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Health Systems

UTSW Nurse Fentanyl Overdoses Lead to $4.5M Settlement

The payment is the largest of its kind in Texas and the second-largest in the nation.
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William P. Clements University Hospital, which is operated by UT Southwestern.
After a three-year investigation, the University of Texas Southwestern Medical Center has agreed to pay a $4.5 million civil settlement for violations of the Controlled Substances Act that allowed hospital staff to divert fentanyl and other drugs from the hospital.  The Drug Enforcement Agency and US Attorney’s Office looked at more than five years of UTSW’s handling of its controlled substances after two nurses overdosed on fentanyl and died in UT Southwestern’s Clements University Hospital. The probe was triggered after the Dallas Morning News investigation found that over 16 months, two nurses died in bathrooms in the hospital from overdoses on medications likely meant for patients. The subsequent federal investigation found 31 instances of missing drugs at UTSW never reported to the DEA.  The settlement is the largest in the state and second-largest in the nation for allegations of drug diversion at a hospital. Much of the conduct described in the settlement agreement is merely alleged, and the agreement does not admit liability by UTSW. But the health system acknowledges and admits that theft and significant loss occurred, and UTSW failed to notify the DEA promptly and that its policies were not consistent with the law.  “For years prior to our investigation, UT Southwestern exhibited an almost shocking disregard for its obligations under the Controlled Substance Act, enabling some employees to steal and abuse prescription narcotics – including powerful synthetic opioids such as fentanyl. We felt that the serial compliance failures we uncovered warranted a multi-million-dollar penalty and a stringent corrective action plan,” said U.S. Attorney Chad Meacham in a release. “In this settlement agreement, we’re doing everything in our power to mitigate the threat of opioid diversion by outlining protocols above and beyond what’s required by law.” Drug overdoses and fentanyl use have been on the rise since the onset of the pandemic. According to the Centers for Disease Control, drug overdose deaths reached a record high of 93,221 in 2020, an increase of more than 20,000 deaths above the previous high and the largest single-year percentage increase in 20 years. In 2015, synthetic opioid overdoses accounted for only 18 percent of all overdose deaths, but in 2020 they were responsible for 60 percent of all overdose deaths.  UTSW was tasked with keeping accurate records and reporting obligations that included monitoring all controlled substance activity within its facilities and notifying the DEA of theft or significant loss. The DEA determined that UTSW didn’t meet those obligations. Settlement documents found that UTSW did not report theft and loss in a timely manner, failed to document the dispensing and “wasting” of controlled substances, and made errors in documenting the controlled substances.  Prior to the investigation, UTSW brought in outside consultants to review the health system’s practices who uncovered record keeping and reporting issues. The system hired additional staff, improved software, and implemented more physical security controls such as lockboxes and tamper-resistant IV tubing. “As a leading health care institution, we are committed to meeting all legal and ethical obligations in every aspect of our operations, and specifically to following best practices in opioid stewardship, consistent with our broad commitment to maintaining a safe clinical care and workplace environment,” UTSW said in a statement. UTSW cooperated with the investigation and worked with the DEA to address deficiencies and strengthen controls. Many changes were made before the settlement, requiring UTSW to adhere to several steps over three years. From the release: 
  • Hiring an external auditor to conduct unannounced audits of controlled substances dispensed via pyxis machines (with a particular focus on auditing fentanyl), with any resulting deficiencies or discrepancies resolved in thirty days, signed off on by the Pharmacist-in-Charge, and provided to DEA;
  • Instituting a training program designed to help employees identify symptoms of addiction and signs of diversion, and to understand the threat diversion poses to patient care and professional reputation;
  • Creating an employee compliance hotline that permits anonymous reporting of suspected drug diversion or drug impairment;
  • Installing security cameras at pyxis machines and providing footage to the DEA upon request;
  • Establishing a database of employees who have been discharged or resigned because of drug diversion, and disclosing relevant information to requesting health facilities conducting pre-employment inquiries; and
  • Permitting DEA personnel to enter UTSW facilities at any time, without prior notice and without a warrant, to verify compliance.
 

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