What was the rationale for the 1992 changes in the Food and Drug ...

[Wadzanai]

What was the rationale for the 1992 changes in the Food and Drug Administration's regulations to permit accelerated approval of drugs for the treatment of life-threatening or severely debilitating disease?
 
  a. To allow for marketing before completion of phase II of drug trials
  b. To ensure that the unknown risks associated with early approval are balanced by the need for effective drugs
  c. To change the rules because existing FDA regulations were too stringent for potentially effective drugs
  d. To accelerate approval of new drugs to give prescribers the option of using them without research findings

Question 2

A nurse is providing education to a patient preparing for discharge from the clinic. The nurse understands that the best way to promote compliance in the patient going home on a new medication is to
 
  a. provide a video for the patient to watch at home.
  b. provide a pamphlet on the new medication.
  c. monitor the patient for an adverse drug response prior to discharge.
  d. ask the patient to restate the instructions and verify understanding.

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Answer to Question 1

ANS: B
Accelerated drug approval was needed to ensure that effective drugs necessary for life-threatening and/or severely debilitating diseases were available but with a balance of benefit/effectiveness and risk.
Phase II drug trials are related to the therapeutic utility and dosage range, not to accelerated approval of drugs.
FDA regulations were not stringent enough, but became so over time to protect consumers.
Accelerated approval of new drugs did not give prescribers the option to use them without research findings. Drugs are approved only after a rigorous clinical trial and research process.

Answer to Question 2

ANS: D
Having the patient to restate the instructions allows the nurse to verify patient understanding.
The nurse will not be able to assess whether the patient learned from the video, because the patient will watch it at home after discharge.
The nurse will not be able to assess whether the patient actually read the pamphlet and understood its contents.
Monitoring the patient does not ensure compliance with the medication and is not indicated in this situation.

[Wadzanai]

TY

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