Comparative Analysis of Regulatory Compliance of Printed versus Digital Drug Promotional Literature: A Cross-sectional Study.

Radhika Sherkhane; Mahamad Ashief; Shashidhar Khemaji

doi:10.51168/94et3507

Autori

Radhika Sherkhane Professor of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India
Mahamad Ashief Postgraduate student of MD Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India
Shashidhar Khemaji Research Assistant in Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

DOI:

https://doi.org/10.51168/94et3507

Cuvinte cheie:

Drug promotional literature, Online promotional literature, drug promotional leaflet, Pharmaceutical Marketing, Drug Promotion, Pharmaceutical product claims, Uniform Code for Pharmaceutical Marketing Practices, Regulatory compliance

Rezumat

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.

Biografii autori

Radhika Sherkhane, Professor of Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

is Professor and former Head of Department of Pharmacology at SDM College of Medical Sciences and Hospital, Dharwad, Karnataka. India
Mahamad Ashief, Postgraduate student of MD Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

is a postgraduate resident student of MD Pharmacology at SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India.
Shashidhar Khemaji, Research Assistant in Pharmacology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

is a research assistant at SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India.

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