After a three-year investigation into UT Southwestern Medical Center’s handling of controlled substances following the deaths of two nurses who overdosed on fentanyl at William P. Clements University Hospital, UT Southwestern has agreed to pay $4.5 million to resolve alleged violations of the Controlled Substances Act.
UT Southwestern allegedly allowed hospital staff to divert fentanyl and other dangerous drugs from the hospital, according to a news release from U.S. Attorney Chad Meacham of the Northern District of Texas.
The civil settlement is the largest payout involving allegations of drug diversion at a hospital in the state of Texas and the second largest in the nation, he said.
According to settlement documents, UT Southwestern violated multiple provisions of the Controlled Substances Act over a five-year period, which allowed its employees to divert controlled substances, including fentanyl, from Clements University Hospital and Zale Lipshy Pavilion.
UT Southwestern had record-keeping and reporting obligations under the U.S. Drug Enforcement Administration which included monitoring all controlled substance activity within its facilities and promptly notifying the DEA whenever a theft or significant loss occurred, according to the release.
DEA authorities determined UT Southwestern’s failure to meet its record-keeping and reporting obligations contributed to the health system’s overall failure to “guard against the theft and diversion of controlled substances.”
A UT Southwestern nurse overdosed on fentanyl diverted from UT Southwestern’s Clements University Hospital and was found dead in a hospital bathroom on Dec. 15, 2016. On April 16, 2018, another nurse overdosed on diverted opioids, including fentanyl, and was found dead in a different Clements University hospital bathroom, officials said.
According to the settlement documents, UT Southwestern did report instances of theft and loss to the DEA but failed to do so in a timely manner. Meacham said the health system failed to properly document the dispensing and “wasting” of controlled substances and made errors in forms documenting the ordering, receipt and distribution of controlled substances, which are all violations of the Controlled Substances Act.
“In this time of record overdose deaths, health care systems must be held to compliance with the Controlled Substances Act,” DEA Dallas Special Agent in Charge Eduardo A. Chávez said. “This is not only their legal responsibility, but also a matter of public trust and public safety. DEA Dallas pledges that we will tirelessly work with our law enforcement and regulatory partners to ensure these rules and regulations are followed to combat the opioid epidemic.”
As part of the settlement between the medical center and the DEA, UT Southwestern has agreed to take significant steps to mitigate its diversion issues. These steps include:
Hiring an external auditor to conduct unannounced audits of controlled substances, with a focus on fentanyl dispensed via pyxis machines, with any resulting deficiencies or discrepancies resolved in 30 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
Permitting DEA personnel to enter UT facilities at any time, without prior notice and without a warrant, to verify compliance.
Meacham said UT Southwestern cooperated with the investigation and began working with the DEA to address deficiencies and strengthen its controls for handling controlled substances. A number of changes were instituted well before the settlement agreement was signed.