Pharmacy Management, Recordkeeping, and Compliance
Pharmacy Management, Recordkeeping, and Compliance
This domain tests the PIC's systems: records, inventory, security, quality improvement, and inspection readiness. MPJE questions often describe an operational failure and ask which record or report is missing.
Core rules
- Records: keep prescription, dispensing, purchasing, and controlled-substance records readily retrievable; federal CSA records must be kept at least 2 years, while ND pharmacy records must be kept 5 years. Store records so they can be produced for Board or DEA inspection.
- Inventory: C-II exact count at initial and biennial inventory; C-III–V estimated count unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required. Record the date, time, and whether done at opening or close.
- Security: limit access to prescription and controlled-substance areas; report theft or significant loss to DEA and the ND Board; maintain a written security policy.
- CQI: ND requires a continuous quality improvement program to detect, document, and prevent dispensing errors; the PIC must ensure staff are trained and errors are reviewed.
- Licensure and CE: renew pharmacy, pharmacist, technician, and intern credentials; complete required CE, including ND law hours.
- Inspections: be able to produce licenses, policies, inventories, PDMP reporting records, and counseling or refusal documentation.
Worked example
A biennial inventory is taken May 1 at 8 a.m. before opening. The pharmacy counts 450 oxycodone 5 mg tablets exactly and estimates 900 alprazolam 0.5 mg tablets. The C-II count must be exact; the C-III estimate is acceptable only if the container has 1,000 units or fewer. If the alprazolam stock is 1,200 tablets, an exact count is required.
Traps
- Keeping records only 2 years because federal law says 2.
- Using an estimated C-II count.
- Failing to report theft or loss.
- No documented CQI review or counseling refusal.