OBJECTIVES:

Saudi Food and Drug Authority (SFDA) established the Proactive Drug Safety Monitoring Program to monitor the safety of registered medicinal products in Saudi Arabia more proactively and efficiently. The Proactive Drug Safety Monitoring Program evaluated the relatedness of adverse drug event (ADE) case reports exported from VigiBase, the World Health Organization global database of individual case safety reports, with a group of medications approved by SFDA.

METHODS:

At the beginning, a list of medications was selected for all registered products by SFDA in 2021. Then, the ADE case reports of the selected medicines were retrieved from VigiBase. After that, a crosschecking of the U.S. Food and Drug Administration, European Medicines Agency and local label information was preformed to exclude the labeled ADEs using the list of retrieved ADEs lists for each medicine. Finally, a comprehensive drug safety review for the unlabeled ADEs was performed using different evidence sources including unpublished clinical trials, literature, local and global spontaneous reports and Periodic Benefit-Risk Evaluation Reports.

RESULTS:

A total of 44 medicines were selected with 4762 reported ADE case reports retrieved from VigiBase. The labelness assessment resulted in requesting of label update for 30 medicines (68.18%). A total of 22 comprehensive drug safety reviews were performed for 40 potential safety signals. The safety review recommendations were requesting additional safety data from pharmaceutical companies (n=5 signals), keeping routine monitoring of the risk (n=21 signals) and closing the signal (n=14 signals).

CONCLUSIONS:

The Proactive Drug Safety Monitoring Program in SFDA successfully improved the identification of new safety information for medicinal products.