6. monitoring dan evaluasi penggunaan obat (1)

8/10/2019 6. Monitoring Dan Evaluasi Penggunaan Obat (1)

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Monitoring dan evaluasi

penggunaan obat


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Farmakovigilan

Cabangilmufarmakologiyangterkait

dengandeteksi,penilaian,

pemahaman,danpencegahanefek

yangtidakdiinginkan(adverse

effects)ataumasalahterkaitobat

(drugreletedproblems)dariobat,

produkbiologis,herbal,danobattradisional(WHO,2002).


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Tujuan Farmakovigilan :

1. Meningkatkan pelayanan pada pasien

2. Meningkatkan keamanan pasien terkait

penggunaan obat3. Mendukung program kesehatan masyarakat

dengan menyediakan informasi yang dapat

dipercaya untuk penilaian risk-benefitobat

yang efisien.


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Informasi kejadianADRpada populasi

khusus orang Indonesia

variasiresponobatdi

dalamtubuh

F.Kinetik

F.Dinamik


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Contoh :

Amerika (1977), Swedia (1974),Jepang, Australia & beberapa negara Eropa

metamizol(antalgin)

sebagai analgetik

Indonesia ??

AE : Agranulositosis

& Diskrasia darah


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TherapeuticDrugMonitoring

TDMdescribesthemonitoringof

concentrationsofdrugsinbodyfluids,

usuallyplasma,fortherapeuticpurposes

Cp = bound drug + unbound drug

Theoretical basis and assumptions


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Indications for T M(a) Improvementinefficacy

1.Prophylacticdrugs:antiarrhythmics

andanticonvulsants 2.Drugswithpharmacokineticproblems

e.g.phenytoinanon-linearkinetics

3.Druginteractionsordiseasestatesliverofrenaldysfunction


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(b) Avoidance of toxicity


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(c) Diagnosis

1. Failure of therapy:

TDM helps distinguish between genuinedrug 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


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Whentomeasure?

Atroughconcentration(i.e.justpriortothe

nextdose)istheusualmeasureofdrug

accumulation. Samplingatthetimeofsymptomsmay

detectpeakconcentrationtoxicity.

Steady-stateconcentrationsarerelevanttochronictherapy.


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Therapeutic range


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Pharmacological treatment of drug dependence

(i) Drug substitution therapy:

A similar drug with different pharmacokinetic properties (usuallylonger t1/2) 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


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(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.

6. monitoring dan evaluasi penggunaan obat (1)

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