Farmakoepidemiologi

Farmakologi (klinik) -
Epidemiologi
Epidemiologi oleh farmakon
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 What is pharmacoepidemiology ?
⚫ Studi penggunaan dan efek obat pada banyak
orang
⚫ Mengandung dua komponen
⚫ Pharmaco
⚫ Epidemiologi
⚫ Ranah farmakoepidemiologi :
⚫ Dibandingkan thd farmakologi klinik
⚫ Kemudian dibandingkan thd epidemiologi

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 pharmacoepidemiology

•The study of the use of & effects of drug in large

number of people
•Concern with the study of edverse drug effect

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 Pharmacoepidemiology vs clinical
pharmacology
⦿ Pharmacology : the study of the effects of drugs
⦿ Clinical pharmacology :
⚫ the study of the effects of drugs in humans
⚫ Therapy should be individualized , need specific patient

Individualisasi terapi memerlukan determinasi rasio

untung/ruginya yg spesifik thd pasien.

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 Prescriber
- Perhatian thd efek menguntungkan &
merugikan
- Tahu bgmn unsur status klinik pasien dp
memodifikasi kemungkinan hasil terapi yg baik

⦿ Contoh : Infeksi, gangguan liver atau renal yg serius

⚫ Penggunaan gentamisin pada pasien gangguan fungsi
liver akan lebih berbahaya dibanding pasien dg fungsi
liver normal

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 ⦿ Pharmacopeidemiology can be useful in providing
information about the beneficial and harmful
effecs of any drug, thus

⦿ permitting a better assessment of the risk/benefit

balance for use of any particular drug in any
particular patient

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 Epidemiology
vs
Pharmacoepidemiology

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 ⦿ Epidemiology :
⦿ the study of the distribution and
determinants of disease in population

⦿ Study of
infectious
diseases in large
population
(epidemics)

⦿ Study of chronic
diseases
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⦿ The field of pharmacoepidemiology

Uses of techniques of chronic disease

epidemiology to study the use of & the
effects of drugs

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 Applications

Useful in Major application

performing the after drug marketing
clinical trial of (post marketing
drugs to marketing drug surveilance)

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 Pharmacoepidemiology
⦿ Bridging between clinical pharmacology &
epidemiology
⦿ From clinical pharmacology,
pharmacoepidemiology borrows its focus of inquiry
(penyelidikan / pemeriksaan)
⦿ From epidemiology, pharmacoepidemiology
borrows its method of inquiry

It applies method of epidemiology to the content

area of clinical pharmacology
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 Historical background
⦿ 1937 : > 100 orang mati gagal ginjal akibat
sulfanilamid elixir dlm dietilen glikol
⦿ 1950 : chloramfenikol menyebabkan anemia
aplastika (adverse drug reaction)
⦿ 1961 : Thalidomide disaster phocomelia
⦿ 1970 : diethyl stilbisterol in utero exposure clear
cell adenocarcinoma of cervix & vagina & other
genital malformations
⦿ 1970 : praktolol oculomucocutaneous syndrome
⦿ 1980-1990 kliokinol Subacute Myelo-optic
Neuropathy (SMON)

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 ⦿ 1980 : ticrynafen death from liver disease
⦿ 1982 : benoxaprofen death from liver disease
⦿ Zomepirac anaphilatoid reaction
⦿ Phenylbutazon blood discrasias
⦿ Indometahzin slow release small intestine
perforations
⦿ Suprofen renal failure
⦿ Silicone breast implant cancer, rheumatologic
disease & other problem
⦿ etc

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 Finally 1980s & 1990s
exclusive emphasis on
drug utilization & adverse reactions,

the use of pharmacoepidemiology to study

beneficial drug effects, the application of health
economics to the study of drug effects, quality
of life studies, meta-analysis etc

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 The current drug approval process

Preclinical testing Clinical testing

⚫ In vitro ⦿ Phase 1
⚫ In situ ⦿ Phase 2
⚫ In vivo ⦿ Phase 3

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 The current drug approval process
⦿ Clinical testing
⚫ Phase 1 :
● By clinical pharmacologist
● Few normal volunteers (humans)
● determinasi metabolisme obat &
kisaran dosis aman
● identifikasi reaksi toksis umum yg
ekstrim

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 ⚫ Phase 2
● By clinical pharmakologist
● Jumlah kecil pasien target yg punya
penyakit
● informasi tambahan farmakokinetik
& reaksi samping umum
● informasi awal tentang kemanjuran

Menentukan dosis harian

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 ⚫ Phase 3
● By clinical-investigator pd banyak
pasien
● randomized clinical trial
(500-3.000) pasien
● evaluasi kemanjuran obat &
informasi lebih
● informasi lebih tentang
toksisitasnya

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Pengujian Pengujian klinik
praklinik

Karakteristik
FK/FD
Uji respons
populasi dalam
Peningkatan dosis
Uji efeikasi Pengawasan
dosis dipandu Besar pasca
FK/FD in vitro
FK Efikasi pemasaran
FK/FD hewan
Penilaian
keamanan Seleksi dosis
FK/FD dalam
populasi khusus
Toksisitas
Variabel pasien
Pengujian
hewan
Fase I

Fase II
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Fase III
 Premarketing

•Ukuran dan waktu terbatas

•Ada pada akhir atau tidak pernah
dipasarkan
•Cenderung sangat artificial
•Pasien yang dekat dengan yang diamati

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 Premarketin
g

* Homogenous subjects to reduce unexplained

variability in the outcome variables meusured
& increase probability

* rarely significant overdoses

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 Postmarketing

•Tambahan ukuran (Additional size)

•Explorasi bagaimana berbagai faktor (other
illness & drugs) dapat memodifikasi efek
obat

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 Postmarketing

* To obtain its safety & efficacy

* Study delayed drug effects
* drug actually being used & determinant
of changes in usage pattern after drug
market
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 Pharmacoepidemiolog
y
•Surveilans obat pascamarketing
•Studi efek obat setelah obat dipasarkan

Pharmaceutical companies
* pharmacoepidemiology study
* pharmacoeconomic study
* quality of life study

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 Potential contribution of
pharmacoepidemiology
A. Information which supplements that
available from pre marketing studies –
kuantifikasi kejadian adverse & benefical
effect

– Precision lebih tinggi

– Pada pasien tidak diteliti (pemasaran) e.g. Usia
Lanjut, anak & waita hamil
– Sebagai modifikasi oleh obat atau penyakit lain
– Relatif thd obat lain yg digunakan unt indikasi
sama
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 Potential contribution of
pharmacoepidemiology
B. New types of information not available
from premarketing

⚫ Delivery of previously undetected adverse &

beneficial effects
⚫ Uncommon effects
⚫ Delayed effects
⚫ Patterns of drug utilitation
⚫ The effects of drug overdoses
⚫ The economic implications of drug use
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 Potential contribution of
pharmacoepidemiology

C. General contribution of pharmacoepidemiology

⚫ Reassurances about drug safety

⚫ Fulfillment of ethical & legal obligations

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 Conclution
The study of the use of & effects of
drug in large number of people

CONCERN with the study of edverse drug effect

COMPARED clinical pharmacology & epidemiology

BRIDGING clinical pharmacology & epidemiology

APPLIES THE METHODS of epidemiology to the

content area of clinical pharmacology
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 Terima kasih
Terima kasih
Terima kasih
Terima kasih

Terima
Terima
kasih kasih

Terima kasih
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