Terra Universal, an environmental solutions company based in Fullerton, California, came to a point recently where it was no longer willing to sell and design clean-room setups for oncology practices unless potential clients first sat down with a consultant who could give them reliable guidance on what they needed. The problem was a set of standards from the US Pharmacopeial Convention (USP <800>) on hazardous drug management that was so complex and so potentially costly that Terra Universal did not feel confident that it would be selling its clients what they needed unless an expert thoroughly versed in the new standards was involved.
USP <800>, which is not yet finalized and is due for implementation in July 2018, was forcing clients who had only recently made purchases of clean rooms and equipment from Terra Universal to come back and ask about the possibility of returning or exchanging equipment for higher levels of protection, said Miriam selling a lot of USP rooms,” she said. “The problem was they weren’t compliant because we were only going with what the customer was asking for. They would come up with designs and later they found out they couldn’t use the clean room any longer because the regulations were changing.” The stainless-steel rooms that Terra Universal supplies to oncology practices can cost in the tens of thousands of dollars. They are designed to create a “negative” air flow that prevents airborne toxins from migrating to other rooms in a building.
The company solved the problem by engaging a regulatory expert who works with the California State Board of Pharmacy to consult with customers prior to any purchase, for a fee of $2500 for a 1-hour call. That money is credited toward purchases above a certain level, and the consultation can save a lot of frustration down the road, so it’s a wise investment for the oncology practice and it means Terra Universal will have fewer dissatisfied customers, Magaña said. “We will not quote a price without the consultation,” she said. “We got to the point where we just wouldn’t do it. It’s not in the customer’s interest to not do it.”
USP <800> has the potential to be a game-changer in the field of oncology practice. It is a set of standards for hazardous drug handling that has been developed and has moved toward adoption at a relatively rapid pace compared with its predecessor, USP <797>, which is a set of sterile drug compounding standards that only touches on hazardous drug management (Figure). The new set of standards addresses the type of equipment that should be used for mixing chemotherapy drugs, facility layouts, room air-exchange requirements, and venting standards. These involve huge expense and add to the economic burden already faced by independent cancer centers across the country. Dispensary and pharmaceutical administrators from oncology practices who spoke with Oncology Business ManagementTM
said many practices have been caught flat-footed by the advent of USP <800>. Many are scrambling to bring their facilities up to the higher level in time for adoption. The problems encountered along the way include financing, diversion of practice resources, and disruption to clinic operations.
Figure. Federal Involvement in Toxic Drug Management
By itself, USP <800> will not carry the force of law. However, the standards are likely to be endorsed by state boards of pharmacy and medicine, which have regulatory power. The US Occupational Health and Safety Administration (OSHA) also is expected to put its heft behind the hazardous drug management guidelines, which were developed over years of increasing evidence that higher standards are essential to protect not just patients but also clinical workers who come into prolonged, daily contact with toxic drug compounds. “The USP <800> standards that are going into effect in July 2018 will be enforceable by a variety of organizations,” said Josh Cox, PharmD, BCPS, director of pharmacy at Dayton Physicians Network, a Dayton, Ohio-based string of 8 oncology centers.