Awareness and Reporting of Antiretroviral Adverse Events among Clients and Health Care Providers at Kilimanjaro Christian Medical Centre: A Cross-Sectional Study

Abstract

Background: Pharmacovigilance is a means of ensuring drug safety, and thus it ensures that the risks associated with medication adminstration and consumption do not outweigh the benefits. Antiretroviral therapy (ART) for HIV care and treatment has reduced mortality and morbidity, but adverse drug reactions (ADRs), which can lead to treatment failure, remain a concern. In 2015 in Tanzania, 688,800 adults were taking ART. All health-care providers are required to report all suspected ADRs seen or reported by their patients using yellow forms available at all care and treatment 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' reporting of ART adverse events at Kilimanjaro Christian Medical Centre (KCMC). Methods: A cross-sectional study using a semi-structured questionnaire was conducted between June and July 2016 within HIV, dermatology, and infectious disease clinics at KCMC. All health-care providers providing HIV services within these clinics completed a questionnaire. Means and standard deviations were used to summarise the numerical data with normal distributions (age of patients), while numerical data that were not normally distributed (duration on ART) were summarised using medians and ranges. Frequencies and percentages were used to summarise categorical variables. Results: All 63 health-care providers agreed that 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 health-care providers reported always filling the ADR report forms; 27 (42.9%) rarely filled the forms, and 32 (50.8%) reported having never filled an ADR reporting form. Training on pharmacovigilance had a positive influence on ADR reporting. Lack of motivation, uncertainty about reporting procedures, lack of time, unavailability of reporting forms, and ignorance were the major factors affecting reporting among health-care providers. Conclusion: The majority of health-care providers were aware of the need and importance of ADR reporting and the national pharmacovigilance system. However, ART adverse events are underreported. More effort is needed to strengthen the continuous reporting of ADRs by providing continuous education to health-care providers; this will lead to their active participation in pharmacovigilance.

Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey

“…Moreover, the tertiary care public hospitals in Pakistan are in the process of shifting from manual to automated systems, and therefore both awareness and access to online ADR reporting are still not prevalent among HCPs [29]. The DRAP has recently launched a web portal for ADR reporting and a mobile application known as Med Safety application for the reporting of ADRs in collaboration with the United Kingdom (20) Medicines and Healthcare products Regulatory Authority [50], Uppsala Monitoring Centre (UMC) and the WHO normally collects and disseminate data about the safety-related issues of the drugs [51]. However, it is too early to establish if ADR reporting has improved after the launch of this mobile application or otherwise.…”

“…Out of which, only 124 reports had been made by the PV centre in Punjab, however, none of the reports was made by the public [19]. To date, the ADR reporting rate in Pakistan is suboptimal and does not meet the WHO standard for ADR reporting, which is 200 ADR reports per million inhabitants in a year [20]. Therefore, the underreporting of ADR remains a major concern in almost all parts of the country.…”