Document Type : Original Article
Authors
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
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.
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