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Therapeutic Drug Monitoring : Handling & Reporting

Prepared by :

Siti Fathiyyah binti Mazelan

Pegawai Farmasi UF48

Hospital Tanah Merah

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Flow Chart of TDM Sampling

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What to Screen ?

  • Sampling Tube
  • Sampling Time
  • Specimen Stability

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Ensure the tube is correct!

Plain Tube WITHOUT GEL

Adults: 3-5mL

Bullet Tube

Pediatric: 0.5mL

ALL drugs EXCEPT Cyclosporin

EDTA tube

Adults: 3-5mL

Cyclosporin ONLY

Do NOT SPIN

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Sampling Time

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Specimen Stability

DRUG

STABILITY

POST SAMPLING

AT 2-8˚C (AFTER SPIN)

Acetaminophen

8 hr

48 hr

Amikacin

8 hr

48 hr

Carbamazepine

8 hr

48 hr

Ciclosporine

8 hr

1 week

Digoxin

6-8 hr

24 hr

Gentamicin

4 hr

1 week

Phenobarbital

8 hr

48 hr

Phenytoin

8 hr

48 hr

Salicylate

4 hr

2 weeks

Theophylline

8 hr

1 week

Valproate Acid

2 days

1 week

Vancomycin

4 hr

48 hr

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TDM Verification

Edit

Order Remarks

Lab Result

Sampling Detail

Save

Edit

Acknow-ledge

Edit

Verify

Print

( 1 copies)

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TDM Verification

Pharmacy Transaction

Clinical

TDM

TDM Verification

Select patient

2

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Edit sampling details

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TDM Verification in PhIS

Verify

Print (1 copies)

Print 1 copies

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TDM Sample Management in PhIS (1)

Pharmacy Transaction

Clinical

TDM

Sample Management

Select patient

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TDM Sample Management in PhIS (2)

Sampling detail

Sample Management

Process Type: LAB Based

Save/Reject

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TDM Sample Management in PhIS (3)

  • Key in the required details
  • 1 sample 1 sample management

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TDM Sample Management in PhIS (3)

  • Key in the required details
  • 1 sample 1 sample management

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TDM Reporting

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TDM Reporting in PhIS (1)

Pharmacy Transaction

Clinical

TDM

TDM Reporting

Search patient

Add

Report

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TDM Reporting in PhIS (2)

Pharmacy Transaction

Clinical

TDM

TDM Reporting

Search patient

Add

Report

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TDM Reporting in PhIS (3)

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TDM Reporting in PhIS (4)

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TDM Reporting in PhIS (5)

* Once confirm cannot edit

Report

Save

Check

Confirm

Print

Handle by PRP

Discussed with: PF

Report prepared by: PRP

Report checked by: PF

Handle by PF

Discussed with: PF

Report prepared by: PF

Report checked by: PF

Compulsory entry:

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Who to take charge?

Discussed with

Report checked by

8am – 5pm

PF Ward

PF Ward

AOH (result received after 5pm)

PF PM/ON shift

PF PM/ON Shift

Weekdays

PH/ Weekends

Discussed with

Report checked by

8am – 3pm

PF AM Shift

PF AM Shift

Result received before 3pm but report undone till 3pm

PF AM Shift

PF PM Shift

Result received after 4pm

PF PM/ON Shift

PF PM/ON Shift

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What to Check?

  • Patient’s name
  • Correct drug
  • Weight / PMA &PNA
  • Pre & Post levels
  • The recommendation:
    • Dose
    • Frequency
    • Starting date
    • Starting time
  • Re-monitor level on:
    • Date
    • Time

**Always correlate the intervention with the laboratory results or clinical conditions.

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Double check the recommendation

Double check the recommendation

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Gentamicin

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Case Scenario (1)

Patient currently on IV Gentamicin 12mg OD (3.9 mg/kg/day)

SrCr (21/06/24) : 35 umol/L

Weight : 3.07 Age : 6 Days

PRE : 0.57 mg/L (<1)

POST : 7.35 mg/L (5-12)

Ke : 0.114 hr-1

T1/2 : 6.098 hr

T : 18.24 hr

Cmax: 7.78 mg/L

Cmin : 0.509 mg/L

Vd :1.64 L (0.538 L/kg)

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Patient currently on IV Gentamicin 9mg OD (3.8mg/kg/day)

Last dose : 21/6/2024 @ 3pm

Weight : 2.35kg Age: 10days

SrCr (21/06/24) : 51.17 umol/L

PRE : 2.05 mg/L (<1)

POST : 8.07 mg/L (5-12)

Ke : 0.061 hr-1

T1/2 : 11.38 hr

T : 34.136 hr

Cmax: 8.32 mg/L

Cmin : 1.93 mg/L

Vd : 1.408L (0.599 L/kg)

Case Scenario (2)

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Case Scenario (2)

If 9mg 36hourly,

Expected Cmax: 7.197mg/L

Expected Cmin : 0.8mg/L

Suggestion:

  1. Monitored PRE is TOXIC and POST level is WITHIN therapeutic range.
  2. Suggest to WITHOLD for 36 hours from the last dose and change regime to IV Gentamicin 9mg 36hourly to be served on 23/6/2024 at 6AM.
  3. Kindly monitor renal profile closely.
  4. Thank You

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Case Scenario (3)

Patient currently on IV Gentamicin 13mg OD (3.98 mg/kg/day)

SrCr (20/06/24) : 73 umol/L

PRE : 2.16 mg/L (<1)

POST : 11.18 mg/L (5-12)

Ke : 0.073 hr-1

T1/2 : 9.484 hr

T : 28.452 hr

Cmax: 11.596 mg/L

Cmin : 2.008 mg/L

Vd : 1.36 L (0.416 L/kg)

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Amikacin

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Case Scenario (1)

Patient currently on IV Amikacin 35mg OD (11.86 mg/kg/day)

SrCr (21/06/24) : 37.59 umol/L

Weight : 2.95kg Age : 7 days OL

POST 2H : 26.52 mg/L

POST 7H : 10.72 mg/L

  • Ke : 0.181 hr-1
  • T1/2 : 3.825 hr
  • T : 11.476 hr
  • Cmax: 31.78 mg/L
  • Cmin : 0.413 mg/L
  • Vd : 1.12 L (0.378 L/kg)

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Vancomycin

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Vancomycin

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Reference

  • Clinical Pharmacokinetic Pharmacy Handbook Second Edition (2019)

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Vancomycin

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Vancomycin in Normal Renal Function

Patient currently on IV Vancomycin 1000 mg BD (12.5 mg/kg/dose)

Last dose served on 13/5/24 at 8.00pm

SCr: 71 umol/L (8/5/24)

Pb: right wrist abscess

Tissue c&s (10/5/24) : MRSA positive

12/5/2024 : iv vancomycin 1500mg STAT

PRE : 8.32 mg/L (10-20)

POST :17.69 mg/L (20-40)

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Vancomycin in Normal Renal Function

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Vancomycin in Normal Renal Function

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Ke :0.079 hr-1

T1/2 : 8.728 hr

T : 26.18 hr

Cmax: 19.152 mg/L

Cmin : 7.386 mg/L

Vd : 84.96 L ( 1.062 L/kg)

AUC inf: 13.269

AUC elim: 148.93

AUC 24: 324.398

By using Vd population:

  • Exp AUC24: 344.64mg.hr/L

Vancomycin in Normal Renal Function

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Vancomycin in Normal Renal Function

  • Calculated AUC24: 324.4 mg.hr/L was BELOW therapeutic range (400-600).
  • Suggest to INCREASE IV Vancomycin 1250 mg BD ( 15.6 mg/kg/dose) starting today (14/5/24 @ 8pm) .
  • Kindly dilute IV Vancomycin 1250mg in 250ml NS and run over 2hours.
  • To take pre and post level on 15/5/24 @ 7.30pm and 11pm, respectively.
  • Kindly monitor renal profile closely.
  • Thank you.

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Paracetamol

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Guide for PCM Toxicity

1. Do confirm

  • Dose
  • Weight of patient
  • Strength of paracetamol
  • Type of paracetamol (ER/IR)
  • Type of Ingestion (Acute/Chronic Ingestion)
  • Any symptoms (Nausea/Vomiting/Abdominal pain)
  • Time of Ingestion

2. If Multiple Ingestion

  • Do not use Rummack Matthew Nomogram
  • May Commence NAC

3. If Acute Ingestion

  • Use Rummack Matthew Nomogram

4. NAC dose kindly refer CPPH