Critical appraisal of Drug Promotional Literatures (DPLs) as per World Health Organization (WHO) guidelines
Keywords:Drug promotional literatures, Drug marketing, Ethical drug promotion
Background: The study was aimed to critically analyse Drug Promotional Literatures (DPLs) using WHO guidelines. This would help to create awareness about DPLs amongst healthcare providers thus encouraging the improvement of healthcare system.
Methods: This cross sectional observational study was carried out at Department of Pharmacology, Medical College Baroda. DPLs were collected & critically analysed for consistency, accuracy, validity of the provided information as per WHO guidelines.
Results: Out of total 616 DPLs collected, 371 satisfied the inclusion criteria. None of the DPL was fulfilling all criteria according to WHO guidelines. Most of DPLs were having information regarding; generic name / INN (98.39%), brand name (100%), amount of active ingredient per dosage (94.07%), approved therapeutic uses (84.91%), dosage form (91.37%) and name & address of manufacturers (91.91%). Of all the DPLs, information provided for safety parameters like; name of active ingredient known to cause problem (11.59%), dosage regimen (32.88%), side effects & drug reaction (14.56%), major drug interactions (14.02%) and precautions, contraindications and warning (14.29%) seemed to be grossly neglected. Total of 431 claims were evaluated, of which the most common type of claim was efficacy (55.45%). Relevant references to claims were present in (48.74%) DPLs. Total 203 references were evaluated from 371 DPLs, of which maximum reference were from journal article (74.38%).
Conclusions: From this study, it was concluded that pharmaceutical companies didn’t follow the WHO guidelines for ethical drug promotion, thus failing to fulfil the rational promotion of drugs. Given the present findings physicians should be cautious about drawing conclusions regarding medicine based on DPLs provided by pharmaceutical companies.
Ethical criteria for medicinal drug promotion. World Health Organization [Online]. 1988 May 13. Available at: http://www.who.int/medicinedocs/collect/edmweb/pdf/whozip08e/ whozip08e.pdf.
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.
Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ. 2005;172:487-91.
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.
OPPI code of pharmaceutical marketing practices. 2007. Available at: http://www.indiaoppi.com/OPPI%20Code%20of%20 Marketing%202007.pdf [Online].
Stryer D, Bero LA. Characteristics of materials distributed by drug companies. An evaluation of appropriateness. J Gen Intern Med. 1996;11:575-83.
Smart S, Williams C. Evidence based advertising. Half of drug advertisements in BMJ over six months cited no supporting evidence? BMJ. 1997;315:1622-3.
Mindell J, Kemp T. Evidence based advertising. Only two fifth of advertisements cited published, peer reviewed references? BMJ. 1997;315:1622.
Rohra DK, Gilani AH, Memon IK, Perven G, Khan MT, Zafar H, et al. Critical evaluation of claims made by pharmaceutical companies in drug promotional material in Pakistan. J Pharm Pharm Sci. 2006;9:50-9.
Villanueva P, Peiro S, Librero J, Pereiro I. Accuracy of Pharmaceutical Advertisements in Medical Journals. Lancet. 2003;361:27-32.
Loke TW, Koh FC, Ward JE. Pharmaceutical advertisement claims in Australian medical publications: Is evidence accessible, compelling and communicated comprehensively? Med J. 2002;177(6).
Brody H. The company we keep: Why physicians should refuse to see pharmaceutical representatives. Ann Fam Med. 2005;3:82-5.
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.
Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA. 2000;283:373-80.
Gopalakrishnan S, Murali R. India: Campaign to tackle unethical promotion. World Health Organization. Essential drugs monitor [Online] 2002:22. Available at: http://www.apps.who.int/medicinedocs/pdf/s4937e/s4937e.pdf
Lexchin J. Enforcement of codes governing pharmaceutical promotion: What happens when companies breach advertising guidelines? CMAJ. 1997;156:351-6.
Medhi B, Prakash A. Ideal characteristics of promotional literature. In: Practical Manual of Experimental and Clinical Pharmacology. 1st Edition. India: JBPMP. 2010:342-345.
Khakhkhar T, Mehta M, Shah R, Sharma D. Evaluation of drug promotional literatures using WHO guidelines. J Pharm Negative Results. 2013;4:33-8.
Jadav SS, Dumatar CB, Dikshit RK. Drug promotional literatures (DPLs) evaluation as per World Health Organization (WHO) criteria. J App Pharm Sci. 2014;4(06):084-8.
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(1):2-6.
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.
Chakraborty A, Das SC. What not to do of drug promotion. 2005:16-3. Available at: http:// www.expresspharmaonline.com/ 20051130/ research02. html [Online].
Stimson GV. Information contained in drug advertisements. BMJ. 1975;4:508-9.