SYSTEMIC SOLUTIONS, LEGISLATIVE AND ORGANIZATIONAL FRAMEWORKS AIMED TO PREVENT OR MITIGATE DRUG SHORTAGES IN EUROPEAN COUNTRIES

Author(s)

Bochenek T1, Godman BB2, Bucsics A3, De Weerdt E4, Fürst J5, Gailite E6, Hotvedt TA7, Huys I4, Inotai A8, Joppi R9, Malaj A10, Margus K11, Marković-Peković V12, Simoens S4, Slaby J13, Sović Brkičić L14, Gürpınar EU15, Vella Bonanno P16, Warminska EJ17, Pilc A18
1Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland, 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK, 3University of Vienna, Vienna, Austria, 4KU Leuven, Leuven, Belgium, 5ZZZS (Health Insurance Institute of Slovenia), Ljubljana, Slovenia, 6State Agency of Medicines, Riga, Latvia, 7Norwegian Medicines Agency, Oslo, Norway, 8Syreon Research Institute, Budapest, Hungary, 9Local Health Unit of Verona – Veneto Region, Verona, Italy, 10University of Medicine Tirana, Tirane, Albania, 11Estonian State Agency of Medicines, Tartu, Estonia, 12Ministry of Health and Social Welfare, Banja Luka, Republic of Srpska, Bosnia and Herzegovina, 13State Institute for Drug Control, Prague, Czech Republic, 14Croatian Health Insurance Fund, Zagreb, Croatia, 15Turkish Medicines and Medical Devices Agency, Ankara, Turkey, 16, Mellieha, Malta, 17, Warsaw, Poland, 18Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland

OBJECTIVES: The shortages of medicines have become an issue in many countries. This negatively impacts on the quality and efficiency of the care of patients. The scientific evidence regarding drug shortages in terms of their extent and rationale is still scarce. The goal of this study was to characterize, compare and evaluate potential solutions and legislative frameworks which exist within health care systems across a range of European countries, aimed at preventing or mitigating drug shortages. METHODS: The survey was distributed among national health authority and health insurance company experts knowledgeable of the European pharmaceutical markets. It included questions pertaining to: 1) general characteristics of drug shortages; 2) alertness on drug shortages and description of information systems; 3) public service obligations; 4) regulations associated with the problem of drug shortages. RESULTS: The findings are based on feedback from 16 European countries. In the majority of countries formal definitions of drug shortages currently don’t exist. Shortages have occurred in all countries throughout the last decade and have typically been increasing. The types of medicines experiencing shortages are generally well recognized, however the frequency and duration of shortages are varied and unpredictable. The notification-related obligations of Marketing Authorization Holders in cases which could lead to drug shortages exist in almost all countries. At least one institution per country is involved in national reporting system but access to information is often limited to the public. In the majority of countries, there exist formal obligations associated with supplying medicines to cover patients’ needs so as not to compromise patient care. A few countries have attempted to limit parallel exports to cope with drug shortages. CONCLUSIONS: Drug shortages have become an increasingly important public health problem. Its characteristics varies across the European countries. Several lessons can be drawn based on a collective international experience.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP34

Topic

Economic Evaluation, Health Policy & Regulatory, Health Service Delivery & Process of Care, Real World Data & Information Systems

Topic Subcategory

Approval & Labeling, Cost/Cost of Illness/Resource Use Studies, Health & Insurance Records Systems, Hospital and Clinical Practices, Prescribing Behavior, Pricing Policy & Schemes

Disease

Multiple Diseases

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