Abstract

This report evaluates the improvement in targeted spontaneous adverse drug reactionreporting and the quality of reports, demographic distribution, regimens implicated, the most commonly reported adverse drug reactions (ADRs) as well as concomitant conditions. Reported cases of ADRs in the Mpumalanga anti retroviral treatment (ART) programme from July, 2011 to February, 2013 were evaluated. A total of 1,756 ADR reports were received from the province. 495 were males (28.9%), 1,057 female (60.19%) and in 204 (11.6%) reports, gender was not reported. 908 were satisfactorily completed, 445 (49%) reported one ADR, 366 (40.3%) two ADRs, and 97 (10.7%) reported three or more. The most commonly reported ADR was peripheral neuropathy and the most prescribed regimen was d4T/3TC/EFV. d4T-containing regimens were the highest suspect drug combinations. Correlations were observed between d4T and the occurrence of peripheral neuropathy and lipodystrophy, nevirapine (NVP) and efavirenz (EFV) with rash while zidovudine (AZT) was observed to be associated with anaemia. Tuberculosis was found to be the most clinically significant concomitant medical condition with the highest frequency (32.3%). The review observed a significant increase in ADR reports as well as ADRs associated with the use of ART. Periodic review of data on the national pharmacovigilance database will reveal interesting trends in future.

Key words: Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), adverse drug reactions (ADRs), pharmacovigilance, decentralized, clusters.