Effingham Health System paying largest settlement ever for thousands of unaccounted Oxycodone tablets

Effingham Health System paying largest settlement ever for thousands of unaccounted Oxycodone tablets
Updated: May. 16, 2018 at 12:30 PM EDT
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EFFINGHAM CO., GA (WTOC) - The Effingham Health System has agreed to pay the nation's largest penalty settlement of its kind to resolve allegations the health system failed to provide effective controls and procedures to guard against theft and loss of controlled substances, leading to significant diversion of opioids and failing to timely report the suspected diversion to the Drug Enforcement Administration.

The health system has agreed to pay $4.1 million to resolve the allegations.

The DEA launched the investigation in 2017 after receiving reports of diversion at Effingham Health System.

The release from the United States Attorney's Office states, "DEA determined that tens of thousands of oxycodone 30mg tablets were unaccounted for, and were believed to have been diverted over more than a four-year period, in violation of the hospital's responsibilities under the Controlled Substances Act. DEA also determined that Effingham Health System failed to notify DEA of the suspected diversion within the time required by federal law."

The release also states, "Effingham Health System cooperated with the DEA's investigation and, prior to this investigation, overhauled its pharmacy operations to help ensure that it will avoid diversions in the future. Since the investigation began, Effingham Health System has worked cooperatively with the DEA and the U.S. Attorney's Office to finalize a plan to address the identified deficiencies in Effingham Health System's handling of controlled substances and entered into an agreement with the DEA to memorialize the plan. Components of the plan include quarterly internal accountability audits and requirements to keep detailed records that track all controlled substances within the hospital."

The Effingham Health System released the following statement on Wednesday:

We would like to acknowledge today's news release from the Southern District of Georgia, U.S. Attorney's Office, regarding Effingham Health System. As that release states, Effingham Health System has agreed to settle a civil penalty related to alleged recordkeeping and notification violations of the Controlled Substances Act.  The recordkeeping relates to pharmacy operations dating back to March of 2013 and does not reflect the current processes or procedures at the Hospital.

"We appreciate the cooperative nature of the United States Attorney's Office and Drug Enforcement Agency (DEA), for recognizing the efforts put forth since 2016 to improve pharmacy operations, "says Fran Baker-Witt, CEO for Effingham Health System. "We were dismayed to find, through this investigation, vulnerabilities in our prior record keeping and reporting systems."

As referenced in the U. S. Attorney's Office release, prior to the investigation and dating back to 2016, new leadership at Effingham Health System began overhauling Pharmacy operations to improve processes and systems that include the implementation of best practices.

"We are experiencing a national opioid crisis and drug diversion is a challenge facing all healthcare systems, including some of the largest hospitals in our country," says Fran Baker-Witt, CEO for Effingham Health System. "We understand we have a critical responsibility to ensure that controlled substances are tracked and safeguarded, from theft or loss, and we take that responsibility seriously."

This settlement is not an admission of liability, but in the spirit of cooperation, it has allowed us to avoid extensive legal expenses and costs related to an ongoing investigation. It assures that an ongoing investigation will not interrupt, or compromise, the care we provide our patients.

Effingham Health System has been transforming procedures over the past two years. Upon notice of the government investigation, the Hospital expanded its internal review and expedited changes. The pharmacy is under new pharmacy leadership. We have implemented new resources including electronic inventory systems to protect the integrity of orders, track inventory and dispense medications. These measures are monitored and reported on.

Our mission remains to provide every patient an experience of compassion, quality care, and service excellence at its highest level of customer expectation.

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