Diversion, waste management go hand in hand
Kerri O’Keefe had worked as a care aide in the emergency department at Vancouver General Hospital (VGH), in British Columbia, for more than 15 years, transporting patients and helping them with all their basic needs. She loved her job—but according to news reports in the Vancouver Sun, she also had a desperate addiction to drugs, and working in a busy hospital emergency room was the perfect place to steal them.
The Sun noted that VGH had a number of systems in place to keep controlled substances from being diverted by addicts like Ms. O’Keefe, who had been to rehab twice: physical controls in place to prevent unauthorized access to controlled substances in automated dispensing cabinets, locked cabinets and pharmacy vaults, and periodic counts of controlled substances and documentation when removing them from storage. But it had failed to secure opioids and other drugs ripe for diversion in one key place: the trash.
Ms. O’Keefe would ransack sharps bins and other biohazard waste containers, digging out discarded vials and syringes that still contained leftover traces of morphine and fentanyl and sneaking them home in her backpack, where she would inject the collected remnants. On Aug. 20, 2015, Ms. O’Keefe died of an overdose—from not one of the opioid drugs she most commonly diverted but rocuronium, a muscle relaxant used in endotracheal intubations.
VGH is not alone in overlooking the waste stream as an important area to secure controlled substances, said Brian O’Neal, PharmD, senior director of pharmacy and biomedical engineering at Children’s Mercy Hospital, in Kansas City, Mo., and an expert in preventing the diversion of controlled substances.
“I go on consulting trips several times a year, and I’ll pick up a sharps container and tilt it forward to see what’s in there, and this ‘sharps juice’ will just come pouring out,” he said in an interview. “Sharps containers and other hazardous material bins are often just considered to be waste and not all that different from a regular trash can. Environmental services personnel or someone else along those lines has access to them, and they eventually take them to a shed or storage area outside the hospital while awaiting pickup. People think, ‘Who would go into this land mine of needles to get drugs?’
“The answer is, anybody who really has a problem and needs to get their fix. Even if you don’t want to risk being caught sticking a long-handled forceps into a sharps container, you can pretty easily get one off the wall, find out where they’re being stored, intercept them in transit—there are a lot of ways.”
And sharps containers are only one of a number of ways that a truly determined person—staff member, patient or visitor—can get their hands on controlled pharmaceuticals via the hospital waste stream, agreed Lee Murdaugh, RPh, PhD, director of accreditation and medication safety at Cardinal Health. The most common, as Dr. O’Neal noted, is when syringes, vials or even topical transdermal patches (e.g., fentanyl) that have already been used are placed in waste containers.
Another opportunity for drug diversion occurs during the wasting of the controlled substance. The Drug Enforcement Administration (DEA) requires that health care professionals wasting a controlled substance must have an independent witness who cosigns the documentation of the waste. But if the person doesn’t verify that the amount wasted matches what the user has put on the documentation, or doesn’t physically observe the substance actually being disposed of, that drug can be diverted, experts noted.
Chief Pharmacy Officer Stanley Kent, RPh, MS, came to the University of Michigan Health System in Ann Arbor in 2015, 1.5 years after a physician overdosed and a nurse died on the same day in December 2013, after diverting and injecting patients’ pain medications. Those cases had not involved the waste stream, but in overseeing the health system’s initiatives to prevent any such incidents in the future, he found that “witnessing waste” was often a cursory practice. “Health care professionals trust the people they’re working with, so they don’t actually physically watch them waste the drug,” he said. “Their back is turned or they’re across the hallway, and it’s an ideal time for someone to pocket the drug or shoot it into a vial.”
A variation on this theme happens just before the actual wasting. “Someone replaces the controlled substance waste in a vial or syringe with saline,” Dr. Murdaugh said. “This can happen when the person administering the drug draws up what’s needed and turns away or leaves the container unattended, and a very savvy person in the area quickly replaces that controlled substance waste with saline.”
In 2014, the DEA issued new regulations that controlled substances be rendered unretrievable and unusable after disposal. “Pharmaceutical waste companies have [issued] a lot of new products since that ruling to help facilitate compliance,” Dr. O’Neal said (see sidebar).
While the DEA has not endorsed any of the products, he noted that it would be difficult for hospitals to set up a compliant, “home-grown” in-house solution. (The regulations state that mixing the wastage with something like cat litter or coffee grounds—a tactic sometimes used by patients to dispose of their pharmaceutical waste at home—is not compliant.) “The cost of the systems that are out there are really relatively low compared with some of the other things we invest money in.”
Don Albaugh, who retired in December as the Green Environmental Management System’s program manager at the Louis Stokes Cleveland VA Medical Center, in Cleveland, first piloted a system after the DEA regulations were put in place. “It was costly and there was a lot of maintenance involved, so we ended up giving them to our police departments to use,” he said. Ultimately, Mr. Albaugh chose the Stericycle system. “We have a 1-gallon container on each medication cart right next to the Pyxis [BD] machines, so you don’t have to walk to the medication room to waste, and a 3-gallon container in each OR [operating room],” he said. “Stericycle checks the systems weekly, packs them to an incineration facility for destruction and puts new ones in place. People aren’t going to do this unless you make it easy.”
In a survey conducted by ASHP a little over a year ago, at least 30% of hospitals said they used one of these waste management solutions, Dr. O’Neal said. One of those is the University of Michigan, although Dr. Kent declined to name the product they had chosen. “The containers are pretty ubiquitous now anywhere controlled substances are used,” he said.
Regardless of the system used, it’s imperative to ensure compliance with state regulations, Dr. O’Neal stressed. He noted, for example, that one of the manufacturers of these systems advises that, once full, the waste containers can be thrown out with common trash. “The problem is that not all states allow this,” he said. “Some state authorities have told us that it’s allowed if you can verify that there is nothing hazardous in the container, but I can’t really prove that.”