PPLE Module 3 (Reading, lectures,
and extra)
Patient labelling could help prevent serious adverse _ - answer effects
Medication Guides are required if the product has serious _ relative to its benefits of
which the patient should be aware in order to decide whether to use or continue to use
the product - answer risks
Patient adherence to directions is crucial to the drug's _ - answer effectiveness
Patient Package Inserts (PPIs) are required for _ - answer oral contraceptives
failure to include a PPI in an oral contraceptive is _ - answer misbranding
CMI is unreviewed and not regulated by the _ - answerFDA
Med Guides are only for _ (REMS drugs) - answerdangerous
When differentiatinng between giving a patient a CMI and a Med Guide, you HAVE to
give the patient the _. You can give both the Med Guide and the CMI as well -
answerMed Guide
Manufacturers must include a PPI for each contraceptive package, and pharmacists
must
include a PPI with each container dispensed regardless if it is a _ RX or a refill -
answernew
Consumer Medication Information: Congress enacted legislation requiring that
_% of patients getting a new RX would also get useful written information about
their medications - answer95
For specific medications, Medication Guides are required for both new and _ RXs and
Uniform format and _ approval required - answerrefill, FDA
A pharmacist who substitutes a B-rated drug product for the drug prescribed does not
violate the _ because the Orange Book is not a mandate; it is merely a guide. The
pharmacist might violate state law, however. In most states, substitution or switching is
allowed only if the drug is therapeutically equivalent or _ to the prescribed drug. In
addition, switching a B-rated product without evaluating and balancing the clinical risks
increases the pharmacist's risk of civil liability should a patient suffer injury. -
answerFDCA, bioequivalent
and extra)
Patient labelling could help prevent serious adverse _ - answer effects
Medication Guides are required if the product has serious _ relative to its benefits of
which the patient should be aware in order to decide whether to use or continue to use
the product - answer risks
Patient adherence to directions is crucial to the drug's _ - answer effectiveness
Patient Package Inserts (PPIs) are required for _ - answer oral contraceptives
failure to include a PPI in an oral contraceptive is _ - answer misbranding
CMI is unreviewed and not regulated by the _ - answerFDA
Med Guides are only for _ (REMS drugs) - answerdangerous
When differentiatinng between giving a patient a CMI and a Med Guide, you HAVE to
give the patient the _. You can give both the Med Guide and the CMI as well -
answerMed Guide
Manufacturers must include a PPI for each contraceptive package, and pharmacists
must
include a PPI with each container dispensed regardless if it is a _ RX or a refill -
answernew
Consumer Medication Information: Congress enacted legislation requiring that
_% of patients getting a new RX would also get useful written information about
their medications - answer95
For specific medications, Medication Guides are required for both new and _ RXs and
Uniform format and _ approval required - answerrefill, FDA
A pharmacist who substitutes a B-rated drug product for the drug prescribed does not
violate the _ because the Orange Book is not a mandate; it is merely a guide. The
pharmacist might violate state law, however. In most states, substitution or switching is
allowed only if the drug is therapeutically equivalent or _ to the prescribed drug. In
addition, switching a B-rated product without evaluating and balancing the clinical risks
increases the pharmacist's risk of civil liability should a patient suffer injury. -
answerFDCA, bioequivalent
