criticism of drug promotional literature(dpl)

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1. Dr.SOURAV CHAKRABARTY, Post-graduate trainee, Dept. Of Pharmacology, B.S.Medical College Criticism of Drug promotional literature(DPL) 2. Overview Introduction. Drug promotion & its methods. Sources of information for a physician. Regulatory codes & guidelines. Critical appraisal of DPL by a physician. Some recent works on review of DPL. Discussion. Bibliography. Exercise. 3. Introduction Advent of pharmaceutical sciences & globalisation of pharma industry good number of drugs (generic/brand) getting into market everyday. Every day ~ 46 randomized clinical trials are published ~ 1000 new Medline articles ~ 6,000 new articles in biomedical journals Every year ~ 3 million articles published in ~ 30,000 journals Information explosion. 4. Most are me too product,no genuine innovation. Busy hectic professional life for a physician. No formal training of method of appraisal of medical literature during undergraduate MBBS courses. DPL- does Update knowledge OR develop wrong practices? 5. Drug promotion & its methods Drug promotion: All informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase, and/or use of medicinal drugs (WHO 1988). $ 11 billion/year-for drug promotion and marketing, $ 5 billion/year for sales representatives 8000-13000 $ per health care professional/year. Two types- 1. Promotion to health care professional 2. Promotion to general public. 6. Contd Aids- 1. literature: scientific paper,leaflet,brochure,drug reminder etc. 2. Audio-visual aid. 3. Gift item:pen ,paper weight,date calender,notepad. 4. Media: television,internet. 5. visual aid:banner,hording. 6. Direct mailing. 7. Newspaper & magazine. BUT most importantly, verbal presentation by medical representatives. 7. Written literature Protocols as evidence of clinical benefits Publication in non-peer reviewed / obscure journals Graphs with misleading axes! Surrogate end points Claims of superior potency Data from in-vitro studies, healthy volunteers Claims from emerging or scientific opinions Price comparisons Statistics 8. Contd.. Information- more for promoting the drug,rather than educating the physician. 11% of verbal statements are inaccurate. Only 25% of physicians are aware of that. Poor methodological quality of journal advertisements. But still an important medium for updation of knowledge for busy physicians,specially in remote areas. 9. Commonly misused shortcuts for choosing therapies Newer is better Experts know best If there is a mechanism for how a drug works, then it works If my peers are prescribing the drug then so should I. If the patient improves after the drug is prescribed, then the therapy must have worked. If the manufacturer gives gifts, I should support them in return 10. Sources of information for a physician A.Published literature: 1.primary: original publication, research studies, case report, case series, letter to editor, review article. 2.secondary: medline, pubmed, national library of medicine gateway, international pharmacy abstract,toxline, current content. 3.tertiary: textbooks(Harrisons principles of internal medicine),compendia (physicians desk reference) 11. Contd. B.Internet C.CME: Scientific seminar/symposia/case presentation D.Drug promotional literature: scientific paper,,leaflet, brochure, drug reminder etc. E.From expert opinion. 12. Regulatory codes & guidelines Ethical criteria for medicinal drug promotion (WHO 1988) IFPMA Code of Practice (2012) OPPI Code of Pharmaceutical Practices(2012) National legislation: 1. Drugs and Cosmetics Act, 1940 13. Ethical criteria for medicinal drug promotion (WHO 1988) At the Forty-first World Health Assembly(13 may,1988). Objective: To support and encourage the improvement of health care through the rational use of medicinal drugs. Applicability: Both prescription and non prescription medicinal drugs ("over-the-counter drugs"),also traditional medicines as appropriate, and to any other product promoted as a medicine. Do not constitute legal obligations. 14. Contd. medicinal drugs promotion should be reliable, accurate, truthful, informative, balanced,up-to-date, capable of substantiation and in good taste. No misleading or unverifible statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word "safe" should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Do not disguise the real nature of a drug. 15. No financial or material benefit. Essential information criteria for DPL: A.Promotion to the physician: the name(s) of the active ingradient(s) using either international nonproprietary names (INN) or the approved generic name of the drug;) the brand name; content of active ingredient(s) per dosage form or regimen; name of other ingredients known to cause problems; 16. Contd. approved therapeutic uses; dosage form or regimen; side-effects and major adverse drug reactions; precautions, contra-indications and warnings; major interactions; name and address of manufacturer or distributor; reference to scientific literature as appropriate. @(reminder advertisements): the brand name, the international nonproprietary name or approved generic name, the name of each active ingradient,the name and address of the manufacturer/ distributor for the purpose of receiving further information. 17. B.Promotion to the general public: Advertisements claim must be substantiated. Not for scheduled narcotic and psychotropic drugs. lay language : information should be consistent with the approved scientific data sheet. Criteria: the name(s) of the active ingradient(s) using either international nonproprietary names (INN) or the approved generic name of the drug; the brand name; major indication(s) for use; major precautions, contra-indications and warnings: name and address of manufacturer or distributor. 18. Free samples of legally available prescription drugs may be provided in modest quantities to prescribers, generally on request. Sponsorship of a symposia by a pharmaceutical manufacturer or distributor should be clearly stated in advance,at the meeting and in any proceedings. Post-marketing scientific studies and surveillance should not be misused as a disguised form of promotion. 19. Substantiated information on hazards associated with medicinal drugs should be reported to the appropriate national health authority. Adequate lnformation for patients= package inserts, leaflets and booklets-should provide information consistent with that approved by the country's drug regulatory authority. 20. IFPMA & OPPI code IFPMA(International Federation of Pharmaceutical Manufacturers & Associations ) Code of Practice:2012. Adopted by OPPI(Organisation of Pharmaceutical Producers of India) & published as OPPI Code of Pharmaceutical Practices(2012). Effective on 31 December, 2012. . 21. pharmaceutical product- all pharmaceutical or biological products (irrespective of patent status and/or whether they are branded or not) which are intended to be used on the prescription of, or under the supervision of, a healthcare professional and which are intended for use in the diagnosis, treatment or prevention of disease in humans, or to affect the structure or any function of the human body. Scope: Interactions with healthcare professionals, organizations/associations of healthcare professionals, medical institutions and patient organizations, promotion of pharmaceutical products. 22. Exclusion: Promotion of prescription only pharmaceutical products directly to the general public (i.e. direct to consumer advertising). Promotion of self-medication products that are provided over the counter without prescription. Pricing or other trade terms for the supply of pharmaceutical products. The engagement of a healthcare professional to provide legitimate consultancy or other legitimate services to a member company. The conduct of clinical trials (which are governed by separate GCP guidelines). The provision of non-promotional information by member companies 23. Ethical promotion Basis of interaction. Transparency of promotion. Independence of healthcare professionals: no financial benefit or benefit-in- kind Appropriate use Regulations. Pre-approval communications and off-label use: not allowed. BUT,should not restrict a full and proper exchange of scientific information. 24. STANDARDS OF PROMOTIONAL INFORMATION Consistency of Product Information Accurate and Not Misleading Capable of substantiation either by reference to the approved labeling or by scientific evidence. Printed promotional material:criteria the name of the product (normally the brand name);the active ingredients, using approved names where they exist; the name and address of the pharmaceutical company or its agent responsible for marketing the product; date of production of the advertisement; and abbreviated prescribing information which should include an approved indication or indications for use together with the dosage and method of use, and a succinct statement of the contraindications, precautions and side effects 25. Electronic materials, including audiovisuals: same as literature. For websites: the identity of the pharmaceutical company and of the intended audience should be readily apparent; the content should be appropriate for the intended audience; the presentation (content, links, etc.) should be appropriate and apparent to the intended audience; and Information should comply with Drugs & Magic Remedies Act. 26. National legislation Drugs & Cosmetics Act 1940 and Rules 1945, Drugs & Magic Remedies (OA) Act 1954 and Rules 1955, Drugs (prices Control) Order 1995