Journal of Research in Pharmacy Practice

Critical review of drug promotional literature using the World Health Organization guidelines

Document Type : Original Article

Authors

. Puttaswamy Ganashree
. Krishnaswamy Bhuvana
. Narayana Sarala

Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India

Abstract
Objective: Drug promotional literatures (DPLs) are used as a promotional tool to 
advertise new drugs entering the market to doctors. The objective of the present 
study is to evaluate the accuracy of DPLs by using the World Health Organization 
(WHO) criteria.
Methods: An observational study was conducted from March to August 2014. The DPLs 
were collected from various departments at R.L. Jalappa Hospital and Research Centre 
attached to Sri Devaraj Urs Medical College, Kolar, India. The literature was evaluated 
based on 11 criteria laid down by the WHO.
Findings: Two‑hundred DPLs were evaluated. Cardiovascular drugs (34 [17%]) were 
promoted the most, followed by antidiabetic drugs (31 [15.5%]) and antimicrobial 
agents (29 [14.5%]). Single drug was promoted in 134 (67%) and fixed drug 
combination in 66 (33%) brochures. Manufacturer’s name was mentioned in 
194 (97%), but their address was mentioned in 109 (54.5%) claims only. Drug cost 
was revealed only in 12 (6%) DPLs. Each ingredient’s generic name, brand name, 
and dosage form were mentioned in 197 (98%) brochures. Indication for use was 
stated in 193 (96.5%) claims. Contraindications, adverse effects, precautions, and 
drug interactions were listed in 68 (34.5%), 65 (32.5%), 65 (32.5%), and 58 (29%) 
advertisements. References were cited in 133 (66.5%) brochures. Only 63 (31.5%) 
literatures had relevant pictures of drugs being promoted and 59 (29.5%) had a 
graphical representation of pharmacological properties. A total of 131 (69%) DPLs 
followed 50% of the WHO criteria.
Conclusion: Majority of DPLs satisfied only half of the WHO criteria for rational drug 
promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated 
information in DPLs may mislead and result in irrational prescription. Therefore, 
physicians should critically evaluate DPLs regarding updated scientific evidence required 
for quality patient care.

Keywords

Drug brochures
drug promotion
drug promotional literature
1. Shetty VV, Karve AV. Promotional literature: How do we 
critically appraise? J Postgrad Med 2008;54:217‑21.
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.
3. Khakhkhar T, Mehta M, Sharma D. Evaluation of drug 
promotional literatures using WHO guidelines. J Pharm 
Negative Results 2013;4:33‑8.
4. Saxena D, Yadav P, Kantharia DN. Metaphors and symbols 
in drug promotional literature distributed by pharmaceutical 
companies. Natl J Physiol Pharm Pharmacol 2011;1:32‑4.
5. Zetterqvist AV, Mulinari S. Misleading advertising for 
antidepressants in Sweden: A failure of pharmaceutical 
industry self‑regulation. PLoS One 2013;8:e62609.
6. Phoolgen S, Kumar SA, KumarRJ. Evaluation of the rationality 
of psychotropic drug promotional literatures in Nepal. J Drug 
Discov Ther 2012;2:6‑8.
7. Kornfield R, Donohue J, Berndt ER, Alexander GC. Promotion 
of prescription drugs to consumers and providers, 2001‑2010. 
PLoS One 2013;8:e55504.
8. Jadav SS, Dumatar CB, Dikshit RK. Drug promotional 
literatures (DPLs) evaluation as per World Health Organisation 
(WHO) criteria. J App Pharm Sci 2014;4:84‑8.
9. Rohra DK, Gilani AH, Memon IK, Perven G, Khan MT, 
Zafar H, et al. Critical evaluation of the claims made by 
pharmaceutical companies in drug promotional material in 
Pakistan. J Pharm Pharm Sci 2006;9:50‑9.
10. Organization of Pharmaceutical Producers of India (OPPI); 
2012. Available from: http://www.indiaoppi.com/OPPI%20
%Code%20of%20Marketing%202012.pdf. [Last cited on 
2016 Feb 03].
11. Alam K, Shah AK, Ojha P, Palaian S, Shankar PR. Evaluation 
of drug promotional materials in a hospital setting in Nepal. 
South Med Rev 2009;2:2‑6.
12. Cooper RJ, Schriger DL. The availability of references and 
the sponsorship of original research cited in pharmaceutical 
advertisements. CMAJ 2005;172:487‑91.
13. Garje YA, Ghodke BV, Lalan HN, Senpaty S, Kumar R, 
Solunke S. Assessment of promotional drug literature using 
World Health Organization guidelines. Int J Ayurveda Res 
2014;4:3‑5.
14. Cardarelli R, Licciardone JC, Taylor LG. A cross‑sectional 
evidence‑based review of pharmaceutical promotional 
marketing brochures and their underlying studies: Is what 
they tell us important and true? BMC Fam Pract 2006;7:13.
15. Villanueva P, Peiró S, Librero J, Pereiró I. Accuracy of 
pharmaceutical advertisements in medical journals. Lancet 
2003;361:27‑32.
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. Mikhael EM. Evaluating the reliability and accuracy of 
the promotional brochures for the generic pharmaceutical 
companies in Iraq using World Health Organization 
guidelines. J Pharm Bioallied Sci 2015;7:65‑8.
Journal of Research in Pharmacy Practice
Volume 5, Issue 3
Summer 2016
Pages 162-165

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