Therapeutic Drug Monitoring

Introduction, Need of TDM, Factors to be considered during TDM, Limitation, application of TDM

1. Therapeutic Drug Monitoring Dr. Subhash R. Yende Asst. Professor Gurunanak College of Pharmacy, Nagpur

2. Introduction Therapeutic drug monitoring (TDM) refers to the measurement of drug concentrations in biological fluids with the purpose of optimizing a patient’s drug therapy.  TDM refers to the individualization of drug dosage by maintaining plasma or blood drug concentrations within a targeted therapeutic range or window. In TDM clinical pharmacokinetics and laboratory technology were integrated with clinical medicine By combining knowledge of pharmaceutics, pharmacokinetics and pharmacodynamics , TDM enables the assessment of the efficacy and safety of a particular medication in a variety of clinical settings 2 Dr. Subhash R. Yende, GNCP, Nagpur

3. It aims to promote optimum drug treatment by maintaining serum drug concentration within a ‘Therapeutic Range’ 3 Dr. Subhash R. Yende, GNCP, Nagpur

4. Need for TDM Overuse or over prescribing of medicine Multiple drug therapy Toxicity of drug/ Adverse drug reaction Monitoring and detecting drug interactions Non- compliance Medication errors Withdrawal of therapy Drugs like aminoglycoside , phenytoin , digoxin , theophylline , lithium etc require TDM 4 Dr. Subhash R. Yende, GNCP, Nagpur

5. Factors to be considered during TDM Patients data- medical record Therapeutic goal Drug therapy Monitoring parameter Objective parameter Subjective parameter Problems associated with drug therapy 5 Dr. Subhash R. Yende, GNCP, Nagpur

6. Limitations of TDM Expensive Scientific accuracy of the drug assay Laboratory variability in reporting Lack of training and skills Limited accessibility and infrastructure facilities in the rural areas 6 Dr. Subhash R. Yende, GNCP, Nagpur

7. Applications of TDM To assess the appropriateness of dosing regimen to maintain the minimum conc. required to exhibit efficacy To individualize dosing of some drug, to predict a patients dose requirements and t o assess medication compliance To minimize the time period needed for dosage adjustment. To avoid drug toxicity: maintaining a drug within the therapeutic range can help to minimize the risk of toxicity To identify poisons and to assess the severity of poisoning on an emergency basis It provides an opportunity to clinical pharmacist to excel his knowledge and work in area of pharmacotherapeutic 7 Dr. Subhash R. Yende, GNCP, Nagpur

8. Indian scenario for TDM TDM was introduced in India in mid 1980s and last 20 years have seen its growth Still no regulatory guidelines for qualified clinical pharmacist in Indian hospital Pharm D course introduced by PCI There should be constructive collaboration between individual pharmacist, academic leader and hospital administration for training and resource Need support and acceptance of entire medical field and community to enrich this profession 8 Dr. Subhash R. Yende, GNCP, Nagpur

9. Reference AB Budhrani , R. Usman , M Sharma, P Kumar. Concise Course in Pharmacy Practice. S. Vikas and Company. https ://www.slideshare.net/KirshaSkishore/therapeutic-drug-monitoring-92845796 9 Dr. Subhash R. Yende, GNCP, Nagpur