Therapeutic Drug

Monitoring
Harsha Pulpati
KBIPER, Gandhinagar

Therapeutic drug monitoring

The procedure to monitor and maintain drug plasma
concentration at a level which is necessary to produce
therapeutic effect

To maximize the benefit of a prescribed and simultaneously
minimizing its toxicity

Objectives

To achieve optimum drug therapy
To achieve desired pharmacological effect of drug
To monitor serum drug concentration with clinical response
so as to modulate the therapy
To benefit patient
To monitor individual complicating factors








Why TDM is required !!!

Hence to improve the situation, clinical pcokinetics,
Laboratory technology were integrated with clinical
medicine giving birth to TDM


Essential requirement for TDM

Existence of relationship Between dose, concentration
of drug in biological fluid and its Pharmacological and
Pharmacodynamics effect


In order to ensure efficacy and safety of drug

The out come of therapy usually done by
clinically by observing changes in the patient's
sign and symptoms and also my monitoring
relevant laboratory data

TDM is manipulation of the dose by measuring
or monitoring plasma concentration



Most of the factors affecting drug absorption would affect
Serum/plasma concentration level

It is necessary to monitor

1. The patient complies with the diet restrictions, if any
2. Doses are administered as prescribe
3. Reported side effect are observed simultaneously if any
other side effects are observed so mentioned earlier
4. Check for incompatibility
5. Adjust the dose accordining to the patients need
6. Multiple drug therapy



Which drugs require monitoring

Having narrow therapeutic index

Drugs having concentration related
and adverse effects

Showing marked pharmacokinetic variability

In which therapeutic effect is difficult to monitor

TDM is not used if response to the drug therapy
can directly or easily measured

Categories of drugs which required TDM

Antibiotics : Gentamycin
Vancomycin
Chloramphenicol

Anti epileptic drugs : Phenobarbital
Phenytoin
Valproic acid

Anti cancer drugs : Methotrexate

Bronchodilators : Caffeine
Theophyline

Cardiac drugs : Digoxine
Quinidine



Once steady State has been reached about the mean
drug concentration in blood are determined by the Mode of
delivery, bioavailability, interval between dosing as well
as pharmacokinetics of the drug it self

TDM can be divided in the three stages:

1. Production and validation of a suitable analytical techniques
usually the validation technique uses

1. Selection of appropriate samples for analysis and their
preservation

3. To establish that the blood drug concentration correlates
with therapeutic efficacy and/ or toxicity of the drug


Continue

To establish this relationship a few Guideline

Sample should be collected after steady state has reached

Sample should be collected after 20-30 minutes after injection
to ascertain peak level

Peak level are attained after 30-60 minutes of i.m. injection

Trough concentration are defined as serum drug concentration
just prior to next dose

Some interpretation become difficult in some cases of
protein binding or formation of active metabolites



Applications

To asses plasma drug concentration
To avoid drug toxicity
To assess dose adjustment in various disease state
To check effect of unpredictable dose response
curve eg: Phenytoin
To minimize the time period need for dose
adjustment
To identify poison and to assess severity of poison
To check the patient compliance
Adjustment of dose of potent drug eg : Digoxine
To carry out bioavailability studies
Comparison of the drugs


Thank you
A good teacher is like candle
It consumes itself To light the way of others
HAPPY TEACHERS DAY