Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

BACKGROUND: Little research has assessed the quality of manufac- turer-provided prescribing information or documented differences in key aspects of drug information among different marketed generic prod- ucts of the same drug, particularly in the Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of the Middle East. METHODS: We assessed the correctness and completeness of informa- tion pertaining to indications, dosage, cautions/contraindications, side effects and drug interactions in 37 package inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, includ- ing atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), metformin (7 inserts), and omeprazole (9 inserts). We also described de- ficiencies in the quality and quantity of manufacturer-provided informa- tion that could be misleading to patients and prescribers. RESULTS: We found substantial disagreement in information between generic package inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumu- lative average of 63±16% of drug information indicators were in agree- ment with these standard references. Section headings with the least conformity with study references were those related to dosage (57± 28%) and side effects (54±30%). CONCLUSION: Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating cru- cial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and infor- mation interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts.