Assessment of Prescribing Information for Generic Drugs Manufactured in the Middle East and Marketed in Saudi Arabia

    May 2006 in “ Annals of Saudi Medicine ”
    Nicole Gebran, Khaled Al Haidari
    TLDR Generic drug inserts in Saudi Arabia often have inaccurate information, needing better regulation and quality control.
    The study assessed the quality of prescribing information in 37 package inserts for generic drugs marketed in Saudi Arabia and found substantial discrepancies compared to the British National Formulary (BNF) and brand product inserts, with an average agreement of 63±16%. Dosage and side effects sections had the least conformity, at 57±28% and 54±30%, respectively. The study concluded that national authorities should implement measures to correct misleading information and ensure the inclusion of crucial prescribing details, recommending enhanced collaboration among Middle Eastern and international regulatory agencies to maintain quality standards.
    Discuss this study in the Community →