Exam 2 - Reading Questions

Question 1

An NDA is being reviewed by the FDA for approval. The product is used to treat pain and has been found to meet the factors for scheduling. The drug has a higher dependence liability than pregabalin, and it has a greater addiction potential than testosterone. Which of the following schedules is the most appropriate for its future schedule?

a. Schedule I
b. Schedule II
c. Schedule III
d. Schedule IV
e. Schedule V

Answer 1

b. Schedule II

Rationale: The scenario describes a product with a higher dependence liability than pregabalin (schedule 5) and a greater addiction potential than testosterone (schedule III). That means our product has to be either schedule I or II. We also know the drug has a medical use and treats pain, so only option B (schedule II) fits the description of the
product.

Question 2

Select all of the following that are factors considered when deciding whether a drug
should be scheduled.

a. Actual potential for abuse
b. Evidence of pharmacologic effect of the drug
c. Likelihood for use by practitioners
d. Ease of access
e. Psychologic or physiologic dependence

Answer 2

a, b, e

Rationale: Options A (potential for abuse), B (pharmacologic effect), and E (dependence) are in the list of factors for scheduling. Options C and D are not listed factors considered for scheduling.

Question 3

DEA registration is based on the activities a person engages in and the schedules of drugs
handled.
a. True
b. False

Answer 3

a. True

Question 4

A dentist, Dr. James, provides the DEA number BS1435038 when calling in a prescription
for triazolam. This DEA number is obviously fraudulent.
a. True
b. False

Answer 4

b. False

Rationale: This is false. Dentists are full prescribers that have a DEA number that begins with either an A, B. F, or G. The second letter corresponds to the prescriber’s name when first registered and they could have changed their last name, so that can be
different. And if you do the math, the check digit is appropriate, so this number is not obviously fraudulent.

Question 5

A person with a narcotic treatment program registration has no coincident activities that
can be performed.
a. True
b. False

Answer 5

b. False

Rationale: NTPs have coincident activities that were added around 2024. Previously they had no coincident activities they could perform.

Question 6

A patient brings in a prescription for alprazolam for anxiety after the death of a family member. It was written on today’s date by a hospital resident (MD) working on the ED service using an institutional DEA registration number with appropriate suffix. The patient is the neighbor of the resident and was discharged from the ED today. Can you legally fill this?

a. Yes, it meets all requirements for the appropriate use of an institutional DEA number.
b. No, it was not issued in the resident’s scope of employment.
c. Yes, it’s within the prescriber’s scope of practice.
d. No, prescribers cannot issue prescriptions for people they know.
e. Yes, it is not up to the pharmacist to verify that the MD can prescribe drugs where the hospital is located.

Answer 6

a. Yes, it meets all requirements for the appropriate use of an institutional DEA number.

Rationale: To use an institutional DEA number the prescriber must be working within their scope of employment within the usual course of professional practice in the institution and add their assigned DEA suffix to the prescription with the institutional DEA. The institution must verify their licensure and ability to prescribe which is done when assigning a suffix. The institution must then maintain a list of all assigned suffixes for prescribers. In the described situation we know that the provider is working in the ED and was seen in the ED today and prescribed the medication with their appropriate suffix on the prescription. This meets the requirements for prescribing and option A is appropriate. Keep in mind option C is not the most appropriate answer because it doesn’t consider all requirements needed for appropriate prescribing. Even if a
prescriber is working in their appropriate scope, they may not have been working for the hospital at the time of prescribing. Option E is incorrect because as we’ll see in a later reading, pharmacists have a corresponding responsibility for ensuring the proper prescribing and dispensing of a prescription. Options B and D are both incorrect as the prescriber was working, and there’s no limitation in prescribing for someone you know,
even if we may not like it.