Health Professions, 9th Edition Bruce Colbert
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, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
Solution and Answer Guide
Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety
and Drug Regulations
Table of Contents
Chapter Review Quiz Answers........................................................................................................... 2
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
Chapter Review Quiz Answers
1. The first major U.S. drug law was passed in the year _______ and was called the
___________________
Answer: 1906, Pure Food and Drug Act
Feedback: The Pure Food and Drug Act is the first drug law passed in 1906 to
ensure consumer safety.
2. USP stands for ______________________________________________________________________
Answer: United States Pharmacopeia
Feedback: The United States Pharmacopeia is a reference that specifies the official
U.S. standards for making individual drugs.
3. NF stands for ________________________________________________________________________
Answer: National Formulary
Feedback: The National Formulary (NF) is another reference that specifies the
official U.S. standards for making individual drugs. It has been combined with the
United States Pharmacopeia (USP) into one reference book, the USP/NF
4. Which drug law established the USP and NF (which are now one)?
Answer: The Pure Food and Drug Act
Feedback: The 1906 Pure Food and Drug Act established two references of officially
approved drugs: the USP and NP, which were subsequently combined into one
single reference source.
5. The agency that requires you to keep a record of each controlled substance
transaction is the __________
Answer: Drug Enforcement Agency
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances. Anyone who dispenses, receives,
sells, or destroys controlled substances must keep on hand special DEA forms,
indicating the exact current inventory and a two-year inventory of every controlled
substance transaction.
6. Schedule C-______________________________________________ has the lowest potential for
abuse.
Answer: Schedule C-V has the lowest potential for abuse
Feedback: The 1970 Controlled Substances Act classified abused and addicting
drugs into five levels, or schedules, according to their medical value, harmfulness,
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 2
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
and potential for abuse or addiction: C-I, C-II, C-III, C-IV, and C-V, with class C-1 being
the highest potential for abuse, and C-V with the lowest potential for abuse.
7. How long must you keep an inventory record of each controlled substance
transaction at your office? ___
Answer: Two years
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances, including a two-year inventory of
every controlled substance transaction (also see feedback to question 5).
8. Three responsibilities of the FDA include:
_________________________________________________
Answer: Three responsibilities of the FDA may include any of the following:
Oversee testing of all proposed new drugs before they are approved for
marketing
Investigate and remove unsafe drugs from the market
Ensure proper labeling of drugs, foods, and cosmetics
Review new drug applications and petitions for food additives
Inspect plants where foods, drugs, medical devices, or cosmetics are made
Feedback: The increase in the number of drugs produced for marketing brought
dangers to the public. The federal FDA was established to ensure that some basic
standards would be followed. Its responsibilities include the five listed in the
answers above.
9. What types of drugs are listed in the C-V schedule?
__________________________________________
Answer: Drugs that have the lowest abuse potential among the five classes or
schedules of controlled substance, and primarily consist of cough suppressants
containing codeine and antidiarrheal preparations such as diphenoxylate
Feedback: The 1970 Controlled Substances Act classified abused and addicting
drugs into five levels, or schedules, according to their medical value, harmfulness,
and potential for abuse or addiction: C-I, C-II, C-III, C-IV, and C-V, and drugs with the
C-V classification have the lowest potential for abuse.
10. What method is recommended for securing the controlled substances at your
office? ________________.
Answer: The drugs should be kept inside a locked safety box, which is then placed
within in a cupboard that is also locked.
Feedback: The Drug Enforcement Administration enforces security and
accountability related to controlled substances, including that all controlled
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 3
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
substances must be kept inside a locked safety box, which is then placed within in a
cupboard that is also locked.
11. If a patient calls to request a refill of a Percocet (C-II) prescription, how would you
reply? _____________
Answer: A refill for a C-II substance cannot be called into a pharmacy as a new
prescription is required by law.
Feedback: The 1970 Controlled Substances Act set regulations as to which
schedules prescriptions may be phoned in to the pharmacy. A refill for a C-II
substance cannot be called into a pharmacy as a new prescription is required.
12. Dawn Vasquez has a rare disease that requires medication for only a small
population of patients. Which act has allowed her drug to be produced even though
it is not profitable to the pharmaceutical industry?
Answer: The Orphan Drug Act of 1983
Feedback: The 1983 Orphan Drug Act provides pharmaceutical companies financial
incentives to develop medications for diseases that affect only a small number of
people, so that orphan drugs that would otherwise be of low profitability would be
available to patients with rare diseases.
13. A patient calls into the office asking for a new prescription for a narcotic medication
that he has been taking for six months. You bring up his chart and notice that he
has been requesting new prescriptions every 23 days, whereas the medication
should last 30 days. Additionally, the patient also mentions that he feels that he is in
need of a higher dose and gets agitated and irritable when you tell him that he will
need an appointment. What do you think of this? What should you do?
Answer: The medication taking behavior suggests a potential pattern of drug abuse.
Nevertheless, the most appropriate action should be to notify the patient’s
physician so that s(he) can assess the real need of an increase in the dose and/or
frequency of administration.
Feedback: The prescription fill record indicated that the patient is getting the
narcotic more frequently that what is allowed by his physician for his medical
condition. Given the high potential of narcotic abuse, such request needs to be
addressed by the physician.
14. Each drug is given a ____________ number to identify the manufacturer, the drug, and
the package size.
a. FDA
b. USP
c. DEA
d. NDC
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website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
Answer: d
Feedback: The National Drug Code (NDC) is a directory of numerical code that
allows identification of a drug, as well as the package size and the manufacturer.
This directory provides a list of all drugs manufactured for commercial distribution.
The NDC is comprised of three parts: the first part is five numbers and identifies the
manufacturer., the second part is four numbers and identifies the drug, and the
third part is two digits that identifies the package size.
15. Drug standards insure consistency in all the areas EXCEPT
a. strength
b. purity
c. quality
d. size
Answer: d
Feedback: Drug standards assure consumers that the drug they take are of uniform
strength, purity, and quality
16. The Federal Food, Drug, and Cosmetic Act of 1938 established which agency?
a. NDC
b. DEA
c. FDA
d. USP
Answer: c
Feedback: The Federal Food, Drug, and Cosmetic Act of 1938 established the Food
and Drug Administration (FDA).
17. The earliest recorded use of drugs occurred during which civilization?
a. Egyptian
b. Roman
c. Greek
d. Aztec
Answer: a
Feedback: The first documented use of drug was in ancient Egypt.
18. Answer the questions concerning the following three drug labels:
a. Which drug(s) requires a prescription?
Answer: Morphine Sulfate and Procardia (nifedipine)
Feedback: Both Morphine and Procardia (nifedipine) require a prescription and
cannot be purchased over the counter.
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 5
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 1: Consumer Safety and Drug
Regulations
b. Which drug(s) can be bought without a prescription?
Answer: Acetaminophen
Feedback: Acetaminophen can be obtained over the counter from any pharmacy
without a prescription.
c. Which drug(s) requires a DEA number?
Answer: Morphine Sulfate
Feedback: Morphine is a controlled substance that requires not only a prescription
but also that the ordering and dispensing, respectively, needs to be by a physician
and a pharmacist that have a DEA number indicating their proper registration with
the agency.
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website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 2: Drug Names and References
Solution and Answer Guide
Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 2: Drug Names and
References
Table of Contents
Chapter Review Quiz Answers........................................................................................................... 2
© 2023 Cengage. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible 1
website, in whole or in part.
, Solution and Answer Guide: Colbert, Essentials of Pharmacology, 9e, © 2023, 9780357618301; Chapter 2: Drug Names and References
Chapter Review Quiz Answers
Match the definition with the term.
Definition Term Answer
1. List of conditions for which a drug is c. Indications
meant to be used
2. Subcategories of drugs based on their f. Classifications
effects on the body
3. Description of the cellular changes e. Actions
that occur as a result of a drug
4. Conditions for which a drug should a. Contraindications
not be given
Refer to the following drug description to answer questions 5–8.
AZO Standard®
(phenazopyridine HCl tablets, USP)
Product of i-Health, a Division of DSM
Description: AZO Standard (phenazopyridine HCl) is a urinary tract analgesic agent,
chemically designated 2,6-pyridinediamine, 3-(phenylazo), monohydrochloride.
5. The generic name of the drug is
_________________________________________________________
Answer: phenazopyridine HCl
Feedback: The generic name of a drug is a common or general name assigned to
the drug by the United States Adopted Name (USAN) council. It is different from the
trade name by initial lowercase letter and never capitalized.
6. The chemical name of the drug is
_______________________________________________________
Answer: 2,6-pyridinediamine, 3-(phenylazo), monohydrochloride
Feedback: The chemical name of a drug describes the exact molecular formula of
the drug and usually comprises of long, very difficult name to pronounce.
7. The trade name of the drug is
__________________________________________________________
Answer: AZO Standard
Feedback: The trade name of a drug is the name by which a pharmaceutical
company identifies its product. It is copyrighted and used exclusively by that
company and is different from the generic name by capitalized first letter. It is often
shown on labels and references with the symbol ® (for “registered” trademark) after
the name.
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website, in whole or in part.