Implementing a pharmacovigilance program to evaluate cutaneous adverse drug reactions in an antiretroviral access program.

INTRODUCTION Cutaneous adverse drug reactions (cADRs) can cause significant morbidity and distress in patients, especially in the HIV-infected population on antiretroviral therapy. Adverse drug reaction monitoring and ascertaining causality in resource-limited settings remain serious challenges. This study was conducted to evaluate causality and measure the incidence of cADRs in HIV-infected patients on highly active antiretroviral therapy. The study was also designed to test a three-step approach in the monitoring and evaluation of ADRs in resource-limited settings. METHODOLOGY A retrospective review of patient medical records was performed at the Parirenyatwa Family Care Centre, Harare, Zimbabwe. Cases of cADRs were reported to the Medicines Control Authority of Zimbabwe, the main drug regulating body in Zimbabwe, for assessment and causality classification. RESULTS We reviewed 221 randomly selected patient records to determine whether any diagnoses of cADRs were made by clinicians. Causality assessment revealed that 13.1% of cADRs were due to an offending agent in the antiretroviral therapy versus an initial incidence of 17.6% which had been determined by the physicians. CONCLUSIONS cADRs had an incidence of 13.1% within the population under study due to non nucleoside reverse transcriptase inhibitors (NNRTIs). Most reactions were caused by the NNRTIs which contributed 72.4 % of all cADRs. A panel of experts from the drug regulatory authority can be used as an implementation based mechanism in ascertaining causality objectively in settings where resources are constrained.