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Foundations of Pharmacy Care > Exam I: Medication Errors, Polymorphisms > Flashcards

Exam I: Medication Errors, Polymorphisms Flashcards

1
Q

Define medication error

A

”Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer”

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2
Q

Define adverse drug event (ADE)

A

Patient harm from drug exposure (an ADE can occur in the absence of a medication error)

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3
Q

Define a preventable ADE

A

Medication error that reaches the patient and causes harm (~50% of all ADEs)

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4
Q

Define potential ADE

A

Medication error that does not cause harm (didn’t reach patient or just good luck)

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5
Q

Define an adverse drug reaction (ADR)

A

A non-preventable ADE (no medication error occurred but patient still experienced harm from drug exposure)

Also called “side effects”

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6
Q

What are the 4 classifications of an ADE from an IND Safety Report?

A

Life-threatening ADE

Serious ADE

Suspected ADE

Unexpected ADE

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7
Q

Define what a life-threatening ADE is?

A

Places the patient at immediate risk of death

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8
Q

A serious ADE results in (5) ?

A
  1. Patient death
  2. Life-threatening ADE
  3. Hospitalization or prolongation of existing hospitalization
  4. Persistent or significant incapacity or substantial disruption of normal daily life
  5. Congenital anomaly or birth defect – this is why it is important for a subject not to get pregnant during a clinical trial. Most damage is done during the first trimester.
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9
Q

What is an investigator brochure? How does it relate to unexpected ADE?

A

Investigator brochure is provided by the sponsor. It is the protocol and a summary of all the preclinical trial testing.

An ADE not already described in the IB or is more severe than what has been described is considered unexpected.

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10
Q

What is a suspected ADE?

A

There is a reasonable possibility that the drug caused the adverse event.

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11
Q

What is an unexpected ADE? (3)

A
  1. Not included in the Investigator Brochure (IB)
  2. Not described in the IB as occurring at the observed specificity or severity
  3. Not consistent with the risk information described in the IB or general investigational plan (Study Protocol)
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12
Q

Percentage of hospitalized patients that experience an ADE.

A

6.7%

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13
Q

Provide 4 examples of ADEs during Transitions of Care (Hospital Discharge)

A
  1. Medication adherence may suffer (patient anxiety, functional impairment)
  2. Medications may have been stopped, replaced, or added during hospitalization
  3. Poor healthcare provider communication and follow-up exacerbates these problems
  4. Hospital readmission: ADR-related 20%; ADE-related 13%
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14
Q

4,756 significant ADEs reported between 2009-2016 for children related to what types of medication?

A

OTC cough and cold meds

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15
Q

What age range of children are at the highest risk of an ADE?

A

45.8% occurred in children < 6 years old between 2009-2016

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16
Q

ADEs in Children: Dosing errors most common (93.2%)—wrong amount of liquid measured (45% by parent, 28.8% by another caregiver)

True/False

A

True

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17
Q

Medication errors and ADEs can prolong hospitalization and require intervention

About how much money do these errors cost inpatient and outpatient?

A

Inpatient ADEs cost approximately $16.4 billion per year

Outpatient ADEs cost approximately $4.2 billion per year

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18
Q

Most ADEs are not preventable.

True/False

A

False

Two-thirds of ADEs are preventable

Approximately 40% are the result of negligence

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19
Q

Define medical negligence.

A

Failure to use reasonable care, resulting in damage or injury to another

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20
Q

What is an adulterated drug?

A

Multiple points

  • Consists in whole or in part of any filthy, putrid, or decomposed substance
  • If it has been prepared, packed, or held under insanitary conditions
  • If how it was produced, or stored does not conform with current good manufacturing practice
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21
Q

Most common medication error in the pharmacy?

A

Transcribing—medication order interpreted incorrectly (wrong dose or quantity, 25.5%)

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22
Q

Three strategies to reduce medication errors during the prescribing stage.

A
  1. Avoid unnecessary medications
  2. CPOE with clinical decision support system
  3. Medication reconciliation during transitions of care
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23
Q

One strategy to reduce medication errors during the transcribing stage.

A

CPOE to eliminate handwriting errors

24
Q

Three strategies to reduce medication errors in the dispensing stage.

A
  1. Clinical pharmacist to manage medication dispensing
  2. Use of tall man lettering to minimize confusion with LASA medications
  3. Automated dispensing cabinets for high-risk medications
25
Q

What are the five rights? How does it affect medication error rate?

A

Right Medication, in the Right Dose, at the Right Time, by the Right Route, to the Right Patient

Adherence to this reduces medication errors during administration

26
Q

Six ways that medication errors can be reduced during the administration stage.

A
  1. Barcode bedside medication administration
  2. Minimize nurse interruption
  3. Smart infusion pumps
  4. Multicompartment medication devices for patients on multiple medications
  5. Patient education
  6. Improved (easier to read and understand) medication labels
27
Q

What is polypharmacy? Give an example of how this can be problematic.

A

The use of multiple drugs or more than are medically necessary.

Pt prescribed h2 blocker during NPO status to prevent a stress ulcer bleed. Pt discharged with h2 blocker script that they no longer need.

28
Q

What does LASA stand for?

A

Look alike sound alike

29
Q

Factors that can cause variability in drug metabolism from person to person.

A
  1. Genetic factors
  2. Epigenetic factors
  3. Age
  4. Gender
  5. Ethnicity
  6. Disease
  7. Environmental factors
30
Q

What is a epigenetic factor for variability in drug metabolism?

A

Chemical modifications in gene activity (gene “turned on or off”) that do not change the DNA sequence (e.g., methylation of DNA turns the gene off)

31
Q

Name the examples that were provided for environmental factors that can cause variability in drug metabolism.

A
  1. Cigarette smoking, coffee, alcohol
  2. Drug administration (drug interactions), herbals (St. John’s wort)
  3. Exposure to DDT or gasoline fumes
  4. Dietary factors (cruciferous vegetables, char-broiled beef, grapefruit juice)
32
Q

What enzyme metabolizes half of the drugs people can take?

A

Cytochrome P450 3A4 metabolizes half of all drugs people take

33
Q

What substance can inhibit the activity of cytochrome P450?

A

Grapefruit juice

34
Q

Describe Phase I of drug metabolism in humans.

A
  1. Introduces or exposes a functional group

2. Most reactions catalyzed by cytochrome 450 (CYP) enzymes

35
Q

Where is CYP450 located?

A

Located in the liver and intestine

36
Q

Describe Phase II of drug metabolism in humans.

A
  1. Covalent linkage between a functional group on the parent compound with glucuronic acid, sulfate, glutathione
  2. Leads to more rapid excretion
37
Q

Describe the final phase of drug metabolism

A

Pgp exists in the gut wall. Tries to absorb drug across the intestine and it pumps it right back out into the intestine and ends up being excreted in the feces

38
Q

Bioavailability (F) is the portion of the drug that makes it into _____? Where is some of the drug lost?

A

Bioavailability is the portion of the drug that makes it into the systemic circulation.

Some can be lost in the gut wall and/or the liver

39
Q

What are the four phenotypic variants for the first two phases of drug metabolism?

A
  1. Ultra-fast metabolizer (UM)—multiple copies of wt
  2. Extensive metabolizer (EM) —homozygous wt/wt
  3. Intermediate metabolizer (IM) —heterozygous wt/v
  4. Poor metabolizer (PM)—homozygous v/v or heterozygous v1/v2
  • V = variant (mutation)
  • Wt = wild type (normal)
40
Q

What is 6-mercaptopurine (6-MP)? What is it used to treat?

A

Purine antagonist used to treat childhood acute lymphoblastic leukemia (ALL) and (off-label) adult or childhood inflammatory bowel disease (like Crohn’s disease)

41
Q

What is a major precaution that needs to be considered before prescribing 6-MP?

A

The biomarker for 6-MP is the enzyme TPMT

There is a polymorphism present

TPMT IMs and PMs are predisposed to 6-MP toxicity

42
Q

What side effect occurs in TPMT PMs who take 6-MP?

A

Fatal bone marrow suppression

43
Q

6-MP is never prescribed to patients who are PMs of TPMT.

True/False

A

False

Patients with childhood acute lymphoblastic leukemia (ALL) are sometimes prescribed this medication at very low doses because it is important in treating this disease

44
Q

Two inactivation pathways of 6-MP.

A
  1. Inactivation to 6-thiouric acid (6-TU)by xanthine oxidase (XO) in gut wall and liver
  2. Inactivation intracellularly (inside B and T cells) to 6-methyl mercaptopurine (6-MMP) by thiopurine methyltransferase (TPMT)
45
Q

What is the activation pathway for 6-MP?

A
  1. 6-MP to 6-TIMP via HGPRT
  2. 6-TIMP to 6-MMPR via TPMT
  3. 6-MMPR to 6-TXMP via IMPDH
  4. Activation of 6-TXMP to 6-TGNs via GMPS
46
Q

What are the inactive forms of 6-MP?

A

6-TU

6-MMP

47
Q

Why can’t allopurinol be taken with 6-MP?

A

Drugs like allopurinol inhibits XO this is a contraindication

48
Q

PMs experience a shift in 6-MP metabolism that favors the pathway to 6-TGN (active) rather than 6-TU (inactive). Why is this bad?

A

The intermediate 6-MMPR is liver toxic (hepatoxic). A build of this metabolite

6-TGN is responsible for killing leukemia cells but is also toxic to bone marrow cells.

49
Q

Which form of 6-MP is responsible for killing leukemia cells but also bone marrow suppression in PMs?

A

6-TGNs

50
Q

Bioavailability of 6-MP in a normal metabolizer.

A

16%

51
Q

Myelotoxicity means?

A

Bone marrow suppression

52
Q

Describe TPMT activity and 6-MMPs production in PMs.

A

Little to no TPMT activity

No 6-MMPs (Inactive)

53
Q

How long should a prescriber wait after each dose adjustment for an EM of TPMT to reach a steady dose adjustment?

A

Allow 2 weeks to reach steady state after each dose adjustment

54
Q

How long should a prescriber wait after each dose adjustment for an IM of TPMT to reach a steady dose adjustment?

A

Allow 2-4 weeks to reach steady state after each dose adjustment

55
Q

How long should a prescriber wait after each dose adjustment for an PM of TPMT to reach a steady dose adjustment?

A

Allow 4-6 weeks to reach steady state after each dose adjustment

56
Q

EMs for 6-MP begin with a normal dose (1.5mg/kg/d) then adjusts as needed.

What percentage of a normal dose are IMs and PMs prescribed at first?

A

IMs - 30-70% of normal dose and adjust based on degree of myelosuppression and disease-specific guidelines

PMs - Start with 10-fold lower daily dose given 3 times weekly instead of daily and adjust

57
Q

What is the biomarker for nortriptyline? How do PMs respond to this medication?

A

PMs— Reduced TCA metabolism causing higher than expected blood levels of all tricyclic antidepressants (TCAs)

Foundations of Pharmacy Care (12 decks)

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