- Keywords > active pharmacovigilance surveillance
- Keywords > active surveillance system - antiretroviral program
- Keywords > adverse drug reactions (ADRs)
- Keywords > antiretroviral therapy (ART)
- Keywords > drug safety
- Keywords > medicine safety
- Keywords > medicine surveillance systems
- Keywords > pharmacovigilance
- Keywords > pregnancy registry
- Keywords > system of surveillance and control of medicines
(2011; 53 pages)
Nwokike J., A. Stergachis, and P. Gurumurthy. 2011. Development of Active Surveillance System for the Antiretroviral Program in Karnataka State — Protocol and Operation Plan. Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems Program. Arlington, VA: Management Sciences for Health.
Antiretroviral medicines (ARV) at antiretroviral treatment (ART) sites in the State of Karnataka through active surveillance at sentinel sites. The goal of this activity is 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 ARV regimens throughout the State. The proposed system also has applicability for future active surveillance of other medicines, settings, and populations. The active surveillance activity, developed by the Strengthening Pharmaceutical Systems (SPS) Program in consultation with the Karnataka State AIDS Control Society (KSAPS) and other stakeholders, proposes to systematically document and quantify the presence or absence of ARV-related adverse events, and to determine risk factors at sentinel sites. Systematically collecting information about medicines used in a defined population helps ensure that medicines have an acceptable safety profile and are used appropriately.
The active surveillance system will be a multi-center, prospective observational cohort activity designed to evaluate the incidence and identify risk factors for adverse drug events among HIV-infected patients newly placed on antiretroviral therapy. The proposed data collection strategy is based on data that the National AIDS Control Organization (NACO) of the Department of AIDS Control, Ministry of Health and Family Welfare currently requires ART Centres to collect. The system will be implemented with 10 ART sites. The initial emphasis will be to develop, implement, and operate active surveillance among adult HIV-infected patients receiving ARVs throughout the duration of their use of ARVs. Additionally, over the course of the activity period, active surveillance will also be developed and implemented with pediatric patients and with pregnant women who are receiving ARVs. Both groups are vulnerable and understudied. For patients included in this activity, all suspected adverse drug reactions will be documented and evaluated, including mild to moderate events, reactions that result in substitution, switching, and stopping of ARVs, occurrences of hospitalizations, and death. A data coordinating center will be established to provide data management and training support for the active surveillance sites. This activity will ultimately result in the development of a sustainable active surveillance system for longitudinally monitoring the safety of ARV medicines throughout the duration of the ART program.
There is a clear and growing need to better understand the benefits and risks of ARVs under conditions of actual use. Most questions of drug safety may only be answered by observing and analyzing the use and outcomes of therapy in large populations during the post-approval phase.1,2 The active surveillance system presented in this proposal will contribute to the knowledge-base, and help develop infrastructure for future active surveillance approaches. Results will also help inform future revisions to ART treatment guidelines and regulatory decisions. From the perspective of patient care, knowledge of factors that may affect the risk and management of adverse reactions, including other illnesses and conditions, the patient's other current medications, the availability of alternative regimens, and the patient's history of medication intolerance, may lead to improved outcomes.