Pharmacology: Connections to Nursing Practice (Video Notes)

70 vocabulary flashcards covering key pharmacology concepts from the notes.

Reference product

The original biologic or drug product; biosimilars may not be substituted for it unless designated interchangeable.

Biosimilar

A biologic product highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency.

Interchangeable product

A biosimilar that may be substituted for the reference product by a pharmacist without prescriber authorization.

Me-too drug

A drug that mimics a well-known drug by a slight modification of its chemical structure.

Orphan drug

A drug or biologic developed to treat rare diseases affecting fewer than 200,000 people in the United States.

Formulary

A list of approved pharmaceutical products and drug recipes used by a health system.

Pharmacopeia

A medical reference summarizing standards of drug purity, strength, and directions for synthesis.

CDER

Center for Drug Evaluation and Research; FDA center responsible for evaluating drugs.

CBER

Center for Biologics Evaluation and Research; FDA center for biologics.

CFSAN

Center for Food Safety and Applied Nutrition; FDA center addressing safety of foods and supplements.

NDA

New Drug Application; FDA submission seeking approval to market a new drug.

Phase 1 trial

Early human trial with 20–80 healthy volunteers to assess safety and dosage.

Phase 2 trial

Trial with 12–350 patients to evaluate effectiveness and continue safety monitoring.

Phase 3 trial

Large-scale trials to assess variability, safety in subgroups, and interactions; hundreds to ~3,000 participants.

Phase 4 (postmarketing surveillance)

Post‑approval monitoring to detect harmful effects in a larger population.

Fast track designation

FDA program to expedite development for unmet needs or significant improvement.

Breakthrough therapy

Designation indicating substantial improvement over existing therapies based on early data.

Accelerated approval

Approval based on surrogate endpoints to speed access; full benefit demonstrated later.

Priority review

FDA process to shorten review time for promising therapies.

Phase 1–4 timeline

Phases describe increasing safety/efficacy data and population diversity across drug development.

Dependence

A powerful physiologic or psychologic need for a substance.

Controlled substances

Drugs regulated under the Comprehensive Drug Abuse Prevention and Control Act due to abuse potential.

First-pass effect

Liver metabolism of oral drugs reducing systemic availability.

Pharmacokinetics

Study of drug movement through the body (ADME: absorption, distribution, metabolism, excretion).

Absorption

Process by which a drug moves from its site of administration into the bloodstream.

Distribution

Movement of a drug through the body after absorption; influenced by blood flow, solubility, storage, and protein binding.

Metabolism

Biotransformation of drugs, usually in the liver, producing metabolites.

Excretion

Elimination of drugs from the body, primarily via the kidneys.

Enteral route

Drug delivery to the GI tract, orally or via NG/G-tubes.

Oral cavity taste masking

Coating bitter drugs with glucose or inert material to mask taste.

Enteric-coated

Tablets designed to dissolve in the small intestine, protecting from stomach acid.

Extended-release (XR, XL)

Formulations designed to dissolve slowly for a longer duration of action.

Chewing/crushing warnings

Certain formulations should not be chewed or crushed to avoid rapid release or toxicity.

Enteric-coated drugs crushed

Crushing enteric-coated forms can inactivate the drug by exposing it to stomach acid.

Oral transmucosal route

Sublingual/buccal administration with rapid onset due to mucosal absorption.

Nasogastric tube

Administration of drugs through a nasogastric tube.

Gastrostomy tube

Administration of drugs via a gastrostomy tube.

Topical route

Medications applied to skin or mucous membranes; includes topical and transdermal delivery.

Transdermal patch

Topical delivery system that provides controlled drug release through the skin.

Parenteral route

Delivery with needles into skin layers, subcutaneous tissue, muscles, or veins.

Intravenous administration

Drugs delivered directly into the bloodstream for immediate distribution.

Intramuscular administration

Drugs injected into large muscles with rapid absorption due to rich blood supply.

Subcutaneous administration

Drugs injected into subcutaneous tissue with slower, prolonged absorption.

Protein binding

Drugs can reversibly bind to plasma proteins (e.g., albumin), affecting distribution and clearance.

Lipid solubility

Solubility in fats; influences absorption, distribution, membranes crossing, and tissue localization.

Receptor

Cellular molecule that a drug binds to in order to produce effects.

Intrinsic activity

Ability of a drug to activate a receptor and produce a response.

Efficacy

Maximum therapeutic effect that a drug can produce.

Potency

Amount of drug needed to achieve a given effect; higher potency means lower required dose.

LD50

Median lethal dose; dose that kills 50% of animals in preclinical testing.

Pharmacogenetics

Study of how genetic differences affect individual drug responses.

Adverse drug event (ADE)

Any undesirable or potentially harmful effect resulting from drug therapy.

Adverse drug effect

Harmful effect of a drug; may overlap with ADEs and ADRs.

Drug allergies

Immune‑mediated hypersensitivity to a drug (6–10% of adverse reactions).

Idiosyncratic reaction

Unusual, unpredictable adverse reaction not related to the drug’s known action.

Immunosuppressants

Drugs that dampen the immune system; can increase cancer risk.

Hormones or hormone antagonists

Agents related to hormones or blocking hormones; may influence cancer risk or therapy.

Bone marrow toxicity

Toxic effects on bone marrow with potential life‑threatening outcomes.

Cardiotoxicity

Toxic effects on cardiac muscle or function from drugs.

Dermatologic toxicity

Drug‑related skin reactions, from allergic to nonimmune etiologies.

Hepatotoxicity

Liver injury caused by drugs; liver metabolism can generate toxic effects.

Nephrotoxicity

Kidney toxicity from drug exposure; kidneys filter most drugs.

Neurotoxicity

Toxic effects on the nervous system or brain.

Skeletal muscle toxicity

Drug‑related damage to skeletal muscle; some drugs affect muscle tissue.

Drug interaction

When one substance alters another drug’s actions; may be additive, synergistic, or antagonistic.

Additive effect

Combined effect equals the sum of the individual drug effects.

Synergistic effect

Combined effect greater than the sum of the individual effects.

Antagonistic effect

One drug reduces or cancels the effect of another.

Black box warning

FDA‑required warning highlighting serious risks or death risk.

Labeling changes

FDA may require updates to a drug’s labeling to reflect safety information.

Recall

Removal of a defective or unsafe drug product from the market.

Market withdrawal

Formal removal of a drug from the market due to safety or quality concerns.