Module 1 Flashcards

1
Q

The study of drugs.

A

Pharmacology

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2
Q

Pharmakon means this.

A

Remedy

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3
Q

Logos means this

A

Study (or body of knowledge)

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4
Q

What are the three ways to classify therapeutics?

A

Drugs - traditional drugs (i.e. chemical agents)
Biologics - antibodies, hormones
Natural health products - herbals, vitamins, minerals

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5
Q

What branch oversees pharmacologic agents in Canada?

A

Health Canada Products and Food Branch

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6
Q

What are the different directorates of the Health Canada Products and Food Branch?

A

Therapeutic Products Directorate
Biologics and Genetic Therapies Directorate
Natural Health Products Directorate

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7
Q

Oversees traditional drugs such as pills and capsules.

A

Therapeutic Products Directorate

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8
Q

Oversees antibody and hormone-type therapeutics

A

Biologics and Genetic therapies directorate

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9
Q

What are the different ways in which a drug is named?

A

Trade name
Generic name
Chemical (IUPAC) name

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10
Q

Describes the chemical structure of the molecule. Is used by chemists but not by many others.

A

Chemical name

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11
Q

A unique name that identifies a drug. Most commonly used in pharmacology. It is the name that should be used by HCPs

A

Generic name

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12
Q

The name assigned by a drug company, usually easy to remember and marketable.

A

Trade name

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13
Q

What is the issue with trade names?

A

The problem with trade names is that many companies may make the same drug, therefore it may have different trade names.

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14
Q

Approval of marketed drugs in Canada takes approximately ___ years.
The total cost of a new drug can be as high as ___________$.

A

15

800 000 000$

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15
Q

Approval of marketed drugs in Canada goes through many stages. What are they?

A
Pre-clinical testing and Drug discovery
Clinical trial application
Phase 1 clinical trial
Phase 2 clinical trial
Phase 3 clinical trial
New drug submission (NDS) submitted to Health Canada
Phase IV clinical trial
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16
Q

This step of drug testing/development is done in culture cells, living tissue or experimental animals.
The goal is to evaluate biological effects, pharmacokinetics and toxicity.

A

Preclinical testing/Drug discovery

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17
Q

This must be submitted to Health Canada prior to any human studies.
Details all pre-clinical data.
Health Canada will respond within ___ days of receipt.

A

Clinical trial application

30

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18
Q

Involves testing on 20-100 healthy volunteers.

What is evaluated at this stage?

A

Phase 1 clinical testing

Evaluate pharmacokinetics and pharmacodynamics

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19
Q

Involves testing on 300-500 patients with the target disorder.
What is determined at this stage?

A

Phase II clinical trial

Therapeutic effectiveness, side effects and dosing information is gathered

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20
Q

Involves testing on 500-5000 patients with the disorder.

What is determined?

A

Therapeutic effectiveness is verified, long term side effects are assessed

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21
Q

Report detailing the therapeutic effectiveness and safety of the drug.
It includes results from pre-clinical and clinical trials.

A

New drug submission

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22
Q

If the NDS is approved, what does Health Canada issue?

A

Notice of Compliance (NOC) and a Drug information number (DIN)

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23
Q

What is needed to market a drug?

A

NOC and DIN
Notice of Compliance
Drug information number

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24
Q
Includes PMS (post-market surveillance).
Health Canada monitors the efficacy and safety of the drug after it has been marketed.
A

Phase IV Clinical trial

25
Q

What are the different, major routes of administration?

A

Enteral
Parenteral
Topical/other

26
Q

Route of administration that involves the GI tract.

A

Enteral

27
Q

What are the different enteral routes of administration?

A

Oral

Rectal

28
Q

Route involving drug injection.

A

Parenteral route

29
Q

What are the different parenteral routes?

A

Intravenous
Intramuscular
Subcutaneous

30
Q

Study of what the body does to the drug.

Encompasses four factors, what are they?

A

Pharmacokinetics

ADME - absorption, distribution, metabolism, excretion

31
Q

Most orally administered drugs are absorbed in the ____________, transported by the ________ blood supply to the _______.

A

Small intestine
Portal
Liver

32
Q

Primary site of drug metabolism

A

Liver

33
Q

After reaching the liver, what are the two fates of orally administered drugs?

A

Enter the systemic circulation and are distributed to different organs
Enter the bile duct and get excreted back into the intestine, and leave the body in feces

34
Q

What is the primary site of drug excretion?

A

Kidneys

35
Q

These form a barrier against orally ingested drugs, toxins and nutrients

A

Intestinal villi

36
Q

A - Contains genetic material
B - Metabolizes drugs, carbohydrates and steroids
C - Synthesizes proteins (not ribosomes)
D - Processes and packages proteins and lipids
E - Produces ATP
F - Separates the intracellular and extracellular environments

A
A - nucleus
B - smooth ER
C - Rough ER
D - Golgi apparatus
E - Mitochondria
F - Cell membrane
37
Q

Cellular component which is the major determinant of which drugs are able to enter the cell.

A

Cell membrane

38
Q

What is the lipid bilayer composed of? What are these composed of?

A

Phospholipids - contain Two fatty acids (hydrophobic tails) and a polar head group (phosphate)
Proteins and cholesterol are also embedded

39
Q

What are the different ways in which drugs cross the cell membrane?

A

Direct penetration of the cell membrane
Through ion channels and pores
Specific transport proteins (drug transporters)

40
Q

What is needed for a drug to be able to directly penetrate the cell membrane?

A

The drug MUST be lipophilic

41
Q

Channels and pores in cell membranes are very _____.
Only very small compounds (MW < ____) can pass
Channels are very _______ - meaning only certain compounds can fit through them

A

small
<200 Da
selective

42
Q

What is an example of a drug that passes through ion channels?

A

Lithium

43
Q

Carrier proteins that move drugs from one side of the cell membrane to the other.
What are the two types?

A

Drug transporters
Uptake transporters - from outside the cell to inside
Efflux transporters - from inside the cell to outside

44
Q

Important in protecting cells. Present in the intestine, placenta, kidney and BBB.

A

Efflux transporters

45
Q

Important in mediating intestinal absorption, renal excretion and reaching target sites of action inside cells

A

Uptake transporters

46
Q

What are the different types of drug molecules?

A
Polar molecules
Ions
Quaternary ammonium compounds
Ionizable molecules
Lipophilic molecules
47
Q

Water soluble molecules which have an uneven distribution of electrical charge, but no net charge.

A

Polar molecules

48
Q

Atoms or molecules in which the total number of electrons is not equal to the total number of protons, resulting in a net charge.

A

Ions

49
Q

Have at least one nitrogen atom and have a positive charge AT ALL TIMES

A

Quaternary ammonium compounds

50
Q

Can exist in charged (weak acid or base) or uncharged forms.

A

Ionizable molecules

51
Q

Weak acid - determine whether non-ionized or ionized is the majority in each environment.
Acidic, basic.

A

Acidic - uncharged/unionized

Basic - charged/ionized

52
Q

Weak base - determine whether non-ionized or ionized is the majority in each environment.
Acidic, basic.

A

Acidic - ionized

Basic - unionized

53
Q

Able to pass through cell membranes.

A

Lipophilic molecules

54
Q

Most drugs are weak _____ and thus cross membranes more easily in an ________ medium.

A

bases

alkaline

55
Q

Occurs when there is a difference in pH on different sides of a membrane.

A

Ion trapping

56
Q

In ion trapping, where do drugs accumulate?

A

On the side in which they are ionized.

57
Q

How is ion trapping clinically relevant?

A

Used in treatment of overdoses

58
Q

What are the large gaps in capillaries called? How is lipophilic drug movement different from hydrophilic drug movement in capillaries?

A

Fenestrations
Hydrophilic drugs can only pass through fenestrations (or transporters); lipophilic drugs can pass through the membrane or through fenestrations

59
Q

What is different about capillaries at the BBB?>

A

There are no fenestrations; drugs can only enter through transporters or if lipophilic