Introduction Physicians are expected to have concern about the best interest of the patients (Daher, 2013). In response to that expectation, the physicians appear to have interest to update their knowledge about medicine. Actually, this anticipated interest of physicians provided opportunity to the pharmaceutical companies to offer information through the promotional activities in the name of education (May, 1961). Printed promotional materials are the most commonly used promotion tool (Ijoma et al., 2010; Alssageer and Kowalski, 2012) and are design- ed to introduce product to prescriber as well as to increase knowledge about that promoted product by reinforcing the verbal message provided by the medical representatives (Alssageer and Kowalski, 2012). Several studies shows that provision of information on medi- cine usually contaminated with the intentional manipu- lation and misinterpretation as well as claims, which are often inaccurate, exaggerated, ambiguous, contro- versial, oversimplified, irrelevant and false (Norris et al., 2005; Rohra et al., 2006; Othman et al., 2009; Murthy and Krishnamurthy, 2010; Jaykaran et al., 2011; Mikhael, 2015; Randhawa et al., 2015). In addition, essential information like contraindications, warnings and side effects are sometimes absent (Mali et al., 2009; Khakhkhar et al., 2013; Mikhael, 2015). Bangladesh had formulated a Code of Pharmaceutical Marketing Practices (CPMP) in 1994 to promote and support continuous development of and strict adhe- rence to the ethical principles of marketing of pharma- ceutical products (DGDA, 1994; Rahman et al., 1999). Rahman et al. (1999) found that the CPMP failed to ensure minimum scientific information in the drug advertisement. In Bangladesh, gross quantitative and qualitative variations were observed, when information provided in the advertisements was compared with Abstract The present research was conducted to evaluate the quality of pharmaceutical promotional literature. Indications was mentioned in 88.2% promotional literature and less than half (40.0, 33.9 and 38.9%) of these contains side effects, precautions and contraindications respectively. Among the provided information 67.3%, 16.5%, 19.5% and 24.0% matched with the BDNF/BNF res- pectively. Scientific articles (73.3%) were cited most followed by commercial online sources (15.5%), data on file (4.2%), regulatory body approval data (2.9%), product monograph (2.7%) and textbook/reference book (1.6%). Only half (50.2%) of these cited references were retrievable and no ‘data on file’ could be retrieved. Though most (73.2%) of the promotional claims were true, 13.7, 5.9, 4.6 and 2.6% were identified as false, exaggerated, ambiguous and controversial respectively. This revelation about the quality of promotional literature might be an eye opener for the policy makers. More importantly, this may bring alertness among the physicians during interpretation of pharmaceutical promotion literature. Article Info Received: 22 May 2018 Accepted: 27 June 2018 Available Online: 14 July 2018 DOI: 10.3329/bjp.v13i3.36752 Cite this article: Johora F, Rahman MS. Snapshot of the pharmaceutical promotional liter- ature of Bangladesh: A critical review. Bangladesh J Pharmacol. 2018; 13: 214 -21. Snapshot of the pharmaceutical promotional literature of Bangladesh: A critical review Fatema Johora and Md. Sayedur Rahman Department of Pharmacology, Faculty of Basic Science and Paraclinical Science, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. This work is licensed under a Creative Commons Attribution 4.0 License. You are free to copy, distribute and perform the work. You must attribute the work in the manner specified by the author or licensor. A Journal of the Bangladesh Pharmacological Society (BDPS) Bangladesh J Pharmacol 2018; 13: 214-221 Journal homepage: www.banglajol.info Abstracted/indexed in Academic Search Complete, Agroforestry Abstracts, Asia Journals Online, Bangladesh Journals Online, Biological Abstracts, BIOSIS Previews, CAB Abstracts, Current Abstracts, Directory of Open Access Journals, EMBASE/Excerpta Medica, Global Health, Google Scholar, HINARI (WHO), International Pharmaceutical Abstracts, Open J-gate, Science Citation Index Expanded, SCOPUS and Social Sciences Citation Index ISSN: 1991-0088 independent source (Haque et al., 2005). The pharma- cology education was inadequate to prepare the future physician to combat this situation (Rahman, 1995; Rahman, 1999; Begum et al., 1999) and consequently, the misleading claims appearing in the printed promo- tional literature worsened the situation (Islam and Farah, 2007). Present study was conducted in this backdrop, adherence of promotional literature to exis- ting Code of Pharmaceutical Marketing Practice was evaluated along with scientific authenticity of the promotional claims of some selected medicinal products. Materials and Methods Pharmaceutical promotional materials were collected from selected inpatient and out patient departments of BSMMU. Large designed and labelled envelopes were provided to the clinical staffs (medical officers, residents and postgraduate students) to store the promotional materials which they receive from representatives of pharmaceutical companies during one week of study period (study weeks were chosen with 6 working days in each). One similar envelope was also kept with one faculty member of the respective departments for the same purpose and period. Next week, all promotional materials stored in the envelope were collected by the researcher. Pharmaceutical promotional literature were screened and separated from other promotional materials. Then only promotional literature were evaluated for the rest of the study. Step I: Total number of promotional literature of each department was counted. Step II: Promotional literature were categorized into allopathic, Unani, Ayurvedic, herbal, cosmetics, medical device and other. Step III: Promotional literature other than allopathic drugs were excluded. Step IV: Allopathic products were catego- rized and promotional literature other than ‘full advertisement’ were excluded. Step V: Promotional literature of ‘full advertisement’ of few products were excluded from the review process due to absence of information about those products in the latest edition of BDNF or BNF. Step VI: Quality of those selected ‘full advertisements’ was then assessed in two phases. Evaluation of adherence Adherence of all collected promotional literature to the Code of Pharmaceutical Marketing Practices (CPMP) was assessed by a checklist. Among the mentioned parameters of CPMP, presence of selected parameters such as indications, side effects, precautions, contraindications and cited references were assessed. Total 440 promotional literature were evaluated in this phase. Evaluation of authenticity Authenticity of the claims (if present) Later on, promotional claims were evaluated for authenticity. 10 new products (medicinal products those were only present in 4th edition of Bangladesh National Formulary but absent in 3rd edition of Bangladesh National Formulary) were selected from each department for evaluation of promotional claims. When the number of new products was more than 10, then the products were randomly included to be studied. If promotional literature of the same new medicine was found in other department, only one was included to avoid repetition in order to increase product variability. Medicinal products having multiple promotional literature circulated by different manufac- turers were included for separate evaluation. Total 73 promotional literature were evaluated in this phase. Promotional claims were compared with cited referen- ces of promotional literature, original innovator’s pro- duct monograph and also with independent sources of drug information such as BDNF, reference book, “Martindale: The Complete Drug Reference” and/or websites of different regulatory bodies. In case of any inaccessibility of full paper, their abstracts were retrieved. If a product was absent in 4th edition of BDNF, then latest available edition (67th) of BNF was used as an alternative of similar nature. Latest available online edition (36th) of “Martindale: The complete drug refer- ence” was used as a reference book because of its updated regulatory viewpoint, which was suitable for this study. Among the websites of regulatory bodies’, website of Therapeutic Goods Administration (TGA) of Australia was selected for this study. If, any product was not approved in Australia but approved in Bangladesh, in those cases, websites of Medicine and Healthcare products Regulatory Agency (MHRA) of United Kingdom, Food and Drug Administration (FDA) of United States of America and European Medicines Agency (EMA) of European Union were used for evaluation process. Promotional claims were categorized into true, exaggerated, ambiguous, controversial and false on the basis of research findings, regulatory status and availability of products. Results Adherence to code of pharmaceutical marketing prac- tice Table I showed that the printed promotional literature were 77.6, 12.7, 5.0, 2.7, 0.5, 0.12 and 1.2% for allopa- thic, cosmetic, herbal, Unani, Ayurvedic, device and others respectively. Bangladesh J Pharmacol 2018; 13: 214-221 215 All reviewed promotional literature (100.0%) contained name of the active ingredient, trade name and detail information about license holder. Active ingredient per dosage formulation, approved dosage schedule, route of administration was mentioned in 88.9, 66.4 and 86.6% of the reviewed promotional literature respec- tively (Table II). Indications, side effects, precautions and contraindications were mentioned in 88.2, 40.0, 33.9 and 38.9% respectively. Regarding indications, 67.3% (261/388) promotional literature matched with BDNF/ BNF. While regarding side effects, precautions and contraindications 16.5% (29/176), 19.5% (29/149) and 24.0% (41/171) promotional literature matched with BDNF/ BNF (Table III). Table IV showed that 1,020 references were mentioned in 440 promotional literature, of which scientific article, commercial online information sources, data on file, regulatory body approval data, product mono-graph and textbook/reference book were cited as reference in 747 (73.3%), 158 (15.5%), 43 (4.2%), 29 (2.9%), 27 (2.7%) and 16 (1.6%). Out of 1020 references mentioned in the literature, retrieval was possible in 512 (50.2%) cases. Among these retrieved documents, 454, 29, 22, 6 and 1 refe- rences were from scientific article, online commercial sources, product monograph and textbook/ reference book and regulatory body approval data respectively. None of the reference from data on file was retrievable (Table V). Total 153 promotional claims were present in 73 promotional literature of which 98 (64.1%), 46 (30.1%), 4 (2.6%), 1/153 (0.7%), 3 (2.5%) and 1 (0.7%) were about Table I Types of products promoted by the promotional literature Types of products Proportion of promotional litera- tures (n = 810) Allopathic product 77.6% Cosmetic products 12.7% Herbal product 5.0% Unani products 2.7% Ayurvedic products 0.5% Device (medical) 0.1% Others 1.2% Table II Availability of information in the promotional literature according to Code of Pharmaceutical Marketing Practices (CPMP) Proportion of promotional literatures that contains the information (n = 440) Name of active ingredient 100.0% Trade name 100.0% Active ingredient per dos- age formulation 88.9% Approved dosage schedule 66.4% Route of administration 86.6% Indications 88.2% Side effects 40.0% Precautions 33.9% Contraindications 38.9% Detail information about license holder 100.0% Table IV Types of documents cited as reference in promo- tional literature Types of documents Proportion of references (n = 1020) Scientific article 73.3% Commercial online infor- mation sources 15.5% Data on file 4.2% Regulatory body approval data 2.9% Product monograph 2.7% Textbook/Reference book 1.6% Table V Retrievability of the references cited in promotion- al literature Types of documents Proportion of references retrievable Scientific article 60.8% (454/747) Commercial online infor- mation sources 18.4% (29/158) Product monograph 81.5% (22/27) Regulatory body approval data 3.5% (1/29) Textbook/ Reference book 37.5% (6/16) Data on file 0.0% (0/43) Total 50.2% (512/1020) Table III Provided information matched with BDNF/ BNF Proportion of information matched with BDNF/BNF* Indications 67.3% (261/388) Side effects 16.5% (29/176) Precautions 19.5% (29/149) Contraindications 24.0% (41/171) 216 Bangladesh J Pharmacol 2018; 13: 214-221 efficacy, safety, cost, pharmaceutical property, pharma- cokinetic property and others respectively (Table VI). Out of 153 claims, 112 (73.2%), 7 (4.6%), 9 (5.9%), 4 (2.6%) and 21 (13.7%) were found to be true, ambi- guous, exaggerated, controversial and false respectively (Table VII). Discussion Promotional literature are considered as the most widely used pharmaceutical promotional tools, though claimed to be educational materials, the authenticity of provided information is questionable (Avorn et al., 1982). Interactions of physician-pharmaceutical indus- try have been commenced with the motto of ‘keeping modern in medicine’ (Greene and Podolsky, 2009). In the present study, name of the active ingredient with trade name along with detail information about license holder was mentioned in all promotional literature like previous studies (Jadav et al., 2014; Michael, 2015). However, essential prescribing information like thera- peutic indication, side effects, precautions and contra- indications were present in promotional literature in varying degree (88.2, 40.0, 33.9 and 38.9%), which corresponds with some of the previous researches (Alam et al., 2009; Khakhkhar et al., 2013). High propor- tion of exaggerations in case of indications and/or omi- ssions of safety information correspond with a study conducted in Bangladesh (Haque et al., 2005). Scientific articles were cited as references in large proportion (73.3%) of materials, but half of them could not be retrieved, which matches with earlier studies conducted in India (Mali et al., 2010; Randhawa et al., 2015). Similar to Mali et al. (2010), proportion (24.8%) of promotional materials found to cite references from commercial online information sources. Like previous similar studies (Mali et al., 2010; Saibhavana et al., 2015), most (64.1%) of the promotional claims were focused on efficacy of the product rather than safety or cost. Presence of true claim (73.2%) was less than that of another similar study (Rohra et al., 2006). Prevalence of exaggerations (5.9%) corresponds with a study conducted in a developing country (Randhawa et al., 2015). Similar to some previous studies (Rohra et al., 2006; Murthy and Krishnamurthy, 2010), a small pro- portion of promotional claims were either ambiguous (4.6%) or controversial (2.6%) or false (13.7%). The quality of promotional literature indicates the necessity of caution on the part of physicians while interpreting the claims mentioned in these. The policy makers and educators may find these findings interesting to take required regulatory measure. Conclusion The printed promotional materials contain exaggerated claims and other deviations from the standard. 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Int J Pharma Pharmaceut Sci. 2015; 7: 405-07. 218 Bangladesh J Pharmacol 2018; 13: 214-221 Supplementary Table I Claim of efficacy Name of the medicine Claim Anti-claim statement Remarks Aprepitant Superior to ondansetron for the prevention of vomiting Not supported by reference False claim Aprepitant Indicated for prevention of gen- eral nausea and vomiting Ambiguous claim Bisoprolol Most selective Beta-blocker Has higher degree of Beta selective activi- ty than Atenolol, metaprolol but less than Nebinolol Exaggerated Bisoprolol Provides a superb option for the management of hypertension Ambiguous Carbetocin Superior to oxytocin Decrease reduction in the use of addi- tional uterotonics but no difference in blood loss Exaggerated claim Ceftibuten Effective where other fails Similar to cefixime False claim Ceftibuten Better clinical efficacy in compli- cated urinary tract infection (with illustration) Success rate was 78.3% in ceftibuten group and 77.3% in cefixime group, as effective as cefixime Exaggerated claim Ceftibuten Better than cefprozil (with illus- tration) Success rate was 83.3% in Ceftibuen group and 82.5% in Cefprozil group Dapoxetine Provides similar or more efficacy with on-demand therapy com- pared to once-daily Paroxetine An on-demand dose of 30 mg dapoxetine is no more effective than the currently prescribed paroxetine False claim Doxophylline Superior to theophylline in terms of efficacy Not supported by reference Doxophylline The ultimate choice for asthma and COPD Ambiguous claim Duloxetine Established analgesic efficacy across 4 different chronic pain conditions TGA rejected the indication in chronic low back pain and osteoarthritis Exaggerated claim Linalgliptin Improves long-term diabetic management Not supported by reference False claim Olmesartan plus am- lodipine Powerful double digit blood pressure reduction (↓ SBP up to 20.6 mmHg) ↓ SBP up to 16.5 mmHg Exaggerated Olmesartan plus hy- drochlorothiazide For high systolic blood pressure For mild to moderate hypertension Exaggerated claim Pregabalin Quick solution of chronic pain Ambiguous claim Pregabalin Quick solution of chronic pain Solifenacin Significantly improves urgency episodes compared to tolterodine immediate release As effective as tolterodine Controversial Bangladesh J Pharmacol 2018; 13: 214-221 219 Supplementary Table II Claim of safety Name of the medicine Claim Anti-claim statement Remarks Aprepitant Safer than ondansetron Not supported by evidence False claim Aprepitant Indicated in morning sickness during pregnancy Contraindicated in pregnancy, no such indication was found Azilsartan Safe for hepatic and renal im- pairment patients Consider lower starting dose, avoid in severe hepatic impairment; Caution should be advised in severe renal impairment Carbetocin Safer than oxytocin Safety profile is similar to oxytocin Ceftibuten Safe than conventional Not supported by reference Ceftibuten More tolerable to liver Slight elevation of serum level of liver transaminase was 6.5% in both group (Ceftibuten and Cefixime) Deflazacort 1st choice corticosteoroid for diabetic patients Not supported by evidence False Deflazacort Less side effects than methylprednisolone Some reference suggests, some don’t Controversial Deflazacort Less likely to cause hyperten- sion Not supported by evidence, controversial statement was found Controversial claim Difluprednate No chance of IOP rise in long term use Possible elevation in IOP may be substan- tially higher than commonly encountered with other topical steroids False claim Drospirenone plus ethinylestradiol No effect on blood pressure Increased blood pressure as adverse effect Drospirenone plus ethinylestradiol Least chance of weight gain Chance of weight gain Exaggerated claim Glucosamine sulfate plus diacerein Safe for patients with renal impairment Doses of Glucosamine should be adjusted in patients with renal impairment False claim Linagliptin Safe for hepatic impaired pa- tient without dose adjustment Should not be used in patient with severe hepatic impairment False Linalgliptin Suitable for diabetic patient with cardiac problem Safety data is not adequate, may be a new option but invite continue analysis Exaggerated claim Loteprednole Excellent safety profile in terms of IOP elevation than other corticosteroids Not supported by evidence False claim Mirabegron Less side effects than others Less antimuscarinic side effects than others Exaggerated claim Nepafenac Has the least chance of ocular surface complications Not supported by evidence False claim Olmesartan plus am- lodipine Standard fixed dose combina- tion reduces adverse events compared to high dose mono- therapy The profile of drug related adverse events was similar Sodium alginate plus potassium bicarbonate Safest antiulcerant for pregnant women No comparative study was found Trimetazidine Effectively decrease the inci- dence of CIN Trimetazidine intake before elective PCI in diabetic patients with mild-moderate renal dysfunction is associated with decrease incidence of CIN Exaggerated 220 Bangladesh J Pharmacol 2018; 13: 214-221 Supplementary Table III Claims about pharmacokinetics and general benefit Name of the medicine Claim Anti-claim statement Remarks Dapoxetine Rapid absorption rate Ambiguous claim Ebastine Rapid onset of action Linagliptin Patient will get treatment confidence Ambiguous Bangladesh J Pharmacol 2018; 13: 214-221 221 Name of the medicine Claim Anticlaim statement Remarks: DatePrinted: This article was downloaded by you on: Jul 15, 2018