{"title":"药物警戒,原则和操作","authors":"Aurore Gouraud (Praticien hospitalier)","doi":"10.1016/j.sagf.2024.01.010","DOIUrl":null,"url":null,"abstract":"<div><p>La pharmacovigilance a pour objet la surveillance des effets indésirables des médicaments quel que soit leur mode d’utilisation. Le système repose sur la notification spontanée, par les professionnels de santé et les patients, des effets indésirables potentiels dont ils ont connaissance. Ces signalements permettent de mieux identifier les risques associés à l’usage des médicaments et de réévaluer la balance bénéfice-risque pendant toute la durée de leur commercialisation. Ces données de sécurité postautorisation de mise sur le marché revêtent un caractère particulièrement important pour les médicaments utilisés au cours de la grossesse, très rarement étudiés dans cette population pendant leur phase de développement.</p></div><div><p>The purpose of pharmacovigilance is to monitor the adverse effects of medicinal products, regardless of how they are used. The system is based on spontaneous reporting by healthcare professionals and patients of potential adverse reactions of which they are aware. These reports make it possible to better identify the risks associated with the use of medicinal products and thus to reassess the benefit/risk balance throughout the period in which they are marketed. This post-marketing safety data is particularly important for drugs used during pregnancy, as very few drugs are studied in this population during their development phase.</p></div>","PeriodicalId":35460,"journal":{"name":"Revue Sage - Femme","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1637408824000105/pdfft?md5=9b384f0c3af84a9ebdbe960a583bee0e&pid=1-s2.0-S1637408824000105-main.pdf","citationCount":"0","resultStr":"{\"title\":\"La pharmacovigilance, principes et fonctionnement\",\"authors\":\"Aurore Gouraud (Praticien hospitalier)\",\"doi\":\"10.1016/j.sagf.2024.01.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>La pharmacovigilance a pour objet la surveillance des effets indésirables des médicaments quel que soit leur mode d’utilisation. Le système repose sur la notification spontanée, par les professionnels de santé et les patients, des effets indésirables potentiels dont ils ont connaissance. Ces signalements permettent de mieux identifier les risques associés à l’usage des médicaments et de réévaluer la balance bénéfice-risque pendant toute la durée de leur commercialisation. Ces données de sécurité postautorisation de mise sur le marché revêtent un caractère particulièrement important pour les médicaments utilisés au cours de la grossesse, très rarement étudiés dans cette population pendant leur phase de développement.</p></div><div><p>The purpose of pharmacovigilance is to monitor the adverse effects of medicinal products, regardless of how they are used. The system is based on spontaneous reporting by healthcare professionals and patients of potential adverse reactions of which they are aware. These reports make it possible to better identify the risks associated with the use of medicinal products and thus to reassess the benefit/risk balance throughout the period in which they are marketed. This post-marketing safety data is particularly important for drugs used during pregnancy, as very few drugs are studied in this population during their development phase.</p></div>\",\"PeriodicalId\":35460,\"journal\":{\"name\":\"Revue Sage - Femme\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1637408824000105/pdfft?md5=9b384f0c3af84a9ebdbe960a583bee0e&pid=1-s2.0-S1637408824000105-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Revue Sage - Femme\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1637408824000105\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Nursing\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revue Sage - Femme","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1637408824000105","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Nursing","Score":null,"Total":0}
La pharmacovigilance a pour objet la surveillance des effets indésirables des médicaments quel que soit leur mode d’utilisation. Le système repose sur la notification spontanée, par les professionnels de santé et les patients, des effets indésirables potentiels dont ils ont connaissance. Ces signalements permettent de mieux identifier les risques associés à l’usage des médicaments et de réévaluer la balance bénéfice-risque pendant toute la durée de leur commercialisation. Ces données de sécurité postautorisation de mise sur le marché revêtent un caractère particulièrement important pour les médicaments utilisés au cours de la grossesse, très rarement étudiés dans cette population pendant leur phase de développement.
The purpose of pharmacovigilance is to monitor the adverse effects of medicinal products, regardless of how they are used. The system is based on spontaneous reporting by healthcare professionals and patients of potential adverse reactions of which they are aware. These reports make it possible to better identify the risks associated with the use of medicinal products and thus to reassess the benefit/risk balance throughout the period in which they are marketed. This post-marketing safety data is particularly important for drugs used during pregnancy, as very few drugs are studied in this population during their development phase.
期刊介绍:
La revue Sage-femme est la revue scientifique de information et de formation continue de référence des sages-femmes, dont elle affirme la spécificité de exercice.