Systemic solutions, legislative and organisational frameworks aimed to prevent or mitigate drug shortages in European countries

Abstract

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.