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Roach's Introductory Clinical Pharmacology


_________ is the study of drugs and their action on living organisms.

chemical, generic, official, trade, brand

What are the several types of drug names?


__________ name is the scientific term that describes the molecular structure of a drug; it typically is the chemical components of the drug.


__________ name is the general name given to a drug that can be made or marketed by any company; it is non-proprietary.


__________ name is capitalized and is selected by a specific company for marketing purposes.

generic name

To avoid confusion, what name should you use for the drug?


Drugs that retard or destroy pathogens are classified as?

prescription, nonprescription, controlled substance

Once a drug is approved for use, the FDA assigns it to one of the following categories?

Prescription drugs

_________ _________ are designated by the federal government as potentially harmful unless their use is supervised by a licensed health care provider, such as a nurse practitioner, physician, or dentist.

adverse reactions

The nurse administers the drug and monitors the patient for therapeutic effect and _________ ___________.

legend drugs

Prescription drugs, also called ________ ________, are the largest category of drugs.

licensed HCP

Prescription drugs are prescribed by a ?

nonprescription drugs

_____________ ________ are designated by the FDA as safe and can be obtained without a prescription.

over the counter

Drugs that are purchased in a variety of settings, such as a pharmacy, drugstore, or the local supermarket are called ?

nonprescription drugs

Over the counter drugs are known as?

controlled substances

___________ ___________ are the most carefully monitored of all drugs. These drugs have a high potential for abuse and may cause physical or psychological dependency.

physical dependency

___________ ____________ is the habitual use of a drug, in which negative physical withdrawal symptoms result from abrupt discontinuation; it is the body's dependence on repeated administration of a drug.

Controlled Substances

____________ ____________ act of 1970 established a schedule, or classification system, for drugs with abuse potential.

Controlled Substances Act

This act regulates the manufacture, distribution, and dispensing of these drugs.

five schedules

The controlled substances act divides drugs into _____ ___________, based on their potential for abuse and physical and psychological dependence.

Schedule 1

High abuse potential, lack of accepted safety, not approved for medical use in the United States is what schedule?

Schedule 2

Potential for high abuse with severe physical or psychological dependence, approved for medical use in the United States

Schedule 2

The schedule approved for opioids such as meperidine, methadone, morphine, oxycodone, amphetamines; and cocaine.

Schedule 3

Less abuse potential than schedule 2 drugs, potential for moderate physical or psychological dependence

Schedule 3

Examples of this schedule are anabolic steroids, ketamine, hydrocodone/codeine compounded with an nonsteroidal anti-inflammatory drug

Schedule 4

Less abuse potential than schedule 3 drugs, limited dependence potential

Schedule 4

Examples of this schedule are some sedatives and anxiety agents, non-opioid analgesics, "diet drugs"

Schedule 5

Limited abuse potential

Schedule 5

Examples of this schedule are small amounts of opiod (codeine) used as antitussives or antidiarrheals, pregabalin (Lyrica)


(What PREGNANCY category?)
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.


(What PREGNANCY category?)
Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women


(What PREGNANCY category?)
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.


(What PREGNANCY category?)
Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.


(What PREGNANCY category?)
Animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.


Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus.

However, potential benefits may outweigh the risk to the fetus. If needed in a life-threatening situation or a serious disease, the drug may be acceptable if safer drugs cannot be used or are ineffective


Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.

The use of the product is contraindicated in women who are or may become pregnant.


What are the FDA pregnancy risk categories?


Prescription practices of the primary health care provider for controlled substances are monitored by the ?

8-12 hours

In hospitals or other agencies that dispense controlled substances, the scheduled drugs are counted every __ to __ hours to account for each injectable, tablet, or other form of the drug.

7-12 years

Drug development is a long and arduous process that can take from __ to __ years, and sometimes longer.


The ____ has the responsibility for approving new drugs and monitoring drugs currently in use for adverse or toxic reactions.

pre-FDA phase, FDA phase

The development of a new drug is divided into what two phases?


During what phase, does a manufacturer discover a drug that looks promising?

postmarketing surveillance

______________ ____________ occurs after the manufacturer places the drug on the market.

FDA by Medwatch

Health care professionals are encouraged to help with this surveillance by reporting adverse effects by reporting to the?

Orphan Drug Act of 1983

What special program was passed to encourage the development and marketing of products used to treat rare diseases?


How many individuals is it considered to be a "rare disease"?

rare disease

Multiple myeloma, cystic fibrosis, and phenylketonuria are types of what kind of diseases?

Oral drugs

What drugs go through these three phases: pharmaceutic phase, pharmacokinetic phase, and pharmacodynamic phase?

pharmaceutic phase

the drug dissolves


Drugs must be ________ to be absorbed.

parental drugs

What type of drugs are already dissolved and are absorbed more quickly?

enteric coating

Tablets that have an ________ ________ or time-releasing capsules do not disintegrate until they reach the alkaline environment of the small intestine.


____________ refers to activities within the body after a drug is administered.

absorption, distribution, metabolism, excretion

What 4 activites do pharmacokinetics go through?


Another pharmacokinetic component is the ______ ______ of the drug.


is a measure of the rate at which drugs are removed from the body.


__________ follows administration and is the process by which a drug is made available for use in the body.


Which process do the drug particles in the GI tract move into the body fluids?

active transport, passive transport, pinocytosis

What three ways does absorption act in?

active transport

cellular energy is used to move the drug from an area of low concentration to one of high concentration

passive transport

no cellular energy is used as the drug moves from an area of high concentration to an area of low concentration


cells engulf the drug particle (the cell forms a vesicle to transport the drug into the inner cell)

intravenous route

What route are drugs most rapidly absorbed?


(fast or slow) When drugs are absorbed orally, intramuscularly, or sub Q?

first pass effect

the metabolism of orally administered drugs by gastrointestinal and hepatic enzymes, resulting in a significant reduction of the amount of unmetabolized drug reaching the systemic circulation.

protein binding, blood flow, solubilty

Distribution of an absorbed drug in the body depends on __________ _________, _____ _____, and _________.


Drugs bound to protein are pharmacologically _________.

free drugs

Only ____ _____ can produce a therapeutic effect.

large blood supply

A drug is distributed quickly to areas with a _______ _________ ________, such as the heart, liver, and kidneys.

skin and muscle

Distribution of drugs in these areas occur more slowly.


Metabolism is also called?


the process by which the body changes a drug to a more or less active form that can be excreted


What's the resulting form of metabolism?


an inactive form of the original drug


The elimination of drugs from the body is called _________.

kidney disease

Patients with what type of disease may require a dosage reduction and careful monitoring of kidney function?


_____ ______ refers to the time required for the body to eliminate 50% of the drug.


Drugs with a short half life hours?


Drugs with a long half life hours?

onset of action

time between administration of the drug and onset of its therapeutic effect

peak of concentration

when absorption rate equals the elimination rate (not always the time of peak response)

duration of action

length of time the drug produces a therapeutic effect

Pharmacodynamic phase

_________ is the study of the drug mechanisms that produce biochemical or physiologic changes in the body.


_____________ deals with the drug's action and effect in the body.

therapeutic effect

The primary effect of a drug is the desired or _________ ___________.

alteration in cellular function, alteration in cellular environment

A drug exerts its action by two main mechanisms:


The function of a cell is altered when a drug interacts with a ________.

receptor-mediated drug action

This occurs when a drug molecule selectively joins with a reactive site---the receptor--- on the surface of a cell.


When a drug binds to and interacts with the receptor, a ___________ response occurs.


a drug that binds with a receptor and stimulates the receptor to produce a therapeutic response.


a drug that joins with receptors but does not stimulate the receptors

competitive, noncompetitive

What are the two types of antagonists?

competitive antagonist

competes with the agonists for receptor sites.

competitive antagonist

bind reversibly with receptor sites, administering larger doses of an agonist can overcome the antagonist effects.

noncompetitive antagonist

binds with receptor sites and always blocks the effects of the agonists.

Human genome project

was a study to determine the different components of the human genetic code.


is the study of how people's responses to medications are variable due to individual genetic variation.


is the creation of individualized drug therapy that allows for the best choice and dose of drugs.

first trimester (3 months)

Drugs administered to pregnant women, particularly during what trimester, may have teratogenic effects?


any substance that causes abnormal development of the fetus, often leading to severe deformation.

Adverse reactions

_________ ________ are undesirable drug effects.

side effects

to explain mild, common, and nontoxic reactions

adverse reactions

to describe more severe and life-threatening reactions

allergic reaction

is an immediate hypersensitivity reaction.


A drug allergy occurs because the individual's immune system responds to the drug as a foreign substance called _________.


Lymphocytes respond by forming ________.


protein substances that protect against antigens


Common allergic reactions reactions occur when the individual's immune system responds aggressively to the _________.

Chemical mediators

__________ _________ released during the allergic reaction produce symptoms ranging from mild to life-threatening.

primary health care provider

Any indication of an allergic reaction is reported to the ________ ______ ___ _____ before the next dose of the drug is given.


Allergic reactions that occur __________ often are the most serious.

anaphylactic shock

_______ ________ is an extremely serious allergic drug reaction that usually occurs shortly after the administration of a drug to which the individual is sensitive.

immediate medical attention

Anaphylactic shock requires ______ _________ __________.

Anaphylactic shock

Treatment of this is to raise the blood pressure, improve breathing, restore cardiac function, and treat other symptoms as they occur.


_________ (adrenalin) may be given subQ injection in the upper extremity or thigh and may be followed by a continuous intravenous infusion.


_________ and shock may be treated with fluids and vasopressors.


__________ are given to relax the smooth muscles of the bronchial tubes.


____________ and corticosteroids may also be given to treat urticaria and angioedema.


____________ is another type of allergic drug reaction.


manifested by the collection of fluid in the subQ tissues.


What drug allergic rx commonly affects eyelids, lips, mouth, and throat?


Angioedema can be dangerous when the mouth is affected, because the swelling may block the airway and ________ may occur.

drug idiosyncrasy

____ __________ is a term to describe any unusual or abnormal reaction to a drug.


__________ is the study of ways that specific genes can enhance sensitivity or resistance to certain drugs.

pharmacogenetic disorder

____________ _______ is a genetically determined abnormal response to normal doses of a drug.

pharmacogenetic disorder

This abnormal response occurs because of inherited traits that cause abnormal metabolism of drugs.


destruction of red blood cells

blood thinners

Patients with pharmacogenetic disorder use aspirin, chloramphenicol, and the sulfonamides because these drugs are ?

drug tolerance

______ _________ is a term used to describe a decreased response to a drug, requiring an increase in dosage to achieve the desired effect.

opioids, tranquilizers

Drug tolerance may develop when a patient takes certain drugs such as ______ and ________, for a long time.

physical drug dependance

The development of drug tolerance is a sign of _________ _____ _________.

cumulative drug effect

________ ____ ________ may be seen in those people with liver or kidney disease because these organs are the major sites for the breakdown and excretion of most drugs.

cumulative drug effect

This drug effect occurs when the body is unable to metabolize and excrete one dose of a drugbefore the next dose is given

cumulative drug effect

________ _____ _____ can be serious because too much of the drug can accumulate in the body and lead to toxicity.


A ______ ______ interaction occurs when one drug interacts with or interferes with the action of another drug.

additive, synergistic, antagonistic

Drug-drug interactions can produce effects that are ______, _______, _____.

additive drug reaction

________ _______ ________ occurs when the combined effect of two drugs is equal to the sum of each drug given alone.

drug synergism

_______ ___________ occurs when drugs interact with each other and produce an effect that is greater than the sum of their separate actions.

drug synergism

______ __________ is exemplified when a person takes both a hypnotic and alcohol.

antagonistic drug

___________ _____ reaction occurs when one drug interferes with the action of another, causing neutralization or a decrease in the effect of one drug.


When a drug is given orally, food may impair or enhance its ________.

empty stomach

When is drug absorbed into the bloodstream more quickly?(full or empty stomach?)

1 or 2 hours

Drugs that should be taken on an empty stomach are administered __________ after meals.

age, wt, sex, disease, route of administration

What are the factors that influence drug responses?


Infants and children usually require _____ doses of a drug than adults.

kids, adults

What age group usually require smaller doses?


________ is the taking of numerous that can potentially react with one another.

elderly patients

Poly pharmacy is seen particularly in _______ patients who have multiple chronic diseases.

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