Essentials of
Pharmacology for
Health
Professions, 8th
Edition, Bruce
Colbert, Ruth
Woodrow
,CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
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TRUE/FALSE
1. The pharmaceutical manufacturer has the authority to add additional active i
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ngredients to a previously approved pharmaceutical product. th th th th th th
ANS: F t h
According to the 1938 Federal Food, Drug, and Cosmetic Act and Amendment
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s of 1951 and 1962, all labels must be accurate and include a listing of all active
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and inactive ingredients.
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PTS: 1 t h
2. Drug strength may vary with each lot number of a medication.
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ANS: F t h
The 1906 Pure Food and Drug Act established that all drugs marketed in the Unit
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ed States meet minimal standards of strength, purity, and quality.
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PTS: 1 t h
3. The Pure Food and Drug Act of 1906 established drug standards and official dr
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ug references.
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ANS: T t h
This act established that all drugs marketed in the United States meet minimal
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standards of strength, purity, and quality. It also established two official refer
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ences that established the standards for making each drug: The
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U.S. Pharmacopeia (USP) and the National Formulary (NF).
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PTS: 1 t h
4. The 1906 Pure Food and Drug Act established consumer protections to pre
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vent the inclusion of “dangerous ingredients” without the knowledge of the
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consumer.
ANS: T t h
Morphine is one example of a dangerous ingredient that may have been include
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d without the knowledge of the consumer.
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PTS: 1 t h
5. Medication labels need only include the trade name of the drug. th th th th th th th th th th
ANS: F t h
Labels must include a listing of all active and inactive ingredients, warning label
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s on certain preparations, and generic names for the medication
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, PTS: 1 t h
6. The prescriber of the medication is the only health care professional who is r
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esponsible for being aware of new medications, laws, and restrictions.
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ANS: F t h
The health care worker involved in administration of a medication also bears t
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he responsibility of being aware of the laws and restrictions pertinent to that m
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edication.
PTS: 1 t h
7. A double-
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locked system is the recommended method for maintaining security of controll
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ed substances.
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ANS: T t h
A double-
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locked system may include two separate key entries or an electronic user identif
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ication and password access system.
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PTS: 1 t h
8. Health care workers are responsible for maintaining records of all controlled s
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ubstances received, dispensed, and destroyed.
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ANS: T t h PTS: 1 t h
9. Controlled substance records are to be kept for 10 years.
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ANS: F t h
Records for the previous 2 years must be available at all times for inspection. P
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TS: 1 t h
MULTIPLE CHOICE th
1. Identify the drug standard in the following list.
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a. Color c. Shape
b. Strength d. Taste
ANS: B t h
Feedback
A Color is not a standard. th th th th
B Correct!
C Shape is not a standard. th th th th
D Taste is not a standard. th th th th
, PTS: 1 t h
2. The risk of death from the use of street drugs versus prescription m
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edications is mostly due to: th th th th
a. a lack of control over quality, purity, a
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nd strength makes street drugs dang
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erous.
b. the risk is the same for both sources of
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the same substance.
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c. street drugs are approved for use.
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d. the need for a prescription makes dru
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gs hard to obtain.
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ANS: A t h
Feedback
A Correct!
B The lack of enforcement of drug stan
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dards in illegal street drugs poses a si
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gnificant danger for the consumer. th th th th
C The exact composition of a street dru
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g is unknown, and it may contain dan
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gerous contaminants or undisclosed th th th th
additional drugs. th
D Street drugs are illegal. th th th
PTS: 1 t h
3. Drug standards regulate drug manufacture so that medications of the same n
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ame will be of the same:
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a. strength, purity, and quality. th th th
b. shape, color, and taste. th th th
c. purity, shape, and color. th th th
d. quality, color, and shape. th th th
ANS: A t h
Drug standards state that all preparations of the same drug name must be of u
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niform strength, purity, and quality.
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PTS: 1 t h
4. The 1906 Pure Food and Drug Act includes which of the following provisions?
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a. Regulation of drugs sold in the th th th th th