Week 6 Flashcards
what is FDA?
Food and drug act
what is CDSA?
Controlled drugs and substances act
which acts are regulated by the Therapeutic Products Directorate (TPD).
FDA and CDSA
What is TPD?
Therapeutic Products Directorate
Most legislation concerning medication is covered by which act?
FDA
What are scheduled drugs?
Controlled (scheduled) drugs, are ones whose use and distribution are tightly controlled because of their abuse potential or risk
how are drugs which are covered by the CDSA available?
through prescription or not legally allowed in Canada
What is done in Preclinical investigations?
in vitro and animal studies
how many Clinical Phases of investigation are there?
4
what is a Placebo?
Substance that looks like the drug being investigated
Define Double-blind study
neither the subject nor the investigator knows who gets the placebo and who gets the drug
why are blind studies good?
Decreases likelihood of researcher bias
which phases are “pre-market” investigations?
1-3 phases
If approved by Health Canada, the manufacturer will hold a patent for how many years?
8-10 years
What are the 10 rights of medications?
The right client
The right medication
The right dose
The right route
The right site
The right frequency
The right reason
The right time
The right pre-assessment
The right follow up and documentation
