Adverse drug reactions to Ivermectin and Albendazole following mass drug administrations Effets indésirables des médicaments à l'ivermectine et à l'albendazole suite à des administrations massives de médicaments
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Background: The concept of Pharmacovigilance gain worldwide attention following the thalidomide incident of the 1960s.
Objectives: This study aimed at assessing the adverse drug reactions to ivermectin and albendazole recorded in the database of the National Pharmacovigilance Center for all Lymphatic Filariasis campaigns conducted in the country and to determine challenges to reporting of adverse drug reactions during such campaigns in Sierra Leone.
Methods: This study was a mixed descriptive study design that involved the retrospective review of data collected during mass administration of ivermectin and albendazole for lymphatic filariasis between 1st January 2007 and 31st May 2023. A semi-structured questionnaire was administered to staff of District Health Management teams in order to identify possible challenges to the reporting of adverse drug reactions.
Results: Out of the 1135 adverse drug reactions entered into the WHO database, 1.23 % (14) were considered to be serious reactions. The most common adverse reaction recorded was pruritus (9.78%). 93 (93 %) out of the 100 respondents are aware that there is drug safety monitoring programme in Sierra Leone. Eighty (80 %) of the respondents indicated that lack of training on the detection of adverse drug reactions was the major challenge to the reporting of adverse drug reactions.
Conclusion: The study showed that ivermectin and albendazole have a good safety profile. Lack of training on the detection of adverse drug reactions was the major challenge to the reporting of adverse drug reactions.
FRENCH
Contexte: Le concept de pharmacovigilance a gagné en popularité dans le monde entier suite à l'incident de la thalidomide des années 1960.
Objectifs: Cette étude vise à évaluer les effets indésirables des médicaments à l'ivermectine et à l'albendazole enregistrés dans la base de données du Centre national de pharmacovigilance pour toutes les campagnes de lutte contre la filariose lymphatique menées dans le pays et à déterminer les défis liés à la déclaration des effets indésirables des médicaments au cours de ces campagnes en Sierra Leone.
Méthodes: Cette étude était une étude descriptive mixte qui comprenait l'examen rétrospectif des données recueillies lors de l'administration massive d'ivermectine et d'albendazole pour le traitement de la filariose lymphatique entre le 1er janvier 2007 et le 31 mai 2023. Un questionnaire semi-structuré a été administré au personnel des équipes de gestion de la santé du district afin d'identifier les éventuels défis liés à la déclaration des effets indésirables des médicaments.
Résultats: Sur les 1135 effets indésirables des médicaments enregistrés dans la base de données de l'OMS, 1,23 % (14) ont été considérés comme des réactions graves. L'effet indésirable le plus fréquemment enregistré était le prurit (9,78 %). 93 (93 %) des 100 répondants savent qu'il existe un programme de surveillance de la sécurité des médicaments en Sierra Leone. Quatre-vingts (80 %) des répondants ont indiqué que le manque de formation sur la détection des effets indésirables des médicaments était le principal défi à la déclaration des effets indésirables des médicaments.
Conclusion: L'étude a montré que l'ivermectine et l'albendazole présentent un bon profil de sécurité. Le manque de formation sur la détection des effets indésirables des médicaments a constitué le principal obstacle à leur déclaration.
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