(T/F) There are a limited number that the FDA requires the pharmacist to provide a patient package insert with the prescription Correct Answer-True
What are examples of drugs that require a patient package insert when prescribed? Correct Answer-Oral contraceptives
Estrogen-containing drugs
...
PHCY 722 - Quiz 3 Questions with Correct Answers
(T/F) There are a limited number that the FDA requires the pharmacist
to provide a patient package insert with the prescription Correct Answer-
True
What are examples of drugs that require a patient package insert when
prescribed? Correct Answer-Oral contraceptives
Estrogen-containing drugs
Progestational drugs
Estrogen-progestogen oral contraceptives
DES, IUD
What kind of FDCA violation is it when a drug that requires a patient
package insert does not come with one? Correct Answer-Misbranding
A med guide can be thought of as a predecessor for ___________
Correct Answer-REMS
(T/F) The FDA requires that some drugs be dispensed with a med guide
Correct Answer-True
,Whose responsibility is it that pharmacies have med guides to provide
with each necessary drug? Correct Answer-Manufacturer of said drug
What are concerns about the med guide program? Correct Answer-Poor
distribution and availability of Med Guides
Information overload for patients
Interference with work flow
What legal requirement is there to provide med guides with
prescriptions? Correct Answer-None; it is a standard of practice issue,
not a legal one
(T/F) The FDCA prohibits the prescription of medications for off-label
use Correct Answer-False
What are the positives to allowing the prescription of drugs for off-label
use? Correct Answer-Allows clinicians to take advantage of new bodies
of knowledge about drugs as they become available, without having to
wait through the cumbersome process of the drug getting approved for a
separate indication
Patients ultimately benefit from this
, How is an incompetent clinician who is prescribing drugs off-label in an
inappropriate manner dealt with? Correct Answer-Regulatory agency
can revoke license
Malpractice
(T/F) Pharmacists have the authority to refuse to dispense a drug that is
being used off-label Correct Answer-True
(T/F) Pharmacists are required to refuse to dispense a drug that is being
used off-label Correct Answer-False
How do pharmacists determine whether or not to refuse to dispense a
drug that is being used off-label? Correct Answer-Clinical judgement --
determine whether the prescription is appropriate or not
How do pharmacists know whether or not a drug is being used off-label
or not? Correct Answer-Clinical judgement -- sometimes it can be
difficult, however, since prescribers don't necessarily have to include the
indication in the prescription order
Why would prescribers be opposed to a law requiring that indications be
included on all prescriptions? Correct Answer-"How dare you pill
pushers question me?" (cringe)
Would have to incorporate an extra step in workflow
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