Download 1. The US Food and Drug Administration (FDA - Power

1. The U.S. Food and Drug Administration (FDA) Risk Evaluation and Mitigation
Strategy (REMS) document entitled a Blueprint for Prescriber Education for ExtendedRelease and Long-Acting Opioid Analgesics, released in 2012, was a
A. Set of guidelines to help guide the provider assess the benefits and the risks of
prescribing chronic opioid therapy (COT)***
B. Set of rules to help guide the provider when prescribing COT
C. Set of regulations to help guide the provider when prescribing COT
D. Set of legislation to help guide the provider when prescribing COT
Correct Answer: A
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to
require a REMS) from manufacturers to ensure that the benefits of a drug or biological
product outweigh its risks.
2. The FDA REMS document from 2012 endorses which of the following, as it relates
to COT:
A. Use of screening tools for aberrant drug seeking behavior associated with COT
B. Use of urine drug monitoring (UDM) when prescribing COT
C. USE of patient and prescriber agreements (PPAs) when prescribing COT
D. All of the above***
Correct Answer: D
The REMS document endorses the use of all the above when prescribing COT.
3. The use of Prescription Drug Monitoring Program (PDMP) reports helps to identify
those patients that may be exhibiting aberrant drug-seeking behavior by providing
which of the following:
A. A list of prescribers that have been prescribing a patient opiates***
B. A list of chemicals that are present in a patient’s body
C. A document that is signed by both the patient and provider that guides therapy
D. Data to the local Drug Enforcement Administration (DEA) office
Correct Answer: A
PDMP reports provide data about prescriptions that a given patient has received in
a given time frame, including a list of prescribers, a list of pharmacies where
prescriptions for the patient have been filled, and the patient’s medical history.
4. Which of the following is not a standard test given to patients to screen for risk for
opioid misuse:
A. Opioid Risk Tool (ORT)
B. Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)
C. Current Opioid Misuse Measure (COMM)
D. PPA***
Correct Answer: D
All the above are standard and accepted risk screening assessment tools used to
assess the risk for opioid misuse before a patient is prescribed a controlled
substance, EXCEPT ”PPA” which is the abbreviation for the patient and
prescriber agreement.
5. Which of the following contribute to the complexity of prescribing COT:
A. Patient expectations of COT therapy
B. Providers’ emotional reactions
C. Public health issues
D. All of the above***
Correct Answer: D
All of the above contribute to the complexity of prescribing COT.
6. Which of the following is the appropriate conversion morphine equivalent dose
(MED) for hydromorphone:
A. 1 MED
B. 1.5 MED
C. 3 MED
D. 5 MED***
Correct Answer: D
The equianalgesic MED for hydromorphone is between 4 and 7.
7. Which is the appropriate equianalgesic conversion MED for methadone
A. 1 MED
B. 1.5 MED
C. 3 MED
D. None of the above***
Correct Answer: D
There is no set conversion equianalgesic dose for methadone because the
conversion dose for methadone depends on the amount of morphine that a patient
is currently using.
8. Which of the following is a dose of morphine that is associated with a significantly
higher risk of accidental overdose:
A. 70 MED
B. 80 MED
C. 90 MED
D. 100 MED***
Correct Answer: D
A dose of more than 100 MED is associated with an 8 to 9 times higher risk of
accidental overdose.
9. If a patient is exhibiting aberrant drug seeking-behavior by repeatedly claiming
their opioid prescription has been lost and calling for early refills, which of the
following is the best course of action:
A. Provide the local DEA office with the patient’s name
B. When counseling the patient, keep the discussion solely on the patient safety***
C. Provide the local Board of Pharmacy with the patient’s name
D. When counseling the patient, focus solely on the patient’s actions
Correct Answer: B
By focusing on patient safety, the focus is taken off the patient’s actions and the
discussion generally goes smoother; referring the patient’s name to a law
enforcement agency is only appropriate in the case of prescription forgery or
selling of prescriptions
10. When dispensing a COT medication, which of the following can help the pharmacist
make the best decision:
A. Use the same tools and thought process as with any other chronic medication
B. Use a Universal Precautions model when counseling your patient
C. Use a T.H.I.N.K. model when counseling your patient
D. All of the above***
Correct Answer: D
By using all the tools that a pharmacist normally uses when counseling about
other chronic medications, as well as the tools employed by the Universal and
T.H.I.N.K. models of patient counseling, the pharmacist should be able to provide
patient counseling that provides the needed data to the patient and, at the same
time, removes the stigma associated with COT medications.