A Study on Evaluation of Drug Package Inserts in Kashmir, India

Abstract

Background: Drugs constitute a major part of the therapeutic modality for most of the patients. Accurate and authentic drug information is important for its safe and effective marketing. Drug package insert (PI) is the primary source of such information. They serve very important role in minimizing the medication errors. PIs need to be updated regularly, but despite regulations, studies have shown that Indian PIs provide inadequate information. Aims and Objectives: To check the completeness of information provided in package inserts of allopathic drugs. Material and Methods: This observational study was carried out for a period of 3months in the department of pharmacology, GMC Srinagar. 139 PIs were collected from local pharmacies and drug store of tertiary care hospital of Government Medical College, Srinagar.17 duplicate package inserts were excluded. The remaining PIs (122) were evaluated according to section 6.2, 6.3 of schedule D (II), Drugs and Cosmetics Act (1940) and Rules (1945).Data was entered in Microsoft Excel Sheet and then analyzed. Results: Among 122 PIs evaluated maximum package inserts were of antibiotics (15%) and anti-diabetics (15%) followed by CNS drugs (14%). Considering the dosage forms 60% inserts wereoral preparations followed by intravenous injections 17%. Regarding the various components of Section 6.2 of Schedule D (II), Drug and Cosmetic Act, posology and method of administration was present in 100% inserts, special precautions and warnings were present in 97%, side effects in 96%, contraindication in 94%. With regards the components of Section 6.3, excipients were mentioned in 78% inserts, incompatibility in 49% inserts, shelf life in the product package for sale was present in 28%, shelf life after dilution in 30%. Conclusion: Our study concluded that only a few inserts contained all the headings of Section 6.2 and 6.3 of Drug and Cosmetic Act (1945). Completeness of information has improved a lot as compared to past, still a lot needs to be done so that patients can derive maximum benefit from them. This demands strict scrutiny of inserts by regulatory authorities.