Education

1. Dr Akhil Agrawal
Senior PG Resident
SKNMC,Pune

2.  11% per cent of the verbal statements about drugs
made by medical representatives to the clinicians
have been found to be inaccurate.
 Surprisingly only 25% physicians are aware that the
information provided is wrong
 “Promotion” means any activity undertaken, organised or sponsored by
a member company which is directed at healthcare professionals to
promote the prescription, recommendation, supply, administration or
consumption of its pharmaceutical product(s) through all media,
including the internet and mobile SMS etc.(OPPI)
 WHO has defined drug promotion as
“all informational and persuasive activities by manufacturers, the effect
of which is to induce the prescription, supply, purchase and/or use of
medicinal drugs.”

3. *
 Brief overview of principles & regulations relatedto
promotional review andapproval.
 All theattendees understand the basicsof
Promotional Material Review process.
 Those pursuing career in Pharmaceutical Industry
would be at least primed if not prepared for the
futurerole.

4. *
 Fierce competition, lack of quality ofreps.
 Drug reps promotea drug’s effectiveness while playing down
therisks.
 Claiming that the risk is seen with othercompeting
products, but not theirdrug.
 Overstating theeffectiveness of adrug

6. The commercial needs of countless, fiercely
competing pharmaceutical companies has led
them to depend on the tried and tested 3Cs:
 Convince if possible,
 Confuse if necessary, and
 Corrupt if nothing else works
Chandra M Gulhati
Monthly Index of Medical Speciality (MIMS)
India

7. *
 Globally Companies penalized forunethical
promotionpractices
 Off label promotion is seen asviolationof
ethical promotional practices
 Local regulatorychanges requiring industry tocomply
with common promotionalguidance
 Presence of a Uniform code of Marketingpractice
prepared by the Dept ofPharmaceuticals

8. Off Label Promotion
2. http://altmentalities.wordpress.com/2011/03/03/corporate-fine/ accessesd5th April 2013

9. *
 Authentic - Concordancewith known benefit of drug
 Exaggerated - Beyond the actual benefit
 Controversial - Fewclinical studiessupportwhile
othersdisposed
 Misrepresentationof published data tosuit the
company
 False - Nostudies tosupportthe useof the drug
Murthy MB. Authenticity of claims made in drug promotional literature. J Pharmacol 2010; 42(1): 59–60.

10. *
Codes
 International
 IFPMA
 National
 Organisation of Pharmaceutical Producers of
India (OPPI)
 UCPMP guidelines of Department of
Pharmaceuticals(DOP)

11. *
 Productmonographs
 Detail Aid
 Newsletter
 Booklets
 Leave behind literatures
 Training material
 Speaker slides/slidedecks
 Patient educationMaterial
 Advertisements
 Reminderadvertisement
 Completeadvertisements

12. *
The materials could beclassified as
 Print
 Electronic includingaudiovisual
 Telemarketing
 SMS
 Apps…….
This could vary depending upon the imagination and
creativity of the productmanager
It could befor
 Health Care Professionals
 Patients

15. *
Guiding Principles based on the 2012 IFPMA Code of Practice:
1. Pharmaceutical companies will conform to high standards of quality,
safety and efficacy as determined by regulatory authorities.
2. Pharmaceutical companies’ interactions with stakeholders must at all
times be ethical, appropriate and professional.
3. Pharmaceutical companies are responsible for providing accurate,
balanced and scientifically valid data on products.
4. Promotion must be ethical, accurate, balanced and must not be
misleading.

16.  Consistency of Product Information:
 It is understood that national laws and regulations usually dictate
the format and content of the product information communicated
on labelling, packaging, leaflets, data sheets and in all promotional
material.
 Healthcare professionals in India should have access to similar data
to those being communicated by the same company in other
countries.
STANDARDS OF PROMOTIONAL INFORMATION:

17. Accurate and Not Misleading:
 Promotional information should be clear, legible, accurate, balanced,
fair, objective and sufficiently complete to enable the recipient to
form his or her own opinion of the therapeutic value of the
pharmaceutical product concerned.
 Promotional information should be based on an up-to-date
evaluation of all relevant evidence and reflect that evidence clearly.
 It should not mislead by distortion, exaggeration, undue emphasis,
omission or in any other way.
 Descriptions such as 'safe' and 'no side effects' should generally be
avoided and should always be adequately qualified.

18. Substantiation:
 Promotion should be capable of substantiation either by
reference to the approved labeling or by scientific evidence.
 Such evidence should be made available on request to
healthcare professionals.
 Companies should deal objectively with requests for
information made in good faith and should provide data which
are appropriate to the source of the inquiry.

19.  The disease: The drug should be indicated for the conditions for
which it is promoted as described by the existing guidelines.
 The need: Does the need for the promoted drug really exist? The
physician should consider the problems with the existing
recommended therapy and whether the new drug can overcome the
problems.
 The patient: The patients in whom the drug was tested should
resemble the general population.
Shetty vv,Karve AV;promotional literature:how do we critically appraise; J Postgraduate Med ,July 2008,Vol 54,Issue 3
What to look for?

20. *
It can be classified as:
 Disease-oriented
Patient-oriented.
The disease- oriented outcomes show the results in
terms of biological parameters, e.g. BP. This change
may not translate into an actual benefit to the patient.
The patient-oriented outcome is the one which
evaluates actual benefits to the patient in terms of
mortality, better quality of life and decreased cost.
Also, look for the statistics of the studies quoted.

21. 5.1 All Printed Promotional Material, including Advertisements: All printed
promotional materials other than those covered in 5.2 below must be
legible and include:
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.
* OPPI code of pharmaceutical practices
PRINTED PROMOTIONAL MATERIAL

22. 5.2 Reminder Advertisements:
 A “reminder” advertisement is defined as a short
advertisement containing no more than the name of
the product and a simple statement of indications
to designate the therapeutic category of the
product.
 For “reminder” advertisements, “abbreviated
prescribing information” referred to in 5.1 above
may be omitted.

24. The same requirements shall apply to electronic promotional materials as
applied to printed materials. Specifically, in the case of pharmaceutical
product related 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
Information should comply with Drugs & Magic Remedies Act
ELECTRONIC MATERIALS, INCLUDING AUDIOVISUALS:

26.  The name(s) of the active ingredients(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.
Advertisements for public

27.  The following minimum information, must be given clearly and
legibly and must be an integral part of the advertisement:
 The relevant product authorization number and the name and
address of the holder of the authorization or the business name
and address of the part of the business responsible for placing the
medicinal product on the market
 The name of the product, and a list of the active ingredients, using
the common name, placed immediately adjacent to the most
prominent display of the name of the product
 Recommended dosage, method of use and, where not obvious,
method of administration
 Adverse reactions, warnings and precautions for use, and relevant
contraindications of the product
 A statement that additional information is available on request
 The date on which the above particulars were generated or last
updated
*

28.  Promotional material such as mailings and journal advertisements must not be
designed to disguise their real nature.
 Promotional material must conform, both in text and illustration, to canons of good
taste and must be expressed so as to recognize the professional standing of the
recipients and not be likely to cause any offence.
 The names or photographs of healthcare professionals must not be used in
promotional material.
 Promotional material must not imitate the devices, copy, slogans, or general layout
adopted by other companies in a way that is likely to mislead or confuse.
 Where appropriate (for example, in technical and other informative material), the
date of printing or of the last review of promotional material must be stated.
 Extremes of format, size, or cost of promotional material must be avoided.
 Audio-visual material must be accompanied by all appropriate printed material so
that all relevant requirements of the Code are complied with.

29. 1.The names of the active ingredients using either international non-
proprietary names or the approved generic names of the drug
2.The brand name
3.Content of active ingredient per dosage form or regimen
4.Name of other ingredients known to cause problems, i.e., adjuvant
5.Approved therapeutic uses
6.Dosage form or regimen
7.Side effects and major adverse drug reaction
8.Precautions, contraindications, and warnings
9.Major interactions
10.Name and address of the manufacturer or distributor
11.Reference to scientific literature as appropriate.
WHO criteria to be followed by pharmaceutical
industries for the completeness of DPL

30. *
 Check for completeness of the Standard requirements
for all inputs
 Check if claims are accurate, balanced and
substantiated.
 Avoid superlatives or use of the word safe.
 Ensure the material is in good taste
 No pre approval promotion.
 Materials directed to patients should not have
product branding

31.  Check alignment with the therapeutic area understanding
and existing medical update .
 Look at guidelines or review scientific data on the topic
to know the clinical significance and appropriateness
of the claim.
 If required talk to experts on the topic before the input is
approved.

32.  Avoid disparaging remarks aboutcompetitors
 Effortshould be made to highlightstrength of your brand
 Graphs and diagrams should not bemisleading.
 Statistical significance should be mentioned along withthe
numerical values.
 Clinical datashould be promoted with complete
information including samplesize.

33. *
 Check if on label or off label
 Brand name with generic name at least 1/3rd the size of the
brand name
 Intended audience.
 Disclaimers if appropriate
 Latest updated API with version and legible font whenever
claims are made.
 Correct references and referencing
 Unique input identification number
 Company name, logo and address for furtherinformation
 Full PI availability and instruction for referring to fullPI
before use.

34. *
Claims
For Further Information Please writeto
Company Name logoaddress
For
the
use
of
a
registered
medical
practioneer
only
Disclaimer if relevant
Brand name
Generic name
API along with thelatest
version number
Unique InputNo
References

35. *Promo Material Review Form
 Initiator name and dateof initiation
 Name of theproduct
 Unique inputnumber
 Type of material
 Intended audience
 Mandatory and optionalsignatures
 Special approvals
 Date of receipt, subsequent reviewsand final
approvals

36. *
 Quality of promotional materials prepared bythe
company speaks for the quality of the scientific
excellence of thecompany.
 Inappropriate promo materials mayaffect the
reputationof the Pharmaceuticalcompany
 Roleof medical affairs is extremely important to this
vital activity.

37. *
 UCPMP guidelines issued
by the departmentof
pharmaceuticals (DOP).
 Organisation of
Pharmaceutical Producers
of India (OPPI code)
sections 3,4,5 and6.

41. 3/19/2015