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      Drug shortages in European countries: a trade-off between market attractiveness and cost containment?

      research-article
      , , ,
      BMC Health Services Research
      BioMed Central
      Drug shortage, Drug supply, Health policy

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          Abstract

          Background

          Drug shortages are a global problem. While extensively studied in the United States, numbers about drug shortages in European countries are scarce. This study aims to collect and present data about drug shortages in European countries.

          Methods

          A reporting template for the collection of data about drug shortages was designed based on a literature search. Countries offering a reporting system for drug shortages such as Belgium, the Netherlands, England, Italy, France, Germany and Spain were included in this study. Data about the characteristics of the drugs in shortage and the causes of the shortage were collected from publicly available online reporting systems. Descriptive analyses were performed.

          Results

          Drug shortages included in the considered reporting systems can be characterized as branded, oral drugs that affect different disease domains. When considering essential medicines and oncology drugs, generic injectables are more involved. Causes for drug shortages are largely underreported. In case the cause is known, production problems take the lead.

          Conclusions

          Reporting of drug shortages in Europe needs to be standardized and more transparency about the reasons for drug shortage is required to investigate the problem. A link between production problems and market attractiveness and market capacity is recognized to be at the root of drug shortages in U.S. Such insights are highly lacking in Europe. Monitoring of the effect of national and European health policies on the sustainability of the drug market is required to present fundamental solutions and to tackle the problem of drug shortages in Europe.

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          Most cited references15

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          Shortages of medicines: a complex global challenge.

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            Economic and technological drivers of generic sterile injectable drug shortages.

            Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration's (FDA's) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to "push the envelope" on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.
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              Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?

              To explore the current status (2010) of tendering programs for outpatient pharmaceuticals in the European countries and how these programs operate. A survey was designed to assess the features of tendering programs in European countries. All 27 countries of the European Union plus Norway were included in the study. The survey was sent to national representatives of authorities and organizations and to academic researchers with expertise in the domain. Nineteen of the 28 countries have responded to the questionnaire (68%). Seven countries have adopted tendering programs for pharmaceuticals in ambulatory care. Tendering was more popular in countries with a mature generic medicines market (54%) than in countries with a developing generic medicines market (12.5%). A legal basis, criteria to grant the tender, the number of winners and the duration of the tender were amongst the features for the program to work. Tendering programs can achieve savings in the short term. There are however some problems allied with the policy and the effects in the long term are still unclear. It can be concluded that the policy can work, but the features of the programs have to be well-thought-out. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
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                Author and article information

                Contributors
                Kim.Pauwels@pharm.kuleuven.be
                Isabelle.Huys@pharm.kuleuven.be
                Minne.Casteels@med.kuleuven.be
                Steven.Simoens@pharm.kuleuven.be
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                26 September 2014
                26 September 2014
                2014
                : 14
                : 1
                : 438
                Affiliations
                KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Onderwijs en Navorsing 2, Herestraat 49, P.O. Box 521, 3000 Leuven, Belgium
                Article
                3515
                10.1186/1472-6963-14-438
                4263120
                25257912
                98d52951-ac0c-4931-9bbf-bcb9713bfcde
                © Pauwels et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 18 December 2013
                : 18 September 2014
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2014

                Health & Social care
                drug shortage,drug supply,health policy
                Health & Social care
                drug shortage, drug supply, health policy

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