Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries
Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
29403372
PubMed Central
PMC5779072
DOI
10.3389/fphar.2017.00942
Knihovny.cz E-zdroje
- Klíčová slova
- Europe, European Union, Western Asia, drug shortage, health care system, legislation, organizational framework, pharmaceutical policy,
- Publikační typ
- časopisecké články MeSH
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.
7th Respiratory Medicine Department Athens Chest Hospital Sotiria Athens Greece
Agency for Medicinal Products and Medicinal Devices Ljubljana Slovenia
Analytical Expertise Centre Ministry of Health Baku Azerbaijan
Chania General Hospital Crete Greece
Clalit Health Services Headquarters Tel Aviv Israel
Clinical Centre of Serbia Belgrade Serbia
CNAMTS Statutory Health Insurance for Salaried Workers Paris France
Croatian Health Insurance Fund Zagreb Croatia
Dentons Europe Dąbrowski i Wspólnicy sp k Warszawa Poland
Department of Drug Management Faculty of Pharmacy UBT Prishtina Albania
Department of Medicines Health Insurance Institute Ljubljana Slovenia
Department of Pathology Forensic Medicine and Pharmacology Vilnius University Vilnius Lithuania
Department of Pharmaceutical and Pharmacological Sciences KU Leuven Leuven Belgium
Department of Pharmacy University of Medicine Tirana Albania
Escola Superior de Tecnologia e Gestão Instituto Politécnico de Portalegre Portalegre Portugal
Estonian State Agency of Medicines Tartu Estonia
Graduate School of Business Administration Bar Ilan University Ramat Gan Israel
Health Department Bern University of Applied Sciences Bern Switzerland
Health Economics Centre Liverpool University Management School Liverpool United Kingdom
Institute of Orthopaedic Surgery Banjica Belgrade Serbia
Local Health Unit of Verona Veneto Region Verona Italy
Mechanism of Coordinated Access to Orphan Medicinal Products Brussels Belgium
Ministry of Health and Social Welfare Banja Luka Republic of Srpska Bosnia and Herzegovina
National Organization for Medicines Athens Greece
Norwegian Medicines Agency Oslo Norway
Panhellenic Association of Hospital Pharmacists Athens Greece
RG Chair in Law and the Human Genome University of the Basque Country Leioa Spain
School of Mechanical and Materials Engineering University College Dublin Dublin Ireland
State Agency of Medicines Riga Latvia
State Agency of Medicines Tartu Estonia
State Institute for Drug Control Prague Czechia
State Medicine Control Agency Vilnius Lithuania
Syreon Research Institute Budapest Hungary
Turkish Medicines and Medical Devices Agency Ankara Turkey
University Hospital of Psychiatry Zurich Zurich Switzerland
University Pharmacy Department of Pharmacy Administration Semmelweis University Budapest Hungary
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