Overview of the causes and management of drug shortages in the United States and in Hungary

Abstract

Drug shortages are a multifactorial international concern that is increasingly reported all over the world. A continuously rising number of cases could be observed since 2001, but the issue is particularly significant since 2009. In Hungary, the same increasing tendency was observed; while in 2012 464 shortages occurred, in 2020 1466 cases were reported. According to the Food and Drug Administration, there are three root causes behind the shortages, but several factors can be derived from them. This paper aims at conducting a comprehensive review of literature, exploring these factors in detail and thereby explaining how each of these factors contributes to shortages. Furthermore, it will illustrate how the lack of sufficient information due to an imperfect warning system also contributes to the issue. As the problem affects every stakeholder in the supply chain from patients to Marketing Authorisation Holders, each party should be involved in the development and implementation of mitigating strategies that can provide the basis of policy measures. The article highlights how international trends both in terms of affected therapeutic areas and causes of shortages are reflected in the Hungarian markets; therefore similar approaches could be adapted to tackle the issue domestically and deliver enduring solutions.