Reporting and recording of adverse drug reactions of highly active antiretroviral therapy by HIV infected patients and healthcare professionals respectively in the Ethekwini Metropolitan of Kwa-Zulu Natal, South Africa: a cross-sectional and retrospective comparative study

INTRODUCTION: even though Highly Active Antiretroviral Therapy (HAART) is effective in managing Human Immuno-deficiency Virus (HIV) infection, it is not without its adverse drug effects (ADE) and or adverse drug reactions (ADRs). The study of ADRs associated with HAART in hospitals and clinics is crucial in gauging the burden of the severity of morbidity and mortality in such facilities, hence the reporting of such ADRs is important. METHODS: the study was divided into 2 phases: the 1(st) phase entailed collecting data from HIV infected patients using a questionnaire on ADR experienced, whilst the 2(nd) phase was a retrospective analysis of respective patients´ medical files to record if an ADR was experienced. Three antiretroviral clinics linked to public sector facilities in EThekwini Metro, Kwa-Zulu Natal were the study sites. RESULTS: seventy-two percent of patients reported at least one ADR after HAART initiation. Skin rash (11%) was the most commonly stated ADR by patients, whilst anemia (29%) and cardiovascular disease (23%) were the most commonly recorded ADRs on the patients´ medical files. Of those patients who reported ADRs, 57% were on the first line regimen consisting of Tenofovir, Emtricitabine and Efavirenz. Thirty-six patients reported that they were admitted to hospitals due to ADRs, however none resulted in death. These ADRs were experienced by patients on different regimens, with 10 admissions from the same regimen. CONCLUSION: adverse drug reactions were experienced by South African patients, however the reporting of ADRs by patients were inconsistent with what was recorded on their medical files.