Analytical evaluation of drug package inserts in India.
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Date
2015-03
Journal Title
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Abstract
Background: A drug package insert or prescribing information is a document
provided along with a prescription medication to provide additional information
about that drug. Drug package inserts are approved by the administrative licensing
authority. A package insert is intended to provide information for the safe and
effective use of the respective drug. Product information provided by pharmaceutical
companies has been determined to be far from adequate and not conforming with
requirement of Indian regulatory. Hence, it was decided to conduct a study to assess
the presentation and completeness of clinically important information provided in
the currently available package inserts in India.
Methods: Package inserts were provided by five pharmacies on request. The
package inserts were collected in 10 weeks’ period and then they were analyzed
for presentation and completeness of clinical information according to heading
mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. If
the information was present under relevant heading, it was scored as one. Otherwise
as score of zero was assigned. Total score for each heading was calculated by adding
the score from the individual package inserts.
Results: 70 package inserts were included in the study. None of the reviewed package
inserts contained all the sections as required by the Drugs and Cosmetics Act. Total
15 headings were evaluated under both Section 6.2 and 6.3, highest value for the
presence of heading were 12 out of 15 heading evaluated. That shows the best value
of compliance was 80%.
Conclusion: Accurate drug product information is important for the safe and effective
use of medicines. Hence, pharmaceutical companies and regulators should ensure
that accurate and up to date product information is provided in the package inserts.
Description
Keywords
Drug package inserts, Drug & Cosmetic Act, Prescribing information
Citation
Solank Sandip Natwarlal, Chhaiya Sunita B, Mehta Dimple S, Trivedi Madhav, Acharya Tejas, Patel Dhwani. Analytical evaluation of drug package inserts in India. International Journal of Basic & Clinical Pharmacology. 2015 Mar-Apr; 4(2): 322-324.