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.

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