Sentinel Site–Based Pilot Active Surveillance Pharmacovigilance in the Vietnam ART Program
(2010; 39 pages)


Proposed is a pilot system for monitoring the safety and tolerability of antiretroviral therapy (ART) at sentinel sites in Vietnam through sentinel site active surveillance. It aims to develop, implement, and demonstrate the local feasibility of a practical and sustainable pharmacovigilance system that could later be scaled up to monitor the safety of antiretroviral medicine (ARV) regimens across Vietnam. It also has applicability for future active surveillance of other medicines, settings, and populations. The active surveillance activity, developed in consultation with stakeholders, proposes to systematically document and quantify the presence or absence of ARV-related adverse events and to determine risk factors at three sentinel sites in Vietnam. For this pilot activity, it is proposed that the active surveillance be initiated and evaluated at three outpatient ART health care facilities, two in Ho Chi Minh City (HCMC) and one in Hanoi. Systematically collecting information about medicines used in a defined population can help ensure that medicines have an acceptable safety profile and are used safely.

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