Analysis of Drug Promotional Literature Against WHO Ethical Criteria for Medicinal Drug Promotion

Abstract

Aim: To analyse drug promotional literature available in a tertiary care teaching hospital using the WHO Ethical Criteria for Medicinal Drug Promotion.

Materials and Methods: A cross-sectional observational study was conducted in the Departments of Pharmacology and ENT at MMIMSR, MMDU, Mullana. A total of 300 drug promotional literature (DPL) brochures related to allopathic medicines were collected from various clinical departments and evaluated according to the WHO Ethical Criteria for Medicinal Drug Promotion. Promotional claims were categorized into efficacy, safety, cost-effectiveness, convenience, pharmacokinetic properties, pharmaceutical properties, and exaggerated claims. Data were analysed using SPSS version 22.0 and expressed as frequencies and percentages.

Results: Single-drug formulations constituted 59.67% of promotional materials, while fixed-dose combinations accounted for 40.33%. Cardiovascular (18.67%) and endocrine (18.3%) drugs were the most frequently promoted therapeutic categories. Efficacy-related claims were the most common (47.3%), followed by safety claims (19.0%), whereas 7.7% of advertisements contained exaggerated or unjustified claims. Brand name (100%), dosage form (100%), generic name (98.7%), and manufacturer details (99%) were reported in most brochures. However, essential safety information was incompletely presented, with contraindications mentioned in 62.7%, warnings in 55%, precautions in 50%, and drug interactions in 54% of the promotional materials. Scientific references were cited in only 45% of brochures. None of the promotional materials fulfilled all WHO ethical criteria.

Conclusion: Drug promotional literature demonstrated only partial compliance with WHO Ethical Criteria for Medicinal Drug Promotion. While basic product information was generally adequate, important safety information and scientific evidence were frequently omitted. Regular monitoring of pharmaceutical promotional materials and training healthcare professionals in the critical appraisal of DPL are essential to promote rational, evidence-based prescribing.