Abstract:
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 wellestablished
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.
