University of Cape Town prioritizes pharmacovigilance approaches that are most efficient at assessing the burden of drug-related morbidity and mortality on the healthcare system. The focus is on Adverse Drug Reaction (ADR) in HIV infected patients, but the proposed multicentre hospital surveys will also evaluate serious ADRs in HIV uninfected patients. The aim wherever possible is to strengthen pharmacovigilance for all medicines. The approaches are intended to identify gaps and future priorities of the national drug policy, strengthen and evolve the existing national pharmacovigilance structure and strengthen the link between drug safety surveillance and improving the quality of care for patients infected with HIV/AIDS. The goals are to develop systems to assess the burden of clinically significant adverse drug reactions and to create a sustainable and responsive system for reporting of ADRs, which links ADR reporting to provision of information and clinical advice. The objectives are: to perform a gap analysis and landscaping exercise of existing pharmacovigilance structures and activities, in collaboration with the NDOH; to describe the frequency, nature and preventability of ADRs which result in hospital admission, and ADRs occurring during admission; to determine to what extent ARV and antitubercular medicines contribute to the burden of adverse drug reactions resulting in hospitalisation and occurring in hospital; and to strengthen the capacity to collect ART program surveillance data by establishing reasons for treatment-limiting toxicities in treating adults and children, broadly representative of the national programme, with the possibility of expansion to further sites.

"The Division of Clinical Pharmacology at the University of Cape Town has been at the forefront of ADR surveillance and drug policy for many years. The Medicines Information Centre of the Division of Clinical Pharmacology at the University of Cape Town was allocated funding by the Department of Health in 2004 to run an HIV medicines information service (HIV Hotline) and to support the passive reporting of ARV adverse drug reactions of the National Adverse Drug Event Monitoring Centre of the Medicines Control Council. All of the objectives of the proposal were met. These activities have been sustainable and have expanded with subsequent funding of the National HIV Hotline from the Foundation for Professional Development (who are funded largely by PEPFAR), and an enhanced ARV passive reporting system was set up in collaboration with the Western Cape provincial government with funding from the Global Fund. Adverse event reporting was nested within routine program monitoring requirements with all facilities reporting serious ADRs as a monthly reporting requirement. The proposal prioritises pharmacovigilance approaches that are most efficient at assessing the burden of drug-related morbidity and mortality on the healthcare system. The focus is on ADRs in HIV infected patients, but the proposed multicentre hospital surveys will also evaluate serious ADRs in HIV uninfected patients. The aim wherever possible to strengthen pharmacovigilance for all medicines. The approaches are intended to identify gaps and future priorities of the national drug policy, strengthen and evolve the existing national pharmacovigilance structure and strengthen the link between drug safety surveillance and improving the quality of care for patients infected with HIV/AIDS.