Legal and Ethical Issues Flashcards
Before approval for sale, Health Canada reviews drug products to assess:
safety, efficacy and quality
What year was the Canadian Food and Drugs Act enacted
1953
what year was the controlled drug and substances act enacted
1997
the CSDA replaced the?
1961 Narcotic control act
what year was the food and drug regulations enacted
2003
most dangerous drugs including heroin, cocaine and morphine
Schedule I
Cannabis and its derivatives
Schedule 2
Amphetamines and LSD
Schedule 3
Benzodiazepines, barbituates, considered harmful but have therapeutic uses
schedule IV
precursors required to produce controlled substances
Schedule VI
specifies amounts of cannabis and cannabis resin to charge and sentence
Schedules VII and VIII
Schedule IX
regulates devices to make tablets and capsules
is the national drug schedule part of legislation?
No
National Drug schedule I
requires prescription
National drug schedule II
only at pharmacy, behind desk. No prescription required
National drug schedule III
In pharmacy, but self-selection
National drug schedule: unscheduled drugs
available for sale at any retail outlet
Brand name is also called the?
proprietary name
problems with brand names and generic names?
- people can overdose thinking they are 2 different things.
- Products with the same trade name could also have different active ingredients.
- Drugs can be reformulated without changing the brand name
Phase I clinical trials
use healthy volunteers. Tests metabolism, pharmacokinetics and biologic effects
Phase II clinical trials
Uses patients. Tests therapeuticlity and dosagerange
Phase III clinical trails
Uses patients. Tests safety and effectiveness.
phase IV clinical trials
postmarketing surveillance
Drug polymorphism
effect of clients age, sex, and body composition on their ability to absorb and metabolize a drug
