This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.
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.
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.
aForum for Collaborative HIV Research, School of Public Health, University of California Berkeley, Washington, USA
bStrengthening Pharmaceutical Systems (SPS) Program, Center for Pharmaceutical Management, Management Sciences for Health Arlington, USA
cDepartments of Epidemiology & Global Health, Global Medicines Program, University of Washington, Seattle, USA
Correspondence to Veronica Miller, PhD, 1608 Rhode Island Ave, Suite 212, Washington DC, 20036, USA. Tel: +1 202 974 6290; e-mail: firstname.lastname@example.org