CALIFORNIA—Omnicare Inc., a subsidiary of CVS Health and a provider of pharmacy services to long-term care facilities, agreed to pay the United States a $15.3 million civil penalty on Wednesday, May 13 to resolve allegations that the company violated federal law by allowing opioids and other controlled substances to be dispensed without a valid prescription.
In California, Omnicare operated in the cities of Canoga Park, San Diego, Lodi, Hayward, Sacramento, and Redding. The company operates “closed door” pharmacies that are not available for public entrance by customers. Omnicare delivers controlled substances to nursing homes and other long-term care facilities daily.
Deliveries of prescription medications were made directly available to the patients living at the long term care facilities. The company also delivered limited stockpiles of controlled substances in “emergency kits” that were to be dispensed to patients in the event of an emergency. The emergency kits often include opioids and other controlled substances that are commonly abused and diverted.
The disbursement of such opioids and controlled substances were tightly controlled and tracked in Omnicare’s inventory. The controlled substances should have only been dispensed pursuant to a valid prescription per federal code. The United States alleged that Omnicare violated the federal Controlled Substances Act in its handling of emergency prescriptions, its controls over the emergency kits, and its processing of written prescriptions.
The complaint against Omnicare alleged that the company lacked required elements such as the prescriber’s signature or DEA number to disperse opioids. The federal investigation conducted found that Omnicare failed to control emergency kits by improperly permitting the long term care facilities to remove opioids and other controlled substances from emergency kits days before doctors provided a valid prescription.
“With the opioid crisis still a very real concern, every entity that handles dangerous drugs will be held accountable to ensure powerful narcotics are properly dispensed and not diverted to the black market,” said United States Attorney Hanna.
The investigation revealed that Omnicare repeated failures in its documentation and reporting of oral emergency prescriptions of Schedule II controlled substances. Schedule II substances include:
- Hydromorphone (Dilaudid®)
- Methadone (Dolophine®)
- Meperidine (Demerol®)
- Oxycodone (OxyContin®, Percocet®)
- Fentanyl (Sublimaze®, Duragesic®)
As part of the settlement agreement with Omnicare, the company obliged to paying $15.3 million in civil penalties and entered into a Memorandum of Agreement with the Drug Enforcement Administration that will require Omnicare to increase its auditing and monitoring of emergency kits placed at long term care facilities.
The settlement agreement resolves Omnicare’s civil liability for the alleged CSA violations.
This matter was investigated by the DEA’s Field Divisions in Denver, Los Angeles, San Francisco, and Seattle in conjunction with five United States Attorney’s Offices: the Central District of California, the Eastern District of California, the District of Colorado, the District of Oregon, and the District of Utah.