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 in  Case control studies
“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 shorter observational studies
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 perjalanan
◦ Primary and secondary diagnosis kejadian dalam jangka lama
◦ What medications were taken ◦ Obat yang penggunaanya sering
◦ Nature of adverse event, supporting lab data
 Kronologis Kejadian ADR  Follow-up methodology
◦ Clinical course of event, signs, symptoms, intervention ◦ Kejadian yang sering terjadi atau onsetnya cepat
◦ How long was the pt taking the suspected drug
◦ Obat jarang digunakan
 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 rates
 Small sample size  Chart/record review
◦ For the 95% probability to detect an ADR, the  Computerized ADE surveillance system
number of subjects needed to be followed is 3
times the incidence of the event

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 Reports can be submitted 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;
rate
unreliable numerator and very limited
ability to estimate the denominato
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:
cost feasible for
ongoing surveillance

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 ADE surveillance system  Review methods

 Generate alert system
 Create daily report
◦ Patient name, Diagnosis, ADE signal, drugs given
 Independent verification by clinical
pharmacist or trained nurse
 Verified ADE & inform clinicians
◦ Reviewing the chart
◦ Talking with clinicians caring for the patient
◦ Interviewing the patient, when possible
 Causality assessment
◦ Naranjo Score
◦ Severity—berat ringannya ADE
◦ Preventability—kemungkinan dapat dicegah

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 A weighted score based on answers to a short,

short  Mild
standardized questionnaire that correlates ◦ No change in therapy, treatment or length of
with causality probability 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 necessary l
The ADR is NOT preventable
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.
If answers are all negative to the above, then proceed to Section
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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