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      A Qualitative Approach to a Better Understanding of the Problems Underlying Drug Shortages, as Viewed from Belgian, French and the European Union’s Perspectives

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          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.

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          Most cited references 14

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          Impact of drug shortages on U.S. health systems.

          A study was performed to quantify the personnel resources required to manage drug shortages, define the impact of drug shortages on health systems nationwide, and assess the adequacy of information resources available to manage drug shortages. An online survey was sent to the 1322 members of the American Society of Health-System Pharmacists who were identified as directors of pharmacy. Survey recipients were asked to identify which of the 30 most recent drug shortages listed affected their health system, to identify actions taken to manage the shortage, and to rate the impact of each shortage. Employees responsible for completing predefined tasks were identified, and the average time spent by each type of employee completing these tasks was estimated. Labor costs associated with managing shortages were calculated. A total of 353 respondents completed the survey, yielding a response rate of 27%. Pharmacists and pharmacy technicians spent more time managing drug shortages than did physicians and nurses. There was a significant association between the time spent managing shortages and the size of the institution, the number of shortages managed, and the institution's level of automation. Overall, 70% of the respondents felt that the information resources available to manage drug shortages were not good. The labor costs associated with managing shortages in the United States is an estimated $216 million annually. A survey of directors of pharmacy revealed that labor costs and the time required to manage drug shortages are significant and that current information available to manage drug shortages is considered suboptimal.
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            ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems.

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              Causes of drug shortages in the legal pharmaceutical framework.

              Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages.

                Author and article information

                Role: Academic Editor
                PLoS One
                PLoS ONE
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                5 May 2015
                : 10
                : 5
                [1 ]Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland
                [2 ]Chair of Epidemiology and Preventive Medicine, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland
                [3 ]Department of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland
                York University, CANADA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: PB TB A. Prokop A. Pilc. Performed the experiments: PB TB A. Prokop. Analyzed the data: PB TB A. Prokop. Contributed reagents/materials/analysis tools: PB TB A. Prokop. Wrote the paper: TB PB A. Prokop A. Pilc.

                ‡ These authors also contributed equally to this work.


                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

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                Figures: 2, Tables: 1, Pages: 20
                The authors have no support or funding to report.
                Research Article
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