Introduction:

Drug Promotional Literatures (DPLs) are major marketing tools to promote drugs by pharmaceutical companies. World Health Organization (WHO) guidelines for ethical medicinal drug promotion dictate that promotional literature should contain certain information. Many previous studies were conducted in India to evaluate the DPLs. These studies found that the information provided is not consistent with the code of ethical promotion.

Recent studies, however, have not evaluated the various claims presented in the DPLs. With this background, this study was undertaken to evaluate the rationality of DPLs as per WHO criteria, and also to analyze the claims in detail.

Objectives:

The study was aimed to evaluate DPLs for accuracy of the information, and criteria for ethical medicinal drug promotion using WHO guidelines. Claims made in the literature along with their references were also evaluated in detail.

Material and Methods:

This was an observational and cross–sectional study. It was conducted over a period of 4 months. DPLs were collected from various clinical departments at Vydehi Institute of Medical Sciences and Research Centre, Bangalore, India. Two independent researchers evaluated them. In addition to the fulfillment of “WHO criteria, 1988,” the DPLs were also evaluated for the type of claims, and pictorial content presented and the references.

Results:

A total of 155 DPLs were evaluated. Indications for use and safety information was mentioned in only 73.54% and 36.13% of the literature respectively. Only 26 (16.77%) of the DPLs had mentioned description of pharmacological effects, and 14 (9.03%) had mentioned about the pharmacokinetic parameters of the drugs. 769 claims were found from 155 DPLs, which were supported by 402 references. Only one DPL was without claims. Out of these references 91.62% were from Journal articles. The quality of all DPLs was good but font sizes in some were very small making it difficult to read. Overall, none of the DPLs fulfilled all WHO criteria.

Conclusion:

It was concluded from this study that nothing has changed in the last the last ten years. Pharmaceutical industries did not follow WHO guidelines while promoting their drug products. Now days, companies promote and advertise products through innovative content in respective electronic devices. Awareness of prescribers on unethical promotion is important. Both company and stake holders should join hands, as patient benefit is the ultimate goal