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.

Original languageEnglish
Pages (from-to)178-185
Number of pages8
JournalIndian Journal of Pharmaceutical Education and Research
Volume53
Issue number1
DOIs
Publication statusPublished - 01-01-2019

Fingerprint

Carbapenems
Powders
Injections
meropenem
Nursing Staff
Workload
Nurses
Delivery of Health Care
Research

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

@article{45b2eea95fd24dc19c397802dae7d261,
title = "A critical and comparative study on patient information leaflet, primary label and primary carton of a carbapenem dry powder injectable",
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.",
author = "Tippavajhala, {Vamshi Krishna} and Lalit Kumar and Sathyanarayana, {Muddukrishna Badamane} and Girish Thunga and Chandran, {Viji Pulikkel} and Sohil Khan and Kulyadi, {Girish Pai}",
year = "2019",
month = "1",
day = "1",
doi = "10.5530/ijper.53.1.23",
language = "English",
volume = "53",
pages = "178--185",
journal = "Indian Journal of Pharmaceutical Education and Research",
issn = "0019-5464",
publisher = "Association of Pharmaceutical Teachers of India",
number = "1",

}

TY - JOUR

T1 - A critical and comparative study on patient information leaflet, primary label and primary carton of a carbapenem dry powder injectable

AU - Tippavajhala, Vamshi Krishna

AU - Kumar, Lalit

AU - Sathyanarayana, Muddukrishna Badamane

AU - Thunga, Girish

AU - Chandran, Viji Pulikkel

AU - Khan, Sohil

AU - Kulyadi, Girish Pai

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85062101638&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85062101638&partnerID=8YFLogxK

U2 - 10.5530/ijper.53.1.23

DO - 10.5530/ijper.53.1.23

M3 - Article

VL - 53

SP - 178

EP - 185

JO - Indian Journal of Pharmaceutical Education and Research

JF - Indian Journal of Pharmaceutical Education and Research

SN - 0019-5464

IS - 1

ER -