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Medical Center Fined Millions for Violations of Controlled Substance Act

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University of Texas Southwestern Medical Center. | Image from UT Southwestern

The University of Texas Southwestern Medical Center has been penalized $4.5 million by federal law enforcement for its alleged failures in enforcing regulations under the Controlled Substances Act (CSA).  

UT Southwestern agreed to pay the penalty to resolve allegations that these violations allowed hospital staff to divert controlled substances from its hospitals.

The civil settlement is the result of a joint investigation by the DEA and U.S. Attorney’s Office into UT Southwestern’s management of controlled substances. The investigation began in 2018 after two nurses were found dead in a UTSW hospital’s bathrooms from fentanyl overdoses, just sixteen months apart.

According to the investigation’s findings, UT Southwestern failed to document the dispensation and waste of controlled substances properly, as well as to report theft and loss of these substances to the DEA in a timely manner.

The medical center additionally failed to maintain effective measures to detect or prevent diversions of dangerous medications initially. The DEA found instances of registered nurses diverting controlled substances over extended periods of time, which unfortunately resulted in the two fatal fentanyl overdoses in 2016 and 2018.

U.S. Attorney Chad Meacham stated, “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.”

DEA Dallas Special Agent in Charge Eduardo A. Chávez further commented, “The University of Texas Southwestern Hospital has an obligation to keep the highest standard of care for their patients. They also have an obligation of internal safeguards to keep controlled substances from being diverted.”

The settlement also provides for a detailed corrective action plan agreed upon by UT Southwestern and the DEA, which includes: unannounced audits of controlled substances, implementation of a training program to educate employees on drug addiction and diversion, creation of a hotline where drug-related suspicions can be reported, installation of security cameras where controlled substances are kept or dispensed, the establishment of a database detailing drug-diversion-related employee information, and allowance of DEA personnel to enter UT Southwestern facilities at any time without notice or a warrant.

Though UT Southwestern’s settlement agreement does not equate to an admission of liability, the medical center does acknowledge and admit to theft and loss of controlled substances in its facilities, as well as its failure to notify the DEA of such thefts and losses with proper urgency and its negligence to ensure that all policies and procedures align with CSA requirements.

This settlement is the largest of its kind from a hospital in Texas, and the second-largest in the nation, according to the U.S. Department of Justice.

“In this time of record overdose deaths, health care systems must be held to compliance with the Controlled Substances Act. This is not only their legal responsibility but also a matter of public trust and public safety,” Special Agent Chávez said. “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.”

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