Objective Evaluation of Generic Drug Information

BACKGROUNDLittle research has assessed the quality of manufacturer-provided prescribing information or documented differences in key aspects of drug information among different marketed generic products 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.METHODSWe assessed the correctness and completeness of information 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, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), metformin (7 inserts), and omeprazole (9 inserts). We also described deficiencies in the quality and quantity of manufacturer-provided information that could be misleading to patients and prescribers.RESULTSWe 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 cumulative average of 63±16% of drug information indicators were in agreement 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%).CONCLUSIONOur results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts.

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“…Generic drugs were found to have insufficient information on clinical data, pharmacokinetics, safety, side effects and non-clinical tests. 19 …”

Section: Discussionmentioning

confidence: 99%

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

Gebran

Haidari

2006

Annals of Saudi Medicine

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“…Since generics and their brand-name counterparts have different additives such as preservatives and coloring agents, the quality of generics is often questioned by physicians and pharmacists [1]. Studies have questioned the equivalence of some generics to their brand-name counterparts in terms of clinical efficacy and safety, and there is a lack of clinical information and data on the clinical efficacy and safety of generics [2,3]. …”

Section: Introductionmentioning

confidence: 99%

Relationship between the usability and physicochemical properties of triamcinolone acetonide ointments

Inoue

Maeda

Furuya

et al. 2013

Results in Pharma Sciences

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The purpose of this study was to examine the physicochemical properties of TA ointments and conduct a human sensory test to assess the properties of those ointments. Physicochemical assessment was done via near-infrared (NIR) absorption spectroscopy, measurement of water content, microscopy, and measurement of viscoelasticity. The human sensory test examined 5 aspects (texture, cohesiveness, spreadability, smell, and feel). Three TA ointments were used: TA-A, a brand-name preparation, and TA-B and TA-C, two generics. The sensory test revealed significant differences between TA-A and TA-B and TA-C in terms of cohesiveness and spreadability. Significant differences between TA-A and TA-C and between TA-B and TA-C in terms of feel were noted. Microscopic examination revealed that TA-C had good dispersibility while TA-A and TA-B produced crystallization. NIR spectroscopy revealed differences in absorption spectra attributed to oil and water content in TAA, TA-B, and TA-C. Measurement of water content indicated water content of 0.06 ± 0.02% for TA-A, 0.08 ± 0.08% for TA-B, and 36.7 ± 1.19% for TA-C. Assessment of viscoelasticity indicated that stress decreased for all 3 ointments at 35 °C compared to that at 25 °C. TA-A and TA-B were found to have a higher percent decrease in stress than was TA-C. These findings indicate that differences in the types and content of additives caused differences in the physicochemical properties of individual ointments. In addition, differences in physicochemical properties presumably resulted in the close correlation between cohesiveness and spreadability in the sensory test.

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