Antiretroviral drugs are successful in controlling HIV/AIDS and reducing disease progression. Antiretroviral regimens are stopped in up to 25% of all patients during their initial treatment therapy as a result of adverse drug effects, failing treatment and nonadherence within the initial eight months of treatment (Sharma et al., 2007: 235). A pharmacovigilance surveillance system makes it possible for physicians, pharmacists and other healthcare providers to report suspected ADRs. The purpose of this system is to operate as a guide in identification of new ADRs and predisposing risk factors to known ADRs.
The objective of this study was to assess the prevalence and documentation of adverse drug reactions (ADR) in the private and public antiretroviral clinics in Maseru district, with special reference to zidovudine (AZT) and tenofovir (TDF) - based regimens. The empirical investigation was divided into two phases. The first phase was a cross-sectional quantitative retrospective drug utilisation review study which focused on the occurrence of adverse drug reactions in patients taking zidovudine (AZT) and tenofovir (TDF). The second phase, a survey in a form of questionnaires for the health professionals.
Drug utilisation review: The sample size of patients was 300. Of the 44 patients who experience ADRs, 72.73% (n = 32) were female and 27.27% (n = 12) were male. A greater number of patients who experienced ADRs were females with 43.18% (n = 19) presenting with skin rash, 27.27% (n = 12) with nausea/vomiting, and 2.27% (n = 1) with diarrhoea. In male patients, 2.27% (n = 1) had peripheral neuropathy, 18.18% (n = 8) skin rash, 2.27% (n = 1) Fanconi syndrome, 2.27% (n = 1) nausea/vomiting, and 2.27% (n = 1) diarrhoea. Patients whose ART regimen changed due to ADRs were five. 60% (n = 3) of the patients were females and 40% (n = 2) were males. There was an estimated increase of 0.0025 cell/mm³, 0.0026 cell/mm³, 0.0024 cell/mm³, 0.0025 cell/mm³, and of 0.0019 cell/mm³ in CD4 cell count per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. An estimated increase of 0.00021 g/dL, 0.00022 g/dL, 0.00018 g/dL, 0.00022 g/dL, and of 0.00020 g/dL in Hb profile per day occurred according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated increase of 0.000062%, 0.000046%, 0.000068%, 0.000062%, and of 0.00017% in neutrophil count according to sex, age group, weight group, initial ART regimen, and ADRs per day, respectively. There was an estimated increase of 0.000044 IU/L, 0.000043 IU/L, 0.000046 IU/L, and of 0.000028 IU/L in ALT according to sex, age group, weight group, and initial ART regimen per day, respectively. An estimated decrease of 0.000013 IU/L in ALT according to ADRs per day also occurred. There was an estimated decrease of 0.00038 µmol/L, 0.00039 µmol/L, 0.00040 µmol/L, 0.00040 µmol/L, and of 0.00028 µmol/L in serum creatinine per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated decline of 0.00023 mmol/L, 0.00022 mmol/L, 0.00023 mmol/L, 0.00024 mmol/L, and of 0.00015 mmol/L per day in urea according to sex, age group, weight group, initial ART regimen, and ADRs, respectively.
Health professional’s questionnaire: 49 health professionals responded to the questionnaire. 100% (n= 49) of the participants showed that they did not use the yellow card scheme to report ADRs. 34.65% (n = 17) use the individual case safety reports. 57.14% (n = 28) used the structured databases to report ADRs. 85.71% (n = 42) documented in the patient bukana, and 6.12% (n = 3) used the HIV/AIDS ART card to document ADRs occurrence. 91.84% (n = 45) of the health professionals never filled the ADR reporting form in their working environment.
In conclusion, adverse drug reactions occurring in a hospital or healthcare facility should be recorded and reported by the medical practitioners, nurses, pharmacists, and the pharmacy technicians. Therefore, it is important to assess the continuous evaluation of the benefits and harm of medicines which will help in achieving the ultimate goal of making safer and more effective treatment available for patients. As well as to help the health professionals to participate in the very important process of continuous surveillance of safety and efficacy of pharmaceutical products used in clinical practice.