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PAT 201 CH 1-4 Questions and Answers with 100%
VERIFIED Solutions UPDATED!!!
Pharmacotherapy
the application of drugs for the purpose of disease prevention
and treatment of suffering
Therapeutic agents may be classified as
Traditional drugs, biologics, natural health products
Biologics
agents naturally produced in animal cells, by microorganisms,
or by the body itself.
Examples: hormones, monoclonal antibodies, natural blood
products,vaccines, interferon
Natural Health Products (NHP)
variety of products such as herbal medicines, homeopathic
remedies and nutritional supplements.
How many steps are there for the approval of drugs in Canada
8 steps
STEP 1 DRUG APPROVAL PROCESS
Initial drug research is conducted (no trials yet)
Step 2 of drug approval process
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Pre clinical trials- cultured cells, tissues, animals (no human
testing yet)
Step 3 of drug approval process
Once clinical trials (human testing) they proceed 4 phases once
application is approved by Health Canada
Step 3 of Phase 1
SAFETY PHASE: small group of healthy humans
Step 3 of Phase 2
EFFECTIVENESS PHASE: small group of humans with the target
disorder
Step 3 of Phase 3
CONFIRMATION PHASE: larger groups of patients with the
target disorder
Step 3 of Phase 4
MONITORING PHASE: after the drug is approved and in the
market, more information gathered
Step 4 of drug approval process
The pharmaceutical company completes a New Drug
Submission (NDS) to Health Canada. This report details
important safety and efficacy information, including testing
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data, how the drug product will be pronounced and packaged,
expected therapeutic benefits, and adverse reaction
Step 5 of the drug approval process
A committee of drug experts, including medical and drug
scientists, reviews the NDS to identify potential drug benefits
and risks
Step 6 of the drug approval process
Health Canada reviews information about the drug and passes
on details to healthcare provider and consumers
Step 7 of drug approval process
Health Canada issues a Notice of Compliance and Drug
Identification Number. Manufacturer must have these to
market the drug
Step 8 of Drug approval process
Health Canada continues to monitor the drug after marketing
Therapeutic classification
describes what is being treated by the drug
-isn't as complicated
- clearly state what a drug does clinically
(E.g. elevated blood pressure)
example of therapeutic classification
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Antihypertensive, Anticoagulant
pharmacological classification
The way drugs work at molecular, tissue, body system levels
-specific
-what does it do in the body to make that effect?
- addresses a mechanism of action, or HOW a drug produces its
effects in the body
(E.g. diuretic treats hypertension by lowering plasma volume)
example of pharmacologic classification
diruetic, calcium channel blocker, angiotensin-converting
enzyme inhibitor, adrenergic antagonist, SSRI, vasodilator
Organizing drug information by therapeutic classification
Anticoagulants= inhibiting blood clotting
Antihyperlipidemics= lowering blood cholesterol
Antihypertensive= Lowering blood pressure
Antiarrhythmics= Restoring normal cardiac rhythm
Antianginals= Treating angina
Organizing Drug Information by Pharmacological Classification
Diuretic= Lowering plasma volume
Calcium channel blocker= blocking heart calcium levels
PAT 201 CH 1-4 Questions and Answers with 100%
VERIFIED Solutions UPDATED!!!
Pharmacotherapy
the application of drugs for the purpose of disease prevention
and treatment of suffering
Therapeutic agents may be classified as
Traditional drugs, biologics, natural health products
Biologics
agents naturally produced in animal cells, by microorganisms,
or by the body itself.
Examples: hormones, monoclonal antibodies, natural blood
products,vaccines, interferon
Natural Health Products (NHP)
variety of products such as herbal medicines, homeopathic
remedies and nutritional supplements.
How many steps are there for the approval of drugs in Canada
8 steps
STEP 1 DRUG APPROVAL PROCESS
Initial drug research is conducted (no trials yet)
Step 2 of drug approval process
,2|Page
Pre clinical trials- cultured cells, tissues, animals (no human
testing yet)
Step 3 of drug approval process
Once clinical trials (human testing) they proceed 4 phases once
application is approved by Health Canada
Step 3 of Phase 1
SAFETY PHASE: small group of healthy humans
Step 3 of Phase 2
EFFECTIVENESS PHASE: small group of humans with the target
disorder
Step 3 of Phase 3
CONFIRMATION PHASE: larger groups of patients with the
target disorder
Step 3 of Phase 4
MONITORING PHASE: after the drug is approved and in the
market, more information gathered
Step 4 of drug approval process
The pharmaceutical company completes a New Drug
Submission (NDS) to Health Canada. This report details
important safety and efficacy information, including testing
,3|Page
data, how the drug product will be pronounced and packaged,
expected therapeutic benefits, and adverse reaction
Step 5 of the drug approval process
A committee of drug experts, including medical and drug
scientists, reviews the NDS to identify potential drug benefits
and risks
Step 6 of the drug approval process
Health Canada reviews information about the drug and passes
on details to healthcare provider and consumers
Step 7 of drug approval process
Health Canada issues a Notice of Compliance and Drug
Identification Number. Manufacturer must have these to
market the drug
Step 8 of Drug approval process
Health Canada continues to monitor the drug after marketing
Therapeutic classification
describes what is being treated by the drug
-isn't as complicated
- clearly state what a drug does clinically
(E.g. elevated blood pressure)
example of therapeutic classification
, 4|Page
Antihypertensive, Anticoagulant
pharmacological classification
The way drugs work at molecular, tissue, body system levels
-specific
-what does it do in the body to make that effect?
- addresses a mechanism of action, or HOW a drug produces its
effects in the body
(E.g. diuretic treats hypertension by lowering plasma volume)
example of pharmacologic classification
diruetic, calcium channel blocker, angiotensin-converting
enzyme inhibitor, adrenergic antagonist, SSRI, vasodilator
Organizing drug information by therapeutic classification
Anticoagulants= inhibiting blood clotting
Antihyperlipidemics= lowering blood cholesterol
Antihypertensive= Lowering blood pressure
Antiarrhythmics= Restoring normal cardiac rhythm
Antianginals= Treating angina
Organizing Drug Information by Pharmacological Classification
Diuretic= Lowering plasma volume
Calcium channel blocker= blocking heart calcium levels
