The U.S. Pharmacopeia (USP) continues to revise its standards to protect workers exposed to hazardous drugs, including those involved in compounding medications.
Although employee health may not have oversight of a facility’s hazardous drug policy, involvement and awareness is encouraged to protect workers. Hazardous drugs like those used in oncology include those that can cause cancer, genetic damage, and reproductive problems. While these effects necessitate following workers long-term, immediate effects of being exposed to the drugs include nausea, dizziness, and nasal damage.
The three general hazardous drug categories are antineoplastic, non-antineoplastic, and reproductive hazards. Design improvements may be needed to prevent exposures, but there also are compliance factors like insufficient stocks of personal protective equipment or failing to wear it if available. Occupational exposures also can occur if facilities are not using closed-system drug transfer devices. (See Hospital Employee Health, March 2018.)
HEH talked to Ken Maxik, director of patient safety for CompleteRx, a hospital pharmacy management company, about some of the changes.
HEH: Can you generally describe some of the actions the USP is taking?
Maxik: Over the last couple of years, the USP has been making some changes to their sterile and nonsterile compounding. They started by releasing USP 800, which deals with hazardous drug compounding. Then earlier this year they released USP 795, which deals with nonsterile compounding. Then more recently they released USP 797, which deals with sterile compounds.
What they essentially did in trying to match these three chapters is break off the section on hazardous drug compounding, which previously was a part of USP 797. They created it as a new chapter in USP 800, which I believe they did to place greater emphasis on safety related to compounding hazardous medications. In the [overview] of the USP 800 chapter, they point out that part of the purpose of the chapter is to describe worker safety.
HEH: Is this more a matter of emphasis, or are their new recommendations that employee health professionals should be aware of?
Maxik: There are changes. For example, they are now recommending that you conduct environmental wipe sampling of your hazardous drug surfaces for residue. They are also recommending that you have policy and procedures for safety data sheets to document effective training and proper garbing. They also outline that they now want you to use closed-system transfer devices. That must be used for administration. That is something that is new, and they are recommending that you use closed system devices for the compounding portions. They are trying to prevent aerosolization from occurring. They also aligned that with a recommendation to have a medical surveillance program in place [for employees].”
HEH: Are these recommendation or requirements?
Maxik: USP by itself does not enforce its own recommendations. They do not have an enforcement division. The way that USP recommendations get enforced is through state boards of pharmacy and accreditation organizations, which adopt the USP recommendations. They either put it into their accreditation standards or their state board rules and regulations.
HEH: Generally, when you look at these changes, would you say that healthcare facilities that adopt these measures will better protect their workers?
Maxik: Absolutely. We are already finding in facilities that we are working with that the pharmacies have placed the recommended changes into their capital budgets. That way, they can redesign their clean rooms and split out the separate clean rooms for hazardous compounding. Also, many of the organizations have begun to conduct risk assessments, which are called for in the USP 800 chapter. They are now identifying and assessing the risks to employees. I’m certainly not saying everybody didn’t have something previously, but they are developing what their organization’s mitigation strategies will be for those potential risks.