Failure to Maintain Controlled Substance Records and Oversight by Pharmacist
Penalty
Summary
The facility failed to ensure that the pharmacist was responsible for establishing and maintaining a system of records for the receipt and disposition of all controlled medications, as required by federal regulations. The facility's policy required consistent receiving and tracking of controlled substances to prevent and detect diversion, but this was not followed. A narcotic reconciliation issue was identified when an LVN requested additional narcotics for a resident before it was due, and video surveillance later showed the LVN removing narcotic cassettes from the locked medication room. An audit revealed that 2550 narcotic tablets and 2 vials of morphine were missing, with missing paperwork on 85 narcotic cassettes and 2 vials of liquid morphine. The facility identified contributing factors such as lack of overflow accountability and the pharmacy not tracking required control sheets, with leadership changes cited as a root cause for process failures. The pharmacist stated he was unaware of his federal responsibilities and had not established or maintained records of receipt and disposition of controlled medications, nor performed routine audits to reconcile narcotic drug usage or collaborated with facility staff to ensure safe and secure handling of these drugs. The pharmacist believed his responsibility ended once the narcotics were dispensed to nursing, and he relied on DEA software alerts to identify issues. This lack of oversight and failure to follow established procedures allowed narcotic medications to be diverted without detection.