(P-364) The Establishment of Regional Pharmacovigilance (PV) Centers in Saudi Arabia

Background: As part of Saudi Food and Drug Authority’s (SFDA) responsibilities, which include the monitoring of the safety, efficacy and quality of pharmaceutical products in the kingdom. The project of regional pharmacovigilance centers was established to enhance pharmacovigilance activities among health institutions across the country; these centers have been geographically distributed across the kingdom using a decentralized approach to maintain wide diversity with an achieved target of 25 participating center.

Objectives: To measure the increase rate of Adverse Drug Event (ADE) reports after the Establishment of Regional Pharmacovigilance (PV) Centers.

Methods: The project was initiated during the 2nd quarter of 2018 with a total of 25 collaborating centers by the end of 2019. The primary outcome of this project is to measure the increase rate of ADE reports. Therefore, several initiatives were done to overcome underreporting of ADEs by the centers which included; conducting periodic workshop and meetings, providing educational material (such as; roll-up banners to educate the public on adverse drug event reporting, how to report adverse drug events, and when to seek medical attention). In addition to motivating the centers’ representatives by presenting awards to the participating organizations in honor of their achievement in multiple events and conferences sponsored by the SFDA. After completion of the project, we retrospectively measured all ADE reports received by the 25 participating institutions before and after the initiation of the regional PV centers project. Descriptive statistics were used to describe the study’s finding.

Results: A significant increase of ADE reports in 2020 was noticed due to all the initiatives that were conducted during 2019 with all pharmacovigilance regional centers. As a result, the number of ADE reports received by NPC in 2019 were 5637 reports, compared to a total of 28021 reports received during 2020. This increase in reports submission is estimated to be approximately 397%.

Conclusions: In conclusion, implementation of pharmacovigilance regional centers is still relatively new to the kingdom. However, the contribution of these regional centers has had a significant improvement in the reporting culture as evident by the increases in ADE reporting. Future plans for this project is to not only to measure the quantity of this change but also, to evaluate the quality of reports by measuring the completeness score for each ADE report.