Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania

Abstract

Introduction The increased access to medicinal products in Africa is not well-matched with the pharmacovigilance capacity to monitor drug safety. The objective of this study was to assess the functionality and identify the strengths and limitations of the national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania, and compare these systems. Methods Legal and statutory documents governing the pharmacovigilance systems of each participating country were examined by assessors prior to on-site review. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the East African Community Harmonized Pharmacovigilance Indicators tool, supplemented with indicators from the World Health Organization (WHO) Global Benchmarking Tool. Responses were recorded, and data were analyzed. Results The pharmacovigilance systems were supported by law and regulations in line with international standards. Standard operating procedures for receiving, processing, and communicating suspected adverse event reports were in place, but reporting of suspected medicine-related harm from stakeholders was inadequate in all countries. The number of Individual Case Safety Reports (ICSRs) received by NMRAs in Kenya, Ethiopia, and Tanzania (mainland) were 35.0, 6.7, and 4.1 per million inhabitants, respectively, in the last calendar year. At the time of assessment, Rwanda did not have an operational system. Overall, ≤ 1% of the total number of health facilities per country submitted ICSRs. Only Kenya and Tanzania had a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in all four countries did not have access to data on drug utilization. Conclusions The national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety.

Estimation of adverse drug reaction reporting in Iran: Correction for underreporting

“…This proportion is low in Iran compared to many developed countries, [34][35][36][37][38][39] ranging from 17.0 to 323.0 per 100 000 population. Nonetheless, this proportion was higher in Iran than in Turkey, 40 Kenya, Ethiopia, and Tanzania, 41 which was 0.4 to 3.5 per 100 000 population. Aagaard et al's study showed that high-income countries had the highest proportions of ADR reporting and low-income countries the lowest, with large variations observed across countries.…”

Evaluation of Pharmacovigilance System in Iran

“…This rate is low in Iran compared to many developed countries, [51][52][53][54][55][56] with rates ranging from 17.0 to 323.0 per 100 000 population. Nonetheless, the rate was higher in Iran than in Turkey, 57 Ethiopia, 58 Kenya, and Tanzania, 59 which was 0.4 to 3.5 per 100 000 population. Furthermore, medicine-related death is a measure of the harmful effects of medicines in the community on hospitalized or non-hospitalized patients.…”

Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania

“…The NTD programs and national pharmacovigilance centers should plan and conduct the abovementioned pharmacovigilance activities to avoid duplication of efforts and optimize the use of resources [ 23 ]. Collaboration with other partners, such as academic institutions and researchers, can further strengthen safety monitoring by conducting pharmacovigilance studies of public health importance [ 25 , 30 ]. Such collaborative safety surveillance would provide information on the safety of the treatment regimens, the true incidence of ADRs, the risk factors, and the tolerance in patients at risk for ADRs.…”

“…Zero ICSRs associated with medicines used in MDA for targeted NTDs were submitted in the last calendar year (2017/2018). In 2017/2018, the majority of ICSRs that were submitted to the national pharmacovigilance center in Ethiopia and Kenya were from the tuberculosis and HIV/AIDS programs [ 30 ]. Unlike the malaria, tuberculosis, and HIV programs, drugs in NTD programs are given through MDA to all at-risk populations without prior diagnosis or screening, with no possibility of post-MDA follow-up for timely identification and management of AEs.…”