Legal + Ethical Issues Flashcards
(34 cards)
What is a drug
Any substance or mixture of substances
What are drugs used for
- Diagnosis, treatment, mitigation, or prevention
- Restoring, converting, or modifying organic functions
- Disinfection when dealing with food
What does health Canada review/assess for drug products
- Safety
- Efficacy
3.Quality
Drug products include
- Prescription and non-prescription pharmaceuticals
- Disinfectants and Sanitizers with disinfectant claims
Canadian Drug Legislations
- Canadian food + drug act
- Controlled drugs + substances act (CDSA)
1953: Canadian food and drug act
- Food, drugs, cosmetics, medical devices
- Divided into parts and schedules
2003: Food + drug regulations
- clarifies terms, importing, and processing in the Canadian food and drug act
- 15 000 products
2013: Prescriptions drug list
- List of all prescription drugs
- excludes those in the controlled substances act
1996: Controlled drugs and substances act (CDSA) replace
Replaces 1961 narcotics control act
How are drugs ordered in the controlled drugs and substances act
schedules I-V
What does the controlled drugs and substances act do
provides legislation and regulatory framework for the control of substances that alter mental processes
What are the standards for scheduling in the controlled drugs and substances act
- International standards
- Dependency potential, risk for abuse, and abuse in Canada
- Danger to public
- Usefulness of the drug
Drugs that alter mental processes cause risk
of harm to individuals or society when diverted or misused
Key points of the CDSA
- Alter mental processes
- Harm Risk
- Divided into schedules
- Only obtained by prescription by licensed practitioner
Who developed the national drug schedule
National Association of Pharmacy Regulatory Authorities (NAPRA)
What recommendations does the national drug schedule follow
National Drug Scheduling Advisory Committee (NDSAC)
What does the National Drug Advisory Committee determine
public access to drugs by 3 schedules and 1 unscheduled category
Schedule 1
Requires Prescription
Schedule 2
Only at pharmacy, behind desk, non-perscription
Schedule 3
Pharmacy, self selection
Unscheduled
Available in any retail center
How are drugs named
- Chemical Name
- Generic Name
- Brand/Trade name
- DIN
Chemical Name
based on chemical structure of drug
-N-acetyl-para-aminophenol
Generic Name
Less complex, assigned by drug developer
-Acetaminophen