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THERAPEUTIC DRUG
MONITORING
For B. Pharmacy
Dr. Pravin Prasad
MBBS, MD Clinical Pharmacology
Lecturer, Department of Clinical Pharmacology
Mahrajgunj Medical Campus, IOM,TU
8 December 2019 (22 Mangsir 2076), Sunday
ACKNOWLEDGEMENTS
INTRODUCTION
Measuring drug concentration
Individualizing the dose
Drug concentration
maintained in target range
THERAPEUTIC DRUG
MONITORING(TDM)
DEFINITION
Pragmatic manipulation of the dose of a drug
using plasma concentration as a guide to
optimize its efficacy, to avoid or identify
toxicity and to detect or confirm poor
compliance
TDM: WHAT’S INCLUDED?
 Measuring drug concentration
 Clinical interpretation
Pharmaco
kinetics
Sampling
Time
Drug
History
Clinical
Condition
SOURCES OFVARIATIONS
Inter-individual Variation
Pharmacokinetic
Variability
Genetic Polymorphism
Pathological and
physiological factors
Intra-individual Variability
Age
Weight
Pathological Factors
Physiological Factors
Concomitant
medications
TDM: CRITERIA
NarrowTherapeutic Range
Significant pharmacokinetic Variability
A reasonable Relationship between plasma
concentrations and clinical effects
Established target concentration range
Availability of cost-Effective drug assay
WHICH DRUGS?
NERVE
TDM: INDICATIONS
Toxicity:
Diagnosing toxicity
Avoiding toxicity
TDM: INDICATIONS
Dosing:
Post dose adjustment
Adequate loading dose?
Patient’s dose requirements
TDM: INDICATIONS
Monitoring:
Assessing compliance
Diagnosing undertreatment
Diagnosing failed therapy
Q: WHYTDM?
A:TDM
TIMING OF PLASMA SAMPLE
At steady state (SS) concentration
 What is it?
 Why?
Just before the next dose is due
 What is it?
 Why?
Consider absorption and distribution
TIMING OF PLASMA SAMPLE
Very long half life- Before SS reached
 To avoid toxicity
 To ascertain adequate dosing
Suspected toxicity due to peak
concentrations
Method of Monitoring
TDM:THE PROCESS
Request forTDM
Laboratory
measurement
Result
communication
Clinical
Interpretation
Therapeutic
Management
INTERPRETINGTDM NUMBER
Needs to be individualised
Before adjusting dose, ascertain:
 Sample timing
 SS reached or not
 Patient compliance
 Other causes • Change in electrolytes
• Serum albumin
concentration
• Possible drug interaction
• Co-morbidity
MEASURING AND MONITORING
Within a clinically useful timeframe
Trained staff
Quality assay
Units in report
Reference values
LIMITATIONS
Limited number of drugs
Scientific accuracy
Laboratory variability
Limited accessibility
Validity of suggested target ranges
Drugs with active metabolites
VALUES FROM OUR
LABORATORY
Drug Normal Range (μg/mL)
Phenytoin 10-20
Phenobarbitone 15-40
Paracetamol 10-20
Carbamazepine 4-12
TDM: CONCLUSION
Team work involving clinicians, pharmacologists,
paramedical & laboratory staff.
Aims at better management of drug therapy by
individualization of therapy taking plasma levels
of the drug as guide.
Before attemptingTDM, its limitations must be
kept in mind that only certain drugs fit into the
category.
TDM LAB OFTUTH
TDM LAB OFTUTH
TDM LAB OFTUTH
LIQUID CHROMATOGRAPHY
MASS SPECTROMETRY
WORKING PRINICIPLE
ANY QUERIES?

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TDM for B Pharm practical-2019

Editor's Notes

  1. Individualization of dosage by maintaining plasma or blood drug concentration within a target range
  2. 3.Digoxin and hypokalemia 4.PD t1/2 >> PKt1/2 e.g reserpine,MAO(-),vigabatrin,hit and run drugs 5.e.g levodopa ,enalapril 6.antihypertensives,hyperglycemics,oral anticoagulants,diuretics 7.Penicillin
  3. Provides the clinician with greater insight into the factors determining the patients response to drug therapy. It can help to distinguish a noncompliant patient and a patient who is a true non-responder.