US Attorney Jane E. Young announced on June 21, 2023, that a New Hampshire hospital will pay $2 million to resolve allegations that it violated the Controlled Substances Act (CSA) by failing to keep accurate records of controlled substances, including opioids. She said it was one of the largest settlements of drug diversion claims against a hospital in the United States.
The Drug Enforcement Administration (DEA) began an investigation of the hospital after a nurse had stolen twenty-three intravenous bags of fentanyl solution from an automatic medication dispensing machine. The hospital initially disclosed this theft to the DEA in February 2022. It later reported that an additional six hundred thirty-four bags of fentanyl were unaccounted for. The nurse that allegedly stole these drugs died on March 3, 2022.
In April 2022, DEA investigators conducted audits of eight controlled substances at the hospital’s inpatient pharmacy, which included audits of fentanyl 2ml vial; fentanyl 50 ml vial; fentanyl 50 ml IV bag; midazolam 2ml vial; lorazepam 1ml vial; hydromorphone 4mg tablet; hydromorphone 1 ml vial; and morphine sulfate 1ml vial. This audit revealed an additional 17,961 missing controlled substance units and various related recordkeeping deficiencies on the part of the hospital, such as failing to maintain accurate purchase and dispensation records.
The audit also revealed that, among other things, the hospital failed to regularly review reports to look for possible diversion, to have sufficient structures in place to alert it to the greatly increased purchasing of controlled substances from one month to the other, and to enforce various controlled substance security policies.
The settlement resolved the allegations that the hospital violated the recordkeeping requirements of the CSA and its regulations. As part of the settlement, in addition to the improvements voluntarily undertaken by the hospital before and after the DEA investigation, it has agreed to additional security and recordkeeping measures.
Compliance Perspective
Issue
According to F755, facilities must provide pharmaceutical services (including procedures that ensure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. Facilities must employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility, establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation, and determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. Regulations require that the facility have a system to account for controlled medications’ receipt and disposition in sufficient detail to enable an accurate reconciliation, and that the facility conduct a periodic reconciliation. F761 says that facilities must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
Discussion Points
- Review policies and procedures regarding the management of controlled substances in order to prevent loss, diversion, or accidental exposure.
- Train staff regarding the required documentation of and accounting for controlled medications prescribed and administered to residents, and to report any suspected incident of diversion to a supervisor or through the Hotline.
- Periodically audit to ensure that all controlled substances are accounted for each shift, and that proper documentation of controlled substances has occurred. Compare controlled substance sign-out logs with Medication Administration Records and progress notes to determine that accurate recording has occurred. Interview residents to determine that their comfort level is in keeping with expectations based on physician orders for pain relieving drugs. Thoroughly investigate and respond to any identified concerns. Your consultant pharmacist can be included in this effort.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
