Abstract

The South African National Department of Health have successfully completed the implementation of a new decentralized patient-centred pilot pharmacovigilance programme in Mpumalanga province. The objective was to integrate the programme into the daily activities of healthcare providers at treatment level.  Firstly, we carried out a one-day pre-training site visit to ascertain the training needs and readiness for the programme. Thereafter, we facilitated four one-day interactive pharmacovigilance training sessions for 69 healthcare providers. Further, we provided them with resource materials for successful program initiation at facility level. We then evaluated the effectiveness of the training and program through a before-after study. At baseline, 80 % of the workers reported no previous PV training while 7% reported an initial training when joining the facility, 4% received training at least once a year and 9% gave no response. Further, 67 % of the participants reported that they had no active pharmacovigilance programme at their institutions and only 16 % reported an active programme. The proportion of healthcare workers indicating an increased understanding of pharmacovigilance and awareness of the importance of reporting ADRs increased significantly after the training. A marked improvement in individualized patient management was also observed. We have successfully piloted a decentralized pharmacovigilance program in Mpumalanga province which has resulted in improved pharmacovigilance activities in ARV therapy. Stakeholders in South African pharmacovigilance have endorsed our model to be rolled out to the rest of the country.

Key words: Pharmacovigilance, decentralized, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).