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SHORT COMMUNICATION
Year : 2016  |  Volume : 5  |  Issue : 1  |  Page : 45-49

Evaluation of rationality of printed promotional medicine literature


1 Department of Pharmacology, Peoples College of Medical Sciences and Research Center, Bhopal, Madhya Pradesh, India
2 Department of Oral Pathology and Microbiology, Peoples Dental Academy, Bhopal, Madhya Pradesh, India

Date of Web Publication13-Jan-2016

Correspondence Address:
Vipin Kumar Jain
Department of Pharmacology, Peoples College of Medical Sciences and Research Center, Bhopal - 462 037, Madhya Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2278-344X.173871

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  Abstract 

Background: Pharmaceutical companies indulge in medicine promotion through printed material which is distributed to the prescribers. The aim of this study was to evaluate the rationality of such printed promotional medicine literature and find if it was in accordance with World Health Organization (WHO) recommendation and assess the promotion in regard to medicine interactions, truthfulness and accuracy of the contents, validity of the references quoted, and other qualitative content.
Materials and Methods: This was an observational, cross-sectional study on 300 printed brochures of modern and herbal medicines collected by the investigators from private practitioners in Bhopal, which were distributed by the medical representatives. These were assessed for complying with the WHO criteria of 1988, medicine interactions, accuracy, consistency, and validity with the quoted reference in the promotional literature. We also assessed whether the quoted study was sponsored, correlation of pictorial content with given scientific data and actual area utilization for the information.
Results: The majority of the brochures were not in accordance with the WHO criteria. The most of the studies quoted in references were of randomized controlled trials, but the data quoted were inconsistent with the original reference. About 18% of the studies focused on the patient-oriented outcome like mortality, whereas 57.7% included disease-oriented outcome. Around 80% of the brochures contained emotionally exaggerated, nonscientific claims. Maximum brochures promoted heir, other branded medicines also.
Conclusion: Pharmaceutical companies followed the WHO guidelines to some extent but not completely to promote their products with commercial intention rather than deliver the scientific content.

Keywords: Brochures, patient-oriented outcome, therapeutic information, World Health Organization guideline


How to cite this article:
Jain VK, Kaore SN, Amane HS, Jain M, Katakwar M, Thawani V. Evaluation of rationality of printed promotional medicine literature. Int J Health Allied Sci 2016;5:45-9

How to cite this URL:
Jain VK, Kaore SN, Amane HS, Jain M, Katakwar M, Thawani V. Evaluation of rationality of printed promotional medicine literature. Int J Health Allied Sci [serial online] 2016 [cited 2022 Dec 3];5:45-9. Available from: https://www.ijhas.in/text.asp?2016/5/1/45/173871


  Introduction Top


It is a known that medicine promotion is indulged by pharmaceuticals companies who get the printed promotional medicine literature (PML) distributed to the prescribers. While this is known to be an effective means of promoting the medicines, the consistency, validity, and educational value of these material remains questionable.[1],[2],[3],[4] The World Health Organization (WHO) has laid the guidelines for such material which is circulated, at its 1988 Geneva summit.[5] Direct-to-physician (DTP) is one of the popular means of medicine promotion by the pharmaceutical industry.[6] References quoted in printed PML have been found to be based on the studies of poor methodological quality.[7] Whereas, the DTP brochures should contain scientifically consistent and valid visual data, because physicians who rely on these tend to be the heavy prescribers and more willing to try new medications,[8],[9],[10] it has been found that most contain irrelevant pictures.[11]

Hence, this study aimed to evaluate the rationality and educational content of printed brochures collected from private clinicians of Bhopal city on the basis of WHO criteria for ethical medicine promotion.


  Materials and Methods Top


This was an observational, cross-sectional study of 300 PML Brochures collected from various private practitioners of Bhopal city between August and October 2013, which were distributed by the medical representatives. The collected material was screened to exclude the literature pertaining to medicinal devices and equipment, for example, insulin pump; glucometer; orthopedic prosthesis; medicine lists containing more than four brands; and reminder advertisements since these do not present any therapeutic information and have different criteria for evaluation.[5] The PML were assessed as per following criteria:

  • PML assessed as per WHO criteria
    • The name (s) of the active ingredient (s) using either international nonproprietary name or the approved generic name of the medicine
    • The brand name
    • Amounts of active ingredient (s) per dose
    • Other ingredients known to cause problems, i.e., adjuvant
    • Approved therapeutic uses
    • Dosage form or dosage schedule
    • Safety information including side effects and major adverse drug reactions, precautions, contraindications and warnings, and major drug interactions
    • Name and address of manufacturer or distributor
    • References to scientific literature as appropriate.


  • PML assessed for authenticity
  • The PML was assessed for consistency and validity with respect to the actual studies upon which the promotional statements were based. Availability and result/outcome of the quoted study from hard copy/web search, without any manipulation to prop up the claims in PML, were considered as consistent. Those which did not match the original content and were slanted, tilted, or twisted to suit the PML were termed inconsistent. Only those references that quoted randomized controlled trials (RCTs) were accounted as valid references. The study outcome was measured as either patient-oriented or disease-oriented. Patient-oriented outcomes directly reflected and affected the patient, such as perception of symptoms, for example, pain. Disease-oriented outcomes were those characteristics of the disease itself, for example, change in blood pressure.[6] The sponsorship and funding of the study in quoted references were also assessed to know the conflict of interest.

  • The PML evaluated for relevancy of its pictorial content.
  • The PML were evaluated for relevancy of its graphs, tables, pictures with the scientific data and actual area utilization for brief prescription information (BPI), and font size. The area was calculated by measuring breadth and width of space occupied by BPI using a transparent ruler and expressed in cm 2. Similarly, the total area of literature was calculated to find how much percentage of it was utilized for BPI.[1] The font size of 12 was considered optimal, 8–12 as readable, and <8 as nonreadable. The font size was measured in consultation with a qualified journalist by referring to the font type and size table.

  • Brand comparison, specific instructions of particular medicines, and extravagant claims were also noted.



  Results Top


Out of the 315 brochures collected, 15 were excluded as these did not meet the inclusion criteria, thus 300 PDL were included for analysis. Not a single PML fulfilled all the criteria recommended by the WHO. Of all, 13.9% PML met the WHO criteria, except giving the information related to the adjuvant. Most (63%) of PML fulfilled six out of nine criteria, and it was seen that maximum PML lacked safety information and appropriate references. Only 16.5% of these PML had detailed safety information. We found that 17% PML mentioned medicine interactions which were found to be valid [Table 1].
Table 1: Assessment of promotional brochures as per WHO criteria

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For authenticity of references, we assessed retrievability and validity of references. Of all the PML reviewed 80% had quoted references, of these 40% brochures cited two or more references, while 20% did not give a single reference to support their claims. Some PML gave pictures of persons dressed as clinicians or quotes.

We could retrieve 426 out of 513 (83%) of references quoted in PML. Out of which 410 were journal articles, of which 344 were retrievable, either as a hard or soft copy. Among the retrievable journal references 275 were of the RCTs, hence were considered to be valid and included for further analysis [Graph 1 [Additional file 1]].

One-third of the RCTs either used comparative medication, while 51.6% either used placebo (12%) or nothing in the control group (39.6%) for comparing with newer agents. More than half (57.7%) of RCTs had a disease-oriented outcome, while 21.8% had patient-oriented outcome [Table 2]. We found that 16.3% studies were sponsored by pharmaceutical companies, and all of these favored the study outcome, another 10% were institutional and government sponsored studies while nearly three-fourth of the studies did not mention any conflict of interest [Table 2].
Table 2: Characteristics of journal references retrieved from promotional brochures

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We analyzed 127 PML which contained pictorial content, out of which 44.8% were found to be scientifically valid graphical depiction as line diagram, tables, bar diagram, or scatter diagram while the rest 55.2% were pseudographs (graphical presentation without proper axes, labeling legend, or just arrows with numbering showing reduction or increase [11]) or irrelevant pictures. We found irrelevant pictures in 86% of the PML, which has been noted by others also.[11]

The area utilized for BPI was >50% in 83% of PML and <50% in 17% PML where much space was devoted to giving information not related to medicine, treatment, or disease; just for making the PML more attractive and catchy at the cost of sacrificing other essential scientific information. About 98% of PML had a brand name in font size disproportionally large versus BPI mentioned in these, which indicated that the pharmaceutical companies focused on brand name promotion.

The brand comparison was found in 18/300 PML (6%), but this was without any supporting scientific data. Out of the 300 PML, 93 (31%) had special instructions mentioned, for example, bisphosphonates should be taken on empty stomach with one glass of water. About 80% PML had the statements/claims not related to the therapeutic information such as medicine packaging “Alu-Alu pack,” “ first time in India,” “Flash tab Technology,” or other emotional claims to promote their product. The most of the claims were not supported by relevant data which could be used in the decision-making process and even if citations were provided, these were from unpublished data or were not from peer reviewed references.[12],[13],[14],[15],[16] Only a few claims were evidence-based with a higher level of evidence.[17],[18] Herbal medicinal brochures which constituted 6% of PML showed 25/28 references to be retrievable, among which 5/18 journal references were found to be valid.


  Discussion Top


It was found that WHO criteria were not followed in totality in the majority (86%) of PML and even the safety-related information, and appropriate references (consistent data) were lacking in the majority of the PML. Only 16.5% of the PML gave safety information which indicates that pharmaceutical companies' attitude to compromise the safety information. Other researchers have also observed that WHO guidelines were not followed by pharmaceutical companies while promoting medicines.[19]

We found that most of the PML utilized more than 50% space for BPI, and few PML utilized <50% for BPI, hence the practitioners were left with lesser therapeutic data to infer about the promoted medicine. Using larger font size for brand name, bigger than the size of text used for other scientific information appears to be a strategy of pharmaceutical companies for medicine promotion. It was observed that even if the brochure had the right mix of words and sentences, there was trouble with volume of information, especially if closed and small text are jumbled together, resulting in nonreadable content.[20]

The primary source of information about the medicines for the general practitioners was found to be the promotional literature delivered by medical representatives.[3],[12],[21] The companies make the PML catchy, less focusing on providing essential therapeutic information or quote unscientific information which makes a doctor prescribe the promoted products rather than focusing on its rational use. This usually leads to irrationality which creeps up in practice since there is no cost efficacy or cost-benefit information about the promoted product. Accordingly, such PML may not be of much help to the healthcare providers, to firmly rely on, if the rational use of such medications is to be practiced.[22],[23] A Sudanese study reported that about one third of the interviewed 160 pharmaceutical representatives admitted that they do not always mention contraindications, precautions, medicine interactions. Only 4.3% mentioned the side effects of their products promoted by them during their medicine detailing visits.[12],[24]

Reference citations were usually done to earn credibility, but many of the citations were from unpublished documents or data of the file, which in scientific writing should not be quoted since these are not in public domain. Supporting scientific evidence is an important aspect to be considered in evaluating promotional literature. Systematic reviews of RCT are considered to be the strongest level of evidence.[12] We found that majority of the studies were randomized, but the comparator arm in many of these was either placebo or no medication at all, which is likely to favor the patient-oriented outcome rather than a disease-oriented outcome in favor of the trial medicine. Our observations support findings of others [6] who have reported that published studies sponsored by pharmaceutical companies were 4 times more likely to have outcomes favoring the sponsor's product than were the studies that had other types of sponsors. It can be said that although pharmaceutical companies exert control over their clinical trials, the clinical outcome of studies conducted at academic health centers may have a role in complementing the postmarketing surveillance of new medicines after Food and Drug Administration approval.[6] A lot of funds are required for medicine development, and the majority of academic institutions lack such financial resources to carry out good quality studies. Hence to carry out the authentic scientific studies, there is a strong need for substantial funding. Others have reported that references were cited in PML to increase the credibility, but these were found to be of poor quality studies and were difficult to retrieve.[1] In some cases, the cited references led to articles published in non-English journals, and the translated abstract or full-text articles of the same were unavailable.[25] In our study, of the retrievable journal references mentioned in PML, 45% were available as free online abstracts. It is suggested that when such references are quoted in PML, in academic interest these articles should either be made available as full-text online or a free of charge, hard copy is supplied when demanded to ensure accessibility to facts.

The information in promotional literature is known to influence the prescriptions the most of the times.[12] Medical journals have been the prime media used for medicine advertising and the message left by these journal advertisements was clearly remembered by the doctors.[26] It has been shown that majority (55.40%) of respondents were influenced by the journal advertisements [26] and among the medicine advertisements published in the Indian medical journals, only 28% claims were supported by references, and the most common references were of journal articles (75%).[25],[27] Advertisements in journals seem to be a popular medium used by the pharmaceutical industry for medicine promotion although its truthfulness and credibility remain questionable. Ethical advertisements should be promoted by the editorial board of journals by regular monitoring until that self-regulation by medical practitioners can work.[26]

Using the pictures of clinicians and their quotes in medicine advertising is unethical and a crime as per the law of the land. Hence, medical professionals will do well to desist from falling for the advertisement offers.


  Conclusion Top


We found that the pharmaceutical companies followed the WHO guidelines to some extent but partially. They promoted their products with commercial intention rather than deliver the scientific content.

There is a strong need for keeping the private practitioners updated through credible and reliable medicine information system, which will discourage the prescribers from depending on the PML for the medicine information. The pharmaceutical companies should abide by the promotional guidelines laid by the regulatory authorities.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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