pharmaceutical companies spend money to develop appropriate literature to market their new drugs. ppt throws light on how healthy skepticism will help the health care practitioners to interpret the literature presented by the medical representatives

1. DRUG PROMOTIONAL LITERATURE
Dr. VANI. J
Assistant Professor,
Dept of Pharmacology
Akash Institute of Medical Sciences and Research Centre,
Bangalore

2. WHO Criteria:
“Medicinal Drug Promotion refers to all the informational and
activities of manufacturers and distributors, the effect of which is to
the prescription, supply, purchase and / or use of medicinal drugs”
Criteria for Medicinal Drug Promotion, World Health Organisation. Endorsed by the 33rd World Health Assembly, May 1986,
Resolution No. WHA21.41.

3. EFFECTIVE PROMOTION
& PROFIT
PURE & AUTHENTIC DATA
FEDERAL & SELF IMPOSED
LAWS
CONSCIENCE
CARE FOR FELLOW HUMANS

4. Current Big Pharma
Drug Promotion – Strategies & Guidelines
How it Started - History
Drug Promotion Literature (DPL)
Critical Appraisal of DPL
Outline

5. Rs. 34, 33, 56, 00, 00, 000
lakh crore or trillion
https://igeahub.com/2017/03/14/top-10-pharmaceutical-companies-2017/

9. MARKETING STRATEGIES
GIFTS

10. DPL
SCIENTIFIC
PAPER
PRODUCT
MONOGRAPH
PAMPHLETS
LEAVE
BEHIND
LEAFLETS
BROCHURE
DRUG
REMINDER
FLIP CHARTS
CDs, Slide
decks, i-Pad
flips

11. Person with Medical
Background
Persons with
Science
Background
HOW DPLs ARE PREPARED?

16. HUGE FUNDING
TEAM WORK
WELL TRAINED MEDICAL REPRESENTATIVES
THE DPLs –RATIONAL?
TRANSPARENT?
COMPLETE?
SUPPORTED BY APPROPRIATE
DATA?
NO MISREPRESENTATION?

17. STORY OF ROFECOXIB

19. IS IT A NEW TREND?

21. `

22. US
• Federal Trade
Commission
• FDA
• State Deceptive
Trade Practices
Laws
• State Tort Laws
• DDMAC of CDER
UK
• Medicines and
Health
Regulatory
Agency (MHRA)
- (legal)
• Association of the
British
Pharmaceutical
Industry (ABPI) -
Self-regulation
INDIA
• OPPI Code of
Pharmaceutical
Practices(2012)
• National
legislation:Drugs
and Cosmetics
Act, 1940
Ethical criteria for medicinal drug promotion (WHO
1988) (Modified in 2015)
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of
Practice (2012)
Uniform code of Pharmaceuticals Marketing Practices (2012)

23. Ethical criteria for medicinal drug promotion
(WHO 1988) Modification (2015)
• 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
• No financial or material benefit.

24. Essential information criteria for DPL
• Name(s) of the active ingredient(s) using either international
nonproprietary names (INN) or the approved generic name of the drug;)
• the brand name;
• Content and amount of active ingredient(s) per dosage form or regimen;
• name of other ingredients known to cause problems;
• Approved therapeutic uses;
• Dosage form or regimen;
• Safety information:
• 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.

26. EXCIPIENTS
DILANTIN

27. DATA
 Omission
 Misrepresentation
 Disillusion

28. DATA OMISSIONS

36. INDIAN DATA
• Most common DPL: of CVS &
Antidiabetic followed by
antiBIOTIC
• 50-60% of the DPL adhere to the
given guidelines
• Risk benefit analysis & Drug
Interaction details were missing
often
• RCT references were considered
as the most authentic

40. DATA MISREPRESENTATION

41. Is Cal Ripken in the ad?
(Appeal to celebrity)

44. Appeal to popularity
Shaughnessy AF, Slawson DC, Bennett JH. Separating the wheat from the chaff:
identifying fallacies in pharmaceutical promotion. J Gen Intern Med 1994;9:563-7.

47. Fallacy of ignoratio elenchi

50. Appeal to Emotion

53. DATA DISILLUSION

57. ADDITIONAL FACTORS WHICH CAN BE CONSIDERED
• AUTHENTICITY TO LOCAL POPULATION
• CONFLICT OF INTEREST

58. Even when regulated,
advertising is still advertising
HEALTHY SCEPTICISM IS ALWAYS GOOD.
THANK YOU!