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Information adequacy of medicine package inserts in India: A critical evaluation

OBJECTIVES: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level o...

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Autores principales: Barkondaj, Bikramjit, Mukhopadhyay, Kaushik, Das, Suvajit, Chatterjee, Chandan, Mukherjee, Sonali, Hazra, Avijit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112326/
https://www.ncbi.nlm.nih.gov/pubmed/34012905
http://dx.doi.org/10.4103/picr.PICR_177_18
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author Barkondaj, Bikramjit
Mukhopadhyay, Kaushik
Das, Suvajit
Chatterjee, Chandan
Mukherjee, Sonali
Hazra, Avijit
author_facet Barkondaj, Bikramjit
Mukhopadhyay, Kaushik
Das, Suvajit
Chatterjee, Chandan
Mukherjee, Sonali
Hazra, Avijit
author_sort Barkondaj, Bikramjit
collection PubMed
description OBJECTIVES: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. MATERIALS AND METHODS: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. RESULTS: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15–19). Deficiencies were observed under important headings. For example, “references” were mentioned in only 6.67% and “date of last updating” in only 19.26% of PIs. Other notable shortcomings were in “disposal” (not mentioned in 92.59%), “effects on ability to drive and use machines” (76.30%), “pharmaceutical incompatibilities” (66.67%), “shelf life” (62.96%), “excipients” (60.00%), and “overdose” (17.78%) information. Information on “generic name,” “composition,” and “indications” were however provided by all (100%) PIs. CONCLUSIONS: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information.
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spelling pubmed-81123262021-05-18 Information adequacy of medicine package inserts in India: A critical evaluation Barkondaj, Bikramjit Mukhopadhyay, Kaushik Das, Suvajit Chatterjee, Chandan Mukherjee, Sonali Hazra, Avijit Perspect Clin Res Original Article OBJECTIVES: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. MATERIALS AND METHODS: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. RESULTS: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15–19). Deficiencies were observed under important headings. For example, “references” were mentioned in only 6.67% and “date of last updating” in only 19.26% of PIs. Other notable shortcomings were in “disposal” (not mentioned in 92.59%), “effects on ability to drive and use machines” (76.30%), “pharmaceutical incompatibilities” (66.67%), “shelf life” (62.96%), “excipients” (60.00%), and “overdose” (17.78%) information. Information on “generic name,” “composition,” and “indications” were however provided by all (100%) PIs. CONCLUSIONS: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information. Wolters Kluwer - Medknow 2021 2020-05-07 /pmc/articles/PMC8112326/ /pubmed/34012905 http://dx.doi.org/10.4103/picr.PICR_177_18 Text en Copyright: © 2020 Perspectives in Clinical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Original Article
Barkondaj, Bikramjit
Mukhopadhyay, Kaushik
Das, Suvajit
Chatterjee, Chandan
Mukherjee, Sonali
Hazra, Avijit
Information adequacy of medicine package inserts in India: A critical evaluation
title Information adequacy of medicine package inserts in India: A critical evaluation
title_full Information adequacy of medicine package inserts in India: A critical evaluation
title_fullStr Information adequacy of medicine package inserts in India: A critical evaluation
title_full_unstemmed Information adequacy of medicine package inserts in India: A critical evaluation
title_short Information adequacy of medicine package inserts in India: A critical evaluation
title_sort information adequacy of medicine package inserts in india: a critical evaluation
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112326/
https://www.ncbi.nlm.nih.gov/pubmed/34012905
http://dx.doi.org/10.4103/picr.PICR_177_18
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