Continuing the State’s crackdown on doctors who disregard prescribing restrictions on the potent fentanyl painkiller “Subsys,” the State Board of Medical Examiners (“the Board”) has temporarily suspended the license of a Warren County physician amid allegations he indiscriminately prescribed the oral spray drug outside its federally-approved use as a cancer pain medication.
Dr. Kenneth P. Sun, who practices pain management medicine in Phillipsburg, agreed to the temporary suspension of his license amid allegations he engaged in professional misconduct and gross negligence by indiscriminately prescribing Subsys, a drug approved by the federal Food and Drug Administration (“FDA”) strictly to treat breakthrough pain in cancer patients who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.
Sun allegedly prescribed Subsys to several non-cancer patients for whom such a drug was “contraindicated” because of the associated risks of addiction, overdose and death. He is the third physician to be sanctioned under the State’s crackdown on doctors who disregard FDA restrictions on the prescription of Subsys, one of six transmucosal immediate release fentanyl ("TIRF") medications that instantly deliver the powerful painkiller fentanyl through the oral membranes.
“These are extremely potent drugs approved only for use in cancer patients who have built up a tolerance for them. Doctors who prescribe Subsys or other TIRF medications for any other use, as we allege Dr. Sun did, face immediate disciplinary action,” said Attorney General Christopher S. Porrino. “We will do everything within our regulatory power to stop irresponsible physicians from exposing patients to grave danger or death by indiscriminately prescribing them these highly-restricted drugs.”
According the Consent Order between Sun and the Board, Sun’s “off-label” prescription of Subsys to non-cancer patients “jeopardized his patients’ welfare in reckless or willful disregard of the drug’s unequivocal and well-established risks” and flouted the rules for prescribing it. Sun’s license will remain suspended pending the resolution of the allegations against him and pending further Order by the Board, under the terms of the Consent Order.
If proven, Sun’s indiscriminate prescribing of Subsys – an opioid approximately fifty times more powerful than heroin and one hundred times more powerful than morphine – would demonstrate a clear and imminent danger to the public and provide the Board with grounds to suspend or revoke his license, according to the State’s allegations.
In October 2016, Attorney General Porrino and Director Lee issued a public alert warning patients and doctors alike of the risks associated with prescribing Subsys and other TIRF medications outside their approved use to treat cancer pain.
That warning came as the State filed an action against a Cherry Hill family physician for allegedly prescribing Subsys “off-label” to three patients, one of whom died.
As part of the State’s initiative to determine whether doctors have been prescribing Subsys appropriately, investigators with the Enforcement Bureau of the Division of Consumer Affairs inspected patient records at six doctors’ offices statewide, and subpoenaed patient records from 10 others. Inspections and investigations of off-label prescribing of Subsys will continue as part of this initiative.
Since then, the Board has temporarily suspended the license of the Cherry Hill physician whose patient died after being improperly prescribed Subsys. The doctor’s license will remain suspended until the allegations against her are resolved. The Board also permanently revoked the license of a Middlesex pain management specialist amid allegations he indiscriminately prescribed Subsys to his patients, and following his criminal conviction in a sophisticated fraud and money laundering scheme in connection with his practices.
Patients who believe they were prescribed Susbys in violation of the FDA restrictions should contact the Division of Consumer Affairs by calling 1-800-242-5846 (toll free within New Jersey) or 973-504-6200.