Global study shows drug shortages can become a systemic issue for millions

In the largest study of its kind, new global research has revealed that drug shortages can become a systemic issue affecting the health of millions of patients and impacting health care systems in Europe and North America.

Drug shortages are a complex worldwide challenge that are not just an inconvenience to patients but can cause significant harm. When vital medicines are unavailable, patients’ health is at risk from treatment failure or delays, being prescribed less effective alternatives, or even missing out on care altogether. This can lead to worsening illnesses, complications, or higher health care costs.

The World Health Organization (WHO) has called drug shortages a global health challenge that requires urgent action and the European Medicines Agency (EMA) keeps a catalog of medicine shortages.

In collaboration with other global institutes, a research team from the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford—co-lead by Theresa Burkard and Marta Pineda-Moncusí—analyzed real-world health care data from 52 large databases covering over 600 million people. They looked at the use of 57 medicines, including antibiotics, cancer treatments, and therapies for chronic illnesses.

Pineda-Moncusí, lead researcher of the new study published in The Lancet Public Health said, “Monitoring of drug shortages is essential to evaluate and mitigate their impact on patient care. While the EMA keeps records of medicines in short supply, we wanted to go further and understand how these shortages translated into changes in medicine use across Europe and North America. Our question was whether drug shortages resulted in drops in the rate and overall level of use of medicines, or whether they led to changes in usage patterns and treatment purposes.”

The study found that some shortages affected nearly all countries, while others varied in intensity, leading to drops in incidence and prevalence of use, or changes in drug utilization and indication.

The key findings:

• Shortages were linked to sharp drops in medicine use—in some cases by more than a third.
• Commonly used drugs such as amoxicillin (an antibiotic) and varenicline (a treatment to stop smoking) saw major declines in availability.
• Some medicines were used differently during shortages—for example, sarilumab, a treatment for arthritis, was redirected for use in COVID-19 patients, leaving many chronic disease patients with fewer options.
• In certain cases, alternative medicines filled the gap, such as nicotine replacement therapies when varenicline was unavailable. But in many situations, no good replacement was observed, raising concerns for patient safety.

EHDEN led the creation of a unique network of more than 200 European data sources from 29 countries with data mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model. This enabled federated analytics to run across multiple geographies and health care settings, revealing the most complete picture to date on the impact of drug shortages on patient care in Europe and North America.

Prof Peter Rijnbeek from Erasmus MC, coordinator of the EHDEN project, mentioned, “This study demonstrates how data standardization enables evidence generation an unprecedented scale. Hard work does pay off. I look forward to all the insights the EHDEN network can produce in the future to improve patient care.”

Pineda-Moncusí added, “Because medicine supply chains are global, shortages in one country often spill over into others. The impact for patients can be devastating on their health. Our use of large-scale health data can help health providers identify problems faster, guide smarter policies to forecast demand, encourage safe and effective alternatives, strengthen supply chains and to prioritize vulnerable patients when shortages do occur.”