CHAPTER 2 : DRUG REGULATIONS EXAM QUESTIONS

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CHAPTER 2 : DRUG REGULATIONS EXAM QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -24 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: 1) Which was the greatest problem with patent medicines in early America that led to drug legislation?

• They were only distributed in elixir formulation.
• They had dangerous or addictive substances.
• They smelled like medicine.
• They could only be made out of natural products.

Answer:

Answer: 2

Explanation: Many did contain dangerous or addictive substances such as morphine or cocaine.

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Question 2: 14) Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of a control group. A client asks the nurse what a placebo is. Which response by the nurse is the most appropriate?

• "A placebo is a substance that has no therapeutic effect."
• "A placebo is a similar drug that is safe."
• "A placebo is a drug that has been tested before."
• "A placebo is an over-the-counter drug."

Answer:

Answer: 1

Explanation: A placebo is an inert substance that has no therapeutic effect and is used as a control.

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Question 3: 9) Nursing students are studying which drug types must have Food and Drug Administration (FDA) approval before being marketed. The students know that which drugs must have approval from the FDA before being marketed?

• Biologics
• Cosmetics
• Herbal preparations
• Dietary supplements

Answer:

Answer: 1

Explanation: Biologics must have FDA approval before being marketed.

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Question 4: 20) The nurse is working in a cancer treatment center. A client diagnosed with terminal cancer has received a prescription for morphine (MS Contin), a Schedule II drug for pain control. After medication teaching, which statement by the client indicates appropriate understanding?

• "I should call the office three days before I need a refill called in to the pharmacy."
• "I will need to see the provider each time for my refill."
• "This is an addictive drug, so I should try not to take it."
• "After the first prescription, my doctor will be able to call in my prescription."

Answer:

Answer: 2

Explanation: The client will need to see the provider each time a refill is needed.

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Question 5: 12) The client receiving a newly released medication is experiencing adverse effects. Why does the nurse report these adverse effects as part of the postmarketing surveillance stage of the drug approval process?

• The clinical trials are continuing to collect new data.
• Individual client response is compared with the clinical trial data.
• The efficacy of the drug is determined for new drugs.
• Harmful effects in the larger population continue to be monitored.

Answer:

Answer: 4

Explanation: Some harmful effects are subtle, take longer to appear, and are not identified until the drug is prescribed to a large number of people; thus, postmarketing surveillance for harmful effects must be reported.

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Question 6: 13) Which statements regarding the preclinical research stage of drug development are true? Select all that apply.

• Most drugs do not proceed past the preclinical stage because they are found to be too toxic

or just ineffective.

• At the end of the preclinical research stage, client variability is determined and potential

drug-drug interactions are examined.

• The preclinical stage of research involves extensive testing on animals in the laboratory to

determine if the drug will cause harm to humans.

• Preclinical research results are always inconclusive.
• The Food and Drug Administration (FDA) is responsible for extensive testing for safety before

the pharmaceutical company can begin the preclinical research stage of development.

Answer:

Answer: 1, 3, 4

Explanation: Most drugs do not proceed past the preclinical research stage of development because they are found to be either too toxic or just ineffective.The preclinical stage of development involves extensive testing on human and microbial cells and on animals to determine drug action and to predict whether the drug will cause harm to humans.Because lab tests cannot accurately predict human response to a drug, preclinical research results are always inconclusive.

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Question 7: 6) One of the first standards used by pharmacists for preparation and potency of drugs was a formulary. What did early formularies contain?

• Names of patent medicines and natural drugs
• Lists of pharmaceutical products and drug recipes
• Lists of various drugs' strengths based on individual pharmacies
• Lists of various drugs' potency based on geographic region

Answer:

Answer: 2

Explanation: Early formularies did contain a list of pharmaceutical products and drug recipes.

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Question 8: 21) A nurse educator is preparing a lecture regarding prescriptive authority for advanced practice registered nurses (APRNs). Which statement is appropriate for the educator to include in the lecture regarding this topic?

• APRNs can only prescribe medications when under the supervision of a physician.
• APRNs prescribe medications based on federal regulations.
• APRNs prescribe medications based on state regulations.
• APRNs prescribe medications based on local regulations.

Answer:

Answer: 3

Explanation: APRNs prescribe medications based on state regulations. This is an appropriate statement to include in the lecture.

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Question 9: 10) Which statements regarding the role of the U.S. Food and Drug Administration (FDA) are true? Select all that apply.

• The FDA is responsible for ensuring the security of human drugs.
• The FDA publishes a summary of the standards of drug purity and strength.
• The FDA ensures the availability of effective drugs.
• The FDA takes action against any supplement that is deemed to be unsafe.