Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India
Chinju Sara Cherian, Liya Roslin Joseph, Santosh Ramakrishnan Pillai.
Abstract
Background: Package inserts (PIs) are source of drug information provided for the effective use of marketed drugs by prescribers and patients.
Aims and Objectives: This study was done to evaluate the completeness of information provided in medicinal PIs.
Materials and Methods: This descriptive study was done using 100 PIs collected from the drug store in a tertiary care hospital located in South Kerala for 2 months. They were evaluated in terms of completeness as per the criteria mentioned in Schedule D of the Drug Cosmetic Act 1945 and graded into Grade A (>20), Grade B (10–20), and Grade C (
Key words: Package Inserts; Drug Information; Drug and Cosmetic Act; Medication Error
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