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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Audit of Patient Information Leaflets available with topical medicines for patient use

Author: SUJALBEN PATEL, SUJAL V. PATEL
Abstract: Patient information leaflet (PIL) is an important form of written information which aids the patients and their caregivers to understand the medication prescribed for a disease and the process of administration. However, poorly designed leaflets may lead to lack of adherence to the proposed treatment. Information in PILs must confirm to the highest standards of scientific accuracy, comprehension, and design in such a way that help easy to read and understand. The study was undertaken with the aim of assessing the quality of patient information leaflets of topical preparations of drugs currently available in the market supplied from pharmaceutical manufacturers by analyzing the design and contents and assessing readability. Total 60 patient information leaflets of topical preparations were analyzed with respect to content, design and format. Readability was assessed using Flesch Readability Ease formula. The study showed that 37% of PILs mentioned of side effects and 60% mentioned of warnings.12% PILs mentioned posology and 10% mentioned excipient details. Only 3% leaflets were in different language other than English. The study results also showed that 77% of the PILs were very difficult to read and 2% of PILs had standard readability score. Contents and design needed further improvement for wider acceptance of use by patients. Most PILs were found to have difficulty in reading probably because of less use of vernacular language. Hence, providing a high quality PIL with very good readability, good design and updated contents would increase the adherence to the treatment.
Keyword: Patient Information Leaflet, Package Insert, PIL Readability, PIL Contents
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