A Study of Package Inserts in Southern India

• Main Authors: Deepak Ramdas, Ananya Chakraborty, Swaroop HS, Syed Faizan, Praveen Kumar V, Srinivas BN
• Format: Article
• Language: English
• Published: JCDR Research and Publications Private Limited 2013-11-01
• Series: Journal of Clinical and Diagnostic Research
• Subjects: drug-information; package inserts; anti-diabetic; anti-hypertensives; hypolipedemics
• Online Access: https://jcdr.net/articles/PDF/3583/16-%206353_E(R)_F(P)_PF1(PP)_PFA(Pr_P).pdf

Introduction: Package insert is an officially approved document that accompanies a drug. It is intended to provide information for the safe and effective use of a drug and contains information based on regulatory guidelines. Sometimes, information provided in the package inserts is suboptimal which can led to medication errors. This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic, antihypertensive and hypolipedemic drugs in India. Material and Methods: Around 130 package inserts were collected from pharmacies located at different areas of Bangalore. They were analyzed based on criteria mentioned in Schedule D of Drug and Cosmetic act 1945. Results and Observations: Out of 134 package inserts, 64 were anti-diabetics, 40 anti-hypertensives, and 30 hypolipedemics. Out of them, 31 (23.14%) belonged to Grade ‘A’ (including all injectable preparations) and remaining 76.86% to Grade ‘B’. None of the PIs belonged to Grade ‘C’. The inserts were inadequate in many aspects; for example, they had unclear instructions about generic name of other ingredients used, about handling, undesirable effects, pediatric and geriatric use, and guidelines for use of the drugs. Conclusion: This study indicated that information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.