Abstract Issue

Volume 3 Issue 1 (January-March) 2014

Original Articles

Assessment of Package Inserts
Dr. Misbahuddin

Background: For marketed products to be used safely and effectively, accurate and trustworthy drug information is crucial. Package Inserts (PIs) are the main source of drug information.The present study was conducted to assess Package Inserts. Materials & Methods: 110 Package Inserts (PIs) was studied. A total score of 25 was assigned to each, based on 25 criteria. Presence of information was scored as ‘1’ and absence was scored ‘0’. Total score was expressed in percentages. If a package insert met more than 20 criteria, it was graded as ‘A’; 10-20 criteria as ‘B’, and less than 10 as ‘C’. Results: Out of 110 Package Inserts (PIs), 72% were from Indian companies and 28% from multinational companies. The difference was significant (P< 0.05). There were 55 anti-diabeticsPIs, 38 anti-hypertensives and 17 Hypolipedemic PIs. Under anti-diabeticsPIs, 40 were oral and 15 injectable. Under anti-hypertensivesPIs, 32 were oral and 6 were injectables. Under Hypolipedemic PIs, 16 were oral and 1 was injectable. The difference was significant (P< 0.05).24.6% had grade A and 74.4% had grade B. The difference was significant (P< 0.05). Conclusion: The examined package inserts lacked information pertinent to the safe and efficient use of medication. Therefore, it is advised that the current package inserts be updated in accordance with the standards outlined in Schedule D of the Drug and Cosmetic Act of 1945.

 
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