Understanding and Responding

to Pharmaceutical Promotion

Noor Wijayahadi
 OBAT PALING LAKU

 LIPITOR > SIMVASTATIN, ATORVASTATIN

Obat Baru tidak betul-betul lebih baik
 Kemandirian dokter ??
8 dari 10 terima gifts, free food , free lunch
 8 dari 10 terima obat sampel
 4 dari 10 dibiayai ikut seminar, meetings ,
conferences, dll
 3 dari 10 dibayar sebagai consultants,
pembicara seminar, dll.
Dana Promosi obat resep
 Bentuk marketing “modern”
 Industry-sponsored CME (Pendidikan
Kedokteran Berkelanjutan)
 Membiayai senior ‘opinion leaders’
 Ghost-writing artikel jurnal
 Membiayai pembuatan Pedoman Diagnosa
dan Terapi
 Public relations campaigns including
unbranded ‘disease-oriented’ advertising
 Bentuk marketing “modern”
 Mendanai patient groups and medical
societies
 Market seeding research (‘Phase IV’ studies
without clear scientific objectives)
 Internet advertising
 Journal supplements and free journals
 Pharmacy discounts linked to sales volume*
 Bonus penjualan ??
Number of sponsored meetings and
talks in the US, 1999 and 2004
Efek dari obat sampel pada penulisan
resep
Penggunaan Gabapentin (Neurontin)
diluar indikasi resmi (off labeled)
 Klaim Indikasi (~ ‘Labelled Use’)

 Label = indikasi resmi sewaktu obat diberi

ijin pemasaran
 ‘Off-label Use’ = pemakaian diluar indikasi
resmi
 Di banyak negara maju (Persem. Inggeris ,
Australia, Belanda, Scandinavia, Jepang,
dsb) pemakaian obat dibatasi oleh label
 ‘Labelled Use of Drugs’

 Australia membatasi resep utk labelled

indication di seluruh negara melalui
Pharmaceutical Benefits Scheme (PBS)
 Off-label use dimungkinkan, namun
harus disertai alasan yang valid
 Resep2 dicheck melalui computer-system
dan dicocokkan dg label
 Satu resep berisi 1.4 R/ (Data: MEDICARE Austr.)
 Indonesia
 Off-label use marak karena BPOM tidak
memberlakukan peraturan ini
 Dokter bebas pakai obat utk indikasi yang
bukan2 (AB utk flu mgk separoh lebih dari semua
pemakaian AB)

 Ditumpangi promosi sesat pabrik obat

 MIMS Indonesia ngawur: indikasi diperlebar,
efek samping disembunyikan
 Antibiotics for The Common Cold
Benefit on Day 5?

120%
100%
80%
Doxycycline
60%
Placebo
40%
Antibiotics
20% do not
shorten
0%
duration of
0 1 2 3 4 5 6 7 8 9 10 11 12 13 sickness
Stott, BMJ 1976;2:556
 Copy, cut & paste

 It is now easy to sound scientific:

 ‘While Metronidazole has been given with no

apparent adverse effects during all stages of
pregnancy (Peterson et al,1966; Voogd, 1981), its use during
the first trimester is not recommended.’
» (Goodman & Gilman 8th ed 1990)
 Beberapa mis-informasi dalam MIMS (1)

 Adalat : Tablet biasa tidak untuk hipertensi

 Furosemid : Tablet biasa tidak untuk hipertensi
 HCT : Dosis dianjurkan 50–200 mg / hari ;
seharusnya 12.5 – 25 mg / hari
 Chlortalidone :Untuk hipertensi dianjurkan sampai
100 mg/hari; seharusnya 12.5 – 25
mg/hari
 Tranexamic acid: Tidak untuk setiap perdarahan,
hanya jika kekurangan fibrinogen
 Codipront 30 mg :Kontraindikasi untuk semua penderita
asma , tidak hanya untuk serangan
akut
 Beberapa mis-informasi dalam MIMS (2)
 Zyloric : Kontraindikasi pada “ acute attack gout“
 Teofilin : Dosis 200 mg terlalu besar
 Felodipin : Tidak disebut sediaan slow-released
 Ciprofloxacin : Indikasi infeksi kulit & soft tissue
serta upper resp. tract tidak dibenarkan
 Sefalosporin G2 : Kurang cocok untuk skin & soft
tissue dan upper resp. tr.
 Ampisilin : Tidak cocok untuk skin, soft tissue,
mulut , dan gigi
 Ampisilin- klavulanat : Tidak disebut “untuk kuman
penghasil penisilinase “
 Seminar Kedokteran ?

 ‘Pendidikan dokter’ sudah beralih

dari universitas ke industri obat
 Br’fast, lunch, dinner Sabtu-Minggu
hilangkan pikir sehat Senin-Jumat
 Yang salah jadi benar, yang
benar jadi salah
 Gampang pengaruhi dokter (?)
 Perbandingan
sebelum vs sesudah mendapat promosi

 Mayoritas dokter menyangkal kalau hadiah bisa

mempengaruhi peresepan mereka
 Makin banyak terima hadiah  mereka makin
kurang percaya kalau mereka dipengaruhi
 Makin sering kontak dengan detailer  makin
banyak permintaan dokter untuk memasukkan
“obat” kedalam formularium
 Perbandingan
sebelum vs sesudah mendapat promosi

 Pemberian dana akomodasi seminar/kongres/free-

lunch/ riset obat dsb  makin banyak permintaan
dokter untuk memasukkan “obat” kedalam
formularium
 Makin sering ketemu detailer  makin kurang
kritis dalam menilai akurasi klaim obat
 Pembiayaan CME/PKB  meningkatkan
peresepan obat sponsor
 Perbandingan
sebelum vs sesudah mendapat promosi

Makin sering kontak dengan detailer 

 harga resep meningkat
 obat baru cepat dipakai
 resep obat generik menurun
Techniques that influence
the use of medicines
 Jalan pintas pembuatan Resep
 Percaya rekomendasi ekspert/senior
 Banyak teman sejawat yang meresepkan
 Obat yang pertama terlintas di benak kita
 Ada sampel/gambar/brosur yang terlihat

 Pertimbangan rasional tidak dikerjakan

 Sasaran teknik2 promosi:
 Advertisements
 Pharmaceutical sales representatives
 Sponsorship  expert or peer key opinion leaders
 Public relations
Tujuan Promosi Obat
 Survey pada dokter
tentang pengaruh detailer
 3 cara
informasi obat menjadi tidak benar
 Pemberian informasi yang cacat
(inaccurate, exaggerated, ambiguous or
oversimplified);
 Penghilangan informasi yang relevan
 Penyisipan dengan informasi yang tidak
relevan
Khasiat dilebih-lebihkan
Efek Samping diminimalkan
Tekhnik “mempengaruhi” yang sering
digunakan detailer
Tekhnik “mempengaruhi” yang sering
digunakan detailer
Effects of "cme" on volume of prescribing
Patient and prescriber views on the
influence of gifts in a US survey
 Common beliefs about promotion

 “I’m too clever to be influenced.”

 “I’m just helping out my patients.”
 “I don’t take any notice.”
 “I see them all so I’m not influenced by any.”
 3 Strategi mengurangi efek buruk promosi
pada peresepan

 Meminimalkan pertemuan/paparan promosi

 Menghindari efek buruk promosi
 Konsisten menggunakan cara diagnosis dan
terapi yang baik / standar
Analisis Kritis terhadap
Promosi / Iklan Obat
 Info yang harus ada

 Nama zat aktif sesuai international nonproprietary

name (INN) atau nama generik obat
 Brand name;
 Content of active ingredient(s) per dosage form or
regimen;
 Name of other ingredients known to cause
problems;
 Approved therapeutic uses;
 Info yang harus ada

 Dosage form or regimen;

 Side effects and major adverse medicine
reactions;
 Precautions, contraindications and warnings;
 Major interactions;
 Name and address of manufacturer or distributor;
 Reference to scientific literature as appropriate.
(WHO, 1988)
 Information in advertisements in
developed and developing countries
What’s wrong??
Misleading use of relative risk reductions
How to evaluate data and graphs presented in
pharmaceutical advertisements
 Is information presented as either absolute risk
reductions (ARR) or number needed to treat
(NNT)?
 Does the advert indicate if a study was
randomised and blinded?
 When statistical significance is given are
confidence intervals and power calculations
included?
 Are graphs simple to read and do they have
appropriately labelled axes?
How to evaluate data and graphs presented in
pharmaceutical advertisements

 Are graphs obscured by other visual material?

 Are the titles of graphs clear and do they explicitly
say what the graph is about?
 If the graph comes from an article or another
source is it reproduced exactly as it appeared in
the original source?
 Are data in graphs presented in such a way as to
make it easy to determine whether or not any
differences are clinically meaningful?
Types of claims in pharmaceutical
advertisements
 common problems with referencing in
advertisements
 No references are provided for claimed treatment
effects;
 Reference is to company “data on file”, which is
not publicly available and has not been
independently reviewed;
 A poster presentation is cited; generally
inadequate information is provided on methods in
poster presentations to judge reported results;
 Review articles that selectively present results are
cited, not original research;
 common problems with referencing in
advertisements
 The referenced article is in a journal supplement
sponsored by the manufacturer;
 Study results in the cited reference are
inconsistent with the advertising claim;
 The study is of poor methodological quality,
raising questions about the validity of the results.
 How to evaluate references

 Do citations contain all of the information

necessary to identify references?
 Are all references cited retrievable including those
to “data on file”?
 Are references of high methodological quality?
 Do journal references come from peer-reviewed
medical or pharmacy journals?
 Did the company finance the research reported in
the reference?
 How to evaluate the text in
pharmaceutical advertisements
 Are generic names used as frequently as brand
names and is the type the same size as that used
for the brand name?
 Are claims in advertisements restricted to
unambiguous clinical outcomes or meaningful
economic claims?
 If there are claims about surrogate endpoints is
there also information that directly links changes
in these end points to meaningful clinical
outcomes?
 How to evaluate the text in
pharmaceutical advertisements
 Are all claims for safety, effectiveness and cost-
effectiveness in advertisements backed up by
high-quality evidence (evidence from meta-
analyses or randomised, controlled trials)?
 If there are claims for use of a medicine in a
particular population are they based on high-
quality evidence that comes from medicine use in
that population?
 Is information about safety given the same
prominence and placement as information about
effectiveness?
 How to evaluate the text in
pharmaceutical advertisements
 Do economic claims give actual prices of different
alternatives? Are there vague claims about costs,
such as “costs less”?
 Do advertisements for antibiotics recommend use
that is consistent with guidelines to prevent
unnecessary development of resistance?
What’s wrong ?
 How to evaluate pictures and images in
pharmaceutical advertisements
 Do the people portrayed in the advertisements
reflect the racial and ethnic composition of people
in your country?
 Are both men and women portrayed in
advertisements as both patients and healthcare
providers in equal numbers?
 Are the ways that men and women are portrayed
(as workers, facial expressions, body language,
etc.) similar?
 How to evaluate pictures and images in
pharmaceutical advertisements
 How are the elderly portrayed in advertisements?
 Are symbols or metaphors used in
advertisements?
 What kinds of associations do these symbols and
metaphors convey?
 Are illnesses portrayed as individual events or are
they put into a social context?
 Five top medicines by US DTCA
spending January - November 2004
 Responding to patients’ requests for
advertised medicines
 Shift the discussion away from the medicine to
the patient and his or her symptoms;
 Determine the diagnosis, if there is one and
whether a medicine is needed;
 Explain the range of drug and non-drug
treatments, including the likely outcome with no
treatment;
 If treatment is needed, explain your
recommendation for treatment; if it is not needed,
explain why not;
 Responding to patients’ requests for
advertised medicines
 Explore the beliefs that have led to the request;
 Discuss the role of pharmaceutical advertisers;
 Refer to reliable information sources.
 Key principles of bioethics
1. Respect for autonomy
 Respect for autonomy requires that patients
should be encouraged and assisted, whenever
possible, to make informed and voluntary
decisions about their health care. It is the basis
for informed consent in interactions between
health professionals and patients.
2. Nonmaleficence
 This is the principle to do no harm. Doctors
should strive not to cause needless harm or injury
to the patient, either through the treatment that is
provided or by not providing needed care.
3. Beneficence
 Health-care providers have a duty of care to
benefit patients to the maximum extent possible in
the circumstances. This goal applies both to
individual patients, and to the good of society as a
whole, for example, in efforts to prevent antibiotic
resistance.
4. Justice
 Justice in health care is usually defined as
distributive fairness: to provide to each according
to his or her needs, regardless of ability to pay. It
supports the sharing of resources to provide
health care for all.
 Educational material on evidence-
based medicine
 The Centre for Evidence-Based Medicine (Oxford)
http://www.cebm.net/index.asp
 The Centre for Evidence-Based Medicine
(Toronto) http://www.cebm.utoronto.ca/
 The Evidence-Based Medicine Toolkit
http://www.med.ualberta.ca/ebm/ebm.htm
 How to get the results you want from a
clinical trial
 Compare your medicine to an inferior treatment;
 Compare your medicine to too low a dose of a
competitor (for more effectiveness);
 Compare your medicine to too high a dose of a
competitor (for fewer side effects);
 Use too small a sample to show differences;
 Use multiple endpoints and publish only those
that look best;
 How to get the results you want from a
clinical trial
 Do multicentre trials and publish results only from
centres with the best results;
 Conduct subgroup analyses and publish only
those that are favourable;
 Present results that are most likely to impress—
for example, reduction in relative rather than
absolute risk.
 Useful websites on evidence-based
medicine and critical appraisal skills
Organisations that carry out systematic reviews of
clinical evidence
 The Cochrane Collaboration – an international
organisation that carries out systematic reviews
of health care interventions (includes database of
systematic reviews)
 (Source: http://www.cochrane.org/)
 Dr. Wind Dinkes DKI Jakarta

Duricef mg 350 No. X (Puyer) Rp. 134.000,-

Puyer No XV Rp. 8.600,-
Total Harga Rp. 142.800,-

Alternatif 1 Alternatif 2
Doxef Rp. 48.900,- Cefadroxil Rp. 23.700,-
Puyer Rp. 8.600,- Puyer Rp. 8.600
Total Harga Rp. 57. 500,- Total Harga Rp. 32.300
 RS Kanker “DHARMAIS”

RESEP ASLI
Medrol 4 mg X Rp. 31.300
Claritin VII Rp. 41.850,-
Zantac XV Rp. 106.300,-
Vantiz X Rp. 30.200,-
Total Harga Rp. 209.650

ALTERNATIF 1 ALTERNATIF 2

Lameson 4 mg Rp, 28.400 Methyl prednisolon Rp. 16.900

Alloris Rp. 30.300 Loratadine Rp. 5.200
Rantin 150 mg Rp. 70.700 Ranitidine Rp. 12.900
Vantiz Rp. 30.200 Vantiz Rp. 30.200
Total Harga Rp. 159.600 Total Harga Rp. 65.200
 Resep RS Islam Jakarta

Resep Asli
Daonil XXXX Rp. 93.700,-
Glucopace 500 LX Rp. 74.000,-
Nervitone XXX Rp. 25.700,-
Harga Rp. 193.400,-

Alternatif 1 Alternatif 2
Prodiamel Rp. 16.400,- Glibenclamide Rp. 7.000,-
Glukotika 500 Rp. 65.600,- Methormin 500 Rp. 28.400,-
Nervitone E Rp. 25.700,- Nervitone E Rp. 25.700,-
Total Harga Rp. 107.700,- Total Harga Rp35.400,-
Rp. 61.100,-