USP <800> Answers Some Difficult Questions About Hazardous Drug Safety
Exposure to hazardous drugs (HDs) puts healthcare workers at risk for myriad adverse effects. Until recently, consistent safety information for HD administration and disposal has been lacking. However, with USP Chapter <800> going into effect in December 2019, U.S. Pharmacopeia has changed the landscape of HD safety guidelines.
In a session presented on September 8, 2020, during the inaugural ONS Bridge™ virtual conference, Seth Eisenberg, ASN, RN, OCN®, BMTCN®, and AnnMarie Lee Walton, PhD, MPH, RN, OCN®, CHES, addressed some of the difficult questions oncology nurses face about HD safety and USP <800> requirements.
Handling and Containing HDs
Most of USP <800> is specific to compounding, including best practices for engineering controls, the speakers explained. Nursing content is largely buried within its 18 sections. Nurses familiar with the ONS safe handling guidelines will not find too many new requirements, but some standards and recommendations will require a change in practice.
Of note, USP <800> defines staff training needs when handling hazardous drugs. Healthcare workers who may be exposed to HDs should participate in education and training prior to handling HDs.
“Growing evidence shows that healthcare workers not directly handling antineoplastic drugs are exposed to them,” Walton said. “Training must be specific to the healthcare worker’s role. It must be documented and competency assessed annually.”
Wipe testing should be done initially as a benchmark and after every six months, or more often if containment is a problem, including locations where the drugs are not administered (e.g., nurses stations, breakrooms). Begin remediation if contamination is found.
USP <800> focuses on the use of closed-system drug-transfer devices (CSTDs) when compounding hazardous drugs, the speakers explained. CSTDs prevent the escape of HDs outside the system and the transfer of contaminants into the system. The devices are required during the administration of antineoplastic HDs when the dosage form allows.
“Until recently, most nurses were not aware of CSTDs,” Eisenberg said. “Although many of the devices have been available for more than a decade, it took USP <800> to make the term—and the devices themselves—part of everyday practice.”
Alternative duty is also covered in USP <800> and must be considered at the institutional level. The chapter contains explicit instructions on how to request alternative duty and the options available to staff who are pregnant, breastfeeding, or trying to conceive.
Personal Protective Equipment
USP <800> does not differ from ONS guidelines on personal protective equipment, which require gowns, double gloves, and face protection if splashing is a risk. Nurses and institutions should take note about the usage of gowns, because the speakers said that surveys have repeatedly demonstrated poor adherence, especially when compared with glove use.
Nurses must understand the criteria for managing HD waste products, including proper disposal of excreta in both health facility and home settings. Provide patient and caregiver education that family members should use a different toilet if it is available, use gloves when coming into contact with bodily fluids, and wipe toilets to remove antineoplastic drug residue.
“The age-old practice of double-flushing toilets is now only beneficial in low-flow toilets,” Walton said. “Some facilities recommend use of plastic-backed pads, but more data are needed on their efficacy.”
With proper medical surveillance and emerging data, the hope is HD exposure will be reduced through improved handling and disposal education.
“We have come so far and learned so much in the past decade about how to protect ourselves when handing antineoplastic drugs,” Eisenberg said. “I am so hopeful about the use of CSTDs as an engineering control for nursing. That said, there is still more for us to figure out.”