Measures to manage, reduce and prevent medicines shortages in European countries in 2020. (30th September 2020)

• Record Type: Journal Article
• Authors: Vogler, S; Fischer, S
• Is Part Of: European journal of public health. Volume 30:Number 5(2020)
• Publication Date: 2020-09-30
• Subjects: Epidemiology -- Europe -- Periodicals; Public health -- Europe -- Periodicals; 362.109405
• DOI: 10.1093/eurpub/ckaa165.1054
• Languages: English
• ISSNs: 1101-1262

Abstract

Abstract: Background: Several countries have seen an increase in medicines shortages that constitute a major public health threat as they can negatively impact the health outcomes of patients. The study aims to survey measures that European countries apply or consider introducing to address medicines shortages. Methods: A questionnaire was sent to the public authorities, as involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, in 47 countries, thereof 44 countries of the WHO European region. Respondents were asked to report measures in place or being discussed as of the first quarter of 2020. Results: Preliminary data from 8 countries (Albania, Austria, Finland, Germany, Italy, the Netherlands, Romania, Sweden; further responses are expected) show that national registers to which manufacturers notify, usually on a mandatory basis, upcoming and existing shortages (including end dates and causes in some countries) are common (all countries but Albania). Medicine reserve supplies that have to be kept for defined medicines exist in Albania and Finland; they are being established the Netherlands and are under discussion in Germany and Sweden. Finland and Italy allow issuing export bans for targeted medicines; this possibility is before implementation in Austria, was planned and then withdrawn in Romania and is under discussion in the other countries (except Albania). Further measures include simplified import permits (with patient information leaflets in foreign language), working groups with relevant stakeholders and financial sanctions for manufacturers in case of non-supply. Conclusions: Governments have been reacting to shortages by implementing appropriate measures and adapting existing ones. Actions taken differ with regard to stakeholders addressed, the degree of obligation and the focus (optimising the management of existing shortages vs. prevention of future supply limitations). Key messages: A mix of measures to address medicine shortages is applied in European countries. Recently, the number of measures increased, and actions requested from stakeholders tend to have become mandatory.