- From LexisNexis® Mealey’s™ Daily Legal News.
Walgreens Co. will pay $ 80 million in civil penalties and will shut down a Florida drug distribution center and close six Florida pharmacies for two years as part of a settlement of investigations into record-keeping and dispensing violations of controlled drugs, the U.S. Drug Enforcement Administration (DEA) and Walgreens announced June 11 (In the Matter of Walgreen Co., Docket No. 13-1, DEA).
The settlement is the largest in the agency’s history, the DEA said in its June 11 press release.
According to a settlement and memorandum of agreement released by the DEA, the agency in September issued an order for Walgreens to show cause why the agency should not suspend the company’s DEA registration to distribute Schedule II-V controlled substances under the Controlled Substances Act. At various times between September and February, the DEA issued show-cause orders for Walgreens drug distribution center in Jupiter, Fla., and for Walgreens pharmacies in Hudson, Fort Pierce, Oviedo, Port Richey, Fort Pierce and Fort Myers, all in Florida.
The cases were consolidated as In the Matter of Walgreen Co. (Docket No. 13-1, DEA) in a DEA administrative proceeding.
Drug Diversion Facilitated
The DEA said Walgreens committed an unprecedented number of record-keeping and dispensing violations that allowed controlled substances such as oxycodone and prescription pain drugs to be diverted for abuse and illegal black market sales. The agency said the Walgreens distribution center in Jupiter was the largest supplier of oxycodone to retail pharmacies in Florida.
The DEA said the Jupiter distribution center failed to report suspicious drug orders received from Walgreens pharmacies. “Walgreens’ alleged failure to sufficiently report suspicious orders was a systematic practice that resulted in at least tens of thousands of violations and allowed Walgreens’ retail pharmacies to order and receive at least three times the Florida average for drugs such as oxycodone,” the DEA said in its release.
The six Walgreens pharmacies that got drugs from the Jupiter distribution center filled prescriptions “they knew or should have known were not for legitimate medical use,” the DEA said. It said those pharmacies failed, as per DEA regulations, to mark controlled substances prescriptions that were outsourced to large pharmacies known as a “central fills.”
Because the pharmacies did not identify the outsourced prescriptions, the DEA said it could not determine if the prescriptions were filled at the retail pharmacies or at a central fill. As a consequence, the agency said it could not determine the accuracy of the pharmacies’ drug records.
The DEA says Walgreens admitted that it failed to uphold its obligations to the agency and agreed to create a Department of Pharmaceutical Integrity to ensure compliance with regulations and prevent diversion of controlled substances. The agency said Walgreens also agreed to enhance its training and compliance programs and will no longer compensate pharmacists based on the number of prescriptions filled.
The DEA said the settlement resolves investigations by its Miami office and the U.S. Attorney for the Southern District of Florida and open civil investigations in the Districts of Colorado, Eastern Michigan and Eastern New York.