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Fundamentals of Pharmacology > ADRs and Clinical Study > Flashcards

ADRs and Clinical Study Flashcards

1
Q

What are the Different Types of ADRs and their A-F classification?

A
  • Type A: Augmented, dose related (usually resolved by reducing dose)
  • Type B: Bizarre, unrelated to dose, includes hypersensitivity
  • Type C: Chronic, dose and time related
  • Type D: Delayed, time related
  • Type E: End of use, related to drug withdrawal
  • Type F: Failure, unexpected failure of therapy
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2
Q

Discuss Type A: Augmented, dose related (usually resolved by reducing dose)

A
  • Predictable from known pharmacology
    • 3 principal mechanisms
      • exaggerated therapeutic response at target site
      • desired pharmalogical effect but at another site
      • impaired metabolism
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3
Q

Discuss Type B: Bizarre, unrelated to dose, includes hypersensitivity

A
  • Unpredictable
    • Severe reactions
    • Causes:
      • abnormal drug metabolism or receptors
      • allergic reactions
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4
Q

Discuss Type C: Chronic, dose and time related

A
  • Often due to adaptive changes at receptor or metabolism
    • development of drug tolerance (e.g. opioids)
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5
Q

Discuss Type D: Delayed, time related

A
  • Only acceptable if benefits outweigh risk (e.g. infertility in young person receiving cancer treatment)
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6
Q

Discuss Type E: End of use, related to drug withdrawal

A
  • Rebound after abrupt discontinuation
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7
Q

Discuss Type F: Failure, unexpected failure of therapy

A
  • Drug interactions
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8
Q

What are the reasons for paracetamol toxicity?

A
  • Hepatotoxicity in overdose
    • toxic metabolite formed if there is insufficient levels of glutathione
      • Treatment: glutathione-like molecule NAC
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9
Q

What are the reasons for Gray Baby Syndrome?

A
  • Chloramphenicol
  • Due to impaired glucoronisation in neonates
  • Also due to impaired renal clearance
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10
Q

What are the symptoms of Gray Baby Syndrome?

A
  • Abdominal distension
  • Diarrhoea
  • Vomiting
  • Circulatory collapse and death
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11
Q

What are the reasons of Gasping Baby Syndrome?

A
  • Benzyl alcohol
  • Related to immaturity of glycine conjugation system resulting in accumulation of benzoic acid metabolite
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12
Q

What are the symptoms of Gasping Baby Syndrome?

A
  • Metabolic acidosis
  • Seizures
  • Gasping
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13
Q

Define On-Target ADRs

A

Exaggerated drug response at the correct receptor site

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14
Q

Define Off-Target ADRs

A

Drug affects unintended target

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15
Q

Define Idiosyncratic

A

Unknown mechanism

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16
Q

Aspirin on-target ADRs

A

Prevents blood clotting as intended, but too much (GIT)

17
Q

Aspirin off-target ADRs

A

Trough mechanism independent off blood clotting (e.g. bronchospasms in asthmatics)

18
Q

Define Teratogens

A

An agent or factor which causes malformation of an embryo without affecting the mother

19
Q

What are risk factors for ADRs?

A
  • Pregnancy
    • first trimester > most drug risk
      • embryo most vulnerable to teratogens
    • second and third trimester
      • affects functional development or growth
  • Food, Herbs & Other Medicines
    • Foods may compete for ADME
      • induce or inhibit metabolic enzymes
    • K+ competes with digoxin for transporter sites
    • Herbs acting via same mechanism increases drug effects and chance of toxicity
20
Q

How are ADRs monitored in Australia?

A
  • Reduce polypharmacy
  • Simple medication regimens
  • Educating patients
  • Post marketing surveillance
21
Q

Define Standard Deviation

A

Measure of how spread out measurements are around the mean

22
Q

What are reasons for patient randomisation?

A
  • Prevents ‘data-skewing’
  • Eliminates bias
23
Q

What are the typical designs of four phases in drug testing?

A
  1. Phase 1
    • group of 3 patients
    • used to learn ‘maximum tolerated dose’ of a drug
    • is the drug safe?
  2. Phase 2
    • Therapeutic activity screen
    • Confirm dose-range is similar in most people
    • How well does it work?
  3. Phase 3
    • Experimental group vs. control group
    • Randomisation, blinding
    • Compare it with standard deviation
  4. Phase 4: Post marketing study
    • After drug has been marketed
    • Designed to monitor the effectiveness of the approved intervention
    • Collect information abount adverse effects with widespread use
24
Q

What is a placebo effect?

A

Beneficial effect produced by a placebo drug or treatment, due to patient’s belief in that treatment

25
Q

Why is study blinding important?

A
  • Patient may have preconceived notions about the benefits of therapy
  • Patients try to get well
26
Q

What is the importance of power analysis?

A
  • Allows use to determine the sample size required to detect an effect of a given size with a given degree of confidence
    • properly designed study, power expected >80%

Fundamentals of Pharmacology (21 decks)

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