Unit 1 Pharmacology PP

Flashcards covering key pharmacology concepts: definitions, drug development and regulation, pharmacokinetics/dynamics, routes/mechanisms, adverse effects, nursing process, dosage calculations, OTC/herbal therapies, and patient safety.

What is pharmacology?

The study of the biological effects of chemicals (drugs) introduced into the body to cause a change.

What is pharmacotherapeutics (clinical pharmacology)?

The use of drugs to treat, prevent, and diagnose disease

What is pharmacodynamics?

The study of the interactions between the chemical components of living systems and foreign chemicals that enter those systems, including effects on cell functioning.

What is pharmacokinetics?

The study of absorption, distribution, metabolism (biotransformation), and excretion of drugs.

What does dynamic equilibrium refer to in pharmacology?

The actual amount of drug that reaches the body results from a balance of absorption, distribution, metabolism, and excretion.

What are the major stages of drug development and approval in the U.S.?

Preclinical trials (animals), Phase I (healthy volunteers), Phase II (patients with disease), Phase III (larger patient populations), FDA approval, Phase IV (post-marketing surveillance).

What is therapeutic response?

The beneficial or desired effect of a drug.

What is an adverse drug reaction?

Undesirable or potentially dangerous negative effects of a drug.

What is an allergic response to a drug?

An immune-mediated adverse reaction to a drug (drug allergy).

What are nursing responsibilities in drug therapy?

Administration of drugs, assessing drug effects, interventions to ensure tolerability, patient teaching, and monitoring to prevent medication errors.

Name the steps of the nursing process as it relates to drug therapy. (ADPIE)

Assessment, Diagnosis, Planning, Implementation, Evaluation.

How can nurses and patients help prevent medication errors?

By following safety checks and the rights of medication administration, involving prescribers, pharmacists, nurses, and patients in a safety process.

What are the eight rights of medication administration?

Right patient

Right drug

Right storage

Right route

Right dose

Right preparation

Right time

Right recording

What measuring systems are used in dosage calculations?

Metric system, Apothecary system, Household system (also Avoirdupois and units).

What are the four main sources of drugs?

Natural sources: 1) plants, 2) animals, 3) inorganic compounds

Synthetic sources: 4) chemically produced; includes drugs from genetic engineering

What is the FDA drug evaluation sequence?

Preclinical testing, Phase I-III trials, FDA approval, Phase IV post-marketing surveillance.

What is the difference between brand-name and generic drugs?

Brand-name drugs are patented

Generics are produced after patent expiry and are bioequivalent, though they may have different bioavailability within accepted margins.

What is bioavailability?

The degree to which a drug becomes available to the target tissue after administration.

What is off-label use?

The use of a drug for an indication not approved by the FDA.

What is the difference between a scheduled and non-scheduled drug under the Controlled Substances Act?

Schedules categorize drugs by abuse potential and medical use; higher schedules have stricter controls (DEA enforcement).

What are the main federal regulations that govern drugs? (6)

Pure Food and Drug Act (1906)

Federal Food, Drug, and Cosmetic Act (1938)

Durham-Humphrey Amendment (1951)

Kefauver-Harris Act (1962)

Controlled Substances Act (1970)

Orphan Drug Act (1983).

What did the Kefauver-Harris Act require?

Efficacy as well as safety of drugs had to be established before market approval.

What is the purpose of the Controlled Substances Act (1970)?

Regulate scheduling, distribution, storage, and use of controlled drugs; enforcement by the DEA.

What is a loading dose?

A higher initial dose used to reach the drug’s therapeutic (critical) concentration more quickly.

What is the critical concentration?

The amount of drug needed to produce a therapeutic effect.

What is the role of the liver in pharmacokinetics?

The primary site of biotransformation (metabolism); includes the first-pass effect and cytochrome P450 system.

What is the primary organ for drug excretion?

The kidneys, though drugs can also be excreted via skin, saliva, lungs, bile, and feces.

What factors influence drug absorption?

Route of administration, perfusion to the site, fat content of tissue, temperature, pH of the environment, time in the stomach, presence of food or other drugs.

What factors influence drug distribution?

Lipid solubility, tissue perfusion, cell membrane permeability, and plasma protein binding (blood-brain barrier; placenta and breast milk).

What is the blood–brain barrier and its significance?

A selective barrier that requires lipid-solubility for drugs to pass into the CNS.

What is the first-pass effect?

Metabolism of a drug in the liver before it reaches systemic circulation, reducing bioavailability.

What is selective toxicity?

A drug’s ability to attack a specific enzyme system or process unique to foreign cells, minimizing damage to healthy cells.

What are primary and secondary drug actions?

Primary actions are extensions of the therapeutic effect (overdose

Secondary actions are undesired effects in addition to the pharmacologic effect.

What are the four types of drug allergies (hypersensitivity) and a brief example?

Type I immediate hypersensitivity (anaphylaxis)

Type II antibody-mediated cytotoxic

Type III immune complex–mediated (serum sickness)

Type IV cell-mediated (delayed).

What are interventions for a Type I hypersensitivity reaction?

Withdraw the allergen; administer epinephrine; maintain airway and blood pressure; in less severe cases, antihistamines; prevention includes Medic-Alert and emergency epinephrine kit as appropriate.

What are the basic components of the nursing process for patient safety? (ADPIE)

Assessment, Diagnosis, Planning, Implementation, Evaluation; apply holistic, patient-centered care and integrate basic sciences, social sciences, and education.

What are common adverse effects associated with toxicity on organ systems?

Hepatotoxicity (liver injury), nephrotoxicity (renal injury), and other systemic toxicities.

Why is OTC drug safety a concern?

OTC drugs can mask underlying diseases, interact with prescription medications, and lead to overdoses if not used as directed.

What are herbal medicines in the context of regulation?

Herbal medicines are often considered dietary supplements, not FDA-regulated drugs, leading to less oversight and potential drug interactions.

What is the role of medication error reporting programs (ISMP MedWatch, etc.)?

To report and analyze medication errors at national and institutional levels to prevent recurrence.

Natural sources used to make drugs: (3)

Plants

Animals

Inorganic compounds

Synthetic sources used to make drugs: (1)

Chemically produced; includes drugs from genetic engineering