Sudut pandang iklan obat dari keamanan medis Dr. Freddy Wilmana, MFPM, SpFK, Dipl.WOSAAM Medical & Pharmaceutical Consultant Jakarta 20 th July, 2017 [email protected] [email protected] www.linkedin.com/in/freddywilmana
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Sudut pandang iklan obatdari keamanan medis
Dr. Freddy Wilmana, MFPM, SpFK, Dipl.WOSAAM
Medical & Pharmaceutical Consultant
Jakarta 20th July, 2017
[email protected]@internode.on.net
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
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
4
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 over-the-counter medicines
• Primary aim is to promote responsible self-medication to consumers and professionals.
• National Advertising Division (NAD)
• self regulation censorship for Ads
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
FDA ROLE IN OTC ADVERTISING
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.
FTC ADVERTISING LAW BASICS
PASTI……….???Dalam medis/kedokteran …..TIDAK ADA PASTI 100%Contoh2 banyak ….sekarang banyak gugatanSeperti 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.
fwilmana @ pacific.net.id 12
Steps in appearance of intact drug in circulation
pH = 1 - 3
pH = 5 - 7
disintegration
disintegration
disso-
lution
disso-
lution
absorption
intestinal
metabolism
absorption
hepatic
metabolism
clearancefaeces
Pharmacological effect
gastric emptying rate
intestinal transit rate
fwilmana @ pacific.net.id 13
IV (Inhalation)
IM
Oral
Patch
Hours Post Administration
Pla
sm
a C
on
cen
trati
on
Routes of Administration
10 mg dose
Factors that determine the intensity of drug response
BERBAGAI DEFINISI
•Obat dan racun bedanyamenstabilkan atau merusak
kestabilan suatu sel.
•Jika merusak disebut racunjikalau tidak merusak/membantu
sel untuk mencapai kestabilanitulah 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 akutatau gejala akut sementara.
2. Penyakut kronik menahun umunya ditangani oleh dokteryang sesuai.
3. Karena ini maka iklan obat TIDAK bolehmenganjurkanpemakain berlebih beberapa hari.
4. Contoh : kalau DIARE berulang dan kronik , sebaiknya pergiperiksakan ke dokter karena bukan merupakan diare non-spesifik
5. Obat sakit kepala. Tidak boleh diberikan terlalu lama.
MISLEADING YANG TIDAK AMAN
IKLAN TIDAK BOLEH MENCANTUMKAN INFORMASI YANG DAPATMENDORONG PENGGUNAAN BERLEBIHAN DAN PENGGUNAAN TERUSMENERUS SEPERTI PENGGUNAAN KATA “SELALU”, “RUTIN” DAN KATA-KATA LAIN YANG BERMAKNA SAMA.
EFEK KRONIK RANITIDINE
MHRA GUIDANCE NOTES
www.mhra.gov.uk
www.pagb.org.uk www.clearcast.co.uk
Implementation
CONTENT OF OTC ADVERTISEMENT
• Advertisements should contain information that is reliable, accurate, truthful, informative, balanced, up-to-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
Pre-
control
Post-event
surveillance
Self-
regulationCo-regulation Govt./public control
Italy ✓ ✓
Japan ✓ ✓ ✓
Lithuania ✓ ✓
Mexico ✓ ✓ ✓
Netherlands ✓ ✓
New Zealand ✓ ✓
Norway ✓ ✓ ✓
Philippines
Poland ✓ ✓ ✓
Portugal ✓ ✓ ✓
Romania ✓ ✓ ✓
Russia ✓ ✓ ✓
Slovak Republic ✓ ✓ ✓
Slovenia ✓ ✓
Spain ✓ ✓
Sweden ✓ ✓
Switzerland ✓ ✓ ✓
Thailand ✓ ✓ ✓
Turkey N/A N/A N/A N/A N/A
Ukraine ✓
United Kingdom ✓ ✓
United States ✓ ✓ ✓
Venezuela ✓ ✓
OVERVIEW OF ADVERTISING CONTROL MEASURES
28
fwilman
a@ya
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.com
29
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.
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.
Pesan-pesan untuk dibawa pulang
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