Comparative Analysis of Regulatory Compliance of Printed versus Digital Drug Promotional Literature: A Cross-sectional Study.
DOI:
https://doi.org/10.51168/94et3507Keywords:
Drug promotional literature, Online promotional literature, drug promotional leaflet, Pharmaceutical Marketing, Drug Promotion, Pharmaceutical product claims, Uniform Code for Pharmaceutical Marketing Practices, Regulatory complianceAbstract
Background
Regulatory compliance with drug promotional literature guidelines is crucial for pharmaceutical marketing. This study graded and compared the compliance of offline and online literature as per the regulatory standards.
Methods
A quantitative, cross-sectional, comparative analysis of the promotional literature for prescription drugs available as printed copies collected from a tertiary care hospital in South India was performed with that of online literature obtained from various websites. Promotional materials for devices, supplements, and traditional medicines were excluded. A total of 250 (130 offline and 120 online) pieces of literature were analyzed by using a harmonised 11-item checklist based on World Health Organization and the Uniform Code for Pharmaceutical Marketing Practices 2024 guidelines to assess core drug information, safety data, and scientific substantiation as provided by the regulatory bodies. Data were analyzed using descriptive statistics and Pearson's Chi-square test, with p < 0.05 considered statistically significant.
Results
Of the 130 printed and 120 digital literatures, most were classified as Grade B, with printed ones demonstrating better overall compliance than digital material (Grade A: 9.2% vs. 0%; Grade C: 6.2% vs. 27.5%). Printed leaflets were significantly more likely to include dosage forms and precautions, whereas online material had more frequently mentioned therapeutic indications (p < 0.05). Safety information, including adverse drug reactions, contraindications, drug interactions, and scientific references, was inadequately reported in both groups.
Conclusion
These findings indicate that clinicians should exercise critical scrutiny rather than implicit trust while evaluating pharmaceutical promotional claims. To bridge this quality gap, there is a need for a dedicated oversight body to monitor regulatory compliance, alongside a greater commitment to veracity from pharmaceutical manufacturers.
Recommendations
Future research must focus closely on establishing post-UCPMP compliance behaviour, evaluating the direct influence of DPL quality on clinician prescribing behaviour, and integrating ethical promotion principles into graduate medical education.
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