detection
Last reviewed 01/2018
Detection of adverse drug reactions is very difficult. For example, a premarket trial of 3000 patients will, with a poisson distribution, detect 1 adverse effect if there is an incidence of 1 in 1000, assuming no background incidence. The higher the background incidence with a rare adverse effect, the harder the adverse effect is to detect.
Surveillance and detection is by:
- anecdotes - unorganised
- voluntary reporting - organised. Yellow cards in the BNF
- others: - intensive event recording - prospective - cohort - studies - case-control studies - population statistics - record linkage