Bochenek Tomasz, Abilova Vafa, Alkan Ali, Asanin Bogdan, de Miguel Beriain Iñigo, Besovic Zeljka, Vella Bonanno Patricia, Bucsics Anna, Davidescu Michal, De Weerdt Elfi, Duborija-Kovacevic Natasa, Fürst Jurij, Gaga Mina, Gailīte Elma, Gulbinovič Jolanta, Gürpınar Emre U, Hankó Balázs, Hargaden Vincent, Hotvedt Tor A, Hoxha Iris, Huys Isabelle, Inotai Andras, Jakupi Arianit, Jenzer Helena, Joppi Roberta, Laius Ott, Lenormand Marie-Camille, Makridaki Despina, Malaj Admir, Margus Kertu, Marković-Peković Vanda, Miljković Nenad, de Miranda João L, Primožič Stanislav, Rajinac Dragana, Schwartz David G, Šebesta Robin, Simoens Steven, Slaby Juraj, Sović-Brkičić Ljiljana, Tesar Tomas, Tzimis Leonidas, Warmińska Ewa, Godman Brian
Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
Analytical Expertise Centre, Ministry of Health, Baku, Azerbaijan.
Front Pharmacol. 2018 Jan 18;8:942. doi: 10.3389/fphar.2017.00942. eCollection 2017.
Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.
在越来越多的国家，药品短缺已被认定为一个公共卫生问题。这可能会对患者护理的质量和效率产生负面影响，还会导致治疗成本增加以及医疗服务提供者的工作量加大。短缺问题也引发了伦理和政治问题。关于药品短缺的科学证据仍然匮乏，但可以从跨国分析中汲取许多经验教训。本研究的目的是描述、比较和评估当前一系列欧洲和西亚国家医疗保健系统内旨在预防或缓解药品短缺的系统性措施以及立法和组织框架。该研究设计为回顾性、横断面、描述性和观察性研究。通过向来自卫生部、国家药品机构、地方卫生当局、其他卫生或药品定价与报销当局、健康保险公司和学术机构的高级人员进行调查来收集信息，这些人员了解所研究的28个国家的药品市场情况。我们的研究发现，目前只有少数国家对药品短缺有正式定义。药品短缺的特征，包括其种类、持续时间、频率和动态变化，被发现是可变的，有时难以评估。已确定了众多信息中心。尽可能向公众提供药品短缺信息是对该问题进行更深入研究并找出解决方案的前提条件。施加公共服务义务、提供开具未获许可药品的正式可能性以及临时禁止平行出口是普遍采取的措施。我们研究的一个积极发现是确定了众多旨在预防或缓解药品短缺的自下而上的举措和组织框架。应仔细评估、监测并向更广泛的国际受众介绍从这些举措中汲取的经验和教训，以供认真评估。为了能够找到解决药品短缺问题的办法，迫切需要制定一套关于药品短缺的商定定义以及评估和监测方法。这一工作正在推进。
