| アブストラクト | 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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| 投稿者 | Pineda-Moncusi, Marta; Rekkas, Alexandros; Martinez Perez, Alvaro; Leis, Angela; Lopez Gomez, Carlos; Fey, Eric; Bruninx, Erwin; Maljkovic, Filip; Sanchez-Saez, Francisco; Rodeiro-Boliart, Jordi; Zsuzsa Kiss, Loretta; Franz, Michael; Mayer, Miguel-Angel; Eleangovan, Neva; Pulido, Pau Pericas; Natsiavas, Pantelis; Sen, Selcuk; Cooper, Steven; Reisberg, Sulev; Manlik, Katrin; Price, David Brendan; Moscetti, Luca; Merkelbach, Manon; Tadrous, Mina; Rappoport, Nadav; Claire, Ravinder; Garcia-Torrens, Salvador; Prieto-Alhambra, Daniel; Rijnbeek, Peter R; Burkard, Theresa |
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| 組織名 | Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences,;Centre for Statistics in Medicine, University of Oxford, Oxford, UK.;Institute of Applied Biosciences, Centre for Research and Technology, Hellas,;Greece.;Joint Research Unit on ICT Applied to the Reengineering of Socio-Healthcare;Processes, The Health Research Institute Hospital La Fe, Valencia, Spain.;Research Programme on Biomedical Informatics, Hospital del Mar Research;Institute, Barcelona, Spain.;Big Data, AI, Biostatistics, and Bioinformatics Platform, The Health Research;Institute Hospital La Fe, Valencia, Spain.;iCAN Digital Precision Cancer Medicine Flagship, University of Helsinki and;Helsinki University Hospital, Helsinki, Finland.;Medical Affairs Department, Pfizer, Brussels, Belgium.;Heliant, Belgrade, Serbia.;Health Services Research and Pharmacoepidemiology Unit, FISABIO, Valencia, Spain;;Department of Applied Statistics and Operational Research, and Quality,;Universitat Politecnica de Valencia, Valencia, Spain.;Impacte i Prevencio dels Trastorns Mentals, Institut de Recerca Sant Joan de Deu,;Sant Boi de Llobregat, Spain.;Institute for Clinical Data Management, Semmelweis University, Budapest, Hungary.;Center of Health Data Science, Berlin Institute of Health at Charite,;Universitatsmedizin Berlin, Berlin, Germany.;Institute, Barcelona, Spain; Department of Control and Management, Hospital del;Mar, Barcelona, Spain.;Observational and Pragmatic Research Institute, Singapore.;Health Data Research Platform, Health Research Institute of the Balearic Islands,;Palma, Spain.;Institute of Applied Biosciences, Centre for Research and Technology Hellas,;Thessaloniki, Greece.;Division of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul;Faculty of Medicine, Istanbul University, Istanbul, Turkiye.;Optimum Patient Care, Oakington, UK.;Institute of Computer Science, University of Tartu, Tartu, Estonia; STACC, Tartu,;Estonia.;Pharmaceuticals and Integrated Evidence Generation, Bayer, Berlin, Germany.;Observational and Pragmatic Research Institute, Singapore; Centre of Academic;Primary Care, Division of Applied Health Sciences, University of Aberdeen,;Aberdeen, UK.;Division of Oncology, Azienda Ospedaliera Universitaria di Modena, Modena, Italy.;VieCuri Medical Center, Venlo, Netherlands.;Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.;Software and Information Systems Engineering, Ben-Gurion University of the Negev,;Beersheba, Israel.;National Institute for Health and Care Excellence, London, UK.;Hospital de Denia, Alicante, Spain.;Centre for Statistics in Medicine, University of Oxford, Oxford, UK; Department;of Medical Informatics, Erasmus University Medical Center, Rotterdam,;Netherlands. Electronic address: daniel.prietoalhambra@ndorms.ox.ac.uk.;Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,;Netherlands. |
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