Background: The research and marketing of a new drug requires a lot of money by the pharmaceutical companies. Promotion through advertising brochures and leaflets is widely used to influence the physicians. Most of the times, this information is the only source of new drug information for the physicians. Hence, this study to analyze the appropriateness, accuracy, and validity of promotional drug literatures was undertaken.Methods: Promotional materials were collected from outpatient departments of C. U. Shah Medical College and Hospital, Surendranagr. They were evaluated according to the “WHO criteria, 1988,” and the references cited to support the claims were checked for their validity and authenticity. The images and the pictorial content were evaluated to find out any biased nature of gender representation.Results: Evaluation of the total 486 brochures showed that none of them fulfilled all the nine criteria. Of the 308 claims, only 208 (42.79%) gave references to support the claims. Only 27 (39.13%) of the research articles among the 125 journal article cited were of high methodological quality. Among the 218 human figures, 144 were patients, and 103 were doctors. Female patients (62.5%) were depicted more than male patients (37.5%).Conclusion: The present study showed that pharmaceutical companies do not strictly follow the WHO guidelines and majority of the research were sponsored by companies. Hence, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs

Bhatt, Preeti Narendra

Chhaiya, Sunita B.

Mehta, Dimple S.

English

International Journal of Basic & Clinical Pharmacology

Print ISSN 2319-2003 | Online ISSN 2279-0780doi: 10.5455/2319-2003.ijbcp20150433IJBCP International Journal of Basic & Clinical Pharmacologywww.ijbcp.com International Journal of Basic & Clinical Pharmacology | March-April 2015 | Vol 4 | Issue 2 Page 325Research ArticleAn analytical survey of promotional drug literatures at C. U. Shah Medical College and Hospital, SurendranagarPreeti Narendra Bhatt*, Dimple S. Mehta, Sunita B. ChhaiyaINTRODUCTIONThe research of a new drug requires a lot of money by the pharmaceutical companies. However, even after the approval the pharmaceutical manufacturers invest a lot of money for the marketing and promotion of new drugs.1 According to WHO, promotion refers to ‘all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase, and/or use of medicinal drug.2 The most widely used technique for promotion is “direct to physician” marketing. This type of marketing is done in the form of gifts, free samples, and drug brochures or through sponsored continued medical education.3 Promotion through advertising brochures and leafl ets is widely used to infl uence the physicians. Most of the times, the information given by the medical representatives through the promotional literatures is the only source of new drug information for the physicians.1,4 Hence, the information provided by these promotional literatures can infl uence the prescribing decision of the physician and thus should be critically appraised.5,6To evaluate the appropriateness of promotional drug literatures, WHO has published ethical criteria for medicinal drug promotion in 1988.2 These criteria constitute general principles for ethical standards which can be adopted by governments according to their local needs. In India, with the help of the WHO criteria, a self-regulatory code of OPPI and IFPMA is available, which regulates the promotional activity of pharmaceutical industries.7 In US, the FDA released a draft guidance in February 2008 for “good reprint practices” with regard to the distribution of medical/scientifi c journal articles or reference publications to healthcare professionals by drug/medical device manufacturers that discuss unapproved new uses for approved drugs or approved or cleared medical devices that are being marketed.8METHODSThis observational cross-sectional study was based on critical evaluation of drug promotional literatures after getting approval from Scientific Research Committee. ABSTRACTBackground: The research and marketing of a new drug requires a lot of money by the pharmaceutical companies. Promotion through advertising brochures and leafl ets is widely used to infl uence the physicians. Most of the times, this information is the only source of new drug information for the physicians. Hence, this study to analyze the appropriateness, accuracy, and validity of promotional drug literatures was undertaken.Methods: Promotional materials were collected from outpatient departments of C. U. Shah Medical College and Hospital, Surendranagr. They were evaluated according to the “WHO criteria, 1988,” and the references cited to support the claims were checked for their validity and authenticity. The images and the pictorial content were evaluated to fi nd out any biased nature of gender representation.Results: Evaluation of the total 486 brochures showed that none of them fulfi lled all the nine criteria. Of the 308 claims, only 208 (42.79%) gave references to support the claims. Only 27 (39.13%) of the research articles among the 125 journal article cited were of high methodological quality. Among the 218 human fi gures, 144 were patients, and 103 were doctors. Female patients (62.5%) were depicted more than male patients (37.5%).Conclusion: The present study showed that pharmaceutical companies do not strictly follow the WHO guidelines and majority of the research were sponsored by companies. Hence, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs.Keywords: Promotional literatures, World Health Organization criteria, Drug promotionDepartment of Pharmacology, C. U. Shah Medical College and Hospital, Surendranagar, Gujarat, IndiaReceived: 09 February 2015Accepted: 07 March 2015*Correspondence to:Dr. Preeti Narendra Bhatt,Email: preeti1310@gmail.comCopyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.Bhatt PN et al. Int J Basic Clin Pharmacol. 2015 Apr;4(2):325-329 International Journal of Basic & Clinical Pharmacology | March-April 2015 | Vol 4 | Issue 2 Page 326The brochures were collected from various outpatient departments (OPD) running at C. U. Shah Medical College and Hospital, Surendranagar. The study was conducted over a period of 1-year from September 1st 2012 to August 31st 2013. From all the collected brochures, only those that were product advertisement and which marketed a single drug were included. Promotional material for various surgical instruments, medicinal devices, drug monographs, drugs’ names list and reminder advertisements were excluded from the study. Reminder advertisements do not include therapeutic information and have different criteria for evaluation.9The survey was done to analyze the promotional materials for their appropriateness, accuracy and ethical status according to “WHO criteria for ethical medicinal drug promotion, 1988.”WHO criteria for ethical medicinal drug promotion includes nine criterias,2 which are:1. The name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug2. The brand name3. Amount of active ingredient(s) per dose4. Other ingredients known to cause problems, i.e., adjuvant5. Approved therapeutic uses6. Dosage form or dosage schedule (while analyzing, dosage form and the schedule were evaluated separately)7. Safety information including side effects and major adverse drug reactions, precautions, contraindications and warnings, and major drug interactions8. Name and address of manufacturer or distributor9. Reference to scientifi c literature as appropriate.Whenever a claim is made in these advertisements, a reference should be included that refl ects the scientifi c evidence. The claim must be consistent with the cited research and the research should be of proper methodology. The validity and authenticity of references were evaluated by answering the following fi ve questions:• Are all references cited retrievable?• Are references of high methodological quality (which includes meta-analysis, systemic reviews and randomized controlled trials)?• Did the company fi nance the research reported in the reference?A reference was considered available if a soft copy of the cited material in the National Library of Medicine’s PubMed or website of mentioned journal, freely in either full text or abstract format. References other than journal articles were searched through Google meta search engine.The images and the pictorial content were evaluated for any type of gender bias, if any, in representing either doctors or patients in the promotional materials. The Chi-square test was applied to fi nd the statistical signifi cant difference and p<0.01 was considered statistically signifi cant.RESULTSA total of 765 promotional materials were collected from various OPDs running at C. U. Shah Medical College and Hospital, Surendranagar. Of them, only 486 promotional brochures satisfi ed the inclusion criteria and then analyzed and evaluated.Type of drug promotedThe total number of drugs that were promoted was 486, of which drugs belonging to the cardiovascular group (140, 28.8%) were the most marketed. Antimicrobial agents (97, 19.9%) and nutritional agents (49, 10%) like multivitamins and probiotics followed next in marketing. The classifi cation as per the type of drug promoted is shown in Table 1 (Figure 1).Table 1: Classifi cation as per type of drug promoted in literature (n=486).Type of drug promoted Number of promotional literatures, n (%)Cardiovascular drugs 140 (28.8)Antimicrobial agents 97 (19.9)Nutritional 49 (10)Central nervous system-related 36 (7.4)Respiratory system-related 33 (6.8)Hormonal and anti-diabetics 31 (6.4)NSAIDS and other analgesics 24 (4.9)Gastrointestinal system-related 24 (4.9)Dermal 20 (4.2)Ophthalmologic 17 (3.5)Miscellaneous* 15 (3.1)*Miscellaneous: Antiseptics, muscle relaxants, anticholinergics, etc., NSAIDS: Non-steroidal, anti-infl ammatory drugs140974936333124242017 15Cardiovascular drugsAntimicrobial agentsNutritionalCentral Nervous System-relatedRespiratory System-relatedHormonal and AntidiabeticsNSAIDS and other analgesicsGastrointestinal System-relatedDermalOphthalmologicMiscellaneousFigure 1: Classifi cation as per the type of drug promoted (n=486).Bhatt PN et al. Int J Basic Clin Pharmacol. 2015 Apr;4(2):325-329 International Journal of Basic & Clinical Pharmacology | March-April 2015 | Vol 4 | Issue 2 Page 327Appraisal according to the WHO criteriaEvaluation of the total 486 brochures showed that none of them fulfi lled all the nine criteria. The generic name and brand name were mentioned in all the collected brochures. However, information regarding references (52.5%), safety (30.5%) and adjuvant (9%) were mentioned in a lesser number of promotional materials. Information having only three criteria; namely INN, brand name, and amount of active ingredient per dose, were found in 4.2% of all the brochures (Table 2 and Figure 2).Validity of referencesOf the 486 brochures, 308 (63.37%) made claims about their respective drug. Only 208 (42.79%) gave references to support the claims. Retrievability of these references was checked and it was found that almost all (195, 93.75%) were retrievable. Among them, maximum references were from journal articles (125, 60.1%) of which research articles (69, 55.2%) had a major share. Rest of the references were from books, websites, and data on fi le. Among the research articles, only 27 (39.1%) were found to be of high methodological quality. It was also found 48 (69.6%) research articles referred were sponsored by the same company manufacturing the drug.Images and picturesImages in the form of human fi gures were found in 218 (44.9%) brochures. Overall 247 human fi gures were there in these 218 promotional materials, among which 144 (58.3%) were of patients and the rest 103 (41.7%) were representing physicians. This difference was found to be statistically not signifi cant (p=0.0151). Of the 144 patients, 90 (62.5%) were females and 54 (37.5%) were males. The difference was statistically highly signifi cant (p=0.062). Of the 103 physicians, 54 (52.4%) were males, and 49 (47.6%) were females. The difference in gender distribution among physician representation was statistically not signifi cant (p=0.7646) (Figure 3).DISCUSSIONThe present study showed that pharmaceutical companies do not strictly follow any particular guideline in promotion of their drugs especially in the case of promotional literatures. Table 2: Evaluation of promotional literature as per WHO criteria for ethical medicinal drug promotion, 1988 (n=486).Criteria Number of promotional literatures, n (%)INN* 486 (100)Brand name 486 (100)Active drug per dose 465 (95.7)Adjuvant 9 (1.8)Approved therapeutic use** 432 (88.9)Dosage form 486 (100)Dosage schedule 350 (72.01)Safety information 148 (30.5)Name and address of the manufacturer 467 (96.1)References to scientifi c information 255 (52.5)*International non-proprietary name/approved generic name; **Drug use approved as per Central Drug Standard Control Organization, INN: International non-proprietary names050100150200250300350400450500486 486 4659432486350148467255No. of promotional literaturesFigure 2: Evaluation of promotional literature as per World Health Organization criteria for ethical medicinal drug promotion, 1988.Bhatt PN et al. Int J Basic Clin Pharmacol. 2015 Apr;4(2):325-329 International Journal of Basic & Clinical Pharmacology | March-April 2015 | Vol 4 | Issue 2 Page 328The cardiovascular group of drugs were the most promoted group of drugs, which might be due to the many fold rise in the incidence of cardiovascular related diseases. However, the increase in promotion of antimicrobial agents might be risky because of the development of drug resistance due to overuse. The WHO criteria were not fulfi lled in all the brochures. Information regarding adjuvant and safety information which includes adverse drug reactions, contraindications, and drug interactions were neglected more often. More emphasis was given on attractive drug formulations and emotional claims regarding safety and effi cacy. Our fi ndings were found to be similar to those of previous studies.10,11 Claims outnumbered the references provided in the promotional drug literatures, which were also reported by a study done by Islam and Farah.12 Reference citations were found to be of poor quality and doubtful retrievability. The authenticity of the results of the references cited could not be justifi ed as they were sponsored by the companies. Earlier studies done by Van Winkelen et al.13 and Cooper and Schriger14 have raised similar suspicions over the authenticity and reliability of the references. The images used in the brochures depicted both patients with the targeted disease and the treating physicians. Females with good looks were portrayed showing the effect of taking the marketed drug. A study by Curry and O’Brien15 has shown that male heart patients and depressed female patients were represented more which strengthens our gender association. However, among the images of the treating doctor, female physicians were almost equally represented as the male physicians. This fi nding was in contrast to earlier studies regarding the gender bias of images in promotional material.16,17 It is to be understood that drug promotional literatures are formed in such a way that physicians can be infl uenced to prescribe that drug. Hence, pharmaceutical companies use images of attractive persons as patients or physicians for marketing.CONCLUSIONGiven the present findings, physicians should remain cautious before prescribing the advertised drug solely on the basis of the information given in the promotional drug literatures. Further, physicians should practice the principles of evidence-based medicine in evaluating the validity of published studies. Since pharmaceutical companies do not strictly follow the WHO guidelines, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs.One major limitation of this study is that it is cross-sectional in nature, so the study design fails to measure any concrete outcome or cause and effect. Furthermore, the drug promotional materials’ collected only from various OPDs of a tertiary level teaching hospital were analyzed, and those distributed to the private practitioners were not evaluated.ACKNOWLEDGMENTSWe would like to acknowledge the Dean, the Superintendent, the Scientifi c Research Committee and various clinical departments of C. U. Shah Medical College and Hospital, Surendranagar for extending their help and support in carrying out this study.Funding: No funding sourcesConfl ict of interest: None declaredEthical approval: The study was approved by Scientifi c Research CommitteeREFERENCES1. Drug promotion. World Health Organization, 2004. Available at http://www.who.int/medicines/areas/rational_use/drugPromodhai.pdf. Cited on 2014 August.2. Ethical criteria for medicinal drug promotion. World Health Organization, 1988. Available at http://www.who.int/medicinedocs/collect/edmweb/pdf/whozip08e.pdf. Cited on 2014 July.3. Lexchin J. Physicians and drug companies interact. Can Fam physician. 1993;39:1881-2.4. Greenhalgh T. Drug prescription and self-medication in India: an exploratory survey. Soc Sci Med. 1987;25(3):307-18.5. Gutknecht DR. Evidence-based advertising? A survey of four major journals. J Am Board Fam Pract. 2001;14(3):197-200.6. Villanueva P, Peiró S, Librero J, Pereiró I Accuracy of pharmaceutical advertisements in medical journals. Lancet. 2003;361:27-32.7. OPPI code of pharmaceutical marketing practices, 2007. Available at http://www.indiaoppi.com/OPPI%20Code%20of%20Marketing%202007.pdf. Cited on 2014 August.8. US Food and Drug Administration. Guidance for Industry: good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientifi c Reference Publications on Unaproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. c2008. Available at http://www.fda.gov/oc/op/goodreprint.html. Cited on 2014 August.9. Reminder Ad (Correct), 2012. Available at http://www.fda.gov/Drugs/ResourcesForYou/PrescriptionDrugAdvertising/ucm083573.htm. Cited on 2014 September.10. Vlassov V, Mansfi eld P, Lexchin J, Vlassova A. Do drug advertisements in Russian medical journals provide essential information for safe prescribing? West J Med. 2001;174(6):391-4.0102030405060708090Male FemalePatient (n=144) 54 90Physician (n=103) 54 4954905449No. of images in promotional literatures(n=247)Figure 3: Difference in the gender representation in images shown in drug promotional literatures.Bhatt PN et al. Int J Basic Clin Pharmacol. 2015 Apr;4(2):325-329 International Journal of Basic & Clinical Pharmacology | March-April 2015 | Vol 4 | Issue 2 Page 32911. Mali SN, Dudhgaonkar S, Bachewar NP. Evaluation of rationality of promotional drug literature using World Health Organization guidelines. Indian J Pharmacol. 2010;42(5):267-72.12. Islam MS, Farah SS. Drug promotional brochure as a source of drug information in Bangladesh: a critical analysis of the brochures for the authenticity of information. Calicut Med J. 2008;6(1):e5.13. Van Winkelen P, van Denderen JS, Vossen CY, Huizinga TW, Dekker FW. How evidence-based are advertisements in journals regarding the subspecialty of rheumatology? Rheumatology (Oxford). 2006;45(9):1154-7.14. Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. Can Med Assoc J. 2005;172(4):487-91.15. Curry P, O’Brien M. The male heart and the female mind: a study in the gendering of antidepressants and cardiovascular drugs in advertisements in Irish medical publication. Soc Sci Med. 2006;62(8):1970-7.16. Leppard W, Ogletree SM, Wallen E. Gender stereotyping in medical advertising: much ado about nothing. Sex Roles. 1993;29:829-38.17. Jaykaran, Yadav P, Kantharia ND, Saxena D. Gender and racial bias in drug promotional material distributed by pharmaceutical companies. J Pharmacol Pharmacother. 2012;3(1):55-6.doi: 10.5455/2319-2003.ijbcp20150433Cite this article as: Bhatt PN, Mehta DS, Chhaiya SB. An analytical survey of promotional drug literatures at C. U. Shah Medical College and Hospital, Surendranagar. Int J Basic Clin Pharmacol 2015;4:325-9.

An analytical survey of promotional drug literatures at C. U. Shah Medical College and Hospital, Surendranagar

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An analytical survey of promotional drug literatures at C. U. Shah Medical College and Hospital, Surendranagar

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