Drug shortages in European countries: a trade-off between market attractiveness and cost containment?

Abstract

Background: Drug shortages are a global problem. While extensively studied in the United States, numbers about drug shortages in European countries are scarce. This study aims to collect and present data about drug shortages in European countries.

Methods: A reporting template for the collection of data about drug shortages was designed based on a literature search. Countries offering a reporting system for drug shortages such as Belgium, the Netherlands, England, Italy, France, Germany and Spain were included in this study. Data about the characteristics of the drugs in shortage and the causes of the shortage were collected from publicly available online reporting systems. Descriptive analyses were performed.

Results: Drug shortages included in the considered reporting systems can be characterized as branded, oral drugs that affect different disease domains. When considering essential medicines and oncology drugs, generic injectables are more involved. Causes for drug shortages are largely underreported. In case the cause is known, production problems take the lead.

Conclusions: Reporting of drug shortages in Europe needs to be standardized and more transparency about the reasons for drug shortage is required to investigate the problem. A link between production problems and market attractiveness and market capacity is recognized to be at the root of drug shortages in U.S. Such insights are highly lacking in Europe. Monitoring of the effect of national and European health policies on the sustainability of the drug market is required to present fundamental solutions and to tackle the problem of drug shortages in Europe.

Figure 1

Reporting template for drug shortages.

Figure 2

Proportion of reported shortages per country. n = 161.

Figure 3

Proportion of reported drugs per Anatomic Therapeutic Chemical Class. Drugs classified in the group “other” include antiparasitic products, insecticides and repellents, products for the respiratory system, products for the sensory organs, drugs affecting blood and blood forming organs and dermatologicals. These are all grouped for the sake of clarity. n = 161.

Figure 4

Proportion of the reported drugs per cause for drug shortages. The proportion of drugs per cause is shown for a) overall drugs (n = 171), b) essential drugs (n = 200) and c) oncology drugs (n = 71).

Figure 5

Proportion of the reported drugs per route of administration. The proportion of drugs per route of administration is shown for a) overall drug (n = 671), b) essential drugs (n = 200) and c) oncology drugs (n = 71).