Deck 2: Drug Regulations

Question 1

During the rise of patent medicines in America in the 1800s,there were few attempts to regulate drugs.Which statements accurately depict this situation?
Select all that apply.

A)Patent medicines contained a brand name that clearly identified the product.
B)Patent medicines claimed to cure just about any disease or condition.
C)Patent medicines were often harmless and ineffective.
D)Many patent medicines contained addictive substances.
E)Patent medicines could not make false therapeutic claims.

Answer 1

Patent medicines contained a brand name that clearly identified the product.
Patent medicines claimed to cure just about any disease or condition.
Patent medicines were often harmless and ineffective.
Many patent medicines contained addictive substances.

Question 2

One of the first standards used by pharmacists for preparation and potency of drugs was a formulary.What did early formularies contain?

A)Names of patent medicines and natural drugs
B)Lists of pharmaceutical products and drug recipes
C)Lists of various drugs' strengths based on individual pharmacies
D)Lists of various drugs' potency based on geographic region

Answer 2

Lists of pharmaceutical products and drug recipes

Question 3

Which statements regarding the role of the U.S.Food and Drug Administration (FDA)are true?
Select all that apply.

A)The FDA is responsible for ensuring the security of human drugs.
B)The FDA publishes a summary of the standards of drug purity and strength.
C)The FDA ensures the availability of effective drugs.
D)The FDA takes action against any supplement that is deemed to be unsafe.
E)The FDA facilitates the availability of safe drugs.

Answer 3

The FDA is responsible for ensuring the security of human drugs.
The FDA ensures the availability of effective drugs.
The FDA takes action against any supplement that is deemed to be unsafe.
The FDA facilitates the availability of safe drugs.

Question 4

A client says to the admitting nurse,Why do you need to know the names of all the over-the-counter supplements I take? They aren't drugs." Which responses by the nurse are the most appropriate?
Select all that apply.

A)The admitting physician needs to know everything you are taking."
B)You're right.I'm not sure why the admitting paperwork asks for this information.Would you mind listing them anyway?"
C)The law requires us to keep a list of over-the-counter drugs and supplements that you are taking."
D)It is true that supplements are not considered drugs; however,some of these products can cause adverse effects with prescribed drugs."
E)We need to know if you are having an allergic reaction to one of them."

Question 5

The nursing student is studying how priority drugs receive accelerated approval by the Food and Drug Administration (FDA)as part of the FDA modernization.Which conditions are the priority drugs used to treat?

A)Diseases that previously were treated with older and less popular drugs
B)Diseases that affect only a small percentage of the population
C)Diseases for which the community raises money for treatment
D)Serious and life-threatening conditions that lack effective treatments

Question 6

The Pure Food and Drug Act (PFDA)of 1906 was significant in that it gave the government the power to prohibit drug labels from claiming false therapeutic benefits.However,there were still several weaknesses in the legislature of this act.Which statements most accurately describe these weaknesses?
Select all that apply.

A)This law did not require drug manufacturers to prove that the drug was effective in its claims.
B)This law did not prevent drugs from being marketed for any disease.
C)This law required all drug labels to accurately describe their contents.
D)This law required adequate testing for safety prior to marketing.
E)This law did not encourage the development of drugs for rare or unusual disorders.

Question 7

Which was the greatest problem with patent medicines in early America that lead to drug legislation?

A)They were only distributed in elixir formulation.
B)They had dangerous or addictive substances.
C)They smelled like medicine.
D)They could only be made out of natural products.

Question 8

The nurse explains to the client that during the Food and Drug Administration (FDA)drug approval process,clinical investigators from many different medical specialties address concerns.What concerns are addressed?

A)Whether a New Drug Application (NDA)must be filed
B)The marketability of the drug
C)What the cost of the drug should be
D)Whether or not the drug is safe

Question 9

The client was taking a prescription medication that is now available over the counter.The client asks the nurse,"Why do some medications become available over the counter and other medications remain prescription drugs?" Which response by the nurse is the most appropriate?

A)"Drugs with the least amount of side effects can become over-the-counter."
B)"Drugs that have a high safety margin may be reclassified to over-the-counter."
C)"The longer the drug is on the market,the better its chance of going over-the-counter."
D)"If the pharmaceutical company pays the FDA a large amount of money,it can have its drug reclassified."

Question 10

The client says to the nurse,"I wonder if I am considered a drug addict.I went to pick up my medication from the drug store and the pharmacist told me that the drug was a controlled substance." Which response by the nurse is the most appropriate?

A)"If you continue on this medication for a long time,you will become addicted to it."
B)"You are not an addict,but the Drug Enforcement Agency (DEA)will be watching your prescription drug habits now."
C)Any drug that has a potential for abuse is considered a controlled substance and is restricted.This does not mean the pharmacist will think you are an addict."
D)"Do you think that you are addicted to your medication?"

Question 11

A nurse educator is preparing a lecture regarding prescriptive authority for advanced practice registered nurses (APRNs).Which statement is appropriate for the educator to include in the lecture regarding this topic?

A)APRNs can only prescribe medications when under the supervision of a physician.
B)APRNs prescribe medication based on federal regulations.
C)APRNs prescribe medication based on state regulations.
D)APRNs prescribe medication based on local regulations.

Question 12

The client receiving a newly released medication is experiencing adverse effects.Why does the nurse report these adverse effects as part of the postmarketing surveillance stage of the drug approval process?

A)The clinical trials are continuing to collect new data.
B)Individual client response is compared with the clinical trial data.
C)The efficacy of the drug is determined for new drugs.
D)Harmful effects in the larger population continue to be monitored.

Question 13

Which statements regarding the preclinical research stage of drug development are true?
Select all that apply.

A)Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective.
B)At the end of the preclinical research stage,client variability is determined and potential drug-to-drug interactions are examined.
C)The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans.
D)Preclinical research results are always inconclusive.
E)The Food and Drug Administration (FDA)is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.

Question 14

The nurse is working in a cancer treatment center.A client diagnosed with terminal cancer has received a prescription for morphine (MS Contin),a schedule II drug for pain control.After medication teaching,which statement by the client indicates appropriate understanding?

A)"I should call the office three days before I need a refill called in to the pharmacy."
B)"I will need to see the provider each time for my refill."
C)"This is an addictive drug,so I should try not to take it."
D)"After the first prescription,my doctor will be able to call in my prescription."

Question 15

Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of a control group.A client asks the nurse what a placebo is.Which response by the nurse is the most appropriate?

A)A placebo is a substance that has no therapeutic effect."
B)"A placebo is a similar drug that is safe."
C)"A placebo is a drug that has been tested before."
D)"A placebo is an over-the-counter drug."

Question 16

A pharmaceutical representative comes to the primary care office and states that his company is marketing a new drug that does not need approval by the Food and Drug Administration (FDA).What is the best response of the nurse?

A)"Is this a drug in clinical trials? Those are the only drugs that don't have to have FDA approval."
B)"Is this an over-the-counter drug? Over-the-counter drugs do not need FDA approval."
C)"Your company must be involved in academic research if the drug doesn't need FDA approval."
D)"Any pharmaceutical company must have FDA approval before marketing a drug."

Question 17

In the early 1800s,it became clear that the standardization of drug purity and strength was necessary.Which reasons reflected this need?
Select all that apply.

A)Strength and purity of products varied from region to region and batch to batch.
B)Strength and purity of products depended on the pharmacist's experience.
C)Strength and purity of products would vary in size,taste,and nutritional value.
D)Strength and purity were mostly guaranteed if products were produced locally,which caused a hardship for those outside the region.
E)Strength and purity could be trusted when the product had gone through extensive local testing.

Question 18

Nursing students are studying which drug types must have Food and Drug Administration (FDA)approval before being marketed.The students know that which drugs must have approval from the FDA before being marketed?

A)Biologics
B)Food supplements
C)Herbal preparations
D)Dietary supplements

Question 19

A client is talking to the nurse and is expressing doubt about whether to take a drug that is advertised on television.The client does not believe that commercials for drugs tell the truth.Which rationale will the nurse use when responding to the client?

A)Advertisements are not legally binding and can be misleading.
B)All drugs must be advertised in media to inform the public.
C)Manufacturers have some ability to change things when advertising drugs.
D)False claims of a drug's therapeutic effect are prohibited by law.

Question 20

The nurse is teaching a class about over-the-counter (OTC)medications at a senior citizen center.Which statement by a participant indicates the teaching was effective?

A)"Over-the-counter medications are safe,as long as we don't take them at the same time as our prescription medications."
B)"Over-the-counter medications are safe; otherwise,they would require a prescription."
C)"We should not take any over-the-counter medications without first calling our primary health care provider because these medications can interact with other prescriptions or products."
D)"We must read all the label directions before taking any over-the-counter medications."

Question 21

A nurse educator is discussing the prescriptive authority of health care providers to a group of new employees.Which health care providers are able to prescribe medications to clients?
Select all that apply.

A)Registered nurses
B)Physicians
C)Nurse practitioners
D)Nurse managers
E)Physical therapists

Question 22

The nurse is teaching a client the importance that a placebo plays in drug research.Which items are appropriate for the nurse to include in the teaching session?
Select all that apply.

A)The research drug must be compared to an inert substance to determine effectiveness.
B)The placebo will be given to a control group,and those results will be compared to the group taking the research drug.
C)During the trials,neither group will know if they have the placebo drug or the research drug.
D)The research drug will be considered for a New Drug Application (NDA)if it is found to be effective and safe when compared to the placebo drug.
E)Before the clinical trials,the research drug will be tested on select clients against another standard drug used for the same condition.