Monitoring Adverse Drug Reactions in the Public Health Programs: The Case of the Nigeria TB Program
(2008; 50 pages)


The public health programs provide unique opportunities for improving pharmacovigilance activities in resource limited settings. Such programs use limited number of medicines in large population of people and data is more readily available. The medicines may be new with limited experiences from their real life use. As access to medicine improves, there is a need to continually monitor the safety of these medicines throughout use. Medicine safety data will ultimately provide vital information on the rate of known side effects, the occurrence of rare ADR, and the monitoring of the risks and benefits of the medication to inform regulatory and treatment guidelines decision making. The National Tuberculosis and Leprosy Control Program (NTBLCP) of Nigeria currently implements a successful TB directly observed treatment shortcourse program and intends to improve on the monitoring of the safety of the medicines used in this program. An assessment was therefore conducted to identify opportunities and challenges and recommend options towards improving ADR monitoring. The assessment involved data collection through document review, structured interviews, and questionnaires administered to key stakeholders, opinion leaders and informants, site visits, and presentations to stakeholders.

Findings include weak ADR reporting culture attributed to a demanding guideline and cumbersome ADR form, limited collaboration between the public health programs and the national pharmacovigilance center, lack of awareness and training on the need for ADR monitoring, and lack of institutional capacity for improving safety monitoring. It is recommended that the NTBLCP work closely with stakeholders in the immediate to simplify and institutionalize ADR reporting using the TB treatment card.

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