Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

INTRODUCTION: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. METHODOLOGY: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. RESULTS: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. CONCLUSION: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Drug change: 'a hassle like no other'. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel.

BACKGROUND: Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting. METHOD: Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held. RESULTS: The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety. CONCLUSION: DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

A national drug related problems database: evaluation of use in practice, reliability and reproducibility.

BACKGROUND: A drug related problems database (DRP-database) was developed on request by clinical pharmacists. The information from the DRP-database has only been used locally e.g. to identify focus areas and to communicate identified DRPs to the hospital wards. Hence the quality of the data at the national level is unknown, which may compromise national analyses for benchmarking and identification of national focus areas. OBJECTIVE: The aim of the study was to evaluate the use in practice, reliability and reproducibility of the DRPs documented in the Danish drug related problems database. SETTING: Danish hospital pharmacies. METHODS: Practice use of the DRP-database was explored by an electronic questionnaire distributed to hospital pharmacies, and consisted of questions regarding current and previous use of the DRP-database. The reliability was evaluated by comparing the categorization of 24 cases by clinical pharmacists with categorization performed by the project group. Reproducibility was explored by re-categorization of a sample of existing records in the DRP-database by two project group members individually. MAIN OUTCOME MEASURES: Observed proportion of agreement and Fleiss' kappa as measures of inter-rater reliability and reproducibility. RESULTS: The practice use study of 12 hospital pharmacy locations revealed that when implementing the DRP-database, the majority of identified DRPs are documented in the DRP-database, however, some variations throughout the country exist. The interrater reliability study of 34 clinical pharmacists showed high inter-rater reliability with the project group (Fleiss' kappa = 0.79 with 95 % CI (0.70; 0.88)), and the reproducibility study also documented high inter-rater reliability of a sample of 379 records from the DRP-database re-categorized by two project group members (Fleiss' kappa = 0.81 with 95 % CI (0.78; 0.85)). CONCLUSION: The study showed high reliability and reproducibility of the DRP-database, however, some local variation in the use of the DRP-database throughout the country existed affecting the overall quality. These findings indicate that data in the DRP-database may be pooled, and national analyses may be conducted to explore development areas for common interest.

Characterization of drug-related problems identified by clinical pharmacy staff at Danish hospitals.

BACKGROUND: In 2010, a database of drug related problems (DRPs) was implemented to assist clinical pharmacy staff in documenting clinical pharmacy activities locally. A study of quality, reliability and generalisability showed that national analyses of the data could be conducted. Analyses at the national level may help identify and prevent DRPs by performing national interventions. OBJECTIVE: The aim of the study was to explore the DRP characteristics as documented by clinical pharmacy staff at hospital pharmacies in the Danish DRP-database during a 3-year period. SETTING: Danish hospital pharmacies. METHOD: Data documented in the DRP-database during the initial 3 years after implementation were analyzed retrospectively. The DRP-database contains DRPs reported at hospitals by clinical pharmacy staff. The analyses focused on DRP categories, implementation rates and drugs associated with the DRPs. MAIN OUTCOME MEASURE: Characteristics of DRPs. RESULTS: In total, 72,044 DRPs were documented in the DRP-database during the first 3 years of implementation, and the number of documented DRPs increased every year. An overall stable implementation rate of approximately 58 % was identified. The DRPs identified were multi-facetted, however evenly distributed for each of the 3 years. The most frequently identified DRP categories were: "Dose", followed by "Nonadherence to guidelines" and "Supplement to treatment". The highest implementation rates were found for the following DRP categories: "Non-adherence to guidelines" (79 %) followed by "Therapeutic duplication" (73 %) and "Dosing time and interval" (70 %). Even though the top 25 drugs were involved in 58 % of all DRPs, multiple drugs were associated with DRPs. The drugs most frequently involved in DRPs were paracetamol (4.6 % of all DRPs), simvastatin (3.0 %), lansoprazole (2.7 %), morphine (2.6 %) and alendronic acid (2.4 %). CONCLUSIONS: The study found that a national database on DRPs contained multi-facetted DRPs, however evenly distributed for each of the 3 years. Even though the top 25 drugs were involved in 58 % of all DRPs, multiple drugs were associated with DRPs. The study emphasizes the importance of detecting and intervening for DRPs.