ABSTRACT
Objectif: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. Matériel et Méthodes: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. Résultats: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). Conclusion: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays
Objective: The objective was to take stockof the regulation of clinical trials in Mali. Material and Methods: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). Conclusion: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries
Subject(s)
Clinical Trials, Phase I as Topic , Sanitary Utilities , Ethics Committees, Clinical , Medical Device Legislation , Regulatory Frameworks for Health , MaliABSTRACT
Background Snakebite is a common neglected public health issue, especially in poor rural areas of sub-Saharan Africa, Asia and Latin America. Passive immunotherapy with safe and effective antivenom is the only approved treatment for it. This study aimed to determine the incidence of snakebites, and to assess the availability and accessibility of antivenoms, from 2010 to 2014, in Burkina Faso. Methods The assessment of snakebite cases managed in all health facilities from 2010 to 2014 was performed from the Statistical Yearbook of the Ministry of Health. Antivenom consumption data were collected from the drug wholesalers established in Burkina Faso. Results Snakebites are among the five leading causes of consultations in health districts. From 2010 to 2014, 114,126 envenomation cases occurred in Burkina Faso, out of which 62,293 (54.6 %) victims have been hospitalized resulting in 1,362 (2 %) deaths. The annual incidence and mortality were respectively 130 bites and 1.75 deaths per 100,000 inhabitants. The amount of antivenom sold by wholesalers were 5,738 vials with a total cost of US$ 539,055 (annual average = US$ 107,811). The high cost of these antivenoms (between US$ 42 and 170 per dose according to brand) limited their use by rural people, the main victims of snakebites, whose income is insufficient. Thus, only 4 % of patients received antivenom treatment over the past five years. The price of antivenom was reduced in 2015 to US$ 3.4 by a public drug wholesaler. Conclusion The study confirmed the high burden of snakebites in Burkina Faso. To better manage envenomation, Burkina Faso implemented a strategy consisting in seeking affordable sources of antivenom supply of good quality and innovative mechanisms of subsidy.(AU)
Subject(s)
Poisoning , Snake Bites , Antivenins , Retrospective Studies , Costs and Cost AnalysisABSTRACT
Snakebite is a common neglected public health issue, especially in poor rural areas of sub-Saharan Africa, Asia and Latin America. Passive immunotherapy with safe and effective antivenom is the only approved treatment for it. This study aimed to determine the incidence of snakebites, and to assess the availability and accessibility of antivenoms, from 2010 to 2014, in Burkina Faso. Methods The assessment of snakebite cases managed in all health facilities from 2010 to 2014 was performed from the Statistical Yearbook of the Ministry of Health. Antivenom consumption data were collected from the drug wholesalers established in Burkina Faso. Results Snakebites are among the five leading causes of consultations in health districts. From 2010 to 2014, 114,126 envenomation cases occurred in Burkina Faso, out of which 62,293 (54.6 %) victims have been hospitalized resulting in 1,362 (2 %) deaths. The annual incidence and mortality were respectively 130 bites and 1.75 deaths per 100,000 inhabitants. The amount of antivenom sold by wholesalers were 5,738 vials with a total cost of US$ 539,055 (annual average = US$ 107,811). The high cost of these antivenoms (between US$ 42 and 170 per dose according to brand) limited their use by rural people, the main victims of snakebites, whose income is insufficient. Thus, only 4 % of patients received antivenom treatment over the past five years. The price of antivenom was reduced in 2015 to US$ 3.4 by a public drug wholesaler. Conclusion The study confirmed the high burden of snakebites in Burkina Faso. To better manage envenomation, Burkina Faso implemented a strategy consisting in seeking affordable sources of antivenom supply of good quality and innovative mechanisms of subsidy.
Subject(s)
Antivenins/analysis , Retrospective Studies , Poisoning/classification , Health Services AccessibilityABSTRACT
La recherche et le developpement de medicaments antidrepanocytaires est une priorite en Afrique; ou vivent la grande majorite des personnes souffrant de drepanocytoses. C'est dans ce sens que le FACA a ete developpe au Burkina Faso; a partir de la Medecine Traditionnelle et avec le soutien du bureau regional de l'OMS. Les proprietes antifalciformantes; anti-inflammatoires; antipyretiques et myorelaxantes ont ete evaluees. Il en est de meme de la toxicite. Les plantes composant le FACA; agissent en synergie contre les principaux symptomes de la crise drepanocytaire. Administre en evaluation clinique; le FACA est bien tolere et reduit de maniere significative; la frequence des crises. Apres son autorisation de mise sur le marche; le FACA fait maintenant l'objet d'une production industrielle