Open AccessInformation adequacy of medicine package inserts in India: A critical evaluation
Author(s) -
Bikramjit Barkondaj,
Kaushik Mukhopadhyay,
Somak Kumar Das,
Chandan Chatterjee,
Sonali Mukherjee,
Avijit Hazra
Publication year - 2021
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/picr.picr_177_18
Subject(s) - checklist , package insert , observational study , formulary , medicine , statutory law , pharmacy , interquartile range , food and drug administration , family medicine , business , actuarial science , medical emergency , psychology , pharmacology , surgery , political science , law , cognitive psychology
Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market.