Nursing - Pharmacology Unit 1

Postmarketing studies

Adverse reaction reporting. Surveys/sampling/testing. Inspections.

A patient has a malignant brain tumor, what pharmacokinetic phase may be affected by the presence of a tumor?

Distribution phase

Instillations and Irrigations

Drugs applied into body cavities or orifices. These routes may include the eyes, ears, nose, urinary bladder, rectum and vagina.

PO

by mouth

Pharmacoeconomics

deals with decision making relative to proper drug choices

pharmacogenomics

deals with the influence of genetic variation on drug response in patients by correlating gene expression or actual variants of the human genome.

Dissolution

determines how quickly the drug disintegrates and disperses into simpler forms.

Childhood Vaccine Act

(1986) authorized the FDA to acquire information about patients taking vaccines.

Boxed Warnings

(1997) warnings for drugs with "special problems"

Phases of Approval for Therapeutic/Biological Drugs

1. Preclinical investigation. 2. Clinical investigation. 3. Review of the New Drug Application (NDA). 4. Postmarketing surveillance.

Outcomes that are focused on for production related decisions/therapy

1. benefit in dollars. 2. effectiveness in health improvement. 3. Minimization in terms of the same benefit provided to together in a similar group. 4. improved utility

The kidneys filter on average --

180 L of blood a day

Food and Drug Administration (FDA) (1988)

Agency of the U.S. Department of Health and Human Services. Regulates food and drugs.

The provider has ordered atropine, a drug that will prevent the patient's own chemical, acetylcholine from causing parasympathetic effects. What type of drug would atropine be considered?

An antagonist

Dietary Supplement Health and Education Act (1994)

An attempt to control misleading industry claims.

Blocks Hormonal Activity

Angiotensin-converting enzyme inhibitor

Treat Angina

Antianginal

Influence Blood Clotting

Anticoagulant

Restore Normal Cardiac Rhythm

Antidysrhythmic

Lower Blood Cholesterol

Antihyperlipidemic

Lower Blood Pressure

Antihypertensive

NDA Review

Averages 24 months. Requires NDA Submission and NDA approval. Clinical Phase III trials and further animal testing.

Clinical Investigation

Averages 5 years. Crucial process in approval process.

Calcium Channel blocker

Blocks heart calcium channels

Adrenergic Antagonist

Blocks physiological reactions to stress

Controls whether prescription drugs and OTC drugs may be used for therapy

Center for Drugs Evaluation and Research (CDER)

Schedule V Drug Examples

Cough medications that have not more than 200 milligrams of codeine per 100 mL.

The patient requires a drug that is known to be completely metabolized by the first-pass effect. What change will be needed when this drug is administered?

Drug must be given by a nonoral route such as parenterally

Over the counter drugs

Drugs that do not require a prescription

household system

English measurements (cups, pints, quarts)

National Center for Complementary and Alternative Medicine (NCCAM)

Federal Government's lead agency for scientific research and information about CAM therapies.

Food, Drugs, and Cosmetic Act (1938)

First law preventing the sale of drugs that had not been thoroughly tested before marketing.

Pure Food and Drug Act (1906)

Gave government power to control the labeling of medicines.

Schedule I Drug Examples

Heroin, lysergic acid diethylamide (LSD). marijuana, peote, methaqalone, ecstasy.

A patient has an order for a tetracycline antibiotic and has been instructed to avoid taking the medication with foods, beverages, or drugs that contain calcium, iron, or magnesium. The patient takes the antibiotic along with a daily multivitamin, not realizing that the vitamin contains iron. What effect may this have on the tetracycline?

Impaired absorption

A patient who is in renal failure may have a diminished capacity to excrete medications. The nurse must assess the patient more frequently for what development?

Increased risk for drug toxicity.

The nurse reads that the drug to be given to the patient has a narrow therapeutic index. The nurse knows that means that the drug has what properties?

It has a narrow safety margin and even a small increase in dose may produce adverse or toxic effects.

Nurse looks up butorphanol (Stadol) in a drug reference guide prior to administering the drug and notes that it is a partial agonist. What does the term tell the nurse about the drug?

It is a drug that produces a weaker, or less efficacious response than an agonist drug.

What is the rationale for the administration of a loading dose of a drug?

It more rapidly builds plasma drug levels to a plateau level.

Schedule V Drugs

Lowest abuse potential/physical dependency, psychological dependency. Used therapeutically without prescription

Black Box Warnings

One of the primary alerts for identifying extreme adverse drug reactions discovered during and after the review process.

Center for Food Safety and Applied Nutrition (CFSAN)

Oversees administration of herbal products and dietary supplements

Category X Teratogenic Risk

Poses most danger to the fetus. Especially during the 1st Trimester.

Sherley Amendment (1912)

Prohibited the sale of drugs labeled with false therapeutic claims

A patient with cirrhosis of the liver exhibits decreased metabolic activity: This will require what possible changes?

Reduction in the dosage of the drugs. More frequent monitoring for adverse drug effects.

CBER - Center for Biologics Evaluation and Research

Regulates the use of biologics including serums, vaccines, and blood products.

Category A Teratogenic Risk

Safest group of drugs

Biologics Control Act (1902)

Standardizes the quality of serums and other blood-relation products

First comprehensive publication of drug standards in the US

U.S. Pharmacopoeia (1820)

Modern group in the US regarding pharmacopoeia

U.S. Pharmacopoeia-National Formulary (1975)

Dilates peripheral blood vessels

Vasodilator

receptor

a cellular macromolecule that a medication binds to

agonist

a drug that produces the same type of response as the endogenous substance

Controlled Substance

a drug whose use is restricted by Controlled Substances Act 1972

Frequency distribution curve

a graphical representation of the number of patients responding to a drug action at different doses.

graded dose-response

a measurement of responses to a drug at different doses

After a drug is administered, it is called

a medication

partial agonist or agonist-antagonist drug

a medication that produces a weaker or less efficacious response than an agonist.

Dependence

a physiological/psychological need for a substance

Enzyme induction

ability to increase metabolic activity in the liver

Conjugates

addition of side chains during metabolism

pc

after meals; after evening

Biologics

agents naturally produced in animal cells, microorganisms, or the body.

minimum effective concentration

amount of drug required to produce a therapeutic effect

Duration of drug action

amount of time it takes for a drug to maintain its desired effect until termination of action.

allergic reaction

an acquired hyperresponse of body defenses to a foreign substance (allergen)

physical dependence

an altered physical condition caused by the adaption of the nervous system to repeated drug use.

FDA's Critical Path Initiative

an effort to modernize the sciences to enhance the use of bioinformation to improve the safety, effectiveness, and manufacturability of medical products.

First-pass effect

an important mechanism, drugs are metabolized by the liver and go into circulation

STAT order

any medication that is needed immediately

Pharmacotherapy or Pharmacotherapeutics

application of drugs for the purpose of disease prevention and treatment of suffering.

pharmacogenetics

area of study that examines the role of heredity in drug response

ad lib

as desired/as directed

Generic Name

assigned by U.S. Adopted Name Council

Trade Name

assigned by company marketing of the drug

Chemical name

assigned using standard nomenclature by the IUPAC

affinity

attraction

ac

before meals

Barriers that prevent medications from entering

blood-brain barrier, fetal-placental barrier.

Therapeutics

branch of medicine concerned with the prevention of disease and treatment of suffering.

cap

capsule

Enterohepatic recirculation

circulating substances back to the liver from the intestines

Combination drug

contains more than one active generic ingredient.

Median effective dose

dose in the middle of the frequency distribution curve

median toxicity dose

dose that will produce a given toxicity to a group of patients

gtt

drop

drug-protein complexes

drug + plasma protein

single order

drug given only once

standing order

drug given out in certain circumstances

inhalations

drugs applied to the respiratory tract by inhalers, nebulizers, or positive pressure breathing

dermatologic preparations

drugs applied to the skin, using topical route. Includes creams, lotions, gels, powders, and sprays.

enteral route

drugs given orally and those administered through nasogastric or gastrostomy tubes.

prescription drugs

drugs with a prescription assigned by an authorized person

What is the term used to describe the magnitude of maximal response that can be produced from a particular drug?

efficacy

hepatic microsomal enzyme system

enzyme complex in the liver that helps with drug metabolism. Also called the P-450 System

q6h

every six hours

qid

four times a day

maintenance doses

given to keep the plasma drug concentration in the therapeutic range

Schedule I drugs

have highest potential for abuse. highest potential for physical/psychological dependency. limited to no therapeutic use.

Schedule II Drugs

high abuse potential/physical dependency/psychological dependency

Loading dose

higher amount of drug, often given only once or twice to "prime" the bloodstream with a sufficient level of drug

h or hr

hour

Mechanism of action

how a drug produces its physiological effect in the body.

potency

how well a drug works to achieve a therapeutic effect

Preclinical Investigation

includes initial synthesis of drug. Animal testing. Extensive laboratory research. Averages 18 months

psychologically dependent

individual has a compelling desire for a drug

IM

intramuscular

IV

intravenous

Cotransport

involves movemnt of two or more chemicals across the membranes

drug effect

known effects with an intended therapeutic outcome

toxic concentration

level of drug that will result in serious adverse effects.

Formulary

list of drugs and drug recipes

Diuretic

lowers plasma volume

efficacy

magnitude of maximal response that can be produced from particular drug.

Therapeutic Index

median lethal dose divided by median effective dose

Pharmacopoeia

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

peak plasma level

medication has reached its highest concentration in the bloodstream.

buccal route

medication placed in oral cavity to be absorbed through the inside of the patient's cheeks

sublingual route

medication placed under the tongue and allowed to dissolve slowly

AM

morning

Active Transport of drugs

movement of a chemical against a concentration or electrochemical gradient

Diffusion/Active transport of drugs

movement of a chemical from an area of higher concentration to an area of lower concentration

Complementary and alternative medication therapies involve

natural plant extracts, herbs, vitamins, minerals, and unconventional techniques.

no

number

apothecary system

older system of measurement (minims, fluid drams, ounces, grains)

Withdrawal

physical signs of discomfort that occur when a drug is no longer available

Teratogenic Risk

places drugs into categories A, B, C, D, X

Therapeutic range

plasma drug concentration between the minimum effective concentration and the toxic concentration

Absoprtion

process involving the movement of a substance from its site of administration, across body membranes, to circulating fluids.

Excretion

removal of drugs from the body

Onset of drug action

represents the amount of time it takes to produce a therapeutic effect after drug administration

Anaphylaxis

severe type of allergic reaction that involves the massive systemic release of histamine and other chemical mediators of inflammation that can lead to life threatening shock.

IND - INvestigation New Drug Application

submitted for Phase I clinical trials to determine significant therapeutic benefits.

Teratogen

substance that has the potential to cause a defect in an unborn child during pregnancy.

Prodrugs

substances have no pharmacologic activity unless they are first metabolized to their active form

Rx

take

Compliance

taking a medication in the manner prescribed by the health care provider. following instructions on the label.

The faster the dissolution

the faster the drug is absorbed.

plasma half life

the length of time required for the plasma concentration of a medication to decrease by one-half after administration

Bioavailability

the physiological ability of the drug to reach its target cells and produce its effects.

Pharmacokinetics

the study of drug movement throughout the body

Therapeutic classification

therapeutic usefulness in treating particular diseases

Distribution

transport of drugs throughout the body

bid

twice a day

side effect

unintended outcome of a drug

idiosyncratic responses

unpredictable and unexplained drug reactions

Ophthalmic Administration

used to treat local conditions of the eye and surrounding structures.

pharmacologic classification

way a drug works at the molecular, tissue, and body system levels.

Prototype drug

well understood drug model with which other drugs in its representative class are compared.