{"title":"[Pharmacovigilance notification by dental surgeons in France: A ten-year analysis of the French database].","authors":"Antonin Vagnet, Hélène Peyrouzet, Viktoryia Prontskus, Corinne Guihard, Lucie Vettoretti, Marie Blanche Valnet Rabier","doi":"10.1016/j.therap.2025.02.011","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Dentists, in their practice, bear responsibility for the benefits and the risks associated with the medications they prescribe. Their code of ethics grants them the freedom to prescribe while encouraging them to limit their interventions to what is strictly necessary for the quality and effectiveness of care. Furthermore, dentists also face ontological adverse effects resulting from medications they did not personally prescribe. A study based on the analysis of cases recorded over ten years in the national pharmacovigilance database (BNPV) is relevant for assessing the current state of pharmacovigilance reports submitted by dentists.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of the cases recorded in the BNPV, reported by dentists between 01/01/2013 and 31/12/2023.</p><p><strong>Results: </strong>Over 10 years, 509 reports were recorded, representing 0.06% of all registered cases. These reports were divided into three main groups. Among the 509 declarations, 24.8% were cases associated with medications used in the field of dentistry, such as anti-inflammatory drugs, antibiotics, local anaesthetics, and local antiseptics. In total, 35.2% were cases of odontological adverse effects, such as jaw osteonecrosis, gingival hypertrophy, and oral ulcers. Finally, 28.3% of the cases involved reports of adverse effects related to coronavirus disease 2019 (COVID-19) vaccination, which began in late December 2020.</p><p><strong>Conclusion: </strong>The low rate of pharmacovigilance reports by dentists in France over the past ten years highlights an issue of underreporting of adverse effects in dental practice. Recent literature emphasizes the importance of pharmacovigilance reporting in the field of dentistry, particularly concerning odontological effects.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.therap.2025.02.011","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Dentists, in their practice, bear responsibility for the benefits and the risks associated with the medications they prescribe. Their code of ethics grants them the freedom to prescribe while encouraging them to limit their interventions to what is strictly necessary for the quality and effectiveness of care. Furthermore, dentists also face ontological adverse effects resulting from medications they did not personally prescribe. A study based on the analysis of cases recorded over ten years in the national pharmacovigilance database (BNPV) is relevant for assessing the current state of pharmacovigilance reports submitted by dentists.
Methods: We conducted a retrospective analysis of the cases recorded in the BNPV, reported by dentists between 01/01/2013 and 31/12/2023.
Results: Over 10 years, 509 reports were recorded, representing 0.06% of all registered cases. These reports were divided into three main groups. Among the 509 declarations, 24.8% were cases associated with medications used in the field of dentistry, such as anti-inflammatory drugs, antibiotics, local anaesthetics, and local antiseptics. In total, 35.2% were cases of odontological adverse effects, such as jaw osteonecrosis, gingival hypertrophy, and oral ulcers. Finally, 28.3% of the cases involved reports of adverse effects related to coronavirus disease 2019 (COVID-19) vaccination, which began in late December 2020.
Conclusion: The low rate of pharmacovigilance reports by dentists in France over the past ten years highlights an issue of underreporting of adverse effects in dental practice. Recent literature emphasizes the importance of pharmacovigilance reporting in the field of dentistry, particularly concerning odontological effects.
期刊介绍:
Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject.
The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.