Allegations include recordkeeping violations and failure to maintain adequate controls
United States Attorney Erica MacDonald today announced that COBORN’S, INCORPORATED d/b/a COBORN’S PHARMACY has agreed to pay $225,000 in civil penalties for allegedly failing to comply with recordkeeping and other requirements of the Controlled Substances Act, which enabled a Coborn’s Pharmacy employee to engage in a years-long pattern of diverting opioids for personal use.
According to the allegations, between 2011 and 2015, COBORN’S PHARMACY did not adequately monitor its employee’s conduct, and failed to keep complete and accurate records regarding the receipt and dispensing of Schedule II controlled substances, including but not limited to oxycodone and hydrocodone. These alleged violations enabled the pharmacist in charge of one of COBORN’S PHARMACY’s retail stores to fabricate nine patient accounts and create numerous false prescriptions that were recorded on COBORN’S PHARMACY’s computerized prescription management system. At the time, COBORN’S PHARMACY’S system did not consistently identify and process cash prescriptions, failing to prevent the diversion that occurred.
Congress enacted the Controlled Substances Act’s recordkeeping and prescribing requirements to prevent the diversion of controlled substances for illegal purposes. As a result of COBORN’S PHARMACY’s alleged actions, hundreds of doses of controlled substances went unaccounted for and were diverted for illicit purposes, namely personal use by the pharmacist in charge.
Upon learning of its employee’s pattern of theft, COBORN’S PHARMACY reported the misconduct to the Drug Enforcement Administration (DEA), leading to a federal investigation that resulted in the pharmacist in charge pleading guilty to Obtaining Controlled Substances by Fraud in violation of 21 U.S.C. §§ 843(a)(3) and (d)(1). COBORN’S PHARMACY has since enhanced its recordkeeping and compliance program, including making needed improvements to its computerized prescription management system, in response to concerns raised by DEA in the course of an audit revealing shortages and overages of various controlled substances and problematic recordkeeping procedures. This settlement addresses the independent obligation of COBORN’S PHARMACY to ensure it has systems in place adequate to prevent theft and fraudulent prescriptions from occurring in the future, as required by 21 U.S.C. §§ 827, 829, 942, and associated regulations.
“Prescription drug diversion can lead to devastating consequences for individuals, families and communities," said U.S. Attorney Erica MacDonald. “Pharmacies must uphold their obligation to ensure that these dangerous drugs are tracked and safeguarded in compliance with the Controlled Substances Act’s strict requirements."
“Pharmacies are responsible for helping ensure that medications are not diverted," Drug Enforcement Administration Omaha Division Diversion Program Manager William Stockmann said. “In addition to policing employees and customers, pharmacies are required to inventory their controlled substances, verify the dispensing of controlled substances and monitor daily record-keeping requirements. When one or more of these responsibilities break down, diversion occurs and medication has the potential to fall into the wrong hands. As seen with this pharmacist, opioid addiction and abuse can affect anyone, no matter the profession. Addiction does not discriminate."
This case was investigated by the Diversion Group of the Drug Enforcement Administration, Minneapolis-St. Paul District Office and handled by the Affirmative Civil Enforcement unit of the U.S. Attorney’s Office for the District of Minnesota.
The claims resolved by the settlement are allegations only; there has been no determination of liability.
Source: U.S. Department of Justice, Office of the United States Attorneys
