Walgreens Corp., the nation’s largest drugstore chain, agreed Tuesday to pay $80 million in civil penalties to resolve accusations of negligently letting controlled substances such as oxycodone and other prescription pain killers be diverted for abuse and black-market sales.
Mark R. Trouville, the special agent in charge of the U.S. Drug Enforcement Administration’s Miami field division, said the agreement settles administrative actions and civil penalties regarding Walgreens‘ Jupiter, Fla., distribution center and six Walgreens retail pharmacies, along with similar open civil investigations in Colorado, Michigan and New York.
The settlement, the largest in DEA history, resolves charges that the company committed an unprecedented number of record-keeping and dispensing violations. The Walgreens distribution center in Jupiter was the largest supplier of oxycodone to retail pharmacies in Florida.
“National pharmaceutical chains are not exempt from following the law. This settlement sends out a clear message that all DEA registrants will be held accountable when they violate the law and threaten public health and safety,” Mr. Trouville said. “The DEA will continue its efforts to work with our registrants and our law enforcement partners to combat pharmaceutical drug abuse and diversion in Florida.”
The settlement agreement covers accusations that the Jupiter distribution center failed to comply with regulations that required it to report to the DEA suspicious prescription drug orders it received from Walgreens‘ retail pharmacies. Walgreens‘ purported 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.
Mr. Trouville also said the six retail pharmacies in Florida that received the suspicious drug shipments from the Jupiter distribution center filled customer prescriptions that they knew or should have known were not for legitimate medical use. In addition, he said, these retail pharmacies and others in the U.S. failed to properly identify and mark, as required by DEA regulations, hard-copy controlled-substance prescriptions that were outsourced to a “central fill” pharmacy for filling.
Without Walgreens‘ retail pharmacies identifying these outsourced prescriptions, the DEA could not accurately determine which prescriptions were filled from the retail pharmacies’ own drug supplies and which were filled by a “central fill.” Consequently, the DEA could not determine the accuracy of the retail pharmacies’ drug records.
In addition to the $80 million civil penalties, Mr. Trouville said, the settlement revokes the company’s ability to distribute or dispense controlled substances for two years, ending in 2014. As part of the settlement, Walgreens admitted that it failed to uphold its obligations as a DEA registrant regarding the above-described conduct. Furthermore, Walgreens has agreed to create a Department of Pharmaceutical Integrity to ensure regulatory compliance and prevent the diversion of controlled substances.
Mr. Trouville also said Walgreens agreed to enhance its training and compliance programs, and to no longer monetarily or otherwise compensate its pharmacists based on the volume of prescriptions filled.