Pharmacies should plan to become compliant with USP 800 for hazardous drug handling

Patricia C. Kienle, RPh, director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions, is urging pharmacies to begin planning to become compliant with requirements for handling hazardous drugs, specified in the United States Pharmacopeia’s (USP) draft chapter 800.

“The whole point of chapter 800 is worker safety as well as patient safety and environmental protection,” said Kienle, who chairs the United States Pharmacopeial Convention’s expert panel on compounding with hazardous drugs, which wrote chapter 800.  “Almost everything in 800 has already been published in public documents, so it is not going to go away. The issue is out there and needs to be addressed.”

While the public comment period on chapter 800 ends May 31, 2015, the chapter may be published in early 2016 and becomes enforceable at “some future time,” Kienle said. USP chapters generally have a six-month time frame between the time they are first published as a final document and the time they become official, but there have been some suggestions to extend that time period, Kienle added.

Storage of hazardous drugs

Storage of hazardous drugs is likely to be one of the biggest compliance hurdles in chapter 800, according to Kienle. The draft requires facilities to maintain a separate storage area for antineoplastic hazardous drugs that require manipulation (other than counting), a negative-pressure room with 12 or more air changes an hour.

Other hazardous drugs – those that are reproductive hazards only or are non-antineoplastics – may be stored with the antineoplastic agents. Or, if the pharmacy performs an assessment of risk for specific dosage forms, they may be handled with other containment strategies, according to Kienle.

The hazardous drug storage language is already a requirement of chapter 797 now, so it should not come as a surprise to pharmacies, according to Kienle. “They [healthcare facilities] need to move their hazardous drugs into a safe place that will prevent the contamination and exposure. In many cases, the ideal spot to put that would be inside your negative-pressure clean room.”

Many facilities will likely not have to build or create a separate storage room. “Many people will be able to reconfigure some space, but if the drug also requires refrigeration, it needs to be protected as well,” Kienle said.

Pharmacies can also conduct training of employees now, before chapter 800 is finalized.  “They need to be comfortable that people mixing these hazardous drugs are aware of the risks and have the appropriate personnel equipment for handling them,” Kienle said.