The Missing 38 Tablets, a Recall Notice, and an Abandoned CSOS Certificate
A pharmacist newly appointed as PIC at a Murray pharmacy conducts an internal review. Findings: (a) the last biennial inventory, dated 20 months ago, listed oxycodone 15 mg at 300 tablets; the perpetual log and a fresh physical count now show 262 tablets, with no dispensing or return record accounting for the difference; (b) 60 tablets of expired hydrocodone are sitting unsecured on a back shelf; (c) three vials of a non-controlled injectable subject to a Class II recall are still in stock, and the wholesaler's recall notice has never been opened; (d) Schedule II orders are placed through CSOS, but the pharmacist who held the CSOS certificate has left, and staff have been told to "just use the old login"; (e) the pharmacy has a power of attorney on file for the wholesaler.
1. What must be done about the 38 unaccounted-for oxycodone tablets, and to whom, in what form, and how quickly?
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This is a loss that must be investigated, documented, and reported - not adjusted away.
Investigate first: re-count with a second person, check all dispensing records, invoices, return/transfer documents, CSOS and DEA Form 222 records, waste documentation, and the possibility of a misfiled dispensing record. Interview staff. Look for signs of diversion (broken counts, altered records, staff with access).
Federal reporting: a registrant must notify the DEA field division in writing within one business day of discovery of a theft or significant loss (21 CFR 1301.76(b)) and must complete DEA Form 106 (Report of Theft or Loss). Whether a loss is "significant" is a judgment based on the drug, quantity, pattern, and the adequacy of internal controls; a 38-tablet oxycodone loss against a 300-tablet inventory (about 13%) with no paper trail is very likely reportable, and the safer course is to report it. Report promptly in any case if there is evidence of theft, and file a police report.
State and internal: notify the Utah Division of Occupational and Professional Licensing as the Board's rules require (confirm the current notice deadline and format), and notify the wholesaler and insurer as appropriate. Take a fresh inventory of the affected drug so the baseline is reset, correct the perpetual record with a documented adjusting entry - never a silent overwrite - and put in place the controls the investigation shows were missing.
Test-taking point: in-transit losses, breakage, and dispensing errors have different reporting paths; the reportable event here is unexplained disappearance.
2. How should the expired hydrocodone and the recalled injectable be handled?
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Expired hydrocodone (a Schedule II controlled substance): it cannot remain on an unsecured shelf and cannot be dispensed, sold, returned to a non-registrant, or thrown in the trash or sewer. Secure it immediately in the locked controlled substance area, segregate it, and record it. Disposal options:
- Transfer to a DEA-registered reverse distributor, with the required record for the schedule involved (a DEA Form 222 or CSOS order is used to transfer Schedule II to the reverse distributor; Schedule III–V move on invoices/records).
- On-site destruction with DEA Form 41, documented and witnessed as the regulations require.
- Use of an authorized collector consistent with current DEA rules.
A return to the wholesaler for credit is only permissible where the wholesaler is DEA-registered to handle it and the correct transfer document is used. Keep the Form 41/222 copies and the destruction or transfer record for the required retention period.
Recalled injectable: stop dispensing immediately. Quarantine all affected lots in a clearly labeled, physically separated location. Open and read the recall notice to determine the class, the affected lots and expiration dates, the required action (return, destruction, or continue dispensing with caution) and whether the manufacturer or wholesaler requires the pharmacy to notify patients or prescribers - that obligation turns on the recall instructions, not on the pharmacist's own view of risk. Reconcile inventory to find out whether any affected units were dispensed and to whom. Return per the notice's instructions, obtain and keep documentation of the return and credit, and do not release the quarantine until the recall is closed out. A Class II recall describes a potential for temporary or reversible harm, which is precisely why quarantine must be immediate rather than "next week."
3. What is wrong with the CSOS arrangement, and what is the correct fix involving the certificate and the power of attorney?
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What is wrong: a CSOS certificate is issued to an individual person, not to a pharmacy, and it cannot be shared, borrowed, or used after that person leaves employment. Having staff log in under a departed pharmacist's certificate is a serious violation of the electronic order regulations and destroys the audit trail that CSOS exists to create. It is also the kind of finding an inspector will characterize as a recordkeeping and control failure, and it may support unprofessional conduct allegations against the responsible pharmacist.
Correct fix:
- Have the departing pharmacist's CSOS certificate revoked and ensure the credentials are deactivated and not used for any further orders.
- Have the new pharmacist apply for and obtain his or her own CSOS certificate, linked to the pharmacy's DEA registration.
- In the interim, order Schedule II substances using the paper single-sheet DEA Form 222, signed by a person authorized under a valid power of attorney.
- Review the power of attorney file: each person authorized to sign 222 forms needs a POA executed by the registrant, kept on file and available for inspection, and updated whenever personnel change. Purchasing staff who only prepare orders still cannot sign.
- Update written procedures so that certificate and POA changes are part of the onboarding and offboarding checklist, not an afterthought.