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.

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.

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.

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.

Use of Computerized Physician Order Entry with Clinical Decision Support to Prevent Dose Errors in Pediatric Medication Orders: A Systematic Review.

BACKGROUND: Prescribing is a high-risk task within the pediatric medication-use process and requires defenses to prevent errors. Such system-centric defenses include electronic health record systems with computerized physician order entry (CPOE) and clinical decision support (CDS) tools that assist safe prescribing. The objective of this study was to examine the effects of CPOE systems with CDS functions in preventing dose errors in pediatric medication orders. MATERIAL AND METHODS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 criteria and Synthesis Without Meta-Analysis (SWiM) items. The study protocol was registered in PROSPERO (CRD42021277413). The final literature search on MEDLINE (Ovid), Scopus, Web of Science, and EMB Reviews was conducted on 10 September 2023. Only peer-reviewed studies considering both CPOE and CDS systems in pediatric inpatient or outpatient settings were included. Study selection, data extraction, and evidence quality assessment (JBI critical appraisal tool assessment and GRADE approach) were carried out by two individual reviewers. Vote counting method was used to evaluate the effects of CPOE-CDS systems on dose errors rates. RESULTS: A total of 17 studies published in 2007-2021 met the inclusion criteria. The most used CDS tools were dose range check (n = 14), dose calculator (n = 8), and dosing frequency check (n = 8). Alerts were recorded in 15 studies. A statistically significant reduction in dose errors was found in eight studies, whereas an increase of dose errors was not reported. CONCLUSIONS: The CPOE-CDS systems have the potential to reduce pediatric dose errors. Most beneficial interventions seem to be system customization, implementing CDS alerts, and the use of dose range check. While human factors are still present within the medication use process, further studies and development activities are needed to optimize the usability of CPOE-CDS systems.

Medication errors related to high-alert medications in a paediatric university hospital - a cross-sectional study analysing error reporting system data.

BACKGROUND: Paediatric patients are prone to medication errors, and only a few studies have explored errors in high-alert medications in children. The present study aimed to investigate the prevalence and nature of medication errors involving high-alert medications and whether high-alert medications are more likely associated with severe patient harm and higher error risk classification compared to other drugs. METHODS: This study was a cross-sectional report of self-reported medication errors in a paediatric university hospital in 2018-2020. Medication error reports involving high-alert medications were investigated by descriptive quantitative analysis to identify the prevalence of different drugs, Anatomical Therapeutic Chemical groups, administration routes, and the most severe medication errors. Crosstabulation and Pearson Chi-Square (χ2) tests were used to compare the likelihood of more severe consequences to the patient and higher error risk classification between medication errors involving high-alert medications and other drugs. RESULTS: Among the reported errors (n = 2,132), approximately one-third (34.8%, n = 743) involved high-alert medications (n = 872). The most common Anatomical Therapeutic Chemical subgroups were blood substitutes and perfusion solutions (B05; n = 345/872, 40%), antineoplastic agents (L01; n = 139/872, 16%), and analgesics (N02; n = 98/872, 11%). The majority of high-alert medications were administered intravenously (n = 636/872, 73%). Moreover, IV preparations were administered via off-label routes (n = 52/872, 6%), such as oral, inhalation and intranasal routes. Any degree of harm (minor, moderate or severe) to the patient and the highest risk classifications (IV-V) were more likely to be associated with medication errors involving high-alert medications (n = 743) when compared to reports involving other drugs (n = 1,389). CONCLUSIONS: Preventive risk management should be targeted on high-alert medications in paediatric hospital settings. In these actions, the use of intravenous drugs, such as parenteral nutrition, concentrated electrolytes, analgesics and antineoplastic agents, and off-label use of medications should be prioritised. Further research on the root causes of medication errors involving high-alert medications and the effectiveness of safeguards is warranted.

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.

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.

Dose error reduction software in medication safety risk management - optimising the smart infusion pump dosing limits in neonatal intensive care unit prior to implementation.

BACKGROUND: Smart infusion pumps with dose error reduction software can be used to prevent harmful medication errors. The aim of this study was to develop a method for defining and assessing optimal dosing limits in a neonatal intensive care unit's smart infusion pump drug library by using simulation-type test cases developed based on medication error reports. METHODS: This mixed-methods study applied both qualitative and quantitative methods. First, wrong infusion rate-related medication errors reported in the neonatal intensive care unit during 2018-2019 were explored by quantitative descriptive analysis and qualitative content analysis to identify the error mechanisms. The researchers developed simulation-type test cases with potential errors, and a literature-based calculation formula was used to set upper soft limits to the drug library. The limits were evaluated by conducting programming of pumps without errors and with potential errors for two imaginary test patients (1 kg and 3.5 kg). RESULTS: Of all medication errors reported in the neonatal intensive care unit, 3.5% (n = 21/601) involved an error or near-miss related to wrong infusion rate. Based on the identified error mechanisms, 2-, 5-, and 10-fold infusion rates, as well as mix-ups between infusion rates of different drugs, were established as test cases. When conducting the pump programming for the test cases (n = 226), no alerts were triggered with infusion rates responding to the usual dosages (n = 32). 73% (n = 70/96) of the erroneous 2-, 5-, and 10-fold infusion rates caused an alert. Mix-ups between infusion rates triggered an alert only in 24% (n = 24/98) of the test cases. CONCLUSIONS: Simulation-type test cases can be applied to assess the appropriateness of dosing limits within the neonatal intensive care unit's drug library. In developing the test cases, combining hospital's medication error data to other prospective data collection methods is recommended to gain a comprehensive understanding on mechanisms of wrong infusion rate errors. After drug library implementation, the alert log data and drug library compliance should be studied to verify suitability of dosing limits.

Integrating medication risk management interventions into regular automated dose dispensing service of older home care clients - a systems approach.

BACKGROUND: Automated dose dispensing (ADD) services have been implemented in many health care systems internationally. However, the ADD service itself is a logistic process that requires integration with medication risk management interventions to ensure safe and appropriate medication use. National policies and regulations guiding ADD in Finland have recommended medication reconciliation, review, and follow-up for suitable risk management interventions. This implementation study aimed to develop a medication management process integrating these recommended risk management interventions into a regular ADD service for older home care clients. METHODS: This study applied an action research method and was carried out in a home care setting, part of primary care in the City of Lahti, Finland. The systems-approach to risk management was applied as a theoretical framework. RESULTS: The outcome of the systems-based development process was a comprehensive medication management procedure. The medication risk management interventions of medication reconciliation, review and follow-up were integrated into the medication management process while implementing the ADD service. The tasks and responsibilities of each health care professional involved in the care team became more explicitly defined, and available resources were utilized more effectively. In particular, the hospital pharmacists became members of the care team where collaboration between physicians, pharmacists, and nurses shifted from parallel working towards close collaboration. More efforts are needed to integrate community pharmacists into the care team. CONCLUSION: The transition to the ADD service allows implementation of the effective medication risk management interventions within regular home care practice. These systemic defenses should be considered when national ADD guidelines are implemented locally. The same applies to situations in which public home care organizations responsible for services e.g., municipalities, purchase ADD services from private service providers.

What Severe Medication Errors Reported to Health Care Supervisory Authority Tell About Medication Safety?

OBJECTIVES: This study investigated severe medication errors (MEs) reported to the National Supervisory Authority for Welfare and Health (Valvira) in Finland and evaluated how the incident documentation applies to learning from errors. METHODS: This study was a retrospective document analysis consisting of medication-related complaints and authoritative statements investigated by Valvira in 2013 to 2017 (n = 58). RESULTS: Medication errors caused death or severe harm in 52% (n = 30) of the cases (n = 58). The majority (83%; n = 48) of the incidents concerned patients older than 60 years. Most likely, the errors occurred in prescribing (n = 38; 47%), followed by administration (n = 15; 19%) and monitoring (n = 14; 17%). The error process often included many failures (n = 24; 41%) or more than one health professional (n = 16; 28%). Antithrombotic agents (n = 17; 13%), opioids (n = 10; 8%), and antipsychotics (n = 10; 8%) were the therapeutic groups most commonly involved in the errors. Almost all error cases (91%; n = 53) were assessed as likely or potentially preventable. In 60% (n = 35) of the cases, the organization reported actions taken to improve medication safety after the occurrence of the investigated incident. CONCLUSIONS: Medication errors reported to the national health care supervisory authority provide a valuable source of risk information and should be used for learning from severe errors at the level of health care systems. High age remains a key risk factor to severe MEs, which may be associated with a wide range of medications including those not typically perceived as high-alert medications or high-risk administration routes. Despite being complex processes, the severe MEs have a great potential to lead to developing systems, processes, resources, and competencies of health care organizations.

Systemic Causes of In-Hospital Intravenous Medication Errors: A Systematic Review.

OBJECTIVES: Delivery of intravenous medications in hospitals is a complex process posing to systemic risks for errors. The aim of this study was to identify systemic causes of in-hospital intravenous medication errors. METHODS: A systematic review adhering to PRISMA guidelines was conducted. We searched MEDLINE (Ovid), Scopus, CINAHL, and EMB reviews for articles published between January 2005 and June 2016. Peer-reviewed journal articles published in English were included. Two reviewers independently selected articles according to a predetermined PICO tool. The quality of studies was assessed using the GRADE system and the evidence analyzed using qualitative content analysis. RESULTS: Eleven studies from six countries were included in the analysis. We identified systemic causes related to prescribing (n = 6 studies), preparation (n = 6), administration (n = 6), dispensing and storage (n = 5), and treatment monitoring (n = 2). Administration, prescribing, and preparation were the process phases most prone to systemic errors. Insufficient actions to secure safe use of high-alert medications, lack of knowledge of the drug, calculation tasks, failure in double-checking procedures, and confusion between look-alike, sound-alike medications were the leading causes of intravenous medication errors. The number of the included studies was limited, all of them being observational studies and graded as low quality. CONCLUSIONS: Current intravenous medication systems remain vulnerable, which can result in patient harm. Our findings suggest further focus on medication safety activities related to administration, prescribing, and preparation of intravenous medications. This study provides healthcare organizations with preliminary knowledge about systemic causes of intravenous medication errors, but more rigorous evidence is needed.

Systemic Defenses to Prevent Intravenous Medication Errors in Hospitals: A Systematic Review.

OBJECTIVES: Intravenous medication delivery is a complex process that poses systemic risks of errors. The objective of our study was to identify systemic defenses that can prevent in-hospital intravenous (IV) medication errors. METHODS: A systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted. We searched MEDLINE (Ovid), Scopus, CINAHL, and EMB reviews for articles published between January 2005 and June 2016. Peer-reviewed journal articles published in English were included. Two reviewers independently selected articles according to a predetermined PICO tool. The quality of studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation system, and the evidence was analyzed using qualitative content analysis. RESULTS: Forty-six studies from 11 countries were included in the analysis. We identified systemic defenses related to administration (n = 24 studies), prescribing (n = 8), preparation (n = 6), treatment monitoring (n = 2), and dispensing (n = 1). In addition, 5 studies explored defenses related to multiple stages of the drug delivery process. Systemic defenses including features of closed-loop medication management systems appeared in 61% of the studies, with smart pumps being the defense most widely studied (24%). The evidence quality of the included articles was limited, as 83% were graded as low quality, 13% were of moderate quality, and only 4% were of high quality. CONCLUSIONS: In-hospital IV medication processes are developing toward closed-loop medication management systems. Our study provides health care organizations with preliminary knowledge about systemic defenses that can prevent IV medication errors, but more rigorous evidence is needed. There is a need for further studies to explore combinations of different systemic defenses and their effectiveness in error prevention throughout the drug delivery process.

Safety, time and cost evaluation of automated and semi-automated drug distribution systems in hospitals: a systematic review.

OBJECTIVES: To systematically review automated and semi-automated drug distribution systems (DDSs) in hospitals and to evaluate their effectiveness on medication safety, time and costs of medication care. METHODS: A systematic literature search was conducted in MEDLINE Ovid, Scopus, CINAHL and EMB Reviews covering the period 2005 to May 2016. Studies were included if they (1) concerned technologies used in the drug distribution and administration process in acute care hospitals and (2) reported medication safety, time and cost-related outcomes. RESULTS: Key outcomes, conclusions and recommendations of the included studies (n=30) were categorised according to the dispensing method: decentralised (n=19 studies), centralised (n=6) or hybrid system (n=5). Patient safety improved (n=27) with automation, and reduction in medication errors was found in all three systems. Centralised and decentralised systems were reported to support clinical pharmacy practice in hospitals. The impact of the medication distribution system on time allocation such as labour time, staffing workload or changes in work process was explored in the majority of studies (n=24). Six studies explored economic outcomes. CONCLUSIONS: No medication distribution system was found to be better than another in terms of outcomes assessed in the studies included in the systematic review. All DDSs improved medication safety and quality of care, mainly by decreasing medication errors. However, many error types still remained-for example, prescribing errors. Centralised and hybrid systems saved more time than a decentralised system. Costs of medication care were reduced in decentralised systems mainly in high-expense units. However, no evidence was shown that implementation of decentralised systems in small units would save costs. More comparable evidence on the benefits and costs of decentralised and hybrid systems should be available. Changes in processes due to a new DDS may create new medication safety risks; to minimise these risks, training and reallocation of staff resources are needed.

Facilitators and barriers in implementing medication safety practices across hospitals within 11 European Union countries

BACKGROUND: The study was carried out as part of the European Network for Patient Safety (EUNetPas) project in 2008-2010. OBJECTIVE: To investigate facilitators and barriers in implementation process of selected medication safety practices across hospitals within European Union countries. METHODS: This was an implementation study of seven selected medication safety practices in 55 volunteering hospitals of 11 European Union (EU) member states. The selected practices were: two different versions of medicine bed dispensation; safety vest; discharge medication list for patients; medication reconciliation at patient discharge; medication reconciliation at patient admission and patient discharge, and sleep card. The participating hospitals submitted an evaluation report describing the implementation process of a chosen practice in their organisation. The reports were analysed with inductive content analysis to identify general and practice-specific facilitators and barriers to the practice implementation. RESULTS: Altogether 75 evaluation reports were submitted from 55 hospitals in 11 EU member states. Implementation of the medication safety practices was challenging and more time consuming than expected. The major reported challenge was to change the work process because of the new practice. General facilitators for successful implementation were: existence of safety culture, national guidelines and projects, expert support, sufficient resources, electronic patient records, interdisciplinary cooperation and clinical pharmacy services supporting the practice implementation. CONCLUSIONS: The key for the successful implementation of a medication safety practice is to select the right practice for the right problem, in the right setting and with sufficient resources in an organization with a safety culture

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Strategies for improving medication safety in hospitals: Evolution of clinical pharmacy services.

BACKGROUND: Medication safety risks are the most important preventable factors jeopardizing patient safety. To manage these risks, extending pharmacists' involvement in patient care and patient safety work has been systematically addressed in patient safety initiatives since the early 2000s. OBJECTIVE: To explore the extent and range of clinical pharmacy services in Finnish hospitals to promote medication safety: 1) in 2011, when the first National Patient Safety Strategy, the new Health Care Act and the Medicines Policy 2020 had been recently enacted; and 2) five years later in 2016. METHODS: The study was conducted in 2011 and 2016 as a national online survey targeted to hospital pharmacies (n = 24) and medical dispensaries (n = 131 in 2011; n = 28 in 2016). The questions were analyzed using descriptive statistics and qualitative content analysis. RESULTS: Overall response rate was 60% in 2011 and 52% in 2016. Clinical pharmacy services were provided by 51% of the responding units in 2011, whereas by 85% in 2016. The reported number of clinical pharmacists had increased during the five years. The most notable increase in reported tasks occurred in conducting medication reconciliations (+63% increase in the number of providing units). By 2016 pharmacists had extended their tasks particularly towards system-based medication safety work: e.g. developing instructions for medication-use (91% of the responding units), creating and updating medication safety plans (87%) and using medication error reports in developing the process of medication use safer (78%). Pharmacists' participation in long-term continuing education became more common in 2016, which was perceived as helpful in extending their responsibilities to improve medication safety. CONCLUSION: Pharmacists' involvement in patient care and system-based medication safety work was reported to become more common in Finnish hospitals during 2011-2016. This development is in line with patient safety policy initiatives and its impact on patient care outcomes should be followed up.

Facilitators and barriers in implementing medication safety practices across hospitals within 11 European Union countries.

BACKGROUND: The study was carried out as part of the European Network for Patient Safety (EUNetPas) project in 2008-2010. OBJECTIVE: To investigate facilitators and barriers in implementation process of selected medication safety practices across hospitals within European Union countries. METHODS: This was an implementation study of seven selected medication safety practices in 55 volunteering hospitals of 11 European Union (EU) member states. The selected practices were two different versions of medicine bed dispensation; safety vest; discharge medication list for patients; medication reconciliation at patient discharge; medication reconciliation at patient admission and patient discharge, and sleep card. The participating hospitals submitted an evaluation report describing the implementation process of a chosen practice in their organisation. The reports were analysed with inductive content analysis to identify general and practice-specific facilitators and barriers to the practice implementation. RESULTS: Altogether 75 evaluation reports were submitted from 55 hospitals in 11 EU member states. Implementation of the medication safety practices was challenging and more time consuming than expected. The major reported challenge was to change the work process because of the new practice. General facilitators for successful implementation were existence of safety culture, national guidelines and projects, expert support, sufficient resources, electronic patient records, interdisciplinary cooperation and clinical pharmacy services supporting the practice implementation. CONCLUSIONS: The key for the successful implementation of a medication safety practice is to select the right practice for the right problem, in the right setting and with sufficient resources in an organization with a safety culture.

Inter-rater reliability of medication error classification in a voluntary patient safety incident reporting system HaiPro in Finland.

BACKGROUND: Medication errors are common in healthcare. Medication error reporting systems can be established for learning from medication errors and risk prone processes, and their data can be analysed and used for improving medication processes in healthcare organisations. However, data reliability testing is crucial to avoid biases in data interpretation and misleading findings informing patient safety improvement. OBJECTIVE: To assess the inter-rater reliability of medication error classifications in a voluntary patient safety incident reporting system (HaiPro) widely used in Finland, and to explore reported medication errors and their contributing factors. METHOD: The data consisted of medication errors (n = 32 592), including near misses, reported by 36 Finnish healthcare organisations in 2007-2009. The reliability of the original classifications was tested by an independent researcher reclassifying a random sample of errors (1%, n = 288) based on narratives. The inter-rater reliability of agreement (κ) of the classifications was calculated to describe the degree of conformity between the researcher and the original data classifiers. Descriptive statistics were used to describe the medication errors. RESULTS: The inter-rater reliability between the researcher and the original data classifiers was acceptable (κ ≥ 0.41) in 11 of 42 (26%) medication error classes. Thus, these errors could be pooled from different healthcare units for the exploration of medication errors at the level of all reporting organisations. Contributing factors were identified in 48% (n = 137) of the medication error narratives in the random sample (n = 288). The most commonly reported errors were dispensing errors (34%, n = 10 906), administration errors 25% (n = 7972), and documentation errors 17% (n = 5641). CONCLUSIONS: The data classified by different classifiers can be pooled for some of the medication error classes. Consistency of the classification and the quality of narratives need improvement, as well as reporting and classification of contributing factors to provide high quality information on medication errors.

How to make medication error reporting systems work--Factors associated with their successful development and implementation.

This study explored factors associated with successful development and implementation of medication error reporting (MER) systems in different healthcare contexts. A descriptive online questionnaire comprising of structured and open-ended questions was responded to by 16 medication safety experts in 16 countries. The present paper describes the rich and multidimensional qualitative data from the experts' narratives from open-ended questions. Several factors related to the national context of MER systems, i.e., the operational environment, were identified to impact successful development and implementation of these systems. The factors were: awareness of deficiencies in medication safety at local and national levels to justify the need for MER systems; gaining political will for the development and implementation actions together with international and governmental support; creating or reforming legislation and national regulations, guidelines and strategies to support MER; allocation of adequate human and financial resources; establishment of an organisation or centre to coordinate and lead MER; and extending systems approach and safety culture to all parts of the operational environment to facilitate openness on and learning from medication errors. In conclusion, operational environments of MER systems must be constructed to support functionality of these systems, and need to be improved in many countries.