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Published on:January 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(1):178-185
Original Article | doi:10.5530/ijper.53.1.23

A Critical and Comparative Study on Patient Information Leaflet, Primary Label and Primary Carton of a Carbapenem Dry Powder Injectable


Authors and affiliation (s):

Vamshi Krishna Tippavajhala1, Lalit Kumar1, Muddukrishna Badamane Sathyanarayana2, Girish Thunga3, Viji Pulikkel Chandran3, Sohil Khan4, Girish Pai Kulyadi1,*

1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka– 576104, INDIA.

2Department of Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka–576104, INDIA.

3Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka– 576104, INDIA.

4School of Pharmacy and Pharmacology, Quality Use of Medicines Network, Menzies Health Institute, Griffith University, Gold Coast, AUSTRALIA.

Abstract:

Introduction: The main aim of this project was to study the patient information leaflets (PIL), primary labels (PL) and primary cartons for their adequacy, harmonization of printed text matter meeting regulatory requirements. Methods: The study involved comparative evaluation of PIL, PL and primary cartons of generic and innovator brands. Three different marketed brands of Meropenem for Injection IP were considered for this research study which include the innovator product, coded as brand A and two generic products coded as brands B and C respectively. Additionally, a survey was conducted among nurses to check their awareness on errors in PIL’s. Results: The study revealed that innovator product’s PIL, PL and primary carton was free of critical, major and minor observations. However, generic brands PIL, PL and primary cartons were found to have all the three types of observations. Owing to routine work load and busy hospital ward activities, nursing staff were unaware of the errors found in the PIL’s and assumed that the information was reliable. Conclusion: It’s necessary to assure uniform and standard text matter content across PIL, PL and primary cartons thus, avoiding misleading information to healthcare professionals and patients.

Key words: Patient information leaflet, Primary label, Primary carton, Text matter, Harmonization.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs