Legal and Ethical Issues Flashcards

1
Q

Before approval for sale, Health Canada reviews drug products to assess:

A

safety, efficacy and quality

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2
Q

What year was the Canadian Food and Drugs Act enacted

A

1953

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3
Q

what year was the controlled drug and substances act enacted

A

1997

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4
Q

the CSDA replaced the?

A

1961 Narcotic control act

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5
Q

what year was the food and drug regulations enacted

A

2003

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6
Q

most dangerous drugs including heroin, cocaine and morphine

A

Schedule I

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7
Q

Cannabis and its derivatives

A

Schedule 2

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8
Q

Amphetamines and LSD

A

Schedule 3

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9
Q

Benzodiazepines, barbituates, considered harmful but have therapeutic uses

A

schedule IV

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10
Q

precursors required to produce controlled substances

A

Schedule VI

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11
Q

specifies amounts of cannabis and cannabis resin to charge and sentence

A

Schedules VII and VIII

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12
Q

Schedule IX

A

regulates devices to make tablets and capsules

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13
Q

is the national drug schedule part of legislation?

A

No

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14
Q

National Drug schedule I

A

requires prescription

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15
Q

National drug schedule II

A

only at pharmacy, behind desk. No prescription required

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16
Q

National drug schedule III

A

In pharmacy, but self-selection

17
Q

National drug schedule: unscheduled drugs

A

available for sale at any retail outlet

18
Q

Brand name is also called the?

A

proprietary name

19
Q

problems with brand names and generic names?

A
  1. people can overdose thinking they are 2 different things.
  2. Products with the same trade name could also have different active ingredients.
  3. Drugs can be reformulated without changing the brand name
20
Q

Phase I clinical trials

A

use healthy volunteers. Tests metabolism, pharmacokinetics and biologic effects

21
Q

Phase II clinical trials

A

Uses patients. Tests therapeuticlity and dosagerange

22
Q

Phase III clinical trails

A

Uses patients. Tests safety and effectiveness.

23
Q

phase IV clinical trials

A

postmarketing surveillance

24
Q

Drug polymorphism

A

effect of clients age, sex, and body composition on their ability to absorb and metabolize a drug