FARMAKOLOGI KLINIK

dr. Gestina Aliska, Sp.FK

Bagian Farmakologi & Terapi Fakultas Kedokteran
Universitas Andalas
DEFINITION

WHO

Clinical Pharmacology is the scientific discipline

that involves all aspects of the relationship between
drugs and humans

The term ’clinical pharmacologist’ is commonly used in the

professional sense to refer to physicians who are specialists in
clinical pharmacology.
AIM

Drug

Quality Efficacy Safety

 Teaching

Patient Care Clinical Research

Pharmacology

Goverment
Clinical Pharmacology in
Patient Care
 clinical care of patients can be improved
 The RATIONAL USE of medicines  individual patients &
patient populations
 Clinical care of paediatric and geriatric patients needs special
attention
 the critical evaluation of new and old therapies 
pharmacoepidemiological
 Drug and Therapeutics Committees where they help the
rational introduction and use of new and expensive medicines
into the delivery of health care.
 Therapeutic drug monitoring
 Monitoring adverse reactions
 RATIONAL DRUG USE

Ratio

Benefit – Risk - Cost

F.Kinetika F Dinamika F Ekonomi

 PHARMACOLOGICAL ASPECTS
IN CLINICAL PRACTICE

Pharmacokinetic Pharmacodynamic

How drugs act

The dynamics of drug conc. in
the body

* Absorption / bioavailability

* Distribution
* Biotransformation

* Excretion
THERAPEUTIC DRUG MONITORING
(TDM)
Measuring the plasma drug conc.

Provide useful information about

the adequacy of the dosage
regimen or the likehood toxicity
Therapeutic Drug Monitoring (TDM)

Ph kinetic Ph dynamic

Drug-
interaction
• Measuring/ • Therapeutic
interpreting response
plasma drug conc. • Side effects
• Toxic effects
 Time-drug conc. relationship
40

30
Drug toxicity

20

Therapeutic level
10
m.e.c
Low therapy

1 2 3 4
Time (hour)
 Therapeutic Drug Monitoring (TDM)

1. Narrow margin of safety drugs

2. Drugs for prevention/ therapy of life threatening

diseases or life saving drugs

3. Difficulty in ditinguishing between the effects

of a disease and the toxic effects of a drug
4. Potent drugs  drug amount is very small
5. Drugs that show variability of drug conc.
in plasma
Factors that modify drug plasma
concentration for a given dose

• Drug formulation
• Drug interaction
• Environmental factors
• Genetic variation
• Renal and hepatic function
Reasons for monitoring
drug treatment

1. To see whether there is

therapeutic response

2. To assess drug toxicity

3. To assess compliance
Examples of difficulty in ditinguishing between
the effects of a disease and
the toxic effects of a drug

1. Digoxin toxicity Congest.Heart Failure

Nausea / anorexia / arrythmias

2. Gentamycin toxicity Gram (–) septicaemia

Renal damage
Pharmacokinetic parameters

Cmax (peak)

Half life
AUC 24

Cmin
(trough)
Time
 Visualisation of half-life
First order elimination of a drug (t ½ : 2 hours)
20 The plasma conc. falls by half each half-life

10
t½

5 t½
2.5 t½

2 4 6
Hours
Clinical application of half life (t½)

* Designing drug dosage regimen

* Determining time to reach steady state

drug level which show clinical effect

* Determining time to reach the drug level

which have no clinical effect anymore
 CONSIDERATION

Ph’kinetic Ph’dynamic Ph’economic

RATIONAL & GOOD CLINICAL THERAPY

DOSE ADJUSTMENT
 Dose adjustment
 Renal failure  Stage of failure
 penyesuaian dosis pada gangguan fungsi ginjal tidak
diperlukan jika
 (a) fraksi obat yang diekskresi utuh oleh ginjal (fR) < 0.33
dan metabolitnya tidak aktif, berapapun LFGnya, dan juga
 (b) pada gangguan fungsi ginjal ringan atau LFG > 0.67 nilai
normal, berapapun fRnya.
 penyesuaian dosis diperlukan pada semua derajat
gangguan fungsi ginjal
 untuk obat dengan margin of safety yang sempit dan
eliminasi terutama melalui ginjal, misalnya aminoglikosida,
vankomisin, dan digoksin.
 Hepar impairment
 Rumus Cockcroft & Gault
Thank You =)

Questions??