Adverse Drug Reactions Flashcards

1
Q

Define: Adverse Drug Reactions

A

A response to a drug which is noxious and unintended, and which occurs at doses normally use in man for prophylaxis, diagnosis or therapy of disease

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2
Q

What are the 4 classes of ADRs?

A

Augmented (Type A)

Bizarre (Type B)

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3
Q

Explain: Type A reactions

A

Augmented Reactions

  • caused by an excess of the drugs wanted pharmacological effect
  • Usually when drug has a narrow therapeutic index
  • Dose related ADRs usually caused altered pharmacokinetics
  • mortality is low, morbidity is high
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4
Q

Examples of Type A ADRs?

A
Laxatives - diarrhoea
Opiate analgesics - constipations
Diuretics - incontinence
Potassium supplement - hyperkalaemia
Insulin - hypoglycaemia
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5
Q

Why do Type A ADRs affect children/elderly and renal/hepatic disease patients more?

A

multiple factors, but because of the different pharmacokinetics (drugs absorption/excretion)

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6
Q

Explain: Type B reactions?

A

Bizarre reaction

relatively rare, and not dose related (e.g. allergy, idiosyncratic reactions, genetically determined effects, not predictable)

Allergic reactions (hypersensitivity)
do not resemble pharmacological actions
reactions occurs on re-exposure to even small amount of drug

Severe reaction includes: anaphylaxis

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7
Q

Example of Type B reactions?

A
  • Carbimazole - Agranulocytosis
  • Paroxetine - Hepatitis
  • Statins - myostis, myalgia, myopathy, rhabdo
  • ACE inhibitors - Angioedema
  • Penicillin - Rash
  • SJS Syndrome
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8
Q

Example of Type C reaction?

A

Chronic or long-term effects

  • osteoporosis with steroids and PPIs
  • Thyroid dysfunction with amiodarone
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9
Q

Example of Type D reaction?

A

Delayed

  • delayed skin reactions in the week following the procedure not uncommon
  • flu-like illness can develop
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10
Q

Explain: Type E Reaction

A

End of dose

  • withdrawal effects after long-term treatment
  • rebound responses
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11
Q

Example of Type E reaction?

A

e.g. Beta Blockers, nasal sprays, PPIs

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12
Q

Example of Pharmacodynamic ADR

A

Asthmatic pt

  • needs B agonist to relax airways
  • if given a b blocker, may suffer severe asthma attack.

Parkinsons Pt

  • needs something for N&V
  • given metaclopramide, suffered worse extra-pyramidal s/e because metoclopramide affects dopamine receptors in the brain
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13
Q

What/where are the classification of ADR in the BNF

A

page 12-15 - ADRs

  • Very common =>1 in 10
  • Common = 1 in 100 to 1 in 10
  • Uncommon = 1 in 1000 to 1 in 100
  • Rare = 1 in 10000 to 1 in 1000
  • Very rare = less than 10000`
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14
Q

What is a Serious Reaction?

A
Fatal
Life threatening
Disabling or incapacitating
Result in prolonged hospitalisation
Congenital abnormalities OR 
Medically significant
  - may not be life threatening but for pt it is extreme, e.g. headache

CHECK YELLOW CARD AT BACK OF BNF

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15
Q

What ADR can be caused by: NSAIDs

A

Dyspepsia

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16
Q

What adverse effects do Antipsychotics cause?

A

Extra-pyramidal (motor control and co-ordination)

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17
Q

WHat ADR do Iron Preps cause?

A

Nausea & Vomiting

18
Q

What ADRs do ABx cause?

A

Rash/Allergy

19
Q

What ADRs do Calcium Channel Blockers cause?

A

Oedema

20
Q

What ADRs do opiate analgesics cause?

A

Constipation

21
Q

What ADRs do diuretics cause?

A

Hypokalaemia

22
Q

What ADRs do ACEi cause?

A

Cough

23
Q

What ADRs do Cephlasporins cause?

A

Pseudomembranous colitis

24
Q

Which groups are at high risk of ADRs?

A
  • very young and >70
  • females > men
  • End stage organ failure (renal/hepatic)
  • polypharmacy
  • multiple disease states
25
Q

High risk drugs for ADRs?

A

Drug classes:

  • NSAIDs
  • Anticoags (bleeding)
  • Abx (used a lot)
  • Digoxin (narrow therapeutic index)
  • Diuretics (used in old)
  • hypoglycaemic agents
  • antiepileptics (valproate)
26
Q

Adverse effects of NSAIDs?

A
  • most common group (responsible for 60-70% of all ADRs admitted/occuring in hospital)
  • irritant to GI tract
  • skin reactions common
  • caution in asthmatic, may worsen
  • caution in hepatic/cardiac/renal pts
  • high mortality risk
27
Q

How to reduce risk of ADRs?

A

Always take detailed drug Hx
Only use drugs where clearly indicated
Stop drugs that arent needed
Check dose and response, particularly in young/old, those with renal/hepatic or cardiac disease

28
Q

How many volunteers/pts involved before a new medicine can be licensed?

A

2000-3000

29
Q

What to report through yellow card?

A

Any serious ADRs

Any ADRs for a black triangle drug (CSM)

30
Q

What is the significance of a black triangle drug

A

Sometimes a new drug, sometimes something theyre keeping an eye on

31
Q

What do cytochrome P450 Inducers do?

Examples:
CRAPS out drugs

A

Reduce the conc of drugs metabolised by the cytocrome P450 system

Carbamazepine
Rifampicin
bArbituates
Phenytoin
St Johns Wort
32
Q

What do Cytochrome P450 inhibitors do?

Examples:
Some Certain Silly Compounds Annoyingly Inhibit Enzymes, Grrr

A

Inc conc of the drug metabolised by the cytochrome p450 system

Sodium valproate
Ciprofloxacin
Sulphonamide
Cimetidine/omeprazole
Antifungals, amio
Isoniazid
Erythromycin/clarithromycin
Grapefruit juice
33
Q

Examples of drugs which interact with enzyme inhibitor/inducers?
(7 points)

A
Warfarin
COCP
Theophylline
Corticosteroids
Tricyclics
Corticosteroids
Pethidine
Statins
34
Q

Interaction between:

Metformin and cimetidine?

A

inhibits renal elimination

35
Q

Interaction between:

Gentamycin and Loop diuretics?

A

Renal failure risk

36
Q

Interaction between:

ACEi & K+ sparing diuretics

A

Risk of hyperkalaemia

37
Q

Interaction between:

ACEi and metformin

A

enhance hypoglycaemic effect

38
Q

Interaction between:

statin & amiodarones

A

inc statin conc and therefore risk of rhabdo

39
Q

Interaction between:

thiazide & PPI

A

Hyponatraemia

40
Q

Interaction between:

thiazide and lithium

A

inc toxicity

41
Q

Drugs with narrow therapeutic range that may have many interactions? (need looking up)

Guys With Large Dongles Totallly Make Perfect Internet Connections

A
Gentamycin
Warfarin
Lithium
Digoxin
Theophylline
Methotrexate
Phenytoin
Insulin
Ciclosporin