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

Bibliographic Data

ID15469870
AuthorsAbbie Barry (0000-0002-3859-3660, Karolinska University Hospital), Sten Olsson (0000-0002-6078-0649, Karolinska University Hospital), Christabel Khaemba (0000-0003-0543-9920, Pharmacy and Poisons Board), Joseph Kabatende (0000-0002-3718-3213, Rwanda Development Board), Tigist Dires (Ethiopian Food and Drug Authority, Africa Avenue, Kirkos Sub City, P.O. Box 5681 Addis Ababa, Ethiopia), Adam M Fimbo (0000-0002-9356-2218), Adam Fimbo (Tanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania), Omary Minzi (0000-0001-8692-1924, Muhimbili University of Health and Allied Sciences), Emile Bienvenu (0000-0002-1555-7376, University of Rwanda), Eyasu Makonnen (0000-0002-9259-5288, Addis Ababa University), Appolinary Kamuhabwa (0000-0001-6895-9187, Muhimbili University of Health and Allied Sciences), Margaret Oluka (0000-0002-4881-8667, University of Nairobi), Anastasia N Guantai (University of Nairobi), Anastasia Guantai (University of Nairobi), Eugène van Puijenbroek (0000-0002-2236-1398, Netherlands Pharmacovigilance Centre Lareb), Ulf Bergman (0000-0003-4654-2211, Karolinska University Hospital), Alex Nkayamba (Tanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania), Michael Mugisha (0000-0002-0632-0713, University of Rwanda), Gurumurthy Parthasarathi (0000-0002-5997-1157, Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, P.O. Box 505155 Gaborone, Botswana), Eleni Aklillu (0000-0002-9788-0790, Karolinska University Hospital, corresponding author)
Year2021
Volume18
Issue4
Pages1941-1941
Publication date2021-02-17
Open AccessYes
TypeARTICLE
VenueInternational Journal of Environmental Research and Public Health (JOURNAL)
Journal identifiersISSN: 1661-7827 • E-ISSN: 1660-4601
PublisherMultidisciplinary Digital Publishing Institute (PUBLISHER • CH)
DOI10.3390/ijerph18041941
PMID33671293
OpenAlexW3133282602
LanguageEN
Citations received2
References cited16

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

Adverse effect · Business · Environmental health · Environmental planning · Geography · Pharmacovigilance · Political science · Public health · Public relations · Stakeholder · Tanzania · Antibiotic Use and Resistance · Medicine · Nursing · Pharmaceutical Quality and Counterfeiting · Tuberculosis Research and Epidemiology · Pharmacology

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