2. Therapy- Treatment given to
patient
Administration of potent
medication
Therapeutic window-
Concentration maintained
between minimum effective
and maximum safe
concentration
Potent drug-narrow range
Slight variation and non
compliance could prove fatal
effect.
‘ NEED FOR TDM’
3. Need for TDM
Treatment are super specialized.
Patient take more than one medication
Interactions may happen
Patients not following prescription
2 major sources of variability
- pharmacokinetics (dose and plasma concentration)
- pharmacodynamics (drug conc. at the receptor site)
ADME CONSIDERED IN TDM
4. Categories of drugs require TDM
Cardiac drug
Antiepileptic
Bronchodilators
Immunosuppressant
Anti-cancer drugs
Psychiatric drug
5. Which drugs requires monitoring?
Showing marked pharmacokinetic variability
Concentration related to ADR
Narrow therapeutic index
Defined therapeutic concentration range
In which desired therapeutic effect is difficult to
monitor
6. When should TDM be requested?
Drug assay are expensive
TDM is used to assist the drug therapy
Appropriate indication for TDM includes-
1. A patient with inadequate clinical response
2. A patient with irreversible sign and symptoms
3. To minimize risk of drug toxicity
4. To individualize dosing for some drugs
5. To help to predict patient dose requirement
6. To assist medication compliance
7. To identify poison and to assess the severity of
poisoning in emergency
7. Management of therapy using plasma concentration
Request to laboratory
Analysis Quality Assessment
Report Interpretation clinical action
Record previous report
8. Factors considered during TDM
Factors affect serum drug concentration and need to be
considered during interpretation of the assay.
1. Patient demographics
- patient information
- patient age
- address, occupation, reference
- indication for TDM
- etiology
- past treatment, present treatment
- investigation
9. Dosage regiment and duration of therapy
Pathological factors
- patient abnormalities
i.e. vomiting, diarrhea, inflammation
Alcohol and tobacco use
- non specific microsomal enzyme induction
- result in increased clearance and decrease serum
concentration.
i.e. phenytoin, theophylline
10. Medicine or Sampling error
- TDM is incompatible with drug administration
record
Laboratory errors
- Laboratory error is suspected result should be
repeated or sent to different lab
Sampling time
- Serum concentration depend on time when the
blood is drawn for assay
- Time and date should be monitored
11. Patient compliance
- Concentration is lower than accepted their may
be possibility of non- compliance
Individual capacity of ADME
- Renal impairment
- Hepatic impairment
Altered protein binding
12.
13. Role of Pharmacist
Multidisciplinary function
Requires collaborative work
1. Initial optimization of drug, dosage form, interval,
route of administration in view of individual variables
2. Assessment and adjustment of dosage regiment for
patients with hemodialysis or peritoneal dialysis
3. Assessment of possible cause.
- i.e. non compliance, bioavailability problem,
medication error, interaction
4. Management of acute drug intoxication
14. Scenario of TDM in India
TDM is available in two ways
1. Clinical Pharmacology department
2. Private medical laboratories
15. Number of factors influence the use of TDM in
India
Cost
Alternative medical service
Malnutrition
Ethnic difference
Variation in bioavailability