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 B
Explanation
a) The Physician's Desk Reference (PDR) is a valuable resource but is primarily designed for physicians. It contains drug manufacturer information but may lack nursing-specific details like patient education, nursing interventions, and administration guidelines.
b) A Nurse's Drug Guide/Handbook is the best resource for nurses because it includes essential nursing considerations such as patient education, side effects, contraindications, nursing interventions, and administration tips.
c) A drug package insert provides useful information but is not comprehensive and does not include nursing-specific recommendations. It primarily contains manufacturer-provided details on indications, dosing, and warnings.
d) Drug Facts and Comparisons is a resource primarily used by pharmacists for comparing medications rather than providing nursing-focused drug information.
Correct Answer is ["A","C"]
Explanation
a) Teaching the patient how to cope with therapy is part of the nurse's responsibility to ensure the patient understands the treatment regimen, side effects, and how to manage any challenges, thus improving outcomes.
b) Providing therapy refers to administering medications, but nurses generally do not "provide therapy" in the broader sense (such as deciding what therapy a patient needs beyond the prescribed drug regimen).
c) Evaluating the effectiveness of therapy is the nurse's responsibility as part of the ongoing assessment. The nurse should monitor how well the drug is working and identify any adverse effects.
d) Altering the drug regimen is outside the nurse’s scope of practice. Nurses can suggest changes or communicate concerns, but altering drug regimens requires a healthcare provider’s approval.
e) Recommending over-the-counter medications for adverse effects is not within the nurse's scope unless advised by a healthcare provider. Nurses should guide patients based on provider orders and not independently suggest over-the-counter remedies.
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