Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey

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dc.contributor.author Suku, C.K.
dc.contributor.author Sabblah, G.
dc.contributor.author Darko, M.
dc.contributor.author Muthuri, G.
dc.contributor.author Abwao, E.
dc.contributor.author Pandit, J.
dc.contributor.author Osakwe, A.I.
dc.contributor.author Elagbaje, C.
dc.contributor.author Nyambayo, P.
dc.contributor.author Khoza, S.
dc.contributor.author Dodoo, A.N.
dc.contributor.author Pal, S.N.
dc.date.accessioned 2018-09-10T13:52:16Z
dc.date.available 2018-09-10T13:52:16Z
dc.date.issued 2015-08
dc.identifier.citation Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme Robert Kimutai, Ahmed M. Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A. G. Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna Clin Drug Investig. 2017; 37(3): 259–272. Published online 2017 Jan 9. doi: 10.1007/s40261-016-0481-0 PMCID: PMC5315726 Article PubReader PDF–569KCitation Support Center Support Center en_US
dc.identifier.other doi: 10.1007/s40264-015-0331-7
dc.identifier.uri http://ugspace.ug.edu.gh/handle/123456789/24025
dc.description.abstract Introduction Cohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice. Go to: Objective The aims of this study were to describe the experiences of National Pharmacovigilance Centres (NCs) that have used CEM to monitor artemisinin-based combination therapy (ACT) for uncomplicated malaria in the African setting, to raise awareness of some of the challenges encountered during implementation and to highlight aspects of the method that require further consideration. Go to: Method A questionnaire-based survey was conducted to capture the experiences of NCs that have implemented CEM for active post-marketing surveillance of antimalarial medicines in sub-Saharan Africa. Six NCs were identified as having implemented CEM programmes and were invited to participate in the survey; five NCs indicated willingness to participate and were sent the questionnaire to complete. Go to: Results Four NCs responded to the survey—Ghana, Kenya, Nigeria and Zimbabwe—providing information on the implementation of a total of six CEM programmes. Their experiences indicate that CEM has helped to build pharmacovigilance capacity within the participating NCs and at the monitoring sites, and that healthcare providers (HCPs) are generally willing to participate in implementing the CEM method. All of the programmes took longer than expected to complete: contributing factors included a prolonged enrolment period and unexpectedly slow data entry. All of the programmes exceeded their budget by 11.1–63.2 %. Data management was identified as a challenge for all participating NCs. Go to: Conclusions The reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation. en_US
dc.language.iso en en_US
dc.publisher Drug Safety en_US
dc.subject Event Monitoring en_US
dc.subject Antimalarials en_US
dc.subject Africa en_US
dc.subject medicines safety en_US
dc.subject Public Health en_US
dc.subject National Pharmacovigilance Centres en_US
dc.subject Ghana en_US
dc.subject Kenya en_US
dc.subject Nigeria en_US
dc.subject Zimbabwe en_US
dc.title Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey en_US
dc.type Article en_US


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