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HLSC 220 Pharmacotherapeutics for Health Professionals 💊 > Legal & Ethical Issues- Ch 3 > Flashcards

Legal & Ethical Issues- Ch 3 Flashcards

1
Q

What does Health Canada assess drug products for before approval for sale?

A

Safety
Efficacy
Quality

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2
Q

What are the 2 acts of Canadian Drug Legislation?

A

Canadian Food and Drugs Act
Controlled Drugs and Substances Act

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3
Q

What year was the Canadian Food and Drugs Act created?

A

1953
-Has been revised since

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4
Q

What is the Canadian Food and Drugs Act?

A

Control of food, drugs, cosmetics, medical devices etc
Divided into Parts and Schedules
Drug product Database

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5
Q

What is the Drug Product Database?

A

Information on drugs approved for use in Canada
~15,000 products

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6
Q

What regulations are adjunct to the Food and Drugs Act?

A

Food and Drugs Regulations 2003
-to Clarify terms, importing, processing

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7
Q

What schedule were Prescription drugs in Food and Drugs regulations 2003?

A

Were schedule F but are now in the Prescription Drug List (Dec 2013)

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8
Q

What year was the Controlled Drugs and Substances Act created?

A

1996

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9
Q

What did the CSDA 1996 replace?

A

1961 Narcotic Control Act

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10
Q

If drugs are not included in the Prescription Drug List (Dec 2013) where are they covered?

A

CSDA 1996

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11
Q

What is the Controlled Drugs and Substances Act (CSDA 1996)?

A

Control of certain processes that alter mental processes and have a harm risk
-Substances are divided into Schedules

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12
Q

How can controlled drugs and substances be obtained?

A

Only by prescription from a licensed practitioner

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13
Q

What factors do the standards for scheduling drugs (CSDA) depend on?

A

-International standrads
-Dependency potential, risk for abuse and abuse in Canada
-Danger risk to public
-Usefulness of drug

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14
Q

Who developed the National Drug Scheduling Model?

A

National Association of Pharmacy Regulatory Authorities (NAPRA)
-Follow recommendations of the National Drug Scheduling Advisory Committee (NDSAC)

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15
Q

What does the Committee (NDSAC) determine?

A

Public access to drugs into 3 schedules plus 1 unscheduled category

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16
Q

What is Schedule I?

A

Requires prescription
-Controlled Drug and Substances Act

17
Q

What is Schedule II?

A

Only at the pharmacy, behind the desk. No prescription required

18
Q

What is Schedule III?

A

In pharmacy but self-selection

19
Q

What are Unscheduled drugs?

A

Available for sale in any retail outlet

20
Q

What are the three types of drug names?

A

Chemical name
Generic Name
Trade name

21
Q

What is a chemical name?

A

Based on chemistry
e.g, N-acetyl-para-aminophenol

22
Q

What is a generic name?

A

Less complex name assigned by a drug developer
e.g, Acetaminophen

23
Q

What is a Brand/trade name?

A

The marketing name
e.g, Tylenol

24
Q

What is a DIN?

A

Drug Identification Number assigned after approved for sale

25
Q

How many mg of acetaminophen molecules are in 1 regular Acetaminophen tablet?

A

325 mg

26
Q

What are the Nursing Values and Ethical Responsibilities described in the CNA code of ethics?

A
  • Promoting safe, compassionate, competent and
    ethical care
  • Promoting health and well-being
  • Promoting and respecting informed decision-
    making
  • Honouring dignity
  • Maintaining privacy and confidentiality
  • Promoting justice
  • Being accountable
27
Q

What are some ethnocultural considerations?

A

Assess the influence of a patient’s cultural beliefs, values and customs
-Environmental e.g diet and nutrition
-Ethnocultual and genetic (inherited) factors

28
Q

What is assessed via ethnocultural assessment?

A
  • Health beliefs and practices
  • Past uses of medicine
  • Folk remedies – eating mud; milk poultice
  • Home remedies- vinegar on wounds
  • Use of nonprescription drugs and natural health
    remedies
  • Responsiveness to medical treatment
  • Religious practices and beliefs
  • Dietary habits
29
Q

Under the Food and Drugs Act are natural health products (NHPs) legislated?

A

Yes but not as drugs and more accessible
-Less regulated

30
Q

Examples of NHPs?

A

Vitamin and mineral supplements
Herbal products

HLSC 220 Pharmacotherapeutics for Health Professionals 💊 (15 decks)

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