Analytical Evaluation Of Drug Package Inserts

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dc.contributor.authorPatel, Sanskruti Jen_US
dc.contributor.authorDumra, Gurusharan H.en_US
dc.contributor.authorSingh, Adarshjiten_US
dc.date.accessioned2020-01-02T06:24:18Z
dc.date.available2020-01-02T06:24:18Z
dc.date.issued2019-01
dc.description.abstractIntroduction: Package inserts are officially approved documents accompanying the drug which intends to provide information on safety and effectiveness of the product. This information is in accordance to country specific regulatory guidelines. It serves as a source of information to both users and prescribers. Hence the information incorporated has to be optimal to avoid medication errors.Objectives: Evaluate the package inserts for completeness of information according to heading mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945.Methods: Package inserts were collected from five pharmacies on request over a duration of 1 month and were analysed for the completeness of information according to Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. Information if present under the defined header, was scored one and zero if not. Total score ofeach header was calculated by adding the score from the individual package insert.Results: 80 package inserts were included in the study. None of the reviewed package inserts contained all the headers as required by the Drugs and Cosmetics Act. Total 16 headings were evaluated under both Section 6.2 and 6.3, highest value for the presence of heading were 15 out of 16 headers. That shows the best value of compliance was 93.75%.Conclusion: Present study encountered incompleteness of information in the package inserts. It is, therefore recommended that regulatory body should strengthen rules and regulations for the pharmaceutical companies to increase the compliance of adequacy of information in their package inserts to ensure rationale, effective and safe use of medicinesen_US
dc.identifier.affiliationsFirst Year Postgraduate Resident, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad,Gujarat-380008,Indiaen_US
dc.identifier.affiliationsAssociate Professor, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad,Gujarat-380008,Indiaen_US
dc.identifier.affiliationsProfessor and Head, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad,Gujarat-380008,Indiaen_US
dc.identifier.citationPatel, Sanskruti J, Dumra, Gurusharan H., Singh, Adarshjit. Analytical Evaluation Of Drug Package Inserts. Society Of Medical Sciences. 2019 Jan; 21(32): 1-10en_US
dc.identifier.issn0975-8917
dc.identifier.issn2249-7935
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/190110
dc.languageenen_US
dc.publisherSociety Of Medical Sciencesen_US
dc.relation.issuenumber32en_US
dc.relation.volume21en_US
dc.titleAnalytical Evaluation Of Drug Package Insertsen_US
dc.typeJournal Articleen_US
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