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Background: Pharmacovigilance is a means of ensuring drug safety and thus ensuring the risk of drug use does not outweigh the benefit. Antiretroviral therapy for HIV care and treatment has been reported to have reduced mortality and morbidity but has adverse drug reactions. These adverse drug reactions (ADR) lead to treatment failure. In 2015 in Tanzania 688,800 adults were taking ART. All health care providers are required to report all suspected adverse drug reactions seen or reported by their patients using the yellow forms that are available at all CTC centres in Tanzania. However the actual practice of reporting is not taking place. This study aimed to explore the patients’ knowledge and HIV/AIDS health care providers’ and reporting practices of adverse events of ART, with the specific objective to determine the knowledge of patients on ART adverse events and practices of health care providers on reporting of ART ADR at Kilimanjaro Christian Medical Centre (KCMC).
Methods: A cross-sectional study using a semi-structured questionnaire was conducted between June to July 2016 within HIV, dermatology and infectious disease clinics at KCMC. All health care providers (HCPs) providing HIV services within these clinics completed a questionnaire. Mean and standard deviation were used to summarize the numerical data with normal distribution (age of patients) while undistributed numerical data (duration on ART) was summarized using median and range. Frequency and percentage was used to summarize categorical variables.
Results: All 63 HCPs , agreed ADR reporting was necessary. Forty six (73%) were aware of the national ADR reporting system but only 32(50.8%) reported having received training on pharmacovigilance. Only 4(6.3%) of all HCPs reported to always fill ADR report forms, 27(42.9%) rarely filled the forms and 32(50.8%) reported to have never filled an ADR reporting form. Training on pharmacovigilance had positive influence towards ADR reporting. Lack of motivation, unsure on how to report, Lack of time, unavailability of reporting forms and ignorance were the major factors affecting reporting among HCP.
Conclusion: Whilst the majority of HCPs were aware of the need and importance of ADR reporting and the national pharmacovigilance system, the study suggests, however, there exists an under reporting of ART adverse events. More effort is needed to strengthen the continuous reporting of ADRs by providing continuous education to health care providers that will lead to their active participation in pharmacovigilance.