FW iklan obat dari sudut pandang medis @ BPOM

Sudut pandang iklan obat
dari keamanan medis
Dr. Freddy Wilmana, MFPM, SpFK, Dipl.WOSAAM
Medical & Pharmaceutical Consultant
Jakarta 20th July, 2017
[email protected]
[email protected]
www.linkedin.com/in/freddywilmana
Disclosure & Disclaimer
▪ I have no conflict of interest to
disclose with respect to this
presentation.
▪ My comments reflect my own
views and do not necessarily
reflect the views of the Team or
any individual Team-member
4
DEFAULT REGULATORY
POSITION
•From most restrictive/least ideal to least
restrictive/ideal:
✓No advertising of OTCs permitted
✓OTC advertising not permitted, but with
some exceptions
✓OTCs advertisable, but with some
exceptions
✓All OTCs advertisable
OTC ADVERTISING REGULATION
GUIDELINE IN USA
• Organization that are involved in the control of OTC medicines
advertising are:
• Food & Drug Administration (FDA)
• Federal Trade Commission (FTC)
• Broadcasting networks
• Trade association related to the control of OTC medicines advertising
is CHPA (Consumer HealthCare Products Association)
• CHPA is the USA trade association for manufacturers of branded overthe-counter medicines
• Primary aim is to promote responsible self-medication to consumers and
professionals.
• National Advertising Division (NAD)
• self regulation censorship for Ads
FDA ROLE IN OTC ADVERTISING



FDA control mainly OTC labeling, not advertising
Primarily FTC, not FDA, will investigate
FDA will provide advertising/promotional material to
FTC along with an explanation and data that is
relevant to the claim
•
•

MOU (Memorandum of Understanding) allows interagency
sharing of confidential information
Usually a follow-up call or e-mail
Any additional data to support the advertising
/promotional claim sent to FTC, not FDA
FTC ADVERTISING LAW BASICS
1. Needs to have prior substantiation that an objective claim in an
ad is true before they run the advertisement.
2. deception policy, the FTC looks to real life situations and how
consumers would interpret an ad. Even if the individual parts
of an ad were technically “true,” if the overall ad seeks to
mislead informed choice through misrepresentations or
omissions, the FTC can act against the advertiser.
3. unfairness policy, FTC may act against ads that cause
substantial consumer harm that are not outweighed by a
consumer or competitive benefit or where a consumer could not
reasonably avoid the harm.
PASTI……….???
Dalam medis/kedokteran …..TIDAK ADA PASTI 100%
Contoh2 banyak ….sekarang banyak gugatan
Seperti kasus kasus obat acne, estetik,, Surabaya dll
PAGB CODES OF ADVERTISING PRACTICE
General principles (cont.)
• Advertising can only refer to the prevention
of symptoms and the use of a product in
chronic conditions, if this is in line with the
Summary of Product Characteristics.
• Advertising shall not contain material which
could lead to consumers making an
erroneous self-diagnosis.
• Advertising shall not claim or imply, that a
product’s effects are guaranteed.
Steps in appearance of intact drug in circulation
Pharmacological effect
pH = 1 - 3
absorption
dissolution
hepatic
metabolism
disintegration
gastric emptying rate
pH = 5 - 7
intestinal transit rate
dissolution
intestinal
metabolism
absorption
disintegration
fwilmanafaeces
@ pacific.net.id
clearance
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Plasma Concentration
Routes of Administration
IV (Inhalation)
IM
10 mg dose
Oral
Patch
Hours Post Administration
fwilmana @ pacific.net.id
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Factors that determine the intensity of drug response
BERBAGAI DEFINISI
•Obat dan racun bedanya
menstabilkan atau merusak
kestabilan suatu sel.
•Jika merusak disebut racun
jikalau tidak merusak/membantu
sel untuk mencapai kestabilan
itulah yang disebut obat
Because No Drug is Ideal……..

Because no drug is ideal…….
–
–
–
–

No medications are ideal
No drug is safe
All drugs can produce side effects
Drug responses may be difficult to predict
All members of health care team must
exercise care to promote therapeutic
effects and minimize drug induced harm
– Health care team………members…?
– we are all in the team
PENYAKIT AKUT -- KRONIK
1. Pada umumnya obat bebas digunakan untuk penyakit akut
atau gejala akut sementara.
2. Penyakut kronik menahun umunya ditangani oleh dokter
yang sesuai.
3. Karena ini maka iklan obat TIDAK boleh
menganjurkanpemakain berlebih beberapa hari.
4. Contoh : kalau DIARE berulang dan kronik , sebaiknya pergi
periksakan ke dokter karena bukan merupakan diare nonspesifik
5. Obat sakit kepala. Tidak boleh diberikan terlalu lama.
MISLEADING YANG TIDAK AMAN
IKLAN TIDAK BOLEH MENCANTUMKAN INFORMASI YANG DAPAT
MENDORONG PENGGUNAAN BERLEBIHAN DAN PENGGUNAAN TERUS
MENERUS SEPERTI PENGGUNAAN KATA “SELALU”, “RUTIN” DAN KATAKATA LAIN YANG BERMAKNA SAMA.
EFEK KRONIK RANITIDINE
MHRA GUIDANCE NOTES
Implementation
www.mhra.gov.uk
www.pagb.org.uk
www.clearcast.co.uk
CONTENT OF OTC
ADVERTISEMENT
• Advertisements should contain information that is
reliable, accurate, truthful, informative, balanced, upto-date, capable of substantiation and in good taste.
They should not contain any misleading or
unverifiable or omissions likely to induce medically
unjustifiable use or to give rise to undue risks.
• Advertising to the general public (consumer)
• Advertising to the pharmacists, doctors, and
wholesalers (professional)
GUIDELINES ON MEDICAL PRODUCTS
AND APPLIANCES – MALAYSIA
General Principles (cont.)
•
•
Trust, Fear or Superstition;
Advertisements should not :• be so framed as to abuse the trust of the
consumer or exploit his lack of experience or
knowledge.
• without justification play on fear
• play on superstition or exploit the superstitious.
• directly or by implication exploit the religious
requirement/beliefs of any community
Advertising shall not cause consumers
unwarranted anxiety with regard to any
ailment
[email protected]
-----
[email protected]
[email protected]
[email protected]
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OVERVIEW OF ADVERTISING CONTROL
MEASURES
Precontrol
Italy
Post-event
surveillance
Selfregulation
Co-regulation
✓
Govt./public control
✓
Japan
✓
Lithuania
✓
✓
✓
✓
Mexico
✓
✓
Netherlands
✓
✓
New Zealand
✓
✓
✓
Norway
Philippines
Poland
✓
✓
✓
✓
✓
✓
Portugal
✓
✓
✓
Romania
✓
✓
✓
Russia
✓
✓
✓
Slovak Republic
Slovenia
Spain
✓
✓
✓
✓
✓
✓
✓
✓
✓
Sweden
Switzerland
✓
Thailand
✓
✓
N/A
N/A
Turkey
✓
✓
N/A
United States
Venezuela
N/A
N/A
✓
Ukraine
United Kingdom
✓
✓
✓
✓
✓
✓
✓
✓
[email protected]
They found that false claims, which are factually false or
unsubstantiated, were rare, with only 1 in 10 claims false.
False advertising is illegal and can lead to criminal and
civil penalties.
Most claims were potentially
misleading -- 6 in 10 claims left
out important information,
exaggerated information, provided
opinions, or made meaningless
associations with lifestyles,
the researchers said.
[email protected]
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[email protected]
[email protected]
[email protected]
Bentuk apresiasi di UK
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[email protected]
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Pesan-pesan untuk dibawa pulang
Jadi intinya iklan obat yang baik itu harus memiliki
karakteristik sebagai berikut:
1. Pesannya dibuat/dirancang untuk memenuhi
kebutuhan khalayak yang sudah ditentukan, memiliki
tujuan yang spesifik,
2. Memiliki konsep kreatif yang dapat menarik perhatian
dan pesan farmasetis-medis yang aman.
3. Menggunakan teknik eksekusi pesan yang tepat, efek
medis yang tidak menyesatkan.
4. Sudah waktunya kita adakan Best OTC drug ad, bukan
no. 1 OTC drug berdasarkan sales/penjualan.
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