Bruce Hayton, MD
Practice manager Andrea Anderson can tick off the hazardous drug–handling rules that her office does not satisfy, according to her understanding of pending United States Pharmacopeial Convention (USP) General Chapter <800> standards. For starters, the hood for handling biologics isn’t vented to the outdoors, and there’s no negative-pressure room to safely contain and exhaust potentially tainted air. The clinic uses the wrong type of shelving and has no anteroom, no scrubbable walls, and no place to separately store hazardous and nonhazardous drugs.
Practices now have a little more time to finance and plan improvements like these. In September USP said it is postponing the date when the new standard becomes “official” to December 2019, almost a year and half later than previously scheduled. The delay is meant to allow alignment of the rules with the next revision of USP <797>, an older standard on sterile compounding in pharmacies.
Yet the postponement has done little to alleviate fears that USP <800> could broadly hurt community oncology when the rules do become final. Aimed at protecting health care workers from exposure to hazardous drugs that may increase risk of cancer and reproductive problems, the standard will be enforced or mandated by a number of agencies, including the FDA, CMS, and Occupational Safety and Health Administration (OSHA) at the federal level. In many states the rules also have been or will soon be codified into law.
Anderson, who helps run the solo physician practice of Bruce Hayton, MD, in Wildomar, California, said she is in the process of adopting closed-system transfer devices (CSTD) that attach to vials, tubing, and syringes, an important measure to prevent release of drug vapors or liquids. But the office’s location on the ground floor of a 2-story building means there’s no space to build additional rooms or reroute the heating, ventilation, and air-conditioning system (HVAC), which also would be very costly, she said. She looked into using a freestanding trailer for drug compounding but dropped that option when she learned it could cost hundreds of thousands of dollars.
Anderson said she’s in the clear so far because California’s medical board has not yet decided which parts of the drug-handling rules it will enforce. But if the state does fully adopt USP <800> for medical practices, the prospects could be grim. “If they enforced it, if it had severe penalties, if they were going to visit every single practice, we would close our doors. We wouldn’t be able to meet any of it. That’s just the reality of it,” she said. “And we’re not the only ones. Your larger practices that have the infrastructure or the resources have been able to do those compliance buildouts, but your solo practitioners will close their doors. They won’t exist any longer.”
Howard Levine, PharmD, is pharmacy director at Queens Medical Associates of Fresh Meadows, New York, where plans were already in place to make a half-million dollars of upgrades to comply with USP <800>. The delay in implementation won’t change that, as it’s fairly certain that the new standards will be no less stringent following the alignment with USP <797>. “Nowhere [in the delay notice] does it say they’re going to change the USP <800> specs,” he said. Queens Medical was all set to begin renovations in January to meet the previous deadline for compliance.
“We’re probably still going to start renovating, but we’ll probaby not put those last pieces in—which are the expensive pieces for the HVAC—until we get that much closer.” If there are any changes to the new standards, they probably won’t involve lower costs of implementation, Levine added. Some believe that the difficulty of complying with USP <800> will lead to significant restructuring in the way community oncology is delivered. They say that practices will be forced to shut down or curtail their hazardous-drug administration services.
“You’re going to see widespread consolidation. Some practices will have to close, and some will have to send patients to neighboring centers that are larger,” said Denise Needham, PharmD, regional director of pharmacy at MaineHealth’s Coastal Healthcare Alliance, which has 2 oncologists at 2 small hospitals. “Particularly what you’ll see hit are those in rural areas that allow patients to get chemotherapy in their community. They’re going to have to send patients to the neighboring city.” She noted that her comments reflect her opinions and not necessarily those of MaineHealth.