ADR

Question 1

Define ADR

Answer 1

any response to a drug which is noxious, unintended, and which occurs at doses normally (and appropriately) used in man for the prophylaxis, diagnosis, or therapy of disease’

Question 2

Type A ADR classification

Answer 2

Augmented (dose related)
* predictable reaction based on the pharmacology of the drug (often an exaggeration of effect)
* relationship to dose
* common occurrence (about 80% of ADRs)
* usually mild
* high morbidity and low mortality
e.g.
sedation with the use of antihistamines

Question 3

Type B ADR classification

Answer 3

Bizarre (hypersensitivity non-dose related)
* unpredictability
* no relationship to dose
* uncommon occurrence (about 20% of ADRs)
* increased severity
* high morbidity and high mortality
* lack of reproducibility in animal models.

interstitial nephritis with the use of NSAIDs

interstitial nephritis = renal lesion that typically causes a decline in kidney function and is characterized by an inflammatory

Question 4

Type C ADR classification

Answer 4

CHRONIC, dose-related and time-related
occurrence as a consequence of long-term use

Tolerance to alcohol from repeated use, requires larger and larger dose to have effect
OR
Abrupt discontinuation of beta-blockers can lead to a “rebound” effect characterized by tachycardia and hypertension

Question 5

Type D ADR classification

Answer 5

delayed, time-related
appearance of delayed effects.
carcinogenesis (e.g. the association of lymphoma with immunosuppressive drugs

Question 6

Type E ADR classification

Answer 6

end-of-use, withdrawal
uncommon and are related to withdrawal of a drug
Opioid withdrawal

Question 7

Type F ADR classification

Answer 7

Failure unexpected failure of therapy
common and are often caused by a drug interaction (e.g. inadequate dose of the oral contraceptive when a drug that induces the metabolism of oestrogen is administered concomitantly).

Question 8

Factors that contribute to ADR

Answer 8

age, gender, presence of concurrent disease, multiple chronic medical problems, drug class, polypharmacy, renal/hepatic impairment, genetics, history of prior drug reaction, the drug dose, and the duration and frequency of drug use.

Question 9

How to report ADR

Answer 9

Report to TGA
Include pt info, obs
Include med info (5 rights)
Include pt reaction and classification
Include how ADR was managed (if applicable)

Question 10

Australian categorisation system for prescribing medicines in pregnancy

Answer 10

A no effect, taken by many
B1 taken by limited pregnant ppl with no harm, taken by animals with no effect
B2 Taken by limited preg ppl, inadequate animal testing no evidence of harm
B3 limited preg ppl, no effect, limited animals with some effect
C have caused harmful effects in ppl preg, can be reversible
D have caused problems and adverse effects
X HIGH RISK not to be used on pregs