Critical evaluation of drug promotional literature using the WHO guidelines: A hospital-based, cross-sectional, and observational study

Abstract

Background: Drug promotional literatures (DPLs) offered by pharmaceutical companies are crucial tools for promoting their products to prescribers. The printed DPLs distributed by pharmaceutical companies are frequently biased, according to numerous studies. Aims and Objectives: The study was undertaken with the objective of evaluating the accuracy of the DPL using the World Health Organization (WHO) criteria. Materials and Methods: A cross-sectional and observational study of 6-month duration was carried out in the outpatient departments of a tertiary care hospital to analyze the DPL of different pharmaceutical companies using the WHO criteria for “Ethical criteria for medicinal drug promotion, 1988.” Microsoft Excel was used for the analysis of descriptive statistics. Results: A total of 246 (75.5%) brochures satisfied more than 50% of the WHO criteria. References to scientific literature 146 (44.8%); efficacy information 60 (18.4%); side effects and major adverse drug reactions (ADRs), precautions, warnings and contraindications, and major drug interaction 76 (23.3%), 54 (16.6%), and 56 (17.2%) respectively; exaggerated claims 112 (34.5%); fixed dose drug combination promotion 221 (67.5%); single DPL with multiple drug promotion 104 (31.9%) were the relevant percentage distribution of various components of the total DPLs analyzed in the study. Conclusion: The pharmaceutical companies adequately advertise their brand and generic names, and dose and dosage forms but lack the adequacy and accuracy in the safety and efficacy information, and the source of literature in their respective drug promotional materials.