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ABSTRACT
| Title |
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SCOPE OF IMPROVEMENT OF PATIENT INFORMATION LEAFLETS IN RANDOMLY SELECTED THERAPEUTIC CLASSES OF DRUGS |
| Authors |
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Kanad Deepak, Ankit Gaur |
| Keywords |
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Drug package inserts, Direct-to-consumer pharmaceutical advertising, Patient information leaflets, Drug information leaflets. |
| Issue Date |
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Mar 2018 |
| Abstract |
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Background: Patient information leaflets (PILs) or drug package inserts are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines. Objective: The objective of this study was to point out a wide-scope of improvement in manufacturer’s way of presentation so that maximum benefits can be achieved by both the manufacturers and the consumers. Materials & Methods: The survey was conducted in the southern region of Moga, Punjab, India over a period from July 2017 to January 2018. Leaflets were sought from pharmacies located in the region for drug products. The clinical information included in the package inserts was analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945. The completeness of information was verified by comparing it with product monograph. We also tried to find out the “Scope of Improvement” of the product and scored regarding 10 different attributes under a Binary Scale Method. Result: The 50 patient information leaflets studied included 25 oral, 15 injectable, and 10 topical preparations marketed by 50 different pharmaceutical companies in India. None of the reviewed inserts contained all 17 sections as required by the Drugs and Cosmetics Act. The best value of compliance was 82%. Only 16% of the inserts contained instructions for use of the medicinal product. However, shelf life after dilution and shelf life after first opening the container was given much less importance as compared to the shelf life as packed for sale. Incompatibilities were provided only in 30% of the inserts. In case of "Scope of Improvement". The obtained information content was scored out of 10 and was found to be in the average score range of maximum 6.2 (scored by Antihypertensives) to minimum 3.4 (scored by Vitamin Supplements). Conclusion: Labels of medicines without sufficient information can be dangerous and inefficient in use by the consumers. Therefore there is a need to frame strict regulations and focus on its proper implementation to make the labels standard and of maximum-benefit both for producers and consumers |
| Page(s) |
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46-50 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 9, No.03 |
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