title: Pharmacovigilance and global HIV/AIDS.
abstract: OBJECTIVE
  This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Forum for Collaborative HIV Research, School of Public Health, University of California Berkeley, USA. veronicam@berkeley.edu
authors.forename: Veronica
authors.initials: V
authors.lastname: Miller
authors.forename: Jude
authors.initials: J
authors.lastname: Nwokike
authors.forename: Andy
authors.initials: A
authors.lastname: Stergachis
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D014943:Global Health; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006291:Health Policy; D006801:Humans; D060735:Pharmacovigilance; D055818:Public-Private Sector Partnerships
chemical_list: D019380:Anti-HIV Agents