Adverse Drug Reaction-Related to Drug Shortage: A Retrospective Study on the French National Pharmacovigilance Database
| dc.rights.license | open | en_US |
| dc.contributor.author | BOURNEAU-MARTIN, Delphine | |
| dc.contributor.author | BABIN, Marina | |
| dc.contributor.author | GRANDVUILLEMIN, Aurelie | |
| dc.contributor.author | MULLET, Charlotte | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | SALVO, Francesco
IDREF: 221043470 | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | SINGIER, Allison | |
| dc.contributor.author | CELLIER, Morgane | |
| dc.contributor.author | FRESSE, Audrey | |
| dc.contributor.author | DE CANECAUDE, Claire | |
| dc.contributor.author | PIETRI, Tessa | |
| dc.contributor.author | DRABLIER, Guillaume | |
| dc.contributor.author | GENIAUX, Helene | |
| dc.contributor.author | LAGARCE, Laurence | |
| dc.contributor.author | LAROCHE, Marie-Laure | |
| dc.contributor.author | BRIET, Marie | |
| dc.date.accessioned | 2022-10-31T10:20:20Z | |
| dc.date.available | 2022-10-31T10:20:20Z | |
| dc.date.issued | 2023-03 | |
| dc.identifier.issn | 1365-2125 (Electronic) 0306-5251 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/170169 | |
| dc.description.abstractEn | AIM: 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.iso | EN | en_US |
| dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
| dc.subject.en | Adverse drug reaction | |
| dc.subject.en | Drug shortage | |
| dc.subject.en | Medication error | |
| dc.subject.en | Pharmacovigilance | |
| dc.title.en | Adverse Drug Reaction-Related to Drug Shortage: A Retrospective Study on the French National Pharmacovigilance Database | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1111/bcp.15550 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 36177609 | en_US |
| bordeaux.journal | British Journal of Clinical Pharmacology | en_US |
| bordeaux.page | 1080-1088 | |
| bordeaux.volume | 89 | |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 3 | |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | AHEAD_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-03834969 | |
| hal.version | 1 | |
| hal.date.transferred | 2022-10-31T10:20:24Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_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 |
