Medication Package inserts, concept among doctors pharmacists and laypersons- A beneficial guidance or a source of confusion

Kafeel, Huda

doi:10.31254/jmr.2016.2305

Cited by 3 publications

(2 citation statements)

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“…All these emerging issues aggravate the need of providing a detailed PI in every drug formulations. Several studies have demonstrated that a good PI with accurate reliable and approved information can provide a desirable better health outcome (Khafeel et al) [4].…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of Patient Package Insert of Marketed Brands of Antibiotic Eye Drops

VK¹,

DESHPANDE²,

NAYAK³

et al. 2022

Asian J Pharm Clin Res

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Objective: In Indian scenario, there is a huge gap between the patient and health care workers leading to self-medication practices, antibiotic resistance, and adverse drug reactions. These emerging issues aggravate the need of providing a detailed package inserts (PI) in every drug formulations. Hence, this study was conducted with the objective to assess the completeness of a package insert and evaluate the content of information in PI among national and international pharmaceutical brands. Methods: A prospective, cross-sectional, and observational study was conducted over 50 PI belonging to different class of antibiotic eye drops and same antibiotic from different pharmaceutical companies. Medication belonged to both international and national pharmaceutical companies and they were evaluated according to standards laid down by Drugs and Cosmetic Act (1940) and Rules (1945) covered under the section 6.2 and 6.3. Results: The content of information was haphazard in both national and international PI but international PI was more valuable. International PI had clear information regarding warning and precautions and adverse effects. List of excipients, shelf life, storage indication, and handling were very well demarcated in both the level of pharmaceuticals. Conclusions: The study revealed major lacunae in the context of package insert with reference to prevailing guidelines. The most of the brands did not have PI and the quality of information in package insert of international brand was more superior to national brands.

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Section: Introductionmentioning

confidence: 99%

Comparative Study of Patient Package Insert of Marketed Brands of Antibiotic Eye Drops

VK¹,

DESHPANDE²,

NAYAK³

et al. 2022

Asian J Pharm Clin Res

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show abstract

“…3 A survey based study done by Kafeel et al analyzed that 75.6% responders believed that reading package inserts affect health outcomes. 4 It is written in a non-promotional, nonmisleading and easy to understand language. In India, the standards of package insert are formalized by the 'drugs and cosmetics act (1940) and rules (1945).…”

Section: Introductionmentioning

confidence: 99%

Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective

Vikas

Gupta

2020

Int J Basic Clin Pharmacol

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Background: A package insert (PI) should contain all the information required for safe and effective use of the medicine. The present study evaluated and compared the completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies based in India.Methods: A total 150 PI’s consisting of 75 package inserts of Indian and foreign multinational pharmaceutical companies in India were collected and analyzed based on the criteria of Indian drugs and cosmetics rules, 1945 under section 6.2, 6.3 of schedule D, which consists of 25 parameters. Each criteria was scored for presence of information as ‘1’, absence as ‘0’. Total score was 25, score >20 was graded as ‘A’, 10-20 as ‘B’ and <10 as ‘C’. Data was expressed as numbers and percentage.Results: Total 150 PI evaluated included antimicrobials, antipsychotics etc. Out of all the PIs 26% belonged to grade A, 70% belonged to grade B and 4% belonged to grade C. Lack of information was found in both the categories of PIs. Foreign PIs performed better in comparison to Indian PIs as in grade A, 27 out of 41 PIs were foreign whereas 56 PI’s in grade B were Indian and 47 were foreign. Both categories of PI showed good information about active ingredient, dosage form, warnings, contraindications and lacked information about retail price and references etc.Conclusions: Both categories of PIs were deficient in completeness of information. The pharmaceutical companies, both national and foreign, must provide the information as per regulatory norms.

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Bioavailability of dronedarone tablets administered with or without food in healthy participants

Naccarelli,

McKindley,

Rashkin

et al. 2024

American Heart Journal Plus: Cardiology Research and Practice

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Medication Package inserts, concept among doctors pharmacists and laypersons- A beneficial guidance or a source of confusion

Cited by 3 publications

References 0 publications

Comparative Study of Patient Package Insert of Marketed Brands of Antibiotic Eye Drops

Comparative Study of Patient Package Insert of Marketed Brands of Antibiotic Eye Drops

Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective

Bioavailability of dronedarone tablets administered with or without food in healthy participants

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