Multiple Choice
Identify the
choice that best completes the statement or answers the question.
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1.
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The ____________________ defined what drugs require a prescription.
A. | 1970 Poison Prevention Packaging Act | B. | 1962 Kefauver-Harris
Amendment | C. | Sherley Amendment | D. | 1951 Durham-Humphrey
Amendment |
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2.
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A need for tighter drug regulations from the thalidomide lesson led to
the
A. | Kefauver-Harris Amendment. | B. | Durham-Humphrey Amendment. | C. | Food and Drug Act of
1906. | D. | Food Drug and Cosmetic Act. |
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3.
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Legend drugs should have the legend ____________________________ on the
manufacturer’s label.
A. | “Federal law prohibits transfer of this prescription” | B. | “Store at room
temperature” | C. | “For external use
only” | D. | “RX only” |
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4.
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In clinical trials, testing is done
A. | on mice. | B. | on people. | C. | in
vitro. | D. | on dogs. |
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5.
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The main purpose of phase I clinical trials is
A. | efficacy. | B. | dosage. | C. | safety. | D. | economics. |
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6.
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The daily sales limit of pseudoephedrine base is
A. | 3.6 grams per household. | B. | 3.6 grams per purchaser. | C. | 3.6 grams per
transaction. | D. | 3.6 grams per day. |
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7.
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The National Drug Code (NDC) is assigned by the
A. | FDA. | B. | DEA. | C. | CDER. | D. | manufacturer. |
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8.
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DEA form __________________ is used to order Schedule II controlled
substances.
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9.
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In each state, pharmacists are licensed by the
A. | DEA. | B. | FDA. | C. | federal
government. | D. | state board of pharmacy. |
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10.
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Doing what is required is
A. | compliance. | B. | a protocol. | C. | liability. | D. | exempt. |
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Matching
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A. | adverse reaction | B. | controlled substance mark | C. | DEA
number | D. | exempt narcotics | E. | injunction | F. | legend
drug | G. | liability | H. | “look-alike”
regulation | I. | NDC (National Drug Code) | J. | negligence | K. | pediatric | L. | placebo | M. | product
labeling | N. | recall | O. | therapeutic |
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11.
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The number all prescribers of controlled substances are assigned and which must
be used on all controlled drug prescriptions.
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12.
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A court order preventing a specific action, such as the distribution of a
potentially dangerous drug.
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13.
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An inactive substance given in place of a medication.
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14.
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An unintended side affect of a medication that is negative or in some way
injurious to a patient’s health.
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15.
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Any drug which requires a prescription and this “legend” on the
label: Rx only.
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16.
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Failing to do something you should have done.
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17.
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Having to do with the treatment of children.
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18.
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Important associated information that is not on the label of a drug product
itself.
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19.
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Federal law requires that a drug and/or its container not be imitative of
another drug so that the consumer will be misled.
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20.
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Means you can be persecuted for misconduct.
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21.
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The action taken to remove a drug from the market and have it returned to the
manufacturer.
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22.
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The mark (CII-CV) which indicates the control category of a drug with a
potential for abuse.
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23.
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The number on a manufacturer’s label indicating the manufacturer and
product information.
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24.
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Medications with habit-forming ingredients that could be dispensed by a
pharmacist without a prescription.
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Match the term with the Controlled Substance or Recall A. | Schedule I Drugs | B. | Schedule II Drugs | C. | Schedule III
Drugs | D. | Schedule IV Drugs | E. | Schedule V Drugs | F. | Class I
Recall | G. | Class II Recall | H. | Class III
Recall |
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25.
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Amphetamines, opium, cocaine, methadone, and various opiates are included on
this schedule.
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26.
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Anabolic steroids and various compounds containing limited quantities of
narcotic substances such as codeine are included on this schedule.
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27.
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When a product is not likely to cause adverse effects.
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28.
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Compounds containing limited amounts of a narcotic such as codeine are included
in this group.
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29.
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When a product my cause temporary but reversible adverse effects, or in which
there is little likelihood of serious adverse effects.
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30.
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Heroin, various opium derivatives, and hallucinogenic substances are included
on this schedule.
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31.
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Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital
are included in this group.
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32.
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When there is a strong likelihood that the product will cause serious adverse
effects or death.
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Short Answer
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33.
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Why is blind testing used in the drug approval process?
____________________________________________________________________________________________________________________________________________________________________________________
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34.
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Give three reasons why OTC labels should be clear and understandable.
A. _______________________________________
B.
_______________________________________
C.
_______________________________________
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35.
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Why are some drugs “controlled” by the DEA?
___________________________________________________________________________________________________________________________________________________________________________________________________________
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36.
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Give three reasons why failing to do something could result in a criminal charge
of negligence.
A.
______________________________________________
B.
______________________________________________
C.
______________________________________________
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