Clinical, Economic and Policy Implications of Drug Shortages in the European Union.

Drug shortages are an international problem, which seems to worsen. In this paper, the clinical, economic and policy implications of drug shortages are discussed, based on data available for the EU. Research on the clinical impact is scarce. Most data describe that patients will experience more side effects or need to postpone their treatment. However, more detailed research such as case studies and the number of patients affected are lacking. Information on the economic impact is described as an estimation of the time spent by hospital pharmacies. Other stakeholders are also burdened: manufacturers loose part of their profit, patients may pay more for the alternative treatment and society pays for additional health-care costs. However, no data are available. Again more detailed and objective research is necessary to know where the problem is situated and how solutions can be proposed. Policy implications are also rather scarce. However, once more detailed and objective research has been conducted, policy changes will follow. All stakeholders should be involved in the discussions, prior to the implementation of policy measures.