Evaluation of drug promotional literature for abbreviated prescribing information using WHO and OPPI guidelines in a tertiary care hospital: a cross sectional study

Dr. Priyanka M Tawte; Dr. Pramod D Shankpal; Dr. Nishikant H Madkholkar

Volume : X, Issue : VII, July - 2020

Evaluation of drug promotional literature for abbreviated prescribing information using WHO and OPPI guidelines in a tertiary care hospital: a cross sectional study

Dr. Priyanka M Tawte, Dr. Pramod D Shankpal, Dr. Nishikant H Madkholkar

Abstract :

Background – Pharmaceutical companies are competing for development and marketing of drugs and spend huge amount of money on drug promotions. WHO has laid down ethical criteria for medicinal drug promotion and pharmaceutical industries have to implement these guidelines. In India, promotional activities by pharmaceutical companies are governed by Organization of Pharmaceutical Producers of India(OPPI), a self–regulatory code of pharmaceutical marketing practices. It is essential to critically and scientifically evaluate the drug promotional literature as this may affect drug prescription and utilization. Objective – Evaluate the completeness of drug promotional literature using WHO guidelines and completeness of abeviated prescribing information in drug promotional literature material using OPPI guidelines. Methods – 130 drug promotional literatures were randomly taken from different outpatient departments and were screened. Results – None of drug promotional literature fulfilled all WHO criteria. The name of the active ingredient and and name, content of active ingredient per dosage were featured in 100% of literature, name and address of pharmaceutical company were mentioned in 64%, abeviated prescribing information(API) was present in 42%, and references were mentioned in 76% of drug promotional literatures. Out of 46 drug promotional literatures in which API was present, indications were listed in 95.65%(44/46), dosage, method of use and contraindications featured in 100%, precautions and side–effects present in 4.34%(2/46). Conclusion – Most of the Pharmaceutical companies do not follow WHO and OPPI guidelines for promotion of their product in India. Therefore strict regulations should be made for proper promotion of information about drug product.