Snapshot of the pharmaceutical promotional literature of Bangladesh: A critical review

Fatema Johora and Md. Sayedur Rahman

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 respectively. 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 an eye opener for the policy makers. More importantly, this may bring alertness among the physicians during interpretation of pharmaceutical promotion literature.

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 designed 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 medicine usually contaminated with the intentional manipulation and misinterpretation as well as claims, which are often inaccurate, exaggerated, ambiguous, controversial, 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 adherence to the ethical principles of marketing of pharmaceutical 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 independent source (Haque et al., 2005). The pharmacology 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 promotional literatures worsened the situation (Islam and Farah, 2007). Present study was conducted in this backdrop, adherence of promotional literatures to existing 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 outpatient 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 literatures 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 literatures of each department was counted. Step II: Promotional literatures were categorized into allopathic, Unani, Ayurvedic, herbal, cosmetics, medical device and other. Step III: Promotional literatures other than allopathic drugs were excluded. Step IV: Allopathic products were categorized and promotional literatures other than ‘full advertisement’ were excluded. Step V: Promotional literatures 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 literatures 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 literatures 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 4^th edition of Bangladesh National Formulary but absent in 3^rd 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 literatures 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 literatures circulated by different manufacturers were included for separate evaluation. Total 73 promotional literatures were evaluated in this phase.

Promotional claims were compared with cited references of promotional literatures, original innovator’s product 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 4^th edition of BDNF, then latest available edition (67^th) of BNF was used as an alternative of similar nature. Latest available online edition (36^th) of “Martindale: The complete drug reference” 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 practice

Table I showed that the printed promotional literatures were 77.6, 12.7, 5.0, 2.7, 0.5, 0.12 and 1.2% for allopathic, cosmetic, herbal, Unani, Ayurvedic, device and others respectively.

All reviewed promotional literatures (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 literatures respectively (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 literatures 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 literatures matched with BDNF/ BNF (Table III).

Table IV showed that 1,020 references were mentioned in 440 promotional literatures, of which scientific article, commercial online information sources, data on file, regulatory body approval data, product monograph 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 literatures, retrieval was possible in 512 (50.2%) cases. Among these retrieved documents, 454, 29, 22, 6 and 1 references 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 literatures of which 98 (64.1%), 46 (30.1%), 4 (2.6%), 1/153 (0.7%), 3 (2.5%) and 1 (0.7%) were about efficacy, safety, cost, pharmaceutical property, pharmacokinetic 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, ambiguous, exaggerated, controversial and false respectively (Table VII).

Discussion

Promotional literatures 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 industry 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 literatures like previous studies (Jadav et al., 2014; Michael, 2015). However, essential prescribing information like therapeutic indication, side effects, precautions and contra-indications were present in promotional literatures 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, 2013). High proportion of exaggerations in case of indications and/or omissions 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 proportion 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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