Indian Journal of Pharmacology Medknow Publications on behalf of Indian Pharmacological Society ISSN: 0253-7613 EISSN: 1998-3751 Vol. 36, Num. 5, 2004, pp. 313-315

Indian Journal of Pharmacology, Vol. 36, No. 5, October, 2004, pp. 313-315

Research Letter

Pharmaceutical drug advertisements in national and international journals

Tandon Vishal, Gupta BM, Khajuria V

Post Graduate Department of Pharmacology & Therapeutics, GMC, Jammu (J&K) - 180 001
Correspondence Address:Post Graduate Department of Pharmacology & Therapeutics, GMC, Jammu (J&K) - 180 001 dr_vishaltandon@yahoo.com

Code Number: ph04105

Sir,

Recent advances in research and clinical experiences keep on changing the drug therapy for many diseases. Therefore, scientific information on new drugs and therapeutics is undoubtedly of paramount importance. Industry drug advertisements are intended to be persuasive rather than educational and it is not meant for educating the physicians in the use of drugs.[1] However, a busy doctor unable to find time to update himself may start relying on drug advertisements. The drug advertisements in journals usually give inadequate and substandard information.[2] Although this aspect had been explored in the past by many authors,[2],[3] in the present study, a retrospective comparative evaluation was carried out to analyze the drug information provided in pharmaceutical advertisements in national and international journals. For this purpose 54 advertisements from 50 issues of national journals and 50 advertisements from 50 issues of international (USA and UK) journals were selected and reviewed. The list of titles of national and international journals from which these advertisements were selected is shown in [Table - 1]. The journals selected were for the years 2001 to 2003 and included those from medicine and surgery. Only new drug advertisements were included while reminder/repeat advertisements were excluded in the present study. The information was collected using the format of drug information sheets suggested by the WHO′s ethical criteria for medical drug promotion,[4] that included details about the brand name/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects. The percentage of advertisements providing information about each aspect was worked out. The data obtained from national and international journals were compared using the Chi-square test and P<0.05 was considered significant. The results are shown in [Table - 2].

The present study indicated differences in the drug information provided in the advertisements published by national and international journals. The advertisements in international journals provided more complete drug information as per the recommendation laid down by WHO in comparison to national journals. However, they were found to be deficient in providing information regarding some of the aspects like pharmacological effects (12%), mechanism of action (16%) and pharmacokinetic data (8%). Whereas, the information in the advertisements of the national journals was inadequate in nearly all aspects of pharmacological data, clinical information (0%), pharmaceutical information (0-33.3%) and legal aspects (0-11.11%). The main stress in national journals appeared to be on brand names (100%), indication (92%) and address of manufacturers (88.88%).

This discrepancy in the drug information provided by drug advertisements in national and international journals might possibly be due to different regulatory requirements of various countries. In India we have "The Drug And Magic Remedies Act 1954" with amendment in 1992 to take this aspect into account. The objective of this Act is to control advertisements which are false/misleading and objectionable. However, this Act is silent on ensuring the adequacy of drug information in new drug advertisements in journals; as a result the industry learnt to take advantage of the loopholes in the law.[3] We also have an organization of pharmaceutical manufacturers in India (OPPI), which is bound to follow a self-regulatory code of pharmaceutical marketing suggested by the International Federation of Pharmaceutical Manufacturers Association (IFPMA).[5] IFMPA suggests that full advertisements in print must include the name of the product, active ingredients, name and address of the company, an approved indication, dosage and method of use, contraindications, precautions and side-effects. In light of the present study how far this code is strictly followed in India cannot be precisely stated. Double standards might be adopted by pharmaceutical companies to follow this code in developing countries as suggested by Thawani, 2002,[3] but the present study surely indicates that the IFPMA code is followed strictly in developed countries like the USA and UK.

Regulatory requirements are different even in the various developed countries. The FDA in the USA, under the authority of the Federal Food, Drug and Cosmetic Act lay down guidelines[6] for "product claim" ads to provide basic pharmacological information, including the name of product, uses, side-effects, contraindications, drug benefits with regard to safety and effectiveness, risk information, limitation of efficacy, limitation to use, product hazards, and management of overdosage. Further, these drug advertisements cannot be false or misleading and cannot omit material facts. Whereas the UK legislation[7] (The Medicines, Monitoring of Advertising, Amendment Regulations, 1999) requires the license number, supply classifications, name and address of the marketing authorization holder, name of the product, list of its active ingredients, indications, side-effects, precautions, contraindications, dosage form, method of use, warnings, and cost to be included in the advertisements meant for persons qualified to prescribe or supply. Moreover, there are agencies like the MCA (Medicine Control Agency) in the UK to ensure these regulations strictly.

In view of these discrepancies, we suggest that a uniform regulation and code should be followed and effectively supervised to overcome this problem. There is a need for every member country to follow WHO′s ethical criteria for medical drug promotion strictly, so that new drugs are rationally used. Drug advertisements are not meant to educate doctors but due to lack of time they may be used for that purpose. Hence, it is important that comprehensive information be given in these advertisements.

Therefore, pharmaceutical companies, editorial offices of various national journals and the government must recognize this problem and ensure the adequacy of drug information in these advertisements, in the overall interests of healthcare of the society.

ACKNOWLEDGEMENT

REFERENCES

Copyright 2004 - Indian Journal of Pharmacology

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