The European Drug Shortages Formulary (EDSForm) project plays a key role in the EDQM’s efforts to address medicine shortages in Europe. With work led by the European Drug Shortages Formulary Working Party (EDSForm WP), the aim of the project is to provide guidance for hospital and community pharmacists on preparing unlicensed pharmaceutical preparations for use during medicine shortages, both ongoing and potential. The EDSForm WP (Terms of reference) focusses on two distinct types of deliverables to support this initiative:
EDSForm monographs that provide methods for the preparation and quality control of standardised unlicensed pharmaceutical preparations to be used as a temporary replacement for essential but potentially unavailable licensed medicines.
EDSForm WP technical recommendations for the preparation (when considered appropriate) of extemporaneous or stock unlicensed pharmaceutical preparations to be used during active shortages of licensed medicines for which there is no suitable EDSForm monograph.
Framework and procedure documents have been issued by the EDSForm WP for each of these two deliverables. They outline the content, aim and use of the deliverables and the steps taken for their sourcing, selection, drafting and maintenance, respectively.
This set of documents was approved by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) at its 20th plenary meeting in October 2024, and by the European Pharmacopoeia Commission (EPC) at its 180th session in November 2024.
This is a major step forward that opens a new chapter for the EDSForm project, with work to commence immediately on the first seven Formulary monographs that have already been identified by the EDSForm WP experts during their initial priorisation work:
- paracetamol, oral liquid
- furosemide, solution for injection
- metronidazole, oral solid
- sulfamethoxazole and trimethoprim, oral liquid
- amoxicillin, oral solid
- methotrexate, concentrated solution for injection
- rifampicin, oral liquid
The EPC also approved the addition of a technical recommendation on sulfamethoxazole and trimethoprim, oral liquid products to the work programme, both to cover current needs and to address supply difficulties observed for these products.