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Chapter 3 Self Test

Multiple Choice
Identify the choice that best completes the statement or answers the question.
 

 1. 
Both domestic and imported drugs require approval by (a/the) _______________ before they can be marketed in the United States.
A.
FDA
B.
US Marshal
C.
DEA
D.
US Customs
 

 2. 
The _____________________ prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs.
A.
1938 Food, Drug and Cosmetic (FDC) Act
B.
Food and Drug Act of 1906
C.
Harrison Act
D.
1990 Omnibus Reconciliation Act
 

 3. 
In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Narcotic Act of 1914 required that all manufacturers, importers and physicians prescribing  narcotics be
A.
licensed.
B.
taxed.
C.
licensed and taxed.
D.
fined.
 

 4. 
The Food and Drug Administration was initially named the
A.
Food, Drug, and Alcohol Commission.
B.
Food, Drug and Weapons Administration.
C.
Food, Drug, and Hazardous Substance Regulatory Agency.
D.
Food, Drug and Insecticide Administration.
 

 5. 
Because of fatal poisoning from liquid sulfanilamide, the ________________________ required new drugs be shown to be safe before marketing.
A.
Food and Drug Act of 1906
B.
1938 Food, Drug, and Cosmetic Act
C.
1951 Durham Humphrey Amendment
D.
1990 Omnibus Budget Reconciliation Act (OBRA)
 

 6. 
The _____________ required child-proof packaging for most prescription drugs.
A.
Food, Drug, and Cosmetic Act
B.
Poison Prevention Packaging Act
C.
Durham-Humphrey Amendment
D.
Kefauver-Harris Amendment
 

 7. 
The 1984 Hatch-Watchman Act allowed for
A.
quicker introduction of genetic drugs only.
B.
extension of drug patent terms only.
C.
quicker introduction of drugs and extension of drug patents.
D.
introduction of generic versions of trade drugs regardless of patent terms.
 

 8. 
Pharmacists were required to offer counseling to Medicaid patients by the
A.
Durham-Humphrey Amendment.
B.
1990 Omnibus Budget Reconciliation Act (OBRA).
C.
Kefauver-Harris Amendment.
D.
Harrison Act.
 

 9. 
Drugs that require prescriptions are  _________________ drugs.
A.
Durham
B.
Humphrey
C.
legend
D.
Kefauver
 

 10. 
An inactive substance given in place of a medication during clinical trials is a
A.
pediatric.
B.
phase 2.
C.
phase 3.
D.
placebo.
 

 11. 
The FDA requires ___________________ phases of testing in humans.
A.
two
B.
three
C.
four
D.
five
 

 12. 
The main purpose of phase 2 clinical trials is
A.
dosage.
B.
economics.
C.
animals.
D.
effectiveness.
 

 13. 
Phase 3 clinical trials generally have ____________________ participants.
A.
several hundred to several thousand
B.
20-100 patients
C.
less than 10
D.
up to several hundred.
 

 14. 
The Pediatric Labeling Rule of 1994 mandates that
A.
all drug trials include children after a drug has been fully tested on adults.
B.
all drugs carry information for pediatric use based on studies of adults and other pediatric treatment information.
C.
all drugs have pediatric dosing and safety information on their labels if the drug has potential use for pediatric patients.
D.
all drug labels indicated whether they have been tested on children.
 

 15. 
After a patent has expired for a medication, other manufactures may copy the drug and release it under the _______________ name.
A.
generic
B.
trade
C.
brand
D.
patent
 

 16. 
Manufacturers of generic drugs
A.
need to perform the same safety and effectiveness testing required for new drugs.
B.
do not need to perform the same safety and effectiveness testing but do need to demonstrate that a drug is pharmaceutically equivalent to the corresponding propriety drug.
C.
do not need to perform the same safety and effectiveness testing but do need to demonstrate a drug is therapeutically equivalent to the corresponding proprietary drug.
D.
do not need to perform the same safety and effectiveness testing but do need to demonstrate that a drug is both pharmaceutically and therapeutically equivalent to the corresponding proprietary drug.
 

 17. 
Drugs that do not require a prescription are ___________________ drugs.
A.
FDA
B.
OTC
C.
Durham-Humphrey
D.
legend
 

 18. 
The Combat Methamphetamine Epidemic Act requires that OTC cold and allergy medications that contain which of the following drugs be kept behind the counter?
A.
antihistamine
B.
methamphetamine
C.
ephedrine and pseudoephedrine
D.
antitussive
 

 19. 
Pharmacy technicians may sell exempt narcotics
A.
without approval from the pharmacist if they record the sale in a record book.
B.
only with approval from the pharmacist.
C.
after the pharmacist has approved and documented the sale in the record book.
D.
without approval or documentation of the sale.
 

 20. 
A prescription to dispense Plan B®
A.
is not required.
B.
is required for patients under 17.
C.
is required for patients 17 years of age and under.
D.
is required for patients 17 years of age and under unless otherwise allowed by state law.
 

 21. 
Of the following Schedule of drugs, which one deals with drugs that have no accepted medical use in the United States?
A.
Schedule I
B.
Schedule II
C.
Schedule III
D.
Schedule IV
 

 22. 
Amphetamines, opium, cocaine, and methadone are in DEA schedule _________ because they have a high potential for abuse and may lead to physical or psychological dependence.
A.
II
B.
III
C.
IV
D.
V
 

 23. 
The FDA reporting system for adverse effects that occur from use of approved drugs is called
A.
Class I.
B.
MedWatch.
C.
VAERS.
D.
Class II.
 

 24. 
_____________________ drug recalls are issued by manufacturers when there us strong likelihood that a product will cause serious adverse effects or death.
A.
Class I
B.
Class II
C.
Class III
D.
Class IV
 

 25. 
A technician could be prosecuted for misconduct called ______________ if s/he incorrectly labeled a prescription.
A.
liability
B.
insubordination
C.
negligence
D.
compliance
 

 26. 
Basic criminal and civil laws, like theft, discrimination, sexual harassment, and fraud, apply to pharmacy technicians.
A.
True
B.
False
 

 27. 
Pharmacies located in the health care institutions (hospitals, etc) are required to follow regulations of this organization:
A.
ASHP
B.
USP
C.
ASCP
D.
JCAHO
 

Matching
 
 
Match the terms.
A.
medications with habit-forming ingredients that can be dispensed by a pharmacist without a prescription to persons at least 18 years of age.
B.
any drug which requires a prescription and this “legend” on the label:  Rx only.
C.
failing to do something you should have done.
D.
important associated information that is not on the label of a drug product itself.
E.
legal responsibility for costs or damages arising from misconduct or negligence.
F.
status of medications like Plan B® that are classified as both prescription and OTC drugs.
G.
the action taken to remove a drug from the market and have it returned to the manufacturer.
H.
the mark (CII-CV) which indicates the control category of a drug with a potential for abuse.
I.
the number on a manufacturer’s label indicating the manufacturer and product information.
J.
Federal law that sets daily and monthly limits on OTC sales of pseudoephedrine and ephedrine.
K.
an inactive substance given in place of a medication.
L.
having to do with treatment of children.
M.
drug products that contain identical amounts of the same active ingredients in the same dosage.
N.
pharmaceutical equivalents that produce the same effects in patients.
O.
five groups of drugs identified by the 1970 Controlled Substance Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth in the CSA.
P.
an unintended side effect of a medication that is negative or in some way injurious to a patient’s health.
Q.
a court order preventing a specific action, such as the distribution of a potentially dangerous drug.
R.
specific guidelines for practice.
S.
doing what is required.
 

 28. 

 adverse effect
 

 29. 

 Combat Methamphetamine Epidemic Act (CMEA)
 

 30. 

 compliance
 

 31. 

 controlled substance mark
 

 32. 

 controlled substances
 

 33. 

 dual marketing
 

 34. 

 exempt narcotics
 

 35. 

 injunction
 

 36. 

 legend drug
 

 37. 

 liability
 

 38. 

 NDC (National Drug Code)
 

 39. 

 negligence
 

 40. 

 pediatric
 

 41. 

 pharmaceutical equivalent
 

 42. 

 placebo
 

 43. 

 product labeling
 

 44. 

 protocol
 

 45. 

 recall
 

 46. 

 therapeutic equivalent
 



 
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