Global pharmacovigilance for antiretroviral drugs: Overcoming contrasting priorities

Abstract

As of 2010, over 5 million peopleworldwide have access to antiretroviraldrugs (ARVs) [1]. With increased accesscomes a greater need to monitor andpromote the safety and effectiveness ofthese essential medicines. Few resource-limited countries have all the structures,systems, or resources necessary to supportmedicines safety activities [2,3]. Diverseinternational efforts to provide optimaltreatment could be compromised by theabsence of robust strategies and frame-works for monitoring of inappropriate use,toxicity, drug-drug interactions, diversion,and substandard medicines [4]. Whileisolated episodes of substandard medica-tion distribution have been identified andhandled through the involvement of theWorld Health Organization (WHO), glob-al pharmacovigilance is needed to fullyunderstand the extent of the issue. Loss ofconfidence in the safety of ARVs couldlead to poor adherence and the emergenceof drug resistance, reduced demand fortherapy, or inappropriate switching tomore toxic or expensive medicines. Asustainable pharmacovigilance system canhelp achieve comprehensive, safe, andeffective healthcare. Efforts to date haveattempted to address the need for respon-sive drug safety monitoring systems forARVs in resource-limited settings (RLS)but with varying success. The Forum forCollaborative HIV Research (Forum) wasasked to use its neutral setting for keystakeholders from the United Nations andgovernment agencies, donors, industry,academia, multilateral organizations, andimplementers to discuss the creation of asustainable global pharmacovigilance sys-tem for ARVs that would be applicable inRLS. A meeting was convened by thecovigilance systems, the need to developsystems that may differ from well-estab-lished models, and the need to assess thefeasibility of novel models offer opportu-nities for innovation. Barriers among thesechannels of funding in established systemsare not applicable in RLS. Sustainableglobal pharmacovigilance must derivesupport from operational, research,andprogrammatic funds as programs, such ashealth care delivery and pharmacovigi-lance, are inextricably intertwined in thissetting with the need for epidemiologicaland implementation research