{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T04:00:17Z","timestamp":1781150417226,"version":"3.54.1"},"reference-count":36,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"GSK"},{"DOI":"10.13039\/100005624","name":"PATH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005624","id-type":"DOI","asserted-by":"publisher"}]},{"name":"AIRP"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>In C\u00f4te d\u2019Ivoire, pharmacovigilance is not a routine activity in most healthcare facilities and many healthcare professionals have limited knowledge of pharmacovigilance methods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>This study aimed to evaluate the quality of adverse event (AE) reports submitted to the central Pharmacovigilance Unit in C\u00f4te d\u2019Ivoire and to perform causality assessments (CAs) on each report.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This was a descriptive, retrospective analysis of AE reports notified between January 2019 and February 2020 by healthcare providers in C\u00f4te d\u2019Ivoire.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We assessed 141 verified reports of suspected adverse reactions to medicines, of which 118 reports were eligible for inclusion in the analysis of report quality using a modified Beckmann method. CAs were performed using the World Health Organization-Uppsala Monitoring Center (WHO-UMC) method and French CA method.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Of 118 AE reports, 28 (23.7%) had very good\/good quality, 74 (62.7%) were average, 12 (10.2%) had poor quality, and 4 (3.4%) contained insufficient information for assessment. CAs could be performed for all reports except the four with insufficient information (three had no information on patient or suspected drug; all four had no information on the AE), although the reliability of the CA for poor quality reports was questionable. There was no significant difference in distribution of causality ratings calculated by the WHO-UMC method (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.42) or the French method (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.91) by report quality.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>There is underreporting of AEs in C\u00f4te d\u2019Ivoire and most AE reports had average quality. The reliability of the CA, irrespective of method used, was dependent on the quality of reporting. Further training and mentoring of healthcare providers are required to increase the number and completeness of AE reports submitted to the central Pharmacovigilance Unit, and thereby directly support more accurate CAs in C\u00f4te d\u2019Ivoire.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420986261446480","type":"journal-article","created":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T04:03:36Z","timestamp":1780977816000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["A descriptive, retrospective analysis of the quality of spontaneous adverse event reporting to the C\u00f4te d\u2019Ivoire Pharmaceutical and Regulatory Authority and its impact on the causality assessment"],"prefix":"10.1177","volume":"17","author":[{"given":"Mamadou","family":"Kamagat\u00e9","sequence":"first","affiliation":[{"name":"Service de Pharmacologie Clinique, UFR-Sciences M\u00e9dicales Bouak\u00e9, Universit\u00e9 Alassane-Ouattara, Abidjan, C\u00f4te d\u2019Ivoire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7747-8788","authenticated-orcid":false,"given":"Viviane","family":"Jusot","sequence":"additional","affiliation":[{"name":"GSK, Building WN23-D1, Avenue Fleming, Wavre 1300, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diaby","family":"Mory","sequence":"additional","affiliation":[{"name":"H\u00f4pital g\u00e9n\u00e9ral de Grand-Bassam, Grand-Bassam, C\u00f4te d\u2019Ivoire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amadou","family":"Barry","sequence":"additional","affiliation":[{"name":"GSK, Casablanca, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F\u00e9lix","family":"Adou","sequence":"additional","affiliation":[{"name":"Autorit\u00e9 Ivoirienne de R\u00e9gulation Pharmaceutique (AIRP), Abidjan, C\u00f4te d\u2019Ivoire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Kirabo","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teodora","family":"Perger","sequence":"additional","affiliation":[{"name":"GSK, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yolanda","family":"Guerra Mendoza","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,6,8]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"World Health Organization. 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The global smart pharmacovigilance strategy https:\/\/www.who.int\/publications\/i\/item\/9789240116757 (2025 accessed 08 January 2026)."},{"key":"e_1_3_4_8_2","unstructured":"AIRP. Autorit\u00e9 Ivoirienne de R\u00e9gulation Pharmaceutique https:\/\/www.airp.ci\/ (2024 accessed 08 January 2026)."},{"key":"e_1_3_4_9_2","unstructured":"Uppsala Monitoring Centre. Members of the WHO Programme for International Drug Monitoring https:\/\/who-umc.org\/about-the-who-programme-for-international-drug-monitoring\/member-countries\/ (2025 accessed 08 January 2026)."},{"issue":"1","key":"e_1_3_4_10_2","first-page":"32","article-title":"Diagnosis of pharmacovigilance difficulties by health professionals in C\u00f4te d\u2019Ivoire","volume":"6","author":"Kamagat\u00e9 M","year":"2016","unstructured":"Kamagat\u00e9 M, Yavo J-C, Die-Kakou H. Diagnosis of pharmacovigilance difficulties by health professionals in C\u00f4te d\u2019Ivoire. 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