Experiences of patient organizations' involvement in medicine appraisal and reimbursement processes in Finland - a qualitative study.

BACKGROUND: This study investigated how patient representatives have experienced their involvement in medicines appraisal and reimbursement processes with the Council for Choices in Health Care in Finland (COHERE) and the Pharmaceuticals Pricing Board (PPB) and how authorities perceive the role of patient organizations' input. METHODS: Semi-structured thematic individual and pair interviews were conducted in 2021 with representatives (n = 14) of patient organizations and government officials (n = 7) of the Ministry of Social Affairs and Health. The interview data were analyzed using qualitative content analysis. RESULTS: Patient representatives expressed their appreciation for the PPB and the COHERE in creating consultation processes and systematic models that support involvement. However, there were many challenges: patient representatives were uncertain about how their submissions were utilized in official processes and whether their opinions had any significance in decision-making. Patients or patient organizations lack representation in appraisal and decision-making bodies, and patient representatives felt that decision-making lacked transparency. The importance of patient involvement was highlighted by the authorities, but they also emphasized that the patient organizations' contributions were complementary to the other materials. Submissions regarding the medications used to treat rare diseases and those with limited research evidence were considered particularly valuable. However, the submissions may not necessarily have a direct impact on decisions. CONCLUSIONS: The interviews provided relevant input for the development of involvement processes at the PPB and COHERE. The interviews confirmed the need for increased transparency in the medicines assessment, appraisal, and decision-making procedures in Finland.

Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders.

BACKGROUND: Ensuring equal access to medicines and their appropriate and safe use at reasonable costs are core functions of health systems. Despite that, few descriptions of national medicines policies' development processes and implementation strategies have been published. This study aimed to describe the government program-based development of the Rational Pharmacotherapy Action Plan in Finland as a part of the undergoing major health and social service system reform, also covering the implementation of rational pharmacotherapy in the reformed system and processes. METHODS: The data of this qualitative study consisted of public reports and Steering Group meeting memos related to the development of the national Rational Pharmacotherapy Action Plan that the Ministry of Social Affairs and Health coordinated. Qualitative content analysis applying systems theory and the conceptual framework of integrated services as theoretical frameworks was used as an analysis method. RESULTS: The national Rational Pharmacotherapy Action Plan covering 2018-2022 was created in a bottom-up development process involving a wide range of stakeholders. Rational pharmacotherapy was redefined by adding equality as the fifth pillar to complement the previously defined pillars of being effective, safe, high-quality, and cost-effective. The Action Plan formed a normative framework for long-term development, with a vision and principles focusing on people-centeredness, better coordination and management of the medication use processes, the continuity of treatment paths and the flow of patient and medicines information through partnerships, and evidence-informed policies and practices. CONCLUSION: Through intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy along with strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated and reformed national social and health services system. The development of the pharmaceutical system has several national and EU-level dependencies requiring political long-term commitment. While the Action Plan differs from the national medicines policy, it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso, and macro levels of the service system.

Trends in dispensing errors reported in Finnish community pharmacies in 2015-2020: a national retrospective register-based study.

BACKGROUND: Community pharmacies are responsible for dispensing of medicines and related counselling in outpatient care. Dispensing practices have remarkably changed over time, but little is known about how the changes have influenced medication safety. This national study investigated trends in dispensing errors (DEs) related to prescribed medicines, which were reported in Finnish community pharmacies within a 6-year period. METHODS: This national retrospective register study included all DEs reported to a nationally coordinated voluntary DE reporting system by Finnish community pharmacies during 2015-2020. DE rates, DE types, prescription types, individuals who detected DEs and contributing factors to DEs were quantified as frequencies and percentages. Poisson regression was used to assess the statistical significance of the changes in annual DE rates by type. RESULTS: During the study period, altogether 19 550 DEs were reported, and the annual number of error reports showed a decreasing trend (n = 3 913 in 2015 vs. n = 2 117 in 2020, RR 0.54, p < 0.001). The greatest decrease in reported DEs occurred in 2019 after the national implementation of the Medicines Verification System (MVS) and the additional safety feature integrated into the MVS process. The most common error type was wrong dispensed strength (50% of all DEs), followed by wrong quantity or pack size (13%). The annual number of almost all DE types decreased, of which wrong strength errors decreased the most (n = 2121 in 2015 vs. n = 926 in 2020). Throughout the study period, DEs were most commonly detected by patients (50% of all DEs) and pharmacy personnel (30%). The most reported contributing factors were factors related to employees (36% of all DEs), similar packaging (26%) and similar names (21%) of medicinal products. CONCLUSIONS: An overall decreasing trend was identified in the reported DEs and almost all DE types. These changes seem to be associated with digitalisation and new technologies implemented in the dispensing process in Finnish community pharmacies, particularly, the implementation of the MVS and the safety feature integrated into the MVS process. The role of patients and pharmacy personnel in detecting DEs has remained central regardless of changes in dispensing practices.

Evolution of Intravenous Medication Errors and Preventive Systemic Defenses in Hospital Settings-A Narrative Review of Recent Evidence.

OBJECTIVES: Intravenous drug administration has been associated with severe medication errors in hospitals. The present narrative review is based on a systematic literature search, and aimed to describe the recent evolution in research on systemic causes and defenses in intravenous medication errors in hospitals. METHODS: This narrative review was based on Reason's theory of systems-based risk management. A systematic literature search covering the period from June 2016 to October 2021 was conducted on Medline (Ovid). We used the search strategy and selection criteria developed for our previous systematic reviews. The included articles were analyzed and compared to our previous reviews. RESULTS: The updated search found 435 articles. Of the 63 included articles, 16 focused on systemic causes of intravenous medication errors, and 47 on systemic defenses. A high proportion (n = 24, 38%) of the studies were conducted in the United States or Canada. Most of the studies focused on drug administration (n = 21/63, 33%) and preparation (n = 19/63, 30%). Compared to our previous review of error causes, more studies (n = 5/16, 31%) utilized research designs with a prospective risk management approach. Within articles related to systemic defenses, smart infusion pumps remained most widely studied (n = 10/47, 21%), while those related to preparation technologies (n = 7/47, 15%) had increased. CONCLUSIONS: This narrative review demonstrates a growing interest in systems-based risk management for intravenous drug therapy and in introducing new technology, particularly smart infusion pumps and preparation systems, as systemic defenses. When introducing new technologies, prospective assessment and continuous monitoring of emerging safety risks should be conducted.

Collaborative medication reviews in community pharmacies-Drug-related problems and the process of communicating them with physicians: A retrospective validation study.

Background and Aims: Cooperation between practicing community pharmacists (PPs) and primary care physicians has traditionally been limited, with scarce communication on therapeutic issues. The aim of this study was to assess how PPs communicate in writing with physicians regarding (1) the clinically relevant problems they have identified in patients' medications and (2) recommendations to solve the problems to identify development needs in the communication process. Methods: This retrospective validation study assessed medication reviews conducted by PPs in collaboration with home care nurses, practice nurses, and physicians for 46 older (≥65 years) home care clients in the Municipality of Lohja, Finland. The therapeutic and communicative appropriateness of clinically relevant drug-related problems (DRPs) identified by PPs and reported in writing to physicians was blindly evaluated by (1) an accredited pharmacist (AP) and (2) two physicians specialized in geriatric pharmacotherapy. Descriptive statistical analysis was conducted to compare the assessments. Results: The PPs (n = 13) identified 189 DRPs and made 4.1 recommendations per patient in 46 written reports to physicians. Of the PPs' written recommendations for medication changes, 46% (155/334) were the same as those by the AP. The two specialized physicians evaluated 69% and 67% of PPs' recommendations to be clinically relevant. The way the DRPs and recommendations to solve them were communicated was evaluated as appropriate in 38% and 38%, respectively, of the case reports written by the PPs. Conclusion: The PPs were able identify DRPs quite well, particularly inappropriate medication use, according to current care guidelines and formularies. It was found that improvement was needed in the communication of DRPs in written reports with physicians. Interprofessional learning by working in care teams would be suitable for strengthening patient care-oriented competencies.

Harmonizing the definition of medication reviews for their collaborative implementation and documentation in electronic patient records: A Delphi consensus study.

BACKGROUND: Medication review practices have evolved internationally in a direction in which not only physicians but also other healthcare professionals conduct medication reviews according to agreed practices. Collaborative practices have increasingly highlighted the need for electronic joint platforms where information on medication regimens and their implementation can be documented, kept updated, and shared. OBJECTIVE: The aim of this study was to harmonize the definition of medication reviews and create a unified conceptual basis for their collaborative implementation and documentation in electronic patient records (definition appellation: collaborative medication review). METHODS: The study was conducted using the Delphi consensus survey with three interprofessional expert panel rounds in September-December 2020. The consensus rate was set at 80%. Experts assessed the proposed definition of collaborative medication review based on an international and national inventory of medication review definitions. The expert panel (n = 41) involved 12 physicians, 13 pharmacists, 10 nurses, and six information management professionals. The range of response rates for the rounds was 63-88%. RESULTS: The experts commented on which of the pre-selected items (n = 75) characterizing medication reviews should be included in the definition of collaborative medication review. The items were divided into the following five themes and 51 of them reached consensus: 1) Actions included in the collaborative medication review (n = 24/24), 2) Settings where the review should be conducted (n = 5/5), 3) Situations where the review should be considered as needed and carried out (n = 10/11), 4) Prioritization of top five benefits to be achieved by the review and 5) Prioritization of top five patient groups to whom the review should be targeted. CONCLUSIONS: A strong interprofessional consensus was reached on the definition of collaborative medication review. The most challenging was to identify individual patient groups benefiting from the review.

Sleep medicines are often prescribed for older adults (≥75 years) without appropriate dosing instructions: A nationwide retrospective register study in Finland.

BACKGROUND: Sleep medicines should be prescribed cautiously, accompanied by instructions that ensure appropriate use and reduce risks. This is especially important for older adults, for whom many of these medicines are classified as potentially inappropriate medicines. METHODS: We investigated the use and appropriateness of dosing instructions for sleep medicines (described in the Finnish National Current Care Guideline for Insomnia) prescribed for older adults (≥75 years) and dispensed with instruction label in pharmacies. The retrospective reimbursement register data for year 2020 by the Social Insurance Institution of Finland was used as the data source (1,080,843 purchases by 143,886 individuals of which 565,228 purchases were pharmacy dispenses). The appropriateness of the pharmacy dosing instructions containing keyword(s) referring to insomnia treatment was examined according to the prescribed dose, time of intake, frequency of use, and warnings/remarks. A random sample of 1000 instructions was used to manually analyze the phrasing and appropriateness. OUTCOMES: We focused our analysis on 58.1% (328,285 purchases by 87,396 individuals) of the pharmacy dispenses, which contained dosing instructions referring insomnia treatment. Of these, zopiclone and mirtazapine were the most prescribed drugs (134,631 and 112,463 purchases, respectively). Dose and time of intake were specified in most of the instructions (98.4% and 83.4%, respectively), whereas frequency of use was specified in 57.3%. A small percentage of the instructions included warnings/remarks (2.8%). Overall, only 2.1% of the instructions contained information about a single dose, time of intake, temporary use, and warnings/remarks and were thus defined as sufficient. Notably, 47.7% (n = 515,615) of all the purchases in our dataset were dispensed via automated multi-dose dispensing systems, which is aimed for long-term treatment. INTERPRETATION: It is common to prescribe sleep medicines for older adults without appropriate dosing instructions, particularly excluding warnings against long-term, regular use. Actions to change the current prescribing practices are warranted.

Understanding medication-related burden from patient perspectives: a qualitative study testing the applicability of the conceptual model among chronically ill outpatients in Finland.

OBJECTIVES: Disease self-management and medication therapy can cause burden to patients that can influence adherence. The conceptual model 'patients' lived experience with medicine' (PLEM) brings new insights into medication-related burden (MRB) from patient perspective. This study aimed to test the applicability of the PLEM model by interviewing chronically ill patients in Finland and to investigate the MRB experienced by the Finnish patients. DESIGN: Focus group discussion study conducted online via Zoom. Directed qualitative content analysis guided by the PLEM model. SETTING: Outpatient primary care in Finland. PARTICIPANTS: Chronically ill outpatients (n=14) divided into five focus groups according to their chronic condition: asthma (n=3), heart disease (n=3), diabetes (n=6), intestinal disease (n=2). RESULTS: Our findings were mainly in line with the PLEM model although some new contributing factors to MRB emerged. In general, the participants were satisfied with their medication, and that it enabled them to live normal lives. The most common causes of MRB were medication routines and the healthcare system. The participants introduced two new aspects contributing to MRB: medication-related environmental anxiety associated with the waste resulting from medicine use, and the effect of medication use on their working life. Our findings are consistent with previous findings that a higher level of MRB may lead to independently modifying the medication regimen or not taking the medicine. CONCLUSIONS: Our findings provide further evidence that the PLEM model is an applicable tool also in the Finnish context for gaining better understanding of MRB in chronically ill patients self-managing their long-term medications. The model provides a promising tool to understand the connection between MRB and the rationale for not always taking medicines as prescribed. Further research is needed to explore the potential of the model in extending patient perspectives in chronic disease management.

State of the European Union's early notification obligation for drug shortages: enforcement and compliance in eight European countries (2020-2022).

BACKGROUND: Early notification of impending drug shortages is essential for mitigating or preventing shortages. Since 2019 pharmaceutical companies in the European Union (EU) and European Economic Area (EEA) must notify authorities of drug shortages at least two months in advance. This study's aim was to investigate how advance notification of pharmaceutical shortages is functioning in EU/EEA countries and factors possibly associated with differences in notification times. METHODS: This was a retrospective register study using data from publicly available drug shortage registers of all national authorities in the EU/EEA area having such a register. Actual notification times for all drug shortages during January 2020-November 2022 were calculated and included in the descriptive quantitative analysis. RESULTS: Data from eight countries (Belgium, Croatia, Finland, Germany, Norway, Slovakia, Slovenia, and Sweden) were available (18,987 notifications in total). Only 5.2% of all shortage notifications were made at least 60 days in advance and 56.2% of all notifications were made on the shortage's starting day or even later. Data on production-related shortages were available in Belgium, Croatia, Germany, and Norway (n = 2097 showing that 3.9% of those shortages were notified at least 60 days in advance, but 74.3% were made on the starting day or even later. The longest advance notification times for drug shortages were found in Finland during a 12-month period in June 2021-May 2022 when progressive notification fees were in effect. During this national policy experiment, 20.0% of the shortages (n = 1754) were notified at least 60 days in advance, while 24.9% of the notifications occurred on the starting day or even later. Data on notification times for permanent market withdrawals of drugs were available in three countries (Belgium, Slovenia, and Slovakia, n = 1737): 21.2% of these notifications were made at least 60 days in advance, while 45.5% of the notifications occurred on the starting day or even later. CONCLUSIONS: The EU regulatory requirement adopted in 2019 for early notification of drug shortages was unsuccessful in the eight countries having openly available statistics for follow-up. The national policy experiment in Finland with a progressive notification fee seemed to increase compliance with early notification.

Medication risk checklist for older adults (LOTTA) - development and validation of a self-assessment tool.

BACKGROUND: Patient safety strategies highlight patients' own active involvement in ensuring medication safety. A prerequisite for involving patients in their medication therapy is having tools that can assist them in ensuring safe medicine use. Older home-dwelling adults with multiple medications are at high risk for medication-related problems, yet only a few age-specific patient self-administered medication risk screening tools exist. This study aimed to develop, validate, and assess the feasibility of a self-administered medication risk checklist for home-dwelling older adults ≥65 years. MATERIALS AND METHODS: The draft checklist was formed based on a validated practical nurse-administered Drug Related Problem Risk Assessment Tool supplemented with findings from two systematic literature reviews. The content validity of the draft checklist was determined by a three-round Delphi survey with a panel of 19 experts in geriatric care and pharmacotherapy. An agreement of ≥80% was required. A feasibility assessment (i.e. understandability of the items, fill-out time of the checklist) of the content-validated checklist was conducted among older adults ≥65 years (n = 87) visiting community pharmacies (n = 4). Data were analysed using qualitative content analysis. RESULTS: The final validated and feasibility-tested Medication Risk Checklist (LOTTA) for home-dwelling older adults consists of eight items screening the highest priority systemic risks (three items), potentially drug-induced symptoms (one item), adherence, and self-management problems (four items). The checklist proved feasible for self-administration, the mean fill-out time being 6.1 min. CONCLUSIONS: A wide range of potential medication risks related to the medication use process can be identified by patient self-assessment. Screening tools such as LOTTA can enhance early detection of potential medication risks and risk communication between older adults and their healthcare providers. A wider and more integrated use of the checklist could be facilitated by making it electronically available as part of the patient information systems.

Patient safety strategies highlight patients' own active involvement in ensuring medication safety, which in turn, requires easy-to-use tools to self-assess potential medication risks and communicate them with healthcare providers.This study produced a short, age-specific eight item Medication Risk Checklist (LOTTA) to be self-administered by home-dwelling older adults to identify major systemic risks, potential drug-induced symptoms, adherence, and self-management problems related to medication taking.To facilitate the use of the checklist in early detection of potential medication risks, future studies should focus on converting the LOTTA list into electronic form and pilot its use as an integrated part of the electronic patient information system.

Development of a Preventive Health Screening Procedure Enabling Supportive Service Planning for Home-Dwelling Older Adults (PORI75): Protocol for an Action Research Study.

BACKGROUND: In Finland, at least 1 in 4 residents will be >75 years of age in 2030. The national aging policy has emphasized the need to improve supportive services to enable older people to live in their own homes for as long as possible. OBJECTIVE: This study aimed to develop a preventive health screening procedure for home-dwelling older adults aged 75 years to enable the use of clinical patient data for purposes of strategic planning of supportive services in primary care. METHODS: The action research method was applied to develop the health screening procedure with selected validated health measures in cooperation with the local practicing interprofessional health care teams from 10 primary care centers in the Social Security Center of Pori, Western Finland (99,485 residents, n=11,938, 12% of them >75 years). The selection of evidence-based validated health measures was based on the national guide to screen factors increasing fall risk and the national functioning measures database. The cut-off points of the selected health measures and laboratory tests were determined in consecutive consensus meetings with the local primary care physicians, with decisions based on internationally validated measures, national current care guidelines, and local policies in clinical practice. RESULTS: The health screening procedure for 75-year-old residents comprised 30 measures divided into three categories: (1) validated self-assessments (9 measures), (2) nurse-conducted screenings (14 measures), and (3) laboratory tests (7 measures). The procedure development process comprised the following steps: (1) inventory and selection of the validated health measures and laboratory tests, (2) training of practical nurses to perform screenings for the segment of 75-year-old residents and to guide them to possible further medical actions, (3) creation of research data from clinical patient data for secondary use purposes, (4) secondary data analysis, and (5) consensus meeting after the pilot test of the health screening procedure for 75-year-old residents procedure in 2019 based on the experiences of health care professionals and collected research data. CONCLUSIONS: The developed preventive health screening procedure for 75-year-old residents enables the use of clinical patient data for purposes of strategic planning of supportive services in primary care if the potential bias by a low participation rate is controlled. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48753.

Applicability of drug-related problem (DRP) classification system for classifying severe medication errors.

BACKGROUND: Several classification systems for medication errors (MEs) have been established over time, but none of them apply optimally for classifying severe MEs. In severe MEs, recognizing the causes of the error is essential for error prevention and risk management. Therefore, this study focuses on exploring the applicability of a cause-based DRP classification system for classifying severe MEs and their causes. METHODS: This was a retrospective document analysis study on medication-related complaints and authoritative statements investigated by the Finnish National Supervisory Authority for Welfare and Health (Valvira) in 2013-2017. The data was classified by applying a previously developed aggregated DRP classification system by Basger et al. Error setting and harm to the patient were identified using qualitative content analysis to describe the characteristics of the MEs in the data. The systems approach to human error, error prevention, and risk management was used as a theoretical framework. RESULTS: Fifty-eight of the complaints and authoritative statements concerned MEs, which had occurred in a wide range of social and healthcare settings. More than half of the ME cases (52%, n = 30) had caused the patient's death or severe harm. In total, 100 MEs were identified from the ME case reports. In 53% (n = 31) of the cases, more than one ME was identified, and the mean number of MEs identified was 1.7 per case. It was possible to classify all MEs according to aggregated DRP system, and only a small proportion (8%, n = 8) were classified in the category "Other," indicating that the cause of the ME could not be classified to specific cause-based category. MEs in the "Other" category included dispensing errors, documenting errors, prescribing error, and a near miss. CONCLUSIONS: Our study provides promising preliminary results for using DRP classification system for classifying and analyzing especially severe MEs. With Basger et al.'s aggregated DRP classification system, we were able to categorize both the ME and its cause. More research is encouraged with other ME incident data from different reporting systems to confirm our results.

Developing an In-House Comprehensive Medication Review Training Program for Clinical Pharmacists in a Finnish Hospital Pharmacy.

Long-term continuing education programs have been a key factor in shifting toward more patient-centered clinical pharmacy services. This narrative review aims to describe the development of Helsinki University Hospital (HUS) Pharmacy's in-house Comprehensive Medication Review Training Program (CMRTP) and how it has impacted clinical pharmacy services in HUS. The CMRTP was developed during the years 2017-2020. The program focuses on developing the special skills and competencies needed in comprehensive medication reviews (CMRs), including interprofessional collaboration and pharmacotherapeutic knowledge. The program consists of two modules: (I) Pharmacist-Led Medication Reconciliation, and (II) CMR. The CMRTP includes teaching sessions, self-learning assignments, medication reconciliations, medication review cases, CMRs, a written final report, and a self-assessment of competence development. The one-year-long program is coordinated by a clinical teacher. The program is continuously developed based on the latest guidelines in evidence-based medicine and international benchmarking in cooperation with the University of Helsinki. With the CMRTP, we have adopted a more patient-centered role for our clinical pharmacists and remarkably expanded the services. This program may be benchmarked in other countries where the local education system does not cover clinical pharmacy competence well enough and in hospitals where the clinical pharmacy services are not yet very patient-oriented.

Self-assessed medication risk factors as part of comprehensive health screening in home-dwelling older adults.

Background: Poor medication management may negatively impact the health and functional capacity of older adults. This cross-sectional study aimed to identify medication-related risk factors in home-dwelling residents using a validated self-assessment as part of comprehensive health screening. Methods: The data were derived from comprehensive health screening (PORI75) for older adults of 75 years living in Western Finland in 2020 and 2021. One of 30 validated measures in health screening focused on identifying medication-related risk factors (LOTTA Checklist). The Checklist items were divided into (1) systemic risk factors (10 items) and (2) potentially drug-induced symptoms (10 items). Polypharmacy was categorized according to the number of used drugs: (1) no polypharmacy (<5 drugs), (2) polypharmacy (≥5 and <10), and (3) excessive polypharmacy (≥10). The linearity across these three polypharmacy groups was evaluated using the Cochran-Armitage test. Results: Altogether, 1024 out of 1094 residents who participated in the health screening consented to this study (n = 569 in 2020 and n = 459 in 2021). The mean number of all drugs in use was 7.0 (range 0-26; SD 4.1), with 71% of the residents using >5 drugs, that is, having polypharmacy. Of the systemic risk factors most common was that the resident had more than one physician responsible for the treatment (48% of the residents), followed by missing drug list (43%), missing regular monitoring (35%), and unclear durations of the medication (35%). The most experienced potentially drug-induced symptoms were self-reported constipation (21%), urinating problems (20%), and unusual tiredness (17%). An increasing number of drugs in use, particularly excessive polypharmacy, was associated with various medication-related risk factors. Conclusion: As a part of comprehensive health screening the LOTTA Checklist provides useful information to prevent medication-related risk factors in home-dwelling older adults. The Checklist could be used to guide planning and implementing health services in the future.

Developing Medication Review Competency in Undergraduate Pharmacy Training: A Self-Assessment by Third-Year Students.

Pharmacists are increasingly involved in medication history taking, medication reconciliation, and review in their daily practice. The objectives of this study were to investigate third-year pharmacy students' self-assessed competency in medication reviews and gather their feedback for further development of medication review training in their curriculum. The study was conducted as a self-assessment of third-year pharmacy students at the completion of their second three-month internship period in a community pharmacy in 2017-2018. The students were assigned to review medications of a real patient under the supervision of a medication review accredited pharmacist during their internship. The self-assessment was carried out via an e-form, which was created for this study. Recently established national medication review competence recommendations for pharmacists were used as a reference. Students (n = 95, participation rate: 93%) self-assessed their competency as good or very good in 91% (n = 28) of the competency areas listed in the self-assessment. The highest proportion of competencies that were self-assessed as good or very good included using medication risk management databases and evaluating the clinical importance of the information (97%, n = 92). The lowest proportion of competencies was found in applying clinical information from the key laboratory tests to patient care and knowing which laboratory tests are most important to monitor in each condition and medication (36%, n = 34). The students suggested that their pharmacy education should contain more medication review assignments as group work and that an elective course on medication reviews should be compulsory for all pharmacy students.

Why medicines are used differently from prescribed: a protocol for a prospective patient-oriented observational case study to investigate reasons for non-adherence in primary care.

INTRODUCTION: Patients do not always tell the physician if they have used medicines differently from prescribed. The challenges that patients experience in medication self-management and adherence have been prioritised globally as among the most crucial factors influencing the effectiveness and safety of pharmacotherapies. METHODS AND ANALYSIS: This study protocol presents a new patient-oriented method to investigate reasons for non-adherence using pharmacist-conducted medication reconciliation in a primary care clinic as data collection point. By interviewing, the pharmacist will learn how the patient has been taking the prescribed medicines and whether any non-prescription medicines and food supplements have been used for self-medication. The pharmacist will document the findings of the conversation to the electronic patient record in a structured format. The pharmacist will collect data related to the characteristics of the patients and outpatient clinics, patients' diseases and medications, and medication discrepancies. These data will be analysed for descriptive statistics to identify (1) the number of discrepancies between the physician's prescription orders and the patient's self-reported use of the medicines, (2) what kind of discrepancies there are, (3) which are high-risk medicines in terms of non-adherence and (4) why medicines were taken differently from prescribed; based on the results, (5) a preliminary conceptual model of patient-reported reasons for non-adherence will be constructed. TRIAL REGISTRATION NUMBER: NCT05167578.

Using Healthcare Failure Mode and Effect Analysis in prospective medication safety risk management in secondary care inpatient wards.

OBJECTIVES: The evaluation and improvement of medication management processes is an essential part of preventive medication risk management strategies in hospitals. The aim of the present study was to identify and analyse risks of a new electronic medication management process and to suggest improvements to manage the identified risks in a secondary care hospital. METHODS: The electronic medication management process of four wards at the Lapland Central Hospital, Finland was evaluated by Healthcare Failure Mode and Effect Analysis (HFMEA). The multidisciplinary HFMEA team consisted of five experts who identified the failure modes and rated their hazard scores (scale of 1-16). In addition, the patient safety incident reports of the hospital were used for identification of failure modes. Safety recommendations were identified, prioritised and implemented with a follow-up evaluation. RESULTS: The team identified five phases in the electronic medication management process. Altogether, 35 potential failure modes were found, with eight being classified as the most severe (hazard score >8). The given recommendations (n=15) concerned improvements to the electronic medical record (EMR) (n=8) and to the work processes of the wards (n=7). Only two of the recommendations were fully implemented, and five were under development or partly implemented after a 15-month follow-up period. CONCLUSIONS: For identifying risks associated with electronic medication management and for compiling related safety recommendations, triangulation of different risk identification methodologies is recommended. When implementing electronic medication management, appropriate patient identification in medication administration should be ensured together with EMR development. Systematic efforts should be made for the effective implementation of the safety recommendations. Further research is warranted to explore barriers to implementing safety improvements, especially in small healthcare units in rural areas.

The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland.

BACKGROUND: Biological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases. Biosimilars, clinically equivalent to biological originator products, are expected to restrain drug costs in the biological market. OBJECTIVE: This study aimed to examine the impact of the biosimilar market entry on the prices of the reference products in outpatient care in Finland, investigate the impact of biosimilar market entries on price competition among biological medicinal products, and examine how the prices and market shares of outpatient biosimilars have developed in Finland during 2009-2020. METHODS: This retrospective register study applied data from IQVIA covering national community pharmacy wholesale data between 1 January, 2009, and 31 August, 2020, for somatropin, epoetin, filgrastim, follitropin, insulin glargine, insulin lispro, etanercept, pegfilgrastim, adalimumab, teriparatide, and enoxaparin biosimilars and their reference products, in addition to two relevant insulin products. We determined the monthly wholesale amounts in defined daily doses and wholesale weighted average prices (excluding value-added tax) per defined daily dose for each product. We analyzed the evolution of the price and market shares. We performed a linear segmented regression analysis to examine the impact of the market entry of biosimilars on the prices of reference products. RESULTS: The prices of the reference products mainly decreased after the biosimilar entered the market. If the reference product price was not reduced, it was no longer reimbursable after evaluation under the Health Insurance Act, leading to marginal market shares. The changes in the prices of biosimilars were not as remarkable as the changes in the prices of reference products after the biosimilar market entry. For most active substances, biosimilar prices were stable or decreased. The utilization of biosimilars varied widely between different active substances at the end of the observation period. CONCLUSIONS: Changes in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future.

National and transnational drug shortages: a quantitative descriptive study of public registers in Europe and the USA.

BACKGROUND: Drug shortages are a growing global problem, posing clinical and economic challenges. To understand them better, we conducted an inventory of national public drug shortage registers and their comparability in Europe and the USA. METHODS: The study was based on openly accessible drug shortage notifications published by national drug authorities. These data were obtained from all national data sources mentioned on the European Medicines Agency's (EMA's) web page and FDA in the USA. After selection of the countries with comparable data, descriptive statistics were used to present characteristics of the shortages both across countries and within countries for 9 months (January-September) in 2020. We studied whether the shortages that occurred in these countries were the same, and how shortages were distributed by therapeutic uses and formulations. We also investigated price variation between the United States and Finland among drugs in shortage in one formulation category (creams and gels). RESULTS: Finland, Sweden, Norway, Spain, and the United States had suitable registers and were included. Altogether 5132 shortage reports from Finland (n = 1522), Sweden (n = 890), Norway (n = 800), Spain (n = 814), and the United States (n = 1106) were published during the study period. Of active ingredient level shortages 54% occurred in only one country, and 1% occurred in all five. However, at the country level, where there was one or more shortage notifications in an ATC active ingredient category, 19-41% were in a single country. The distributions by ATC therapeutic class and drug formulation differed substantially between countries, particularly between the USA and European countries. Injectables had a high shortage risk in the USA (57% of all shortages versus 17-31% of all shortages in the European countries). By contrast, shortages in gels and creams occurred only in European data (4-6% of all shortages). In the price comparison, creams and gels in shortage in Finland were 160% more expensive in the USA where these shortages were not detected. CONCLUSIONS: Public drug shortage registers are vital data sources for proactively maintaining and managing a reliable drug supply. However, our study demonstrates that much work remains to standardize the contents and quality of public register data. Shortages may not be solely a consequence of manufacturing disruptions but may reflect other contributing factors in the international drug distribution and supply mechanisms, including price differences and profit margins between national pharmaceutical markets. Data to perform practical and useful international comparisons to understand these shortages are required.

Risk assessment tools for QT prolonging pharmacotherapy in older adults: a systematic review.

PURPOSE: Many drugs are associated with the risk of QT prolongation and torsades de pointes (TdP), and different risk assessment tools (RATs) are developed to help clinicians to manage related risk. The aim of this systematic review was to summarize the evidence of different RATs for QT prolonging pharmacotherapy. METHODS: A systematic review was conducted using PubMed and Scopus databases. Studies concerning risk assessment tools for QT prolonging pharmacotherapy, including older adults, were included. Screening and selection of the studies, data extraction, and risk of bias assessment were undertaken. RESULTS: A total of 21 studies were included, involving different risk assessment tools. Most commonly used tools were risk scores (n = 9), computerized physician order entry systems (n = 3), and clinical decision support systems (n = 6). The tools were developed mainly for physicians and pharmacists. Risk scores included a high number of risk factors, both pharmacological and non-pharmacological, for QT prolongation and TdP. The inclusion of patients' risk factors in computerized physician order entry and clinical decision support systems varied. CONCLUSION: Most of the risk assessment tools for QT prolonging pharmacotherapy give a comprehensive overview of patient-specific risks of QT prolongation and TdP and reduce modifiable risk factors and actual events. The risk assessment tools could be better adapted to different health information systems to help in clinical decision-making. Further studies on clinical validation of risk assessment tools with randomized controlled trials are needed.