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

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Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden
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Pharmacy and Poisons Board, Kenya Lenana Road, P.O. Box 27663-00506 Nairobi, Kenya
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Rwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue Kigali, Rwanda
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Ethiopian Food and Drug Authority, Africa Avenue, Kirkos Sub City, P.O. Box 5681 Addis Ababa, Ethiopia
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Tanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania
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Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013 Dar es Salaam, Tanzania
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College of Medicine and Health Sciences, University of Rwanda, KK 737 Kigali, Rwanda
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Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 9086 Addis Ababa, Ethiopia
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Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT Africa), College of Health Sciences, Addis Ababa University, P.O. Box 9086 Addis Ababa, Ethiopia
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Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya
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Pharmacovigilance Centre Lareb, 5237 MH ’s-Hertogenbosch, The Netherlands
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Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, P.O. Box 505155 Gaborone, Botswana
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Author to whom correspondence should be addressed.
Academic Editor: Paul B. Tchounwou
Int. J. Environ. Res. Public Health 2021, 18(4), 1941; https://doi.org/10.3390/ijerph18041941
Received: 22 January 2021 / Revised: 10 February 2021 / Accepted: 12 February 2021 / Published: 17 February 2021
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. View Full-Text
Keywords: pharmacovigilance; medicine safety; Neglected Tropical Diseases Program; public health program; East Africa pharmacovigilance; medicine safety; Neglected Tropical Diseases Program; public health program; East Africa
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MDPI and ACS Style

Barry, A.; Olsson, S.; Khaemba, C.; Kabatende, J.; Dires, T.; Fimbo, A.; Minzi, O.; Bienvenu, E.; Makonnen, E.; Kamuhabwa, A.; Oluka, M.; Guantai, A.; van Puijenbroek, E.; Bergman, U.; Nkayamba, A.; Mugisha, M.; Gurumurthy, P.; Aklillu, E. Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania. Int. J. Environ. Res. Public Health 2021, 18, 1941. https://doi.org/10.3390/ijerph18041941

AMA Style

Barry A, Olsson S, Khaemba C, Kabatende J, Dires T, Fimbo A, Minzi O, Bienvenu E, Makonnen E, Kamuhabwa A, Oluka M, Guantai A, van Puijenbroek E, Bergman U, Nkayamba A, Mugisha M, Gurumurthy P, Aklillu E. Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania. International Journal of Environmental Research and Public Health. 2021; 18(4):1941. https://doi.org/10.3390/ijerph18041941

Chicago/Turabian Style

Barry, Abbie, 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. 2021. "Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania" International Journal of Environmental Research and Public Health 18, no. 4: 1941. https://doi.org/10.3390/ijerph18041941

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