Student able to explain :

◗ Definition and the field of

pharmacoepidemiology
◗ Development of pharmacoepidemiology
MK CE ◗ Drug development

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◗ Farmakoepidemiologi
◦Farmakologi
◦Epidemiologi
◗ Farmakoepidemiologi  Cabang ilmu
farmakologi yang digunakan untuk
mempelajari efek obat pada populasi
◗ Penggabungan antara farmakologi klinik
dengan epidemiologi
◗ Farmakoepidemiologi  penerapan metode
ilmiah, ilmu dan argumentasi epidemiologi
pada bidang farmakologi klinik
◗ Farmakoepidemiologi  sub disiplin
farmakologi klinik dengan fokus kajian adl
efek obat pada populasi
Tidak memerlukan pengukuran aspek
farmakokinetik maupun farmakodinamik
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 ◗ Farmakoepidemiologi  ilmu yang mendasari
metode pengembangan obat pada tahap uji
klinik fase 4 (post marketing drug
surveillance)

◗ farmakologi klinik menekankan

Farmakokinetik
◦farmakodinamik Penelitian efek obat setelah obat dipasarkan
secara luas.

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◗ Bersifat lintas sektoral ◗ Describe
◦Akademisi ◗ Explain

◦Industri ◗ Control
◦Badan POM
◗ Predict
◦Lembaga sosial

The use and effects of drugs in a defined

time, place and population

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◗ Determine how a drug performs in clinical
practice (effectiveness, safety) ◗ Randomized controlled trials
◗ Frequently used for post-marketing
surveillance
◗ Cohort studies
◗ Identify rare adverse events or events that occur
◗ Case control studies
in special populations ◗ Cross-sectional studies
◗ Document new uses of approved drugs ◗ Descriptive studies-drug use, case reports
◗
Determine long term effects of drugs, or effects
on ultimate vs. intermediate outcomes
◗ Automated databases facilitate
◗
Used by the BPOM to allow priority drugs in observational studies
shorter time
◗
Used by the BPOM to modify product labeling
or approval status

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◗ Demografi Penderita, Penyakit, obat dan ◗ Case-control methodology
Reaksi yang terjadi
Age, race, gender
◦Kejadian yang jarang terjadi atau
◦ Primary and secondary diagnosis perjalanan kejadian dalam jangka lama
What medications were taken Obat yang penggunaanya sering
Nature of adverse event,
supporting lab data ◗ Follow-up methodology
◗ Kronologis Kejadian ADR ◦Kejadian yang sering terjadi atau onsetnya
Clinical course of event, signs,
symptoms, intervention
cepat
◦ How long was the pt taking the ◦Obat jarang digunakan
suspected drug
◗ Indikasi dan Alasan
Pemberian Obat
◦ Why was the drug prescribed
Did the event abate when drug stopped, and recur
when restarted

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◗ Short duration
◗ Narrow population
◗ Narrow indication ◗ Voluntary reporting
◗ Limited comorbidities and cotherapies ◦Traditional method but low detection
◗ Small sample size rates
◦For the 95% probability to detect an ADR, the ◗ Chart/record review
number of subjects needed to be followed is ◗ Computerized ADE surveillance system
3 times the incidence of the event

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◗ Reports can be submiitttted by mail, phone, fax
or
internet
◗ Recent calling for an independent drug safety
board considering the record of recalls and
difficulty with causality assessment and
estimates for level of risk
◗ Causality assessment is difficult
◗ Subject to underreporting
◗ Not possible to calculate an incidence rate;
unreliable numerator and very limited
ability to estimate the denominator
◗ Reporting rates vary with the age of the
drug, publicity, type of reaction, marketing
promotion, local policy, indication for use,
frequency of use
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◗ Retrospective review of charts by expert
clinicians, using predetermined criteria to
search for ADE
◗ High detection rate,
◗ high cost: only for research purpose
◗ A computer system screens for ADE signals
indicating a possible ADE
◗ High detection rate & low cost: feasible for
ongoing surveillance
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◗ ADE surveillance system ◗ Review methods
◗ Generate alert sys tem Reviewing the chart
Talking with clinicians caring for the
◗ C reate daily report patient
◦Patient name, Diagnosis, ADE signal, drugs given ◦Interviewing the patient, when possible
◗ Independent verification by clinical ◗ Causality assessment
pharmacist or trained nurse ◦Naranjo Score
◗ Verified ADE & inform clinicians Severity—berat ringannya ADE
◦Preventability—kemungkinan dapat dicegah

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◗ A weighted score based on answers to a short, ◗ Mild
standardized questionnaire that correlates No change in therapy, treatment or length
with causality probabiilliitty of stay(LOS)
◗ Doubtful (<1)
◗ Moderate
Require change in drug therapy, treatment
◗ Possible (1-4)
◦Temporary alteration in organ function
◗ Probable (5-8) ◦Increased LOS < 2 days
◗ Definite (>9) ◗ Severe
◦Life-threatening
Permanent organ
damage Increased LOS >
2 days Contribute to
death

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◗ Shumock and Thornton s criteria
◗ At least one of them met the criteria, such
ADEs considered to be preventable
SECTION A
Answering “yes” to one or more of the following implies that
an ADR is DEFINITELY preventable.
1. Was there a history of allergy or previous reactions to the
drug?
2. Was the drug involved inappropriate for the patient’s clini
cal condition?
3. Was the dose, route, or frequency of administration inap
propriate for the patient’s age, weight, or disease state?
If answers are all negative to the above, then proceed to Se
ction B  
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SECTION B
 Answering “yes” to one or more of the following implies that an AD
R is PROBABLY preventable
SECTION C
1. Was required therapeutic drug monitoring or other The ADR is NOT preventable
necessary l aboratory tests not performed?
2. Was a documented drug interaction involved in the ADR?
3. Was poor compliance involved in the ADR?
4. Was a preventative measure not administered to the patient?
5. If a preventative measure was administered, was it inadequate
and/or inappropriate? Answer ‘NO’ if this question is nonapp
lic able.are all negative to the above, then proceed to S e c t i o n
If answers
C

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◗ Type A
◦Predictable, preventable, dose-dependent
◦Rarely life-threatening
◗ Type B
Idiosyncratic, allergic, rarely preventable, not
dose- dependent
◦Potentially life-threatening

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