- Mots-clés > active pharmacovigilance surveillance
- Mots-clés > active surveillance system - antiretroviral program
- Mots-clés > adverse drug reactions (ADRs)
- Mots-clés > antiretroviral therapy (ART)
- Mots-clés > medicine safety
- Mots-clés > medicine surveillance systems
- Mots-clés > pharmacovigilance
- Mots-clés > system of surveillance and control of medicines
- Mots-clés > seguridad de los medicamentos
(2011; 78 pages)
Walkowiak, H., J. Nwokike, and A. Stergachis. 2011. Development of Active Surveillance System for the Antiretroviral Program in Karnataka State, India. Stakeholder Workshop, July 15, 2011: Meeting Notes. Submitted to the U.S. Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.
The Strengthening Pharmaceutical Systems Program (SPS) has been working in India since December 2009 using field support funding received from the US Agency for International Development (USAID) India Mission to assist the Karnataka State AIDS Prevention Society (KSAPS) and other local partners to address pharmaceutical management issues related to the management of antiretroviral therapy (ART)-related medicines. In 2010-11, SPS is assisting KSAPS to identify and initiate strategies for strengthening ART program pharmacovigilance activities in the State of Karnataka. KSAPS expressed interest in expanding medicine safety activities for the ART program in this high HIV burden state beyond the reporting of aggregate adverse drug reaction (ADR) figures identified through passive surveillance to the National AIDS Control Organization (NACO). In addition, KSAPS was interested in exploring options for incorporating active surveillance pharmacovigilance methods such as cohort studies or registries into the ART program. KSAPS and other partners, including NACO agreed that a useful contribution of SPS would be to develop a proposal for establishing a system and platform for active safety surveillance and longitudinal monitoring of patients on antiretroviral medicines (ARVs) in Karnataka. Although focused on Karnataka, the proposal would benefit NACO and the Pharmacovigilance Programme of India for Assuring Drug Safety (PvPI) by contributing a methodology for active surveillance within public health programs and for ART Centres in other states in India.
On July 15, 2011, SPS and KSAPS presented the draft protocol and operational plan to stakeholders for comment at a one-day stakeholder workshop held at the offices of the Karnataka Health Promotion Trust (KHPT) in Bangalore. The workshop was supported by the USAID-funded Samastha project which is led by KHPT in partnership with EngenderHealth and Population Services International. The presentations, comments and feedback received from stakeholders are summarized in these meeting notes.