Abstract
The problem of drug shortages has been reported worldwide, gaining prominence in multiple domains and several countries in recent years. The aim of the study was to analyze, characterise and assess this problem in Belgium and France, while also adopting a wider perspective from the European Union. A qualitative methodological approach was employed, including semi-structured interviews with the representatives of respective national health authorities, pharmaceutical companies and wholesalers, as well as hospital and community pharmacists. The research was conducted in early 2014. Four themes, which were identified through the interviews, were addressed in the paper, i.e. a) defining drug shortages, b) their dynamics and perception, c) their determinants, d) the role of the European and national institutions in coping with the problem. Three groups of determinants of drug shortages were identified throughout this study: manufacturing problems, distribution and supply problems, and problems related to economic aspects. Currently, the Member States of the European Union are striving to resolve the problem very much on their own, although a far more focused and dedicated collaboration may well prove instrumental in coping with drug shortages throughout Europe more effectively. To the best of the authors’ knowledge, this is the first qualitative study to investigate the characteristics, key determinants, and the problem drivers of drug shortages, focusing on this particular group of countries, while also adopting the European Union’s perspective.
Highlights
Drug shortages have been reported for several years, it is only recently that the reports seem to be gaining prominence in several classes of medicines and in multiple countries [1,2,3,4]
Four interviewees were from the pharmaceutical companies, four represented the wholesale distributors and four represented the pharmacies
Should be construed as drug shortages having increased over time was denied by some stakeholders
Summary
Drug shortages have been reported for several years, it is only recently that the reports seem to be gaining prominence in several classes of medicines and in multiple countries [1,2,3,4]. For the purpose of this study, drug shortages were defined as a situation in which the current or projected demand of a medicine at user level is inadequately met. Their origins are complex, diverse and differ among regions and countries [6,7,8]. A non-exhaustive list of causes for drug shortages was provided recently by Birgli’s research, including those stemming from both unpredictable and predictable reasons [6]. The second group of reasons comprises: product discontinuation, industry consolidation (mergers and acquisitions), limited manufacturing capacity, just-in-time inventories, rationing/quotas, deliberate shortages used to manipulate prices, market shifts, launches of new competitors, new formulations, or patent expiry
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