) [reference 57803] were collected for both of the primary interview studies. New consent or approval for this secondary analysis was not obtained. This could be considered to be a limitation. The strength of a secondary analysis is, on the other hand, that it relieves the burden for interviewees, and heads of units who collaborated with us, to identify, access, and recruit research participants. The research question guiding this secondary analysis is close to the original studies’ research questions.

Results

The analysis showed that healthcare providers experience the resident’s medication list as a tool for ensuring appropriate medication use, and for maintaining proper patient safety, but also to help them feel confident in their actions when managing medications. An updated list was perceived as essential to safeguard uniform practice, and when communicating with other healthcare personnel and residents. However, encountering outdated and unrevised medication lists was common. In these situations, healthcare providers had to rely on their experience and thorough knowledge of the resident to guarantee appropriate medication use. To be able to maintain proper patient safety when handling incorrect lists, the healthcare providers said they requested medication reviews. There appear to be differences between different sheltered housing locations regarding how updated the lists are, and how healthcare providers collaborate with the prescriber, revealing how well the list works as a tool for the healthcare provider. The analysis identified the medication lists functioning as a tool for the healthcare provider within two main themes, with two subthemes, respectively, as shown in Table 2.

Table 2. Overview of Results: Main Theme, Themes and Subthemes

Discussion

PRNM prescriptions and administration may increase efficiency of care since they allow frequent and intermittent medicine use, without having to contact the prescriber for new prescriptions. Nurses’ involvement in decision making and patient care may therefore increase (Haw & Wolstencroft, 2014). The premise for optimal use of PRNM is, however, that prescriptions must be monitored continually to ensure appropriate medication use (Barr et al., 2018). The main results from this study show that reality may not agree with the premise. Medication lists are important tools for the healthcare provider, ensuring appropriate medication use and maintaining proper patient safety. The interviewees in this study expected updated and unambiguous medication lists, contributing to uniform practice and improving confidence when communicating with residents, next-of kin, or colleagues about the administration of PRNM. However, the nurses more often experience ambiguous medication lists, which result in a perceived shift in the distribution of responsibility between nurses and GPs, resulting in nurses requesting regular medication reviews.

Conclusion

Healthcare providers in this study experience drug lists to be important for daily practice. The lists are used as tools to maintain appropriate drug use and maintain patient safety when administrating PRNMs in sheltered housing. Several of the healthcare providers experience today’s practice as being put under pressure to achieve the goal of safe management of PRNMs. The interviewees in this study want closer collaboration with the GP to cope with their experienced challenges, such as systematic medication reviews. Medication reviews could contribute to updated medicine lists, and at the same time contribute to closer collaboration between healthcare providers in sheltered housing and the GP.

References

• Barr, L., Wynaden, D., & Heslop, K. (2018). Nurses’ attitudes towards the use of PRN psychotropic medications in acute and forensic mental health settings. International Journal of Mental Health Nursing, 27(1), 168–177. https://doi.org/10.1111/inm.12306
• Berland, A., & Bentsen, S. B. (2017). Medication errors in home care: A qualitative focus group study. Journal of Clinical Nursing, 26(21–22), 3734–3741. https://doi.org/10.1111/jocn.13745
• Carayon, P., Hundt, A. S., Karsh, B., Gurses, A. P., Alvarado, C., Smith, M., & Brennan, P. F. (2006). Work system design for patient safety: The SEIPS model. BMJ Quality & Safety, 15, i50-i58. https://doi.org/10.1136/qshc.2005.015842
• Davies, E., & O’mahony, M. (2015). Adverse drug reactions in special populations: The elderly. British Journal of Clinical Pharmacology, 80(4), 796–807. https://doi.org/10.1111/bcp.12596
• Devik, S. A., Alteren, J., & Olsen, R. M. (2021). Kunnskap og vilje, men uten myndighet? [Knowlegde and will, but no authority?]. In M. Hedlund, K. Ingstad, & A. Moe (Eds.), God hels: Kunnskap for framtidens kommunehelsetjeneste [Good health: Knowledge for future primary healthcare] (pp. 45–67). https://doi.org/10.18261/9788215042985-2021-03
• Devik, S. A., Olsen, R. M., Fiskvik, I. L., Halbostad, T., Lassen, T., Kuzina, N., & Enmarker, I. (2018). Variations in drug-related problems detected by multidisciplinary teams in Norwegian nursing homes and home nursing care. Scandinavian Journal of Primary Health Care, 36(3), 291–299. https://doi.org/10.1080/02813432.2018.1499581
• Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (2000). To err is human: Building a safer health system. National Academy Press.
• Dörks, M., Schmiemann, G., & Hoffmann, F. (2016). Pro re nata (as needed) medication in nursing homes: The longer you stay, the more you get? European Journal of Clinical Pharmacology, 72(8), 995–1001. https://doi.org/10.1007/s00228-016-2059-4
• Daatland, S. O., Høyland, K., & Otnes, B. (2015). Scandinavian contrasts and Norwegian variations in special housing for older people. Journal of Housing for the Elderly, 29(1–2), 180–196. https://doi.org/10.1080/02763893.2015.989778
• Frydenberg, K., & Brekke, M. (2012). Poor communication on patients’ medication across health care levels leads to potentially harmful medication errors. Scandinavian Journal of Primary Health Care, 30(4), 234–240. https://doi.org/10.3109/02813432.2012.712021
• Haggerty, J. L., Roberge, D., Freeman, G. K., & Beaulieu, C. (2013). Experienced continuity of care when patients see multiple clinicians: A qualitative metasummary. The Annals of Family Medicine, 11(3), 262–271. https://doi.org/262-271.10.1370/afm.1499
• Hammar, T., Ekedahl, A., & Petersson, G. (2014). Implementation of a shared medication list: Physicians’ views on availability, accuracy and confidentiality. International Journal of Clinical Pharmacy, 36(5), 933–942. https://doi.org/10.1007/s11096-014-0012-0
• Haw, C., & Wolstencroft, L. (2014). A study of the prescription and administration of sedative PRN medication to older adults at a secure hospital. International Psychogeriatrics, 26(6), 943–951. https://doi.org/10.1017/S1041610214000179
• Heaton, J. (2008). Secondary analysis of qualitative data: An overview. Historical Social Research/Historische Sozialforschung, 33(3(125)), 33–45. https://www.jstor.org/stable/20762299
• Helsedirektoratet [The Norwegian Directorate of Health]. (2020). I trygge hender 24/7 [In safe hands]. https://pasientsikkerhetsprogrammet.no/
• Kim, J. M., Suarez-Cuervo, C., Berger, Z., Lee, J., Gayleard, J., Rosenberg, C., Nagy, N., Weeks, K., & Dy, S. (2018). Evaluation of patient and family engagement strategies to improve medication safety. The Patient: Patient-Centered Outcomes Research, 11(2), 193–206. https://doi.org/10.1007/s40271-017-0270-8
• Lenander, C., Bondesson, Å., Viberg, N., Beckman, A., & Midlöv, P. J. B. (2018). Effects of medication reviews on use of potentially inappropriate medications in elderly patients: A cross-sectional study in Swedish primary care. BMC Health Services Research 18(1), 616. https://doi.org/10.1186/s12913-018-3425-y
• Lindblad, M., Flink, M., & Ekstedt, M. (2017). Safe medication management in specialized home healthcare: An observational study. BMC Health Services Research, 17(1), 1–8. https://doi.org/10.1186/s12913-017-2556-x
• Longtin, Y., Sax, H., Leape, L. L., Sheridan, S. E., Donaldson, L., & Pittet, D. (2010). Patient participation: Current knowledge and applicability to patient safety. Mayo Clinic Proceedings 85(1),53–62, https://doi.org/10.4065/mcp.2009.0248
• Lovdata (2008). Forskrift om legemiddelhåndtering for virksomheter og helsepersonell som yter helsehjelp. [Regulations on medication management for services and health professionals providing healthcare]. (FOR-2008-04-03-320). https://lovdata.no/forskrift/2008-04-03-320 Lovdata (2011). Helse- og omsorgstjenesteloven. Lov om kommunale helse- og omsorgstjenester m.m. [The act on municipal healthcare services] LOV-2011-06-24-30;2011. https://lovdata.no/dokument/NL/lov/2011-06-24-30
• Lovdata (2012). Forskrift om fastlegeordning i kommunene [Regulations on general practitioners in the municipalities]. FOR-2012-08-29-842;. https://lovdata.no/dokument/SF/forskrift/2012-08-29-842
• Malterud, K. (2012). Systematic text condensation: A strategy for qualitative analysis. Scandinavian Journal of Public Health, 40(8), 795–805. https://doi.org/10.1177/1403494812465030
• Manskow, U. S., & Kristiansen, T. T. (2021). Challenges faced by health professionals in obtaining correct medication information in the absence of a shared digital medication list. Pharmacy, 9(1), 46. https://doi.org/10.3390/pharmacy9010046
• Melby, L., Ågotnes, G., Ambugo, E. A., & Førland, O. (2019). Kartlegging av medisinskfaglig tilbud i sykehjem og heldøgns omsorgsboliger [Mapping of medical services in nursing homes and sheltered housing] (Vol. 3). Senter for omsorgsforskning: Rapportserie. Retrieved from https://ntnuopen.ntnu.no/ntnuxmlui/bitstream/handle/11250/2596428/Rapport%2003_19_webFinal.pdf?sequence=1&isAllowed=y
• Modig, S., Holmdahl, L., & Bondesson, Å. (2016). Medication reviews in primary care in Sweden: Importance of clinical pharmacists’ recommendations on drug-related problems. International Journal of Clinical Pharmacy, 38(1), 41–45. https://doi.org/10.1007/s11096-015-0189-x
• Murray, L. (2017). The role of the registered nurse managing pro re nata (PRN) medicines in the care home (nursing): A case study of decision making, medication management and resident involvement. [Doctoral dissertation, University of Hertfordshire]. https://doi.org/10.18745/th.17989
• Nilsen, M. K., Sletvold, H., & Olsen, R. M. (2020). “To give or not to give medication, that is the question”. Healthcare personnel’s perceptions of factors affecting pro re nata medication in sheltered housing for older adults: A focus-group interview study. BMC Health Services Research, 20(1), 1–11. https://doi.org/10.1186/s12913-020-05439-4
• Nilsen, M. K., Sletvold, H., & Olsen, R. M. (2021). Sometimes we just have to trust our gut feeling and hope the reporting is good. Tidsskrift for Omsorgsforskning [Journal of Care Research], 7(3), 1–15. https://doi.org/10.1186/s12913-020-05439-4
• Odberg, K. R., Hansen, B. S., & Wangensteen, S. (2019). Medication administration in nursing homes: A qualitative study of the nurse role. Nursing Open, 6(2), 384–392. https://doi.org/10.1002/nop2.216
• Payne, R. A., & Avery, A. J. (2011). Polypharmacy: One of the greatest prescribing challenges in general practice. British Journal of General Practice, 61(583), 2. https://doi.org/10.3399/bjgp11X556146
• Rahmner, P. B., Gustafsson, L. L., Holmström, I., Rosenqvist, U., & Tomson, G. (2010). Whose job is it anyway? Swedish general practitioners’ perception of their responsibility for the patient’s drug list. The Annals of Family Medicine, 8(1), 40–46. https://doi.org/10.1370/afm.1074
• Reason, J. (2000). Human error: Models and management. BMJ, 320(7237), 768–770. https://doi.org/10.1136/bmj.320.7237.768
• Rose, A. J., Fischer, S. H., & Paasche-Orlow, M. K. (2017). Beyond medication reconciliation: The correct medication list. JAMA, 317(20), 2057–2058. https://doi.org/10.1001/jama.2017.4628
• Ruggiano, N., & Perry, T. E. (2019). Conducting secondary analysis of qualitative data: Should we, can we, and how? Qualitative Social Work, 18(1), 81–97. https://doi.org/10.1177/1473325017700701
• Rønningen, S. W., Bakken, K., & Granås, A. G. (2013). Behovsmedisinering i sykehjem: Forskrivning, bruk og dokumenatsjon av effekt [Medication needs in nursing homes: Prescribing, use and documentation of effect]. Sykepleien Forskning [Norwegian Journal of Clinical Nursing], 8(1), 14–24. https://doi.org/10.4220/sykepleienf.2013.0005
• Seidling, H. M., Mahler, C., Straßner, C., Strauß, B., Bernhard, G., Szecsenyi, J., Haefeli, W. E., & Wehrmann, U. (2019). Use of medication lists: A population-based approach to increase the prevalence of medication lists within a region in Germany. Pre-post study]. International Journal of Clinical Pharmacology and Therapeutics, 57(8), 375. https://doi.org/10.5414/CP203447
• Shay, L. A., & Lafata, J. E. (2015). Where is the evidence? A systematic review of shared decision making and patient outcomes. Medical Decision Making, 35(1), 114–131. https://doi.org/10.1177/0272989x14551638
• Stasinopoulos, J., Bell, J. S., Ryan-Atwood, T. E., Tan, E. C. K., Ilomäki, J., Cooper, T., Robson, L., Sluggett, J. K., & Ilomäki, J. (2018). Frequency of and factors related to pro re nata (PRN) medication use in aged care services. Research in Social & Administrative Pharmacy, 14(10), 964–967. https://doi.org/10.1016/j.sapharm.2017.11.004
• Stokes, J. A., Purdie, D. M., & Roberts, M. S. (2004). Factors influencing PRN medication use in nursing homes. Pharmacy World and Science, 26(3), 148–154. https://doi.org/10.1023/B:PHAR.0000026803.89436.a8
• Solberg, H., Devik, S. A., Bell, H. T., & Olsen, R. M. (2022). The art of making the right exception to the “rule”: Nurses’ experiences with drug dispensing in nursing homes. Geriatric Nursing, 44, 229–236. https://doi.org/10.1016/j.gerinurse.2022.02.019
• Tariq, A., Georgiou, A., & Westbrook, J. (2013). Medication errors in residential aged care facilities: A distributed cognition analysis of the information exchange process. Journal of Medical Informatics, 82(5), 299–312. https://doi.org/10.1016/j.ijmedinf.2012.08.006
• Vaismoradi, M., Amaniyan, S., & Jordan, S. (2018). Patient safety and pro re nata prescription and administration: A systematic review. Pharmacy, 6(3), 95. https://doi.org/10.3390/pharmacy6030095
• World Health Organization. (2017). Medication without harm: Global patient safety challenge on medication safety. file:///C:/Users/01700274/Downloads/WHO-HIS-SDS-2017.6-eng.pdf
• World Health Organization. (2019). Medication safety in polypharmacy: Technical report. https://www.who.int/publications/i/item/medication-safety-in-polypharmacy-technical-report

Methods

Results

Nurses and MDs in primary healthcare generally experienced the task of obtaining and sharing CPI as a significant challenge, especially related to patients’ medication information. One main pattern that emerged from our material was that the participants regularly experienced situations where access to CPI was limited, and where professional tasks had to be performed without having all relevant information at hand. When analyzing the material, we found that the participants typically described experiences of five sorts: 1) excessive time consumption, 2) frustration, 3) uncertainty, 4) dependency, and 5) complexity and risk. In the following sections, we explore these experiences in more detail.

Excessive Time Consumption

The participants reported that when access to CPI was limited, excessive time consumption was a common consequence: “I spend 40% of my workday getting information” (Nurse). In terms of both losing time designated to core tasks as well as “stealing” time from other health professionals, one MD stated, “Not only does it cost me time, but it costs the specialist and GP time as well”. One of the main reasons for excessive time consumption was said to be the lack of adequate digital solutions for sharing CPI across health services, which hindered information access.

[It is] difficult with systems that do not communicate and retrieve all the information. It is not easy. It does not come automatically, and we have to search for the information. (MD)

Some participants also reported that pre-existing time shortages could result in new problems, for example when nurses lack the time to obtain medical records with an updated medication list for new patients:

We have a busy time schedule, and you may not be able to do things as fast as you should. The patient arrives and then it may take a week before you realize that you need to obtain a medical record. (Nurse)

Also, most participants mentioned that they spend a lot of extra time gathering core information about new patients:

I spend a lot of unnecessary time calling around to find the right person and the right department in the hospital for information about a patient. (Nurse)

As illustrated above, the participants reported considerable time consumption, that is time spent searching for CPI, and that this was viewed as “excessive” by the participants.

Discussion

Our results indicate that nurses and MDs in Norwegian nursing homes and home care services have extensive experience of situations where inadequate access to CPI affected patient safety and quality of care. Our participants regularly linked these challenges to absent or inadequate digital solutions for accessing and sharing CPI across healthcare services. This complements a qualitative study of clinicians’ perspectives, that revealed multiple areas in which the lack of interoperability led to ineffective processes and a lack of data in care coordination and transitions (Samal et al., 2016).

Another main challenge was excessive time consumption. This finding complements a 2020 review of nurses’ time use after the implementation of health technology, that shows how nurses, after implementation, use more time documenting but less time administering medications, and that this in sum enables more time with the patient (Moore et al., 2020). Our findings complement this review by documenting how actual health professionals in Norwegian nursing homes and home care services experience their time use before the implementation of the SCR and SML.

Another finding was that limited access to CPI caused uncertainty about the correctness of the information at hand. This finding complements a cross-sectional study from the U.S. that evaluated the completeness and timeliness of information transfer and communication between a hospital and a post-acute care facility (PAC). The study reported that nurses and clinicians at the PAC experienced substantial deficits in content and timeliness of health information exchange (Jones et al., 2017). Another study from Sweden reported that both human limitations and technical deficiencies could lead to medication errors and patient harm (Bengtsson et al., 2021). Our findings complement both these studies, by documenting how problems concerning information timeliness and correctness are experienced by actual health professionals in a Norwegian nursing home and home care setting before the implementation of the SCR and SML.

A similar problem was the frequent incomplete or delayed approval of discharge summaries from hospitals. As with the abovementioned limited access to CPI, this was also perceived as a major source of uncertainty. In addition, it was linked to frustration, and dependency. This finding complements Samal et al., who claim that the completion of structured discharge summaries before discharge from hospital should be one of the main targets for quality improvement (Samal et al., 2016). We complement Samal’s point about discharge summaries and quality improvement, by showing different ways in which incomplete discharge summaries are experienced by actual health professionals in a Norwegian nursing home and home care setting before the implementation of the SCR and SML.

E-messages were commonly used in communication between nurses, MDs and general practitioners (GPs) in our study, to clarify a patient’s medications and/or the need for observation. Some participants experienced quick answers from the GPs, although many reported that it could take days or even weeks to receive an answer to a question or clarification. Two Norwegian studies explored the impact of electronic messaging on patients in patient transition, and concluded that the introduction of e-messages, as well as information and communication technology, can support the work of nurses in the transition situation and benefit patients (Hellesø et al., 2016; Melby et al., 2015). Our study provides important nuances to these previous studies, as e-messages have certainly eased communication challenges, especially between GPs and nurses in home care, but limitations concerning CPI access and exchange is still a main issue and source of frustration and uncertainty among nurses and MDs.

In our study, both nurses and doctors reported that they often had to handle unnecessarily complex situations resulting from limitations in the access to and exchange of CPI, and that they considered this complexity as a threat to patient safety. This finding is in accordance with previous Norwegian studies reporting how inadequate information exchange poses a threat to patient safety, since fragmented patient information and poor communication with and between services can lead to potentially harmful medical/medication errors (Frydenberg & Brekke, 2012; Remen & Grimsmo, 2011). Our results also complement a qualitative study from the US, which explored nurses’ perspectives on improving information exchange between hospitals and home healthcare, and revealed the following challenges: ineffective communication, technological factors, poor medication management, and different patient factors (Sarzynski et al., 2019). Our findings complement these studies by documenting how challenges are experienced as an increase in complexity by actual health professionals in Norwegian nursing home and home care settings.

Conclusion and Future Research

Equipped with accurate and updated CPI, health professionals can act with precision and confidence as participants in complex and fine-tuned co-operation, oriented towards the delivery of health services tailored to a patient’s needs. Our results show that having access to accurate and updated CPI is not always the case in primary healthcare in Norway. The current digital solutions limit an effective utilization of health sector resources, and digital interaction is not fully prevalent. In Norway, most nursing homes and home care services do not yet have access to a summary care record (SCR), although the implementation process and the use of SCR have now started in some municipalities. The shared medications list (SML) is at present being piloted in one municipality in Norway, and a full national rollout is planned in 2023–2025. In this situation, our chapter provides important new insights into how the present challenges are experienced by nurses and MDs in nursing homes and home care services in six municipalities in Norway. We found that accessing CPI was widely experienced as challenging among the participants. It was linked to frustration, uncertainty, unnecessary time-consumption and complexity, and was perceived as a threat to patient safety and to quality of care. Based on our findings, we contend that future eHealth initiatives aimed at improving quality and safety in healthcare must address these challenges in accessing CPI directly, especially in the critical phase of patient transition between levels of care. The knowledge presented in this chapter will serve as a baseline for the longitudinal main study on the implementation of SCR and SML in Norway. Our findings will enable monitoring the effects, limitations and possibilities of ongoing and planned national eHealth initiatives. The next steps following this pre-study of SCR and SML implementation will be to investigate the experiences of nurses and MDs during and after the implementation of the SCR and SML in the same six municipalities.

References

• Bengtsson, M., Ekedahl, A. I., & Sjostrom, K. (2021). Errors linked to medication management in nursing homes: An interview study. BMC Nursing, 20(1), 69. https://doi.org/10.1186/s12912-021-00587-2
• Donaldson, L. J., Kelley, E. T., Dhingra-Kumar, N., Kieny, M., & Sheikh, A. (2017). Medication without harm: WHO’s third global patient safety challenge. The Lancet, 389(10080), 1680–1681. https://doi.org/10.1016/S0140-6736(17)31047-4
• Dyb, K., & Warth, L. L. (2018). The Norwegian national summary care record: A qualitative analysis of doctors’ use of and trust in shared patient information. BMC Health Services Research, 18(1), 252. https://doi.org/10.1186/s12913-018-3069-y
• Eden, K. B., Totten, A. M., Kassakian, S. Z., Gorman, P. N., McDonagh, M. S., Devine, B., Pappas, M., Daeges, M., Woods, S., & Hersh, W. R. (2016). Barriers and facilitators to exchanging health information: A systematic review. International Journal of Medical Informatics, 88, 44–51. https://doi.org/10.1016/j.ijmedinf.2016.01.004
• Frydenberg, K., & Brekke, M. (2012). Poor communication on patients’ medication across health care levels leads to potentially harmful medication errors. Scandinavian Journal of Primary Health Care, 30(4), 234–240. https://doi.org/10.3109/02813432.2012.712021
• Glaser, B., & Strauss, A. (1967). The discovery of grounded theory: Strategies for qualitative research. Aldine.
• Granja, C., Janssen, W., & Johansen, M. A. (2018). Factors determining the success and failure of eHealth interventions: Systematic review of the literature. Journal of Medical Internet Research, 20(5), e10235. https://doi.org/10.2196/10235
• Greenhalgh, T., Stramer, K., Bratan, T., Byrne, E., Russell, J., & Potts, H. W. (2010). Adoption and non-adoption of a shared electronic summary record in England: A mixed-method case study. BMJ, 340, c3111. https://doi.org/10.1136/bmj.c3111
• Hellesø, R., Melby, L., Brattheim, B., & Toussaint, P. (2016). Exchange of information between hospital and home health care: A longitudinal perspective. Studies in Health Technology and Informatics, 225, 349–353. https://doi.org/10.3233/978-1-61499-658-3-349
• Helsenett, N. (2018). What is a summary care record? Retrieved from https://www.helsenorge.no/en/summary-care-record/kjernejournal-for-safer-healthcare/
• Institute of Medicine Committee on Data Standards for Patient Safety. (2004). Patient safety: Achieving a new standard for care. National Academies Press (US).
• Institute of Medicine Committee on Quality of Health Care in America. (2001). Crossing the quality chasm: A new health system for the 21st century. National Academies Press (US).
• Jones, C. D., Cumbler, E., Honigman, B., Burke, R. E., Boxer, R. S., Levy, C., Coleman, E. A., & Wald, H. L. (2017). Hospital to post-acute care facility transfers: Identifying targets for information exchange quality improvement. Journal of the American Medical Directors Association, 18(1), 70–73. https://doi.org/10.1016/j.jamda.2016.09.009
• Kierkegaard, P. (2013). eHealth in Denmark: A case study. Journal of Medical Systems, 37(6), 9991. https://doi.org/10.4338/ACI-2014-06-RA-0055
• Malterud, K. (2001a). The art and science of clinical knowledge: Evidence beyond measures and numbers. The Lancet, 358(9279), 397–400. https://doi.org/10.1016/S0140-6736(01)05548-9
• Malterud, K. (2001b). Qualitative research: Standards, challenges, and guidelines. The Lancet, 358(9280), 483–488. https://doi.org/10.1016/S0140-6736(01)05627-6
• Manskow, U. S., & Kristiansen, T. T. (2021). Challenges faced by health professionals in obtaining correct medication information in the absence of a shared digital medication list. Pharmacy, 9(1), 46. https://doi.org/10.3390/pharmacy9010046
• Melby, L., Brattheim, B. J., & Helleso, R. (2015). Patients in transition. Improving hospital-home care collaboration through electronic messaging: Providers’ perspectives. Journal of Clinical Nursing, 24(23–24), 3389–3399. https://doi.org/10.1111/jocn.12991
• Moore, E. C., Tolley, C. L., Bates, D. W., & Slight, S. P. (2020). A systematic review of the impact of health information technology on nurses’ time. Journal of the American Medical Informatics Association, 27(5), 798–807. https://doi.org/10.1093/jamia/ocz231
• Remen, V. M., & Grimsmo, A. (2011). Closing information gaps with shared electronic patient summaries: How much will it matter? International Journal of Medical Informatics, 80(11), 775–781. https://doi.org/10.1016/j.ijmedinf.2011.08.008
• Samal, L., Dykes, P. C., Greenberg, J. O., Hasan, O., Venkatesh, A. K., Volk, L. A., & Bates, D. W. (2016). Care coordination gaps due to lack of interoperability in the United States: A qualitative study and literature review. BMC Health Services Research, 16, 143. https://doi.org/10.1186/s12913-016-1373-y
• Sarzynski, E., Ensberg, M., Parkinson, A., Fitzpatrick, L., Houdeshell, L., Given, C., & Brooks, K. (2019). Eliciting nurses’ perspectives to improve health information exchange between hospital and home health care. Geriatric Nursing, 40(3), 277–283. https://doi.org/10.1016/j.gerinurse.2018.11.001
• Strauss, A., & Corbin, J. (1994). Grounded theory methodology: An overview. In Denzin & Lincoln (Eds.), Handbook of qualitative research, (pp. 273–285). Sage.
• Strauss, A., & Corbin, J. M. (1997). Grounded theory in practice. Sage.
• The Norwegian Directorate of eHealth (NDE) (2018). National eHealth strategy and goals 2017–2022. https://www.ehelse.no/publikasjoner/nasjonal-e-helsestrategi-og-mal-2017-2022
• Tjora, A. (2010). Kvalitative forskningsmetoder i praksis [Qualitative research in practice]. Gyldendal Norsk Forlag.
• Trondsen, M., Bolle, S., Stensland, G., & Tjora, A. (2014). Video-confidence: A qualitative exploration of videoconferencing for psychiatric emergencies. BMC Health Services Research, 14(1), 544. https://doi.org/10.1186/s12913-014-0544-y

Background

Research Methodology

Losing Concentration on the Medicine Round: A Sample Narrative

The situation I am going to tell you about is typical for distributing medicines in the ward. This is when the residents have their breakfast. The residents need their medicines in the morning. Administering medicines during breakfast requires time and concentration. When I administer medicines, I follow my own and the ward’s routines, and I follow a specific route. Before I start the medicine round, I check the medicine in the dose distribution system according to the medicine journal. I find the medicine that is not in the dose distribution system in the medicine room or the refrigerator. I prepare the drug trolley and bring with me the medicine journal, glasses, and a jug of water.

Normally, I begin distribution of medicines in the living room, where most of the residents have their breakfast. Sometimes residents ask me for help getting to the living room, either by using the alarm clock or asking me for help. Then, I interrupt the medicine round: close, and lock the drug trolley and help the resident. Other times, residents may ask for painkillers. I check which medicine they can get in the medicine journal, and if the painkillers are in the dose distribution system. If not, I interrupt the medicine round and return to the medicine room for the resident’s painkillers. When I return to the living room, there are often colleagues requesting medicines on behalf of other residents. In the living room, I distribute the medicines based on where the residents are placed. While I hand out, colleagues can ask for medicine for the residents eating their breakfast. Other nurses who help residents with care can ask for painkillers. Again, I check the medicine journal, find painkillers, and sign the medicine journal before I give the medicine to the resident.

Interruptions from colleagues happen many times every day, and mostly I find them disturbing. When I prepare the medicine round, I am very concentrated. When I am disturbed, I lose concentration. I must work my way into the procedure again, and that takes time. There are situations where I am not interrupted, when I administer medicines the way I find appropriate. I do not experience it as an interruption when communicating with residents, serving coffee, or bringing the residents water. But sometimes there are too many tasks like this. Then I experience them as interruptions, and I lose concentration.

Many interruptions like this, not only in the living room, residents’ rooms, and corridors, but also in the medicine room, delay distribution and increase time pressure. The consequence might be that the residents do not receive their medicine at the right time. Other disturbances where I lose concentration are when I must interrupt distribution and answer the phone or an alarm clock. There is a doctor’s visit every Wednesday. Sometimes the doctor comes earlier than the predicted routine, and other times I am so late that I am not done with the medicine round. The interruptions delay and shift the work I am responsible for in the ward. This applies not only to administering medicines. Patients do not receive their medication on time, which has consequences for treatment, care, and patient safety.

Conclusions

The resident’s needs define whether a work interruption is a work interruption or a source of knowledge important for medication treatment in nursing homes. When nurses administer medicines, they simultaneously give medicines and acquire knowledge about the resident’s health. Interruptions as a source of knowledge should therefore receive greater attention in the organization of medication administration, especially aimed at interruptions related to caring and medical treatment. Greater attention to interruptions as a source of knowledge also contributes to increased knowledge about the patient, safeguarding patient safety. This knowledge forms the basis for the nurse’s assessments and decisions about further treatment and care, as well as aiding the development of evidence-based practice in nursing homes. A change in focus requires management, and an organization in which tasks that are not related to medication treatment and care are handled by other professionals than nurses.

References

• Abdelhadi, N., Drach-Zahavy, A., Srulovici, E. (2021). Work interruptions and missed nursing care: A necessary evil or an opportunity? The role of nurses’ sense of controllability. Nursing Open, 00, 1–11. https://doi.org/10.1002/nop2.1064
• Alteren, J., Hermstad, M., Nerdal, L. & Jordan, S. (2021). Working in a minefield: Nurses’ strategies for handling medicine administration interruptions in hospitals: A qualitative interview study. BMC Health Services Research, 21, 1094. https://doi.org/10.1186/s12913-021-07122-8
• Alteren, J., Hermstad, M., White, J., & Jordan, S. (2018). Conflicting priorities: Observation of medicine administration. Journal of Clinical Nursing, 27, 3613–21. https://doi.org/10.1111/jocn.14518
• Aristotle (2006). Etikk. Et hovedverk i Aristoteles’ filosofi, også kalt «den nikomakiske etikk». [Ethics. A major work of Aristotle’s philosophy, also called “the Nicomachean Ethics”]. (3rd edition). Gyldendal Akademisk. (3rd issue 1999).
• Biron, A. D., Lavoie-Tremblay, M., & Loiselle, C. G. (2009). Characteristics of work interruptions during medication administration. Journal of Nursing Scholarship, 41(4), 330–336. https://doi.org/10.1111/j.1547-5069.2009.01300.x
• Colligan, L., & Bass, E. J. (2012). Interruption handling strategies during pediatric medication administration. BMJ Quality & Safety, 21, 912–7. https://doi.org/10.1136/bmjqs-2011-000292
• Cottney, A., & Innes, J. (2015). Medication-administration errors in an urban mental health hospital: A direct observation study. International Journal of Mental Health Nursing, 24, 65–74. https://doi.org/10.1111/inm.12096
• Dilles, T., Elseviers, M. M., Rompaey. B. V., Bortel, L. M. V., & Stichele, R. R. V. (2011). Barriers for nurses to safe medication management in nursing homes. Journal of Nursing Scholarship, 43(2), 171–180. https://doi.org/10.1111/j.1547-5069.2011.01386.x
• Gadamer, H-G., (2003). Forståelsens filosofi. Utvalgte hermeneutiske skrifter. [Understanding philosophy. Selected hermeneutical writings]. Cappelen Akademisk Forlag.
• Getnet, M. A., & Bifftu, B. B. (2017). Work interruption experiences by nurses during medication administration process and associated factors, Northwest Ethiopia. Nursing Research and Practice, 8937490(7). https://doi.org/10.1155/2017/8937490
• Jennings, B. M., Sandelowski, M., & Mark, B. (2011). The nurse’s medication day. Qualitative Health Research,21(10), 1441–51. https://doi.org/10.1177/1049732311411927
• Lee, L. Y-k., Tiu, M. M-h., Charm, C. Y-c., & Wong, K-f. (2015). An observational study on work interruptions during medication administration in residential care homes for older people. Journal of Clinical Nursing, 24, 3336–3339. https://doi.org/10.1111/jocn.12966
• McLeod, M., Barber, N., & Franklin, B. D. (2015). Facilitators and barriers to safe medication administration to hospital inpatients: A mixed methods study of nurses’ medication administration processes and systems (the MAPS Study). PLOS One. https://doi.org/10.1371/journal.pone.0128958
• Odberg, K. R., Hansen, B. S., & Wangensteen, S. (2018). Medication administration in nursing homes: A qualitative study of the nurse role. Nursing Open, 6, 384–392. https://doi.org/10.1002/nop2.216
• Odberg, K. R., Hansen, B. S., Aase, K., & Wangensteen, S. (2017). Medication administration and interruptions in nursing homes: A qualitative observational study. Journal of Clinical Nursing, 27, 1113–1124. https://doi.org/10.1111/jocn.14138
• Pharm, A. A. A-J. B. S., & Doucette, W. R. (2017). Comprehensive literature review of factors influencing medication safety in nursing homes: Using a systems model. JAMDA, 18, 470–488. https://doi.org/10.1016/j.jamda.2016.12.069
• Schroers, G. (2018). Characteristics of interruptions during medication administration: An integrative review of direct observational studies. Journal of Clinical Nursing, 27, 3462–71. https://doi.org/10.1111/jocn.14587
• Schutijser, B. C. F. M., Klopotowska, J. E., Jongerden, I. P., Spreeuwenberg, P. M. M., Bruijne, M. C. D., & Wagner, C. (2018). Interruptions during intravenous medication administration: A multicentre observational study. Journal of Advanced Nursing, 75, 555–62. https://doi.org/10.1111/jan.13880
• Sitterding, M. C. (2014). Situation awareness and the selection of interruption handling strategies during the medication administration process: A qualitative study. [Doctoral dissertation, Indiana University].
• Sitterding, M. C., Ebright, P., Broome, M., Patterson, E. S., & Wuchner, S. (2014). Situation awareness and interruption handling during medication administration. Western Journal of Nursing Research, 36(7), 891–916. https://doi.org/10.1177/0193945914533426
• Sulosaari, V., Suhonen, R., Leino-Kipli, H. (2010). An integrative review of the literature on registered nurses’ medication competence. Journal of Clinical Nursing, (20), 464–478. https://doi.org/10.1111/j.1365-2702.2010.03228.x
• Thomson, M. S., Gruneir, A., Lee, M., Baril, J., Field, T. S., Gurwitz, J. H., & Rochon, P. A. (2009). Nursing time devoted to medication administration in long-term care: Clinical, safety, and resource implications. Journal of the American Geriatrics Society, 57, 266–272. https://doi.org/10.1111/(ISSN)1532-5415
• Trbovich, P., Prakash, V., Stewart, J., Trip, K., & Savage, P. (2010). Interruptions during the delivery of high-risk medications. Journal of Nursing Administration, 40(5), 211–218. https://doi.org/10.1097/NNA.0b013e3181da4047
• Westbrook, J. I., Li, L., Hooper, T., Raban, M. Z., Middleton, S., & Lehnbom, E. C. (2017). Effectiveness of a “Do not interrupt” bundled intervention to reduce interruptions during medication administration: A cluster randomised controlled feasibility study. BMJ Quality & Safety, 26(9), 734–742. https://doi.org/10.1136/bmjqs-2016-006123
• World Health Organization, WHO. (2016). Medication errors. Retrieved May 19, 2022, from http://apps.who.int/iris/bitstream/10665/252274/1/9789241511643-eng.pdf?ua=1&ua=1
• World Health Organization, WHO (2020). Patient safety. Retrieved May 19, 2022, from Patient safety (who.int).

Medication Administration Events

Older patients are vulnerable to adverse drug events due to individual factors, such as frailty, disability, comorbidity, drug interactions and a high prevalence of polypharmacy. Also, high potency drugs such as opioids, antipsychotics, antidepressants, antiepileptics and anti-infectives increase the risk of cognitive impairment and falls (Al-Jumaili & Doucette, 2017; Field et al., 2001; Herr et al., 2017; Violan et al., 2014).

Patient safety literature describes the following system-level factors affecting the risk of adverse drug events (Al-Jumaili & Doucette, 2017):

• staff competence
• indistinct procedures
• inadequate staffing
• high workload
• time pressure
• interruptions
• ineffective interprofessional collaboration

These factors are supported by findings from audits by the Norwegian Board of Health Supervision (2010). They found deviations from standards in medication management in 51 out of 67 (76%) of the nursing homes audited. The deviations included: unclear lines of responsibility; time pressure; lack of competence; poor interprofessional collaboration; variations in observing and documenting the effects of medications; poor availability of vital patient information due to multiple documentation systems; and separate documentation systems for the medical doctor.

International literature indicates that 13%-31% of all nursing home patients experience some form of medication administration error. Simultaneously, the incidence of severe adverse drug events is low (Al-Jumaili & Doucette, 2017; Ferrah et al., 2017). In Norway, there is no available information on medication administration events in nursing homes or in primary healthcare in general.

The Medication Administration Process

The medication administration process is well documented to be complex and dynamic across healthcare domains, and this also holds true in the nursing home context (Carayon, et al., 2014). Traditionally, nurses are taught to practice the six “rights” of medication administration: 1) right patient; 2) right medication; 3) right dosage; 4) right route; 5) right time; and 6) right documentation (Yoost et al., 2015). The nurse plays a central role throughout the medication administration process (Jennings et al., 2011; Odberg et al., 2019). Specific tasks related to medication administration are often difficult to separate from work processes of daily care. To structure and describe the medication administration process, it may be deconstructed into six consecutive stages:

The following flowchart (Figure 1), is based on observations of the medication administration process in two Norwegian nursing homes, visualizing the dynamic flow and intrinsic complexity of delivering medications to nursing home patients (Odberg et al., 2017). The stages of the medication administration process are vertically listed on the left side in Figure 1, while on the right side are corresponding elements detailing tasks and interactions.

Human Factors and Patient Safety

To gain further knowledge of the complexity of the medication administration process in nursing homes, including the facilitators and barriers to safe medication administration, a socio-technical systems approach is useful. Human factors embodies a systems approach concerned with designing safe and effective systems with human beings at the core (Dul et al., 2012). Carayon et al. (2006) describe a human factors system engineering model promoting patient safety, the System Engineering Initiative for Patient Safety (SEIPS model). The basis of the model lies in the interacting elements of the work system, as shown in Figure 2. The five elements of the work system: persons, physical environment, tasks, tools and technology, and organization, do not exist as isolated cells. Still, they interact in often subtle ways and must, therefore, be seen as a whole. These elements interact when humans engage in healthcare processes, such as medication administration in nursing homes, to produce specific outcomes. Outcomes may be positive or negative consequences of different processes in the work system. An example of a negative outcome is an adverse drug event, while a positive outcome can be safe and effective medication administration.

The five elements of the work system can be described as follows (Carayon et al., 2006; Dul et al., 2012; Holden et al., 2013):

Persons are at the center of the work system and represent the stakeholders involved in a given process: patients, next of kin, registered nurses, physicians or other healthcare professionals. These individuals exhibit cognitive, physical, and psychosocial characteristics, such as age, experience, competence, knowledge, training or education.

The physical environment represents the characteristics of the facilities in which healthcare workers provide care, including: noise, temperature, lighting layout, distances and air quality.

Tasks are the specific activities within different work processes, such as medication administration, and are characterized by attributes describing difficulty, complexity and variety.

Tools and technology specify how healthcare workers utilize equipment and medical devices, such as medical electronic administration records, blood glucose meters or tools to mobilize patients. Typical features relate to the usability, familiarity, functionality and portability of various equipment.

Organization indicates the collective structures that guide and organize activities, resources, time and space. Typical examples are work schedules, management type, policies or patient safety culture.

Human factors provides insights into healthcare processes by offering distinct, descriptive opportunities to simplify and visualize complex systems and processes. Using the work system of the SEIPS model as descriptive categories facilitates structuring the medication administration process.

Methodology

The PhD thesis on which this chapter is based used a QUAL-qual mixed methods study design (Morse, 2016). The main component (QUAL) was 140 hours of observations, while the supplemental component (qual) consisted of 16 individual interviews (Odberg, 2020).

By conducting a re-analysis of data using a narrative synthesis (Thomas & Harden, 2008), this chapter offers new insights into the medication administration process by further reflecting on the work system complexity of nursing homes, and how this influences the safety of medication administration. New data is presented in the form of quotations throughout the results section below.

Two different nursing home wards in different municipalities were recruited to capture some of the variability in Norwegian nursing homes. They were one urban palliative care nursing home ward (A), and one rural nursing home ward (B) catering to persons with dementia. The inclusion criteria for participating in the interviews were that staff members had a role in the medication administration process and were employed in at least a 50% position. In all, sixteen participants agreed to be interviewed, including special care nurses, registered nurses, nurse managers, medical doctors, physical therapists, and nursing assistants.

Data was collected through 140 hours, distributed between participant field observations spread evenly across wards A and B (QUAL), and semi-structured individual interviews (n = 16) (qual) with healthcare professionals dispersed across wards A and B. An interview guide and an observation guide based on the work system of the SEIPS model were used. Inductive and deductive qualitative content analyses inspired by Elo and Kyngäs (2008) were performed.

Ethics

All participants were informed about confidentiality and of the right to withdraw at any time. The study adhered to ethical guidelines and was approved by NSD (NO: XX).

Results

The study confirmed the picture of medication administration in nursing homes as a complex and dynamic process, in which the characteristics of the socio-technological work system interact and adapt according to shifting circumstances. The medication administration process according to the six stages (Figure 1) was found to contain 60 facilitators and barriers to safe medication practice. Throughout the process, the nurse plays a central role, compensating for variations in the work system, while demonstrating great flexibility in meeting the demands of the patients.

A nurse described how the workplace had transformed with increasing complexity during the past few years:

Our patients have more complex illnesses than was the case earlier. A few years ago, this was a place for persons with dementia, and they were quite healthy. However, now we receive patients with more diverse and complex illnesses. Everything from heart and lung diseases, atrial fibrillation and all the medications that follow. It has become a lot more taxing to follow up, medically speaking.

While another nurse reflects on the increased workload associated with medication administration:

The complexity of medication administration varies a lot. We have oral, subcutaneous, and transcutaneous patches. Some patients have tablets, mixtures, patches, and a pump as well … Then it becomes an issue, and you have to sit down and take stock.

Figure 3 is an adapted SEIPS model documenting how the 60 facilitators and barriers to safe medication administration have been condensed into 17 groups, and systematized across the five work-system elements. A + indicates a facilitator, while a – indicates a barrier. Some groups exhibit both, +/-, and thus indicate dual traits that may perform as both facilitators and barriers, depending on the circumstances. Dual traits are a novel element and tied to how individual staff members embody different knowledge and competence, which in turn will influence how they perform their tasks in different situations. For example, the electronic Medication Administration Record (eMAR) is in itself complex, multilayered software, and effective workflow depends on IT skills and knowing specific codes and shortcuts by heart.

Persons

This work-system element focuses on the nurse’s role, and how individual variations and differences in competence and experience can function as facilitators or barriers in how staff use their flexibility to modulate team composition, navigate everyday care, and perform medication administration.

In the context of the two nursing homes, different stakeholders were involved at different times of the medication administration process. The main ones included the patients and their informal carers, and professional stakeholders such as registered nurses (RN), nursing assistants, physicians and physiotherapists. The RN’s unique role, being involved in all the stages of the medication administration process, was reflected in how RNs took on responsibilities beyond their given assignments to ensure patient care. The RNs expended massive resources navigating everyday tasks in order to perform medication administration of a very high standard. Time pressure, singular responsibility, high activity, and demands for documentation required strict prioritizing. In many instances, the nurse felt constrained by administrative tasks and delegated direct patient care to colleagues. These decisions also impacted the team composition during a shift. A nursing assistant described this collaboration:

We use each other’s strengths and qualities and trust each other, assign tasks and cooperate. Sometimes I have shortcomings, and a nurse is needed; other times I can assist them (the nurses) when things are bustling. We cannot relieve the nurses for everything, but I do what I can for them, and that seems to work.

A vital facilitator was identified by three specific characteristics of the RNs: compensatory, flexible and adaptable.

The RNs compensated for the different individual skill sets and competencies of the surrounding staff on a given shift. This dynamic and continuous evaluation led to shifting responsibilities, where the RNs often took on tasks beyond their work description to fulfill all medication-related tasks.

On a given shift, the RN had to be flexible regarding structuring the workday and delegating medication-related tasks. As team members differed from day to day, a particular regard for individual skill-sets and competencies always informed the RN’s role. Sometimes lack of skill redundancy on a shift led to vulnerabilities as the single RN prioritized administrative tasks.

The RN constantly adapted to changing workloads and a shifting environment, working with different staff members. Staff stability and good leadership were therefore underscored as essential to minimize stress and ensure good collaboration.

These characteristics were crucial to enable safe medication administration, and showed how tenacious and vulnerable this balancing act of the RN was.

Organization

Three distinct features of the facilitators and barriers stood out under the work-system element of organization (Figure 3): leadership was fluid; membership stability was important; and vulnerable shifts could be critical.

Scattered and fluid leadership was a barrier affecting the day-to-day handling of medications. This was reflected clearly on a team level, where the role of team leader was interchangeable, depending on shifting conditions in the ward. If circumstances arose where the team leader had to shift priorities, another team leader was appointed ad hoc with a minimal transfer of information. Consequently, the responsibilities of the different team members often appeared unclear, and, in addition, guidelines and procedures to supplement decision-making when needed were inadequate. A nurse manager described how task delegation ideally took place:

As a leader, I get an overview and assign patients and tasks, and help them structure their workday. The staff is organized into groups with primary care nursing, and I assign them their tasks to the best of my ability. Even though they get assigned to a group of patients, they should be flexible and help each other.

Another example of fluid leadership arose during pre-visitations when an RN as team leader prepared for the ward round with the resident physician. The RNs may have more familiarity with the patients, and sometimes they were more experienced than the physician. Consequently, in some cases, the RNs took on tasks and responsibilities beyond their training and expectations, as they saw it necessary to safeguard the medication administration process.

Membership stability was found to facilitate safe medication management during periods of high activity in the wards. Several staff members reported that working together during extreme conditions led to more effective communication and better task distribution. One may assume that heavy workloads over more extended periods might lead to resignations and higher turnover, but it was also found to be an incentive that induced the staff to find creative solutions and creative workarounds. Membership stability within work groups thus seemed to counter adverse conditions and have a stabilizing effect:

When you work with someone you do not know or assistants you do not fully trust, you spend much energy caring about their tasks as well. You feel the responsibility of having an overview, since you are unsure whether all tasks will get done the way you would like them to. (Interview with an RN)

Meanwhile, periods of high activity also led to vulnerabilities, as there were few extra resources to handle unforeseen situations. Extreme situations led to the staff needing to prioritize medications for those patients most in need, while stable and self-sufficient patients received less attention. Sometimes this resulted in missing or delayed medications, and less time to observe, document, and perform generic administrative tasks. Vulnerable shifts as barriers were typically night shifts, weekends, and major vacations that coincided with heavy workloads and unforeseen activities, increasing the perceived risk of medication administration errors. Shortcuts, workarounds, and an acceptance of these inferior working conditions became accepted and normalized by the staff, while they also described such shifts as highly challenging and debilitating. To counter vulnerable shifts, the staff always tried to plan ahead:

I think they (the nurses) are good at preparing for the night shifts in a way that ensures that all the patients will receive the best possible care. Somehow they get ready if they identify increasing unrest or something else in the ward. If patients are ill, they prepare for the night. They may contact the doctor and arrange a prescription for morphine, and even prepare the medicine itself in advance. (Interview with a nursing assistant)

Over time an acceptance of inferior working conditions and behavior that may deviate from standards and norms seemed to grow.

Tools and Technology

Two key barriers are presented in Figure 3: inferior technological solutions and technological interruptions.

Nursing homes use many different tools and technologies to perform daily activities. Many medication-related tasks are tied directly to documentation and the use of electronic medication administration records (eMAR). Other municipalities may apply different types of software to fulfill the same role, replacing paper records of journal entries, patient records, medical records, and nursing reports. This, however, poses challenges for the staff due to poor design choices, lengthy login procedures, separate closed modules within the same software, and challenges when communicating with external networks and devices. Together, it leads to an inferior technological solution for supporting administrative tasks in general, and documenting medication administration in particular.

The eMAR is not very user friendly. It is all about how it is put together, searching for specifics is nearly impossible … you just have to read and read until you find it … some information just seems to disappear and you have to retrieve it manually. (Interview with an RN)

An example of this is how on-demand medication documentation exists within separate modules in the eMAR, which do not connect to the primary medical records. In turn, this leads to double documentation and creative workarounds, and in some instances also delays or omissions of documentation.

Another key barrier in this work-system element is technological interruptions. They are typically caused by inferior technology, such as a lack of Wi-Fi or bugs and glitches in the documentation software forcing the user to alter, delay or omit tasks. An example of a technological interruption was during pre-visitation, when the physician depended on an application on a mobile device to access the Norwegian Medicines Manual for Health Personnel. However, this meeting took place in the basement and lacked Wi-Fi or cellular signals. This led to significant delays and disrupted the medication review.

Physical Environment

In the physical environment, active and passive interruptions were prominent, as shown in Figure 3.

The physical environment of the nursing home plays a distinct role in how and where the staff perform medication-related tasks. The medicine rooms were far from the nursing station and adjoining patient rooms in both of the observed nursing homes. To compensate, the staff used mobile medication trolleys extensively, which often led to medication administration occurring in busy environments characterized by interruptions and a cluttered workspace.

I believe the nursing station is unfit, there is so much noise. There are always people coming and going … It makes it hard to concentrate and be focused on our task … Also the computers are there and you never get the peace and quiet you should … so it is not the best. (Interview with an RN)

Two additional types of interruptions were identified that affected the medication administration process. Firstly, there were passive interruptions, such as background noise and activities that may lower cognitive functions and proceed to become active interruptions.

Secondly, active interruptions occur when a primary work task is disrupted due to nearby activities, conversations, incoming calls or spontaneous engaging in conversations. Breaks in a primary task often led to extended breaks before resuming, or that the staff member took on a secondary task even though the primary task did not always resume. Active interruptions often took place in busy environments, such as the nursing station or common rooms. Most active interruptions had negative outcomes, but sometimes they could also lead to positive ones. Examples of positive outcomes were informal conversations about patient issues that led to discoveries or revelations resulting in changes in medications or treatment plans.

Tasks

In this work-system element, the extensive number of tasks, double documentation, double-check, and multi-dosage medications were vital facilitators and barriers.

Within the medication administration process, we identified 29 distinct tasks throughout the six stages from ordering to observing and documentation (Figure 1). These tasks were perceived differently among the professional stakeholders, sometimes with a feeling of being overwhelmed by all the daily activities:

And then we have so many different tasks. You are supposed to take part in the social patient-related activities in the ward. You have medication administration, mapping of patients, follow-up of the annual controls, medication reviews, blood sampling and such. Then comes the doctor’s visitation, for which you are responsible. Moreover, there are many practicalities to handle. (Interview with an RN)

The RN often regarded medication-related tasks as complex and challenging, while nursing assistants tended to view the process as more linear and rule-bound. The mapping of the medication administration process within the work system of the nursing homes revealed that most barriers occurred during the first two stages: ordering and transcribing. These barriers are often related to unclear communication and inferior documentation systems. Therefore, ordering and transcribing seem to be especially vulnerable to medication administration errors, potentially cascading, thus causing sequential errors and adverse events at a later stage.

Double-check is often marked as a critical step in delivering medications to the patients, but practical challenges often interfere. A lack of qualified health care personnel or busy schedules sometimes do not permit double-control, and creative workarounds often replace this safety measure. An example arose when an RN prepared intravenous morphine for a patient, but there was no qualified personnel nearby to perform the obligatory double-check. The RN documented the process by taking pictures with a private cellular device and sending them to an off-duty colleague for confirmation. Night shifts present a particular challenge:

To be honest, double-checking medications on a night shift … That just does not work. (Interview with an RN)

Double documentation was detectable, since the RNs kept separate notes in a “black book” to keep track of daily activities and medication-related tasks. This was partly due to challenges maintaining an effective workflow in the eMAR. To ease the transition between modules in the eMAR, medical charts were sometimes printed and put in a patient folder and stored physically.

Many patients use multi-dose medications. These are prescribed two weeks at a time and then dispensed and delivered to the wards from the pharmacy. The RN would then manually alter all previous multi-dose medicines and physically transfer them to new dispensers. This often proved challenging, as visitations took place once or twice a week and often led to prescription changes. In addition to being time-consuming, it was also a perceived safety risk.

Human Factors and Steps to Minimize Adverse Drug Events

As medication administration is ingrained in the daily activities of healthcare professionals’ work in nursing homes, identifying single measures to improve medication management or reduce medication administration events is challenging. Using human factors to categorize facilitators and barriers across the various work-system elements may aid such efforts. Since prior interventions, such as guidelines or checklists, aiming to safeguard medication administration in nursing homes only partly address all the challenges, systematically mapping facilitators and barriers may inform future improvement efforts (Keers et al., 2013; Odberg et al., 2020). This study shows how facilitators and barriers across the five elements of the work system may impact the medication administration process. Yet, it is essential to keep in mind that they interact dynamically. This means that changes in one work-system element may have consequences in one or several interconnected elements. For example, the physical distance between the medicine room and the ward (physical) affects social interactions (persons) and how the staff manages medications (task), making the medication administration process more susceptible to interruptions. At the same time, social congregation around the medication trolley may also serve as a safety net, where potential medication events are intercepted before reaching the patient. Therefore, being surrounded by colleagues is often perceived as an added safety measure by the staff, and may reflect a need for vigilant communication and coordination to promote safe practices (Odberg et al., 2017; Raban & Westbrook, 2014). In consequence, moving the medicine room closer to the ward or altering the medication trolley routines may have unforeseen consequences.

Working together in limited physical spaces also increases the risk of being interrupted. At the same time, the literature describes several interventions to minimize interruptions, but the evidence is scarce that such interventions reduce medication events, since the complexity of the work system often entails unforeseen consequences. Examples of interventions to reduce interruptions are: dedicated medication rooms; the use of yellow vests or tabards; no-interrupt zones; safety checklists; and various technological solutions (Lapkin et al., 2016; Westbrook et al., 2017). Since humans are at the center of the work system, interventions that improve the cognitive skills needed to cope with interruptions may have a more effective impact. Nursing students training to handle interruptions in a simulated environment report heightened awareness and positive learning experiences in relation to how they perceive the medication administration process. The nursing students also learned techniques for managing interruptions by using enhanced clinical reasoning and judgement (Hayes et al. 2015). Training nursing home staff on how to handle interruptions may therefore be a useful measure.

Double-checking as a procedure involving independent, simultaneous medication checking by two competent persons was a critical factor identified in the two nursing homes in our study. Several barriers across the work-system elements seem to play a role in how the staff manages the practice of double-checking. Vulnerable shifts (organization), varying competence (persons), unclear guidelines (organization), team composition (persons), under par technological solutions (technology), and task complexity (tasks) all contribute to the challenging nature of mandatory double-checks. The study showed that problems most often arose when there was only one RN on a shift. This often resulted in workarounds and delays, or altogether skipping the double-check. Nevertheless, adverse medication events still appear to occur during double-checking, and RNs have mixed perceptions of the procedure. It is a way of feeling safe for some, while others perceive it as redundant (Alsulami et al., 2012). At the same time, there is little evidence for the effectiveness of double-checking in reducing medication errors (Lapkin et al., 2016). More research is needed to explore the efficacy of double-checking in nursing homes.

Double documentation often introduces the risk of adverse events. This study showed how the first two stages of the medication administration process (ordering and transcribing) were especially vulnerable to many associated barriers across several work-system elements. Most visible was how a lack of computers with eMAR functionality, or separate modules within the eMAR, led to analogue solutions and double documentation. Such practices may lead to subsequent problems retrieving vital information quickly or losing information, leading to sequential issues (Carayon et al., 2014). An example from the observations showed how the staff had documented the weight of a patient in a separate folder that had gone missing. The patients’ weight was essential to dose a specific drug, resulting in dosing and prescribing having to be postponed to the next week. Electronic medication administration record systems may reduce the perceived risk of committing medication errors (Alenius & Graf, 2016), but it seems that only well-integrated electronic barcoding effectively reduces medication events. Electronic barcoding entails measures to check correct medicines, dosages and patient identity (Shah et al., 2016).

Nursing Homes as Complex Adaptive Work Systems

Most of the identified facilitators and barriers in the two nursing homes indicate how the staff change behavior and reasoning to overcome challenges and perform safe medication administration. From a human factors perspective, the wards’ functionality reflects how different adjustments across each of the work-system elements interact during medication administration to balance the work system as a whole.

Nursing homes can, therefore, be labelled as complex adaptive work systems. They may be described as nonlinear, in which diverse agents capable of spontaneous self-organization interact. These dynamic work systems evolve and adapt to meet foreseen and unforeseen events (Matlow et al., 2006; Rouse, 2008). Individuals make adaptations according to psychological, physical, and social rules, and they adapt to each other. In addition, persons learn from past events. This may result in self-organization, through which patterns of behavior emerge. Such patterns may have healthy or unhealthy consequences for an organization (Rouse, 2008). Examples are when individuals adopt workarounds or shortcuts, such as omitting double-checks or utilizing double documentation. Over time, these practices may spread to the remaining staff and become normalized. The normalization of deviance may be necessary to maintain effective care, but may also create vulnerabilities in the work system enabling adverse events. In most cases though, normalization of deviance centers on adapting to a changing work system, and minimizing the gap between work as imagined and work as done (Hollnagel, 2012; May & Finch, 2009). This is reflected in how staff members utilize their competence, experience and cognitive faculties to provide safe medication management.

Conclusion

The study of two Norwegian nursing home wards identified a total of 60 facilitators and barriers to safe medication administration. Several facilitators and barriers were intertwined, meaning that they could act as both facilitators and barriers depending on situational factors in the nursing home’s work system. Taking the complexity of the medication administration work system into account, it seems prudent that future interventions that address medication safety in nursing homes should be multifaceted, involving all personnel, including leaders. The SEIPS model may facilitate a systems approach that can assist staff and management in nursing homes in identifying relevant critical issues in this area. More specifically, the work-system elements can serve as a practical guide to inform any improvement measures.

References

• Al-Jumaili, A. A., & Doucette, W. R. (2017). Comprehensive literature review of factors influencing medication safety in nursing homes: Using a systems model. Journal of the American Medical Directors Association. https://doi.org/10.1016/j.jamda.2016.12.069
• Alenius, M., & Graf, P. (2016). Use of electronic medication administration records to reduce perceived stress and risk of medication errors in nursing homes. Computers, Informatics, Nursing, 34(7), 297–302. https://doi.org/10.1097/cin.0000000000000245
• Alsulami, Z., Conroy, S., & Choonara, I. (2012). Double checking the administration of medicines: What is the evidence? A systematic review. Archives of Disease in Childhood, 97(9), 833–837. https://doi.org/10.1136/archdischild-2011-301093
• Carayon, P., Schoofs Hundt, A., Karsh, B-T., Gurses, A. P., Alvarado, C. J., Smith, M., & Flatley Brennan, P. (2006a). Work system design for patient safety: The SEIPS model. Quality & Safety in Health Care, 15(1), 50–58. https://doi.org/10.1136/qshc.2005.015842
• Carayon, P., Wetterneck, T. B., Cartmill, R., Blosky, M. A., Brown, R., Kim, R., Kukreja, S., Johnson, M., Paris, B., Wood, K., & Walker, J. (2014). Characterizing the complexity of medication safety using a human factors approach: An observational study in two intensive care units. BMJ Quality and Safety, 23(1), 56–65. https://doi.org/10.1136/bmjqs-2013-001828
• Dul, J., Bruder, R., Buckle, P., Carayon, P., Falzon, P., Marras, W. S., Wilson, J. R., & van der Doelen, B. (2012). A strategy for human factors/ergonomics: Developing the discipline and profession. Ergonomics, 55(4), 377–395. https://doi.org/10.1080/00140139.2012.661087
• Elo, S., & Kyngäs, H. (2008). The qualitative content analysis process. Journal of Advanced Nursing, 62(1), 107–115.
• Ferrah, N., Lovell, J., & Ibrahim, J. (2017). Systematic review of the prevalence of medication errors resulting in hospitalization and death of nursing home residents. Journal of the American Geriatrics Society, 65(2), 433–442. https://doi.org/10.1111/jgs.14683
• Field, T. S., Gurwitz, J. H., Avorn, J., McCormick, D., Jain, S., Eckler, M., Benser, M., & Bates, D. W. (2001). Risk factors for adverse drug events among nursing home residents. JAMA Internal Medicine, 161(13), 1629–1634. https://doi.org/10.1001/archinte.161.13.1629
• Hayes, C., Jackson, D., Davidson, P. M., & Power, T. (2015). Medication errors in hospitals: A literature review of disruptions to nursing practice during medication administration. Journal of Clinical Nursing, 24(21–22), 3063–3076. https://doi.org/10.1111/jocn.12944
• Herr, M., Grondin, H., Sanchez, S., Armaingaud, D., Blochet, C., Vial, A., Denormandie, P., & Ankri, J. (2017). Polypharmacy and potentially inappropriate medications: A cross-sectional analysis among 451 nursing homes in France. European Journal of Clinical Pharmacology, 73(5), 601–608. https://doi.org/10.1007/s00228-016-2193-z
• Holden, R. J., Carayon, P., Gurses, A. P., Hoonakker, P., Hundt, A. S., Ozok, A. A., & Rivera-Rodriguez, A. J. (2013). SEIPS 2.0: A human factors framework for studying and improving the work of healthcare professionals and patients. Ergonomics, 56(11), 1669–1686. https://doi.org/10.1080/00140139.2013.838643
• Hollnagel, E. (2012, February 22–24). Resilience engineering and the systemic view of safety at work: Why work-as-done is not the same as work-as-imagined. [Conference presentation] Bericht zum 58. Kongress der Gesellschaft für Arbeitswissenschaft.
• Jennings, B. M., Sandelowski, M., & Mark, B. (2011). The nurse’s medication day. Quali­tative Health Research, 21(10), 1441–1451. https://doi.org/10.1177/1049732311411927
• Keers, R. N., Williams, S. D., Cooke, J., & Ashcroft, D. M. (2013). Causes of medication administration errors in hospitals: A systematic review of quantitative and qualitative evidence. Drug safety, 36(11), 1045–1067. https://doi.org/10.1007/s40264-013-0090-2
• Lapkin, S., Levett‐Jones, T., Chenoweth, L., & Johnson, M. (2016). The effectiveness of interventions designed to reduce medication administration errors: A synthesis of findings from systematic reviews. Journal of Nursing Management, 24(7), 845–858. https://doi.org/10.1111/jonm.12390
• Matlow, A., Wright, J., Zimmerman, B., Thomson, K., & Valente, M. (2006). How can the principles of complexity science be applied to improve the coordination of care for complex pediatric patients? BMJ Quality and Safety Science, 15(2), 85–88. https://doi.org/10.1136%2Fqshc.2005.014605
• May, C., & Finch, T. (2009). Implementing, embedding, and integrating practices: An outline of normalization process theory. Sociology, 43(3), 535–554. https://doi.org/10.1177%2F0038038509103208
• Ministry of Health and Care Services (2015). Legemiddelmeldingen – riktig bruk – bedre helse. [Medication Paper – correct use – better health.] [White paper 28]. Retrieved from : https://www.regjeringen.no/contentassets/1e17b19947224def82e509ca5f346357/no/pdfs/stm201420150028000dddpdfs.pdf
• Morse, J. M. (2016). Mixed method design: Principles and procedures (Vol. 4). Routledge.
• Norwegian Board of Health Supervision (2010, July), Sårbare pasientar – utrygg tilrettelegging. Funn ved tilsyn med legemiddelbehandling i sjukeheimar 2008–2010, [Vulnerable patients – unsafe faciltating. Results of medication review of nursing homes 2008–2010] [Report]. Retrieved from: https://www.helsetilsynet.no/globalassets/opplastinger/publikasjoner/rapporter2010/helsetilsynetrapport7_2010.pdf
• Odberg, K. R., Hansen, B., Aase, K., & Wangensteen, S. (2017). Medication administration and interruptions in nursing homes: A qualitative observational study. Journal of Clinical Nursing. https://doi.org/10.1111/jocn.14138
• Odberg, K. R., Hansen, B. S., & Wangensteen, S. (2019). Medication administration in nursing homes: A qualitative study of the nurse role. Nursing Open, 6(2), 384–392. https://doi.org/10.1002/nop2.216
• Odberg, K. R., Hansen, B. S., Aase, K., & Wangensteen, S. (2020). A work system analysis of the medication administration process in a Norwegian nursing home ward. Applied Ergonomics, 86, 103100. https://doi.org/10.1016/j.apergo.2020.103100
• Odberg, K. R. (2020). A human factors approach to medication administration in nursing homes. [Doctoral disssertation, University of Stavanger] https://doi.org/10.31265/usps.48
• Raban, M. Z., & Westbrook, J. I. (2014). Are interventions to reduce interruptions and errors during medication administration effective? A systematic review. BMJ Quality and Safety, 23(5), 414–421. https://doi.org/10.1136/bmjqs-2013-002118
• Rouse, W. B. (2008). Health care as a complex adaptive system: Implications for design and management. Bridge-Washington-National Academy of Engineering, 38(1), 17.
• Shah, K., Lo, C., Babich, M., Tsao, N. W., & Bansback, N. J. (2016). Bar code medication administration technology: A systematic review of impact on patient safety when used with computerized prescriber order entry and automated dispensing devices. The Canadian Journal of Hospital Pharmacy, 69(5), 394. https://doi.org/10.4212%2Fcjhp.v69i5.1594
• Statistics Norway (2019, June 24) Sjukeheimar, heimetenestar og andre omsorgstenester. [Nursing homes, home care services and other healthcare services] Retrieved from : https://www.ssb.no/helse/statistikker/pleie
• Thomas, J., Harden, A. (2008). Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Medical Research Methodology, 8(45), 1–10. https://doi.org/10.1186/1471-2288-8-45
• Violan, C., Foguet-Boreu, Q., Flores-Mateo, G., Salisbury, C., Blom, J., Freitag, M., Glynn, L., Muth, C., & Valderas, J. M. (2014). Prevalence, determinants and patterns of multimorbidity in primary care: A systematic review of observational studies. PLOS One, 9(7), e102149. https://doi.org/10.1371/journal.pone.0102149
• Westbrook, J. I., Li, L., Hooper, T. D., Raban, M. Z., Middleton, S., & Lehnbom, E. C. (2017). Effectiveness of a “Do not interrupt” bundled intervention to reduce interruptions during medication administration: A cluster randomised controlled feasibility study. BMJ Quality and Safety, bmjqs-2016-006123. https://doi.org/10.1136/bmjqs-2016-006123
• Yoost, B. L., Crawford, L. R., & Castaldi, P. (2015). Study guide for fundamentals of nursing: E-book. Elsevier Health Sciences.

Methods

A scoping review was conducted to gain knowledge on the use of MDD in primary care (Arksey & O’Malley, 2005). Our aim was to produce a broad overview of the existing peer-reviewed literature addressing MDD and patient safety. We searched the databases Pubmed, Embase, Cochrane and SweMed+, using the keywords “apodos”, “automated medication/drug dispensing”, “automated dose dispensing”, “dosisdispensering”, “multidose”, “multidose dispensing”, “multidose drug dispensing”, and “unit-dose dispensing”. The literature search was broad, semi-systematic (Snyder, 2016), conducted several times, and did not have a time limit. The first search was conducted in 2016 and the last in August 2021. We also contacted authors from Denmark, Finland and the Netherlands (one from each country) asking for more detailed information about their MDD systems.

Titles and abstracts were screened and all articles that included information about MDD were included. Full-text articles were then retrieved and read by two researchers. We also manually searched the reference lists of the included articles to identify papers missed in the search. We included peer-reviewed articles in English or one of the Scandinavian languages.

The inclusion criteria for this literature review were: all qualitative and quantitative studies conducted in a primary care setting or during care transitions for home-dwelling patients using MDD. Studies on hospital in-patients and nursing home residents were excluded. We did not assess the quality of the included studies, but we have highlighted the longitudinal studies and articles that compare MDD to ordinary prescribing.

The main focus of this review was to describe the impact of MDD on patient safety for home-dwelling patients. We categorized the articles by combining, integrating, and summarizing the main outcomes of the papers according to the main objectives in the included studies (Perestelo-Pérez, 2013). The following categories emerged: medication safety, prescribing quality, and patient perspectives. We have also summarized how the MDD system is organized in the different countries and highlighted differences that might affect patient safety.

Results

Medication Safety

Prescribing Quality

Inappropriate or suboptimal prescribing was the area that was studied the most in the studies included here. Most of the 21 studies found that prescribing quality for MDD patients is poor, and seems to be worse for patients with MDD compared to patients with ordinary prescribing.

Patient Perspectives

Discussion

This review, consisting of 60 articles, indicates that MDD increases medication adherence and reduces discrepancies in medication records for patients in primary care. In addition, the MDD system may make it easier to identify medication-related problems and reduce drug-drug interactions. However, MDD also seems to result in more inappropriate prescribing, more medication errors during discharge from hospitals, and may potentially increase the number of drugs prescribed.

Even though MDD is often referred to as a dispensing system and an adherence aid, this review shows that MDD affects more than just dispensing errors and medication adherence. We argue that MDD can affect all steps in the medication-use process: prescribing, dispensing, administration and monitoring. In order to optimise the MDD system and reduce potential negative effects, it is thus necessary to look at the entire medication-use process and all the actors involved.

Administration and Monitoring of MDD Medicines

It is estimated that 50% of patients with chronic illnesses are non-adherent, resulting in poorer health outcomes and increased medical costs (Brown & Bussell, 2011, p. 304). The three quantitative studies on medication adherence in our review all show that MDD users have a higher adherence than non-MDD users (Kwint et al., 2013; Mertens et al., 2020; van Rein et al., 2018). However, in the interviews and surveys, most patients still said that they sometimes had been non-adherent (Bardage & Ring, 2016; Holbø et al., 2019; Larsen & Haugbølle, 2007). Non-adherence is, however, not always inappropriate. Adjusting medication dosages might be valid as a form of intelligent non-adherence, such as skipping diuretics before going shopping. Other adjustments might be the result of having too little information about or understanding of their medicines or diseases. These adjustments, especially when based on too little knowledge, might increase the risk of errors, such as taking out the wrong tablet from the MDD pouches.

We did not find any studies investigating administration errors in home-dwelling MDD patients. However, a Dutch nursing home study showed that despite MDD reducing the frequency of errors, they still occurred in one fifth of medication administrations. The most common types of errors were the wrong administration technique, and medicines given at the wrong time (van den Bemt et al., 2009). Similarly, the Danish Patient Ombudsman found 4,000 incidents relating to MDD during a one-year period. Half of these incidents were related to the administration of medicines, most commonly that the medicines were not given to the patients, they were given at the wrong times, or the patients did not take the medicine (Pasientombuddet, 2013). So even if MDD ensures that the patient gets the right medications, errors can still occur when the medicines are administered, or the patient might not take the medicine at all.

Interestingly, Kwint et al. (2013) found that medication knowledge was lower in MDD users than non-MDD users, and that MDD users had more knowledge of their manually dispensed medicines compared to those in the MDD bags. It would thus seem that the MDD system reduces the patient’s knowledge about medicines. This is similar to findings from studies on other dosing aids. When filled by a third party, dosing aids might reduce the patient’s autonomy and knowledge about medicines, and as such be disempowering (Elliott, 2014).

We also find similar results for the health care personnel who administer MDD to patients. Several had concerns that the MDD system reduced their knowledge of medicines (Nilsen & Sagmo, 2012; Wekre et al., 2011). After introduction of MDD some health care personnel also felt reduced responsibility for medication administration (Nilsen & Sagmo, 2012). If both the nurses and the patient identify symptoms as potential side effects of medications to a lesser degree, this might result in them contacting their GP to a lesser degree as well, which again might result in more inappropriate prescribing for these patients.

Dispensing MDD

Some of the rationale behind implementing MDD has been to reduce dispensing errors. We did not find any studies on the accuracy of MDD dispensing in home-dwelling patients, but studies from other settings have shown that dispensing error rates are very low with MDD, and lower compared to manually filled dosing aids (Gerber et al., 2008; Klein et al., 1994; Palttala et al., 2013; Søndergaard et al., 2005).

Even though MDD seems to increase the chance of giving the right medication at the right time, errors can still occur at a later stage. When a physician changes a patient’s medication, this may wait until the next MDD delivery, the medicine may be administered on the side until the next delivery, or the bags may be manually adjusted. Both of the latter options increase the risk of errors, but for certain medications it might be too long to wait until the next delivery. Manual adjustments are also time consuming (Mertens et al., 2018b).

One of the benefits of the MDD system is that it gives the pharmacist a better overview of medication use, including prescriptions from both GPs and hospital physicians. Increased access to medication history also seems to result in pharmacists detecting more errors and inappropriate prescribing of these prescriptions (Josendal et al., 2021). This increased overview has also been suggested as an explanation as to why these patients seem to have fewer serious drug-drug interactions in their medication lists, and use fewer psychotropic medicines (Johnell & Fastbom, 2008).

However, because the MDD system works as a subscription, and many patients get medicines via their home care service, there is limited contact between the patient and the pharmacist during the dispensing process. It would seem that pharmacists do little patient counselling of home care patients with MDD (Josendal et al., 2021). MDD patients have also reported that they would like more information about the medicines they are taking, the reason for use, information about changes in their treatment, and pictures of the tablets that are dispensed in MDD (Bardage & Ring, 2016). Less contact with the pharmacist might be a contributing factor as to why MDD patients have less knowledge about their medicines.

Prescribing for MDD Patients

Several of the included studies reveal that MDD changes doctors’ prescribing procedures and prescribing patterns. The majority of studies on this topic are, however, from Norway and Sweden, where there are different procedures for prescribing MDD than for ordinary prescriptions. This in itself can increase the risk of errors. GPs might have to document medication changes in several systems, which might increase the risk of duplicate prescriptions and perhaps result in prescriptions not being sent to the correct system, so the patient never gets the intended changes to their MDD.

However, studies from both Finland and the Netherlands, where the prescribing procedures are the same for MDD patients and patients with ordinary prescribing, also find that MDD patients are frequently exposed to PIMs, DDIs and DRPs (Bobrova et al., 2019; Kwint et al., 2011). Though PIMs are common for elderly patients in general (Nyborg et al., 2012), it seems that they are more common in MDD patients than for patients with ordinary prescribing (Johnell & Fastbom, 2008; Sjoberg et al., 2011). It is, however, difficult to assess whether this is due to the MDD system, or whether this is because the patients with the most complex medication regimes use MDD (see also methodological considerations).

The included articles present possible explanations for why MDD patients have more inappropriate prescribing than patients with ordinary prescribing. One explanation might be that the procedures for renewing prescriptions are too automated and the lists might be reviewed less frequently (Sjoberg et al., 2011; Sjoberg et al., 2012; Wallerstedt et al., 2013). This is supported by two Swedish studies showing that MDD patients have fewer changes in their mediation regimen than patients with ordinary prescribing (Sjoberg et al., 2012; Wallerstedt et al., 2013). However, the Finnish study from Sinnemäki et al. (2017) found an increased number of starts and discontinuations in the MDD group compared to patients with ordinary prescribing, which might indicate that this is specific to the Swedish prescribing system.

Regardless of whether MDD is the direct reason for poor prescribing quality, we can see that PIMs and DDIs are very common in MDD patients, and action should be taken to improve the prescribing quality for these patients. A possible way to improve quality would be to do medication reviews. Kwint et al. (2011) found that medication reviews can increase the quality of pharmacotherapy for MDD patients, and other studies have also suggested that MDD medication lists can be used to identify patients with PIMs, who can then be selected for medication reviews (Halvorsen & Granas, 2012; Josendal et al., 2020). However, none of the included articles described regular medication reviews as current practice for these patients.

Even though discrepancies between medication lists in primary care are reduced with MDD, the included studies indicate that discrepancies may increase for patients transitioning from secondary to primary care. Errors during care transitions and discrepancies in the medication lists between the hospital and the GP are very common (Foss et al., 2004; Michaelsen et al., 2015; Redmond et al., 2018; Tam et al., 2005); however, the use of MDD increased the risk of these errors occurring (Bergkvist et al., 2009; Caleres et al., 2020; Midlöv et al., 2005). The included articles found that there was an unclear division of responsibility regarding MDD patients at discharge, which might have led to the errors. In particular, it was unclear who had access to and was allowed to change the medications of MDD patients. Unclear responsibility might also explain why an increased number of prescribers increased the risk of inappropriate prescribing (Söderberg et al., 2013).

Methodological Considerations

The main purpose of this review was to describe and summarize peer-reviewed studies on safety in MDD patients. We found that the procedures for prescribing MDD, the patients offered MDD, and routines among health professionals handling MDD differed between countries. Furthermore, the studies had different approaches, settings and designs. It is therefore difficult to draw definite conclusions about MDD and patient safety. However, this work gives an overview of the literature and highlights some trends that can be used to improve safety for MDD users.

When interpreting the results, it is important to look at the study designs used. Most of the studies did not have a control group. Even for those with a control group, it was difficult to conclude whether the differences we see in prescribing between the two groups are due to the MDD system or other factors related to the patients offered MDD. Patients using MDD generally use more medicines, have more complex drug regimens, and have trouble managing their own medication. Thus they might not be comparable to patients who do not use MDD. The same is true for the longitudinal studies. We can see that the number of PIMs and total number of drugs increase after initiation. However, we cannot conclude whether this is due to the MDD system, or if there was an increase in medications or medication complexity that resulted in the patients starting MDD.

We also acknowledge that the term “multidose” is not easily defined. Some studies may have used other terms and definitions to describe the prepacking of medicine in pouches.

Conclusions

To summarize, the MDD system has both positive and negative effects on patient safety. MDD has the potential to improve some aspects of medication use, in particular by increasing adherence and decreasing the number of discrepancies between home care services and GPs. However, the MDD system does not solve the problems of potentially inappropriate prescribing, medication errors, and the risk of adverse drug events. On the contrary, the MDD system might increase the risk of such events.

In many of the included studies, unclear routines and division of responsibility were suggested as the causes of the negative effects of MDD. This is not surprising as the MDD system has been implemented with the idea that it would primarily relieve the burden of dispensing tablets from many containers, and ease the administration process of handing over the medicines to the patients. However, as this review shows, the MDD system can affect all phases in the medicine-use process. In order to improve the MDD system, it is thus necessary to involve all actors in the process and define their responsibilities. Specifically, we see that there is a need for better systems to identify patients during care transitions, and a need for increased involvement of the patients themselves.

References

• Alassaad, A., Gillespie, U., Bertilsson, M., Melhus, H., & Hammarlund-Udenaes, M. (2013). Prescription and transcription errors in multidose-dispensed medications on discharge from hospital: An observational and interventional study. Journal of Evaluation in Clinical Practice, 19(1), 185–191. https://doi.org/10.1111/j.1365-2753.2011.01798.x
• Association of Finnish Pharmacies. (2003). Annual review: Medicines in prepacked doses. Retrieved from: http://www.apteekkariliitto.fi/media/pdf/annual_report_2003.pdf
• Bakken, T., & Straand, J. (2003). [Improved medicine lists with multi-dose packaging?] in Norwegian. Tidsskrift for Den Norske Laegeforening, 123(24), 3595–3597.
• Bardage, C., Ekedahl, A., & Ring, L. (2014). Health care professionals’ perspectives on automated multi-dose drug dispensing. Pharmacy Practice, 12(4), 470. https://doi.org/10.4321/s1886-36552014000400005
• Bardage, C., & Ring, L. (2016). Patients’ perspectives on automated multi-dose drug dispensing. Journal of Community Medicine & Health Education, 6(1), 393. https://doi.org/10.4172/2161-0711.1000393
• Belfrage, B., Koldestam, A., Sjöberg, C., & Wallerstedt, S. M. (2014). Prevalence of suboptimal drug treatment in patients with and without multidose drug dispensing: A cross-sectional study. European Journal of Clinical Pharmacology, 70(7), 867–872. https://doi.org/10.1007/s00228-014-1683-0
• Bell, H. T., Steinsbekk, A., & Granas, A. G. (2015). Factors influencing prescribing of fall-risk-increasing drugs to the elderly: A qualitative study. Scandinavian Journal of Primary Health Care, 33(2), 107–114. https://doi.org/10.3109/02813432.2015.1041829
• Bergkvist, A., Midlov, P., Hoglund, P., Larsson, L., Bondesson, A., & Eriksson, T. (2009). Improved quality in the hospital discharge summary reduces medication errors – LIMM: Landskrona Integrated Medicines Management. European Journal of Clinical Pharmacology, 65(10), 1037–1046. https://doi.org/10.1007/s00228-009-0680-1
• Bergmo, T. S., Jøsendal, A. V., & Johnsen, E. (2019, November 12–13). Factors easing the transition from paper to electronic prescribing of multidose dispensed drugs (MDD). [Conference paper] SHI2019: 17th Scandinavian Conference on Health Informatics, Oslo, Norway.
• Bobrova, V., Heinämäki, J., Honkanen, O., Desselle, S., Airaksinen, M., & Volmer, D. (2019). Older adults using multi-dose dispensing exposed to risks of potentially inappropriate medications. Research in Social and Administrative Pharmacy, 15(9), 1102–1106. https://doi.org/10.1016/j.sapharm.2018.11.007
• Brown, M. T., & Bussell, J. K. (2011). Medication adherence: WHO cares? Mayo Clinic Proceedings, 86(4), 304–314. https://doi.org/10.4065/mcp.2010.0575
• Caleres, G., Bondesson, A., Midlov, P., & Modig, S. (2018). Elderly at risk in care transitions when discharge summaries are poorly transferred and used: A descriptive study. BMC Health Services Research, 18(1), 770. https://doi.org/10.1186/s12913-018-3581-0
• Caleres, G., Modig, S., Midlöv, P., Chalmers, J., & Bondesson, Å. (2020). Medication discrepancies in discharge summaries and associated risk factors for elderly patients with many drugs. Drugs – Real World Outcomes, 7(1), 53–62. https://doi.org/10.1007/s40801-019-00176-5
• Caleres, G., Strandberg, E. L., Bondesson, Å., Midlöv, P., & Modig, S. (2018). Drugs, distrust and dialogue: A focus group study with Swedish GPs on discharge summary use in primary care. BMC Family Practice, 19(1), 127. https://doi.org/10.1186/s12875-018-0804-8
• Cheung, K.-C., van den Bemt, P. M., Bouvy, M. L., Wensing, M., & De Smet, P. A. (2014). Medication incidents related to automated dose dispensing in community pharmacies and hospitals: A reporting system study. PLOS One, 9(7), e101686. https://doi.org/10.1371/journal.pone.0101686
• Elliott, R. A. (2014). Appropriate use of dose administration aids. Australian Prescriber, 37(2), 46–50.
• Foss, S., Schmidt, J. R., Andersen, T., Rasmussen, J. J., Damsgaard, J., Schaefer, K., & Munck, L. K. (2004). Congruence on medication between patients and physicians involved in patient course. European Journal of Clinical Pharmacology, 59(11), 841–847. https://doi.org/10.1007/s00228-003-0708-x
• Foundation for Pharmaceutical Statistics. (2015). One quarter of the patients over 80 years of age use an MDD system. [Kwart 80-plussers gebruikt een weekdoseersysteem]. Retrieved from https://www.sfk.nl/publicaties/PW/2015/kwart-80-plussers-gebruikt-een-weekdoseersysteem
• Frøyland, H. (2012). Legers synspunkter på multidosepakkede legemidler [Prescribers’ perspectives on multidose drug dispensing]. Norsk Farmaceutisk Tidsskrift, 4, 19–21.
• Gerber, A., Kohaupt, I., Lauterbach, K. W., Buescher, G., Stock, S., & Lungen, M. (2008). Quantification and classification of errors associated with hand-repackaging of medications in long-term care facilities in Germany. American Journal of Geriatric Pharmacotherapy, 6(4), 212–219. https://doi.org/10.1016/j.amjopharm.2008.10.005
• Halvorsen, K. H., & Granas, A. G. (2012). [Multi-dose dispensed drugs in Scandinavia – A systematic review of possibilities and limitations] in Norwegian. Norsk Farmaceutisk Tidsskrift, 4, 22–28.
• Halvorsen, K. H., Granas, A. G., Engeland, A., & Ruths, S. (2012). Prescribing quality for older people in Norwegian nursing homes and home nursing services using multidose dispensed drugs. Pharmacoepidemiology and Drug Safety, 21(9), 929–936. https://doi.org/10.1002/pds.2232
• Hammar, T., Hovstadius, B., Lidström, B., Petersson, G., & Eiermann, B. (2014). Potential drug related problems detected by electronic expert support system in patients with multi-dose drug dispensing. International Journal of Clinical Pharmacy, 36(5), 943–952. https://doi.org/0.1007/s11096-014-9976-z
• Hammar, T., Lidstrom, B., Petersson, G., Gustafson, Y., & Eiermann, B. (2015). Potential drug-related problems detected by electronic expert support system: Physicians’ views on clinical relevance. International Journal of Clinical Pharmacy, 37(5), 941–948. https://doi.org/10.1007/s11096-015-0146-8
• Heier, K., Olsen, V., Rognstad, S., Straand, J., & Toverud, E. (2007a). [Healthcare providers’ experience with multi-dose packaged medicines] in Norwegian. Tidsskrift for den Norske Laegeforening, 127(18), 2382–2385.
• Heier, K., Olsen, V., Rognstad, S., Straand, J., & Toverud, E. (2007b). [Multi dose packaging for elderly outpatients: Correct medicine information and good-bye to the manually dispensed medicines?] in Norwegian. Sykepleien Forskning, 2(3), 166–170.
• Helfo. (2018). Regelverk og refusjonar ved tilskot til multidose (in Norwegian). Retrieved from https://www.helfo.no/regelverk-og-takster/overordnet-regelverk/annet-regelverk-for-kommune/regelverk-for-multidose/regelverk-og-refusjonar-ved-tilskot-til-multidose (cited 10.05.22)
• Herborg, H., Haugbølle, L. S., & Lee, A. (2008). Automated dose dispensing in Danish primary health care: A technology under construction. Pharmacy Practice, 6(2), 103–112. https://doi.org/10.4321/s1886-36552008000200008
• Hindhammer, A., Ali, Z., Pedersen, S. H., Steinland, E., Saether, E. M., & Sorbraten, T. (2012). [Does multidose dispensing of drugs lead to improved medication?] in Norwegian. Norsk Farmaceutisk Tidsskrift, 4, 9–13.
• Holbø, K., Das, A., Bøthun, S., Formanek, M. N., & Halvorsen, T. (2019). [Multidose service for home dwellers: The users’ experiences and a need for new solutions] in Norwegian. Nordic Welfare Research, 4(01), 20–31. https://doi.org/10.18261/issn.2464-4161-2019-01-03
• Johnell, K., & Fastbom, J. (2008). Multi-dose drug dispensing and inappropriate drug use: A nationwide register-based study of over 700,000 elderly. Scandinavian Journal of Primary Health Care, 26(2), 86–91. https://doi.org/10.1080/02813430802022196
• Johnsen, E., Jøsendal, A., & Bergmo, T. (2018). The e-multidose is better for patients’ safety than dosette boxes and faxes. Sykepleien Forskning, 13(e-69983). https://doi.org/10.4220/Sykepleienf.2018.69983en
• Josendal, A. V., & Bergmo, T. S. (2018). [Better agreement between medication records with electronic multidose drug dispensing] in Norwegian. Norsk Farmaceutisk Tidsskrift(4), 21–23.
• Josendal, A. V., & Bergmo, T. S. (2019, November 12–13). How discrepancies in medication records affect the creation and trust in a shared electronic medication list in Norway. [Conference paper] SHI 2019: 17th Scandinavian Conference on Health Informatics, Oslo, Norway.
• Josendal, A. V., & Bergmo, T. S. (2021). From paper to E-prescribing of multidose drug dispensing: A qualitative study of workflow in a community care setting. Pharmacy, 9(1), 41. https://doi.org/10.3390/pharmacy9010041
• Josendal, A. V., Bergmo, T. S., & Granas, A. G. (2020). Potentially inappropriate prescribing to older patients receiving multidose drug dispensing. BMC Geriatrics, 20(1). https://doi.org/10.1186/s12877-020-01665-x
• Josendal, A. V., Bergmo, T. S., & Granas, A. G. (2021). The practice guidelines for multidose drug dispensing need revision: An investigation of prescription problems and interventions. Pharmacy, 9(1), 13. https://doi.org/10.3390/pharmacy9010013
• Klein, E. G., Santora, J. A., Pascale, P. M., & Kitrenos, J. G. (1994). Medication cart-filling time, accuracy, and cost with an automated dispensing system. American Journal of Hospital Pharmacy, 51(9), 1193–1196.
• Koster, E. S., Philbert, D., Blom, L., & Bouvy, M. L. (2016). “These patients look lost”: Community pharmacy staff’s identification and support of patients with limited health literacy. International Journal of Pharmacy Practice, 24(6), 403–410. https://doi.org/10.1111/ijpp.12272
• Kwint, H.-F., Faber, A., Gussekloo, J., & Bouvy, M. L. (2011). Effects of medication review on drug-related problems in patients using automated drug-dispensing systems. Drugs and Aging, 28(4), 305–314. https://doi.org/10.2165/11586850-000000000-00000
• Kwint, H.-F., Stolk, G., Faber, A., Gussekloo, J., & Bouvy, M. L. (2013). Medication adherence and knowledge of older patients with and without multidose drug dispensing. Age and Ageing, 42(5), 620–626. https://doi.org/10.1093/ageing/aft083
• Larsen, A. B., & Haugbølle, L. S. (2007). The impact of an automated dose-dispensing scheme on user compliance, medication understanding, and medication stockpiles. Research in Social and Administrative Pharmacy, 3(3), 265–284. https://doi.org/10.1016/j.sapharm.2006.10.002
• Lea, M., Mowe, M., Mathiesen, L., Kvernrød, K., Skovlund, E., & Molden, E. (2019). Prevalence and risk factors of drug-related hospitalizations in multimorbid patients admitted to an internal medicine ward. PLOS One, 14(7), e0220071. https://doi.org/10.1371/journal.pone.0220071
• Lesen, E., Carlsten, A., Skoog, I., Waern, M., Petzold, M., & Borjesson-Hanson, A. (2011). Psychotropic drug use in relation to mental disorders and institutionalization among 95-year-olds: A population-based study. International Psychogeriatrics/IPA, 23(8), 1270–1277. https://doi.org/10.1017/s1041610211000524
• Lysen, C., Hendriksen, C., Faxholm, M. S., & Reuther, L. O. (2011). [Medication errors after hospitalisation due to multi-dose drug dispensing in the primary sector] in Danish. Ugeskrift for Laeger, 173(33), 1944–1945.
• Lönnbro, J., & Wallerstedt, S. M. (2017). Clinical relevance of the STOPP/START criteria in hip fracture patients. European Journal of Clinical Pharmacology, 73(4), 499–505. https://doi.org/10.1007/s00228-016-2188-9
• Mamen. (2016). [The importance of medication reconciliation to ensure safe transition to electronic multidose] in Norwegian. Norsk Farmaceutisk Tidsskrift, 10, 32–35.
• Mertens, B. J., Kwint, H.-F., van Marum, R. J., & Bouvy, M. L. (2019). Patients’ experiences with multidose drug dispensing: A cross sectional study. International Journal of Clinical Pharmacy, 41(1), 104–112. https://doi.org/10.1007/s11096-018-0749-y
• Mertens, B. J., Kwint, H. F., Belitser, S. V., van der Meer, F. J., van Marum, R. J., & Bouvy, M. L. (2020). Effect of multidose drug dispensing on the time in therapeutic range in patients using vitamin‐K antagonists: A randomized controlled trial. Journal of Thrombosis and Haemostasis, 18(1), 70–78. https://doi.org/10.1111/jth.14625
• Mertens, B. J., Kwint, H. F., van Marum, R. J., & Bouvy, M. L. (2018a). Are multidose drug dispensing systems initiated for the appropriate patients? European Journal of Clinical Pharmacology, 74(9), 1159–1164. https://doi.org/10.1007/s00228-018-2478-5
• Mertens, B. J., Kwint, H. F., van Marum, R. J., & Bouvy, M. L. (2018b). Immediate or deferred adjustment of drug regimens in multidose drug dispensing systems. Research in Social and Administrative Pharmacy, 15(3), 303–309 https://doi.org/10.1016/j.sapharm.2018.05.008
• Michaelsen, M. H., McCague, P., Bradley, C. P., & Sahm, L. J. (2015). Medication reconciliation at discharge from hospital: A systematic review of the quantitative literature. Pharmacy, 3(2), 53–71. https://doi.org/10.3390/pharmacy3020053
• Midlöv, P., Bergkvist, A., Bondesson, Å., Eriksson, T., & Höglund, P. (2005). Medication errors when transferring elderly patients between primary health care and hospital care. Pharmacy World and Science, 27(2), 116–120. https://doi.org/10.1007/s11096-004-3705-y
• Milos, V., Bondesson, Å., Magnusson, M., Jakobsson, U., Westerlund, T., & Midlöv, P. (2014). Fall risk-increasing drugs and falls: A cross-sectional study among elderly patients in primary care. BMC Geriatrics, 14(1), 1–7. https://doi.org/10.1186/1471-2318-14-40
• Morin, L., Johnell, K., Laroche, M.-L., Fastbom, J., & Wastesson, J. W. (2018). The epidemiology of polypharmacy in older adults: Register-based prospective cohort study. Clinical Epidemiology, 10, 289. https://doi.org/10.2147/CLEP.S153458
• Nilsen, M. K., & Sagmo, L. A. (2012). [Multidose drug dispensing in nursing homes. How do nurses think multidose drug dispensing affect the drug handling?] in Norwegian. Norsk Farmaceutisk Tidsskrift, 4(120), 14–18.
• Norwegian Pharmacy Association. (2010). [Pharmacies and pharmaceuticals] in Norwegian. Retrieved from https://www.apotek.no/Files/Filer/Apotekforeningen/2Faktaogtall/2Fakta%20og%20tall/Apotek%20og%20legemidler/Apotek_og_legemidler2010.pdf
• Nyborg, G., Straand, J., & Brekke, M. (2012). Inappropriate prescribing for the elderly: A modern epidemic? European Journal of Clinical Pharmacology, 68(7), 1085–1094. https://doi.org/10.1007/s00228-012-1223-8
• Palttala, I., Heinämäki, J., Honkanen, O., Suominen, R., Antikainen, O., Hirvonen, J., & Yliruusi, J. (2013). Towards more reliable automated multi-dose dispensing: Retrospective follow-up study on medication dose errors and product defects. Drug Development and Industrial Pharmacy, 39(3), 489–498. https://doi.org/10.3109/03639045.2012.670860
• Pasientombuddet. (2013). Dosisdispensering: Identifikation af utilsigtede hændelser og forslag til forebyggende tiltag (in Danish). Retrieved from https://danskepatienter.dk/files/media/Publikationer%20-%20Eksterne/A_Danske%20Patienter%20%28eksterne%29/dosisdispensering_patientombuddet.pdf
• Price Waterhouse Coopers. (2007, January 12). Multidosepakking av legemidler: En samfunnsøkonomisk vurdering av tiltak. [Multidose drug dispensing: An economic assessment of measures]. Oslo. Sosial- og Helsedirektoratet.
• Rechel, B. (2018). Hub-and-spoke dispensing models for community pharmacies in Europe. Eurohealth, 24(4), 3–6.
• Redmond, P., Grimes, T. C., McDonnell, R., Boland, F., Hughes, C., & Fahey, T. (2018). Impact of medication reconciliation for improving transitions of care. Cochrane Database of Systematic Reviews, 8(8), Cd010791. https://doi.org/10.1002/14651858.CD010791.pub2
• Reuther, L. O., Lysen, C., Faxholm, M., Salomon, L., & Hendriksen, C. (2011). Multi-dose drug dispensing is a challenge across the primary-secondary care interface. Danish Medical Bulletin, 58(12), A4341.
• Riksförsäkringsverket. (2001). Medicin på kredit och i påse. Apotekets delbetaliningssystem och dosdispenseringsverksamhet. [The pharmacy’s dose dispensing activities] Riksförsäkringsverket Retrieved from https://www.forsakringskassan.se/wps/wcm/connect/074553ba-8be0-49b1-adbd-c2af8e5fcb55/anser_2001_06.pdf?MOD=AJPERES
• Sinnemäki, J., Airaksinen, M., Valaste, M., & Saastamoinen, L. K. (2017). Impact of the automated dose dispensing with medication review on geriatric primary care patients drug use in Finland: A nationwide cohort study with matched controls. Scandinavian Journal of Primary Health Care, 35(4), 379–386. https://doi.org/10.1080/02813432.2017.1398933
• Sinnemäki, J., Sihvo, S., Isojärvi, J., Blom, M., Airaksinen, M., & Mäntylä, A. (2013). Automated dose dispensing service for primary healthcare patients: A systematic review. Systematic Reviews, 2(1), 1. https://doi.org/10.1186/2046-4053-2-1
• Sinnemäki, J., Saastamoinen, L. K., Hannula, S., Peura, S., & Airaksinen, M. (2014). Starting an automated dose dispensing service provided by community pharmacies in Finland. International Journal of Clinical Pharmacy, 36(2), 345–351. https://doi.org/10.1007/s11096-013-9899-0
• Sjoberg, C., Edward, C., Fastbom, J., Johnell, K., Landahl, S., Narbro, K., & Wallerstedt, S. M. (2011). Association between multi-dose drug dispensing and quality of drug treatment: A register-based study. PLOS One, 6(10), e26574. https://doi.org/10.1371/journal.pone.0026574
• Sjoberg, C., Ohlsson, H., & Wallerstedt, S. M. (2012). Association between multi-dose drug dispensing and drug treatment changes. European Journal of Clinical Pharmacology, 68(7), 1095–1101. https://doi.org/10.1007/s00228-012-1230-9
• Sundvall, H., Fastbom, J., Wallerstedt, S. M., & Vitols, S. (2019). Use of statins in the elderly according to age and indication: A cross-sectional population-based register study. European Journal of Clinical Pharmacology, 75(7), 959–967. https://doi.org/10.1007/s00228-019-02645-w
• Söderberg, K., Bucht, G., & Nilsson, J. (2013). Sämre läkemedelsbehandling med många förskrivande läkare [Poorer medication treatment with many prescribing physicians]. Lakartidningen, 110(CD7T).
• Søndergaard, B., Rossing, C., Haugbølle, L. S., & Lee, A. (2005). Litteraturstudie af dosisdispensering som medicinsk teknologi. [Arbejdsrapport] [Health technology assessment of dose dispensing: A literature review]. [Report] The Danish University of Pharmaceutical Sciences, Danish College of Pharmacy Practice, University of Southern Denmark. Retrieved from https://www.pharmakon.dk/media/1469/mtv_litteraturstud_rapport.pdf
• Tam, V. C., Knowles, S. R., Cornish, P. L., Fine, N., Marchesano, R., & Etchells, E. E. (2005). Frequency, type and clinical importance of medication history errors at admission to hospital: A systematic review. CMAJ: Canadian Medical Association Journal, 173(5), 510–515. https://doi.org/10.1503/cmaj.045311
• Tiihonen, M., Nykänen, I., Ahonen, R., & Hartikainen, S. (2016). Discrepancies between in‐home interviews and electronic medical records on regularly used drugs among home care clients. Pharmacoepidemiology and Drug Safety, 25(1), 100–105. https://doi.org/10.1002/pds.3909
• van den Bemt, P. M., Idzinga, J. C., Robertz, H., Kormelink, D. G., & Pels, N. (2009). Medication administration errors in nursing homes using an automated medication dispensing system. Journal of the American Medical Informatics Association, 16(4), 486–492. https://doi.org/10.1197/jamia.M2959
• van Rein, N., de Geus, K. S., Cannegieter, S. C., Reitsma, P. H., van der Meer, F. J., & Lijfering, W. M. (2018). Multi‐dose drug dispensing as a tool to improve medication adherence: A study in patients using vitamin K antagonists. Pharmacoepidemiology and Drug Safety, 27(1), 46–51. https://doi.org/10.1002/pds.4346
• Wallerstedt, S. M., Fastbom, J., Johnell, K., Sjoberg, C., Landahl, S., & Sundstrom, A. (2013). Drug treatment in older people before and after the transition to a multi-dose drug dispensing system: A longitudinal analysis. PLOS One, 8(6), e67088. https://doi.org/10.1371/journal.pone.0067088
• Wastesson, J. W., Morin, L., Laroche, M. L., & Johnell, K. (2019). How chronic is polypharmacy in old age? A longitudinal nationwide cohort study. Journal of the American Geriatrics Society, 67(3), 455–462. https://doi.org/10.1111/jgs.15717
• Wekre, L. J., Bakken, K., Garasen, H., & Grimsmo, A. (2012). GPs’ prescription routines and cooperation with other healthcare personnel before and after implementation of multidose drug dispensing. Scandinavian Journal of Public Health, 40(6), 523–530. https://doi.org/10.1177/1403494812455468
• Wekre, L. J., Melby, L., & Grimsmo, A. (2011). Early experiences with the multidose drug dispensing system: A matter of trust? Scandinavian Journal of Primary Health Care, 29(1), 45–50. https://doi.org/10.3109/02813432.2011.554002
• Wekre, L. J., Spigset, O., Sletvold, O., Sund, J. K., & Grimsmo, A. (2010). Multidose drug dispensing and discrepancies between medication records. Quality & Safety in Health Care, 19(5), e42. https://doi.org/10.1136/qshc.2009.038745

Background

Transitions in healthcare are well-documented sources of preventable harm. One of the key influencing factors relates to medications and medication management, which often lead to hospital readmissions as a consequence (Dautzenberg et al., 2021; van der Does et al., 2020). More specifically, research has shown that a large percentage of medication errors connected to hospital readmissions (30%) were transition errors, and that 40% of all medication-related readmissions were preventable (Uitvlugt et al., 2021). When a patient is transferred from one healthcare service to another, the risk of adverse events increases (Kapoor et al., 2019). In particular, this relates to coordination, communication and information exchange between the different healthcare actors during this process (Kripalani et al., 2007; Laugaland et al., 2014; Storm et al., 2014). As the world population grows older, and more people receive complex medical care at home and in primary healthcare services, more complex information must be exchanged between healthcare actors (Glans et al., 2020; Schoonover et al., 2014). This implies that the problem of medication-related hospital readmissions is likely to continue to increase.

A hospital readmission is, according to the Norwegian national quality indicator, “an acute admission, regardless of the cause or hospital of the readmission, which occurs between eight hours and 30 days after discharge from a prior hospital stay (primary admission)” (Kristoffersen et al., 2017, p. 5). In addition, the literature often distinquishes between necessary and unnecessary hospital readmissions. Patients are readmitted necessarily if the readmission is due to acute illness, worsening of a chronic illness, complications after surgery, or if they are in need of other kinds of hospital care. An unnecessary hospital readmission is a readmission that could potentially be avoided, but still occurs due to, for example, organizational difficulties, such as lack of patient information, lack of competence or staffing or poor communication between different healthcare actors (Australian Commision on Safety and Quality in Health care, 2019; Kent et al., 2011).

Hospital readmissions related to medications are defined in different ways. The most common definition is, “admissions due to adverse drug reaction (ADR)”, where a drug reaction is an unintended response to a medication, for example a side effect. Another definition is, “admission due to an adverse drug event (ADE)”, which includes any unfortunate occurrence related to the use of a drug. And lastly, a hospital readmission related to medications may be defined as “admission due to drug-related problems”, which includes events involving a patient’s medication, which may inhibit achieving an optimal outcome (Linkens et al., 2020). This chapter includes all types of drug-related hospital readmissions using the term “medication-related readmissions”.

Aim and Research Question

This chapter aims to describe how healthcare personnel perceive medication management as an influence in hospital readmissions from primary healthcare services, and further, what factors within medication management may lead to hospital readmissions.

The research question was as follows: How do healthcare personnel perceive medication management as an influencing factor in hospital readmissions? The results will be discussed in light of previous research and human factors theory.

Context

The Norwegian healthcare service is managed and financed through two separate decision pathways, that is, the specialist healthcare services are subordinate to the state, and the primary healthcare services are subordinate to the municipalities (Grimsmo et al., 2015; Ministry of Local Government and Modernisation, 2019). The specialist healthcare services include somatic and psychiatric hospitals, while the primary healthcare services include general practitioners (GP), nursing homes, home care services, health centers, emergency rooms and rehabilitation services. In Norway, there are 356 different municipalities, and each one provides healthcare services at their own discretion, within comprehensive national regulations (The Health and Care Services Act, 2011). This means that there is considerable variation in how the different primary healthcare services are organized and delivered, including differences in areas of expertise, differences in skill mix, and differences in task allocation (Sperre et al., 2020).

Coordination, cooperation and holistic patient pathways between the hospitals and the primary healthcare services have been on the agenda for decades (Veggeland & Berg, 2013). This did, however, gain even more attention when the coordination reform (an overarching health reform) was introduced to the Norwegian healthcare services in 2012 (Bruvik et al., 2017). This reform encouraged earlier hospital discharges, and subsequently increased the responsibilities of primary healthcare services, particularly in terms of caring for a larger number of patients with complex medical needs (Abelsen, 2014).

Method

This chapter was based on a secondary analysis (Ruggiano & Perry, 2019) of data from a previously conducted case study on hospital readmissions (Glette, 2020; Glette et al., 2019; Glette, Kringeland, et al., 2018; Glette, Røise, et al., 2018). Two municipalities with four affiliated nursing homes (one short-term home and one long-term home in each) were included in the primary study, in addition to a common hospital for both municipalities. Data collection consisted of interviews with general practitioners (GPs) (n = 8), nursing home physicians (n = 2), hospital physicians (n = 15) nursing home leaders (n = 7), nursing home nurses (focus groups) (n = 17), and nursing home observations (ca. 40 hours). In the secondary analysis, Braun and Clarke’s (2006) analysis method was applied (as opposed to Graneheim and Lundman’s approach, which was used in the primary analysis). Braun and Clarke’s (2006) approach enabled the identification of focused features of the dataset, which in this case were medication management and hospital readmissions. The aim of the secondary analysis was to view the dataset in a new way, with the new research question as the backdrop. A distinctive view of the dataset was ensured by using clean uncoded transcripts, and applying a different analysis approach than was used in the parent study (Ruggiano & Perry, 2019). However, some of the results identified in the secondary analysis overlapped with the primary analysis, due a similarity of focus in the two studies. The analysis resulted in three themes, with seven subthemes, describing how medication management may influence hospital readmissions (Table 1 demonstrates the analysis process in Theme 1).

Table 1. Example of Analysis: Theme 1

Ethics

The primary study was approved by The Norwegian Center for Research Data (NSD) (reference number: 49331). All participants signed a written informed consent form before participating in the study. Written approval was retrieved from the participating hospital, and oral approval was received from municipal leaders. Overall, the research complied with the Norwegian National Research Ethics Committee’s research guidelines.

Results

Discussion

The results from this study showed that access to patient information varied, and coordination and communication in relation to medicine changes were poor. These were issues identified in both the hospital and in the primary healthcare service. Moreover, patients were discharged from hospital after medication changes (IV antibiotic to oral antibiotics) without proper observation of the effect of this change, often leading to a relapse and a need for hospital readmission. Most nursing homes had the competence to treat patients with antibiotic IVs, but they did not have access to all antibiotic types. Overall, all healthcare personnel worked to avoid medication-related hospital readmissions.

Conclusion

This study demonstrated a need for improved communication and coordination regarding medication management and medication changes, and in addition, a need to increase healthcare personnel’s knowledge of each other’s activities and treatment capacities. The lack of access to proper communication tools and well-functioning coordination routines were perceived, by the healthcare personnel in this study, as factors increasing medication-related hospital readmissions. Human factor theory can facilitate research exploring healthcare personnel’s perspectives on how these issues may be addressed, and thereby enable organizational changes, which can better support healthcare personnel’s performance. In doing so, unnecessary medication-related hospital readmissions and errors may be reduced.

References

• Abelsen, B., Gaski, M.,. Nødland, S. I,. Stephansen, A. (2014). Samhandlingsreformens konsekvenser for det kommunale pleie-og omsorgstilbudet. [The consequences of the coordination reform for municipal health and care services] International Research Institute of Stavanger (IRIS).
• Australian Commision on Safety and Quality in Health care. (2019). Avoidable hospital readmissions. Our Work. https://www.safetyandquality.gov.au/our-work/indicators/avoidable-hospital-readmissions#definition-of-’hospital-readmission’
• Bellon, J. E., Bilderback, A., Ahuja-Yende, N. S., Wilson, C., Altieri Dunn, S. C., Brodine, D., & Boninger, M. L. (2019). University of Pittsburgh Medical Center home transitions multidisciplinary care coordination reduces readmissions for older adults. Journal of the American Geriatrics Society, 67(1), 156–163. https://doi.org/10.1111/jgs.15643
• Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77–101. https://doi.org/10.1191/1478088706qp063oa
• Breuker, C., Macioce, V., Mura, T., Castet-Nicolas, A., Audurier, Y., Boegner, C., Jalabert, A., Villiet, M., Avignon, A., & Sultan, A. (2021). Medication errors at hospital admission and discharge: Risk factors and impact of medication reconciliation process to improve healthcare. Journal of Patient Safety, 17(7):e645-e652. 10.1097/PTS.0000000000000420.
• Bruvik, F., Drageset, J., & Abrahamsen, J. F. (2017). Fra sykehus til sykehjem – hva samhandlingsreformen har ført til [From hospitals to nursing homes—What the Coordination reform has led to]. Sykepleien Forskning.0.422(2017.60613). https://sykepleien.no/sites/default/files/pdf-export/pdf-export-60613.pdf
• Dautzenberg, L., Bretagne, L., Koek, H. L., Tsokani, S., Zevgiti, S., Rodondi, N., Scholten, R., Rutjes, A. W., Di Nisio, M., Raijmann, R., Emmelot-Vonk, M., Jennings, E. L. M., Dalleur, O., Mavridis, D., & Knol, W. (2021). Medication review interventions to reduce hospital readmissions in older people. Journal of the American Geriatrics Society, 69(6), 1646–1658. https://doi.org/10.1111/jgs.17041
• Frydenberg, K., & Brekke, M. (2012). Poor communication on patients’ medication across health care levels leads to potentially harmful medication errors. Scandinavian Journal of Primary Health Care, 30(4), 234–240. https://doi.org/10.3109/02813432.2012.712021
• Glad, T., Olsen, T. H., & Clancy, A. (2018). Promoting nursing competence in municipal healthcare services: An interview study of experienced nurses’ perceptions. Nordic Journal of Nursing Research, 38(3), 135–142. https://doi.org/10.1177/2057158517721833
• Glans, M., Kragh Ekstam, A., Jakobsson, U., Bondesson, Å., & Midlöv, P. (2020). Risk factors for hospital readmission in older adults within 30 days of discharge: A comparative retrospective study. BMC Geriatrics, 20(1), 467. https://doi.org/10.1186/s12877-020-01867-3
• Glette, M. K. (2020). Exploring hospital readmissions from the primary healthcare service: A multiple case study: Bd. no. 525. University of Stavanger, Faculty of Health Sciences.
• Glette, M. K., Kringeland, T., Røise, O., & Wiig, S. (2018). Exploring physicians’ decision-making in hospital readmission processes: A comparative case study. BMC Health Services Research, 18(1), 725. https://doi.org/10.1186/s12913-018-3538-3
• Glette, M. K., Kringeland, T., Røise, O., & Wiig, S. (2019). Hospital physicians’ views on discharge and readmission processes: A qualitative study from Norway. BMJ Open, 9(8), e031297. https://doi.org/10.1136/bmjopen-2019-031297
• Glette, M. K., Røise, O., Kringeland, T., Churruca, K., Braithwaite, J., & Wiig, S. (2018). Nursing home leaders’ and nurses’ experiences of resources, staffing and competence levels and the relation to hospital readmissions: A case study. BMC Health Services Research, 18(1), 955. https://doi.org/10.1186/s12913-018-3769-3
• Grimsmo, A., Kirchhoff, R., & Aarseth, T. (2015). Samhandlingsreformen i Norge [The Coordination reform in Norway]. Nordiske Organisasjonsstudier, 17(3), 3–12.
• Henke, R. M., Karaca, Z., Jackson, P., Marder, W. D., & Wong, H. S. (2017). Discharge planning and hospital readmissions. Medical Care Research and Review, 74(3), 345–368. https://doi.org/10.1177/1077558716647652
• Holden, R. J., Carayon, P., Gurses, A. P., Hoonakker, P., Hundt, A. S., Ozok, A. A., & Rivera-Rodriguez, A. J. (2013). SEIPS 2.0: A human factors framework for studying and improving the work of healthcare professionals and patients. Ergonomics, 56(11), 1669–1686. PubMed. https://doi.org/10.1080/00140139.2013.838643
• Johnson, A., Guirguis, E., & Grace, Y. (2015). Preventing medication errors in transitions of care: A patient case approach. Journal of the American Pharmacists Association, 55(2), e264–e276. https://doi.org/10.1331/JAPhA.2015.15509
• Jones, C. D., Vu, M. B., O’Donnell, C. M., Anderson, M. E., Patel, S., Wald, H. L., Coleman, E. A., & DeWalt, D. A. (2015). A failure to communicate: A qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations. Journal of General Internal Medicine, 30(4), 417–424. PubMed. https://doi.org/10.1007/s11606-014-3056-x
• Kapoor, A., Field, T., Handler, S., Fisher, K., Saphirak, C., Crawford, S., Fouayzi, H., Johnson, F., Spenard, A., Zhang, N., & Gurwitz, J. H. (2019). Adverse events in long-term care residents transitioning from hospital back to nursing home. JAMA Internal Medicine, 179(9), 1254–1261. https://doi.org/10.1001/jamainternmed.2019.2005
• Kent, T. S., Sachs, T. E., Callery, M. P., & Vollmer, C. M., Jr. (2011). Readmission after major pancreatic resection: A necessary evil? Journal of the American College of Surgeons, 213(4), 515–523. https://doi.org/10.1016/j.jamcollsurg.2011.07.009
• Kerstenetzky, L., Birschbach, M. J., Beach, K. F., Hager, D. R., & Kennelty, K. A. (2018). Improving medication information transfer between hospitals, skilled-nursing facilities, and long-term care pharmacies for hospital discharge transitions of care: A targeted needs assessment using the intervention mapping framework. Research in Social & Administrative Pharmacy : RSAP, 14(2), 138–145. PubMed. https://doi.org/10.1016/j.sapharm.2016.12.013
• Kripalani, S., Lefevre, F. V., Phillips, C. O., Williams, M. V., Basaviah, P., & Baker, D. W. (2007). Deficits in communication and information transfer between hospital-based and primary care physicians: Implications for patient safety and continuity of care. JAMA, 297 8, 831–841. https://doi.org/10.1001/jama.297.8.831
• Kristoffersen, D. T., Hansen, T. M., Tomic, O., & Helgeland, J. (2017). Kvalitetsindikatoren 30 dagers reinnleggelse etter sykehusopphold. Resultater for helseforetak og kommuner 2016. [The quality indicator 30 day readmission after hospitalization results for Norwegian health trusts and municipalities 2016] (Nr. 10/2015). Senter for omsorgsforskning. https://www.fhi.no/globalassets/dokumenterfiler/30-dagers-reinnleggelse-etter-sykehusopphold-resultater-2016.pdf
• Laugaland, K., Aase, K., & Barach, P. (2012). Interventions to improve patient safety in transitional care: A review of the evidence. Work, 41(Supplement 1), 2915–2924. https://doi.org/10.3233/WOR-2012-0544-2915
• Laugaland, K., Aase, K., & Waring, J. (2014). Hospital discharge of the elderly: An observational case study of functions, variability and performance-shaping factors. BMC Health Services Research, 14(1), 1–15. https://doi.org/10.1186/1472-6963-14-365
• Linkens, A., Milosevic, V., van der Kuy, P., Damen-Hendriks, V., Mestres Gonzalvo, C., & Hurkens, K. (2020). Medication-related hospital admissions and readmissions in older patients: An overview of literature. International Journal of Clinical Pharmacy, 42, 1243–1251. https://doi.org/10.1007/s11096-020-01040-1
• Loeb, D. F., Bayliss, E. A., Candrian, C., deGruy, F. V., & Binswanger, I. A. (2016). Primary care providers’ experiences caring for complex patients in primary care: A qualitative study. BMC Family Practice, 17(1), 34. https://doi.org/10.1186/s12875-016-0433-z
• Ministry of Health and Care Services,. (2021). Kommunale helse- og omsorgstjenester [Governmental information page]. https://www.regjeringen.no/no/tema/helse-og-omsorg/helse--og-omsorgstjenester-i-kommunene/id10903/
• Ministry of Local Government and Modernisation. (2019). Inntektssystemet for kommunar og fylkeskommunar 2019. [The income system for municipalities and counties 2019]. https://www.regjeringen.no/no/tema/kommuner-og-regioner/kommuneokonomi/inntektssystemet-for-kommuner-og-fylkeskommuner/id2353961/
• Norwegian Directorate of Health. (2019). Antibiotikabruk i sykehjem [Antibiotic use in nursing homes].[online document] Oslo: Directorate of Health (last update 06th of May 2021). Available from https://www.helsedirektoratet.no/statistikk/kvalitetsindikatorer/legemidler/antibiotikabruk-i-
• Osborn, R., Moulds, D., Schneider, E. C., Doty, M. M., Squires, D., & Sarnak, D. O. (2015). Primary care physicians in ten countries report challenges caring for patients with complex health needs. Health Affairs, 34(12), 2104–2112. https://doi.org/10.1377/hlthaff.2015.1018
• Pinelli, V., Stuckey, H. L., & Gonzalo, J. D. (2017). Exploring challenges in the patient’s discharge process from the internal medicine service: A qualitative study of patients’ and providers’ perceptions. Journal of Interprofessional Care, 31(5), 566–574. https://doi.org/10.1080/13561820.2017.1322562
• Ruggiano, N., & Perry, T. E. (2019). Conducting secondary analysis of qualitative data: Should we, can we, and how? Qualitative Social Work, 18(1), 81–97. https://doi.org/10.1177/1473325017700701
• Rustad, E. C., Seiger, B. E. C., Furnes, B., & Dysvik, E. (2017). Continuity of care during care transition: Nurses’ experiences and challenges. Open Journal of Nursing, 7, 277–293. https://doi.org.10.4236/ojn.2017.72023
• Sankey, C. (2017). Communication with the primary care provider. Cancer Therapy Advisor. https://www.cancertherapyadvisor.com/home/decision-support-in-medicine/hospital-medicine/communication-with-the-primary-care-provider/
• Schoonover, H., Corbett, C. F., Weeks, D. L., Willson, M. N., & Setter, S. M. (2014). Predicting potential postdischarge adverse drug events and 30-day unplanned hospital readmissions from medication regimen complexity. Journal of Patient Safety, 10(4). https://doi.org/10.1097
• Sperre, S., Ingrid, Karanikolos, M., & Sagen, A. (2020). Norway health system review. Health systems in transition. Norwegian Institute of Public Health, 22(1), i–163.
• Storm, M., Siemsen, I. M. D., Laugaland, K., Dyrstad, D. N., & Aase, K. (2014). Quality in transitional care of the elderly: Key challenges and relevant improvement measures. International Journal of Integrated Care, 14, e013–e013. PubMed. https://doi.org/10.5334/ijic.1194
• Søreide, H., Kyrkjebø, D., & Råholm, M. B. (2019). Challenges in municipality healthcare services: The nurse leaders’ perspective. Nursing Open, 6(3), 889–896. https://doi.org/10.1002/nop2.270
• The Health and Care Services Act. (2011). Act on municipal health and care services (LOV-2021-06-18-127). Lovdata. https://lovdata.no/dokument/NL/lov/2011-06-24-30
• Uitvlugt, E. B., Janssen, M. J. A., Siegert, C. E. H., Kneepkens, E. L., van den Bemt, B. J. F., van den Bemt, P. M. L. A., & Karapinar-Çarkit, F. (2021). Medication-related hospital readmissions within 30 days of discharge: Prevalence, preventability, type of medication errors and risk factors. Frontiers in Pharmacology, 12, 567424–567424. https://doi.org/10.1371/journal.pone.0253024
• Van der Does, A. M. B., Kneepkens, E. L., Uitvlugt, E. B., Jansen, S. L., Schilder, L., Tokmaji, G., Wijers, S. C., Radersma, M., Heijnen, J. N. M., Teunissen, P. F. A., Hulshof, P., Overvliet, G. M., Siegert, C. E. H., & Karapinar-Çarkit, F. (2020). Preventability of unplanned readmissions within 30 days of discharge: A cross-sectional, single-center study. PLOS One, 15(4), e0229940. https://doi.org/10.1371/journal.pone.0229940
• Vatnøy, T. K., Karlsen, T. I., & Dale, B. (2019). Exploring nursing competence to care for older patients in municipal in-patient acute care: A qualitative study. Journal of Clinical Nursing, 28(17–18), 3339–3352. https://doi.org/10.1111/jocn.14914
• Veggeland, N., & Berg, O. (2013). Reformer i norsk helsevesen: Veier videre. [Reforms in the Norwegian healthcare system: The road ahead] Akademika Forlag.
• Wallace, E., Salisbury, C., Guthrie, B., Lewis, C., Fahey, T., & Smith, S. M. (2015). Managing patients with multimorbidity in primary care. BMJ : British Medical Journal, 350, h176. https://doi.org/10.1136/bmj.h176
• Wooldridge, A. R., Carayon, P., Hundt, A. S., & Hoonakker, P. L. T. (2017). SEIPS-based process modeling in primary care. Applied Ergonomics, 60, 240–254. https://doi.org/10.1016/j.apergo.2016.11.010
• World Health Organization. (2018). Integrated care for older people: Realigning primary health care to respond to population ageing. World Health Organization. https://apps.who.int/iris/handle/10665/326295

Background

Since the coordination reform (St.meld. nr. 47, 2008–2009), patients are discharged from hospital sooner, and the primary healthcare services are given greater responsibility for health and care services. The increased responsibility for treatment, and the increasing proportion of patients who are seriously ill, place heavy demands on the knowledge and skills of nurses in the primary healthcare services (Bing-Jonsson et al., 2015; Norheim & Thoresen, 2015; Tyrholm et al., 2015). Many elderly patients have comorbidity and use multiple medications. This increases the risk of medication errors, side effects and unfortunate drug interactions (Storli et al., 2016). Focus on safety and proper use of medication is important to the health of elderly people, and has a bearing on their quality of life (Romskaug et al., 2020).

The World Health Organization (2017) has defined medication safety as a global patient safety challenge. Incorrect use of medication can put life, health, and quality of life at risk. Patient safety is about protection against unnecessary injury as a result of the services performed by the healthcare service, or their failure to provide services (World Health Organization, 2017). The Norwegian patient safety program, “In Safe Hands”, puts particular emphasis on the importance of safe medication management to avoid harm to patients (Norwegian Directorate of Health, 2019). Medication errors in hospitals is one of the error categories most commonly reported to the Norwegian Board of Health Supervision, and errors in double-checking are often cited as an important factor (Norwegian Directorate of Health, 2018). In Norway, 190 deaths and 160,000 adverse patient events are caused by medication every year (Olsen & Devik, 2016).

Regulations for medication management for healthcare organizations and personnel are intended to ensure appropriate and good medication management, and they stipulate professional responsibility requirements for all who provide healthcare (Helse- og omsorgsdepartementet, 2014). A survey conducted in 2019 by the Norwegian Nurses Organization showed that three out of ten nurses, on a weekly basis, are afraid of making a mistake that could harm a patient, and they link this to heavy workloads and inadequate training, among other factors (Helmers, 2019). A Belgian cross-sectional study found that nurses experience several barriers to safe medication management in nursing homes (Dilles et al., 2011). A recent systematic review that focused on identifying methods for measuring and describing nurses’ medication administration skills found that medication management requires complex competence (Luokkamäki et al., 2021). The review highlights the need to address and develop nurses’ competence in this field, and safe medication administration was defined as comprising nine areas: (1) safe ordering, handling, storing, and discarding of medications; (2) preparing of medications; (3) the administration of medications to patients; (4) documentation; (5) evaluation and assessment of medication-related issues; (6) drug calculation skills; (7) cooperation with other professionals; and (8) with the patients; and (9) reporting of medication information.

Medication management is one of the key responsibilities of nurses. However, research shows that nurses lack knowledge of how to administer medication (Hagesæter et al., 2016; O’Shea, 1999; Simonsen et al., 2011), and Johansen (2019) points out that nurses’ knowledge of generic substitution is also inadequate. Inadequate mathematical knowledge is one of the factors linked to medication errors (O’Shea, 1999; Sulosaari et al., 2010). An integrative review by Kerari and Innab (2021) provides strong evidence that occurrences of medication errors are directly associated with level of education, training courses and extent of experience. In a qualitative systematic review Schroers et al. (2021) found that fatigue and complacency were personal factors described as reasons for medication errors, while knowledge factors related to lack of medication knowledge. Two smaller Norwegian studies also suggest the same thing. Wannebo and Sagmo (2013) found that nurses have a great need for more knowledge on age-related physiological changes and pharmacology. Måløy et al. (2017) found that, among a sample of 262 nurses, 30% rarely or never read medical literature, and half have never attended a course or taken further education.

A review by Brady et al. (2009) pointed out the importance of management responsibility for systems of reporting and follow-ups of pharmaceutical treatment, in addition to the importance of the nurses’ individual mathematical skills. Andreassen et al. (2011) found that there is little focus on drug calculation in practice. Schroers et al. (2021) emphasize the importance of contextual factors in medication administration, which are often underlying personal and knowledge-based factors. Contextual factors involve workload, interruptions, poor communication, lack of support, physical working conditions, and unsafe practice norms. There is little systematic competence building in the field of practice, and according to Storli et al. (2016), medication management training is not taken sufficiently seriously in the Norwegian context.

Nurses working in primary healthcare have a great responsibility for medication management, but we do not know enough about how they characterize their experience, competence, and competence needs relating to medication management. The aim of this chapter was to study nurses’ experience of medication management in nursing homes and home nursing care, and how they perceive their own medication management practices. We asked the following research questions:

• How do nurses, working in nursing homes and home nursing care, rate their own knowledge and competence in the field of medication management?
• How do nurses update their own knowledge, and what training do they think they need?
• How well do nurses in nursing homes and home nursing care know the medication management procedures in their own workplace?
• Are there differences in knowledge, knowledge needs and knowledge of medication management procedures, which depend on the nurses’ experience and on whether they work in a nursing home or in home-based services?

Method

Ethics

The nurses received an information letter describing the objective of the study, accompanied by the questionnaire and anonymous envelopes to submit their responses. They were informed that participation was voluntary and that their responses would be anonymous. Since the study was anonymous and did not involve processing personal data, the Norwegian Centre for Research Data (NSD) was not notified. The municipalities and institutions in the study are anonymized. In addition, as very few nurses in the sample and in nursing in general are male, we eliminated gender in the analysis to protect informants’ identity. The questionnaire was paper-based, and nurses consented to taking part by completing the questionnaire and submitting it in a sealed envelope in a pigeonhole in the department.

Statistical Analysis

The data were analyzed using SPSS version 24.0. The transfer of data from the completed questionnaire forms to the data matrix was checked by a third party. Univariate analysis was used, and the variables were presented as frequencies and percentages. Bivariate analysis with contingency tables was used to identify relationships between variables. Among other things, we looked at whether self-reported practice, knowledge and skills depended on the nurses’ place of work and work experience (practice, knowledge and skills as dependent variables). We made dummy variables for questions one and 14 in part II, where we assigned the value 0 to “Never” and the value 1 to the answers “1–4 times” and “more than 5 times” for question one. For question 14, we assigned the value 0 to “Yes” and 1 to “No” and “Uncertain”. All the significance tests are two-sided, and p≤0.05 was considered significant. We used Pearson’s chi-square test to test the significance level. Some cells where we found significant differences had the value 0, and they were checked using Fisher’s test. This test produced the same result as the chi-square test, p<0.005.

Results

Of the nurses in our sample, 56.3% were working in nursing homes, 81.6% were working in rotating shifts, and 88.5% were employed in more than 60% of a full-time position (Table 1). The proportion who had less than 4 years’ work experience was 35.6% overall, with a somewhat higher percentage in home nursing care than in nursing homes. Of the nurses who worked in nursing homes, 28.6% had taken further education, while the corresponding percentage for those in home nursing care was only 10.5%.

Table 1. The sample with the number (percentage) who responded in different categories and with the given significance level (p value) and calculation of effect size (Cramer’s V) for the correlation between the sample’s workplace and the relevant variables

^aThe two-sided chi-square test is used unless otherwise specified.
^bFisher’s exact test is used.
^cThe chi-square test was performed on the binary outcome 100% or not 100% of a full-time position. This was done because the high number of cells with few answers posed a problem.

We found a significant correlation between place of work (nursing home or home nursing) and percentage of a full-time position (p = 0.046) and rotating shifts (p = 0.010), respectively, and the power of both these correlations was moderate with Cramer’s V of 0.23 and 0.32, respectively. The correlation between place of work and further education was almost significant (p = 0.060), and the power of the correlation was moderate (Cramer’s V = 0.23). We found no statistically significant relationship between place of work and years of work experience (p = 0.420).

Table 2. How Informants Update Their Knowledge of Medication

Furthermore, 96% of nurses updated their knowledge of medication by reading the Norwegian Pharmaceutical Product Compendium, and 94% did so through conversations with colleagues (Table 2). Contact with doctors was mentioned by 73.5%, and 53% read specialist literature to keep up to date. Experienced nurses and those employed in home nursing care cited professional meetings as a source of knowledge update to a greater extent than nurses working in nursing homes.

When asked how they rated their own medication management skills, 46% of the nurses responded that they were good, 38% that they were very good, and only 3% that they were fair. The nurses’ practice and knowledge of medication management procedures are shown in Table 3. This shows that 34% have given medication to the wrong patient, and 34.7% of nurses in nursing homes and 39.5% of nurses in home nursing care have administered an incorrect dose. Only one nurse reported having administered medication that caused harm to a patient, while 30.6% in nursing homes and 28.9% in home nursing care stated that they have administered medication that had unexpected side effects. As many as 79.6% of nurses working in nursing homes and 76.3% of nurses in home nursing care had administered medication at the wrong time. In addition, 87% of nurses stated that they were familiar with non-conformity procedures and division of responsibility, while 85.7% of nurses in nursing homes and 92.1% of nurses in home nursing care had reported non-conformities. There were no significant differences associated with place of work in these areas. Of the nurses working in nursing homes, 59.2% had administered medication without the patient’s consent, a significantly higher percentage than in home nursing care (34.2%)

Table 3. Self-reported practice and knowledge of medication management procedures by place of work