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

Nenad Miljković, Brian Godman, Milena Kovačević, Piera Polidori, Leonidas Tzimis, Torsten Hoppe-Tichy, Marika Saar, Ioan Antofie, Laszlo Horvath, Thomas De Rijdt, Róbert György Vida, Elena Kkolou, David Preece, Biljana Tubić, Joan Peppaard, Alicia Martinez, Cristina Garcia Yubero, Ratiba Haddad, Dragana Rajinac, Pavle ZelićHelena Jenzer, Franci Tartar, Gunda Gitler, Martina Jeske, Michal Davidescu, Guillaume Beraud, Darija Kuruc-Poje, Kristine Sakstrup Haag, Hanne Fischer, Inese Sviestina, Gordana Ljubojević, Anne Markestad, Vesna Vujić-Aleksić, Lana Nežić, Anica Crkvenčić, Johanna Linnolahti, Bogdan Ašanin, Nataša Duborija-Kovačević, Tomasz Bochenek, Isabelle Huys, Branislava Miljković

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3 Citations (Scopus)

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.
Original languageEnglish
Article number357
Number of pages14
JournalFrontiers in Pharmacology
Volume11
DOIs
Publication statusPublished - 26 Mar 2020

Keywords

  • medicine shortage
  • risk assessment
  • mitigation strategy
  • substitution
  • Europe

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