Targeted spontaneous reporting: assessing opportunities to conduct routine pharmacovigilance for antiretroviral treatment on an international scale

Abstract

Introduction :Targeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy(ART). Minimal data exist on the needs or capacity of facilities to conduct TSR. Objectives :Using data from the International epidemio-logic Databases to Evaluate AIDS (IeDEA) Consortium,the present study had two objectives: (1) to develop a list offacility characteristics that could constitute key assets in the conduct of TSR; (2) to use this list as a starting point to describe the existing capacity of IeDEA-participating facilities to conduct pharmacovigilance through TSR. Methods :We generated our facility characteristics list using an iterative approach, through a review of relevant World Health Organization (WHO) and Uppsala Monitoring Centre documents focused on pharmacovigilance activities related to HIV and ART and consultation with expert stakeholders. IeDEA facility data were drawn from a2009/2010 IeDEA site assessment that included reported characteristics of adult and pediatric HIV care programs,including outreach, staffing, laboratory capacity, adverse event monitoring, and non-HIV care.Results A total of 137 facilities were included: East Africa(43); Asia–Pacific (28); West Africa (21); Southern Africa(19); Central Africa (12); Caribbean, Central, and South America (7); and North America (7). Key facility characteristics were grouped as follows: outcome ascertainment and follow-up; laboratory monitoring; documentation—sources and management of data; and human resources.