Dr. Abdul Rahem, M.Kes.

, Apt
 What is Pharmacoepidemiology?

 Pharmaco - drug or medicine

 Epidemiology - study of the distribution and
determination of diseases in population
 Pharmacoepidemiology - the study of the use and
effects of pharmaceutical products in populations
 Definition of pharmacoepidemiology
 The study of the use and effects of medications in large
numbers of people (Strom)
 The application of epidemiologic knowledge, methods, and
reasoning to the study of the effects (beneficial and adverse)
and use of drugs in human populations. (Porta and Hartzema)
 Pharmacoepidemiology, or drug epidemiology, is the study of
the effects of drugs in population of people.(Muktadir )
 The study of drugs as determinants of health and disease in the
general unselected population. (Spitzer)
 Definition of pharmacoepidemiology
 It is an applied field bridging clinical pharmacology and
epidemiology (Strom)
 It is an amalgam of clinical pharmacology, clinical
epidemiology, medical informatics, and biostatistics (Strom)
 Pharmacoepidemiology collection of several disciplines
(Mahyar Etminan)
 THE RELATIONSHIP BETWEEN
PHARMACOEPIDEMIOLOGY AND OTHER DISCIPLINES
Clinical Pharmacology
– Pharmacoepidemiology is the implementation of epidemiological methods, knowledge
and logical justifications in the field of clinical pharmacology via focusing upon studies
on the drug effects on, and drug use by, large numbers of people. Clinical
pharmacology is a scientific discipline which investigates the efficiency and safety of
drugs and seeks answers to clinical questions.
– Clinical pharmacology focuses on individuals or patient groups in a clinical
environment
Epidemiology
– Epidemiology is defined as the study of the distribution and causes of health-related
events in certain societies and the use of gathered knowledge to control health
problems. Because it investigates drug interactions observed in many people,
– Epidemiology means conducting pharmacoepidemiological studies with a focus on
society and establishing relationships between health cases and drug exposures
conts
 Pharmacoepidemiology takes its focus of
knowledge from clinical pharmacology and the
research methods from epidemiology. In other
words it applies the methods of epidemiology in
the field of clinical pharmacology
 Potential contributions of pharmacoepidemiology
A. Information that supplements the information available from premarketing studies—
better quantitation of the incidence of known adverse and beneficial effects
a. Higher precision
b. In patients not studied prior to marketing, e.g., the elderly, children, pregnant women
c. As modified by other drugs and other illnesses
d. Relative to other drugs used for the same indication
B. New types of information not available from premarketing studies
1. Discovery of previously undetected adverse and beneficial effects
a. Uncommon effects
b. Delayed effects
2. Patterns of drug utilization
3. The effects of drug overdoses
4. The economic implications of drug use
C. General contributions of pharmacoepidemiology
1. Reassurances about drug safety
2. Fulfillment of ethical and legal obligations
Clinical pharmacology

Pharmacoepidemiology

Epidemiology
 Pharmacoepidemiology-collection of several disciplines

Epidemiology
Biostatistics Medicine

Pharmacoepidemiology

Computer programming Administrative data

Pharmacology
 Drug evaluation never ends

preclinical
clinical (I-III)
Discovery &
screening
phase 4
Pre-clinical
development Fase I/IIa
Fase IIb/III
10,000 15-30 10-15 5 1

registration
& launch
Proof of Concept

first administration to man

discovery

approx. 10-12 years

 Pentingnya farmakoepidemiologi

Farma
koepi
demio
logi
 Pentingnya farmakoepidemiologi

Farm
akoep
idemi
ologi
 Aplikasi farmakoepidemiologi

Farm
akoep
idemi
ologi
 STUDI PENGGUNAAN OBAT

• Studi penggunaan obat, adalah mencakup; pemasaran,

distribusi, peresepan, dan penggunaan obat di
masyarakat, dengan perhatian utama pada dampak
pengobatan, baik sosial maupun ekonomi.
• Merupakan studi bagaimana kegunaan obat berkaitan
dengan efek obat, baik yang menguntungkan maupun
yang merugikan
 Lanjutan

• Studi penggunaan obat merupakan bagian yang

esensial dari studi farmakoepidemiologi, karena
bisa menggambarkan secara luas, penggunaan
obat dan faktor yang terkait dengan penggunaan
obat tersebut.
 Kegunaan studi penggunaan obat

 Dapat digunakan sebagai data denominator untuk

mengkalkulasi tingkat reaksi efek samping yang ditimbulkan
oleh obat tersebut
 Untuk memonitor kegunaan obat (terapetik) sehingga problem2
yang mungkin terjadi bisa diantisipasi
 Untuk memonitor informasi dan regulasi mengenai obat
tersebut
 Sebagai penanda dalam estimasi data prevalensi penyakit
 Untuk merencanakan obat yang akan di impor, diproduksi,
didistribusikan.
 Lanjutan
 Tujuan pokok studi penggunaan obat adalah untuk meningkatkan
penggunaan obat yang rasional di populasi.
 Untuk meningkatkan peresepan yang rasional, dosis yang optimal,
indikasi yang benar, dan informasi yang akurat
 Lanjutan

 Studi penggunaan obat dapat memberi sumbangan

pengetahuan tentang effectiveness and safety, karena
dilakukan pada populasi yang heterogen dan dan
dalam jangka waktu yang panjang
 Studi penggunaan obat berfungsi pengalokasian biaya
kesehatan secara rasional.
 Aspek yang dikaji pada studi penggunaan obat

Pattern of use: profil penggunaan obat dan tren dalam

penggunaan obat, serta biaya pengobatan dalam satu periode
tertentu.
Quality of use: membandingkan penggunaan obat dengan
pedoman peresepan nasional, regional dan formularium lokal
(pemilihan jenis obat, biaya, bentuk sediaan, dll)
 Lanjutan

Determinants of use: user characteristics (parameter

sosial, demografi, pemahaman dan sikap user terhadap
obat), prescriber characteristics (jenis spesialis, pendidikan,
dan faktor-faktor yang berpengaruh terhadap keputusan
terapi), and drug characteristics (sifat fisiko kimia dan sifat
terpeutik)

Outcomes of use: health outcomes (benefits and adverse

effects) dampaknya secara ekonomi
 Reaksi obat yang merugikan

 Sejak tahun 1970-an klasifikasi menjadi 2 yaitu

– Type A reactions
– Type B reactions
 Sekarang bisa diklasifikasikan menjadi:
– Type A reactions are generally:
• Dose-related
• Predictable from drug pharmacology
• Common (tidak serius)
• Normally reversible
• May be manageable with dose adjustment.
 Lanjutan
 Type B reactions are generally:
–Not dose-related
–Unpredictable
–Uncommon
–May be serious/irreversible
–Indicative that the drug needs to be stopped.
 Type C (Chronic) – supresi ginjal akibat corticosteroids
 Type D (Delayed) – dyskinesia with neuroleptics
 Type E (End of use) – reaksi putus obat denagn benzodiazepines