EHDEN Megastudy – Characterisation of medicines with suggested drug shortages
Shortages of essential medicines are becoming an increasingly tangible challenge for European healthcare systems, with direct effects on patient safety and continuity of care.
As part of the EHDEN, a European project established with the aim of creating a federated network of health data in Europe, standardized according to the OMOP Common Data Model, a study was conducted to better understand this phenomenon. The study was open to all data partners in the network and included three Italian centres supported by Biomeris: University Hospital of Parma, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico in Milan and Fondazione IRCCS Istituto Nazionale dei Tumori in Milan.
The aim was to analyse the use of medicines subject to shortages between 2010 and 2023, both at the population level and at the individual patient level, considering therapeutic indication, treatment duration, dosage, and available alternatives.
The results show that several medicine shortages were associated with substantial reductions in use: eight medicines experienced a ≥33% decrease in incidence and nine a comparable reduction in prevalence. Varenicline and amoxicillin (alone or in combination with clavulanate) were among the most affected, in terms of the number of countries and databases involved. Changes in clinical practice were also observed, including variations in therapeutic indications, prescribed doses, and treatment duration.
Overall, the results published in The Lancet Public Health highlight a heterogeneous impact of medicine shortages across countries and underline the need for further research to mitigate their effects at a global level.
References:
- Pineda-Moncusí, Marta, et al. “Changes in use and utilisation patterns of drugs with reported shortages between 2010 and 2024 in Europe and North America: a network cohort study.” The Lancet Public Health 10.10 (2025): e835-e847. (link)
