Northeast Hospital Corporation has agreed to pay $1.9 million in civil penalties to resolve allegations that the hospital failed to keep accurate records of controlled substances, thereby violating the Controlled Substances Act (CSA).
Under the CSA, accurate inventorying and tracking of each controlled substance must be done, all the way from the manufacturer to the end user. The recordkeeping requirements are there to prevent misuse of controlled substances and avoid overdoses and other harms.
Northeast Hospital Corporation – part of Beth Israel Lahey Health – does business as Beverly Hospital in Beverly, Mass.; Lahey Outpatient Center Danvers in Danvers, Mass.; BayRidge Hospital in Lynn, Mass.; and Addison Gilbert Hospital in Gloucester, Mass. Each of the locations is separately registered with the Drug Enforcement Agency (DEA) to handle controlled substances.
The DEA started investigating Northeast on March 22, 2018, after it received reports from the hospital that a pharmacy technician employed by the hospital stole nearly 18,000 dosage units of controlled substances, including fentanyl, Percocet, oxycodone, dextroamphetamine, and MS Contin, over more than a year. Northeast stated that the pharmacy technician took the controlled substances from automated dispensing machines, recorded them as “expired,” and failed to return them to the pharmacy located at Beverly Hospital.
Northeast uncovered the diversion in the midst of implementing improvements to its pharmacy operations and controlled substances accountability procedures. Upon making the discovery, Northeast suspended the employee.
In the settlement, Northeast made some admissions, including that it had ordered controlled substances under the Beverly Hospital DEA registration, but subsequently transferred the location of those drugs to other Northeast locations without notifying the DEA that the transfers were made. This happened from April 2016 through December 2019, and included Schedule II and Schedule III-V controlled substances. As noted above, the CSA requires accurate tracking of controlled substances, including when transfers are made among affiliated entities.
The settlement also resolved allegations that Northeast’s actual controlled substances inventory differed from what the records showed should be present. When the DEA counted certain controlled substance dosage units in the automated drug-dispensing machines within the Beverly and Danvers locations, there were discrepancies in the amounts of twelve types of controlled substances at one location and four types of controlled substances at the other location.
In addition to the $1.9 million in penalties, Northeast also agreed to additional security and recordkeeping measures via a Corrective Action Plan (CAP) with the DEA.
What About the Pharmacy Technician?
The pharmacy technician who stole the controlled substances ultimately pled guilty and received a suspended 2 ½ year jail sentence, with three years of probation. The first year of probation involved house arrest (except for work and medical or counseling appointments). In handing down his sentence, Salem District Court Judge Robert Brennan told the pharmacy tech, “you don’t benefit and society doesn’t benefit” from her incarceration.
The technician was also ordered to undergo an evaluation for mental health and substance abuse disorders as part of the Judge’s order referred to “extenuating circumstances,” including mental health issues.