Information in Package Inserts: A study in Eastern India

Abstract

Introduction: Package insert (PI) is the printed leaflet available with the medicines containing information about the drug based on regulatory guidelines for its safe and effective use. Information in a PI is incorporated since the developmental phase of a pharmaceutical product with careful scrutiny of available information. PI contains evidenced based information about a drug, updated from time to time as soon as relevant preclinical and clinical data were obtained. Various studies had shown poor compliance 50-60% to the medicine prescribed for the treatment of chronic conditions like hypertension, diabetes and dyslipidemia. These diseases proved to be major cause of mortality and morbidity related to cardiovascular diseases in India. The information of the PI has an important impact on patients compliance and hence effectiveness of the drug used and for health professionals they can serve as reliable and accurate sources of drug information. Material and Methods: Present study was observational and Prospective with study duration of 1 month. 93 package inserts were collected from different pharmacies of the Patna on request. Analysis of content of Package Insert was based on criteria laid down by Indian Drug and Cosmetic Rules, 1945 under section 6.2 of schedule D. Result: A total number of 106 PI were received, among which 93 PIs were analysed for the result remaining 13 PIs were discarded due to duplicity and unauthenticity. Out of them, 87 were from Indian pharmaceutical companies and 6 from multinational companies [Graph-2]. All PIs of antihypertensives and hypolipedemic were of oral preparations. Out of 93 PIs 37 were antihypertensives, 34 were antidiabetics and 22 hypolipidemics. Out of 34 anti-diabetic PIs, 22 (59.6%) were oral and 12 (40.4%) were injectable preparations. Out of 93 PIs, 40 (43%) belonged to Grade A (including all injectable preparations) and remaining 53 (57%) to Grade B. No PIs belongs to Grade C.87 PIs were from Indian companies and 6 PIs were from multinational companies. It was observed that more PIs from Indian companies belonged to Grade A. Conclusion : we are facing the pandemic of diseases like hypertension, diabetes mellitus and other diseases. In such situation PI can play a vital role in improving the patient compliance and thereby the prognosis of disease. Hence a smart PI which is complete, reliable and up-to-date is the need of the hour.