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.