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Overcoming Barriers to TDM: Information and the TDM Renaissance

Overcoming Barriers to TDM: Information and the TDM Renaissance. How to integrate PK intelligence with routine clinical data. Alexander A. Vinks, PharmD, PhD, FCP Professor of Pediatrics, University of Cincinnati Director, TDM & Clinical PK Lab

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Overcoming Barriers to TDM: Information and the TDM Renaissance

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  1. Overcoming Barriers to TDM: Information and the TDM Renaissance How to integrate PK intelligence with routine clinical data Alexander A. Vinks, PharmD, PhD, FCP Professor of Pediatrics, University of Cincinnati Director, TDM & Clinical PK Lab Cincinnati Children’s Hospital and Medical Center

  2. “Therapeutic Drug Monitoring is the measurement made in the laboratory of a parameter which, with appropriate interpretation, will directly influence prescribing procedures” IFCC/IA-TDMCT Joint Committee 1993

  3. How should we do TDM? • Not to check numbers or “Therapeutic Range” • To describe and understand Drug PK/PD Behavior • Collect informative data to use as Bayesian priors for designing model-based, individualized dosing regimens • Change passive “Monitoring” to active “Management”

  4. The current paradigm Store and analyze data in our Heads, on Paper or in Computers BUT – where’s the link?

  5. Data base structure at CCHMC Clinical Lab KIDS COE CORE LCR NetAccess I yr Info Cerner Openlink Liver CF SQL ADT Neuro

  6. Goal oriented - model based dosing

  7. Running a centralized TDM service

  8. Specific Objectives TDM Study • Implementation of Active Therapeutic Monitoring (ATM): • goal-oriented model-based dosing • active guidance and Bayesian adaptive control vs non-guided TDM • Outcomes - clinical and economical benefits • Cost evaluation of old and new TDM process

  9. Distribution of Peaks & Troughs

  10. Kaplan-Meier survival analysis TDM cost-effectiveness study; van Lent-Evers et al. Ther Drug Monit 1999;21:63-73

  11. Active Therapeutic Monitoring benefits patient outcome TDM cost-effectiveness study; van Lent-Evers et al. Ther Drug Monit 1999;21:63-73

  12. Development of Web-based tools

  13. Web-based data collection tools

  14. Dates and timing of samples • Daily measurements • Early morning troughs • But also other times! • Interpretation?

  15. Liver transplant case history • 10 yr old African American boy • Transplant 1998 • Rejection July 1998 & December 2000 • FK levels <1.5 µg/L at 4 mg bid • Fluctuating levels between 1.5-5 µg/L Q: Compliance – high clearance – other?

  16. Conclusions… • TDM informatics is still in its infancy • Passive monitoring should be replaced by active Management • Need better tools to link all clinical data to drug behavior (PK) data • Data base should link patient info with Population PK, Pharmacogenetics (PG), Adverse Events and Clinical Effects (PD) data

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