Adverse drug reactions Flashcards

1
Q

Adverse reaction

A

Harmful or seriously effects occurring at doses intended for therapeutic effect and which call for reduction of dose or withdrawal of the drug and/or forecast hazard from future administration

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2
Q

Type A vs B Reactions

A
  • Type A reactions : 85-90% of all adverse drug reactions, can affect any individual, given sufficient dose and exposure, and are predictable from the known pharmacologic properties of a drug
  • Type B or allergic drug reaction/hypersensitivity reaction: results from a specific immunologic response to a medication, 10-15% and occurs in a susceptible subgroup of patients, have signs and symptoms that are different from the pharmacologic actions of the drug, and usually cannot be predicted
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3
Q

______: implies a direct action of the drug, often at high dose.

A

Toxicity

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4
Q

Relative vs. types of special cases of toxicity

A
  • Relative toxicity: an ordinary dose that may be toxic due to an underlying abnormality in the patient e.g. kidney disease
  • Mutagenicity, carcinogenicity and teratogenicity are special cases of toxicity.
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5
Q

_____: a low threshold to the normal pharmacological action of a drug

A

Intolerance

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6
Q

______: an inherent qualitative abnormal reaction to a drug, usually due to a genetic abnormality e.g., porphyria-heme synthesis dysfunction.

A

Idiosyncrasy

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7
Q

______ : reactions which result in objectively
reproducible symptoms or signs initiated by exposure to a defined stimulus at a dose tolerated by normal subjects

A

Hypersensitivity

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8
Q

______: personal or familial tendency to develop IgE antibodies in response to low doses of allergens, and to develop typical symptoms e.g. asthma, rhinoconjuctivitis and eczema/dermatitis or tendency to develop allergies

A

Atopy

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9
Q

______: a hypersensitivity reaction initiated by immunological mechanisms

A

Allergy

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10
Q

______: a severe, life-threatening, generalized or systemic hypersensitivity reaction (subset of allergy)

A

Anaphylaxis

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11
Q

Adverse reactions cause ____% of consultations in general practice

A

2-3

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12
Q

Adverse reactions cause ___% of admissions to ICUs

A

3

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13
Q

Overall incidence in hospital in-patients due to adverse reactions is ____%

A

10-20

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14
Q

Adverse reactions cause prolonged hospital stay in ≈___% of patients in acute medical units

A

10

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15
Q

Deaths caused by ADR annually

A

100,000

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16
Q

Drug-induced Skin Reactions

A

– Maculopapular eruptions
– Urticarial rashes and angioneurotic edema
– Fixed drug eruptions
– Photosensitivity, phototoxicity and photoallergy
– Vasculitis
– Hyperpigmentation
– Drug-induced systemic lupus erythematosus
– Anticoagulant-induced skin necrosis
– Severe skin reactions

17
Q

Drug-induced Pulmonary Reactions

A
  • Bronchospasm -can precipitate asthma
  • Drug-induced cough ACE-inhibitors
  • Pulmonary edema
18
Q

Blood Dyscrasias (reactions)

A

Thrombocytopenia
Granulocytopenia
Aplastic anemia
Hemolysis

19
Q

Chronic organ toxicities that can occur due to ADRs

A

Eye: corneal opacities
Liver: cirrhosis
Kidney: nephropathy
Uterus: endometrial cancer

20
Q

ADR’s effects in pregnancy

A
  • Teratogens: in first trimester- alcohol, isotretinoin
  • ↓ fetal bone and tooth development
  • Ototoxicity
  • Drugs given just prior to labor
    vasoconstrictor-s↓fetal blood supply fetal distress
  • Drugs given during labour: diazepam- hypotonia in neonate and ↓ suckling
21
Q

______ is the most common drug allergy

A

Penicillin

22
Q

T/F Complaints of: nausea, vomiting, diarrhea,
headaches, general malaise, dizziness are examples of true allergic reactions

A

False - they are side effects of medication
- Not mediated by the immune response
- Not a contraindication to re-treatment with the
offending agent
- Mitigation: decrease rate of absorption, try food
or snack with oral medications

23
Q

What are Pseudoallergic reactions?

A
  • Direct stimulation of mast cells resulting in release of histamine (flushing) - Opiates, vancomycin (infuse-rate dependent)
  • Non-immunologic activation of the complement cascade (Radiocontrast media)
  • Change in metabolism or production of inflammatory mediators (ACE inhibitors, aspirin, NSAIDS)
24
Q

Characteristics of true allergic reactions

A
  • Mediated by immune response
  • lnvolve lgE, or lgM and/or lgG antibodies, or T-cells
  • Lead to mast cell degranulation and histamine release
  • Present as hives, itching, angioedema, dyspnea, wheezing, anaphylaxis, severe hypotension
  • May recur within or across drug classes due to ability of similar structural components between drugs to elicit similar antigenic responses (penicillins and cephalosporins)
  • Contraindications to re-treatment with the offending agent and/or treatment with other similar drugs
25
Q

Type 1 Allergic reactions

A
  • Hypersensitivity Reactions/Anaphylactic
    lgE-mediated
  • Responsible for urticaria, angioedema, hypotension,anaphylaxis
  • AKA Antibody-mediated anaphylactic reactions
  • AKA lmmediate hypersensitivity reactions
  • Usually occur minutes to 2 hrs after second exposure
  • Most common type of hypersensitivity caused by
    sulfonamide antibiotics
26
Q

Type 2 allergic reactions

A

Type ll Hypersensitivity Reactions/Cytotoxic
- Possess cytolytic and cytotoxic activity
- lgG and lgM - mediated
- Occur 7-21 days after drug initiation
- Result in hemolytic anemia, thrombocytopenia,
neutropenia

27
Q

Type 3 allergic reactions

A

Type lll Hypersensitivity Reactions/lmmune Complex Reactions
- lgG and lgM-mediated
- Antibody-antigen complexes cause damage to entire organs
- Skin, joints, and kidneys are most commonly affected
- Occur in 5-21 days after drug initiation
- Result in vasculitis, maculopapular rash,
glomerulonephritis, or erythema multiforme

28
Q

Type 4 allergic reactions

A

Type lV Hypersensitivity Reactions/Delayed
- AKA cell-mediated hypersensitivity
- Mediated by cytokines released by sensitized T-cells
- Result in activation of immune cascade leading to tissue damage
- Occur 48 - 72 hrs after exposure
- Examples: contact dermatitis, Stevens-Johnson syndrome

29
Q

Stevens-Johnson syndrome is an example of a type ___ allergic reaction

A

4

30
Q

T/F Always weigh the benefits of a particular medication against the risk of a serious reaction

A

T

31
Q

_____ lnvolves giving a patient very small amount of drug and repeating administration with increasing larger amounts

A

Desensitization

32
Q

Why is reporting allergic reactions important?

A
  • Required for manufacturers to document and report ADRs to the FDA
  • Prescribers and other healthcare professional can
    voluntarily report
33
Q

What to report with ADRs/Allergic reactions

A

observed or suspected events with human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for: