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BRACE, health policy, guidance documents

Session: Poster Session C

(030) Pharmacogenomics-Pharmacovigilance Project: SFDA Experience

Wednesday, August 28, 2024
8:00 AM – 1:30 PM CEST
Location: Convention Hall II

    Presenting Author(s)

  • HA

    Hadir Aljohani, Master degree in clinical pharmacy

    drug safety expert
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

    • Co-Author(s)

  • MA

    Maha Alghamdi

    Senior Pharmaceutical Safety Expert
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

  • Manal Alrohaimi, PharmD

    Pharmaceutical Safety Expert
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

  • SA

    Shahad AlNasser, PharmD, MSc, CPHQ

    Drug Safety Expert I
    Saudi Food and Drug Authority, Saudi Arabia

  • NA

    Nouf Al-Fadel, MSc. Clin

    Head of Pharmacoepidemiology Section
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
    Riyadh, Saudi Arabia

  • Fawaz Alharbi, MSc, PhD

    Director Of Drug Safety and Risk Management
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

Background: Pharmacogenomics plays an essential role in improving medication safety. The incorporation of pharmacogenomic data into pharmacovigilance activities has the potential to reduce the occurrence of adverse drug events (ADEs), thereby promoting patient safety.

Objectives: The Pharmacogenomics-Pharmacovigilance Project was conducted by the Saudi Food and Drug Authority (SFDA) to emphasize the significance of pharmacovigilance in the identification of potential safety signals of pharmacogenomics-related ADEs

Methods: First, we have compiled a comprehensive list of products registered with the Saudi Food and Drug Authority (SFDA). These particular products contain CYP2C19*2 and CYP2D6 biomarkers, which have been determined to be the most prevalent among South Asians, including those in Saudi Arabia. Second, we performed a drug labeling assessment regarding the effect of these biomarkers on the risk of developing ADEs by cross-checking the product information approved by the U.S. Food and Drug Administration, European Medicines Agency, and the SFDA to exclude labeled ADEs related to the effect of pharmacogenetic markers on the safety of the products. Third, we conducted a comprehensive drug safety review of the unlabeled ADEs linked to the biomarkers of interest, utilizing various sources of evidence, including unpublished clinical trials, literature, local and global case reports, and other relevant regulatory documents.

Results: A total of 36 registered medicinal products featuring CYP2C19*2 and CYP2D6 biomarkers were included in the project. Upon initial screening process, we reviewed all product information of these medicinal products, and we found that the effect of pharmacogenetic markers was included in 21 local product information. However, we found a lack of knowledge in 11 local product information, so a drug labeling update has been requested. Subsequently, four medicinal products underwent a comprehensive drug safety review in terms of the effect of pharmacogenetic markers. The outcome of these reviews yielded three recommendations for routine risk monitoring. However, the last product was flagged for close signal due to insufficient evidence and the absence of any regulatory actions.

Conclusions: The successful implementation of the Pharmacogenomics-Pharmacovigilance Project by SFDA has led to enhanced identification and evaluation of potential safety signals/information related to biomarkers associated with medication use.