EDQM initiatives regarding medicine shortages
Medicine shortages continue to disrupt European healthcare systems, undermining patient care and escalating costs. While this issue has long been a concern, the consequences of the COVID-19 pandemic and ongoing geopolitical instability have exacerbated the situation. Co-ordinated global efforts are urgently needed to address vulnerabilities throughout the pharmaceutical supply chain.
Pharmacists, both in hospital and community settings, play a critical role in mitigating the impact of these shortages. In certain situations, extemporaneous and stock preparations offer temporary relief from supply disruptions. To this end, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC) have initiated two complementary projects aimed at safeguarding 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
The availability of a reliable methodological guide is crucial for helping healthcare professionals and national authorities identify and select medicines at risk of shortage that can be substituted by standardised stock preparations manufactured in pharmacies. The objective is to provide a last resort option when there is a shortage of licensed medicines in order to ensure continuity of care for patients.
Co-ordinated by the CD-P-PH, this project is conducted by a dedicated expert working group composed of representatives from national authorities, professional healthcare associations and academia. Their mission is to draft the methodological guide. International co-operation is key to the success of this effort, as harmonising strategies and avoiding duplication of work will maximise the impact of this initiative. The project’s kick-off meeting, held in September 2024, was led by a clinical pharmacy expert nominated by the French National Competent Authority.
European Drug Shortages Formulary
The European Drug Shortages Formulary (EDSForm) will be an essential tool to support healthcare professionals in managing the impact of medicine shortages. Freely accessible online, it will provide a compilation of non-mandatory texts (monographs) describing methods for the preparation and quality control of standardised, unlicensed pharmaceutical preparations that can be used as a temporary replacement for licensed medicines during shortages. By enabling pharmacists to produce these alternatives, the formulary will help mitigate the consequences of critical medicine shortages and ensure continuity of care for patients.
The EPC 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 held its kick-off meeting in February 2024, focusing on creating a set of rules and working procedures to guide the formulary’s compilation. In addition to creating this important resource, the working party will also provide ad hoc technical guidance on unlicensed pharmaceutical preparations to address ongoing shortages, further contributing to the resilience of healthcare systems.
