Adverse drug reactions Flashcards
1
Q
What is adverse drug reactions
A
Any response to a drug
that is noxious and unintended
and which occurs at doses normally used in man for prophylaxis,
diagnosis or therapy of disease, or for the modification of physiological
function
2
Q
Effects of ADR
A
Results in death, or is
• life threatening, or requires
• in-patient hospitalisation, or
• prolongation of existing hospitalisation, or
• persistent or significant disability or incapacity, or a
• congenital anomaly/birth defect.
3
Q
Type A ADRs
A
Augmented • Dose related • Predictable • Usually dose dependent-reduce dose • High morbidity, low mortality
4
Q
Type B ADRs
A
Bizarre • Rarely dose dependent • Unpredictable • Responds to drug withdrawal • Low morbidity, high mortality
5
Q
What are black triangle drugs
A
New Drugs- with relatively limited safety information about their safety from clinical
trials.
6
Q
Why is there an asterisk next to the
Black Triangle
A
Some established products may have the Black Triangle
symbol reinstated
