Analytical Evaluation of Drug Package Inserts

Indian Journal of Applied Basic Medical Sciences
Year: 2019, Volume: 21(A), Issue. (1), January
First page: (473) Last page: (486)
Online ISSN: 2249-7935
Print ISSN: 0975-8917
doi:

Analytical Evaluation of Drug Package Inserts
Sanskruti J Patel1, Gurusharan H. Dumra2*, Adarshjit Singh3
1First Year Postgraduate Resident,2Associate Professor,3Professor and Head, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad,Gujarat-380008,India
Corresponding author email id: gurusharandumra@gmail.com

Online Published on 02-Jan-2019

ABSTRACT

Introduction: 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 of each 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 medicines.

Keywords

Drug package inserts, Drug and Cosmetic Act, Prescribing information

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