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2555-1 > Adverse Drug reactions > Flashcards

Adverse Drug reactions Flashcards

1
Q

Define Adverse Drug Reaction:

A

= response to a drug which is noxious and unintended, that occurs at doses normally used for prophylaxis, diagnosis or therapy of disease, of for modifications of psychological function
- different to side effect

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2
Q

Factors which contribute to Adverse drug reactions

A
  • Age (children and elderly)
    • Sex (Females more likely
    • Genetics (genetic polymorphines)
    • polypharmacy (drug interactions)
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3
Q

What is the role of therapeutic good administration (TGA) in regulation of medicines

A

= TGA are regulatory authority for therapeutic goods and maintains Australian Register of Therapeutic goods

- Assessment and monitoring of therapeutic goods in au’s 
- evaluate and regulate BEFORE they reach market
- monitor AFTER they reach market 
- Decisions based on risk-benefit analysis
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4
Q

What is the process by which adverse reactions are reported to the TGA?

A
  • Anyone can report to TGA website

- any adverse reaction of registered/ listed medicines, vaccine, medical devices should be reported regardless

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5
Q

What are the two categorises that adverse drug reactions are classed as?

A
  1. Type A-F based on augmented or bizarre (based on properties of drug)
    • Augmented
    • Bizarre
    • Chronic
    • Delayed
    • End of use (withdrawal)
    • Failure
  2. DoTS Classification (some don’t fit A-F)
    • D = dose related?
    • T = time related
    • S = Susceptibility related
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6
Q

List the Characteristics, examples and management of:

Type A - Augmented

A

Characteristics

  • common
  • predictable
  • related to pharmacological action of the drug
  • dose related

Examples
- Digoxin toxicity

Management
- Reduce the dose or withhold the treatment

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7
Q

List the Characteristics, examples and management of:

Type B - Bizarre

A

Characteristics

  • uncommon
  • not related to pharmacological action of the drug
  • unpredictable
  • may be caused by genetic factor

Examples
- Immunoglogical reactions (allergies)

Management
- Withhold treatment and avoid in future

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8
Q

List the Characteristics, examples and management of:

Type C Chronic

A

Characteristics

  • uncommon
  • related to cumulative dose

Example
- Corticosteroid induced adrenal suppression

Management
- reduce dose or withhold treatment

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9
Q

List the Characteristics, examples and management of:

Type D - Delayed

A

Characteristics

  • uncommon
  • usually dose related
  • occurs or becomes apparent after use of drug

Examples

  • Teretogenesis (birth defects)
  • Cancer

Treatment - irreversible

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10
Q

List the Characteristics, examples and management of:

Type E - withdrawal - End of use

A

Characteristics

  • uncommon
  • occurs soon after withdrawal of drug

Examples
- Opioid withdrawal
benzodiazepine withdrawal

Management
- reintroduce and withdraw slowly

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11
Q

List the Characteristics, examples and management of:

Type F Failure

A

Characteristics

  • common
  • dose related
  • often caused by drug interactions

e.g
oral contraceptive failure

management

  • increased dose
  • consider effects of other therapy
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12
Q

Example of Type A

A

= Digoxin Toxicity

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13
Q

What is the MOA of Digoxin:

A

= slows HR and reduced AV node conduction
= increase forced of myocardial contraction
- inhibits sodium calcium pump

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14
Q

Define therapeutic index:

A

the dosage range in which the drug has the desired effect before effects become adverse, a high therapeutic index is desirable while a low TI means there is a narrow window between the dose that causes therapeutic effect and the dose at which adverse effects occur

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15
Q

Indications of Digoxin

A
  • AF (first line)

- HF last line

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16
Q

What is the role of P-Glycoproteins in Digoxin toxicity

A
  • Drugs that reduce digoxin elimination via inhabitation of P-glycoproteins, leading to increased concentration of drug:
    • Amiodarone
    • Verapamil
    • Diltiazem
    • Clarithromycin
    • Omeprazole
17
Q

Symptoms of Digoxin toxicity

A
  • GI symptoms (nausea and anorexia)

- cardiac symptoms (dysrhythmias)

18
Q

Prevention of digoxin toxicity:

A
  • dose should be tailored according to
    • renal function
    • clinical response
    • concentration monitoring
    • caution with concomitant drugs causing hypothalamic
  • Concentration monitoring
19
Q

Treatment of digoxin toxicity:

A
  • antidote = Digifab
20
Q

What is an example of Type B adverse reaction

A

= Sulfonamide hypersensitivity (allergie)

21
Q

Compare the two types of reactions in a Type B bizarre reaction

A

Type 1 - immediate

e. g. hay fever, penut allergy
- immediate or anaphylactic hypersensitivity
- body encounters antigen and produce IGE antibody against it
- cause inflammatory response

Type IV - Cell mediated or delayed

- delayed reaction 
- activation of adaptive immune system and t-cell involvement 
- infiltration of immune cells and release of cytokines
22
Q

Example of Type C

A

= chronic administration of corticosteroids

23
Q

MOA or corticosteroids

A

= exert Enti-inflammatory on airways and reduce airway hyperactivity

24
Q

indications of corticosteroids

A
  • asthma
  • autoimmune or inflammatory disease
  • COPD
25
Q

Adverse reactions chronic use of corticosteroids:

A
  • immunosuppression –> infection
  • adrenal suppression
  • hypertension
  • cataracts
  • inhibit growth in children
26
Q

How does chronic inhaled corticosteroids lead to oral candidiasis

A

inhaled corticosteroids cause local anti-inflammatory and immunosuppressive effects to site of admin

27
Q

how does chronic inhaled corticosteroid lead to adrenal suppression

A
  • glucocorticoid release controlled by negative feedback loop involving hypothalamus and anterior pituitary
    • admin of glucocorticoids reduces pt ability to synthesis corticosteroids due to supporession of feedback loop —> atrophy of adrenal glands
28
Q

Example of Type D

A

= Thalidomide and teratogenesis

29
Q

Teratogen ?

A

Teratogen = is an agent/factor which causes congenital malformations in the embryo or foetus, a process called teratogenesis

- E.g Agent orange - caused foetal defects
- Warfarin: Foetal warfarin syndrome, foetal bleeding, spontaneous abortion 
- Isotretinoin: ear malfunctions, cleft palate, heart defects
30
Q

What is the Thalidomide tragedy ?

A

Thalidomide was prescribed for morning sickness in pregnant women

- increase in phocomelia (seal limbs) in new bones 
- Discovered that therapeutic doses it produces virtually 100% malformed infants if taken first 3-6 weeks 
- withdrawal from market
31
Q

Drugs for use with pregnancy ?

A
  • most drugs will cross the placenta during pregnancy (potentially harm foetus)
    • Category A, B1, B2, B3, C, D, X
      • A - Drugs which taken by a large number of pregnant women and without increase in the frequency of malformations
      • X - High risk causing permeant damage to foetus
32
Q

Type E example

A

= End/withdrawal syndrome

33
Q

What is physical dependence?

A

Physical dependence = occurs as a result of repeated administration of a drug and means that withdrawal, or use of antagonist of this drug causes adverse psychological effects (sweating, nausea, shivering, piloerection, muscle aches, tachycardia, increased BP)

- withdrawal effects can be experienced when administering an agonist e.g. heroin + Naloxone
- withdrawal refers to the abrupt cessation of a drug where there is physical dependence result in adverse effects 0
34
Q

Which drugs upon cessation may cause withdrawal symptoms?

A
  • opioids - restlessness/ anxiety, runny nose, diarrhoea/vomiting, shivering, piloerection, hostility
    • benzodiazepine - anxiety, dysphoria, irritability, insomnia, sweating, memories impairment, tremor, hallucinations
    • Alcohol
35
Q

How to manage withdrawal?

A
  • Drugs withdrawn gradually and symptoms monitored (dose tapered)
    • pharmacological interventions can be used for withdrawal due to illicit use e.g. method one and opioid withdrawal
    • using benzodiazepine with a longer half life
36
Q

Type F example

A

= Oral contraceptive failure

37
Q

What is the role of cytochrome P450 enzymes metabolism

A
  • Both pills are metabolised by CYP3A4 = metabolism of the pill by CYP450 reduces the plasma concentration of active drug

2555-1 (19 decks)

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