Published: 2020-02-25

A study on the evaluation of drug package inserts: a prospective observational study

Anita Hiraman Yuwnate, Ananya Chakravorty


Background: The package inserts are an important source of information for the patient and the prescribers which are often incomplete in terms of information. Not many of them are patient friendly, usage of technical terms further complicates the scenario amidst inadequate doctor-patient ratio. Aim of the study was to evaluate the completeness of package inserts.

Methods: Hundred package inserts were collected from June 2018 to September 2018 from nearby pharmacies and drug store of a tertiary care hospital, Government Medical College, Akola and evaluated in terms of completeness as per guidelines mentioned in the section D of Drug and Cosmetics Act 1945, language used and addressed to whom. Each guideline followed under section D was given a score of 1 and absence 0 depending upon which grouped as Grade A (>15), Grade B (10-15), Grade C (<10). Result was analysed in Microsoft Excel 2010 expressed in percentage and whole numbers.

Results: Out of the 100 package inserts evaluated the guidelines like mentioning of special circumstances like pregnancy was present in (98%), undesirable effects in 98%. All of them used English with 3% having combination with regional language, 70% had no mention as to whom it is addressed. Grades allotted after evaluation A, B, C, 24%, 74%, 2%.

Conclusions: The present study showed though improvement occurred deficiencies should be corrected and properly scrutinised for better compliance of the patient and effective drug use and to step up the healthcare services in society.


Addressed to whom, Language used, Package inserts, Section D of drug and cosmetics act 1945

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