September 20, 2016
Contact: SA Timothy Desmond
Phone Number: 617-557-2100
Tufts Medical Center & Local Pharmacy Chain Settle Alleged Violations Of Controlled Substances Act
SEP 20 - BOSTON - In concurrence with National Prescription Opioid and Heroin Epidemic Awareness Week, the U.S. Attorney’s Office has reached separate civil settlements with Tufts Medical Center and Eaton Apothecary to resolve allegations of violations of the Controlled Substances (CSA). Today, the U.S. Attorney’s Office reached a $100,000 civil settlement with Tufts Medical Center in connection with the hospital’s negligent recordkeeping of its controlled substances.
“We are committed to using all the tools at our disposal to combat the opioid crisis in Massachusetts,” said United States Attorney Carmen M. Ortiz. “Tufts Medical Center’s willingness to work with the DEA to strengthen controlled substances recordkeeping and security has brought this investigation to a successful conclusion.”
“DEA registrants are responsible for handling controlled substances and ensuring that complete and accurate records are being properly kept and accounted for in compliance with the CSA. When these responsibilities are not adhered to, it allows for the diversion of prescription pain medication, which contributes to the widespread abuse of opiates, is the gateway to heroin addiction, and is devastating our communities,” said Special Agent in Charge Michael J. Ferguson. “In response to the ongoing opioid epidemic, DEA’s obligation is to improve public safety and public health, and we are committed to working with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”
According to the settlement agreement, the hospital failed to maintain accurate inventories of controlled substances and associated records, to keep tight control of prescription pads, and to make required reports to the DEA about thefts or significant losses of controlled substances associated with three former nurses. Tufts Medical Center agreed to pay $100,000 to settle these claims and to permit the DEA to perform administrative inspections of the hospital for the next three years without a warrant. Upon learning of the violations of the CSA at the hospital, Tufts Medical Center cooperated fully with the federal investigation. It also initiated the implementation of new recordkeeping procedures and security measures, including the installation of cameras and lockboxes, to ensure compliance with regulations and to avoid diversion of controlled substances from medical offices. On September 2, 2016, the U.S. Attorney’s Office reached a $100,000 civil settlement with Eaton Apothecary in connection with its improper distribution of addictive narcotics.
“Controlled substances that are handled by pharmacies are subject to strict requirements because of their potential for harm and abuse, which fuels the opioid epidemic,” stated U.S. Attorney Ortiz. “For the sake of patient safety, and to ensure that medications are not stolen or sold on the street, we will continue to monitor pharmacies to ensure that they comply with all legal requirements related to the handling, dispensing, and recordkeeping of controlled substances.”
“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have a high potential for abuse and are extremely addictive, without a valid prescription from a physician,” said DEA SAC Ferguson. “This settlement demonstrates DEA’s pledge to work with our law enforcement and regulatory partners in Massachusetts to ensure that these rules and regulations are followed.”
Eaton Apothecary operates 13 retail pharmacies in eastern Massachusetts. According to the settlement, from January 2012 to January 2016, Eaton Apothecary in Canton dispensed Schedule II medications without a signed prescription on more than 2,000 occasions to Boston-area nursing homes, assisted living facilities, and adult day care centers. On each occasion, the pharmacy received a faxed request from a facility operated by Upham’s Elder Service Plan/PACE, and delivered the drugs to the facility. Then the pharmacy prepared and printed a computer-generated prescription for each order and delivered the printed prescriptions in bulk to Upham’s Medical Director, who signed them after the drugs had already been dispensed. In addition, on two occasions, the pharmacy accepted partly opened blister packs containing unused controlled substances, in violation of DEA regulations. DEA regulations allow unused controlled substances to be returned to a pharmacy only in tamper-proof envelopes that the pharmacy accepts by mail and destroys without opening, or through a locked collection receptacle located in the pharmacy.
These matters were brought as part of the federal response to the growing opioid abuse epidemic in Massachusetts and other New England states. The addictive quality of opioids has contributed to a recent surge in the theft, sale, distribution and misuse of prescription pain medication. As a result, federal, state and local law enforcement and public health authorities are collaborating to support safe prescribing and dispensing of opioid medications.
Michael J. Ferguson Special Agent in Charge of the Drug Enforcement Administration for New England and U.S. Attorney Carmen M. Ortiz made the announcements.