(B-059) The impact of drug shortages in the use of medicines across 52 real-world data sources in 19 countries in Europe and North America

Monday, August 25, 2025

11:30 AM - 1:00 PM ET

Presenting Author(s)

MP

Marta Pineda-Moncusi

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom

Co-Author(s)

EB

Edward Burn

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom
CT

Carmen Olga Torre

Real Wold Data Sciences, Roche Products Ltd, United Kingdom
JR

Jordi Rodeiro-Boliart

Impact and prevention of mental disorders, Sant Joan de Déu Research Institute (IRSJD), Spain
DD

Daniel Dedman

Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, UK, United Kingdom
JP

Jaime Poquet-Jornet

Head of Pharmacy Department. Hospital of Denia. Denia (Alicante). Spain, Spain
AR

Alexandros Rekkas

Institute of Applied Biosciences, Center for Research and Technology Hellas, Thessaloniki, Greece, Greece
LB

Laurent Boyer

CEReSS-Health Services Research and Quality of Life Center, Aix-Marseille University, AP-HM, France, France
FS

Francisco Sanchez-Saez

Foundation for the Promotion of Health and Biomedical Research in the Valencian Community, Spain
Fredrik Nyberg, Prof.

School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden
TJ

Tim Jansen

Dept of Rheumatology, VieCuri MC, Venlo, Netherlands, Netherlands
KM

Katrin Manlik

Bayer AG, Pharmaceuticals, Global Medical & Evidence, Berlin, Germany, Germany
LK

Loretta Kiss

Institute for Clinical Data Management, Semmelweis University, Budapest, Hungary, Hungary
AV

Annelies Verbiest

Department of medical oncology, University Hospital Antwerp, Belgium, Belgium
AL

Angela Leis

Research Programme on Biomedical Informatics, Hospital del Mar Research Institute, Barcelona, Spain, Spain
NR

Nadav Rappoport

Software and Information Systems Engineering, Ben-Gurion University of the Negev, ISRAEL, Israel
EH

Elisa Henke

Institute for Medical Informatics and Biometry, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany, Germany
FM

Filip Maljković

Heliant, Belgrade, Serbia, Serbia
FM

Franz Michael

Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Center of Health Data Science, Germany
PP

Pau Pericàs Pulido

Health Research Institute of the Balearic Islands, Spain
MS

Máté Szilcz

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden, Sweden
JE

Jelle Evers

Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, the Netherlands, Netherlands
SK

Sara Khalid

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom
MT

Mina Tadrous, PhD

University of Toronto, Canada
RS

Reut Sherman Yackob

Deputy Director of Pharmacy Services at the Galilee Medical Center, Nahariya, Israel., Israel
�M

Álvaro Martínez Pérez

La Fe Health Research Institute, Valencia, Spain, Spain
LM

Luca Moscetti

Oncology and Haemathology Department, University Hospital Modena, Italy, Italy
GG

Gianluigi Galli

Scientific Direction - Clinical Trial Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy, Italy
AR

Ana Rodrigues

EpiDoc Unit, NOVA Medical School, Comprehensive Health Research Center (CHRC), Universidade NOVA de Lisboa, Lisbon, Portugal, Portugal
SC

Steven Cooper

Optimum Patient Care Ltd, Cambridge, United Kingdom, United Kingdom
HS

Hadas Shachaf

Bnai Zion Medical Center, Pharmacy department,Israel, Israel
S�

Selçuk Şen

Division of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye, Turkey
CE

Caroline Eteve-Pitsaer

Director of Analytics, Cegedim Health Data, France, France
RN

Raeleesha Norris

InGef - Institute for Applied Health Research Berlin GmbH, Berlin, Germany, Germany
PR

Peter R. Rijnbeek

Department of Medical Informatics Erasmus MC University Medical Center, Netherlands
DP

Daniel Prieto-Alhambra

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom
TB

Theresa Burkard

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom

Background: Shortage of medicines continues to be a major concern and has proven to impact patient care and cause harm.

Objectives: To investigate the impact of reported shortages on patient treatment utilization across 19 countries in Europe and the US between 2010 and 2024.

Methods: This multinational (n=52) cohort study used the OMOP common data model to analyse 52 databases from 18 European countries and the US, including disease registries, primary and secondary care. We measured the annual incidence and prevalence of use of 16 drugs that were confirmed to be in shortage for more than a year by the European Medicine Agency, and 41 alternative drugs. We considered a ≥33% drop in incidence or prevalence after the shortage announcement as a confirmation of impact of the shortage. We also examined changes in patients’ demographics (sex and age at therapy initiation), treatment indication, duration, and dosage.

Results: Among the 16 drugs with a reported shortage, varenicline and amoxicillin (alone and combined with clavulanate) showed a ≥33% drop in incident and prevalent use in many databases (up to 13 and 22, respectively) after their shortage announcements in July 2021 and January 2023, respectively.
Varenicline use declined across most primary care databases, even though the ≥33% threshold was not reached everywhere. Concurrently, numerous databases showed an increased use of nicotine supplements, an alternative treatment, after July 2021. Following varenicline’s shortage announcement, we observed a decline in the cumulative dose in a Dutch primary care database, with the median dose dropping from 84 mg to 28 mg between 2020 and 2023; and a decline in the initial quantity dispensed in Swedish nationwide patient registries, dropping from 112 to 56 tablets between 2021 and 2022. Additionally, treatment duration shortened from 104 to 1 day in a secondary care data from Finland and from 71 to 30 days in a national insurance data from Belgium between 2020 and 2022.
Amoxicillin use dropped sharply before its shortage announcement in 2020, during the COVID-19 pandemic, but rose again in 2022, potentially leading to its shortage in 2023. When examining alternative antibiotics prescribed for common infections, azithromycin showed the most prominent increase in use corresponding with the decline in amoxicillin usage. No apparent changes in patient characteristics or drug use were observed for amoxicillin users.

Conclusions: Shortages altered medication use at the population level, affecting both incidence and prevalence, and led to changes in duration, and initial and cumulative dose . The same shortage impact varied across countries, and not all reported shortages caused substantial changes in use. how this information can be used to predict or mitigate the impact of drug shortages.