Pauwels Kim, Huys Isabelle, Casteels Minne, Simoens Steven
KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Onderwijs en Navorsing 2, Herestraat 49, P,O, Box 521, 3000 Leuven, Belgium.
BMC Health Serv Res. 2014 Sep 26;14:438. doi: 10.1186/1472-6963-14-438.
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.
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.
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.
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.
药品短缺是一个全球性问题。虽然在美国已对此进行了广泛研究，但欧洲国家药品短缺的数据却很稀少。本研究旨在收集并展示欧洲国家药品短缺的数据。
基于文献检索设计了一个用于收集药品短缺数据的报告模板。本研究纳入了提供药品短缺报告系统的国家，如比利时、荷兰、英国、意大利、法国、德国和西班牙。从公开可用的在线报告系统中收集了短缺药品的特征及短缺原因的数据，并进行了描述性分析。
纳入所考虑报告系统的药品短缺可被描述为影响不同疾病领域的品牌口服药。在考虑基本药物和肿瘤药物时，更多涉及的是普通注射剂。药品短缺的原因大多报告不足。若原因已知，生产问题占主导。
欧洲药品短缺的报告需要标准化，并且需要提高药品短缺原因的透明度以调查该问题。在美国，人们认识到生产问题与市场吸引力和市场容量之间的联系是药品短缺的根源。而在欧洲，这种见解非常缺乏。需要监测国家和欧洲卫生政策对药品市场可持续性的影响，以提出根本解决方案并解决欧洲的药品短缺问题。
