Journal of Pharmacovigilance

Evaluating the rationality of claims made in drug promotional literature in West Chennai

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Pavithira Sekar, K Punnagai and Darling Chellathai David

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

Objective: The study was aimed to evaluate the adequacy of information provided by drug promotional literatures using WHO criteria. They were also evaluated for the quality, types of claims and the genuineness of references cited in support of these claims in these literatures. Materials and Methods: 412 drug promotional literatures were collected from 20 busy physicians in the western part of Chennai from their private clinics. In addition to the fulfillment of ?WHO criteria, 1988?, we examined the brochures for the quality of coverage using a pre-tested and pre-validated checklist and types of claims and the genuineness of references cited were evaluated for the retrievability and authenticity. Results: None of the promotional literature fulfilled all the WHO criteria. 91.2% of leaflets satisfied the 4 WHO criteria namely, the brand name, generic name, approved therapeutic uses, name and address of the manufacturer. Most neglected aspect of drug promotion was information regarding Adverse Drug Reactions, drug interactions, precautions and over dosage (<10%). Out of 412 leaflets collected, the quantitative research methods were mentioned in 67(16.2%). Cardiovascular drugs and nutritional supplements were the most promoted drug groups (23% & 17% respectively). A total of 954 claims were made in the 412 drug promotional literatures. References were cited in 47% of the literature of which 96% were from indexed journal and were retrievable. Conclusion: Drug promotional literature analyzed by this study was inadequate in terms of their adequacy, quality and genuineness of coverage. Thus, the pharmaceutical companies did not follow the WHO guidelines while promoting their products, thus aiming to satisfy their commercial motive rather than fulfilling the educational aspect of promotion.

Biography :

Pavithira Sekar completed her MBBS at the age of 24 years from Tamil Nadu Dr. M.G.R. Medical University and is currently pursuing her Post-graduation in Pharmacology from Sri Ramachandra University and Research Institute. She completed a research on evaluating the antioxidant potentials of hedyotisdiffusa by an in vitro study. Currently, she is working on a research project in comparing the efficacy of Gabapentin and Amitriptyline in diabetic neuropathy.