EDQM initiatives regarding medicine shortages
Medicine shortages continue to threaten European healthcare systems, resulting in discontinuity of care and increasing costs. This problem predates 2020 but has been exacerbated by the consequences of the COVID-19 pandemic and an unstable geopolitical situation. Multiple ongoing initiatives have been set up worldwide to tackle shortages at every level of the pharmaceutical supply chain.
Hospital and community pharmacists are on the frontline of efforts to mitigate the consequences of medicine shortages. In some situations, extemporaneous and stock preparations can be a temporary solution. The European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC) have therefore launched two distinct but closely related projects designed to help ensure the availability of safe pharmaceutical preparations of appropriate quality, in close co-ordination with other initiatives undertaken by international partners. Full information on this can be found on the EDQM’s dedicated web page.
Methodological guide to select medicines at risk of shortage
This project is designed to give national competent authorities (NCAs) and healthcare professionals guidance on the identification and selection of medicines that may be in short supply in public health emergencies and can be prepared as standardised stock preparations. It is co-ordinated by the CD-P-PH and will be carried out with the support of a dedicated working group consisting of experts from relevant health authorities or institutions dealing with medicine shortages at national level, healthcare professionals’ associations and academia. A call for experts to establish the working group was launched in November 2023 and the project kick-off meeting is scheduled for early 2024.
Co-ordination and co-operation with international and European partners active in this area will be essential to success, notably to avoid duplication of effort.
European Drug Shortages Formulary
The European Drug Shortages Formulary (EDSForm) will be a separate compilation of non-mandatory texts that is freely available online. The monographs will describe methods for the preparation and quality control of standardised, unlicensed pharmaceutical preparations that can be used as a temporary replacement for licensed medicines should they be unavailable. Such unlicensed formulations prepared by pharmacies will help mitigate the consequences of shortages of licensed medicinal products.
The EPC has successfully set up a dedicated working party for this initiative (EDSForm WP), consisting of 19 experts and one chair, representing 11 member states. The EDSForm WP kick-off meeting was held in February 2024, with the initial priority task of creating a set of rules and working procedures to guide the compilation and drafting of the EDSForm. In addition to its proactive work on the formulary, the WP will provide ad hoc technical guidance on unlicensed pharmaceutical preparations that could be used to mitigate ongoing shortages of critical medicines.
