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

Abbie Barry (), Sten Olsson, Omary Minzi, Emile Bienvenu, Eyasu Makonnen, Appolinary Kamuhabwa, Margaret Oluka, Anastasia Guantai, Ulf Bergman, Eugène Puijenbroek, Parthasarathi Gurumurthy and Eleni Aklillu
Additional contact information
Abbie Barry: Karolinska Institutet, Karolinska University Hospital Huddinge
Sten Olsson: Karolinska Institutet, Karolinska University Hospital Huddinge
Omary Minzi: Muhimbili University of Health and Allied Sciences
Emile Bienvenu: University of Rwanda
Eyasu Makonnen: Addis Ababa University
Appolinary Kamuhabwa: Muhimbili University of Health and Allied Sciences
Margaret Oluka: University of Nairobi
Anastasia Guantai: University of Nairobi
Ulf Bergman: Karolinska Institutet, Karolinska University Hospital Huddinge
Eugène Puijenbroek: Pharmacovigilance Centre Lareb
Parthasarathi Gurumurthy: Botswana Medicines Regulatory Authority
Eleni Aklillu: Karolinska Institutet, Karolinska University Hospital Huddinge

Drug Safety, 2020, vol. 43, issue 4, No 5, 339-350

Abstract: 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.

Date: 2020
References: View complete reference list from CitEc
Citations: View citations in EconPapers (2)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-019-00898-z Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:43:y:2020:i:4:d:10.1007_s40264-019-00898-z

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-019-00898-z

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().