Therapeutic Drug Monitoring

Course Objectives
- Describe the concept and significance of Therapeutic Drug Monitoring (TDM)
- Identify key concepts related to pharmacokinetics and pharmacodynamics
- Relay the drugs that require monitoring
- Discuss the role of TDM in preventing adverse drug reactions.
Course Content
Course Creator: Kirsten Hermens, NCMA-P
Total CE Hours: 1 Credit Hour 
Pace Course #: 586-2407-25

Key Terms: 
- Pharmacokinetics
- Pharmacodynamics
- Therapeutic Range
- Toxicity
- Adverse Drug Reaction (ADR)
 
Outline: 
  • Introduction
  • Key Terms
  • Introduction to Therapeutic Drug Monitoring
    • Brief History of Therapeutic Drug Monitoring
    •  Overview of Therapeutic Drug Monitoring (TDM)
    •  Definition of TDM
    •  Importance of TDM in Patient Care
      • Examples of successful TDM applications
    •  Therapeutic Drug Monitoring (TDM) is useful in cases of 
    • Key Concepts in TDM
      • Therapeutic Range
      •  Bioavailability
        • Examples
          • Oral Administration
          •  Intravenous Administration
      •  Volume of Distribution (Vd)
      •  Steady State
      •  Reaching Steady State 
        • Initial Doses 
        • Time to Steady State
      •  Half-life
      •  Trough
      •  Peak
  •  Pharmacological Foundations
    • Understanding Pharmacokinetics
      • ADME
        • Absorption 
        • Distribution 
        • Metabolism 
        • Excretion
  •  Key Reasons for Importance in TDM
    • Individualized Dosing
    • Understanding Drug Levels
    •  Adjustments for Narrow Therapeutic Window
    •  Monitoring Drug Interactions
  • Pharmacodynamics Essentials
    • Drug-Receptor Interactions
    • Dose-Response Relationship
    •  Therapeutic Index
    •  Index Classifications
      • Narrow Therapeutic Index (NTI)
      • Wide Therapeutic Index (WTI)
    • Factors Affecting Drug Levels
      • Drug Toxicity
        • Types of Toxicity
          • Acute Toxicity 
          • Chronic Toxicity
  • Drugs Commonly Monitored
    • Digoxin 
    • Lithium 
    • Carbamazepine 
    • Theophylline 
    • Phenytoin 
    • Vancomycin 
    • Warfarin 
    • Cyclosporine
  • The Role of Phlebotomy in TDM
    • Overview of Phlebotomy 
  • Purpose and Applications of Phlebotomy:
    • Diagnostic Purposes 
    • Medical Research 
    • Blood Donations 
    • Therapeutic Applications
  •  Phlebotomy Techniques
    • Venipuncture 
    • Capillary Puncture
  • Venipuncture: Impact on TDM accuracy
    • Consistency 
    • Lower Contamination Risk
  •  Capillary Puncture: Impact on TDM accuracy
    • Potential for Contamination 
    • Variability
  •  Therapeutic Drug Monitoring: 
    • Acceptable Specimens For TDM:
      • Whole Blood 
        • Usage 
        • Example
      • Serum 
        • Usage 
        • Example
      •  Plasma 
        • Usage 
        • Example
  • Blood Collection Protocols for TDM
    • Patient Identification 
    • Patient Information 
    • Consent and Comfort
  • TDM Timing of Collection
    • Trough
    •  Peak
  • Drug Half-Life Consideration
    • Reaching Steady State
    •  Trough Level Measurement
  •  Venipuncture Collection Procedure
    • Aseptic Technique
    •  Tube Filling
    •  Post-Collection Handling
  • Impact of Phlebotomy on TDM Accuracy
    • Timing of Blood Collection 
    • Sample Integrity
      • Hemolysis
      •  Contamination
      •  Best Practice
    •  The wrong tube used 
    • Proper Labeling and Documentation
    •  Scenario 
      • Scenario Conclusion
  • Clinical Application of TDM
    • Overview of Laboratory Processing Steps in TDM Specimens
      • Acquiring 
      • Centrifugation 
      • Aliquoting 
      • Storage 
      • Analysis Preparation
    • Interpreting TDM Results
      • Assessment of Results
        • Requires integration with patient-specific data 
        • Age 
        • Organ Function 
        • Sample Timing
      • Pattern Recognition 
        • Therapeutic Range 
        • Subtherapeutic Levels 
        • Toxic Levels 
        • Clinical Decision Support
      • Patient Care
        • Why is TDM Important in Patient Care?
          • Optimizes drug efficacy and safety:
            • Personalized Dosage Adjustment 
            • Monitoring and Response
            •  Managing Drug Interactions and Variability
            •  Improving Compliance and Outcomes
        • Monitoring to Avoid Adverse Reactions 
          • Individualized dosing 
          • Optimal therapeutic range 
          • Early detection of toxicity 
          • Identifying drug interactions 
          • Necessary Adjustments 
          • Education and Support
        • Importance of TDM in Special Patient Populations 
          • Elderly Patients 
          • Pediatric Patients 
          • Immunocompromised Patients 
          • Oncology Patients 
  • Future of Therapeutic Drug Monitoring
    • Emerging TDM technologies
      • Point-of-Care Testing (POCT)
        • Portable Devices 
        • Wearable Sensors 
        • Lab-on-a-Chip (LOC) 
        • Microfluidic Sensors 
      • Pharmacogenomics
        • Genetic Testing for Personalized Medicine
        •  Biomarker Discovery
      •  Artificial Intelligence (AI) and Machine Learning 
        • AI for Data Interpretation 
        • Decision Support Systems (DSS)
      •  Liquid Biopsy 
        • Non-invasive Drug Monitoring
        •  Monitoring Cancer Therapies
      •  Nanotechnology
        • Nanoparticles for Drug Delivery and Monitoring
        •  Nano-sensors
  •  TDM Case Study Scenarios  
    • Monitoring Anti-Seizure Medication in a Pediatric Patient Scenario
    • Monitoring Antibiotics in a Critically Ill Patient Scenario
  • Conclusion

 
References: 
  1. (2024, June 27). Therapeutic Drug Monitoring. Medline Plus; National Library Of Medicine. Retrieved December 08, 2024, from https://medlineplus.gov/lab-tests/therapeutic-drug-monitoring
  2.  (n.d.). Clinical Pharmacology. Merck Manuel. Retrieved December 08, 2024, from https://www.merckmanuals.com/professional/clinical-pharmacology
  3.  Cooney, L., Loke, Y. K., Golder, S., Kirkham, J., Jorgensen, A., Sinha, I., & Hawcutt, D. (2017). Overview of systematic reviews of therapeutic ranges: methodologies and recommendations for practice. BMC medical research methodology, 17(1), 84. https://doi.org/10.1186/s12874-017-0363-z
  4.  (n.d.). Adverse Drug Reaction. Science Direct. Retrieved December 10, 2024, from https://www.sciencedirect.com/topics/medicine-and-dentistry/adverse-drug-reaction
  5.  (2009, March 6). Overview of Therapeutic Drug Monitoring. National Library Of Medicine. Retrieved December 10, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC2687654
  6.  (n.d.). Therapeutic Drug Monitoring. Science Direct. Retrieved December 10, 2024, from https://www.sciencedirect.com/topics/medicine-and-dentistry/therapeutic-drug-monitoring\
  7.  (n.d.). Therapeutic Drug Monitoring. National Library Of Medicine. Retrieved December 10, 2024, from https://pmc.ncbi.nlm.nih.gov/(2022, July 19). Therapeutic Drug Monitoring.
  8.  (2024, September 19). The role of clinical pharmacists in transforming therapeutic drug monitoring. Omnia Health. Retrieved December 10, 2024, from https://insights.omnia-health.com/laboratory/role-clinical-pharmacists-transforming-therapeutic-drug-monitoring
  9. Clinical Pharmacology. Merck Manuels. Retrieved December 11, 2024, from https://www.merckmanuals.com/professional/clinical-pharmacology
  10.  10(2024, July 14). Therapeutic drug monitoring. Life In The Fastlane Medical Education Resources. Retrieved December 11, 2024, from https://litfl.com/therapeutic-drug-monitoring/
  11. (2023, December 11). The Bioavailability of Drugs. National Library of Medicine. Retrieved December 11, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC10745386
  12.  (2019, January 15). Therapeutic Drug Monitoring. Association for Diagnostic and Laboratory Medicine. Retrieved December 11, 2024, from https://myadlm.org/science-and-research/clinical-chemistry
  13.  (n.d.). What is Pharmacokinetics and ADME? Allucent. Retrieved December 11, 2024, from https://www.allucent.com/resources/blog/what-pharmacokinetics-and-adme
  14.  Sims, Pamela. (1992). Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. American journal of pharmaceutical education. 70.
  15. Resources for Nursing (Open RN); Ernstmeyer K, Christman E, editors. Nursing Pharmacology [Internet]. 2nd edition. Eau Claire (WI): Chippewa Valley Technical College; 2023. Chapter 1 Pharmacokinetics & Pharmacodynamics. Available from: https://www.ncbi.nlm.nih.gov/books/NBK595006/
  16.  (n.d.). Pharmacodynamics. Science Direct. Retrieved December 11, 2024, from https://www.sciencedirect.com/topics/medicine-and-dentistry/pharmacodynamics
  17.  (n.d.). Therapeutic Drug Monitoring. Science Direct. Retrieved December 11, 2024, from https://www.sciencedirect.com/topics/nursing-and-health-professions/therapeutic-drug-monitoring
  18.  (2024, February 14). From genes to drugs: CYP2C19 and pharmacogenetics in clinical practice. National Library Of Medicine. Retrieved December 12, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC10899532
  19.  (2017, May 1). Heat effects on drug delivery across human skin. National Library Of Medicine. Retrieved December 12, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC4841791
  20.  (n.d.). Drug Toxicity. Science Direct. Retrieved December 13, 2024, from https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/drug-toxicity
  21. (2019, April 18). Therapeutic Drug Levels. MedScape. Retrieved December 12, 2024, from https://emedicine.medscape.com/article/2172048-overview
  22.  (2021, November 9). Therapeutic Drug Monitoring. Testing.Com. Retrieved December 12, 2024, from https://www.testing.com/tests/therapeutic-drug-monitoring
  23.  (n.d.). Test Catalog. Mayo Clinic Laboratories. https://www.mayocliniclabs.com/test-catalog
  24.  Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients, American Journal of Clinical Pathology, Volume 155, Issue 3, March 2021, Pages 412–417, https://doi.org/10.1093/ajcp/aqaa138
  25.  (2022). A Fundamental Guide To Phlebotomy (1st ed., pp. 51-85). NHCO National Healthcare Certication Organization.
  26. (2022, February 10). Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2024. GENEMOD. Retrieved December 13, 2024, from https://genemod.net/blog/pre-analytical-lab-testing-phase  (2024, July 9). What Is The Process Of Therapeutic Drug Monitoring. My Care Labs. Retrieved December 13, 2024, from https://mycarelabs.com/blog/what-is-the-process-of-therapeutic-drug-monitoring/
  27. Blackwell Science (n.d.). Best Practices In Therapeutic Drug Monitoring. Wiley Online Library. Retrieved December 13, 2024, from https://bpspubs.onlinelibrary.wiley.com
  28.  (2024, March 12). Emerging therapeutic drug monitoring technologies: Considerations and opportunities in precision medicine. Frontiers in Pharmacology. Retrieved December 13, 2024, from https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1348112/full
  29.   D. (2023). Revolutionizing Precision Medicine: Exploring Wearable Sensors for Therapeutic Drug Monitoring and Personalized Therapy. Biosensors, 13(7), 726. https://doi.org/10.3390/bios13070726
  30.   (n.d.). Emerging Technologies Revolutionizing Therapeutic Drug Monitoring. Hilaris Publisher. Retrieved December 13, 2024, from https://www.hilarispublisher.com/open-access/emerging-technologies-revolutionizing-therapeutic-drug-monitoring.pdf
  31.  (n.d.). Selection and Continuation of Antiseizure Medication in Children With Epilepsy. Pediatric Neurology. Retrieved December 13, 2024, from https://www.pedneur.com/article/S0887-8994(23)00096-6/fulltext