Page 23 - FPGEE Management Q&A Book

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ANSWERS

1.(d) All. According to the Orange Book, the FDA will 4. (a) Current DUR procedures in most healthcare
consider a generic product equivalent to a brand plans focus on product-centered utilization trends.
(innovator) drug when both the rate and extent of For example, at the time of analyzing the DUR study
absorption are not significantly different when most of the attention is given to drug products in
administered in the same molar dose of therapeutic terms of dollar costs and total unit dispensing rate.
ingredient under similar experimental conditions in This sometimes may result in unwarranted
single or multiple-dose studies. physician inquiries and intervention that are not
clinically significant.
The FDA has established specific statistical
standards to make the determination of For example, if a patient is taking a proton pump
bioequivalence. Two basic criteria must be met for inhibitor for several months, the computer will
two products to be considered bioequivalent: mark the patient profile to be reviewed for DUR
under the category of “exceeds appropriate
1. The rate and extent of absorption between the duration of use.” The DUR performer in this type of
innovator (also called the “reference”) study does not look in depth for the past patient
company’s product and that of the generic history of severe erosive esophagitis or gastric
manufacturer’s formulation may differ by - surgery.
20%/+25% or less.
In most cases, the drug has been used
2. The 90% confidence interval (CI) for the ratio of appropriately; however the person performing the
the mean response (i.e. AUC, Cmax) of the DUR has been forced into product-centered DUR
generic product to the innovator, using log- without considering the patient past history or
transformed data, is within the limits of 0.8 to clinical status.
1.25.
Switching to patient-centered DUR study provides
2. (b) The prescription for Schedule III, IV and V more accurate clinical status of the patient and
drugs should not be filled after six months helps controlling healthcare cost as well as provides
(07/01/2021) from the date issued, or refilled more more efficient healthcare related services. In this
than 5 times within a 6-month period. type of study, importance is primarily given to
inappropriate utilization of medications and
3. (d) All. Physician assistants (PAs) are healthcare screening of targeted patient-population.
professionals licensed to practice medicine under
the physician’s supervision. For example, patients who are elderly with prior
history of bone fractures and falls may be screened
As part of their comprehensive responsibilities, PAs for drugs that may potentially cause additional falls
conduct physical exams, diagnose and treat and fractures or for drugs that may adversely affect
illnesses, order and interpret laboratory tests, bone mass index. This may include excessive or
counsel on preventive healthcare, assist in surgery, inappropriate use of sedatives or benzodiazepines,
and in most states can write prescriptions. which may cause additional falls.

Because of the close working relationship the PAs 5. (d) All. Medicare Part C, formerly known as
have with physicians, they are educated in the “Medicare+Choice,” is now known as “Medicare
medical model designed to complement physician Advantage.” If a patient is entitled to receive
training. Medicare Part A and enrolled in Part B, he/she is
eligible to switch to a Medicare Advantage plan,
provided that the patient resides in the plan’s

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