(242) Are Drug Safety Measures Harmonized? A Real-World Data from Three Regulatory Authorities

Publication Number: 1287

Background: Risk minimization measures (RMMs) are interventions intended to mitigate or prevent the occurrence of adverse reactions associated with medications. Regulatory authorities, including the Saudi Food and Drug Authority (SFDA), the United States Food and Drug Administration (USFDA), and the European Medicines Agency (EMA) publish RMMs on their websites. Having consistent measures across regulatory bodies benefits medication use and safety and ultimately the patient.

Objectives: This study aimed to investigate whether there is variability in these published RMMs between the three regulatory bodies.

Methods: A specific data collection form was created to extract information from the SFDA’s RMM list, USFDA’s Risk Evaluation and Mitigation Strategy (REMS) list, and EMA’s Risk Management Plan (RMP) list, as of February 2022 all RMMs that were available on the websites were reviewed. Medications with the same trade name were matched across regulators, and unmatched drugs were checked for approval status. For medication groups such as NSAIDs in the SFDA’s RMM list, they were matched by searching for the groups individually in the regulatory websites. The details of medication risks and RMM types were extracted from each matched medication in each regulatory authority. All risks and types of minimizing measures were compared.

Results: A total of 317 medications were retrieved from the SFDA’s RMM list. The majority of medications classes were immunosuppressants (n=60), antihypertensive (n=33), and oncology medication (n=29). There were only 62 medications with REMS from the USFDA website, a total of 14 medications were approved by the SFDA, and only 9 medications were matched with the SFDA’s RMM list. Also, there were 828 medications with RMP from the EMA website, a total of 334 has RMM, 128 are approved by the SFDA, and 71 matched with the SFDA’s RMM list. Furthermore, 7 medications were matched between SFDA, USFDA and EMA. After content review, four medications had similar risks and measures across the regulators and three medications had different risks and measures across the regulators. For the medication groups, a total of 36 groups were in the SFDA’s list, 17 group were matched with the USFDA, and 19 were matched with the EMA. Overall, differences were found in risks and RMMs types between medication groups across regulators.

Conclusions: Our study showed substantial differences among the regulatory authorities regarding RMMs. Harmony in published risk measures can have a significant impact on medication safety.