000			a
999			_c9821 _d9821
003			OSt
005			20191023092112.0
008			191023b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_910054 _aTippavajhala, Vamshi Krishna
245			_aCritical and Comparative Study on Patient Information Leaflet, Primary Label and Primary Carton of a Carbapenem Dry Powder Injectable
250			_aVol.53(1), Jan-Mar
260			_aBengaluru _bIndian journal of pharmaceutical education and research _c2019
300			_a178-185p.
520			_aIntroduction: 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.
650		0	_94639 _aPHARMACEUTICS
700			_910055 _aLalit Kumar
773	0		_dBengluru Association of Pharmaceutical Teachers of India (APTI) _tIndian journal of pharmaceutical education and research _x0019-5464
856			_uhttps://www.ijper.org/sites/default/files/IndJPhaEdRes_53_1_178.pdf _yClick here
942			_2ddc _cAR