01
True or false
1 point
When responding to a request to refill a Schedule II prescription, should the pharmacy keep the prescription and any required communications in its records?
Free Practice Quiz Question List
8 Federal Pharmacy Compliance Practice Cases Online Quiz Questions
Use this free practice quiz with 20 questions to review 8 Federal Pharmacy Compliance Practice Cases, test your knowledge, and prepare for your next test or exam.
20 questions
02
Choose one
1 point
A patient requests a refill of a Schedule II medication, but the prescription record shows no refills remaining. The patient says the prescriber intended to authorize more. What should the pharmacist do?
- A
Dispense the medication as a refill because the patient reports that the prescriber intended to authorize more.
- B
Do not dispense it as a refill; contact the prescriber for a new, valid prescription if treatment is to continue.
- C
Dispense one more refill, then contact the prescriber.
- D
Transfer the remaining refill authorization from another prescription.
03
Written response
1 point
If a controlled-substance discrepancy is determined to be a theft or significant loss, which DEA form must the pharmacy submit? Enter the form identifier.
04
Fill in the blank
1 point
When stock matches a drug recall notice, quarantine it so it cannot be .
05
Choose one
1 point
What health risk does an FDA Class I drug recall indicate?
- A
A remote probability of serious harm, with no possibility of temporary harm.
- B
A reasonable probability of serious harm or death.
- C
Adverse health consequences are unlikely.
- D
Possible temporary or medically reversible harm only.
06
True or false
1 point
True or false: Once a pharmacy knows a recall's class, it can rely on that class instead of following the specific recall notice.
- A
True
- B
False
07
Written response
1 point
If pharmacy records cannot distinguish whether a recalled lot reached patients, name one source from which the pharmacy should seek guidance.
08
Fill in the blank
1 point
When investigating a controlled-substance discrepancy, assess whether it is a theft or .
09
Choose all
1 point
Select all accurate descriptions of FDA Class II and Class III drug recalls.
- A
Class II: Possible temporary or medically reversible harm, or a remote probability of serious harm.
- B
Class II: A reasonable probability of serious harm or death.
- C
Class III: Adverse health consequences are unlikely.
- D
Class III: Possible temporary or medically reversible harm is expected.
10
True or false
1 point
True or false: Every small unexplained controlled-substance discrepancy automatically has the same DEA reporting outcome.
- A
True
- B
False
11
Choose all
1 point
Depending on the medication and REMS program, which of the following may be required before dispensing? Select all that apply.
- A
Pharmacy certification.
- B
Verification of prescriber certification.
- C
Payer approval, which is a universal REMS condition.
- D
Patient enrollment.
- E
Testing or another specified safe-use condition.
12
Choose one
1 point
A prescription is subject to a REMS that requires pharmacy certification and verification of safe-use conditions. The patient requests the medication today, but the system cannot confirm that the conditions are complete. What should the pharmacist do?
- A
Dispense now and complete the verification later.
- B
Dispense if the prescriber says the patient needs the medication today.
- C
Hold dispensing until the applicable requirements and verification are complete, and contact the appropriate parties to resolve the missing information.
- D
Use a general REMS checklist instead of checking the medication's program.
13
Open ended
1 point
A pharmacy receives a recall notice for a specific drug lot. Matching packages are in stock, dispensing records identify some patients who received the lot, and the records cannot distinguish whether other patients received it. Describe the pharmacy's actions for the stock, identifiable patients, and uncertain cases.
14
Choose one
1 point
During a closing count, staff find that the Schedule II inventory is short by several units, and the cause is not immediately clear. What is the best initial response?
- A
Immediately report every unexplained shortage to DEA, regardless of its size or circumstances.
- B
Secure the stock and records, promptly investigate and document the discrepancy, and assess whether it is a theft or significant loss requiring DEA reporting.
- C
Continue dispensing from the inventory while waiting for the next routine count.
- D
Discard the count records and recount only if a patient reports a problem.
15
Choose one
1 point
During a closing count, staff discover an unexplained shortage of several Schedule II units. Which response best follows the federal practice described for handling a discrepancy?
- A
Report every unexplained shortage to DEA immediately, regardless of its size or circumstances.
- B
Wait until the cause is proven before securing the stock or documenting the discrepancy.
- C
Secure the stock and records, investigate and document promptly, and assess whether the event is theft or significant loss.
- D
Adjust the inventory record to match the count and take no further action unless a patient reports a problem.
16
Choose one
1 point
A pharmacy receives a recall notice for a specific medication lot. Matching packages are in stock, and dispensing records may identify patients who received that lot. What is the best response?
- A
Match product and lot numbers, quarantine matching stock, follow the notice’s disposition instructions, and use records to identify potentially affected patients.
- B
Remove all products from the same manufacturer and discard them without checking the recall instructions.
- C
Keep dispensing the product until the manufacturer contacts each patient directly.
- D
Quarantine only packages already opened and leave unopened packages available for dispensing.
17
Choose one
1 point
Which FDA drug recall class describes a product that is unlikely to cause adverse health consequences?
- A
Class I
- B
Class II
- C
Class III
- D
Class IV
18
Choose one
1 point
REMS requirements vary by medication and program. What should a pharmacy consult to determine the applicable requirements before dispensing a REMS drug?
- A
A general REMS checklist used for all medications
- B
The current REMS materials for that specific drug and program
- C
The patient’s preference about which safe-use steps to complete
- D
A prior authorization decision from the payer
19
Written response
1 point
Which federal agency must a pharmacy notify when a controlled-substance event is determined to be a theft or significant loss?
20
Written response
1 point
Which FDA recall class applies when harm may be temporary or medically reversible, or when there is a remote probability of serious harm?