Deck 1: Consumer Safety and Drug Regulations

Question 1

What was the first law in the United States to require all drugs marketed in the United States to meet minimal standards of strength,purity,and quality?

A)Federal Food,Drug,and Cosmetic Act
B)Pure Food and Drug Act
C)Controlled Substances Act
D)Drug Adulteration Prevention Act

Answer 1

Pure Food and Drug Act

Question 2

What legislation requires that new drugs be approved before they are released to the public?

A)The Drug Adulteration Prevention Act
B)The Federal Food,Drug,and Cosmetic Act
C)The Pure Food and Drug Act
D)The Controlled Substances Act

Answer 2

The Federal Food,Drug,and Cosmetic Act

Question 3

In what context are you most likely to see references to USP/NF?

A)Characterization of addiction and abuse potential
B)Identification of indications and contraindications
C)Discussion of drug standards
D)Warning labels

Answer 3

Discussion of drug standards

Question 4

What are legend drugs?

A)Drugs that are exceptionally safe and effective
B)Drugs that have the phrase "Caution-federal law prohibits dispensing without a prescription" on the label
C)Drugs that are manufactured before the Pure Food and Drug Act and therefore exempt from regulation
D)Drugs that have limited profitability because they are used to treat rare illnesses

Question 5

A friend of yours is complaining about the latest drug recall,which has affected her grandmother's heart medication.She asks you whether there are any standards to ensure that a medication is consistent with the claims of its label.How should you respond?

A)Sure,any reliable drug reference will do
B)Yes,the Controlled Substances Schedule
C)Possibly,but only if the physician signed a legal document
D)Yes,the United States Pharmacopeia and National Formulary

Question 6

You're waiting in line at the pharmacy to get your medication,and decide to take a look at your doctor's handwriting on the prescription.You notice the phrase "DEA Number" followed by a code.What does the phrase "DEA Number" represent?

A)The code required to determine whether the drug is reimbursable
B)The physician's license number for your state
C)The drug standards met by the medication prescribed for you
D)The registration number for physicians who prescribe controlled substances

Question 7

Under the schedules used in the United States,which drugs have high abuse potential and can be dispensed only with a written prescription?

A)5 (C-V)
B)2 (C-II)
C)1 (C-I)
D)3 (C-III)

Question 8

Your friend,Thomas,had a serious adverse reaction to an over-the-counter medication and found that a number of other individuals had similar adverse reactions.Which agency is most likely to investigate this situation and take action if a problem is found?

A)Food and Drug Administration
B)United States Pharmacopeia
C)National Formulary Enforcement
D)Drug Enforcement Agency

Question 9

Quinn hears on the news that the FDA has asked a company to withdraw a medication.Under what circumstances can the FDA do this?

A)when more effective alternatives are available
B)never,because only the DEA can do this
C)when it is no longer profitable
D)when the benefits of a drug outweigh its risks

Question 10

Which schedule includes cough suppressants containing codeine and medications for diarrhea?

A)3 (C-III)
B)1 (C-I)
C)5 (C-V)
D)4 (C-IV)

Question 11

Ian,a registered nurse,maintains that he is not a drug abuser,so the 1970 Controlled Substances Act has no relevance for him.Is he right?

A)Yes,except that his state licensing board may place additional restrictions on him.
B)Yes,as long as he does not abuse drugs,this act does not impact him.
C)No,as long as he is careful to avoid the appearance of impropriety and is generally responsible in his all aspects of life.
D)No,because the act lays out his responsibilities with respect to record keeping and administration of controlled substances.

Question 12

After losing your cousin to an overdose of cocaine,you decide to get involved in law enforcement activities related to illicit drugs.Which agency is most likely to interest you?

A)Food and Drug Administration
B)Drug Enforcement Administration
C)Substance Abuse and Mental Health Services Administration
D)National Institute on Drug Abuse

Question 13

To which schedule do mescaline and ecstasy belong?

A)4 (C-IV)
B)1 (C-I)
C)3 (C-III)
D)2 (C-II)

Question 14

What legislation was created in response to a 1937 incident in which an inadequately tested drug caused the deaths of 100 people?

A)Drug Adulteration Prevention Act
B)Pure Food and Drug Act
C)Controlled Substances Act
D)Federal Food,Drug,and Cosmetic Act

Question 15

Which legislation requires that drug preparations containing dangerous ingredients have a labeled container indicating the ingredient?

A)Pure Food and Drug Act
B)Controlled Substances Act
C)Drug Adulteration Prevention Act
D)Federal Food,Drug,and Cosmetic Act

Question 16

Drugs on which schedule may have prescriptions written out by a health care practitioner,but must be signed by the physician?

A)2 (C-II)
B)3 (C-III)
C)1 (C-I)
D)4 (C-IV)

Question 17

What agency was established as a result of the Controlled Substances Act?

A)The Drug Enforcement Administration
B)The National Institute on Drug Abuse
C)The Food and Drug Administration
D)The United States Pharmacopeia

Question 18

Drug standards require that all preparations called by the same drug name must be of uniform .

A)effectiveness and reliability
B)cost,availability,and distribution method
C)dosage and route of administration
D)strength,quality,and purity

Question 19

What agency was established by the Federal Food,Drug,and Cosmetic Act?

A)The Schedule of Controlled Substances Oversight Committee
B)The United States Pharmacopeia and National Formulary
C)The Drug Enforcement Administration
D)The Food and Drug Administration

Question 20

What agency would you expect to inspect plants where food,drugs,medical devices,and cosmetics are made?

A)The Drug Enforcement Agency
B)The Food and Drug Administration
C)The National Formulary
D)The Inspector General

Question 21

After being hospitalized for heart failure,72-year-old Donna returns home with prescription medications.With a renewed focus on her health,she also decides to start taking herbal supplements.Can this create problems?

A)Possibly,but only if she is also taking incorrect doses of the prescription medications.
B)Possibly,but only if she takes higher doses of the herbal supplements than recommended on the packaging.
C)No,because manufacturers must prove that herbal supplements are safe before marketing them.
D)Yes,because herbal supplements can interact with many medications - she should consult her physician first.

Question 22

Jesse often complains about government regulation and maintains that only drugs with potential for abuse or addiction should require prescriptions.What other medications require prescriptions in the United States?

A)Those that have the potential for serious adverse effects if taken improperly
B)Those that are covered by insurance or other reimbursement sources
C)Those that are still protected by patents
D)None;only controlled substances need prescriptions in the U.S.

Question 23

According to your text,who is an excellent resource for you when you are unsure of your legal responsibilities with drugs or have uncertainties about drug therapy?

A)a local pharmacist
B)a DEA agent
C)a pharmaceutical sales representative
D)an attorney

Question 24

Your friend is working at a group home for people with severe developmental disabilities and tells you he administers medications.You know he is not a doctor or nurse and is not,in fact,any sort of licensed health professional.Is this legal?

A)Possibly,as long as a registered nurse is standing right beside him when he administers it.
B)Probably,but only the physician is aware of what's happening,and if the information is kept private.
C)Yes,because unlicensed assistive personnel can legally administer medications.
D)Absolutely not,because the facility can lose its license and certification for allowing it.

Question 25

What is the term for drugs used to treat rare diseases that,because they will be used for so few people,have low profitability?

A)low margin drugs
B)compassionate use drugs
C)generic drugs
D)orphan drugs