One Hundred Missing Tablets and a Biennial Inventory Due in March
At a pharmacy filling about 2,000 prescriptions a week, the monthly controlled substance count shows 100 tablets of hydrocodone/acetaminophen 10/325 and one bottle of alprazolam 1 mg missing from the safe. The prior exact count was 30 days earlier. In between, two technicians and one pharmacist left the staff, and a relief pharmacist from an agency worked six shifts. That same week the pharmacy received two faxed prescriptions: morphine sulfate ER 30 mg #60 from a hospice nurse for a patient enrolled in hospice, and a Schedule II stimulant for a resident of a long-term care facility. The biennial inventory is due in March, and the pharmacy's practice has been to 'estimate' the hydrocodone count because more than 1,000 tablets sit in the vault.
1. What must the pharmacist-in-charge do about the 100 missing tablets, and on what timeline?
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This is a reportable loss, and the clock starts at discovery.
- Under 21 CFR 1301.76(b), a registrant that discovers a theft or significant loss of a controlled substance must notify the DEA Field Division Office in writing within one business day of discovery, using the appropriate DEA form and describing the circumstances. The obligation is not suspended while the pharmacy finishes its internal investigation.
- Notify the Board of Pharmacy as its rules require, and consider local law enforcement if theft is suspected.
- Investigate in parallel, not instead: reconcile the last 30 days of invoices, DEA 222/CSOS records, dispensing records, returns, and waste documentation; interview staff who had access; review who had safe combinations and when the combinations were last changed after the departures.
- Do not adjust the perpetual inventory to make the numbers match and do not backdate or 'correct' records. Falsifying records converts a loss into a much worse violation.
- Fix the access problem: change combinations and passwords, restrict safe access, and document the change. A loss that follows staff turnover and agency coverage is a control failure, and the corrective action is part of the story you will have to tell.
Judgment point: the pharmacy does not get to wait to see whether the tablets 'turn up.' One business day, in writing, then keep investigating.
2. Are the two faxed Schedule II prescriptions valid, and what limits apply to filling them?
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A fax can serve as the original for a Schedule II in narrow circumstances - and both of these may qualify, if the details check out.
- Under 21 CFR 1306.11(h), a faxed Schedule II prescription may serve as the original written prescription when it is for a patient in a long-term care facility, for a patient enrolled in hospice, or for certain compounded preparations for direct administration. Both prescriptions here fall in the covered categories.
- But the document must still be complete: patient name and address, drug, strength, dosage form, quantity, directions, prescriber name, address, and DEA number, date, and the manual signature of the prescriber. A faxed order with a stamped signature or missing elements is not rescued by the exception.
- Verify the qualifying status. The pharmacist should confirm the patient is genuinely enrolled in hospice or is a resident of the facility named; the exception turns on the patient's status, not on the letterhead.
- Partial filling: for patients in a long-term care facility or with a terminal illness, a partial fill may be completed within 60 days of the date the prescription was written - longer than the 30-day window for other patient-requested partial fills.
- Emergency oral orders are a different rule entirely and would not apply here; do not lump the two exceptions together.
3. The biennial inventory is due. What inventory method is required for each of these drugs, and how should the discrepancy affect the inventory?
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The pharmacy's 'we estimate hydrocodone' practice is wrong - and not for the reason the staff thinks.
- Hydrocodone/acetaminophen 10/325 is Schedule II. Hydrocodone combination products were rescheduled from Schedule III to Schedule II in 2014. Schedule II controlled substances require an exact count on inventory. The 1,000-unit estimated-count allowance applies only to Schedule III–V substances, and even there an exact count is required when the container holds more than 1,000 tablets or capsules.
- Alprazolam 1 mg is Schedule IV. An estimated count is permitted only if the container holds 1,000 or fewer units; this bottle is small, so count it exactly.
- Inventory mechanics: taken on the date the pharmacy opens or closes business (or on the biennial date), include all Schedule II–V stock on hand, record whether the count was exact or estimated, and have the person who took the inventory sign and date it. Newly scheduled substances must be included. Records are retained and available for inspection for at least two years.
- The discrepancy must be resolved or disclosed, not averaged away. Signing an inventory you know is wrong is a records violation on top of an unresolved loss. Complete the reconciliation, document the outcome, and - if the loss is real - the inventory and the DEA report will tell the same story, which is exactly what an inspector expects to see.