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Monitoring dan evaluasi

penggunaan obat
Farmakovigilan
Cabangilmufarmakologiyangterkait
dengandeteksi,penilaian,
pemahaman,danpencegahanefek
yangtidakdiinginkan(adverse
effects)ataumasalahterkaitobat
(drugreletedproblems)dariobat,
produkbiologis,herbal,danobat
tradisional(WHO,2002).

Tujuan Farmakovigilan :

1. Meningkatkan pelayanan pada pasien
2. Meningkatkan keamanan pasien terkait
penggunaan obat
3. Mendukung program kesehatan masyarakat
dengan menyediakan informasi yang dapat
dipercaya untuk penilaian risk-benefit obat
yang efisien.
Informasi kejadian ADR pada populasi
khusus orang Indonesia
variasiresponobatdi
dalamtubuh
F.Kinetik
F.Dinamik

Contoh :
Amerika (1977), Swedia (1974),
Jepang, Australia & beberapa negara Eropa
metamizol (antalgin)
sebagai analgetik
Indonesia ??
AE : Agranulositosis
& Diskrasia darah
TherapeuticDrugMonitoring
TDMdescribesthemonitoringof
concentrationsofdrugsinbodyfluids,
usuallyplasma,fortherapeuticpurposes
Cp = bound drug + unbound drug
Theoretical basis and assumptions
(a) Improvementinefficacy
1.Prophylacticdrugs:antiarrhythmics
andanticonvulsants
2.Drugswithpharmacokineticproblems
e.g.phenytoinanon-linearkinetics
3.Druginteractionsordiseasestates
liverofrenaldysfunction
(b) Avoidance of toxicity
(c) Diagnosis
1. Failure of therapy:
TDM helps distinguish between genuine
drug resistance (inappropriate agent),
non-compliance, and adverse effects
that mimic the disease state.
2. Overdose: Cp measurement may
distinguish drug-induced from organic
disease
(e.g.coma caused by sedative overdose)
3. Drug abuse: Confirmation of abstinence,
e.g. narcotic treatment programmes
Whentomeasure?
Atroughconcentration(i.e.justpriortothe
nextdose)istheusualmeasureofdrug
accumulation.
Samplingatthetimeofsymptomsmay
detectpeakconcentrationtoxicity.
Steady-stateconcentrationsarerelevant
tochronictherapy.

Pharmacological treatment of drug dependence


(i) Drug substitution therapy:
A similar drug with different pharmacokinetic properties (usually
longer t
1/2
) is used to decrease the intensity of, and to protract,
the withdrawal process,
e.g. methadone for opiate addiction
benzodiazepines for alcohol withdrawal
nicotine patches for smoking
(ii) Drug antagonist therapy:
After withdrawal has been completed, antagonists
may prevent the reinforcing effects of a rechallenge,
e.g. naltrexone versus heroin.
There is little proof of the efficacy of this.
(iii) Aversive therapy:
A drug may cause aversive symptoms if the drug of
dependence is resumed,
e.g. disulfiram/alcohol.