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.
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Related Questions
Correct Answer is D
Explanation
A. Deficient knowledge may be a concern, but the primary focus here is on the safety risk associated with the side effects of the medication, particularly dizziness and orthostatic hypotension, which increase the risk of falls or injury.
B. Ineffective health maintenance is not specific to the medication side effects and does not directly address the patient's safety risk due to the medication.
C. Readiness for enhanced knowledge is more appropriate when the patient is already familiar with their condition and medication and is ready to learn more. This is not the case here, as the focus is on preventing harm from side effects.
D. Risk for injury is the most appropriate nursing diagnosis. Dizziness and orthostatic hypotension increase the risk of falls, which can lead to injury, making this the most relevant concern in this scenario.
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.
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