MPJE Pharmacy Operations and Recordkeeping Questions and Answers — Questions and Answers
Question 1: A pharmacy needs to destroy a small quantity of expired and damaged hydrocodone/acetaminophen tablets (Schedule II) from its inventory. According to federal law, which of the following is the correct procedure for recording this destruction?
- Complete a DEA Form 106 and have it signed by the pharmacist-in-charge.
- Transfer the substances to a DEA-registered reverse distributor using a DEA Form 222.
- Document the destruction on a DEA Form 41, which must be signed by two authorized employees who witnessed the destruction, and maintain it in the pharmacy's records. (Correct answer)
- Dispose of the tablets in a collection receptacle and notate the disposal in the biennial inventory.
Correct answer: Document the destruction on a DEA Form 41, which must be signed by two authorized employees who witnessed the destruction, and maintain it in the pharmacy's records.
Federal regulations require that when a DEA registrant destroys a controlled substance, the destruction must be recorded on a DEA Form 41. This form must be completed and signed by two authorized employees who personally witnessed the destruction, which must render the substance non-retrievable. The completed form is to be maintained with the pharmacy's records and does not need to be sent to the DEA unless requested.
Question 2: A community pharmacy files its paper prescriptions for controlled substances using a three-file system. Which of the following accurately describes a federally compliant three-file system?
- One file for Schedule II, one file for Schedules III-V, and one file for all non-controlled prescriptions. (Correct answer)
- One file for all controlled substances (Schedules II-V) and two separate files for non-controlled prescriptions.
- One file for Schedule II and another for Schedule III, with Schedules IV, V, and non-controlled substances filed together.
- One file for Schedule II, one file for non-controlled, and one file for all other controlled substances (III, IV, and V) filed together.
Correct answer: One file for Schedule II, one file for Schedules III-V, and one file for all non-controlled prescriptions.
According to 21 CFR 1304.04(h), paper prescriptions for Schedule II controlled substances must be maintained in a separate file. Prescriptions for Schedules III, IV, and V controlled substances must be maintained either in a separate file for just those schedules or in such a form that they are readily retrievable from the other prescription records of the pharmacy. A common and compliant method is a three-file system: one for C-IIs, one for C-III through C-V, and one for non-controlled drugs.
Question 3: The Secure and Responsible Drug Disposal Act of 2010 allows ultimate users to dispose of their unwanted pharmaceutical controlled substances. Which of the following is NOT a DEA-authorized method for an ultimate user to dispose of these medications?
- Depositing them in an authorized collection receptacle at a local pharmacy that is registered as a collector.
- Returning them to the pharmacy where they were originally dispensed for destruction if the pharmacy is not a registered collector. (Correct answer)
- Using a mail-back package provided by a DEA-authorized collector.
- Giving them to law enforcement during a take-back event.
Correct answer: Returning them to the pharmacy where they were originally dispensed for destruction if the pharmacy is not a registered collector.
The Secure and Responsible Drug Disposal Act and its implementing regulations expand disposal options for ultimate users to include take-back events, mail-back programs, and collection receptacles at authorized locations. A pharmacy cannot accept controlled substances back from a patient for disposal unless it has modified its DEA registration to become an authorized collector. Simply being the original dispensing pharmacy does not grant this authority.
Question 4: A pharmacist discovers a significant loss of alprazolam (Schedule IV) during a monthly review. The pharmacy immediately notifies the local DEA Field Division Office in writing within one business day. According to federal regulations effective in 2023, what is the maximum time frame the pharmacy has to complete and electronically submit the DEA Form 106?
- 7 calendar days
- 15 calendar days
- 30 calendar days
- 45 calendar days (Correct answer)
Correct answer: 45 calendar days
A DEA final rule effective July 24, 2023, amended the regulations for reporting theft or significant loss. While the initial written notification to the local DEA field office is still required within one business day of discovery, registrants now have 45 calendar days from the discovery of the loss to complete their investigation and electronically submit the DEA Form 106.
Question 5: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 sets requirements for prescribing controlled substances via the internet. Generally, what is the primary requirement a practitioner must meet before they can legally issue a prescription for a controlled substance to a patient based on a telemedicine encounter?
- The practitioner must obtain a special telemedicine registration from the DEA.
- The practitioner must have conducted at least one prior in-person medical evaluation of the patient. (Correct answer)
- The patient must sign a specific consent form acknowledging the risks of remote prescribing.
- The practitioner must record the entire telemedicine encounter and store it for two years.
Correct answer: The practitioner must have conducted at least one prior in-person medical evaluation of the patient.
The Ryan Haight Act generally requires that a prescribing practitioner must have conducted at least one in-person medical evaluation of the patient before issuing a prescription for a controlled substance via the internet or telemedicine. While there are exceptions and temporary waivers (such as those enacted during the COVID-19 public health emergency), the baseline federal requirement is a prior in-person visit.
Question 6: While federal law requires a biennial inventory of controlled substances, it does not mandate a perpetual inventory for all schedules. However, if a pharmacy chooses to maintain a perpetual inventory for its Schedule II drugs, which of the following is a key operational requirement?
- The perpetual inventory must be submitted to the DEA monthly.
- It eliminates the need to conduct a biennial inventory for Schedule II drugs.
- The inventory must be reconciled with a physical count on a regular basis to promptly detect discrepancies. (Correct answer)
- Only the pharmacist-in-charge is permitted to make entries in the perpetual inventory log.
Correct answer: The inventory must be reconciled with a physical count on a regular basis to promptly detect discrepancies.
A perpetual inventory is an ongoing record of all receipts and disbursements. For it to be effective as a control measure, the recorded balance must be periodically reconciled with an actual physical count of the stock on hand. This regular reconciliation is crucial for quickly identifying and investigating any potential diversion or discrepancies. While not federally mandated for pharmacies, it is a best practice and may be required by some states. It does not replace the biennial inventory requirement.
MPJE Pharmacy Operations and Recordkeeping Questions and Answers
A pharmacy needs to destroy a small quantity of expired and damaged hydrocodone/acetaminophen tablets (Schedule II) from its inventory.
According to federal law, which of the following is the correct procedure for recording this destruction?