Drug Promotional Literature

Dr Karuna Sree P
Associate Professor
Department of Pharmacology
Contents
o Need to know
o What is DPL
o Contents of DPL
o Use
o Criticism of DPL
o Summary
??? Need to know
• Whatever presented in the Drug promotional literature is correct of not?
• Manufacturers – huge investment

• Research clearly shows that doctors who report relying more on promotion tend to
prescribe less appropriately, prescribe more often and adopt new drugs more quickly.
Who publishes the Drug Promotional
Literature
• Promotion is done by the manufacturers and distributors

• "promotion" refers to all informational and persuasive activities

• To induce the prescription, supply, purchase and/or use of medicinal

drugs.

• To make the clinicians aware of the existence of the drug

• Promoting its advantages

• Providing the information on when to prescribe.

Drug promotional literature (DPL)
• It is a source of information regarding drugs

• Provides complete knowledge about its nature, class, pharmacological

effects, known side effects, interactions and contraindications for medical
practitioners as well as for patients.
Forms of DPL
 Advertisements in the journals, magazines or newspapers and
providing the drug information sheet to the clinician.

 Gift articles and free drug samples to the doctors.

 Sponsorship of scientific and educational activities (CME), seminars,

conferences, tours.

 Medical representatives.
Criticizing a DPL
• The criteria should thus assist in judging if promotional practices
related to medicinal drugs are in keeping with acceptable ethical
standards.
Information to be available on DPL
1. International Nonproprietary Name (INN) of each active
substance.
2. Pharmacological data: a brief description of pharmacological
effects and mechanism of action.
3. Clinical information
4. Pharmaceutical information
Clinical Information
a. Indications: whenever appropriate, simple diagnostic criteria should be provided.
b. Dosage regimen and relevant pharmacokinetic data:
i. average and range for adults and children;
ii. dosing interval;
iii. average duration of treatment;
iv. special situations, e.g., renal, hepatic, cardiac, or nutritional insufficiencies that require either increased or
reduced dosage.
c. Contra-indications.
d. Precautions and warnings (reference to pregnancy, lactation, etc.).
e. Adverse effects (quantify by category, if possible).
f. Drug interactions (include only if clinically relevant; drugs used for self-medication should be included).
g. Overdosage: brief clinical description of symptoms; non-drug treatment and supportive therapy; specific
antidotes.
Pharmaceutical information
a. Dosage form.
b. Strength of dosage form.
c. Excipients.
d. Storage conditions and shelf-life (expiry date).
e. Pack sizes.
f. Description of the product and package.
g. Legal category (narcotic or other controlled drug, prescription or non-
prescription).
h. Name and address of manufacturer(s) and importer(s).
 Also check for the authenticity of below info in DPL
1. Check the category of advertisement - a new product or a reminder.
2. Check the claim: like ‘the best’, ‘better’, ‘superior’ etc. and always look for the basis of such claims.
3. Check the pictures and graphics used whether they are relevant to the product.
4. Single/combination product: find out if there is any therapeutic advantage over the single substance.
5. Check the statistics
6. Check the references: References published in old obscure; foreign journals must be scrutinized. References in
only well-established peer reviewed journals should be taken seriously.
7. ‘Symposium proceedings, ‘Data on file’, ‘in press’, ‘unpublished data’, or ‘personal communication’ etc. should
always be suspected
8. Data of post marketing surveillance (PMS): whether it is misused for drug promotion e.g., ‘free from side
effects’, ‘no adverse effects found in PMS’.
9. Check whether all the required information is given or not under appropriate headings.
 Checklist for Critical evaluation of drug promotional literature
Yes/
S. No Checkpoints
No
International Non-proprietary Name ( INN ) of
1.
each active substance
Pharmacological data
2. A brief description of pharmacological effects and
mechanism of action
3. Clinical information
a) Indications ( based on diagnostic criteria)
Dosage regimen and relevant pharmacokinetic data
 Average and range for adults and children
b)  Dosing interval
 Average duration of treatment
 Special situations, e.g., renal, hepatic, cardiac or nutritional insufficiencies that require
either increased or reduced dosage.
c) Contra-indications
Precautions and warnings ( reference to pregnancy,
d)
Lactation, etc.)
e) Adverse effects
f) Drug interactions
Over-dosage:
g)  Brief clinical description of symptoms
 Non-drug treatment and supportive therapy
 Specific antidotes
4. Pharmaceutical information
a) Dosage form
b) Strength of dosage from
c) Excipients
d) Storage conditions and shelf –life ( expiry date )
e) Pack sizes
f) Description of the product and package
Legal category ( narcotic or other controlled drug,
g)
prescription or non- prescription )
h) Name and address of manufacturers and importers
i) References
ThanQ