A Critical Assessment of Rationality in Drug promotion literature using WHO Guidelines
Background Aim: To evaluate the scientific and ethical status of the drug promotional literature available in the Indian market for accuracy, consistency, and validity of information present in it using WHO criteria.
Methods: A cross‐sectional, observational study was carried out in the department of pharmacology for evaluation of 180 drug promotional literature by WHO‐criteria, collected randomly from outpatient departments of JN. Medical College and Hospital, Aligarh, a tertiary care hospital in Northern India. They were also analyzed for different claims, catchy terms, quality of paper and print, and representation of data with statistics/diagram/table and references cited in support of their claims for their source, year of publication, authenticity, and retrievability.
Results: 45% of literature were designed for promotion of fixed dose‐drug combinations (FDCs), and 55% were single-dose formulations. Most of the drug promotional literature collected were from CVS, Endocrinology, GIT & Chemotherapy. Most of them mentioned indication, dosage form, and its strength and description of the product and package. Description of pharmacological effects and mechanism of action was present only in 31% of literature. More than (90%) were lacking information related to indications, correct dosage regimen, and dose adjustments in special situations, as well as the dosage in Paediatrics and elderly. False/tall claims, catchy/broken statements were given in 81% and 58% of literature, respectively. Irrelevant diagrams were depicted in 69%. References were cited in 69% of literature, of which 92% were from indexed‐journals and were retrievable. Conclusion: Critical assessment of drug promotional literature can make drug prescribing more effective. In our study, the majority of DPLs satisfied only half of the WHO criteria, and none of them fulfilled all the specified DPL criteria. Incomplete or embellished information in DPLs may mislead physicians and might lead to an irrational prescribing. Therefore, physicians must critically evaluate DPLs regarding updated scientific evidence required for quality patient care.
2. Mali SN, Dudhgaonkar S, Bachewar NP. Evaluation of rationality of promotional drug literature using World Health Organization guidelines. Indian J Pharmacol. 2010;42:267–72. [PMC free article] [PubMed] [Google Scholar]
3. Loke TW, Koh FC, Ward JE. Pharmaceutical advertisement claims in Australian medical publications: Is evidence accessible, compelling and communicated comprehensively? Med J Aust [serial online] 2002 177(6):[8 screens]. Available from :http://www.mja.com.au /public/issues/177_06_160902/lok10004_fm.html [last cited on 2007 Dec 7].
4. Rohra DK, Gilani AH, Memon IK, Perven G, Khan MT, Zafar H, Kumar R. Critical evaluation of claims made by pharmaceutical companies in drug promotional material in Pakistan. J Pharm Pharmaceut Sci 2006;9:50-9.
5. Villanueva P, Peiro S, Librero J, Pereiro I. Accuracy of pharmaceutical advertisements in medical journals. Lancet 2003;361:27‑32
6. Brody H. The company we keep: Why physicians should refuse to see pharmaceutical representatives. Ann Fam Med 2005;3:82-5. [PUBMED] [FULLTEXT]
7. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. There′s no such thing as a free lunch. Chest 1992;102:270-3. [PUBMED] [FULLTEXT]
8. Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA 2000;283:373-80. [PUBMED] [FULLTEXT]
9. Cardarelli R, Licciardone JC, Taylor LG. A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underling studies: Is what they tell us important and true? BMC Fam Pract 2006;7:13-8. [PUBMED] [FULLTEXT]
10. Ethical criteria for medicinal drug promotion. World Health Organization [Online]. 1988 May13;Availablefrom: http://www.who.int/medicinedocs/collect/edmweb/pdf/whozip08e/whozip08e.pdf.
13. Gopalakrishnan S, Murali R. India: Campaign to tackle unethical promotion. World Health Organization. Essential drugs monitor [Online] 2002. p. 22. Available from: http://www.apps.who.int/medicinedocs/pdf/s4937e/s4937e.pdf
14. Gitanjali B, Shashindran CH, Tripathi KD, Sethuraman KR. Are drug advertisements in Indian edition of BMJ unethical? BMJ [serial online] 1997. Available from: URL: http://www.bmj.com/cgi/content/full/315/7106/459 Aug 23
15. Khakhkhar T, Mehta M, Shah R, Sharma D. Evaluation of drug promotional literatures using WHO guidelines. J Pharm Negative Results 2013; 4:33-8.
16. Vlassov V, Mansfield P, Lexchin J, Vlassova A. Do drug advertisements in Russian medical journals provide essential information for safe prescribing? West J Med 2001; 174:391‑4.
17. Stimson GV. Information contained in drug advertisements. Br Med J 1975; 4:508‑9
18. 18.Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ 2005; 172:487‑91
19. Lohiya S. The suboptimal legibility of prescribing information in pharmaceutical advertisements. J Am Board Fam Pract 2007; 20:314‑5
20. Chakraborty A, Das SC. What not to do of drug promotion! Available from: http://www.expresspharmaonline.com/20051130/research02. shtml [Online]. 2005 Nov
21. JAMA, 2018. DOI: 10.1001/jama.2018.19320
22. Gitanjali B, Shashindran CH, Tripathi KD, Sethuraman KR. Are drug advertisements in Indian edition of BMJ unethical? BMJ [serial online] 1997. Available from: URL: http://www.bmj.com/cgi/content/full/315/7106/459 Aug 23
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