Prospective risk assessment of medicine shortages in Europe and Israel : findings and implications

Miljković, Nenad and Godman, Brian and Kovačević, Milena and Polidori, Piera and Tzimis, Leonidas and Hoppe-Tichy, Torsten and Saar, Marika and Antofie, Ioan and Horvath, Laszlo and De Rijdt, Thomas and Vida, Róbert György and Kkolou, Elena and Preece, David and Tubić, Biljana and Peppaard, Joan and Martinez, Alicia and Yubero, Cristina Garcia and Haddad, Ratiba and Rajinac, Dragana and Zelić, Pavle and Jenzer, Helena and Tartar, Franci and Gitler, Gunda and Jeske, Martina and Davidescu, Michal and Beraud, Guillaume and Kuruc-Poje, Darija and Haag, Kristine Sakstrup and Fischer, Hanne and Sviestina, Inese and Ljubojević, Gordana and Markestad, Anne and Vujić-Aleksić, Vesna and Nežić, Lana and Crkvenčić, Anica and Linnolahti, Johanna and Ašanin, Bogdan and Duborija-Kovačević, Nataša and Bochenek, Tomasz and Huys, Isabelle and Miljković, Branislava (2020) Prospective risk assessment of medicine shortages in Europe and Israel : findings and implications. Frontiers in Pharmacology, 11. 357. ISSN 1663-9812

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Abstract

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.