TDM Flashcards

1
Q

What is TDM?

A

The process to individualize patient drug regimens to achieve optimal therapeutic outcomes

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2
Q

Who is involved with TDM team process?

A

Multiple members of the healthcareteam

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3
Q

What is step 1 of TDM process?

A

Doctor and pharmacist will establish a dosage regimen design to achieve a desired steady state concentration

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4
Q

What data is collected in TDM step 1?

A
  1. Based on population PK parameters
  2. Patient labs and demographics
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5
Q

What is step 2?

A

A blood sample is drawn at an appropriate time and is sent for analysis

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6
Q

What is step 3?

A
  1. Clinical pharmacist will take results from serum concentrations and compare them to therapeutic response
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7
Q

What must a pharmacist must consider when reviewing serum concentration?

A
  1. Whether samples were taken at appropriate times
  2. Pharmacological and PK properties of the drug
  3. Patient information
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8
Q

What type of patient info needs to be considered?

A
  1. Demographics
  2. Clinical status
  3. Other lab values
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9
Q

What are the drugs characteristics for TDM?

A
  1. Drugs with an established relationship between toxicity/therapeutic outcomes and measured serum/blood levels
  2. Narrow therapeutic index
  3. Large interindividual variation of steady state drug levels
  4. Serum drug levels that don’t correlate with given dose
  5. Non linear PK (Saturable metabolic systems)
  6. Clinical response is difficult to predict (immunosuppressants)
  7. Toxicity is difficult to distinguish from underlying disease state (theophylline in COPD)
  8. Efficacy is difficult to establish (phenytoin)
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10
Q

What are cardio active drugs that require routine TDM?

A
  1. Digoxin
  2. Amiodarone
  3. Procainamide
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11
Q

What are Antibiotics drugs that require routine TDM?

A
  1. Gentamycin
  2. Amikacin
  3. Tobramycin
  4. Vancomycin
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12
Q

What are anti epileptic drugs that require routine TDM?

A
  1. Phenytoin
  2. Valproic acid
  3. Carbamazepine
  4. Ethosuximide
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13
Q

What are bronchodilators drugs that require routine TDM?

A
  1. Aminophylline
  2. Theophylline
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14
Q

What are immunosuppresants drugs that require routine TDM?

A
  1. Cyclosporine
  2. Tacrolimus
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15
Q

What are cytotoxic drugs that require routine TDM?

A

Methotrexate

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16
Q

What are alagesics drugs that require routine TDM?

A

Acetaminophen and aspirin

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17
Q

What are antideppressants and psychotics drugs that require routine TDM?

A
  1. Lithium
  2. Tricyclic antidepressants
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18
Q

What are the reasons for drug level determination?

A
  1. Assessment of patient compliance
  2. Non-responsive antibiotic treatment
  3. Aid in predication of adverse effects prior to therapeutic effect observed
  4. Confirmation of drug interactions
  5. Dose adjustments with impaired clearance
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19
Q

Assessment of patient compliance?

A

distinguish between non-compliance and non-response

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20
Q

Non-responsive antibiotic treatment?

A

Determine whether therapy failure is due to inadequate SDC or bacterial resistance

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21
Q

Aid in predication of adverse effects prior to therapeutic effect observed?

A

High trough of gentamicin can lead to renal toxicity

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22
Q

Confirmation of drug interactions?

A

co-administration with enzyme inducers or inhibitors

23
Q

Dose adjustments with impaired clearance?

A

Impaired clearance can lead to high SDC and toxicity with narrow therapeutic index drugs

24
Q

How often should determination be done?

A
  1. Not a routine test for every drug
  2. Only be done when appropriate
25
Q

Why is important to sample at right time?

A

Avoid misinterpretation of data

26
Q

What is the key component of TDM?

A

Sampling time

27
Q

What are the conderations to draw SDC?

A
  1. steady state
  2. Avoid sampling drugs in distributive phase
  3. Times are based on nomograms (acetaminophen(
  4. Based on institutional guidelines
  5. Consider route of administration and dosage form of the drug
28
Q

When do sample an oral formulation?

A

Css (4-5 half lives_

29
Q

When do sample an sustained release oral formulation?

A

Midpoint of dosing interval

30
Q

When do sample a slow IV loading dose formulation?

A

30 minutes after completion of admin

31
Q

When do sample a slow IV continuous infusion without LD formulation?

A

2 half lives

32
Q

When do sample a slow IV continuous infusion with LD oral formulation?

A

4-8 hr during infusion

33
Q

What are the variables that affect PK/PD of TMD?

A
  1. Active metabolites
  2. Disease states
  3. Age
  4. Pregnancy
  5. Drug formulation
  6. Other factors
34
Q

How does active metabolites affect PK/PD of TMD?

A

Effect therapeutic effects

35
Q

How does disease states affect PK/PD of TMD?

A

Acute and chronic diseases can alter clearance

36
Q

How does age affect PK/PD of TMD?

A

Very young or very old can effect

37
Q

How does pregnancy affect PK/PD of TMD?

A

Alter during pregnancy and return to normal postpartum

38
Q

How does drug formulation affect PK/PD of TMD?

A

Formulations and routes of admin may alter PK

39
Q

What are other factors that affect PK/PD of TMD?

A
  1. Smokking
    2.Stress
  2. DDI
  3. FDI
  4. Environmental factors
  5. Circadian rhythm
40
Q

What do skin, hair, gum, and eye exam observe?

A

May be a sign of adverse effects in drugs like phenytoin

41
Q

What do Bacterial culture and sensitivity observe?

A

To ensure proper selection of antibiotic and design of dosage regimen

42
Q

What do Forced Expiratory Volume (FEV1), Peak expiratory flow rate (PEFR), Arterial Blood Gases (ABG) observe?

A

Used as markers for efficacy of bronchodilators like Theophylline

43
Q

What do ECG abnormality, NV, HA observe?

A

Signs of adverse events (ex: digoxin)

44
Q

What do Renal Function Tests (SCr) observe?

A

Indication of nephrotoxicity or reduced elimination (Vancomycin, Aminoglycosides)

45
Q

What do Liver Function Tests (AST, ALT) observe?

A

Marker for liver toxicity (Valproic Acid, APAP, Testosterone)

46
Q

What do Serum Electrolytes (K+) observe?

A

Enhanced Cardio toxicity (digoxin)

47
Q

What do Complete Blood Count (low RBC) observe?

A

Marker for aplastic anemia (carbamazepine)

48
Q

What do Thyroid Function Tests (T3, T4) observe?

A

Altered drug response in hypo or hyperthyroidism (digoxin)

49
Q

What is a TDM request form?

A

Designed to ensure all relevant info is collected

50
Q

Describe the flexible nature of drug reference ranges.

A

Therapeutic range is guide rather than an absolute value:
1. Target gentamicin depends on severity, site of infection, and immune status of patient
2. Reference range may depend on drug indication
3. Reference range doesn’t rule out toxicity in an individual
4. Some side effects are dose dependent
5. Alteration of drug concentration at site of action while SDC is within range
6. Synergistic or additive effects of concomitant drugs

51
Q

Describe the management of drug toxicity?

A
  • must be familiar with methods to manage drug toxicity where appropriate (NAC)
52
Q

Describe continuing education?

A

essential to keep up with new information regarding therapeutically monitored drugs

53
Q

Describe patient education?

A

Patients must know how to take medication and what side effects to expect, times for drug sampling, etc to ensure positive therapeutic outcomes