EDQM initiatives on 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 events related to 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 negative effect of medicines shortages. In some situations, extemporaneous and stock preparations can provide a temporary solution.
The European Committee on Pharmaceutical and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC) at the European Directorate for the Quality of Medicines & HealthCare (EDQM), in synergy with the current array of initiatives, are conducting two distinct but closely related projects designed to help ensure the availability of safe pharmaceutical preparations of appropriate quality. The EDQM will provide the secretariat for these initiatives, which are intended to give member states and healthcare professionals the knowledge and tools they need to provide the healthcare services people require in a timely manner.
Objective: Support national competent authorities and healthcare professionals in the identification and selection of medicines that can be in short supply during public health emergencies and that can be prepared in hospital (and/or community) pharmacies.
Terms of reference for the “Methodological guide to select medicines at risk of shortages”
European Drug Shortages Formulary
Objective: Publish a formulary, a compilation of texts (monographs) describing methods for the preparation and quality control of standardised unlicensed pharmaceutical preparations that could be used as a temporary replacement for potentially unavailable, essential licensed medicines.
The EPC has launched a call for experts to compose a dedicated working party for this initiative: the Working Party on the European Drug Shortage Formulary (WP EDSForm).
It will validate the composition of this WP at its next session,
Terms of reference for the European Drug Shortage Formulary Working Party
- EMA Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
- EMA “Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use”
- CDBIO Equitable access in scarce resources: Equity in healthcare
- HMA “Availability of medicinal products for human use” – Best-practice in EU member states
- EU Commission Structured dialogue on security of medicines supply
- CHESSMEN “Coordination and Harmonisation of the Existing Systems against Shortages of Medicines” EU Joint Action to mitigate medicine’s shortages