Development and validation of patient information leaflet

Laddha, Avinash and Acharya, Leelavathi D and Thunga, Girish (2012) Development and validation of patient information leaflet. Indian Journal of Hospital Pharmacy, 49. pp. 72-78. ISSN 0019-526X

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Abstract

Introduction: Patient Information Leaflets (PILs) is one of the best methods to educate the patient about their condition and medicines. These leaflets provide the essential information which patients need to enable them to use the medicine safely and gain the most benefit. User evaluation testing is one of the most commonly used method to identify the quality of PILs. Objective: The objectives of this study were to develop patient information leaflet for metformin and to perform user testing of these developed leaflets. Methodology: The study was conducted in medical affairs and clinical research department of Ranbaxy Laboratories Ltd., Gurgoan, India. Inclusion criteria for participants were people, age betwween 22-65 years, new users or people who do not normally use medicines, non-technical persons and people having basic knowledge of English language. Exclusion criteria for participants were people who have previously taken or are currently taking the respective medicine for the PIL being tested and people who are engaged with health care related activities. Patients Information Leaflets for metformin was drafted based on the information available in the Summary of Product Characteristics (SmPC) of metformin and it is validated for its readability and comprehensibility. Results: Pilot study on metformin leaflet was performed on two users and no significant problems were addressed during this procedure. Hence first round and second round testing was done for readability and comprehensibility of leaflet through the questionnaires on 10 users. Based on quantitative and qualitative results minor revisions were done. Conclusion: The purpose behind this present study was to prepare the good quality Patient Information Leaflet and to follow the user testing method as per European guidelines on Indian population.

Item Type: Article
Uncontrolled Keywords: Patient information leaflet; metformin; quality; user evaluation testing; readability; comprehensibility.
Subjects: Pharmacy > MCOPS Manipal > Pharmacy Practice
Depositing User: KMC Manipal
Date Deposited: 25 Jun 2015 04:22
Last Modified: 25 Jun 2015 04:22
URI: http://eprints.manipal.edu/id/eprint/143128

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