| アブストラクト | 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. |
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| 投稿者 | Delphine, Bourneau-Martin; Marina, Babin; Aurelie, Grandvuillemin; Charlotte, Mullet; Francesco, Salvo; Allison, Singier; Morgane, Cellier; Audrey, Fresse; Claire, De Canecaude; Tessa, Pietri; Guillaume, Drablier; Helene, Geniaux; Laurence, Lagarce; Marie-Laure, Laroche; Marie, Briet |
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| 組織名 | Department of Pharmacology-Toxicology and Pharmacovigilance, University Hospital;of Angers, Angers, France.;Centre Regional de Pharmacovigilance de Dijon, CHU, Dijon, Bourgogne, France.;Univ. Bordeaux, INSERM, BPH, U1219, Bordeaux, France.;CHU de Bordeaux, Service de Pharmacologie, Bordeaux, France.;CHRU de Nancy - Hopitaux de Brabois, Centre Regional de Pharmacovigilance,;Vandoeuvre-les-Nancy, France.;Service de Pharmacologie Medicale et Clinique, Centre de Pharmacovigilance, de;Pharmacoepidemiologie et d'Informations sur Le Medicament, Faculte de Medecine,;Centre Hospitalier Universitaire, Faculte de Medecine, Toulouse.;Aix-Marseille Universite, Inserm, UMR 1106, Assistance publique - Hopitaux de;Marseille, Service de pharmacologie clinique, Centre regional de;pharmacovigilance, Marseille, France.;Regional Pharmacovigilance Centre of Limoges, Department of;Pharmacology-Toxicology and Pharmacovigilance, CHU Limoges, Limoges, France.;UR 24134 (Vie Sante : Vieillissement, Fragilite, Prevention, e-Sante), IFR OMEGA;HEALTH, Universite de Limoges, Limoges, France.;Universite d'Angers, Angers, France.;MitoVasc Research Institute, Angers, France. |
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