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
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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
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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
✓
✓
✓ ✓
✓
✓
✓ ✓
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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.
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Bentuk apresiasi di UK
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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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