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Original Research

Online Publishing Date:
10 / 08 / 2023

 


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 (<20) based on the degree of completeness and scores obtained. Data were analyzed in Microsoft Excel, expressed in percentages and whole numbers.

Results: Out of 100 PIs, majority (23%) were antimicrobials, followed by bronchodilators (12%). Most of them (86%) were oral preparations, followed by injectable (12%) and topical (2%). On evaluation, 19% of them belonged to Grade A, 78% to Grade B and 3% to Grade C. There were deficiencies in clinical data regarding: Last update (37%), the effect of the ability to drive/use machines (42%), use in pediatric and geriatric information (46%). 49% of them lack information on shelf life. 19% of PIs were from multinational companies and 81% were from Indian companies.

Conclusion: As PIs are incomplete as per regulatory guidelines, it is essential to improve the standards of preparing and monitoring PIs for avoiding medication errors.

Key words: Package Inserts; Drug Information; Drug and Cosmetic Act; Medication Error


 
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How to Cite this Article
Pubmed Style

Cherian CS, Joseph LR, Pillai SR. Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. Natl J Physiol Pharm Pharmacol. 2024; 14(2): 377-381. doi:10.5455/njppp.2023.13.06310202331072023

Web Style

Cherian CS, Joseph LR, Pillai SR. Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. https://www.njppp.com/?mno=156448 [Access: March 14, 2024]. doi:10.5455/njppp.2023.13.06310202331072023

AMA (American Medical Association) Style

Cherian CS, Joseph LR, Pillai SR. Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. Natl J Physiol Pharm Pharmacol. 2024; 14(2): 377-381. doi:10.5455/njppp.2023.13.06310202331072023


Vancouver/ICMJE Style

Cherian CS, Joseph LR, Pillai SR. Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. Natl J Physiol Pharm Pharmacol. (2024), [cited March 14, 2024]; 14(2): 377-381. doi:10.5455/njppp.2023.13.06310202331072023


Harvard Style

Cherian, C. S., Joseph, . L. R. & Pillai, . S. R. (2024) Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. Natl J Physiol Pharm Pharmacol, 14 (2), 377-381. doi:10.5455/njppp.2023.13.06310202331072023


Turabian Style

Cherian, Chinju Sara, Liya Roslin Joseph, and Santosh Ramakrishnan Pillai. 2024. Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. National Journal of Physiology, Pharmacy and Pharmacology, 14 (2), 377-381. doi:10.5455/njppp.2023.13.06310202331072023


Chicago Style

Cherian, Chinju Sara, Liya Roslin Joseph, and Santosh Ramakrishnan Pillai. "Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India." National Journal of Physiology, Pharmacy and Pharmacology 14 (2024), 377-381. doi:10.5455/njppp.2023.13.06310202331072023


MLA (The Modern Language Association) Style

Cherian, Chinju Sara, Liya Roslin Joseph, and Santosh Ramakrishnan Pillai. "Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India." National Journal of Physiology, Pharmacy and Pharmacology 14.2 (2024), 377-381. Print. doi:10.5455/njppp.2023.13.06310202331072023


APA (American Psychological Association) Style

Cherian, C. S., Joseph, . L. R. & Pillai, . S. R. (2024) Critical evaluation of clinical and pharmaceutical information provided with medicinal package inserts in South India. National Journal of Physiology, Pharmacy and Pharmacology, 14 (2), 377-381. doi:10.5455/njppp.2023.13.06310202331072023


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