Components of a REMS program may include:

Correct Answer: D

Rationale: Choice D is correct because REMS programs can include medication guides (patient education), communication plans (provider awareness), and restricted distribution (controlled access), per FDA guidelines. Choice A is incorrect alone as it's one component. Choice B is wrong by itself because communication is just part. Choice C is incorrect solo since restriction is only one element.

Correct Answer: C

Rationale: Choice C is correct because corticosteroids (e.g., prednisone) increase bone resorption, raising osteoporosis risk, unlike the others. Choice A is incorrect as testosterone supports bone density. Choice B is wrong because estrogen prevents osteoporosis. Choice D is incorrect since only corticosteroids fit.

Correct Answer: D

Rationale: Choice D is correct because off-label use lacks FDA approval (unregulated indication), risks ADRs (untested context), and may have limited evidence, per pharmacology concerns. Choice A is incorrect alone as it's one risk. Choice B is wrong by itself because ADRs are just part. Choice C is incorrect solo since evidence is only one issue.

Correct Answer: C

Rationale: The correct answer is C because a higher concentration (500 mg/5 mL) and bid dosing simplifies administration, enhancing compliance. Choice A is incorrect (lower concentration, less convenient). Choice B is wrong (tid less convenient). Choice D is inaccurate (tid and lower dose inconvenient).

Correct Answer: B

Rationale: Choice B is correct because a peak level above the minimum toxic concentration indicates the drug concentration exceeds the safe therapeutic range, likely causing adverse effects. Choice A is incorrect as therapeutic effects occur below toxicity, not above. Choice C is wrong because shortening doses doesn't address an already toxic level; dose reduction is needed. Choice D is incorrect since duration isn't the issue—peak concentration is.

Correct Answer: A

Rationale: Choice A is correct because the Institute of Medicine recommends transparency in conflicts of interest to reduce bias in prescribing education, promoting objectivity. Choice B is incorrect as banning reps isn't a universal recommendation—disclosure is preferred. Choice C is wrong because samples aren't tied to insurance status in this context. Choice D is incorrect since even low-value gifts can influence, and disclosure is the broader solution.

Correct Answer: C

Rationale: Choice C is correct because isotretinoin (Category X) causes severe birth defects and is avoided in pregnancy unless benefits (e.g., life-saving) outweigh risks, unlike others. Choice A is incorrect as fluoxetine (Category C) is often used if benefits justify it, with less severe risk. Choice B is wrong because acetaminophen (Category B) is generally safe in pregnancy. Choice D is incorrect since only isotretinoin fits the strict avoidance criterion.

Correct Answer: A

Rationale: Choice A is correct because acetaminophen is hepatotoxic in high doses, especially risky in liver disease, per hepatology guidelines. Choice B is incorrect as aspirin's liver impact is minimal. Choice C is wrong because ibuprofen is metabolized renally, less liver-dependent. Choice D is incorrect since only acetaminophen fits.

Correct Answer: D

Rationale: Choice D is correct because improper storage can reduce potency (degradation), increase toxicity (chemical changes), and alter appearance (e.g., discoloration), per pharmacology principles. Choice A is incorrect alone as it's one effect. Choice B is wrong by itself because toxicity is just part. Choice C is incorrect solo since appearance is only one outcome.