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

Abbie Barry, Sten Olsson, Christabel Khaemba, Joseph Kabatende, Tigist Dires, Adam Fimbo, Omary Minzi, Emile Bienvenu, Eyasu Makonnen, Appolinary Kamuhabwa, Margaret Oluka, Anastasia Guantai, Eugène van Puijenbroek, Ulf Bergman, Alex Nkayamba, Michael Mugisha, Parthasarathi Gurumurthy and Eleni Aklillu
Additional contact information
Abbie Barry: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden
Sten Olsson: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden
Christabel Khaemba: Pharmacy and Poisons Board, Kenya Lenana Road, P.O. Box 27663-00506 Nairobi, Kenya
Joseph Kabatende: Rwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue Kigali, Rwanda
Tigist Dires: Ethiopian Food and Drug Authority, Africa Avenue, Kirkos Sub City, P.O. Box 5681 Addis Ababa, Ethiopia
Adam Fimbo: Tanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania
Omary Minzi: Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013 Dar es Salaam, Tanzania
Emile Bienvenu: College of Medicine and Health Sciences, University of Rwanda, KK 737 Kigali, Rwanda
Eyasu Makonnen: Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 9086 Addis Ababa, Ethiopia
Appolinary Kamuhabwa: Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013 Dar es Salaam, Tanzania
Margaret Oluka: Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya
Anastasia Guantai: Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya
Eugène van Puijenbroek: Pharmacovigilance Centre Lareb, 5237 MH ’s-Hertogenbosch, The Netherlands
Ulf Bergman: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden
Alex Nkayamba: Tanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania
Michael Mugisha: College of Medicine and Health Sciences, University of Rwanda, KK 737 Kigali, Rwanda
Parthasarathi Gurumurthy: Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, P.O. Box 505155 Gaborone, Botswana
Eleni Aklillu: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden

IJERPH, 2021, vol. 18, issue 4, 1-13

Abstract: Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Keywords: pharmacovigilance; medicine safety; Neglected Tropical Diseases Program; public health program; East Africa (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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