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Drug Promotional Literature

This presentation is about Drug Promotion Literature.

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Drug Promotional Literature

  1. 1. 1 Dr Jayant Rai, 3rd Year Resident, Dept of Pharmacology
  2. 2. Introduction  Drug Promotion All informational and persuasive activities by manufacturers and distributors to induce the prescription, supply, purchase and use of medicinal drugs. 2
  3. 3. Sources of Product literature  Primary: Scientific Journals & Pharmacopeias. Secondary: Index Medicus & Medline. Tertiary: Compendia, Textbooks, Review Articles. Promotional: Folders, Leave-behind Leaflets, Product drop cards, E-mail etc. 3
  4. 4. Promotional Activities A huge part of Pharma companies. A persuasive communication. “Directly approach to Physician”.  Written material. 4
  5. 5. Presented with Sample drugs, Token gifts, Reminder article, Paper weight, Calendar, Notepad etc. Sponsored CME (Continued Medical Education). Advertisements in the medical journals. Information- more for promotion rather than educating the physician. 5
  6. 6. Well known promotional activities is to produce advertising brochures Inaccurate, inadequate and of poor educational value. Can lead to irrational prescribing. 6
  7. 7. 7 Edge Think cutting
  8. 8. Financial Aspects of DPL $ 11 billion/year-for drug promotion and marketing. $ 5 billion/year –for sales representatives. $ 8000-13000 per health care professional/year. 8
  9. 9. 9
  10. 10. Regulatory Codes & Guidelines Ethical criteria for medicinal drug promotion (WHO 1988) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice (2012) Organization of Pharmaceutical Producers of India (OPPI) Code of Pharmaceutical Practices(2007). 10
  11. 11. Regulatory Codes….. National Legislation. Standards for ethical promotion of pharmaceutical products to healthcare professionals. Pharma companies must maintain high ethical standards when conducting promotional activities and comply with applicable legal and professional requirements . 11
  12. 12. Ethical Medicinal Drug Promotion  WHO criteria for Ethical Medicinal Drug Promotion dictate that promotional literature should contain following information…… The name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug. The brand name. Amount of active ingredient(s) per dose. 12
  13. 13. Other ingredients known to cause problems, i.e. adjuvant. Approved therapeutic uses. Dosage form or dosage schedule. Name and address of manufacturer or distributor. 13
  14. 14. Safety information including major adverse drug reactions, Precautions, contraindications and warnings, and major drug interactions. Reference to scientific literature as appropriate. 14
  15. 15. Objectives of Regulation  Medicinal drugs promotion should be Reliable, Accurate, Truthful, Informative, Balanced, up-to-date, Capable of substantiation and in good taste. No misleading or un-verifiable statements & unjustifiable drug use. 15
  16. 16. Comparison of products should be factual & fair. No financial or material benefit. Post-marketing scientific studies and surveillance should not be misused as a disguised form of promotion. 16
  17. 17. Good Promotional Criteria Product claim must identify the drug’s brand & generic names in a proportionate ratio. Pictorial illustrations must be relevant & scientific. Shouldn’t make any claims like “Magical remedy” or “Only cure”. 17
  18. 18. Should contain risks & benefits of the drug. Supported by substantial evidences or clinical experiences. Mention cost properly and the address of the manufacturer & date of production. Information about Adverse Drug Reactions, drug interactions and precautions. 18
  19. 19. Unsubstantiated claims, Catchy phrases, Irrelevant Pictures, Charts & Tables shouldn’t be there. Should inform, educate, stimulate and direct the reader in the simplest and most concise manner. Promotional brochures should give importance to brief prescription information (BPI). Focused, attention-grabbing and benefits-driven. 19
  20. 20. Role of Promotional Literature  Fulfilling requests for information.  Informational displays.  Use as direct mail pieces.  As a sales tool. 20
  21. 21. Advantages  Introduces a new product in the market.  Increases prospects & sales.  Fights competition & Eliminates middlemen.  Educates the target market.  Raises the standard of living. 21
  22. 22. Disadvantages  May be inadequate, inaccurate, invalid, unethical, false, misleading, biased, and deceptive or based on studies of poor methodological quality.  Leads to monopoly, Creates artificial demand.  Increases the price of the product.  Enhances the self medication of patients & May be harmful for the society. 22
  23. 23.  Check list for evaluation of promotional literature Name (INN/ Generic name) Yes/No Brand name Yes/No Active ingredient/contents Yes/No Approved therapeutic use Yes/No Dosages form/ regimen Yes/No Adverse drug reaction: minor/ major Yes/No Precautions, contraindication and warnings Yes/No Name and address of manufacturer Yes/No Scientific references Yes/No
  24. 24. 24  Name (INN/ Generic name) Yes/No  Brand name Yes/No  Active ingredient/contents Yes/No  Approved therapeutic use Yes/No  Dosages form regimen Yes/No  Adverse drug reaction: minor/ major Yes/No  Precautions, contraindication and warnings Yes/No  Name and address of manufacturer Yes/No  Scientific references Yes/No
  25. 25. 25
  26. 26.  Name (INN/ Generic name) Yes/No  Brand name Yes/No  Active/other ingredient/contents Yes/No  Approved therapeutic use Yes/No  Dosages form regimen Yes/No  Adverse drug reaction: minor/ major Yes/No  Precautions, contraindication and warnings Yes/No  Name and address of manufacturer Yes/No  Scientific references Yes/No 26
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