|Year : 2016 | Volume
| Issue : 1 | Page : 37-41
A study of adherence of drug promotional literatures from various clinical specialties to the World Health Organization ethical criteria for drug promotion
Siri Hoovinahole1, Ashwin Kamath2
1 Undergraduate Student, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India
2 Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India
|Date of Web Publication||19-Feb-2016|
Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore - 575 001, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Doctors-prescribing practices are influenced by drug promotional activities. Studies have shown that drug promotional literatures (DPLs) do not conform to the established regulations in many countries. However, whether the non-conformance is more likely in a particular clinical specialty needs to be determined. The objective of our study was to assess the adherence of DPLs sampled from various clinical specialties to the World Health Organization (WHO) criteria for ethical drug promotion and determine the presence of any difference. Methodology: Thirty DPLs were collected from each of the five clinical specialty clinics (General Medicine, Surgery, Obstetrics and Gynecology, Pediatrics and Psychiatry) of a University Teaching Hospital. Each promotional literature was evaluated for adherence to the individual WHO ethical criteria's for drug promotion. Results: More than 80% of the promotional literatures from all the clinical specialties did not contain information on dosage modification, contraindications, precautions, adverse effects, drug interactions, drug over dosage, excipients, storage and shelf-life, and legal category of the drugs. Nearly 19.33% of the DPL were for vitamins, minerals, and nutritional supplements; 13.33% for antimicrobials and 10% for anti-anxiety medications. Conclusions: Our study shows that most of the DPLs across clinical specialties failed to adhere to many of the WHO criteria of ethical drug promotion. The information lacking in the DPLs is critical for rational decision making. Considering that these irregularities are present across clinical specialties, it is important to strengthen the regulations governing drug promotion.
Keywords: Drug promotion, ethics, World Health Organization
|How to cite this article:|
Hoovinahole S, Kamath A. A study of adherence of drug promotional literatures from various clinical specialties to the World Health Organization ethical criteria for drug promotion. J Pharm Negative Results 2016;7:37-41
|How to cite this URL:|
Hoovinahole S, Kamath A. A study of adherence of drug promotional literatures from various clinical specialties to the World Health Organization ethical criteria for drug promotion. J Pharm Negative Results [serial online] 2016 [cited 2017 Dec 18];7:37-41. Available from: http://www.pnrjournal.com/text.asp?2016/7/1/37/177063
| Introduction|| |
Drug promotion is defined by the World Health Organization (WHO) as "all informational and persuasive activities by manufacturers, the effect of which is to induce the prescription, supply, purchase, and/or use of medicinal drugs."  Doctors often use drug promotional literature (DPL) as a source of information about new drugs. Studies have shown that printed advertisements may not always meet the prevalent regulations and guidelines in various countries.  While many drug promotional ads provide no reference to scientific evidence in support of the claims made, those that do cite external documents might misrepresent the scientific data or report the data inaccurately.  These aspects are important considering that pharmaceutical promotion influences physicians prescribing behavior. Physicians who are frequently visited by pharmaceutical representatives are also more likely to deny that they are influenced by such interactions. 
Organization of Pharmaceutical Producers of India (OPPI) established in 1965 is a premier Association of Pharmaceutical Companies in India and is also a scientific and professional body.  The OPPI code includes standards for the ethical promotion of pharmaceutical products to healthcare professionals. The OPPI code has been adopted from the code of ethics of International Federation of Pharmaceutical Manufacturers and Associations, of which OPPI is a member. WHO has also laid down ethical criteria for drug promotion including preparation of promotional literature.  The WHO ethical criteria is inclusive of the OPPI code. The main objective of these ethical criteria for medicinal drug promotion is to support and encourage the improvement of health care through the rational use of medicinal drugs.
Several studies in India have reported on the adherence of DPL to WHO ethical criteria. ,, However, whether the non-conformance is more likely in a particular clinical specialty needs to be determined. The objective of our study was to assess the adherence of DPLs sampled from various clinical specialties to the WHO criteria for ethical drug promotion and determine the presence of any difference.
| Methodology|| |
A descriptive study was carried out at a Tertiary Care Teaching Hospital in South India. Following approval from the Institutional Ethics Committee, DPLs were collected over a period of 2 months from five clinical specialties - General Medicine, Surgery, Obstetrics and Gynecology, Pediatrics and Psychiatry. A total of 150 DPLs were collected, 30 from each clinical specialty, over a period of 2 months by convenience sampling. Reminder ads, drug monographs, promotional literature for medical devices, and alternative medicines were not considered for the study. Each promotional literature was evaluated for adherence to the individual WHO ethical criteria's for drug promotion [Table 1].  Data were entered into the Statistical Package for Social Sciences, IBM Corporation, Version 16.0 and analyzed using descriptive statistics. Numbers are expressed as percentages. Differences between DPLs from different departments were ascertained by using Chi-square test. P < 0.05 was considered statistically significant.
|Table 1: World Health Organization ethical criteria for medicinal drug promotion|
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| Results|| |
A total of 150 DPLs were collected from five different clinical departments and assessed. All the DPLs mentioned the international nonproprietary name of the active substances present in the formulation except for two DPLs from the Surgery Department. The data on listing of clinical indications and description of the pharmacological data are shown in [Table 2]. Six DPLs from the Surgery Department had no indications listed (χ2 [4, n = 150] = 17.96, P = 0.001). DPLs, which lacked an adequate description of pharmacological action, were from the Pediatrics Department followed by Psychiatry (χ2 [8, n = 150] = 30.43, P < 0.001).
|Table 2: Adherence of drug promotional literature from five clinical specialties to WHO criteria with regard to pharmacological actions and clinical indications|
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Adherence to the criteria's related to dosing, safety, and pharmaceutical information is shown in [Table 3], [Table 4] and [Table 5]. Dose was not mentioned in more than 50% of the DPLs from Medicine, Pediatrics, and Psychiatry Departments (χ2 [4, n = 150] = 13.85, P = 0.008). Overall, more than 80% of the DPLs from all the clinical specialties did not contain information on dosage modification, contraindications, precautions, adverse effects, drug interactions, drug over dosage, excipients, storage and shelf-life, and legal category of the drugs.
|Table 3: Adherence of drug promotional literature from five clinical specialties to WHO criteria on dosage form and dosage regimen|
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|Table 4: Adherence of drug promotional literature from five clinical specialties to WHO criteria on clinical information|
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|Table 5: Adherence of drug promotional literature from five clinical specialties to WHO criteria on pharmaceutical information|
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DPLs containing references to scientific literature from the Departments of Surgery, Medicine, Obstetrics, Pediatrics, and Psychiatry were 50%, 53.3%, 66.7%, 15.3%, and 70%, respectively. Least number of the DPLs from Pediatrics Department (4/30) had references mentioned (χ2 [4, n = 150] = 24.38, P < 0.001).
Nearly 19.33% (29/150) of the DPLs were for vitamins, minerals, and nutritional supplements; 13.33% (20/150) for antimicrobials, and 10% (15/150) for anti-anxiety medications.
| Discussion|| |
The primary goal of this study was to determine the adherence of DPLs from various clinical specialties to WHO ethical criteria for drug promotion and detect the presence of any difference between the specialties. We evaluated 30 DPLs, each from five different clinical specialties. Almost all the DPLs contained the international nonproprietary names of the active ingredients. This result is similar to earlier studies from different geographic locations. ,,
Almost 50% of the DPLs from all the departments did not contain adequate information on the pharmacological effects and mechanism of action. Studies have shown that the drugs prescribed by a doctor is influenced by drug promotional activities. , Physicians particularly rely on promotional literature in case of new drugs where these are one of the initial sources of drug information.  Lack of adequate pharmacological information in such a context is significant.
Overall, the adherence to criteria's related to dosage form and regimen was inadequate with roughly 80% of the DPLs failing to provide information on the duration of treatment and dosage modification in special situations. Most of the DPLs did mention the dosage form and strength. DPLs from the Obstetric Department fared slightly better compared to others [Table 2].
Prescribing a drug to a particular patient is based on the risk-benefit analysis. No drug is free of adverse effects and thus information on the possible risks of using a drug is critical in the decision-making process. Most of the DPLs in our study across clinical specialties have lacked in this aspect. More than 80% of the DPLs have provided no information on adverse effects and contraindications, drug interactions, etc., which are required for rational decision making. Compared to listing of clinical information, more percentage of DPLs have cited reference to scientific literature. References help the physician to ascertain the correctness of the claim made in the promotional literature as well as act as a source of information. Among the specialties, pediatric DPLs were least likely to mention the reference literature (4/30). For many clinical indications, the basis for the use of a particular drug has been derived from clinical experience in adult patients. Among these, drugs that have been in use in children for a sufficiently long time have been studied for their efficacy and safety. However, such information requires wider dissemination among prescribers, especially the primary care physicians who cater to the health care needs of children among others. Hence, it is important that the promotional literatures not only present a right balance of benefits and harm, but also provide adequate references to substantiate their claim.
Overall, the findings of our study concur with those from earlier studies although the percentage values may differ. ,, While all the criteria's are important for a promotional literature to be considered rational, the information that were found to be lacking in most of the DPLs are those which would be of most interest to the physician. A similar trend is also seen in drug advertisements in medical journals.  This nonadherence to the ethical drug promotion criteria's can potentially lead to irrational drug prescription. Excessive emphasis on the benefits with inadequate/no information on the risks may lead to a false sense of security among the prescribers. There were differences among the DPLs from various clinical specialties in terms of individual criteria's. However, the widespread lack of information on important pharmacological and clinical aspects in the DPLs overshadows these differences.
Our study has limitations. Only a limited number of DPLs were collected over a short period by convenience sampling. All the WHO criteria for ethical drug promotion need not be present in a DPL depending on the profile of the drug advertised, its intended use and the target population. Hence, the percentages mentioned for some criteria may be an overestimation. However, this is likely to be insignificant considering the overall findings. We also did not evaluate whether the references cited actually substantiate the claim(s) made.
| Conclusions|| |
Our study shows that most of the DPLs across clinical specialties failed to adhere to many of the WHO criteria of ethical drug promotion. The information lacking in the DPLs is critical for rational decision making. Most of the DPLs provided information on the nonproprietary names of the active ingredients, clinical indications, dosage form and strength, name and address of the manufacturer, which are grossly inadequate in informing the physician about a drug, except to act as reminders. Considering that these irregularities are present across clinical specialties and, as reported in other studies, also in the promotional advertisements in medical journals, it is important to strengthen the regulations governing drug promotion. A continuous evaluation of such promotional literature is important to determine the magnitude of the problem and the effectiveness of the control measures implemented. This information is also vital to the physicians whose prescribing behaviors are influenced by such promotional material. Although our study did not find the problem localized to a particular clinical specialty, if inappropriate drug promotion is more widespread in a particular clinical specialty or therapeutic group, more resources can be allocated in the respective specialty (such as education of doctors and publicizing deceptive promotion) to deal with the problem.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Norris P, Herxheimer A, Lexchin J, Mansfield P. Drug Promotion - What We Know, What We Have Yet to Learn. Reviews of Materials in the WHO/HAI Database on drug Promotion. World Health Organization; 2004. Available from: http://www.who.int/medicinedocs/pdf/s8109e/s8109e.pdf
. [Last accessed on 2015 Jan 10].
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 underlying studies: Is what they tell us important and true? BMC Fam Pract 2006;7:13.
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.
Khakhkhar T, Mehta M, Shah R, Sharma D. Evaluation of drug promotional literatures using WHO guidelines. J Pharm Negat Results 2013;4:33-8.
Jadav SS, Dumatar CB, Dikshit RK. Drug promotional literatures (DPLs) evaluation as per World Health Organization (WHO) criteria. J Appl Pharm Sci 2014;4:84-8.
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;2:2-6.
Prosser H, Almond S, Walley T. Influences on GPs′ decision to prescribe new drugs-the importance of who says what. Fam Pract 2003;20:61-8.
Harris G. Pharmaceutical representatives do influence physician behaviour. Fam Pract 2009;26:169-70.
Nath S, Bhowmick S, Dutta T, Chowrasia VR, Bhattacharya S, Chatterjee RN, et al.
A study of promotional advertisements of drugs in a medical journal: An ethics perspective. Indian J Med Ethics 2014;11:237-41.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]