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Pharmacology > Lecture 14: Adverse Drug Reactions > Flashcards

Lecture 14: Adverse Drug Reactions Flashcards

1
Q

Define an adverse drug reaction.

A

Something occurring that was not intended as a result of a drug being given.

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2
Q

Define a medication misadventure.

A

Any sort of hazard or incident that occurred with a med or exam.

Examples:
Pt took wrong med.
Rash from an ABX.

This includes any mediccation error, ADE or ADR

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3
Q

Define a medication error.

A

PREVENTABLE event with POTENTIAL to lead to inappropriate med use or pt harm.

Examples:
Wrong order entered on pt that was caught.
Pt got 10x normal dose fentanyl.

MAY include ADR and ADE but the problem does not always reach the patient

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4
Q

Define an adverse drug event.

A

Any injury caused by a medication.

Examples:
Idiosyncratic thrombocytopenia
Pt got 10x normal dose fentanyl.

Includes ALL adverse drug reactions

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5
Q

Give some examples of an adverse drug reaction.

A

Anaphylaxis from PCN.
Angioedema from lisinopril.

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6
Q

What does an ADR fall under in terms of categories?

A

Is always a subgroup of ADEs and Medications misadventures

CAN be a subgroup of medication errors but not all ADR are medication errors

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7
Q

What are some differences between ADEs and ADRs?

A

ADE = dose can be diff from norm, may or may not be linked to med

ADR = given at proper dose, reaction always related to medication

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8
Q

What are some of the methods used to prove an ADR?

A

Expert judgment/global introspection.
Assessment algorithm.
Bayesian probability estimations of epidemiologic data.

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9
Q

What are some of the assessment algorithms used to track ADRs?

A

Naranjo algorithm
WHO Causality algorithm
Venulet algorithm
Liverpool ADR Causality Assessment Tool (CAT)

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10
Q

What are the gradings for an ADR?

A

Minor
Moderate
Severe
Lethal

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11
Q

What are the reaction types for an ADR?

A

Type A and Type B.

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12
Q

Define the characteristics of a Type A reaction.

A

DOSE DEPENDENT
Related to drug’s MOA.
Reaction comes in a wide range.

80% of all ADRs.

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13
Q

Define the characteristics of a Type B reaction.

A

NOT DOSE DEPENDENT
NOT RELATED to drug MOA.
Influenced by patient specific factors.
Includes allergies, intolerances, and idiosyncractic responses.

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14
Q

What are the 5 mechanisms of ADR classification?

A

Idiosyncratic
Hypersensitivity
Intolerance
Drug interaction
Pharmacologic

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15
Q

Define idiosyncratic reactions.

A

Uncharacteristic response.
Does not occur on admin.
Unpredictable.
Small cohort of patients.

Example:
Drug-induced hepatitis

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16
Q

Define hypersensitvity reactions.

A

reactions not explained by pharmacologic effects of the drug
caused by altered reactivity of patient
includes allergic reactions

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17
Q

Are all allergic reactions adverse reactions?

A

Yes, but not the other way around.

18
Q

Define a type 1 hypersensitivity reaction.

A

True allergic reaction with immediate onset of 1-6 hrs.

MOA:
Allergen beinds to mast cells via IgE receptors.
Releases inflammatory and vasoactive markers.
Itching, hives, hypotension, swelling.

19
Q

Define a type 2 hypersensitivity reaction.

A

Cytotoxic reaction with delayed onset > 72 hrs.

MOA:
Host cells perceived by immune system as foreign.
IgG or IgM antibody binds to host cell.
Cytolysis and destruction occur.

20
Q

What are some examples of a type 2 hypersensitvity reaction?

A

Hemolytic anemia
Thrombocytopenia

21
Q

Define a type 3 hypersensitivity reaction.

A

Immune complex formation with delayed onset > 72 hrs.

MOA:
IgG or IgM antibody binds to antigen, forming complex.
Larger number of complexes deposit on blood vessels.
Local inflammatory reaction, tissue destruction.

22
Q

What are some examples of a type 3 hypersensitivity reaction?

A

Serum sickness
Joint pain
Lymphadenopathy

23
Q

Define a type 4 hypersensitivity reaction.

A

T-cell mediated reaction with delayed onset > 72 hrs.

MOA:
Antigen activates T-cells, creating memory cells.
Antigen detection in the future activates memory cells.
Cytokine releases an inflammatory response.

24
Q

What are some examples of a type 4 hypersensitivity reaction?

A

Variety of rashes
Contact dermatitis

25
Q

What are some of the most common allergies?

A

Peanuts & Soy
Eggs
Dye allergies

26
Q

What meds do I avoid in soy/peanut allergies?

A

Clevedipine, propofol, progesterone (prometrium capsules)

27
Q

What vaccines are OK to give in someone with an egg allergy?

A

Flubok
Flucelvax

28
Q

What are the two main categories of drug-drug interactions?

A

Pharmacodynamic
Pharmacokinetic

29
Q

What are the characteristics of an intolerance reaction?

A

Characteristic effect of a drug produced by a small dose.

AKA a little drug causes huge effects. (generally, symptoms worsen with increasing dose)

They are often difficult to differentiate from side effects.

30
Q

What kind of reaction is a pharmacodynamic reaction?

A

Type A, aka dose-dependent. It is a known effect of the drug, such as hypotension with lisinopril or bradycardia with a betablocker.

31
Q

What is the difference between adverse effects and side effects?

A

Side effects are usually expected that occur regardless of dose.

Adverse effects are usually rarer or not expected. these include type A and B reactions

32
Q

What is MedWatch?

A

FDA reporting program for serious ADRs.

33
Q

What are the only two things you do NOT report to MedWatch?

A

Vaccines (VAERS)
Investigation study drugs (They have their own protocol)

34
Q

What is FAERS?

A

FDA Adverse Event Reporting System.

Houses the data from MedWatch.

35
Q

What is VAERS?

A

Vaccine Adverse Event Reporting System.

Vaccine equivalent of FAERS.

36
Q

What is ISMP?

A

Institute for Safe Medical Practices.
Private reporting system for ADRs, ADEs, and mainly medication errors.

Uses MERP for its reporting. (ISMP Med error reporting program)

37
Q

What is TJC?

A

The Joint Commission.

Tracks sentinel events. Voluntary reporting by healthcare orgs and requires root-cause analysis.

38
Q

What is MedMARX?

A

Subscription based registry of ADEs, ADRs, and med errors.
Voluntary reporting for subscribing facilities.
Consults/provides feedback (only one that does this!!!)

Eventually sends its info to FAERS.

39
Q

What is REMS?

A

Risk Evaluation and Mitigation Strategies

FDA Req for manufacturers and providers for meds with serious risk.

40
Q

What kind of requirements does REMS require?

A

Blood levels
Medication guide dispersal
Elements to assume safe use.

41
Q

What is the overall goal of institution specific reporting?

A

Culture focused on patient safety.

42
Q

What are some common barriers to reporting ADRs?

A

Lack of training
No incentive
Fear of retaliation
Time

Pharmacology (19 decks)

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