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Adverse Drug Reaction-Related to Drug Shortage: A Retrospective Study on the French National Pharmacovigilance Database

dc.rights.licenseopenen_US
dc.contributor.authorBOURNEAU-MARTIN, Delphine
dc.contributor.authorBABIN, Marina
dc.contributor.authorGRANDVUILLEMIN, Aurelie
dc.contributor.authorMULLET, Charlotte
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
IDREF: 221043470
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSINGIER, Allison
dc.contributor.authorCELLIER, Morgane
dc.contributor.authorFRESSE, Audrey
dc.contributor.authorDE CANECAUDE, Claire
dc.contributor.authorPIETRI, Tessa
dc.contributor.authorDRABLIER, Guillaume
dc.contributor.authorGENIAUX, Helene
dc.contributor.authorLAGARCE, Laurence
dc.contributor.authorLAROCHE, Marie-Laure
dc.contributor.authorBRIET, Marie
dc.date.accessioned2022-10-31T10:20:20Z
dc.date.available2022-10-31T10:20:20Z
dc.date.issued2023-03
dc.identifier.issn1365-2125 (Electronic) 0306-5251 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/170169
dc.description.abstractEnAIM: Drug shortage is a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, CI95[17.5;27.0]), the cardiovascular system (16.4%, CI95[11.9;21.4]), and anti-infectives for systemic use (14.3%, CI95[9.7;19.2]) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, CI95[18;24]), skin and subcutaneous (14%, CI95[11;17]), general (13%, CI95[10;17]), and gastrointestinal (8%, CI95[5;11]) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (ME) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasises the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enAdverse drug reaction
dc.subject.enDrug shortage
dc.subject.enMedication error
dc.subject.enPharmacovigilance
dc.title.enAdverse Drug Reaction-Related to Drug Shortage: A Retrospective Study on the French National Pharmacovigilance Database
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/bcp.15550en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed36177609en_US
bordeaux.journalBritish Journal of Clinical Pharmacologyen_US
bordeaux.page1080-1088
bordeaux.volume89
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue3
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03834969
hal.version1
hal.date.transferred2022-10-31T10:20:24Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=British%20Journal%20of%20Clinical%20Pharmacology&rft.date=2023-03&rft.volume=89&rft.issue=3&rft.spage=1080-1088&rft.epage=1080-1088&rft.eissn=1365-2125%20(Electronic)%200306-5251%20(Linking)&rft.issn=1365-2125%20(Electronic)%200306-5251%20(Linking)&rft.au=BOURNEAU-MARTIN,%20Delphine&BABIN,%20Marina&GRANDVUILLEMIN,%20Aurelie&MULLET,%20Charlotte&SALVO,%20Francesco&rft.genre=article


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