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Pharmacology > Legal And Ethical Issues > Flashcards

Legal And Ethical Issues Flashcards

1
Q

Before approval for sale ___ ___ reviews drug products to assess what three things?

A

Health Canada
1. Safety
2. Efficacy
3. Quality

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2
Q

Drug products include

A

-prescription
-nonprescription
-disinfectants/sanitizers

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3
Q

In 1953 what act was created?

A

Canadian Food and Drugs Act

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4
Q

In 1996 what act was created

A

Controlled drugs and substances act

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5
Q

What did the controlled drugs and substances act replace and when?

A

Replaced the: narcotic control act
When: 1961

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6
Q

What was the Food and Drugs act and when was it created?

A

1953
-control of food, drugs, medical devices
-is divided into parts and schedules

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7
Q

In 2003 what act was created?

A

Food and drug regulations
-adjunct to Food and Drugs Act

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8
Q

What is the drug product database in the food and drugs act?

A

Information on drugs approved for use in Canada
-around 15 thousand products

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9
Q

Where was prescription drugs found in the Food and Drugs Act

A

Schedule F (2003)

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10
Q

Where are prescription drugs found now (Dec 2013)

A

In the prescription drug list

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11
Q

What drugs are not included in “prescription drugs” under the Food and Drugs Act

A

Drugs within the Controlled drugs and Substances Act

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12
Q

OTC

A

Non prescription drugs

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13
Q

What is the controlled drugs and substances act?

A

Provides framework for the control of substances that can alter mental processes

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14
Q

How are controlled drugs obtained

A

By prescription from licensed practitioner

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15
Q

Are clinically useful drugs apart of the controlled drugs and substances act included on the prescription drug list?

A

No they are not

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16
Q

controlled drugs and substances act: schedule I to V is defined as

A

Controlled substances

17
Q

controlled drugs and substances act: schedule VI are defined as

A

Precursors
-precursors required to produced controlled substances

18
Q

controlled drugs and substances act: schedule VII and VII are defined as

A

These are actually empty
-previously were cannabis and cannabis resin limits

19
Q

controlled drugs and substances act: schedule IX is defined as

A

Tablet and capsule making devices

20
Q

controlled drugs and substances act: schedule I includes

A

Most dangerous drugs
-opioids (heroin, morphine), cocaine, amphetamines

21
Q

controlled drugs and substances act: schedule II

A

Synthetic cannabinols substances

22
Q

controlled drugs and substances act: schedule III examples

A

LSD

23
Q

controlled drugs and substances act: schedule IV includes

A

Benzodiazepines, barbiturates

24
Q

controlled drugs and substances act: schedule V includes

A

Fentanyl precursors

25
Q

controlled drugs and substances act: schedule VI contains

A

Precursors required to produce controlled substances

26
Q

What are the standards for scheduling of drugs in the controlled drugs and substances act?

A

-international standards
-dependency potential (risk of abuse)
-danger to public
-usefulness

27
Q

What is the national drug schedule

A

National drug scheduling model developed by the national association of pharmacy
-follows recommendations of NDSAC

28
Q

National drug schedule determines public access to drugs into

A

3 schedules and 1 unscheduled category

29
Q

Explain the schedules apart of the national drug schedule

A

S1- requires prescription
S2- only at pharmacy, behind desk, but no prescription required
S3- in pharmacy but self selection
Unscheduled drugs- available for sale in any retail outlet

30
Q

What are the three types of drug names

A

Chemical name, generic name, trade name

31
Q

Chemical name

A

Based on chemistry

32
Q

Generic name

A

Less complex name assigned by drug developer

33
Q

Brand/trade name

A

The marketing name
-Tylenol

34
Q

DIN

A

Drug identification number assigned after approved for sale

35
Q

Regular acetaminophen tablet contains how many mg of acetaminophen molecules

A

325 mg

36
Q

Natural Health Products (NHPs)

A

Vitamins, mineral supplements and herbal products
-considered drugs at level of Food and Drugs Act; Natural Health Products

37
Q

Are NHPs considered Drugs under food and drug regulations

A

No they are not considered drugs

Pharmacology (17 decks)

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