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. 2025 Oct;10(10):e835-e847.
doi: 10.1016/S2468-2667(25)00194-X.

Changes in use and utilisation patterns of drugs with reported shortages between 2010 and 2024 in Europe and North America: a network cohort study

Marta Pineda-Moncusí  1 , Alexandros Rekkas  2 , Álvaro Martínez Pérez  3 , Angela Leis  4 , Carlos Lopez Gomez  5 , Eric Fey  6 , Erwin Bruninx  7 , Filip Maljković  8 , Francisco Sánchez-Sáez  9 , Jordi Rodeiro-Boliart  10 , Loretta Zsuzsa Kiss  11 , Michael Franz  12 , Miguel-Angel Mayer  13 , Neva Eleangovan  14 , Pau Pericàs Pulido  15 , Pantelis Natsiavas  16 , Selçuk Şen  17 , Steven Cooper  18 , Sulev Reisberg  19 , Katrin Manlik  20 , David Brendan Price  21 , Luca Moscetti  22 , Manon Merkelbach  23 , Mina Tadrous  24 , Nadav Rappoport  25 , Ravinder Claire  26 , Salvador Garcia-Torrens  27 , Daniel Prieto-Alhambra  28 , Peter R Rijnbeek  29 , Theresa Burkard  1 ; Drug Shortages EHDEN Study Group
Collaborators, Affiliations
Free article

Changes in use and utilisation patterns of drugs with reported shortages between 2010 and 2024 in Europe and North America: a network cohort study

Marta Pineda-Moncusí et al. Lancet Public Health. 2025 Oct.
Free article

Abstract

Background: Drug shortages can negatively impact patient care. We aimed to estimate the incidence and prevalence of use of medicines with shortages announced by the European Medicines Agency between January, 2013, and September, 2023, and to characterise the users of these drugs.

Methods: In this multinational network cohort study, we used routinely collected data from 52 databases across 18 European countries and the USA covering primary care, secondary care, health insurance claims, and disease registries. We included all participants with a minimum of 365 days of medical history between 2010 and 2024. We estimated annual incidence rates and period prevalence of use of medicines with a reported shortage (n=16), and their key alternatives (n=41). A reduction of 33% or more in incidence or prevalence after the shortage announcement was considered confirmation of a shortage. Additionally, we analysed changes in utilisation in terms of age, sex, indication, duration, and dosage.

Findings: Eight drugs had a 33% or higher reduction in incidence and nine drugs had a 33% or higher reduction in prevalence. Varenicline and amoxicillin (alone or combined with clavulanate) were the medicines affected in the highest number of countries and databases. Additionally, we observed changes in the indication of alteplase (pulmonary embolism indication increased in hospitals in Finland and Germany during the shortage period) and sarilumab (rheumatoid arthritis indication decreased in databases in the UK, Spain, Finland, and Sweden); and among incident users of sarilumab, a decrease in the cumulative dose was observed in databases in the Netherlands (from 84 mg in 2020 to 28 mg in 2023) and a reduction in treatment duration was observed in databases in Finland (from 104 days in 2020 to 1 day in 2022) and Belgium (from 71 days in 2020 to 30 days in 2022).

Interpretation: This study highlighted changes in incidence and prevalence of use of medicines after shortage announcements, and changes observed in patient care in terms of the indication, duration, or prescribed dose of medicines. Our findings showed that some reductions in use were observed across Europe and the USA, and others differed across countries. More research is needed to reduce the effects of drug shortages globally.

Funding: Innovative Medicines Initiative 2 Joint Undertaking.

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Conflict of interest statement

Declaration of interests DBP reports advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, and Teva Pharmaceuticals; consultancy agreements with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Viatris, and Teva Pharmaceuticals; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte) from AstraZeneca, Chiesi, Viatris, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and the UK National Health Service; payment for lectures or speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Inside Practice, GlaxoSmithKline, Medscape, Viatris, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme, and Teva Pharmaceuticals; payment for travel or accommodation or meeting expenses from AstraZeneca, Boehringer Ingelheim, Novartis, Medscape, and Teva Pharmaceuticals; owns 74% of the social enterprise Optimum Patient Care (Australia and UK) and 92·61% of Observational and Pragmatic Research Institute Pte (Singapore); is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. EB own Pfizer Shares. KM is a full-time employee of Bayer. MT has received consulting fees from Health Canada and CDA. PR works for a research group that received unconditional research grants from Chiese, GlaxoSmithKline, UCB, Amgen, Johnson and Johnson, European Medicines Agency, none of which relate the content of this manuscript. TB declares consultant for the Institut Biochimique SA. DPA received grants from Amgen, Chiesi-Taylor, Gilead, Lilly, Janssen, Novartis, and UCB Biopharma to their institution; has conducted consultancy work, with fees paid to his department from AstraZeneca; Janssen has funded training programmes organised by the department; and is a board member of the European Health Data and Evidence Network (EHDEN) Foundation. All other authors declare no competing interests. Views expressed are those of the authors and not their employers or funders.

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