Adverse Drug Reactions Flashcards
1
Q
What is an adverse drug reaction?
A
“A response to a medical product which is noxious and unintended. This can be through normal use of medicine but also as a result of misuse, abuse or medication error”
European Medicines Agency 2012
2
Q
Type A (ADR) Augmented (7)
A
- pharmacologically predictable
- Dose dependant
- relatively frequent
- Discovered pre marketing
- May be managed by dose reduction
- largely preventable
- 80% of all ADR
3
Q
Give 3 examples of Type A ADR
A
- Drowsiness with narcotic analgesics
- GI irritation with NSAIDs
- First dose hypotension with ACE inhibitors
4
Q
Type B (ADR) Bizarre (9)
A
- unpredictable
- independent of dose
- Relatively rare
- discovered post marketing
- drug usually discontinued
- difficult to prevent
- 20 % of all ADR
- may have latent onset
- re challenge dangerous
5
Q
Examples of type B ADR
A
- hypersensitivity reactions
- Aplastic anaemia with chloramphenicol
- Cholestatic hepatitis with chlorpromazine
6
Q
What is the yellow card scheme?
A
- Set up in the 1960s in a response to the thalidomide disaster
- Originally only doctors, dentists and coroners could report but this has gradually changed over the years and now anyone can report (dr, nurse, pt, carer)
7
Q
What should be reported (yellow card scheme)? (3)
A
- Injury does not have to be proven but suspected
- For establish medicines - any serious reactions, even if well known (eg fatal, life threatening, disabling, resulting in a prolonged hospital admission)
- For black triangle products - any suspected reaction, regardless of the seriousness or severity.
(Black triangle symbol for newly licensed drugs for the first 5 years)
8
Q
Some patient groups are more at risk of ADR…..
A
- females
- The elderly
- Those with renal failure
- Genetic factors effecting metabolism
- Those with allergies
- Those with long term health conditions
