REAL EXAM QUESTIONS AND CORRECT ANSWERS (VERIFIED
ANSWERS) GRADED A+ ASSURED SUCCESS !!
Professions with no prescriptive authority in WI - ANSWER--
Psychologists
-Naturopaths
-Chiropractors
-Dietitians
-OT/PT
Physician assistant (PA) prescribing rules - ANSWER--practice
under physician
oversight OR
CPA
-limited to scope of experience
and training
-no requirement for
cosigning
Required Rx label info - ANSWER--pharmacy name/address
-Rx#
-date filled
, -patient name
-prescriber name
-directions for use
-drug name/strength/qty
-refill qty
-expiration
CS: must have original dispensing date and axillary label
Animals: name of animal, species, owner's last name, vet
name/address,
withdrawal time
PRN
Repackaging label requirements - ANSWER--drug
name/form/strength
-
BUD
-NDC + mfr lot OR mfr + mfr lot OR pharmacy
control number
Breakthrough Therapy - ANSWER-Submitted with IND, treats
serious condition
,AND preliminary clinical evidence indicates a potential
substantial improvement
over current
therapies
Accelerated Approval - ANSWER-Discussed with review
divisions
Treats a serious condition AND provides a meaningful
advantage over current
therapies
Approval is based on surrogate endpoint likely to predict clinical
benefit (requires
confirmatory
trials)
Priority Review - ANSWER-Submitted with NDA/BLA, treats a
serious condition
AND provides a significant improvement in safety or
effectiveness
Shorter review time (6 vs 10 months)
, Risk Evaluation and Mitigation Strategy (REMS) - ANSWER-Drug
safety program
required for certain meds with serious
safety concerns
Six
factors
-seriousness of any known or
potential AEs
-expected
benefit
-seriousness of disease or
condition treated
-whether the drug is a new
molecular entity
-expected or actual duration of
treatment
-estimated size of the population likely to
use the drug
Emergency Use Authorization (EUA) - ANSWER-Authorizes
formally unapproved
products for temporary use as emergency
countermeasures