ADRs

Question 1

ADR definition

Answer 1

Adverse events/effects that happen within the therapeutic dose range

Question 2

Factors that contribute to an ADR

Answer 2

Genetics
Age - children or elderly
Sex - more common in females
Polypharmacy

Question 3

A

Answer 3

Augmented (dose related)
- related to pharmacological action of drug
- predictable
- higher dose = higher risk
e.g. digoxin toxicity
e.g. serotonin toxicity

Management:
- reduce dose or withhold

Question 4

B

Answer 4

Bizarre (non-dose related)
- unpredictable
- high mortality
not related to pharmacological action of drug
e.g. immunological reactions - penicillin sensitivity

Management:
- withhold and avoid in future

Question 5

C

Answer 5

Chronic (dose and time related)
- uncommon
- related to cumulative dose
e.g. prolonged NSAID use causing peptic ulcers

Management:
- reduce dose or withhold

Question 6

D

Answer 6

Delayed (time-related)
- occurs or becomes apparent some time after use of drug
- can be dose related
e.g. prednisolone causing carcinogenesis

Management:
- often intractable

Question 7

E

Answer 7

End of use (withdrawal)
- uncommon
- occurs soon after withdrawal of drug
e.g. anti-depressant withdrawal

Management:
- reintroduce
- slower tapering

Question 8

F

Answer 8

Failure (unexpected failure of therapy)
- common
- can be dose related
- often caused by drug interactions
e.g. oral contraceptives used in conjunction with anti-epileptics

Management:
- increase dose
- alter medication therapy

Question 9

Role of the TGA

Answer 9

Assesses and regulates therapeutics before they reach the market

Monitors therapeutics after they reach the market

Risk vs benefit analysis

Question 10

How are ADRs reported to the TGA? (process)

Answer 10

Adverse events are reported to the TGA via the adverse event management system. This is then assessed.

Question 11

Pregnancy drug classification

Answer 11

Australian categorisation system - 7 categories
Cat A (can be used) - X (should not be used)