Analysis of package inserts of anti-diabetic medications in India
Keywords:Package inserts, Antidiabetic, Drug information
Background: Package inserts are printed leaflets accompanying marketed drug products and contain information regarding safe and effective use of drug according to regulatory guidelines. Package inserts are also known as prescription drug label or prescribing information. Need for the study: information’s given in package inserts are suboptimal and can lead to medication error. This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic drugs in India.
Methods: Around 146 package inserts were collected from pharmacies located at different areas of Bangalore. They were analysed based on criteria mentioned in Schedule D of drug and cosmetic act 1945.
Results: Out of 146 package inserts, 56 (38%) belongs to grade A (including all injectable preparation) and remaining 90 (62%) belong to grade B. none of package inserts belong to grade C. Information in package inserts were inadequate in several aspects for example, they had unclear instructions about generic name of other ingredients used, about handling, side effects, shelf life, paediatric and geriatric use and guidelines for use of the drugs.
Conclusions: The study concludes that the information provided in the package insert is not relevant for safe and effective use of medications. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of drug and cosmetic Act, 1945.
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