Drug shortages are a complex, global challenge. When they occur, treatments are delayed, or patients have to take alternative remedies which may not be as suitable for them.
In the worst cases, drug shortages cause deaths. People die as they wait for a treatment or as they react badly to an alternative therapy.
The causes for shortages vary. They can be due to a sudden drop in supply, or a surge in demand. For instance, during the winters of 2022 and 2023 in the northern hemisphere, shortages of medicines like antibiotics and painkillers for respiratory infections occurred because there was a high amount of respiratory viruses in circulation. This rise in infections probably happened because, after years of social distancing and other anti-COVID measures, our bodies were exposed to less pathogens and therefore lost immunity.
Shortages can also be caused by manufacturing issues, a lack of raw materials, quality problems or delivery issues, and can be exacerbated by variations in health system structures across borders, including differences in procurement processes and other logistical factors.
While some of these issues are difficult to avoid, there are potential solutions for others. If more information was available and predictions of shortages could be made, strategies could be defined and rolled out in time to help mitigate them.
Robust real-world data provides fresh insights
The European Health Data and Evidence Network (EHDEN), which started out as an IMI project, has harmonised over 350 million pseudonymised health records to the OMOP common data model, making robust real world data available to answer key questions for health research.
A recently published study used EHDEN to assess the impact of drug shortages on patient care across Europe and North America.
The study analysed data on the incidence and prevalence of medicine use after shortage announcements, focusing on 16 drugs, and found that eight drugs saw a 33% drop in incidence and nine drugs had a 33% or higher drop in prevalence.
“With more than 50 data partners and many European countries represented, this study is the largest real world evidence study ever conducted,” says Daniel Prieto Alhambra of the University of Oxford and Erasmus MC, who was one of the senior authors of the study.
“This study demonstrates the value of the EHDEN network and the public-private partnership to improve preparedness and health resilience by leveraging real world data from many healthcare settings to inform the impact of drug shortages on patient care.”
Complex use patterns following shortages worldwide
While for some drugs a shortage caused a global reduction in use, other drug shortages had varying impacts depending on the country and healthcare setting. The study found that some shortages resulted in an observed increase in the use of alternative treatments, but for others this wasn’t the case.
Sometimes, other drugs were repurposed to address the shortage which subsequently led to a shortage in the repurposed drug. For instance, sarilumab was repurposed to fight COVID-19 during the pandemic, which led to a rise in demand. But the existing production capacity wasn’t great enough to fulfil this demand, leading to a shortage. This affected COVID-19 patients, but it also meant that patients who used sarilumab for its original use, against rheumatoid arthritis, had to go without or use alternative therapies.
Studies like this one are important to understand the impact that drug shortages have, and this study shows that drug shortages result in complex changes in the use of drugs worldwide.
The data from this study can be used in future analyses to help predict drug shortages and design appropriate strategies to combat, mitigate or prevent them. In fact, the DARWIN EU initiative is currently using real-world data – including data partners included in EHDEN – to forecast future shortages of antibiotics, which could help to mitigate potential shortages.
EHDEN was supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.
Definitions Box
Incidence in drug use: Refers to the number of patients who begin taking a drug within a specific time period.
Prevalence in drug use: Refers to the total proportion of a population who use a drug (including both new and existing cases) within a specific time period.
OMOP Common Data Model: A standard for observational healthcare data. If data is harmonised to this model, then standardised analytics can be applied to answer research questions at scale.
Varnicline: A drug used to reduce nicotine addiction.
Amoxicillin: An antibiotic used widely to treat bacterial infections including ear infections, throat infections, pneumonia and more.