View                 Download                 XML
Title : AN EVALUATION OF PACKAGE INSERTS OF ANTIMICROBIAL AGENTS MARKETED IN INDIA
Authors : Patel Suhani V, Desai Chetna K, Patel Prakruti P, Dikshit Ram K
Abstract : PI (n=123) of marketed AMA were collected over 6 months period. Quality of information presented was assessed and scores were given for adherence to Indian i.e. Schedule D of Drugs and Cosmetics Rules, 1945 (DCR) of India (0- 20) and US guidelines (0- 35). Adequate font size was printed in 50% PI. Only 4% PI were complete as per DCR. Adequate information on contra-indications (25%), use during pregnancy/lactation (82%), warning/precautions (92%), drug-drug (59%) and drug-food interactions (36%), adverse drug reactions (61%), effect on ability to drive/use machines (17%), overdosage (36%), uses (48%), pharmacodynamic (32%) and pharmacokinetic properties (61%), use in children (80%) and elderly (52%), preclinical study data (33%), post- marketing surveillance data (7%), references (12%), recent major changes (10%) and patient counseling information (16%) was included in few PI. A more meticulous approach in preparation of PI to include approved, essential, accurate, evidence-based and updated prescribing information is needed.

A PHP Error was encountered

Severity: Notice

Message: Undefined index: HTTP_REFERER

Filename: views/issue_title.php

Line Number: 65

Backtrace:

File: /var/www/html/pharmascholars-com/app_psl/views/issue_title.php
Line: 65
Function: _error_handler

File: /var/www/html/pharmascholars-com/app_psl/controllers/PSL.php
Line: 144
Function: view

File: /var/www/html/pharmascholars-com/index.php
Line: 293
Function: require_once

">Back