Module 1.1 Flashcards
(32 cards)
What is a drug?
Chemical agent that produces physiological responses in the body effects may be desirable or undesirable
Therapeutic/adverse effects ?
Desirable/undesirable
Examples of provincial and federal government regulations
Provincial equals territory
Federal equals health Canada RCMP
What does Canada’s food and drug act and regulations regulate?
Regular information manufactures can put on a drug label
Regulates the purity, strength, and quality of drugs
Protect the consumer from contaminated or unsafe, drugs, foods, cosmetic medical devices
Control, drug and substance act
Provide requirements for the control and sale of narcotics control, drugs, and substance of misuse comprised of eight schedules
Schedule 1 for controlled drugs
Most dangerous includes opiates, heroines, morphine, and cocaine
Schedule 2 for controlled drugs
Cannabis and deratives
Schedule 3 for controllled drugs
Dangerous, but not as dangerous as schedule one
meth LSD
Schedule 4 for controlled drugs
Dangerous, but useful for therapeutic effects
Barbiturates benzos
Schedule 5/6 for controlled drugs
Prosecutors to produce and controlled substances
Shit to make meth and LSD
Schedule 7/8 for controlled drugs
These schedules specify, the months of cannibals you can have/grow
Once approved what is a drug assigned?
A din number
Pre-clinical trials
Usually takes 3 to 5 years
Tested on animals to humans
Lab research
Clinical trials phase 1
Healthy volunteers
need informed consent
Test group under 100
Clinical trials, phase 2
Individuals with a particular disorder
Test group 100 to 300
Clinical trials, phase 3
Individuals with a particular disorder, (large group) mixed with placebo
Test group 1000 to 3000
Clinical trials phase 4
Post marketing studies conducted by drug companies what’s the drug is released in Canada
They can recall at this point
New drugs take about how many years to enter the public market?
12yrs
What is Patient medication act ?
Allows the make of a generic drug after 20 years in the time of the discovery of the first molecule, buy another manufacture
Chemical names
When the drug is first being discovered
Example El, 14 0000
Generic names
Not trademarked, universally accepted
Example ibuprofen
Trade name
The company marketing name
Trademarked
Example Advil, Motrin
Schedule system for a drug sold in Canada schedule 1
Potentially harmful, if used without supervision
Largest category
RX
Administered and signature of a healthcare provider is required
Examples, antibiotics and opiates
Schedule system for a drug sold in Canada schedule 2
Available only from a pharmacist must be in an area with no public access
Example gravel