Bruce Colbert/Adam James/Elizabeth Katrancha
,CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
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TRUE/FALSE
1. The pharmaceutical manufacturer has the authority to add additional active ingredients to
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a previously approved pharmaceutical product.
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ANS: F y e
According to the 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 an
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d 1962, all labels must be accurate and include a listing of all active and inactive ingredient
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s.
PTS: 1 yey e
2. Drug strength may vary with each lot number of a medication. ANS: F
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The 1906 Pure Food and Drug Act established that all drugs marketed in the
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United States meet minimal standards of strength, purity, and quality. PTS: 1
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3. The Pure Food and Drug Act of 1906 established drug standards and official drug reference
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s.
ANS: T y e
This act established that all drugs marketed in the United States meet minimal standards of
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strength, purity, and quality. It also established two official references that established the s
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tandards for making each drug: The ye ye ye ye y e
U.S. Pharmacopeia (USP) and the National Formulary (NF). PTS: 1
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4. The 1906 Pure Food and Drug Act established consumer protections to prevent the inclusi
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on of “dangerous ingredients” without the knowledge of the consumer.
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ANS: T y e
Morphine is one example of a dangerous ingredient that may have been included without t
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he knowledge of the consumer.
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PTS: 1 yey e
5. Medication labels need only include the trade name of the drug. ANS: F
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Labels must include a listing of all active and inactive ingredients, warning
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labels on certain preparations, and generic names for the medication
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, PTS: 1 yey e
6. The prescriber of the medication is the only health care professional who is responsible fo
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r being aware of new medications, laws, and restrictions.
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ANS: F y e
The health care worker involved in administration of a medication also bears the responsibili
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ty of being aware of the laws and restrictions pertinent to that medication.
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PTS: 1 yey e
7. A double-ye
locked system is the recommended method for maintaining security of controlled substances.
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ANS: T y e
A double-
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locked system may include two separate key entries or an electronic user identification and p
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assword access system. ye ye
PTS: 1 yey e
8. Health care workers are responsible for maintaining records of all controlled substances rec
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eived, dispensed, and destroyed.
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ANS: T y e PTS: 1 yey e
9. Controlled substance records are to be kept for 10 years. ANS: F
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Records for the previous 2 years must be available at all times for inspection. PTS: 1
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MULTIPLE CHOICE ye
1. Identify the drug standard in the following list.
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a. Color c. Shape
b. Strength d. Taste
ANS: B y e
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A Color is not a standard.
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B Correct!
C Shape is not a standard.
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D Taste is not a standard.
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, PTS: 1 yey e
2. The risk of death from the use of street drugs versus prescription medications i
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s mostly due to:
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a. a lack of control over quality, purity, and st
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rength makes street drugs dangerous. ye ye ye y e
b. the risk is the same for both sources of the s
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ame substance. ye
c. street drugs are approved for use.
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d. the need for a prescription makes drugs
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hard to obtain. ye ye
ANS: A y e
Feedback
A Correct!
B The lack of enforcement of drug standar
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ds in illegal street drugs poses a significa
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nt danger for the consumer.
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C The exact composition of a street drug is un
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known, and it may contain dangerous conta ye ye ye ye y e ye
minants or undisclosed additional drugs. ye y e ye ye
D Street drugs are illegal. ye ye ye
PTS: 1 yey e
3. Drug standards regulate drug manufacture so that medications of the same name will be of
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the same: ye
a. strength, purity, and quality. ye ye ye
b. shape, color, and taste. ye ye ye
c. purity, shape, and color. ye ye ye
d. quality, color, and shape. ye ye ye
ANS: A y e
Drug standards state that all preparations of the same drug name must be of uniform strengt
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h, purity, and quality.
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PTS: 1 yey e
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 ye ye ye ye ye