A Critical Review of the Drug Promotional Literature Published in Scientific Medical Journals and Available at Outpatient Departments: A Cross-Sectional Observational Study.

Background A vital method used by pharmaceutical companies to make physicians aware of new drugs and increase the prescription and sale of the same is through drug promotion literature (DPL) published in scientific journals and distributed in outpatient departments (OPDs). It is important that drug promotion is done ethically to avoid the spread of false information for which guidelines are available at the international level by the World Health Organization (WHO) and at the national level by the Organisation of Pharmaceutical Producers of India (OPPI). In this study, we aim to review the DPLs used for promotion by market authorization holders (pharmaceutical business entities) in scientific healthcare journals and OPDs for their compliance with the "Ethical criteria for medicinal drug promotion" of the WHO and OPPI Code of Ethics Practice. In addition, we compare the ethical standard of the DPL available in scientific journals and OPDs with respect to existing norms and guidelines. Methodology A cross-sectional, observational study was conducted at a tertiary care teaching institute in Navi Mumbai, India. DPLs were collected from journals available at the institute library nearby published from January-June 2022 and from the outpatient departments of our hospital and other clinics nearby during the same time duration. Analysis was done according to the criteria given in WHO and OPPI guidelines. Each point in the criteria was scored as 1 or 0 based on whether the DPL was compliant or not respectively. DPLs were graded into 3 categories based on percentage compliance: Grade A (>70%), Grade B (35-70%), and Grade C (<35%). Results A total of 370 DPLs were collected, of which 191 (51.6%) were collected from scientific journals and 179 (48.4%) from OPDs. DPLs collected from journals showed that only 7.85% belonged to Grade A (WHO guidelines). According to the OPPI guidelines, 57.59% of the same DPLs belonged to Grade A. DPLs from OPDs showed similar results by both guidelines with >90% belonging to Grade B. Approximately less than 5% of the DPLs belonged to Grade C from both scientific journals and OPDs. Conclusions None of the DPLs were found to be entirely compliant with either of the guidelines. Most of the DPLs from both sources belong to Grade B, with information about adjuvants, adverse drug reactions, contraindications, drug interaction, and references to scientific literature missing from them. DPLs belonging to Grade C even had information about active ingredients missing from them which can lead to serious harm due to the wrong prescription of drugs.