BARRIERS TO TDM

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BARRIERS TO TDM
Philip D. Walson, MD Director, Clinical
Pharmacology Clinical Trials Office Cincinnati
Childrens Hospital Medical Center
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PAST PRESENT Depends on Site
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TDMTHERAPEUTIC DRUG MANAGEMENTNot Monitoring
Not T e D iu M
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HOSPITAL TDM DATA GETTING LIGHT OUT OF A BLACK
HOLE
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TDM10
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10 mg/LH or L
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10 mg/Ldrawn 0800
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10 mg/Ldrawn 08001 hour p dose
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10 mg/Ldrawn 08001 hour p doseduration of Rx
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10 mg/Letc.Other drugsDisease Rxd
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10 mg/Letc.Responses
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10 mg/Letc.CollectionAssayHandling
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10 mg/LAnalyticalClinical Info.PK/PD
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WHAT Clinical Info?

• Demographics - age, race height/weight, gender
• Diagnoses
• Dosage regimen - amount, drug, formulation,
  times
• Responses
• Lab results, handling, methods, etc.

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INFORMATION SOURCES

• Physicians
• Nurses
• Med. Records
• Patients
• Caregivers
• Lab/TDM Service

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QUALITY ASSURANCEJust as important for
clinical data and analysis/interpretation as
for lab results
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QUESTIONS?