Pharmacovigilance Capacity Building in Indonesia 2017–2021: Overview and Impact Trend Analysis

Introduction: From 2017-2021, ISOP Indonesia Chapter (ISOP ID) held 4 workshops related to pharmacovigilance (PV) in Indonesia. The workshops were intended for multi-stakeholders in Indonesia and training materials were developed based on ISOP Curricula on PV in consultation with ISOP Global. Objective: To give an overview on PV capacity building activities held by ISOP ID from 2017 to 2021 and analyse its impact. Methods: Analysis of ISOP training documents and 2022 Training Impact Assessment survey. Results: In total, there are 170 registered participants in the workshops. More than 95.9 % of them came from the pharmaceutical industry and Contract Research Organization (CRO), the rest were academics and none was health care practitioners. The workshops in 2017 and 2019 focused on basic PV, with full attendance rate of 91.5% and 81.5%. In 2017 workshop, participants had an increased median pre-post-test scores score from 14 to 20 (6 points out of total score of 25). In 2019, there was no difference in pre-post test scores of participants, (median score of 7 in pre-test and median score of 8 in the post-test; total score of 10). The workshops in 2018 and 2021 focused on PV system establishment in Pharmaceutical Industry and practice of PV in clinical trials. The events were held for a small group of practitioners from local industry-CRO and had 100% rate of full attendance. Overall evaluation of the workshops shows medium to high satisfaction on the materials delivered in the training. Based on 2022 Training Impact Assessment Survey preliminary results, from 44 respondents, 81.8 % of the participants were still working in PV. Nineteen (43.2%) of the respondents were able to directly apply the knowledge from the workshops to their daily work, while 5 (11.4%) said they did not directly apply the knowledge as institutional changes were needed. About 40 (90.9%) of respondents relayed the knowledge from the workshops to their colleagues and 14 (31.8 %) respondents relayed the knowledge to others outside their own institution. Thirty-four (77.3 %) respondents had additional PV training after the workshops. The main reasons for additional training were the need for knowledge refreshment (16 respondents-36.4%) and company requirement (9 respondents-20.4%). Conclusion: There is a continuous need for PV training in Indonesia, especially from Industry. The awareness and capacity building program need to be intensified for the health care practitioners, academics and