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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.
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.
For a few reasons, however, the effects may not be so dire. The impact is likely to differ among states, which are deciding individually what rules to adopt and how to enforce them. Enforcement might occur infrequently and be advisory in nature or be led by uniformed health officers who impose fines and shut down facilities. Practices that do not have dispensaries are typically overseen by medical boards, which may promote the new rules less energetically than their counterpart pharmacy boards. In most places, pharmacists must substantially comply by December 2019 or their state deadline, whereas some medical boards may not have rules or enforcement mechanisms in place, allowing practices to delay facility upgrades.
Willis Triplett, PharmD, a pharmacy consultant who criticizes USP <800> as needlessly burdensome, noted that a number of states such as New Jersey have already moved to incorporate versions of the guidelines into their laws, which could expose noncompliant practices to tough penalties. He called the New Jersey statute, which became law this year but has not yet gone into effect, “an abomination.” California has a similar law, with the regulations still being written. Meanwhile other states including Indiana, Kentucky, Oklahoma, and Texas are moving against wholesale adoption of USP <800> for medical practices and may adopt less-stringent versions of the rules, Triplett said.
Perhaps because of this variation, many practices are taking a cautious, go-slow approach rather than making renovations to fully comply with the standard. In a survey conducted last year, only 11% of oncology practice managers were actively renovating their compounding facilities, with 26% saying they had already met the standard. Another 18% said they were waiting to see how their state boards of pharmacy would enforce the rules; 26% were studying USP <800>, attending seminars, or working with consultants to calculate the costs; and 24% were doing nothing. The Genentech survey, conducted from July to October 2016, included 91 independent practices, 50 hospitals, and 60 academic centers. Anderson’s practice is in the wait-and-see camp. She said she expects California’s medical board will eventually reach a compromise with the pharmacy board over the rules that practices must follow; in the meantime, she is carefully documenting the measures she is taking toward compliance, such as having staff use CSTD and personal protective devices. In the state labor law that governs medical practices, “showing goodwill and faith in trying to meet some of that goes a long way with USP,” she said.
Similarly, Tri-County Hematology and Oncology, a Massillon, Ohio, practice with 4 oncologists at 2 locations, is updating its drug-handling policies but not making major changes, according to practice manager Ruth Settle. The practice has negative-pressure, externally vented barrier isolators, but its laminar flow hoods are not exhausted to the outdoors, and it lacks anterooms and separate hazardous-drug storage areas. Building anterooms could cost $100,000 and take over space currently used as bedrooms for patients who need to lie down during infusions, Settle said. Ohio has actually had rules similar to USP <800> for some time and is implementing them gradually, she said; for example, existing hoods don’t have to be externally vented until 2019. Settle also said the state board of pharmacy traditionally sends out inspectors only to check new or renovated facilities or if a problem arises, though that could change.
“They say that they’re going to have more inspectors, and they’re going to do more enforcement as this comes out. They’re also saying there could be OSHA and FDA inspectors coming around,” Settle said. “I’m just hoping this little town is off their map.”
If state or federal agencies step up enforcement, she wants it to be realistic and helpful rather than strictly punitive. “I’m hoping that they will see we’ve made some effort to meet their standards and would give us recommendations and a time frame to meet other standards they felt were important,” she said, “because they can just slap a red ticket on your pharmacy and close you down.”
Practice managers say they’re worried because they simply can’t afford upgrades. But Joseph Coyne, a pharmacist and the director of field operations for Clinical IQ, a sterile compounding consultancy, said those fears are largely unwarranted and caused by confusion about the USP standard. Most small practices actually do not need to install a full clean-room setup with a sterile buffer room, an anteroom, and hazardousdrug storage, he said. As long as drugs have a 12-hour by-use date, meaning they are used within 12 hours of being prepared, a clean room is not required.
“Most oncology practices use just-in-time preparation, so they’re using the drug almost immediately. That right away takes the clean-room concept out of the equation,” Coyne said. “That goes from needing several hundred square feet to put a 3-room system together to maybe 100 square feet to take over an exam room. That makes it much more feasible. They need to really understand what their needs are. [Otherwise] they could absolutely be overengineering and overspending for a facility that’s not required for their particular type of practice.” A clinic may be able to limit upgrades to a small compounding area, a 3- to 4-foot-wide hood, and a dispensing cabinet, along with appropriate paint, flooring, and other relatively inexpensive fixes, he said. However, that assumes practices are able to use prepared drugs within the 12-hour time window. At Hayton’s solo practice, short drug expiration dates have proven unworkable, as demonstrated when a compounding pharmacy it uses made upgrades for USP <797> and <800>, Anderson said. “They were delivering only once a week and, though the stability of all compounded drugs were well over 24 hours, the new expiration dates on the labels were within 24 hours or same day. We can’t use them due to the dating issue,” she said.
Coyne noted some other strategies to make compliance more affordable. Hoods can be vented out the side of a building and up the exterior wall, rather than going up through all the floors of a multistory structure. Many managers also don’t realize that hazardous and nonhazardous products may be stored together as long as all the drugs are subsequently treated as hazardous, he said. Nurses will have to start wearing appropriate gloves when administering hydration or anti-emetics, but that is far less costly and disruptive than building a new room.
Coyne, who is advising the Community Oncology Alliance and numerous oncology providers on the new standard, urged practices not to wait for enforcement before complying. Instead they should look online for a USP <800> gap analysis tool that can help them understand where they are out of compliance, figure out exactly what they are required to do, and move ahead with upgrades, using a consultant if needed.
“There will be costs involved for many practices, if not all. Is it totally going to put them out of business? I don’t believe so. I’ve worked with many in the community oncology space, none of which have needed the 3-room suite or the large 6-figure expense. All of them have been able to reasonably manage the expense to comply,” Coyne said. “Assuming practices choose to do it and are willing, we’re not going to see this regulation force everybody back to the hospital. Absolutely not.”
Regardless of how extensive the impact may be, Levine, of Queens Medical, believes the USP <800> delay is a welcome development. “I’m sure that many of the community practices are going, ‘My goodness!’ Because, honestly, knowing what it costs to do this, a lot of practices won’t be able to do it. So you’ve given them a reprieve.”
Genentech. The 2017 Genentech oncology trend report. https://www.genentech-forum.com/ content/dam/gene/managedcare/forum/pdfs/Oncology-Trends/2017_Genentech_Oncology_ Trend_Report.pdf. Published July 2017. Accessed September 25, 2017.