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WHO definition:
Pharmaco = medicine
Vigilare = to watch
– alert watchfulness
– forbearance of sleep; wakefulness
– watchfulness in respect of danger; care; caution;
circumspection
– the process of paying close and continuous attention
Reason 1:
Humanitarian concern –
– Insufficient evidence of safety from clinical trials
– Animal experiments
– Phase 1 – 3 studies prior to marketing authorization
n
recommendations
io
trat
Preclinical
is
Phase IV Spontaneous
Animal Phase I Phase II Phase III
Reg
Experiments Post-approval Reporting
Thalidomide Phocomelia
1965
Practolol 1975 Sclerosing peritonitis
Reason 2
US:
Reason 4:
Dr A. Wh o 31 December 2000
Toxicity
Failure
Non-adherence
Other
Continued
Gu ardi an W eekl y
March 18- 24 2004
Reason 6: Ethics
To know of something that is harmful to another person
who does not know, and not telling, is unethical