ArticleJournal of family medicine and primary care2023
Are we providing complete drug information to its users? Status of information adequacy of package insert in India.
Article in Journal of family medicine and primary care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- Need of hours for drug disposal information with package inserts.Journal of family medicine and primary care · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 ( Conclusion: Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.