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


METHODS
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.
National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, FCT, Nigeria. kunacom@yahoo.com.
Comfort Kunak
CK
Suku
Uppsala Monitoring Centre (UMC), Uppsala, Sweden.
Geraldine
G
Hill
National Pharmacovigilance Centre, Food and Drug Authority (FDA), Accra, Ghana.
George
G
Sabblah
National Pharmacovigilance Centre, Food and Drug Authority (FDA), Accra, Ghana.
Mimi
M
Darko
National Pharmacovigilance Centre, Pharmacy and Poison Board (PPB), Nairobi, Kenya.
George
G
Muthuri
National Pharmacovigilance Centre, Pharmacy and Poison Board (PPB), Nairobi, Kenya.
Edward
E
Abwao
National Pharmacovigilance Centre, Pharmacy and Poison Board (PPB), Nairobi, Kenya.|Bayer HealthCare, Middle Africa Region, Nairobi, Kenya.
Jayesh
J
Pandit
National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, FCT, Nigeria.
Adeline Ijeoma
AI
Osakwe
National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, FCT, Nigeria.
Cassandra
C
Elagbaje
National Pharmacovigilance Centre, Medicine Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe.
Priscilla
P
Nyambayo
National Pharmacovigilance Centre, Medicine Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe.|Department of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Star
S
Khoza
WHO Collaborating Centre (WHO CC) for Advocacy and Training in Pharmacovigilance, School of Medicine and Dentistry, University of Ghana, Accra, Ghana.
Alexander N
AN
Dodoo
Safety and Vigilance (SAV), WHO, Geneva, Switzerland.
Shanthi Narayan
SN
Pal
D000962:Antimalarials / Q000009:adverse effects*; D015331:Cohort Studies; D005869:Ghana / Q000453:epidemiology; D006801:Humans; D007630:Kenya / Q000453:epidemiology; D009549:Nigeria / Q000453:epidemiology; D060735:Pharmacovigilance; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D015030:Zimbabwe / Q000453:epidemiology
D000962:Antimalarials