|Year : 2016 | Volume
| Issue : 3 | Page : 248-252
An evaluation of drug promotional literatures published in scientific medical journals
Pooja M Vachhani, Manish N Solanki, Mira K Desai
Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India
|Date of Web Publication||22-Jun-2016|
Pooja M Vachhani
Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines. Materials and Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards of drug promotion laid by the WHO and IFPMA. Data were analyzed using Fisher's exact test. Results: Out of total 178 DPLs, 103 DPLs were from Indian journals and 75 DPLs were from non-Indian journals. When compared regarding compliance to all the 11 ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, DPLs from indian journals contained significantly less information regarding dosage regimen (P = 0.0096), adverse drug reactions (P = 0.0028), warnings (P = 0.0104) and major drug interactions (P < 0.0001) as compared to non-Indian journals. Compliance to all the five IFPMA criteria was significantly higher in DPLs of non-Indian journals (88%) than Indian journals (39%) (P < 0.0001). Conclusion: Noncompliance to ethical standards of WHO and IFPMA guidelines is more common in DPLs of Indian journals as compared to non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended.
Keywords: Drug promotional literature, ethical criteria for drug promotion, medical journals
|How to cite this article:|
Vachhani PM, Solanki MN, Desai MK. An evaluation of drug promotional literatures published in scientific medical journals. J Pharm Bioall Sci 2016;8:248-52
|How to cite this URL:|
Vachhani PM, Solanki MN, Desai MK. An evaluation of drug promotional literatures published in scientific medical journals. J Pharm Bioall Sci [serial online] 2016 [cited 2020 Jul 13];8:248-52. Available from: http://www.jpbsonline.org/text.asp?2016/8/3/248/180769
According to the World Health Organization (WHO), drug promotion means all the informational and persuasive activities of the pharmaceutical companies, which can induce prescription, supply, purchase, and use of medicinal drugs. Pharmaceutical companies promote their product by many ways such as direct mail advertisements or drug information sheet to the clinician, by medical representatives, gift articles and free drug samples, sponsorship of scientific and educational activities, seminars, conferences and tours. Drug advertisements in the scientific medical journals, magazines and newspapers are another mode of drug promotion. Advertisement in scientific medical journals is one of the important modes of drug promotion especially to the clinicians. They often come across various drug advertisements published in these journals while using them to update their knowledge. Furthermore, clinicians have direct and frequent access to these advertisements which can influence their prescribing pattern. Therefore ideally, the drug promotional literature (DPL) published in these scientific journals should provide scientific, correct, unbiased, and critical information to the health professionals.
At present, two international guidelines exist for drug promotional activities, one of which is “Ethical Criteria for Medicinal Drug Promotion” by the “WHO” and another one is “code of pharmaceutical marketing practices” by “International Federation of Pharmaceutical Manufacturers Associations (IFPMA).” Pharmaceutical promotion is controlled by governmental agencies and/or by the pharmaceutical companies through voluntary code of conduct, most often supported by legislation. Many developed countries like the USA, the UK, Australia, and Canada have their own drug advertisement regulatory agency aiming to provide accurate and balanced information about drugs benefits and risks. Failure to comply the code of drug promotion results into regulatory actions including recalls or seizures of promotional materials or activities, criminal prosecution, issuance of retraction statements, fines, suspension, or expulsion of member company from the association.,,,
However, drug promotional activities in India are not regulated by any such government agency. Secondly, Organization of Pharmaceutical Producers of India (OPPI) has adopted a self-regulatory code of pharmaceutical marketing suggested by the IFPMA. Hence, adherence to this code is not mandatory for the pharmaceutical companies.
Very few studies regarding evaluation of DPL published in scientific medical journals have been reported in India. The study done in Maharashtra found that more than 50% advertisements lacking information regarding side effects and precautions. DPLs published in Indian medical journals are found of poor quality in accordance to WHO criteria. Another study shows low incidence of completeness of information content in pharmaceutical advertisements indicating a lack of adherence to OPPI and the IFPMA guidelines. Tandon et al. also found that the advertisements in international journals are more complied to the recommendations of the WHO, than Indian journals. Comparative data of ethical standards of DPL regarding WHO and IFPMA guidelines between Indian and non-Indian journals are lacking which would provide evidence of strengths and weaknesses of different regulatory systems. Hence, the present study was conducted with a view to evaluating ethical standards of published DPL and its comparison between Indian and non-Indian scientific medical journals regarding compliance to the WHO and IFPMA guidelines.
| Materials and Methods|| |
This observational, cross-sectional study was carried out at Department of Pharmacology over the period of 2 months with prior approval from the Institutional Ethics Committee. Indian and non-Indian scientific medical journals published during the period of July 1, 2013–December 31, 2013 and available from central library of medical college were selected. DPLs for medicines published in selected journals were included in our study, while DPLs promoting medical devices, equipments, prosthesis, and ayurvedic medicines were excluded from the study. DPLs repeated in subsequent issues of same journal or other journals were also excluded from the study. DPLs were grouped into two categories as full and reminder according to their content. Evaluation was done separately for full and reminder types of DPLs. Each DPL was evaluated for compliance to ethical criteria for medicinal drug promotion laid by the WHO  and code of pharmaceutical marketing practices by IFPMA. For full type of DPLs, there are total number of eleven and five criteria for drug promotion according to WHO and IFPMA guidelines, respectively. For reminder type of DPLs, there are total number of four criteria for drug promotion according to both WHO and IFPMA guidelines. All DPLs were evaluated for compliance to each criterion of WHO and IFPMA guidelines. Compliance of DPLs to these guidelines was also compared between Indian and non-Indian journals. Fisher's exact test was used to compare the compliance of DPLs between Indian and non-Indian journals with the help of graph pad software (P < 0.05, considered statistically significant).
| Results|| |
A total of 178 DPLs from five Indian and six non-Indian scientific medical journals were collected in accordance to selection criteria. Out of which, 103 DPLs were from Indian and 75 DPLs were from non-Indian journals. Out of these 103 DPLs from Indian journals, 33 DPLs were of full type and seventy were of reminder type. While out of 75 DPLs from non-Indian journals, 69 DPLs were of full type and 6 were of reminder type. Full and reminder DPLs were evaluated separately.
As shown in [Table 1] and [Table 2], only 6 DPLs (18%) fulfilled all the 11 WHO criteria and 13 DPLs (39%) fulfilled all the five IFPMA criteria among the DPLs published in Indian journals (n = 33). While, 4 DPLs (6%) fulfilled all the eleven WHO criteria and 61 DPLs (88%) fulfilled all the five IFPMA criteria among the DPLs published in non-Indian journals (n = 75). Fulfillment of all the WHO criteria in DPLs of Indian journals was found slightly higher than non-Indian journals, but not significantly. However, fulfillment of all the IFPMA criteria was found significantly higher in DPLs of non-Indian journals as compared to Indian journals (P < 0.0001). In addition to that number of DPLs fulfilling 10 WHO criteria was significantly more from non-Indian journals (58%) than from Indian journals (27%) (P = 0.0056). From non-Indian journals 100% DPLs had fulfilled seven or more WHO criteria which is significantly higher than 85% DPLs of Indian journals, (P = 0.0028). Similarly, fulfillment of 4 or more IFPMA criteria is significantly higher in DPLs of non-Indian journals than Indian journals (P = 0.0028).
|Table 1: Comparison of number of WHO ethical criteria fulfilled by DPLs of Indian and non-Indian journals|
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|Table 2: Comparison of number of IFPMA criteria fulfilled by DPLs of Indian and non-Indian journals|
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When compliance to different individual criteria was compared, significant difference was found between DPLs of Indian and non-Indian journals regarding fulfillment of criteria like dosage regimen (P = 0.0096), side effects (P = 0.0028), precaution (P = 0.0015), contraindications (P = 0.0205), warnings (P = 0.0104), and major drug interactions (P < 0.0001). However, name of other ingredients known to cause problems was mentioned more frequently in DPLs of Indian journals as compared to non-Indian journals (P = 0.0015) [Figure 1]. Date of production of advertisement was mentioned in more number of DPLs from non-Indian journals as compared to Indian journals (P < 0.0001) [Figure 2].
|Figure 1: Comparison of compliance to various WHO criteria between DPLs published in Indian and non-Indian journals. *Significant difference in number of DPLs of Indian and non-Indian journals (P < 0.05 by Fisher's exact test). **Very significant difference in number of DPLs of Indian and non-Indian journals (P < 0.01 by Fisher's exact test). ***Extremely significant difference in number of DPLs of Indian and non-Indian journals (P < 0.0001 by Fisher's exact test)|
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|Figure 2: Comparison of compliance to various IFPMA criteria between DPLs published in Indian and non-Indian journals. *Extremely significant difference in number of DPLs of Indian and non-Indian journals (P<0.0001 by Fisher's exact test). #Very significant difference in number of DPLs of Indian and non-Indian journals (P<0.01 by Fisher's exact test)|
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No significant difference was found between reminder DPLs of Indian and non-Indian journals regarding fulfillment of various WHO criteria. Name and address of manufacturer was the most neglected criterion in reminder DPLs. Fulfillment of all four IFPMA criteria was found higher in reminder DPLs of non-Indian journals (50%) than of Indian journals as none of the DPLs in Indian journal fulfilled all four IFPMA criteria. None of reminder DPLs from Indian journals had mentioned date of production of advertisement while it was mentioned in 50% DPLs of non-Indian journals.
| Discussion|| |
Scientific, correct, unbiased information on benefits and risks of drugs provided in DPLs is crucial to physicians in order to determine the most appropriate treatment for patients. The study was done to evaluate and compare ethical standards of DPLs between Indian and non-Indian scientific medical Journals in accordance to WHO and IFPMA guidelines.
Clinicians have to keep themselves well informed about the hundreds of new drugs entering the market every year. For this, they often have to depend on the drug promotional material by the pharmaceutical companies. Journal advertising is considered as a good source of information about new drugs coming in the market. Hence, pharmaceutical companies should provide accurate, adequate, balanced, and valid information to a clinician. In our study, Indian journals were deficient in providing information about new drugs to physician as less number of full type DPLs than reminder type DPLs were published. They provide information about name of already existing drug and name and address of the manufacturer, while in non-Indian journals majority of the DPLs were full advertisement providing information about new drug or updated/relaunched old drug. Number of full advertisements was significantly more in non-Indian journals (92%) as compared to Indian (32%). This might be due to less number of new drugs entered into Indian market every year.
As observed in study, DPLs from both journals were not fully complied with WHO guidelines regarding fulfillment of all criteria. Previously, poor quality of DPLs has been observed in both developing and developed countries. However, if we exclude lowest presented criteria, i.e. name of other ingredients, rest ten criteria were fulfilled in significantly more number of DPLs of non-Indian journals than Indian journals. So, DPLs of non-Indian journals were more complied with WHO criteria than DPLs of Indian journals. Majority of DPLs had provided brand name, generic name, and approved therapeutic uses, similar to three different Indian studies conducted by Tayade and Kulkarni, Charan J et al. and Ved et al.,, Information on dosage was mentioned in less number of DPLs in the Indian journals as compared to non-Indian journals. Name of other ingredients was the most neglected criterion in both journals. It was also observed that DPLs from Indian journals had significantly less information regarding dosage regimen, side effects, precautions, contraindications, warnings, and major interactions as compared to non-Indian DPLs. Though compliance to WHO criteria in DPLs of Indian journals has been improved as compared to earlier Indian studies by Tayade and Kulkarni, Charan J et al. and Ved et al.,, Still it is poor than DPLs of non-Indian journals.
Furthermore, compliance to IFPMA criteria was found significantly higher in DPLs of non-Indian journals than Indian journals. It was observed in our study that the IFPMA code was followed strictly in non-Indian journals. Date of production of advertisement was mentioned less frequently in DPLs of Indian journals, so the clinician should not be relied upon such DPLs for seeking the latest information regarding drugs. Result of our study showed that DPLs from Indian journals are more complied with IFPMA criteria than WHO criteria. The reason may be the IFPMA code has less number of criteria (only 5) to be presented in DPLs. Information on content of names of other ingredients known to cause problems, warnings and major interactions is not required in IFPMA code.
There may be several reasons which could explain the differences found between DPLs of Indian and non-Indian journals. First, the administration of code of conduct in different countries, in India all the regulatory aspects related to the drug advertisements are covered under the Drugs and Cosmetics Act, 1940 and the Magic Remedies Act, 1954. False/misleading and objectionable advertisements are controlled by this act. Regional ethics committees collect complaints against unethical drug promotional advertisements and forward them to drug controller authorities to take necessary steps to discipline guilty companies. However, many violation of ethical code go unreported. Hence, in this situation, government regulatory bodies have to play an active role. On the other hand, in developed countries like the USA and the UK, administration of ethical code is transparent process. Second, it is supported by well-established legal systems and regulatory agencies.
Non-Indian journals included in our study were from the US and the UK. These countries have dedicated regulatory enforcement units which can investigate possible violations and initiate enforcement proceedings. Any enforcement mechanism requires significant investment and this might be one reason why regulatory bodies are not so robust in developing countries as in developed countries.
Although, quality of DPLs of Indian journals is improved as compared to previous studies, clinically important safety information on contraindications, precautions, warnings, adverse effects, and major interaction is still missing in majority of DPLs. Complete information on benefits and risks of medicines provided in pharmaceutical promotion is crucial to doctors in order to determine the most appropriate treatment for patients. For rational prescribing, a physician should know not only about the effect of drug but also about the harm, so that decision for prescribing can be taken after understanding probability of effect and harm. Several measures can be taken for further improvement in quality of drug advertisement including proactive screening of all DPLs by an independent body before they are published in medical journals. Health professionals should be sensitized and encouraged to improve the reporting rate of violation of code. Strong government regulatory system with sound financial support should be established to improve quality of DPLs in Indian journals. These actions may prevent the dissemination of incomplete information to doctors which may lead to irrational prescribing.
Considering the fact, we have selected medical journals from our library that allowed us to access limited number of journals, secondly majority of the non-Indian journals were from developed countries like the USA and the UK, where strict regulatory agencies for drug promotion are existing. This limits comparison of Indian journals to journals of developed countries not with other developing countries.
| Conclusion|| |
DPLs in Indian journals are not fully complied with WHO and IFPMA code. Further, they are more complied to IFPMA criteria than WHO criteria. Ethical standards in DPLs of Indian journals are improved as compared to previous studies. However, compliance is still poor as compared to DPLs of non-Indian journals. For, further improvement in the quality of DPL in Indian journal, we recommend that code for the drug promotion should be established and supported by strict regulatory implementations that can investigate possible violations and initiate enforcement processing. Doctors and medical students need to be educated to increase their ability to recognize misleading promotional activities and encouraged to report the violation of ethical code of drug promotion.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]