Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso

Pharmacovigilance is based on individual case safety reports. Our study is intended to be a contribution to good practices by the quality assessment of individual case safety reports sent to the National Center for Vigilance in Burkina Faso. We carried out a cross-sectional study which concerned ind...

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Autores principales:	Roamba Nazaire, Ouedraogo Emile Windné, Hoho Youl Estelle Noella
Formato:	article
Lenguaje:	EN FR
Publicado:	EDP Sciences 2021
Materias:	adverse effects drugs who grade pharmacovigilance burkina faso Environmental sciences GE1-350
Acceso en línea:	https://doaj.org/article/e77ef986403e4bcfafa62bdb53a3a938
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spelling	oai:doaj.org-article:e77ef986403e4bcfafa62bdb53a3a9382021-11-12T11:44:08ZQuality assessment of individual case safety reports in pharmacovigilance in Burkina Faso2267-124210.1051/e3sconf/202131901073https://doaj.org/article/e77ef986403e4bcfafa62bdb53a3a9382021-01-01T00:00:00Zhttps://www.e3s-conferences.org/articles/e3sconf/pdf/2021/95/e3sconf_vigisan_01073.pdfhttps://doaj.org/toc/2267-1242Pharmacovigilance is based on individual case safety reports. Our study is intended to be a contribution to good practices by the quality assessment of individual case safety reports sent to the National Center for Vigilance in Burkina Faso. We carried out a cross-sectional study which concerned individual case safety reports sent to the Center between 2009 and 2014. 302 individual case safety reports forms were identified and the rate of notifications per year and per million inhabitants was 2,9. The sex ratio was 0,83 in favor of women and the average age was 14,3. 320 drugs were listed with a predominance of antimalarials (37.8%) and antibiotics (19%). Adverse reactions were mostly cutaneous-allergic (37.9%) and general (25.2%). More than half of individual case safety reports were sent by pharmacists (58.6%) followed by nurses (29.5%) then doctors (6.6%). An analysis of the quality of the files according to WHO criteria gave 25.8% for grade A, 67.2% for grade B and 7% for grade C. The files were transmitted within 15 days in 54% cases. The description of the adverse drug reactions was in accordance with WHO ART terminology in 93.5%. Underreporting is a reality and special attention should be paid to collecting information on adverse drug events.Roamba NazaireOuedraogo Emile WindnéHoho Youl Estelle NoellaEDP Sciencesarticleadverse effectsdrugswho gradepharmacovigilanceburkina fasoEnvironmental sciencesGE1-350ENFRE3S Web of Conferences, Vol 319, p 01073 (2021)
institution	DOAJ
collection	DOAJ
language	EN FR
topic	adverse effects drugs who grade pharmacovigilance burkina faso Environmental sciences GE1-350
spellingShingle	adverse effects drugs who grade pharmacovigilance burkina faso Environmental sciences GE1-350 Roamba Nazaire Ouedraogo Emile Windné Hoho Youl Estelle Noella Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
description	Pharmacovigilance is based on individual case safety reports. Our study is intended to be a contribution to good practices by the quality assessment of individual case safety reports sent to the National Center for Vigilance in Burkina Faso. We carried out a cross-sectional study which concerned individual case safety reports sent to the Center between 2009 and 2014. 302 individual case safety reports forms were identified and the rate of notifications per year and per million inhabitants was 2,9. The sex ratio was 0,83 in favor of women and the average age was 14,3. 320 drugs were listed with a predominance of antimalarials (37.8%) and antibiotics (19%). Adverse reactions were mostly cutaneous-allergic (37.9%) and general (25.2%). More than half of individual case safety reports were sent by pharmacists (58.6%) followed by nurses (29.5%) then doctors (6.6%). An analysis of the quality of the files according to WHO criteria gave 25.8% for grade A, 67.2% for grade B and 7% for grade C. The files were transmitted within 15 days in 54% cases. The description of the adverse drug reactions was in accordance with WHO ART terminology in 93.5%. Underreporting is a reality and special attention should be paid to collecting information on adverse drug events.
format	article
author	Roamba Nazaire Ouedraogo Emile Windné Hoho Youl Estelle Noella
author_facet	Roamba Nazaire Ouedraogo Emile Windné Hoho Youl Estelle Noella
author_sort	Roamba Nazaire
title	Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
title_short	Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
title_full	Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
title_fullStr	Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
title_full_unstemmed	Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso
title_sort	quality assessment of individual case safety reports in pharmacovigilance in burkina faso
publisher	EDP Sciences
publishDate	2021
url	https://doaj.org/article/e77ef986403e4bcfafa62bdb53a3a938
work_keys_str_mv	AT roambanazaire qualityassessmentofindividualcasesafetyreportsinpharmacovigilanceinburkinafaso AT ouedraogoemilewindne qualityassessmentofindividualcasesafetyreportsinpharmacovigilanceinburkinafaso AT hohoyoulestellenoella qualityassessmentofindividualcasesafetyreportsinpharmacovigilanceinburkinafaso
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Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso

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