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Pharmacology and Drug Approval Process

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Questions and Answers

What is the primary purpose of the Notice of Compliance and Drug Identification Number (DIN)?

To ensure drugs are marketed

To track drug prices

To approve drugs without restrictions

To assign a unique identification to drugs (correct)

Drugs in Canada can be used in special circumstances via a program called the Special Access Program.

True

What are the three types of drug names?

Chemical, Generic, Brand

A drug that lowers high blood pressure is known as an __________ drug.

antihypertensive Signup and view all the answers

Which drug schedule requires a prescription from a doctor, nurse, or NP?

Schedule 1 Signup and view all the answers

Match the following drug schedules with their descriptions:

Schedule 1 = Requires prescription for use Schedule 2 = Available only through a pharmacist Schedule 3 = Over the counter drugs Unscheduled = Can be sold anywhere without supervision Signup and view all the answers

The Declaration of Helsinki states that medications in clinical trials must always be compared to a placebo.

False Signup and view all the answers

What is the primary aim of pharmacotherapeutics?

To treat, manage, or alleviate patients' conditions Signup and view all the answers

Pharmacotherapeutics can involve using both synthetic and natural substances.

True Signup and view all the answers

What is an example of a biologic substance mentioned in the content?

Insulin Signup and view all the answers

The three main categories of pharmacotherapeutics are drug medications, biologics, and ________ health products.

natural Signup and view all the answers

Match the following categories with their examples:

Drug medication = Ibuprofen Biologic = Insulin Natural health product = Echinacea Signup and view all the answers

Which of the following statements is true regarding the approval process of drugs?

Drugs undergo multiple phases of clinical trials before approval. Signup and view all the answers

Natural health products are easier to regulate than drugs and biologics.

False Signup and view all the answers

What is a common challenge associated with natural health products?

Inconsistent effectiveness Signup and view all the answers

Study Notes

Pharmacology

Pharmacology is the study of medicines ("pharmacon" = drug/medicine, "logos" = to study).
Used to treat, improve quality of life, and alleviate symptoms.
Focus on treating the underlying cause of symptoms rather than just the symptoms.
Before the 20th century, remedies often came from nature.
Modern medicine often uses artificially replicated active ingredients from natural sources.
Pharmacotherapeutics is the use of drugs to achieve a therapeutic effect.
Nurses play a crucial role in pharmacotherapeutics, managing drug administration, monitoring patient responses, and handling drug interactions.
Three main categories of pharmacotherapeutics:
Drugs/Medications (synthetically produced, ex: ibuprofen)
Biologics (naturally produced in humans, animals, or microorganisms, ex: antibodies, hormones like insulin)
Natural health products (from natural sources, ex: vitamins, minerals, dietary supplements).

Drug Approval Process

Drug development has stringent approval processes involving numerous phases of testing.
Preclinical trials are performed on non-human subjects.
Phases 1, 2, and 3 involve trials on a growing number of human volunteers—healthy first, then people with the condition.
The process culminates in the submission of a New Drug Submission (NDS) to Health Canada for review and approval.
A drug identification number (DIN) is assigned.
Drugs may be available through a special access program in certain situations while awaiting full approval.

Drug Names

Drugs have three types of names:
Chemical names (describe the drug's molecular structure).
Generic names (universally recognized).
Brand/trade names (specific to a particular manufacturer/company).

Drug Classes and Schedules

Drugs are classified into various categories based on their therapeutic effects or mechanisms of action.
Drug classes are often grouped according to their intended use or target effect. Example classes: Antihypertensives, Antiinflammatories
Four main drug schedules:
Schedule 1: Prescription-only use (e.g., medicinal cannabis)
Schedule 2: Pharmacist dispenses (e.g., Tylenol with codeine)
Schedule 3: Over-the-counter drugs (OTC)
Unscheduled: sold without restrictions (e.g., non-medicinal cannabis).

Placebos

Placebos are substances with no medicinal properties, but believed to have effects by the user.

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Description

Explore the fundamentals of pharmacology, focusing on the study of medicines, drug administration, and the role of nurses in pharmacotherapeutics. Additionally, uncover the essential steps in the drug approval process, highlighting the categories of pharmacotherapeutics including medications, biologics, and natural health products.