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. Schedule II drugs are controlled substances with a high potential for abuse. Proper disposal requires a witness, usually another nurse, to verify and cosign the waste to ensure accountability and prevent diversion.
B. Keeping the remaining drug in the patient’s drawer is unsafe and violates controlled substance regulations. Single-use vials should not be stored for later use.
C. While documentation of administered medication is necessary, simply recording the unused amount in the patient’s chart is insufficient. Controlled substances require proper disposal with a witness.
D. Controlled substances cannot be discarded in a general locked collection box without proper witnessing and documentation. The correct procedure is to have another nurse verify and cosign the waste before disposal.
Correct Answer is B
Explanation
a) Herbs are not classified as medications under the Dietary Supplement Health and Education Act of 1994. The law classifies them as dietary supplements, which are not subject to the same rigorous safety and efficacy standards as medications.
b) Discussing herbal remedies with the patient's provider is essential. Herbs can interact with prescribed medications, and their safety and effectiveness can vary. It is important for providers to be aware of any herbal remedies the patient is using to avoid potential harmful interactions.
c) Herbs are not regulated by the government in the same way as pharmaceuticals. The FDA does not determine their safety before marketing, and manufacturers are not required to prove safety or efficacy before selling them.
d) Herbs are not harmless. Some herbs may be ineffective, but others can cause adverse effects, especially when taken alongside other medications. Therefore, it's important to consider their safety in the context of the patient’s overall treatment plan.
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