Ethical compliance of drug promotional literature using WHO criteria: Implications for medicines policy and rational use

Drug promotional literature (DPL) is one of the most common sources of drug information for healthcare professionals. However, incomplete or selective presentation of information may prevent balanced clinical decision making and compromise safe use of drugs. Accurate and evidence-based communication has set standards, embodied in the World Health Organization (WHO) Ethical Criteria for Medicinal Drug Promotion. The study examined the ethical compliance of DPLs and its implications for pharmaceutical policy. We performed a prospective descriptive content analysis at a single tertiary-care healthcare facility in India. Printed DPLs obtained from outpatient departments over a period of five months were included. Unique materials were assessed according to WHO ethical criteria. Descriptive statistics were used to summarize the presence of essential informational elements, and a WHO-compliance index was developed to assess overall compliance. All 270 DPLs reviewed included basic product identifiers. However, information on safety and evidence was reported inconsistently. 24% of materials contained information about adverse drug reactions (ADRs), 20% about contraindications, 20% about drug interactions and 53% about scientific references. Most claims (73%) were about therapeutic efficacy and fewer (27%) about safety and cost. In general, most materials only partially complied with WHO standards. Promotional materials highlighted benefits and downplayed risks and supporting evidence. Although prescribing and economic outcomes were not directly assessed, these information gaps may lead to sub-optimal treatment decisions and inefficient use of resources. As this was a single-center study, the results may have limited generalizability. But the findings highlight the need for increased regulatory oversight, institutional monitoring and periodic audits consistent with WHO norms to encourage rational use of medicines and inform pharmaceutical policy.