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FARMAKOEPIDEMIOLOGI

Peran Farmakoepidemiologi dlm


Menyelesaikan Masalah Obat & Pengobatan
Joyce Novelyn Siagian
Sumber:
Textbook of Pharmacoepidemiology (Strom, Kimmel,
Hennessy)

Sources of Data for


Pharmacoepidemiologic Studies
Spontaneous Reporting
Automated Data Systems
Ad Hoc Studies Ongoing Systems
for Pharmacoepidemiologic Studies
Ad Hoc Studies De Novo Studies

Spontaneous Reporting
Postmarketing Spontaneous
Pharmacovigilance Reporting Systems
Cth: data malformasi pd bayi akibat
thalidomide laporan kasus
Butuh kemampuan identifikasi AE/ ADR
Evaluasi/ pelaporan sulit krn kualitas
pelaporan & tdk ada sistem utk
kelanjutannya sistem pd tiap negara
berbeda
Format pelaporan: karakteristik pasien,
reaksi, kejadian, hasil tes/ prosedur
investigasi, info obat, ringkasan

Drug Development

Spontaneous Reporting
(cont)

Kelebihan:

Cepat mendeteksi kasus


Pelapor bisa siapa saja (dokter, dokter
gigi, apoteker, bidan, perawat, tenaga
kesehatan lain)
Pelaporan didpt dari banyak tempat

Kekurangan:
Kualitas pelaporan msh
Tdk semua kasus didpt bersifat sukarela
Banyak faktor yg mempengaruhi wkt
berbeda

Automated Data Systems


Health Maintenance Organizations/
Health Plans
Commercial Insurance Databases
Medical Record Databases
In hospital Databases
Pharmacy based Medical Record
Linkage Systems

Ad Hoc Studies Ongoing Systems


for Pharmacoepidemiologic Studies
Case Control Surveillance
Wawancara dgn subjek ttg riwayat
kebiasaan minum obat & info lain yg dpt
mempengaruhi penyakitnya analisa

Prescription Event Monitoring


Sistem di Inggris mendpt data
keamanan obat pasca pemasaran melalui
dokter, selain yellow card kedua sistem
saling melengkapi masuk database
dievaluasi di Drug Safety Research Unit
follow up

Ad Hoc Studies De Novo


Studies
Field Studies
Merupakan studi epidemiologi
mengumpulkan data utk mengevaluasi
suatu hipotesis
Berbeda dgn penelitian yg
menggunakan data yg sdh ada
Menggunakan metode yg digunakan dlm
epidemiologi

Ad Hoc Studies De Novo Studies


(cont)

Study Designs Available for


Pharmacoepidemiologic Studies

Choosing Among the Available


Alternatives
Agar suatu studi
farmakoepidemiologi bermakna &
berguna, sesuai dgn tenaga & biaya
yg dikeluarkan:
Pilihlah sumber data & cara pendekatan
yg plg efisien bandingkan kelebihan &
kekurangan sumber data yg ada
Sumber data dpt >1 bersamaan/
paralel optimal
Butuh judgment dari peneliti

Choosing Among the Available Alternatives


(cont)
Pertahankan validitas data, kontrol faktor
perancu, perhatikan tingkat loss to follow
up
Karakteristik pertanyaan penelitian
memberi efek pd pemilihan sumber data:
Hypotesis Generating Studies designed to
raise new questions about possible unexpected
drug effects, whether beneficial or adverse
Hypotesis Strengthening Studies designed to
provide support for, although not definitive
evidence for, existing hypotheses
Hypotesis Testing Studies designed to
evaluate in detail hypotheses raised elsewhere

Generating studies

Strengthening
studies

Testing studies

Pertanyaan:
menghasilkan atau
menciptakan sesuatu

Pertanyaan
mensupport atau
menguatkan secara
objektif

Mengevaluasi dgn
memperhatikan
konfounding faktor

Case control,
prescription event
monitoring, studi
kohort

Spontaneous
reporting system, RCT

Primary records, RCT

The Use of RCT for


Pharmacoepidemiologic Studies

The Use of RCT for


Pharmacoepidemiologic Studies
(cont)

The Use of Meta analysis for


Pharmacoepidemiology

TERIMA KASIH