Critical analysis of drug promotional literature available to the medical practitioners
Keywords:Drug promotional literature, Ethical promotion
Background: To ascertain whether the pharmaceutical companies are following the WHO criteria for “Ethical medicinal drug promotion 1988” and “OPPI Code of pharmaceutical marketing practices, 2012” and to what extent. Also, to evaluate the therapeutic claims made by them in their drug promotional literature and other aspects.
Methods: Drug Promotional Literature (DPL) from different pharmaceutical companies was collected from various Medical practitioners and analysed to see if they achieved objectives. Therapeutic claims made by them were classified as authentic, exaggerated, controversial, false, and misinterpreted.
Results: Total 250 DPLs were collected and critically analysed for information content. Out of the 11 WHO criteria for ethical medicinal drug promotion (1988), Majority (30%) followed only 54.54% of the criteria while only 4% followed 100% of the criteria. The total number of claims in the 250 DPL were 354 of which 52.8% were authentic and 47.2% were misleading. From the misleading claims: 28.7% were exaggerated, 34.7% were controversial, 22.8% were false, 23% were ambiguous.
Conclusions: This study enabled us to find out to what extent the pharmaceutical industries follow the standard criteria for DPL and evaluate the claims made by them. DPL is one of the important sources of drug information. Some of the pharmaceutical companies failed to follow the WHO criteria while advertising their products in order to make them look more lucrative having an underlying commercial motive. As they influence prescribing patterns of the clinicians, misleading promotional literature would result in irrational prescribing of drugs. To avoid this, DPL has to be critically evaluated.
Shetty VV, Karve AV. Promotional literature: How do we critically appraise?. J Postgrad Med. 2008;54(3):217.
Mali SN, Dudhgaonkar S, Bachewar NP. Evaluation of rationality of promotional drug literature using World Health Organization guidelines. Indian J Pharmacol. 2010;42(5):267.
Khakhkhar T, Mehta M, Shah R, Sharma D. Evaluation of drug promotional literatures using WHO guidelines. J Pharmaceut Negative Results. 2013 Jan 1;4(1):33.
Stimson GV. Do drug advertisements provide therapeutic information?. J Med Ethics. 1977;3(1):7-13.
Randhawa GK, Singh NR, Rai J, Kaur G, Kashyap R. A critical analysis of claims and their authenticity in Indian drug promotional advertisements. Adv Med. 2015;2015.
Rohra DK, Gilani AH, Memon IK, Perven G, Khan MT, Zafar H, Kumar R. Critical evaluation of the claims made by pharmaceutical companies in drug promotional material in Pakistan. J Pharm Pharm Sci. 2006;9(1):50-9.
IFPMA Code of Practice. Available at: http://www.ifpma.org/fileadmin /content/Ethics/IFPMA_Marketing_Code/The_Code/IFPMA_Code_2006_Revision_EN.pdf.
Nath S, Bhowmick S, Dutta T, Chowrasia VR, Bhattacharya S, Chatterjee RN, Sarkar A, Mukherjee P. A study of promotional advertisements of drugs in a medical journal: an ethics perspective. Indian J Med Ethics. 2014 Oct;11(4).
Ethical criteria for medicinal drug promotion. World Health Organization.1988 May 13. Available at: http://www.who.int/medicinedocs/collect/ edmweb/pdf/whozip08e/whozip08e.pd.
OPPI Code of Pharmaceutical Practices. Mumbai: Organisation of Pharmaceutical Producers of India 2012. Available at: http:// www.ifpma. org/fileadmin/content/About%20us/2%20Members/Associations/Code India/OPPI_Code_of_Pharmaceutical_ Practices__-_2012.pdf.
Guidelines on the Use of INNs for Pharmaceutical Substances. 1997. Available at: http://www.who.int/medicines/services/inn/innguidance/en/.