Based on the BPH curriculum of TU.

1. Drug Promotion
For BPH 1st Year
Dr. Pravin Prasad
Resident 3rd Year, MD Clinical Pharmacology
Maharajgunj Medical Campus
23rd May, 2017 (9th Jestha, 2074) Tuesday
Endorsed by the thirty-third world health
assembly in May 1986 in resolution
WHA39.27

2. Lesson from 1980s and 1990s…
Drug
Marketing
Statement
Problem Fate
Benoxaprofen
(Eli Lily)
Unique mode
of action
Photosensitivity
Hepatoxicity
Withdrawn
Celecoxib
(Pfizer)
CLASS- lower
incidence of
complication
Similar ulcer
related
complication
? COX-2
selectivity
Rofecoxib
(Merck Sharp
& Dohme)
VIGOR study-
GI safety
Cardiovascular
toxicity
Withdrawal
of drug

3. Introduction
• Promotion
• Refers to 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

4. Drug Promotion: Characteristics
• Should be reliable, accurate, truthful,
informative, balanced, up-to-date, capable of
substantiation and in good taste
• Comparison of products should be factual,
fair and capable of substantiation
• Should not contain misleading or unverifiable
statements or omissions
• Should not be designed so as to disguise its
real nature

5. Standards of Promotional Information
Consistent
Standard Promotional Information
Accurate Substantiable

6. Advertising
• Consistent with the approved scientific data
sheet for the drug concerned or other source
of information with similar content
• Advertisements that make a promotional
claim should at least contain summary
scientific information

7. Advertisements: Basic Requirements
• The brand name
• The name(s) and content per dosage form of the
active ingredient(s)
• Name of other ingredients known to cause
problems
• Approved therapeutic uses
• Dosage form or regimen

8. Advertisements: Basic Requirements
• Major adverse drug reactions and side effects
• Precautions, contra-indications and warnings
• Major interactions
• Name and address of manufacturer or distributor
• Reference to scientific literature as appropriate

9. Reminder Advertisements
• Ought to include at least:
• The brand name
• The INN or approved generic name
• The name of each active ingredient
• The name and address of the
manufacturer or distributor

10. Advertisement to General Public
• Should make substantiated claims only
• Should indicate limitations
• Consistent with the approved scientific data
sheet or other legally determined scientific
basis for approval

11. Advertisement to General Public
• Should not:
• Take undue advantage of people's
concern for their health
• include prescription drugs or drugs for
certain serious conditions
• Include scheduled narcotic and
psychotropic drugs
• Should not be directed at children
Basic Rule: Should help people to make rational decisions

12. Advertisement to general Public:
Basic Requirements
• The brand name
• The name(s) of the active ingredients(s)
• Major indication(s) for use
• Major precautions, contra-indications and
warnings
• Name and address of manufacturer or
distributor
• Price

13. Drug promotion: Other aspects
• Medical Representatives
• Free samples of prescription drugs
• Free samples of non-prescription drugs
• To prescribers
• To general public
• Symposia and other scientific meetings
• Packaging and labelling
• Package inserts, leaflets, booklets

14. To Conclude….
• Cautious use of words like “safe” and “new” in
drug promotional activities
• Vulnerable populations:
• Children
• Pregnant
• Elderly
• Person with chronic disease
Thank you….