A Virginia hospital system has agreed to pay the United States $4.36 million to settle claims that it violated the Controlled Substances Act on numerous occasions between 2017 and 2020. As part of the resolution, the company further agreed to be subject to a period of four years of increased compliance and oversight during which any failure to comply with its obligations may result in contempt of court findings that could result in additional monetary sanctions and injunctive relief. The settlement is the third-largest civil penalty ever obtained from a hospital system under the Controlled Substances Act and the largest ever in the Fourth Circuit.
The claims center around the company’s failure to have effective controls in place to prevent the diversion of powerful painkilling prescription opioids. From 2017 to 2019, an employee diverted more than 11,000 Schedule II controlled substances from the company. From January to May 2020 a second employee tampered with Fentanyl vials and hydromorphone injectables by replacing the controlled substance with saline and diverting the controlled substance.
The United States alleged the company failed to provide effective controls and procedures to guard against the diversion of controlled substances, filled orders for controlled substances without a system in place to disclose suspicious orders of controlled substances, and failed to maintain readily retrievable records of controlled substances.
The agreement resolves the company’s potential civil and criminal liability based on the investigation. As part of the resolution, the company has committed to additional compliance measures including, but not limited to:
- Having cameras at all automated dispensing machines to capture the activity of placing/removing controlled substances
- Promptly reporting losses and diversion of controlled substances
- Taking and reporting disciplinary action against employees found to have been responsible for theft, diversion, or loss of controlled substances
- Maintaining a mandatory random drug testing program for employees
- Conducting a full physical inventory of all federally scheduled II-V controlled substances more frequently than required by law
US Attorney Christopher R. Kavanaugh for the Western District of Virginia said, “As opioid overdose deaths skyrocket, it is critical that healthcare companies are held accountable when they fail to effectively safeguard these powerful prescriptions within their facilities. The oversight provided by this resolution will ensure future compliance involving these important but potentially deadly substances, and the United States Attorney’s Office for the Western District of Virginia will continue to vigorously pursue these cases with our federal and local partners in order to protect Virginia’s communities.”
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.*
