Pharmacology and Drug Approval Process

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.

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.