Abstract
IntroductionWhile 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.MethodologyA 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.ResultsThe 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.ConclusionThe 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.
Highlights
While medicine shortages are complex, their mitigation is more of a challenge
The findings here indicate that five European countries have defined acts addressing shortages, which require risk-assessment implementation should a medicine shortage occur
Acosta et al, 2019 reported numerous publications addressing multiple aspects of shortages in Europe, including their mitigation (Acosta et al, 2019), our findings show that 22 (64.7%) of all survey participants were unaware of any published governmental or non-governmental documents on applied risk assessment dedicated to shortages in their respective country
Summary
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 across healthcare settings. Shortages of medicines have been on the rise globally this century (Gray and Manasse, 2012; American Society of Health-System Pharmacists, 2014; The Society of Hospital Pharmacists of Australia, 2017; Root, 2018; Miljkovic et al, 2019; Videau et al, 2019). Due to their multifaceted nature, there are currently over 26 definitions of medicine shortages from manufacturers, wholesalers, regulators, and healthcare providers (De Weerdt et al, 2015; Fox and McLaughlin, 2018). It is necessary to distinguish several risks emerging from shortages: 1) its occurrence; 2) treatment unavailable to the patient; and
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