Which are responsibilities of the FDA? (Select all that apply.)
To ensure a drug is tested for harmful effects.
To ensure a drug has accurate labeling.
To ensure a drug is free from adverse reactions.
To ensure a drug is affordable.
To ensure a drug is effective.
Correct Answer : A,B,E
a) The FDA is responsible for overseeing the testing of drugs for harmful effects, including preclinical trials and clinical trials, to ensure that drugs do not cause unsafe side effects.
b) The FDA ensures that drugs have accurate labeling, including correct dosage, potential side effects, contraindications, and proper use.
c) The FDA does not guarantee that a drug will be free from adverse reactions. While they regulate and monitor drugs, adverse reactions can still occur after approval, and it is the responsibility of healthcare professionals and the manufacturer to monitor for these post-marketing.
d) The FDA does not ensure drug affordability; the pricing of drugs is influenced by many factors, including market forces, healthcare policies, and manufacturer decisions.
e) The FDA ensures that drugs are effective by overseeing clinical trials to demonstrate that the drug has the intended therapeutic effects for its indicated use.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is A
Explanation
a) The safest action is to consult the pharmacist to determine if the chewable tablet can be crushed without affecting its efficacy or safety. Some chewable tablets must be chewed for proper absorption, while others may be safely crushed.
b) Crushing the tablet without verifying its safety could alter the drug's effectiveness or cause adverse effects, so it should not be done without confirmation.
c) Insisting that the tablet be chewed disregards the child’s potential difficulty with chewing, which may lead to refusal or improper administration.
d) Requesting a liquid form could be an alternative, but it is not the immediate next step. Some medications may not be available in liquid form, so checking with the pharmacist first is the appropriate action.
Correct Answer is A
Explanation
a) Oral medications, such as oral analgesics, undergo a disintegration process in the gastrointestinal (GI) tract before they can be absorbed into the bloodstream. Tablets and capsules must break down into smaller particles to be dissolved and absorbed.
b) Subcutaneous medications bypass the GI tract and are absorbed directly into the tissue, so they do not require a disintegration process.
c) Intramuscular injections are directly absorbed into the bloodstream from muscle tissue and do not require disintegration.
d) Intravenous drugs are delivered directly into the bloodstream and are immediately available for action, eliminating the need for disintegration.
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