Safeguarding against critical medicines’ shortage

Access to essential medicines is on the decline in Europe and this is having a harmful impact on patient health by increasing mortality, adverse events and therapy errors. A number of national and international initiatives have been undertaken to address these shortages, and since 2016, the European Medicines Agency (EMA) has published a public catalogue of medicines under surveillance due to shortages in more than one European country.

In response to this important issue, EHDEN, in collaboration with multiple partners, has launched a study being led by Oxford University entitled: Incidence, prevalence and characterisation of medicines with suggested drug shortages in Europe. Of the seventy EHDEN Data Partners (including EHDEN EFPIA Partners) from nineteen countries that expressed interest in participating, twenty-nine have so far submitted preliminary results. This initiative aims to be the largest observational database study conducted across Europe in terms of the number of databases and geographic representation.

The sharing of anonymous data standardised to a common data model (OMOP) being provided by a diverse and federated European network such as EHDEN enables a faster, more generalisable and complete picture of drug shortages in Europe. The study research began in Q4 2023. It comprises data from the period 2010 – 2023 and includes twenty-five medicines that have been subject to shortages during this time period.

The process: The feasibility step started in November 2023 (databases are first checked to see if they have information on the medicines of interest). The code analysing incidence and prevalence of the medicines is based on an existing package for standardised analytics and will be released soon. The code to characterise patients who have used medicines in shortage is expected to be released in the spring. A webinar with all participants will be planned for June and a study-a-thon to write up the research for September.


“The results of this study will improve our understanding of drug shortages in routine healthcare delivery by showing trends over time, as well as patient characteristics, including treated indications, treatment duration, and dose. The ultimate goal of the findings is to help European efforts to monitor and safeguard the use of critical medicines as part of the global fight against medicine shortages.”

Marta Pineda Moncusi

Postdoctoral Health Data Scientist, Pharmaco- and Device Epidemiology Group, NDORMS, University of Oxford

“The scope of this study is unprecedented. It speaks to the value of a federated data network such as EHDEN that brings together standardised real world data from such a broad and diverse range of data sources across Europe.”

Theresa Burkard

Postdoctoral Data Scientist, Pharmaco- and Device Epidemiology Group, NDORMS, University of Oxford

“This study demonstrates how impactful the EHDEN project truly is. It would not have been possible to run a study at this scale without the efforts of many in the EHDEN consortium that played a significant role in the standardisation of all these data sources to the OMOP CDM via our open calls, those that worked on methods and tools, and our fantastic project management team.”

Professor Peter Rijnbeek

Coordinator of the EHDEN project