Addressing gaps in pharmacovigilance practices in the antiretroviral therapy program in the Eastern Cape Province, South Africa

Background: The use of antiretrovirals (ARVs) is associated with considerable concern regarding adverse drug reactions (ADRs), including both short- and long-term complications. Currently, there is a general underreporting of ADRs in South Africa. In May 2007, the Eastern Cape regional training centre introduced a pharmacovigilance plan for antiretroviral therapy (ART) to improve reporting practices in the area. Objectives: The aim of this study was to gain insight on attitudes and experiences regarding ADR detection and reporting among health care providers (HCPs) shortly after the first formal pharmacovigilance plan for ART was introduced. Methods: Three focus-group discussions were conducted with 12 HCPs. There were 7 nurses, 3 pharmacists, 1 doctor, and 1 auxiliary staff, all recruited from public hospitals and local health authorities in 2 towns in the Eastern Cape Province, South Africa. Results: It was observed that senior HCPs knew that ADRs from ARVs should be reported formally, whereas junior staff did not demonstrate the same knowledge. The participants thought that underreporting from the primary health care level was a major problem. HCPs identified various reasons for underreporting ADRs: problems with filling out the reporting form, lack of training, high workload, lack of feedback, and fears of not being taken seriously. Lack of adequate training in pharmacovigilance led to lack of confidence among the professional nurses in managing ADRs. Conclusions: Increased focus on pharmacovigilance with adequate, continuous training, especially for nurses managing down-referred patients in primary health care on identification and management of ADRs, and practical use of the ADR form may be necessary to improve pharmacovigilance practices in the area. © 2010 Elsevier Inc.