Impact of in-service training on the knowledge, attitude, and practice of pharmacovigilance in Malawi: a cross-sectional mixed methods study.

Background: Spontaneous reporting of adverse drug reaction (ADRs) is low in Malawi. We assessed the impact of training intervention on knowledge, attitudes, and practices of health care professionals (HCPs) in pharmacovigilance (PV).

Methods: We employed a mixed-methods study design. A questionnaire was administered among HCPs who were trained in PV, followed by face-face interviews. We further extracted individual case safety reports which were submitted to the local databasewithin a period of six months prior and after the PV training. Quantitative data was analyzed using STATA 14.1. Paired t-test was used to assess the differences in PV knowledge among HCPs before and after the training. For qualitative data, we manually derived key themes from the participant's responses.

Results: Overall, the mean knowledge score was significantly improved across all the participants from a mean of 56% (95% CI 53% to 58%) to 66% (95% CI 64% to 69%) after the training, p< 0.001. There was a 2.8-fold increase in the number of participants who were able to detect an ADR after the training and a 1.8-fold increase in the percentage of reporting the detected ADRs after the training. Participants expressed preference of a paper-based reporting system to other reporting tools. However, they outlined several challenges to the system which discourages HCPs from reporting ADRs, such as lack of feedback, unavailability of reporting forms and delay to transmit data to the national centre.

Conclusion: The survey found that in-service training for HCPs improves KAP of PV and reporting rates of ADRs. We recommend widening of the training and introducing PV courses in undergraduate programs for health care workers in Malawi.