Missing Hydrocodone and a Biennial Inventory
A pharmacist-in-charge at a community pharmacy in Toledo completes a controlled-substance inventory and finds 180 fewer hydrocodone/acetaminophen 7.5/325 tablets than the perpetual inventory shows. The discrepancy appears to have accrued over 90 days. The pharmacy uses a perpetual inventory system but has no written loss-prevention policy. The PIC suspects a technician diversion but is not sure. The DEA biennial inventory was last completed 22 months ago. The owner asks the PIC to 'just adjust the count' and wait for the next inventory, arguing that a formal report will harm the pharmacy's reputation and that the tablets may still turn up. The PIC is unsure whether a loss of this size is reportable and what records should be reviewed before making a report.
1. What must the PIC do about the missing hydrocodone? Include federal and Ohio reporting obligations.
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The PIC should not simply adjust the count. A loss of 180 tablets of a Schedule II controlled substance is significant and must be investigated and reported. Federal law requires the registrant to notify the DEA of the theft or significant loss and to submit DEA Form 106. The form is generally due within one business day of discovery, and the registrant should also notify the local DEA field office if instructed. Ohio Board of Pharmacy rules require prompt notification to the Board; in practice, the PIC should contact the Board as soon as possible, typically within one business day, and follow its instructions. The PIC should secure the remaining stock, preserve records, and begin an internal review. Adjusting the perpetual inventory without reporting would conceal a reportable loss and could be treated as a recordkeeping violation.
2. Was the pharmacy's inventory schedule compliant? What are the inventory requirements?
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A biennial inventory is required every two years. The last inventory was 22 months ago, which is still within the two-year cycle, so the pharmacy was not yet overdue for the next biennial inventory. However, the pharmacy must also take an initial inventory when it first engages in controlled-substance activity and must take a special inventory on events such as a change of ownership or registration. The inventory must be in writing, include the date and time, be signed by the person taking it, and list the controlled substances by name, strength, and quantity. Schedule II drugs must be counted; Schedule III-V drugs may be estimated if the container is sealed and the estimate is marked. The PIC should verify that the last inventory was complete and signed, and should conduct a new inventory now because of the loss.
3. What records should the PIC review, and what should be documented?
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The PIC should review purchase invoices, receiving records, dispensing records, returns to wholesalers, reverse distributor records, waste logs, and access records for the controlled-substance storage area. The PIC should compare the perpetual inventory against the physical count and identify the period in which the discrepancy began. The PIC should document the investigation, including who was interviewed, what records were examined, and the calculated loss. The PIC should preserve video if available and should not destroy any records. The PIC should document the DEA Form 106 submission and the Ohio Board notification. The PIC should also implement a written loss-prevention policy, restrict access, and consider periodic cycle counts. The documentation should be factual and should not accuse any individual without evidence.