Pharmacology CH 1

category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

generic

The nurse instructs the client that some drugs are no longer covered under patent and may be less expensive. What type of drug is the nurse describing?

Chemical name

The nurse is administering a medication to a client who reports pain in the knees from arthritis. The nurse observes the name of the drug as p-isobutylhydratropic and recognizes that this refers to a:

Gathering data from clients taking the drug after it has been released to market.

The nurse is currently participating in phase IV of a clinical study of a chemotherapeutic drug. What action would the nurse be expected to perform during this phase of testing?

The brand name of the drug must be dispensed.

The nurse is reviewing a prescription for a medication with a client. On the prescription, the nurse read "DAW." What should the nurse teach the client?

Numerous brand names may exist for the same drug, sothe generic drug should be ordered.

The nurse is transcribing physician orders for a client with pneumonia who has been admitted to the hospital. Why should the physician order the medications using the generic name instead of a brand name?

OTC meds are not risk free

The nurse is working in a community outreach clinic. What should the nurse teach a client about over-the-counter medications?

There is less chance of the wrong drug being given, because trade names can be similar.

The nurse received an order for furosemide (Lasix). Why should the nurse write the generic name on the order sent to the pharmacy?

4

The nurse understands that medications are not just manufactured and dispensed. How many phases of clinical trials must a drug go through in order to meet approval standards?

Escherichia coli

Genetic engineering allows scientists to produce human insulin by altering which type of bacteria?

by generic or trade name

How may drugs be prescribed and dispensed

C-IV (Schedule IV)

Less abuse potential than schedule III and limited dependence liability (some sedatives, anti-anxiety agents, and non narcotic analgesics)

giving the drug to clients with the disease that drug is designed to treat

A nurse is involved in a phase II study. The nurse should perform what action?

C-II

A nurse is preparing to administer morphine. The nurse understands that this drug is categorized as which schedule of a controlled substance?

the effect of the drug on the client's body

A nurse is teaching a client about the pharmacotherapeutics of the hormone replacement therapy that the client has been prescribed. What topic should the nurse address?

category X

A nurse is to administer several drugs. A drug belonging to which class would the nurse interpret as being contraindicated for a pregnant woman?

C-II

A physician has ordered subcutaneous injections of morphine every 4 hours as needed for pain for a motor vehicle accident victim. Morphine has a high abuse potential and is categorized in which class of drugs?

genetic engineering

Process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug.

Test the drugs with animals.

Since 1962, newly developed drugs have been extensively tested before being marketed for general use. What do drug companies do to test drugs initially?

category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Category B

Studies indicate no risk to the animal fetus; information for humans is not available. no risk in any of the trimesters

Kefauver-Harris Act of 1962.

The birth defects associated with thalidomide (Thalomid) resulted in legislation known as the:

phase IV study

Which phase of drug development is associated with continual evaluation of the drug?

Schedule I

Which schedule drugs have high abuse potential and no accepted medical use?

A drug is any chemical that can affect living processes.

Which statement correctly defines a drug?

Levothyroxine sodium

While reviewing a package insert for a drug, what would the nurse identify as the drug's generic name?

phase II study

a clinical study on a smaller scale that uses actual patients that have the disease the drug treats/

drug dissolution

A client has been diagnosed with depression following several months of reduced concentration and sleep difficulties. The client has been prescribed buproprion SR 150 mg PO b.i.d. What should the priority nursing assessment be?

phase IV study

A drug has been approved by the Food and Drug Administration. What study phase would occur next?

Check for adverse drug reactions.

A nurse has administered medication to a client per the physician's prescription. Which activity should the nurse perform after administering a medication to a client?

Phase I

A nurse is administering a large number of medications to a diverse group of clients. What types of drugs will be excluded from these medications?

Prescription Drugs

After teaching a group of nursing students about drug classes and categories, the instructor determines that the teaching was successful when the students identify legend drugs as referred to as which medication?

thyroid hormone

After teaching a group of students about the sources of drugs, the instructor determines that the students need additional teaching when they identify what as an example of a drug from a plant source?

category c

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

over the counter drugs

Drugs available to consumers without a prescription. Also called nonprescription drugs

Health care providers report adverse effects to FDA

One of the phases of drug development is the post-marketing surveillance phase. Which activity is carried out during this phase?

Health care providers report adverse effects to FDA.

One of the phases of drug development is the post-marketing surveillance phase. Which activity is carried out during this phase?

category D

What drug category indicates fetal risk where the potential benefit might be acceptable despite the risk?

category X

What drug category indicates fetal risk where the risk outweighs any potential benefit?

pharmacotherapeutics

What is the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease?

Generic drugs must be therapeutically equivalent and less expensive than trade name drugs.

What statement describes a required characteristic of all generic drugs?

category C

Which Food and Drug Administration (FDA) pregnancy category indicates that animal studies on the drug have shown adverse fetal effects, but there are no adequate studies in humans?

Drug Enforcement Agency

Which agency is responsible for the enforcement of controlled substances?

orphan drug

Which drug type has been discovered but not manufactured by any drug company?

Difficulty breathing and maintaining an airway

Which is an example of a black box warning by the Food and Drug Administration (FDA)?

phase IV

continuous evaluation of a drug after it has been released for marketing

generic drugs

drugs sold by their generic name; not brand (or trade) name products

teratogenic

having adverse effects on the fetus

C-II (Schedule II)

high abuse potential with severe dependance liability (narcotics, amphetamines, and barbiturates)

C-I (Schedule I)

high abuse potential, not approved for medical use in the U.S. examples: heroin, LSD, mescaline, ecstasy

preclinical trials

initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects

C-III (Schedule III)

less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, non amphetamine stimulants, limited amounts of certain narcotics)

C-V (Schedule V)

limited abuse potential. small amounts of narcotics (codeine). may be purchased without a prescription, but person must be 18 and purchases must be recorded by pharmacist.

brand name

name given to a drug by the pharmaceutical company that developed it. also called the trade name or proprietary name BIG NAME ON LABEL ex: Marinol or Synthroid

chemical name

name that reflects the chemical structure of a drug LITTLE NAME UNDER BRAND NAME ex: L-thyroxine T4 or delta-9-tetrahydroannabinol

category A

no risk to fetus in first second or third trimester

FDA

regulates the development and sales of drugs

adverse effects

side effects of a drug

generic name

the ? name is used for drugs in a hospital unless it is a DAW.

Generic Name

the original designation that the drug is given when the company created and approves the drug.

pharmacology

the study of the biological effects of chemicals

phase III study

used on a wide clinical scale with patients who have the disease/

phase I Study

uses a small group of healthy individuals