Trends of use of drugs with suggested shortages and their alternatives across 52 real world data sources and 18 countries in Europe and North America

Importance Drug shortages leave affected patients in a vulnerable position. Objective To describe incidence and prevalence of use for medicines with suggested shortages in at least one European country, as announced by the European Medicines Agency, and to characterise the users of these drugs including the indication of use, duration of use, and dosage. Design We performed a descriptive cohort study from 2010 and up to 2024 in a network of databases which have mapped their data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). Setting Settings: included primary care, secondary care, claims and various disease registries. Participants We included all patients with at least 365 days of history on the database. Exposures All medicines with a suggested shortage in at least one European country for more than 365 days (n=18). We also assessed their key alternatives (n=39). Main outcomes and measures We estimated annual incidence rates and period prevalence. A drop in incidence or prevalence of >33% after the shortage was announced was considered confirmation of a shortage. Results Among 52 databases from Europe and the United States, we observed shortages according to decreased incidence of use for 8 drugs and shortages according to prevalence of use for 9 drugs. The drugs varenicline and amoxicillin alone or plus clavulanate were in shortage in the most number of countries. Conclusion and relevance We compiled and analysed data of annual incidence and prevalence of use plus information on patient characteristics, indication, and dose for 57 medicines among 52 databases in Europe and the United States between 2010 and 2024. We detected shortages and observed a change in the users’ characteristics for several drugs. We have described timely real-world scenarios of drug shortages and those unobserved in various health care settings and countries which helps to better understand how drug shortages play out in real life.