Global Pharmacovigilance for ARVs: Overcoming Contrasting Priorities
As of 2010, over 5 million people worldwide have access to antiretroviral drugs (ARVs).
As of 2010, over 5 million people worldwide have access to antiretroviral drugs (ARVs). However with increased access comes a greater need to monitor and promote the safety and effectiveness of these essential medicines. Few resource-limited countries have all the structures, systems, or resources necessary to support medicines safety activities. Diverse international efforts to provide optimal treatment could be compromised by the absence of robust strategies and frameworks for monitoring of inappropriate use, toxicity, drug-drug interactions, diversion, and substandard medicines. While isolated episodes of substandard medication distribution have been identified and handled through the involvement of the World Health Organization (WHO), global pharmacovigilance is needed to fully understand the extent of the issue. This is an important consideration because loss of confidence in the safety of ARVs could lead to poor adherence and the emergence of drug resistance, reduced demand for therapy, or inappropriate switching to more toxic or expensive medicines. A sustainable pharmacovigilance system can therefore help achieve comprehensive, safe, and effective healthcare. Efforts to date have attempted to address the need for responsive drug safety monitoring systems for ARVs in resource-limited settings (RLS) but with varying success.
The Forum for Collaborative HIV Research (Forum) was therefore asked to use its neutral setting for key stakeholders from the United Nations and government agencies, donors, industry, academia, multilateral organizations, and implementers to discuss the creation of a sustainable global pharmacovigilance system for ARVs that would be applicable in RLS. A meeting was convened by the Forum on June 11, with the aim to discuss barriers to progress.
