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Are we providing complete drug information to its users? Status of information adequacy of package insert in India
BACKGROUND: Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as p...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465050/ https://www.ncbi.nlm.nih.gov/pubmed/37649754 http://dx.doi.org/10.4103/jfmpc.jfmpc_1883_22 |
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author | Singhal, Shubha Shah, Rima B. Piparva, Kiran G. Dutta, Siddhartha |
author_facet | Singhal, Shubha Shah, Rima B. Piparva, Kiran G. Dutta, Siddhartha |
author_sort | Singhal, Shubha |
collection | PubMed |
description | BACKGROUND: Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as per Drug and Cosmetic Rule 1945 and US Food and Drug Administration criteria. MATERIALS AND METHODS: A cross-sectional study was conducted on PIs collected from accessible pharmacy stores. Information provided was recorded as per criteria, and total information adequacy score (IAS) and information deficiency (IDS) score were calculated. The association of factors like single-drug/FDCs, a company of origin Indian/multinational, and route of administration (ROA) with IDS was statistically analyzed. RESULTS: Of 120 PIs, 60%, 86.66%, and 73% were single-drug, prescription-drug, and drugs by Indian manufacturers, respectively. Most PIs provided generic names, ROA, and indications for use. 85%, 12%, 29.16%, and 3.33% provided information on PIs on the ability to drive, drug–food interactions, drug–drug interactions, and addiction potential, respectively. Lacking area was information on use in pediatrics–geriatrics (30%), excipients (28.3%), preclinical (15.83%), post-surveillance data (18.33%), and approval date (2.5%). There was a statistically significant difference between pharmaceutical score (3.22 vs 4.12), therapeutic score (11.5 vs 13.18), and total IAS (14.78 ± 3.39 vs 17.31 ± 2.33) of Indian and multinational companies. IDS was statistically significantly different in both pharmaceutical and therapeutic categories for single-drug vs FDCs (P = 0.00001), OTC vs prescription drugs (P < 0.05), and Indian vs multinational companies’ PIs (P = 0.00001). CONCLUSION: Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS. |
format | Online Article Text |
id | pubmed-10465050 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Wolters Kluwer - Medknow |
record_format | MEDLINE/PubMed |
spelling | pubmed-104650502023-08-30 Are we providing complete drug information to its users? Status of information adequacy of package insert in India Singhal, Shubha Shah, Rima B. Piparva, Kiran G. Dutta, Siddhartha J Family Med Prim Care Original Article BACKGROUND: Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as per Drug and Cosmetic Rule 1945 and US Food and Drug Administration criteria. MATERIALS AND METHODS: A cross-sectional study was conducted on PIs collected from accessible pharmacy stores. Information provided was recorded as per criteria, and total information adequacy score (IAS) and information deficiency (IDS) score were calculated. The association of factors like single-drug/FDCs, a company of origin Indian/multinational, and route of administration (ROA) with IDS was statistically analyzed. RESULTS: Of 120 PIs, 60%, 86.66%, and 73% were single-drug, prescription-drug, and drugs by Indian manufacturers, respectively. Most PIs provided generic names, ROA, and indications for use. 85%, 12%, 29.16%, and 3.33% provided information on PIs on the ability to drive, drug–food interactions, drug–drug interactions, and addiction potential, respectively. Lacking area was information on use in pediatrics–geriatrics (30%), excipients (28.3%), preclinical (15.83%), post-surveillance data (18.33%), and approval date (2.5%). There was a statistically significant difference between pharmaceutical score (3.22 vs 4.12), therapeutic score (11.5 vs 13.18), and total IAS (14.78 ± 3.39 vs 17.31 ± 2.33) of Indian and multinational companies. IDS was statistically significantly different in both pharmaceutical and therapeutic categories for single-drug vs FDCs (P = 0.00001), OTC vs prescription drugs (P < 0.05), and Indian vs multinational companies’ PIs (P = 0.00001). CONCLUSION: Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS. Wolters Kluwer - Medknow 2023-07 2023-07-14 /pmc/articles/PMC10465050/ /pubmed/37649754 http://dx.doi.org/10.4103/jfmpc.jfmpc_1883_22 Text en Copyright: © 2023 Journal of Family Medicine and Primary Care 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 Singhal, Shubha Shah, Rima B. Piparva, Kiran G. Dutta, Siddhartha Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title | Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title_full | Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title_fullStr | Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title_full_unstemmed | Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title_short | Are we providing complete drug information to its users? Status of information adequacy of package insert in India |
title_sort | are we providing complete drug information to its users? status of information adequacy of package insert in india |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465050/ https://www.ncbi.nlm.nih.gov/pubmed/37649754 http://dx.doi.org/10.4103/jfmpc.jfmpc_1883_22 |
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