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

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.

Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study

“…In most SSA countries, schistosomiasis and STH are coendemic, hence praziquantel and albendazole are coadministered during MDA. Although coadministration of the two drugs targeting the two NTDs is cost effective, several factors, including risk for drug interaction and overlapping toxicities, underscores the need for safety monitoring [ 14 , 15 ]. Safety monitoring is essential to detect the number, type, and severity of AEs and identify risk factors associated with mass albendazole and praziquantel administration-related AEs for timely interventions, thereby minimizing harm and sustaining public confidence in the MDA [ 16 ].…”

“…Every year, millions of children receive periodic MDA of praziquantel and albendazole in SSA, including Rwanda, but safety data from large-scale active cohort event monitoring (CEM) studies are scarce partly due to lack of fully functional pharmacovigilance systems [ 14 , 21 , 22 ]. The NTD programs prioritize MDA coverage and AEs are often managed and contained at the sites they happened for fear of rumors, which may negatively affect public confidence, and are not reported to the National Medicines Regulatory Authorities (NMRAs) [ 14 , 22 ]. The underreporting of AEs during MDA campaigns makes it challenging to accurately estimate the risks of medicine-related harm and inform healthcare policy and practice [ 14 ].…”

“…The NTD programs prioritize MDA coverage and AEs are often managed and contained at the sites they happened for fear of rumors, which may negatively affect public confidence, and are not reported to the National Medicines Regulatory Authorities (NMRAs) [ 14 , 22 ]. The underreporting of AEs during MDA campaigns makes it challenging to accurately estimate the risks of medicine-related harm and inform healthcare policy and practice [ 14 ]. The WHO recommends active CEM for safety surveillance of medicines used in public health interventions, particularly in areas where passive reporting is challenging [ 23 ].…”

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

“…National medicines regulatory authorities in Africa, including the Tanzania Medicines and Medical Devices Authority (TMDA) strive to obtain safety data after marketing authorization of many drugs [ 10 , 11 ]. A recent comparative assessment of the pharmacovigilance systems in the NTD Programs in four East African countries indicated that no adverse events following MDA were reported to the National Medicines Regulatory Authorities despite millions of people being exposed to MDA in the year 2017/2018 [ 12 ]. Various initiatives have been undertaken to reverse the status-quo, and different methods have been introduced to increase the number of reports.…”

“…Large-scale safety surveillance studies are pivotal in detecting rare severe adverse events [ 16 ]. Although millions of people in Africa are receiving periodic MDA, safety data from large-scale active CEM studies are scarce partly due to the lack of fully functional pharmacovigilance systems in the region [ 10 , 11 , 12 ]. The WHO’s global individual case safety reports database (VigiBase) recently reported serious suspected ADRs and safety signals associated with ivermectin use and the under-reporting of ADRs in SSA [ 17 ].…”