Medicine shortages are a growing problem that compromises patient care. Two key committees at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC), are working together to alleviate shortages through establishing guidelines on the use of unlicensed pharmaceutical preparations prepared in pharmacies. These preparations have already proven to be an effective tool during specific medicine shortages in some countries.
The initiative consists of two recently launched projects.
- “Methodological guide for selecting essential 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.
A call for experts to establish the working group in charge of elaborating the Methodological guide will be launched soon and more details will be communicated to interested parties in due course. Experts will be nominated via the NCAs representing their member states in the CD-P-PH. To ensure alignment and avoid duplication of effort, targeted stakeholders and other working groups and authorities active in medicine shortages at European level, such as the Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) and the Structured dialogue initiative on security of medicines supply led by the EU Commission, will also be invited to nominate representatives.
- European Drug Shortages Formulary
This initiative has been set up to compile monographs detailing preparation and testing of unlicensed pharmaceutical preparations that can fill the gap left when licensed medicinal products are unavailable.
The nomination of experts to elaborate the formulary has already begun. The corresponding working party (EDSForm WP) will be tasked with establishing the rules and working methods for the European Drug Shortage Formulary and developing the monographs themselves. These monographs will be drafted to prepare for potential future medicine shortages and, in specific cases, could also be developed to provide immediate, real-time support in an ongoing shortage.
The EPC is therefore seeking interested qualified professionals with expertise in:
- development and production of pharmaceutical extemporaneous and stock preparations;
- analytical procedures related to quality control of ingredients (APIs and excipients) and pharmaceutical preparations and their development.
Professionals interested in joining the European Pharmacopoeia’s community of experts are invited to consult the Terms of reference for EDSForm WP experts (see the relevant section of the Terms of reference and profile for members of groups of experts and working parties). It is essential that the candidates have access to the laboratory facilities needed to verify proposed production methods or analytical procedures to develop and verify the monographs before their launch.
Full details on how to apply are available on the EDQM web page Join the Network.
More details on the new EDQM initiatives on medicine shortage issues will follow shortly.