Skip Navigation LinksHome > July 2012 - Volume 7 - Issue 4 > Pharmacovigilance and global HIV/AIDS
Current Opinion in HIV & AIDS:
doi: 10.1097/COH.0b013e328354d8e7

Pharmacovigilance and global HIV/AIDS

Miller, Veronicaa; Nwokike, Judeb; Stergachis, Andyc

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Purpose of review: This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.

Recent findings: Over 6 million HIV-infected individuals worldwide are on treatment with more than 150 innovator and generic antiretroviral drug products. This achievement is made possible through sponsorship of HIV/AIDS programs [The Global Fund to Fight AIDS, Tuberculosis and Malaria; the President's Emergency Program for AIDS Relief (PEPFAR)] and the availability of generic fixed-dose combination products. The WHO prequalifies generic drug products used by Global Fund programs; the US Food and Drug Administration tentatively approves generic products used by PEPFAR programs through a fast-track review process. Adequate national or regional quality and safety monitoring systems after drug distribution are lacking. The pharmaceutical sector, a significant player in pharmacovigilance in the developed world, has not been engaged. Innovative approaches based on collaboration and partnerships will be needed. Clinic-based or program-based cohort studies, randomized clinical trials and electronic medical records may contribute pharmacovigilance-relevant information.

Summary: Attention to drug quality and safety is obligatory for long-term program sustainability. Systematic approaches to regional pharmacovigilance that make use of diverse data sources, and collaborative partnerships between industry, clinical and/or research programs and national health authorities can potentially contribute to overall health system strengthening.

© 2012 Lippincott Williams & Wilkins, Inc.


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