Securing Europe's Drug Supply: How EDSForm is Addressing Medicine Shortages

The European Drug Shortages Formulary (EDSForm) project aims to tackle drug shortages across Europe. The initiative, which is led by the European Drug Shortages Formulary Working Party (EDSForm WP), provides pharmacists working in hospitals and community pharmacies with instructions on the preparation of unlicensed pharmaceuticals to mitigate the impact of drug shortages.

There are two main outputs from the project:

• EDSForm monographs, which outline the preparation and quality control of standardised unlicensed pharmaceutical preparations, that can be used as a substitute in the event of a shortage of essential licensed pharmaceuticals.
• Technical recommendations, which provide guidance on the preparation of unlicensed pharmaceutical preparations in cases where an appropriate EDSForm monograph is not available and there is an identified shortage of licensed pharmaceuticals.

The EDSForm WP has developed framework and procedure documents that define the content, purpose and use of the deliverables, as well as measures taken for their procurement, selection, drafting and maintenance processes. These documents were authorized by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and by the European Pharmacopoeia Commission (EPC) in 2024.

This approval is a major milestone for the EDSForm and paves the way for the development of the first seven EDSForm monographs: paracetamol (oral liquid), furosemide (solution for injection), metronidazole (oral solid), sulfamethoxazole and trimethoprim (oral liquid), amoxicillin (oral solid), methotrexate (concentrated solution for injection) and rifampicin (oral liquid).

In order to address current supply challenges, the EPC also endorsed a technical recommendation on sulfamethoxazole and trimethoprim.

Further information regardig this initiative can be found on the website of the EDQM.