A registered nurse at a major cancer center in New York stole opioids by draining syringes and refilling them with tap water to hide the theft, which in turn may have caused an outbreak of water-borne infection among some cancer patients being treated for pain, according to allegations in a federal criminal complaint released earlier this month. Kelsey Mulvey, 27, of Grand Island, is accused of illegally obtaining controlled substances by fraud, tampering, and violations of patient privacy. She faces charges that have a maximum penalty of 10 years in prison and a $250,000 fine. Mulvey worked full-time on a hospital patient floor at the Roswell Park Comprehensive Cancer Center in Buffalo from 2016 to 2018; she was pregnant for much of 2017 and gave birth late in the year. The alleged thefts took place from February to June 2018, after her return from maternity leave. Authorities say Mulvey stole the pain drugs from Pyxis machines, automated dispensing cabinets located in medication rooms on patient floors, which she could access as a Roswell Park nurse. She allegedly stole methadone, oxycodone, lorazepam, and, most commonly, hydromorphone (Dilaudid). The thefts appear to have been motivated by addiction and not by profit, states the criminal complaint. During that same period, Mulvey is accused of failing to properly administer pain medication to 81 cancer patients. Mulvey has pleaded not guilty to the charges, and she was "wiping away tears from her eyes" as she walked into federal court, according to an account in The Buffalo News. "This is not the first time we have investigated and charged a healthcare professional who suffers from addiction," said Gary Loeffert of the Federal Bureau of Investigation, Buffalo, in a press statement. "We will continue to hold medical personnel accountable when they take advantage of their unique position and tamper with drugs needed by their patients, especially when such tampering could cause unnecessary pain and suffering," added Jeffrey Ebersole, US Food and Drug Administration, Office of Criminal Investigations, New York Field Office, in the same statement. Mulvey's lawyer, Carla Benz, Federal Public Defender's Office, Western District of New York in Buffalo, did not respond to Medscape Medical News requests for comment. The criminal complaint and specific charges against Mulvey come 8 months after Roswell Park first publicly disclosed the tampering and the fact that multiple patients had developed infections after receiving water-diluted pain drugs. Prior to that public announcement, in a private meeting with Mulvey last July, officials at the Buffalo-based cancer center accused the nurse of diversion and swapping controlled substances with water and placed her on administrative leave. Barbara Burns, spokesperson, Department of Justice, US Attorney's office, Western District of New York. Three years ago, Leyla Samadi, a registered nurse at Sisters of Charity Hospital in Buffalo, was convicted of a similar crime and received 3 years' probation. She also accessed the drugs, including hydromorphone, via a Pyxis dispensing machine. Automated dispensing machines or cabinets such as Pyxis are vulnerable to misuse, but any drug dispensing system or method can be manipulated by staff, Ashley Glode, PharmD, University of Colorado Anschutz Medical Campus in Aurora, told Medscape Medical News. "Once a medication is received, it can be manipulated before it's given to the patient," she explained. For example, medications in vials are drawn up into a syringe before being administered — but a partial dose can be drawn, leaving excess drug. "You can then put the vial in your pocket," explained Glode, who coincidentally trained as an oncology pharmacist at Roswell Park. Glode also was not surprised that hydromorphone was the drug involved in the recent accusations. "Patients say they get a quick release of pain and a little bit of a high soon after administration," Glode pointed out. Emergency rooms regularly see patients who complain of pain and then specifically request hydromorphone, which may be a sign of addiction, she added. Spike in Waterborne Illnesses at Roswell Park According to the federal criminal complaint, Mulvey has participated in both inpatient and outpatient rehabilitation for drug addiction since leaving Roswell Park. She also attended Alcoholics Anonymous, Narcotics Anonymous, and Statewide Peer Assistance for Nurses and enrolled in the Professional Assistance Program (PAP) twice; she surrendered her nursing license both times for the duration of the treatment. The prosecutors believe that Mulvey had an addiction to hydromorphone. "Mulvey exhibited characteristics of a drug user and addict, including when she came to the hospital on vacation days and attempted to pick up extra shifts," according to the complaint. A witness in the federal complaint described Mulvey as a "cat on a hot tin roof" when, one day in the center's locker room, she witnessed Mulvey open her locker and more than a dozen used syringes fell out. Other unusual events are reported in the complaint. As noted above, Mulvey gave birth in late 2017. The baby's father was an employee in the distribution department at Roswell Park. Upon return from maternity leave, Mulvey and the baby's father "were frequently seen together in the medication room," according to a Roswell Park staff member. Also, Mulvey told coworkers she could not breast-feed due to lack of milk, but then weeks later would leave her unit to "pump breast milk." Altogether, Mulvey failed to administer dispensed pain medication promptly for 81 patients, according to the Pyxis machine records, with lag times ranging from 12 minutes to 1 hour, 52 minutes, with many instances of more than an hour delay. This was in violation of the law. Per New York State Health Rules and Regulations of controlled substances, medications are supposed to be administered "immediately" after being "vended." Complaint author Charles Argento, Special Agent, US Food and Drug Administration, writes: "Based on my training and experience…medical professionals do not always administer medication immediately according to a medical facility's policy. Mulvey's actions, however, in their totality and the consistent and significant timing gap in most of the…occurrences, are not typical." In June and July 2018, there were a total of seven cases of waterborne infections, known as Sphingomonas paucimobilis bacteremia, at Roswell Park. Typically, the center has only one to two patients per year infected with this specific water-based bacteria. A Roswell Park investigation concluded that the three cases in June all involved tampering with compounded hydromorphone 30 mL syringes, which were believed to be replaced with tap water. In one account in the complaint, on June 27, 2018, Mulvey was observed exiting a medication room carrying a backpack. The room was on a unit where Mulvey did not work (but could access the medications). A nursing supervisor noticed the "suspicious" activity and called the Roswell Park pharmacy. It was soon ascertained via record keeping that Mulvey had accessed seven hydromorphone 30 mL syringes but ultimately cancelled the vending and returned the syringes to the cabinet; Roswell Park staff subsequently removed and sequestered the syringes for study. Only days later, testing revealed that four of the seven had grown the waterborne bacteria Sphingomonas paucimobilis, and that 4 of 7 had approximately 80% of the drug removed, having been topped off with tap water. However, a problem with the testing process required that the syringes were retested a few days later, and the entire process was undercut by cross-contamination of the syringes. Further testing showed that three additional syringes had varying amounts of hydromorphone ranging from less than 1% to 55%, and that all had bacterial growth. Six cancer patients who were administered pain medications became ill with related waterborne infections between June 11 and June 16 at Roswell Park, the complaint says. Mulvey appears to be relieved that her actions were discovered, per the complaint. In a jail phone call between her and her brother, which was recorded, Mulvey said she is "very blessed…that she did not live the lifestyle very long…. Had she not been caught…she would probably still be doing it." Source
