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Background: Hospitalized children are prone to experience harm from medication errors (MEs). Strategies to prevent MEs can be developed from identified malfunctioning practices and conditions in the medication use process. In this study, we aimed to identify MEs and potentially unsafe medication practices (PUMPs) in hospitalized children, and to assess the potential harm of these, using raters of different professions.Methods: A 1-week observation using an undisguised technique was conducted on four paediatric hospital wards. One observer followed ward staff during medication prescribing, preparation and administration. MEs and PUMPs were documented using field notes. Three raters including a physician, a nurse and a clinical pharmacist assessed the potential harm of each ME and PUMP using a six-point Likert scale. Agreement was analysed using Fleiss’ Kappa.Results: A total of 16 MEs and 809 PUMPs were identified involving a preparation and administration error rate of 8%. No actual harm to patients was observed during the study. Raters assessed the potential harm of 318 unique MEs and PUMPs. Only slight agreement was found (Kappa = 0.26–0.33). A 4-hour delay in the administration of intravenous cefuroxime received the highest harm score. Observations involving no information during prescribing and variations in medication preparation were considered potentially fatal for medications such as digoxin, morphine, enoxaparin and insulin.Conclusions: MEs and potentially unsafe practices and conditions may affect medication safety of hospitalized children. However, observed MEs did not result in any harm. The agreement among raters assessing the potential harm of observations was low. Alternative methods to determine the clinical relevance of errors are needed.

Background: Medication errors (MEs) in neonates are frequent and associated with increased potential for harm compared with adults. The effect of learning from reported MEs is potentially lacking due to underreporting, lack of feedback and missing actions to improve medication safety. A new approach involving positive recognition of current and future strategies may facilitate greater exploration of how to improve medication safety in neonates. We aimed to explore current and potential future practices to prevent MEs in neonatal intensive care units (NICUs).Methods: Focus group interviews of physicians and nurses were conducted at three Danish NICUs. Participants were included if they had at least 1 month of working experience and provided direct patient care. A semistructured interview guide involving three questions was used: (a) how do you feel about discussing prevention of MEs? (b) how do you currently prevent MEs from occurring? and (c) how can we become better at preventing MEs in the future? Content analysis was used to identify themes in the interviews.Results: Participants commented that MEs still occur and that action must be taken to improve medication safety. Current practices to prevent MEs involved technology, procedures, education, skills and hospital pharmacy services. Potential future practices to prevent MEs included customizing the computerized physician order entry systems to support optimal prescribing, standardizing the double-check process, training of calculation skills and teamwork and increased use of hospital pharmacy services.Conclusions: Several current and potential future practices to reduce MEs in NICUs were identified, highlighting the complexity of MEs. Our findings support an interdisciplinary multifaceted intervention involving both technical and nontechnical elements to improve medication safety in NICUs.

Background: Hospitalized children are at risk of medication errors (MEs) due to complex dosage calculations and preparations. Incident reporting systems may facilitate prevention of MEs but underreporting potentially undermines this system. We aimed to examine whether scenarios involving medications should be reported to a national mandatory incident reporting system and the likelihood of self- and peer-reporting these scenarios among paediatric nurses and physicians.Methods: Participants’ reporting of MEs was explored through a questionnaire involving 20 medication scenarios. The scenarios represented different steps in the medication process, types of error, patient outcomes and medications. Reporting rates and odds ratios with 95% confidence interval [OR, (95% CI)] were calculated. Barriers to and enablers of reporting were identified through content analysis of participants’ comments.Results The response rate was 42% (291/689). Overall, 61% of participants reported that scenarios should be reported. The likelihood of reporting was 60% for self-reporting and 37% for peer-reporting. Nurses versusphysicians, and healthcare professionals with versuswithout patient safety responsibilities assessed to a larger extent that the scenarios should be reported [OR = 1.34 (1.05–1.70) and OR = 1.41 (1.12–1.78), respectively]; were more likely to self-report, [OR = 2.81 (1.71–4.62) and OR = 2.93 (1.47–5.84), respectively]; and were more likely to peer-report [OR = 1.89 (1.36–2.63) and OR = 3.61 (2.57–5.06), respectively]. Healthcare professionals with versuswithout management responsibilities were more likely to peer-report [OR = 5.16 (3.44–7.72)]. Participants reported that scenarios resulting in actual injury or incidents considered to have a learning potential should be reported.Conclusion: The likelihood of underreporting scenarios was high among paediatric nurses and physicians. Nurses and staff with patient safety responsibilities were more likely to assess that scenarios should be reported and to report. Incidents with actual injury or learning potential were more likely to be reported. The potential for improving reporting rates involving MEs seems high.

Patients who transfer from the hospital back to the community are at risk of experiencing problems related to their medications. Hospital pharmacists (HPs) and community pharmacists (CPs) may play an important role and provide transitional pharmaceutical care in transition of care interventions.

Interchangeability between biological medicines and biosimilars, and subsequent substitution by pharmacists represent an important opportunity for costs savings for health care systems. Because biological medicines are complex products, the expert role of the pharmacist to inform patients and support physicians is indispensable. However, regulations on substitution of biosimilars differ around the globe, such that a substitution that is allowed in one country may be forbidden in another. Overall, pharmacists' knowledge of biosimilar medicines is incomplete and hesitancy to engage in substitutions is perceptible. As counter-balancing remedy, continued education about biosimilars is needed among practicing community pharmacists.

Abstract: In this last article in the series the authors focus on the issue of researching and evaluating pharmaceutical policy. The past five articles made an argument for why pharmaceutical policy is important and why it is different from health policy. The evidence base needed for pharmaceutical policymaking is also somewhat specialized in relation to health policy. Taking these differences into consideration the authors provide their definition of pharmaceutical policy. The knowledge base for good pharmaceutical policymaking needs to be broad and include approaches and methodologies ranging from the highly quantitative and experimental to the purely qualitative. Other policy questions such as those concerned with rational use of medicines and economics illustrate that pharmaceutical policy needs more varied approaches than randomized clinical trials alone can provide. The importance of gaining a thorough overview and understanding of the available design and methodological options for policy analysis is emphasized. Research into pharmaceutical policy has many commonalities with evaluation and policy analysis. Some of the main pitfalls that policymakers, researchers and analysts can fall into when formulating and evaluating pharmaceutical policy are discussed and include: using too narrow evaluation questions; choosing inappropriate methods/designs; and the problem of bias and self-censorship. The␣authors conclude this series by advocating a strong focus on research and an international evaluation culture around pharmaceutical policy. They emphasize the importance of pharmaceutical specialists’ (i.e., pharmacists’) involvement in pharmaceutical policy analysis and the policy consultative process.

Abstract In this article the authors deal with issues of drug utilisation from a clinical and policy perspective. They address the difficulties of managing drug therapy on a population level, which is known among professionals, as the problem of rational use of medicines. Various definitions and interpretations are presented and compared. This is followed by a presentation of the concerns associated with pharmaceutical marketing from a policy perspective, including the fear that the dominance of information produced by industry may lead to irrational drug use. Next, the authors review the tools for policy making including educational, managerial, and regulatory interventions. The (often overlapping) concepts of medicines management, clinical pharmacy and pharmaceutical care are then discussed to show how professionals, sometimes in collaboration with policymakers, have tackled the problem of nonrational use of medicines. The authors address the question as to whether the rational use of medicines a universal concept, whether it can be and whether it should be? They argue that, as with most concepts, the rational use of medicines must always be viewed in context. They conclude that pharmacy needs to adapt its way of thinking to include the issue of context. They point out that clinical pharmacists today already adapt their decisons to each patient and patient group. Policymakers are encouraged to adopt a similar approach because populations as well as particular market situations vary and therefore policy solutions cannot be considered universal.

Abstract Pharmaceutical policy is a global concern. It has become a hot political topic in most countries – developed as well as developing – and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

ObjectiveTo consider public perspectives on the use of medicines for non‐medical purposes, a usage called medically‐enhanced normality (MEN).

Background— The study reported here was part of a multi‐study evaluation of new drug distribution legislation in Iceland.

Objectives: Iceland was the first Nordic country to liberalise its drug distribution system, in March 1996. Subsequent regulation in January 1997 increased patients' share of drug costs. The objectives of this study were to test the assumptions that liberalising community pharmacy ownership would lower reimbursement costs for the state's Social Security Institute and that increasing patient charges would reduce use and, therefore, lower the cost to the Institute.Methods: Based on the assumptions, we built and tested two models using interrupted time series designs that contrast the monthly reimbursement costs before and after the legislation and regulation took effect. A control variable (the number of office visits to general practitioners) was tested to assess other events in the health care arena. Monthly data on these variables were provided by the Icelandic State Social Security Institute for January 1993 to August 1998 for reimbursement costs and to December 1998 for office visits to general practitioners.Results: Reimbursement costs have risen steadily throughout the period under study. The interrupted time series analysis did not show a substantial effect from the legislative change in March 1996 or from the regulatory intervention in January 1997.Conclusions: The main argument used for liberalising community pharmacy ownership in Iceland was built on false assumptions regarding the effect on drug reimbursement costs to the state. It will be necessary to find more promising interventions to halt the rapidly increasing cost of drugs.

Objectives— (1) To document types and number of drug‐related problems identified by community pharmacy personnel in Sweden; (2) to determine relationships among the types and number of problems identified and the gender, age and number of prescribed drugs in patients; and (3) to document the interventions made by pharmacy personnel with patients and prescribers.

Transitions of care may result in medication errors, when information about a patient’s medications is not communicated sufficiently. In this clinical record review study, we aimed to evaluate the frequency of undocumented medication discrepancies at discharge from hospital and evaluate which patient characteristics could be associated with undocumented medication discrepancies. Preadmission medication lists were compared against the medication list in the discharge letters, taking into account medication changes documented in the patient record throughout the inpatient stay and in the discharge summary. Out of 200 patients, 174 (87%) were affected by at least one undocumented medication discrepancy, mostly for regular medication. Of the 1972 medications used, 744 (38%) medications were changed without documentation in the patient record, the majority being over-the-counter supplements and herbal medications. Polypharmacy at admission and discharge was associated with increased undocumented medication discrepancies. This study indicates a lack of medication reconciliation during inpatient stay. Correct and complete medication lists at admission and discharge may resolve many of these discrepancies, supporting patient safety at transitions of care.