Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities

Journal Article
  • Nyasha Bakare
  • Ivor Ralph Edwards
  • Andy Stergachis
  • Shanthi Pal
  • Charles B. Holmes
  • Marie Lindquist
  • Chris Duncombe
  • Alex Dodoo
  • Joel Novendstern
  • Jude Nwokike
  • Ricardo Kuchenbecker
  • Judith A. Aberg
  • Veronica Miller
  • Jur Strobos
PLoS Medicine
July 5, 2011; DOI: 10.1371/journal.pmed.1001054.

Summary

With increasing numbers of people worldwide on antiretroviral drugs, the need for improved and sustained global drug safety monitoring or pharmacovigilance is critical. Pharmacovigilance includes monitoring for substandard products, diversion, inappropriate use, and toxicity and is an essential component of safe and effective drug usage. The Forum for Collaborative HIV Research was asked to use its neutral setting for key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers to discuss the creation of a sustainable global pharmacovigilance system for antiretrovirals (ARVs). Important but contrasting priorities and values among stakeholders—all of whom are dedicated to establishing global pharmacovigilance—were identified as barriers to progress. Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies.

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