Controlled-Substance Audit After a Change of Pharmacist-in-Charge
You are the new pharmacist-in-charge of a community pharmacy. During a controlled-substance audit you find: the last biennial inventory is dated 3 years and 2 months ago; the hydrocodone/APAP 5/325 tablet count is 30 tablets less than the perpetual log predicts; a DEA Form 222 book has a missing page; and invoices for two Schedule II purchases are absent. The prior PIC says the 30-tablet discrepancy is probably a counting error and suggests adjusting the log. No police report has been filed.
1. What must you do about the 30-tablet discrepancy?
Read the worked answer
Treat it as a possible theft or significant loss, not a bookkeeping adjustment. DEA requires notification in writing within one business day of discovery of a theft or significant loss, using DEA Form 106, and the state board may require separate notice. Do not simply change the perpetual log to make the count match. Preserve the original records, investigate purchases, dispensing, returns, and access, and document your findings. If the loss is later determined not to be significant, document the basis for that conclusion, but do not delay the initial report on the theory that it is a counting error.
2. What inventory and recordkeeping deficiencies are present?
Read the worked answer
The biennial inventory is overdue: it must be taken every two years, with an exact count for Schedule II and an estimated count for Schedule III-V unless an exact count is required. Controlled-substance records must be kept for two years and be readily retrievable. The missing Form 222 page and missing Schedule II invoices are recordkeeping failures. Obtain or reconstruct invoices from suppliers, document the missing 222 page, and report lost or stolen 222 forms as required. Do not create replacement records that look original.
3. Can you simply take a new inventory today and consider the gap cured?
Read the worked answer
No. Taking an inventory today is prudent, but it does not cure the missing biennial inventory or erase the gap. The required inventory was not taken when due, and the new inventory becomes the next required record, not a substitute for the missing one. Document the corrective action, retain the new inventory, and treat the missing records and discrepancy as compliance issues to disclose and correct. Concealment or backdating would aggravate the violation.