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1MK CEMK CEMK CEMK CE
Student able to explain :
Definition and the field of pharmacoepidemiology
Development of pharmacoepidemiology
Drug development
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2 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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3 farmakologi klinik menekankan Farmakokinetik
farmakodinamik
Farmakoepidemiologi ilmu yang mendasari metode pengembangan obat pada tahap uji klinik fase 4 (post marketing drug surveillance)
Penelitian efek obat setelah obat dipasarkan secara luas.
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4 Bersifat lintas sektoral Akademisi
Industri
Badan POM
Lembaga sosial
Describe
Explain
Control
Predict
The use and effects of drugs in a defined time, place and population
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5 Determine how a drug performs in clinical practice (effectiveness, safety)
Frequently used for post-marketing surveillance
Identify rare adverse events or events that occur in special populations
Document new uses of approved drugs Determine long term effects of drugs, or effects on ultimate vs. intermediate outcomes
Used by the BPOM to allow priority drugs in shorter time
Used by the BPOM to modify product labeling or approval status
Randomized controlled trials Cohort studies Case control studies Cross-sectional studies Descriptive studies-drug use, case reports Automated databases facilitate observational studies
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6 Demografi Penderita, Penyakit, obat dan Reaksi yang terjadi Age, race, gender Primary and secondary diagnosis What medications were taken Nature of adverse event, supporting lab data
Kronologis Kejadian ADR Clinical course of event, signs, symptoms, intervention How long was the pt taking the suspected drug
Indikasi dan Alasan Pemberian Obat Why was the drug prescribed Did the event abate when drug stopped, and recur when restarted
Case-control methodology Kejadian yang jarang terjadi atau perjalanan kejadian dalam jangka lama
Obat yang penggunaanya sering
Follow-up methodology Kejadian yang sering terjadi atau onsetnya cepat
Obat jarang digunakan
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7 Short duration
Narrow population
Narrow indication
Limited comorbidities and cotherapies
Small sample size For the 95% probability to detect an ADR, the number of subjects needed to be followed is 3 times the incidence of the event
Voluntary reporting Traditional method but low detection rates
Chart/record review
Computerized ADE surveillance system
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8 Reports can be submitted be submitted be submitted be submitted by mail, phone, fax or internet
Recent calling Recent calling Recent calling Recent calling for an independent drug safety board considering the recordrecordrecordrecord of recalls and difficulty with causality assessment and estimates for level of riskestimates for level of riskestimates for level of riskestimates for level of risk
Causality assessment is difficultCausality assessment is difficultCausality assessment is difficultCausality assessment is difficult Subject to underreporting Not possible to calculate an incidence rateNot possible to calculate an incidence rateNot possible to calculate an incidence rateNot possible to calculate an incidence rate; unreliable numerator numerator numerator numerator and very limited ability to estimate the denominatodenominatodenominatodenominator
Reporting rates vary Reporting rates vary Reporting rates vary 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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9 Retrospective review Retrospective review Retrospective review 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 costlow costlow costlow cost: feasible for ongoing surveillance
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ADE surveillance system
Generate alert systemGenerate alert systemGenerate alert systemGenerate alert system
Create daily reportCreate daily reportCreate daily reportCreate daily report Patient name, Diagnosis, ADE signal, drugs given
Independent verification by clinical pharmacist or trained nurse
Verified ADE & inform clinicians
ReviewReviewReviewReview methods Reviewing the chart Talking with clinicians caring for the patient Interviewing the patient, when possible
Causality assessmentCausality assessmentCausality assessmentCausality assessment Naranjo Score Severityberat ringannya ADE Preventabilitykemungkinan dapat dicegah
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A weighted score based on answers to a shortA weighted score based on answers to a shortA weighted score based on answers to a shortA weighted score based on answers to a short, standardized questionnaire that correlates correlates correlates correlates with causality with causality with causality with causality probabilityprobabilityprobabilityprobability
Doubtful (9)
Mild No change in therapy, treatment or length of stay(LOS)
Moderate Require change in drug therapy, treatment Temporary alteration in organ function Increased LOS < 2 days
Severe Life-threatening Permanent organ damage Increased LOS > 2 days Contribute to death
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Shumock and Thorntons criteria
At least one of them met the criteria, such ADEs considered to be preventable
SECTION ASECTION ASECTION ASECTION AAnswering 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 patients clini
cal condition?3. Was the dose, route, or frequency of administration inap
propriate for the patients age, weight, or disease state? If answers are all negative to the above, then proceed to SeSeSeSection Bction Bction Bction B
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SECTION B
Answering yes to one or more of the following implies that an AD
R is PROBABLY preventable
1. Was required therapeutic drug monitoring or other 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.
If answers are all negative to the above, then proceed to Section
C
SECTION CSECTION CSECTION CSECTION CThe ADR is NOT preventable
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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
