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

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 Progr...

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Autores principales: Suku, Comfort Kunak, Hill, Geraldine, Sabblah, George, Darko, Mimi, Muthuri, George, Abwao, Edward, Pandit, Jayesh, Osakwe, Adeline Ijeoma, Elagbaje, Cassandra, Nyambayo, Priscilla, Khoza, Star, Dodoo, Alexander N., Pal, Shanthi Narayan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4608977/
https://www.ncbi.nlm.nih.gov/pubmed/26267842
http://dx.doi.org/10.1007/s40264-015-0331-7
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author Suku, Comfort Kunak
Hill, Geraldine
Sabblah, George
Darko, Mimi
Muthuri, George
Abwao, Edward
Pandit, Jayesh
Osakwe, Adeline Ijeoma
Elagbaje, Cassandra
Nyambayo, Priscilla
Khoza, Star
Dodoo, Alexander N.
Pal, Shanthi Narayan
author_facet Suku, Comfort Kunak
Hill, Geraldine
Sabblah, George
Darko, Mimi
Muthuri, George
Abwao, Edward
Pandit, Jayesh
Osakwe, Adeline Ijeoma
Elagbaje, Cassandra
Nyambayo, Priscilla
Khoza, Star
Dodoo, Alexander N.
Pal, Shanthi Narayan
author_sort Suku, Comfort Kunak
collection PubMed
description 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. 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. 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. 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. 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40264-015-0331-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-46089772015-10-21 Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey Suku, Comfort Kunak Hill, Geraldine Sabblah, George Darko, Mimi Muthuri, George Abwao, Edward Pandit, Jayesh Osakwe, Adeline Ijeoma Elagbaje, Cassandra Nyambayo, Priscilla Khoza, Star Dodoo, Alexander N. Pal, Shanthi Narayan Drug Saf Original Research Article 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. 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. 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. 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. 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40264-015-0331-7) contains supplementary material, which is available to authorized users. Springer International Publishing 2015-08-13 2015 /pmc/articles/PMC4608977/ /pubmed/26267842 http://dx.doi.org/10.1007/s40264-015-0331-7 Text en © The Author(s) 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research Article
Suku, Comfort Kunak
Hill, Geraldine
Sabblah, George
Darko, Mimi
Muthuri, George
Abwao, Edward
Pandit, Jayesh
Osakwe, Adeline Ijeoma
Elagbaje, Cassandra
Nyambayo, Priscilla
Khoza, Star
Dodoo, Alexander N.
Pal, Shanthi Narayan
Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title_full Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title_fullStr Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title_full_unstemmed Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title_short Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
title_sort experiences and lessons from implementing cohort event monitoring programmes for antimalarials in four african countries: results of a questionnaire-based survey
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4608977/
https://www.ncbi.nlm.nih.gov/pubmed/26267842
http://dx.doi.org/10.1007/s40264-015-0331-7
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