Legal & Ethical Issues- Ch 3 Flashcards
(30 cards)
What does Health Canada assess drug products for before approval for sale?
Safety
Efficacy
Quality
What are the 2 acts of Canadian Drug Legislation?
Canadian Food and Drugs Act
Controlled Drugs and Substances Act
What year was the Canadian Food and Drugs Act created?
1953
-Has been revised since
What is the Canadian Food and Drugs Act?
Control of food, drugs, cosmetics, medical devices etc
Divided into Parts and Schedules
Drug product Database
What is the Drug Product Database?
Information on drugs approved for use in Canada
~15,000 products
What regulations are adjunct to the Food and Drugs Act?
Food and Drugs Regulations 2003
-to Clarify terms, importing, processing
What schedule were Prescription drugs in Food and Drugs regulations 2003?
Were schedule F but are now in the Prescription Drug List (Dec 2013)
What year was the Controlled Drugs and Substances Act created?
1996
What did the CSDA 1996 replace?
1961 Narcotic Control Act
If drugs are not included in the Prescription Drug List (Dec 2013) where are they covered?
CSDA 1996
What is the Controlled Drugs and Substances Act (CSDA 1996)?
Control of certain processes that alter mental processes and have a harm risk
-Substances are divided into Schedules
How can controlled drugs and substances be obtained?
Only by prescription from a licensed practitioner
What factors do the standards for scheduling drugs (CSDA) depend on?
-International standrads
-Dependency potential, risk for abuse and abuse in Canada
-Danger risk to public
-Usefulness of drug
Who developed the National Drug Scheduling Model?
National Association of Pharmacy Regulatory Authorities (NAPRA)
-Follow recommendations of the National Drug Scheduling Advisory Committee (NDSAC)
What does the Committee (NDSAC) determine?
Public access to drugs into 3 schedules plus 1 unscheduled category
What is Schedule I?
Requires prescription
-Controlled Drug and Substances Act
What is Schedule II?
Only at the pharmacy, behind the desk. No prescription required
What is Schedule III?
In pharmacy but self-selection
What are Unscheduled drugs?
Available for sale in any retail outlet
What are the three types of drug names?
Chemical name
Generic Name
Trade name
What is a chemical name?
Based on chemistry
e.g, N-acetyl-para-aminophenol
What is a generic name?
Less complex name assigned by a drug developer
e.g, Acetaminophen
What is a Brand/trade name?
The marketing name
e.g, Tylenol
What is a DIN?
Drug Identification Number assigned after approved for sale
