USP <800>: Still a Work in Progress?

Because of the risks associated with handling chemotherapy drugs, safety guidelines surrounding their proper use have existed since 1981.¹ The Oncology Nursing Society (ONS) and the National Institute for Occupational Safety & Health (NIOSH) have both recommended oncology nurses receive hazardous drug education, including safe storage, preparation, labeling, transportation, administration, and disposal of hazardous drugs and proper use of personal protective equipment (PPE).²

In 2016, the United States Pharmacopeial Convention (USP) updated the General Chapter USP <800> to set standards for the safe handling of hazardous drugs, with implementation of the new standards set scheduled for December 2019. Almost 3 years after USP <800> became the recommended standard, some hospitals have improved their compliance, but Seth Eisenberg, ASN, RN, OCN, BMTCN, a retired oncology nurse now working as a consultant in Saint George, Utah, believes implementing USP <800> is still a work in progress for many hospitals.

Seth Eisenberg, ASN, RN, OCN, BMTCN

“USP <800> requires pharmacies to store hazardous drugs in an externally ventilated, negative-pressure room with at least 12 air changes per hour,” Eisenberg said in an interview with Oncology Nursing News®. “For pharmacies that were housed in the basement of a hospital, this entail[ed] expensive modifications. In some cases, it was more cost-effective to build a new pharmacy rather than retrofit an old one.”

For nurses, USP <800> compliance entails increasing education about proper handling of hazardous drugs, implementing closed system drug-transfer devices (CSTDs), and using requisite PPE, according to Eisenberg. “One of the biggest changes in USP <800> is the requirement to use CSTDs when administering drugs,” he said. “Although ONS and NIOSH had recommended these devices, they weren’t required.”

CSTDs can prevent or minimize drug leakage, but Eisenberg said the cost can be prohibitive for some hospitals and clinics. “[Because] some components of CSTDs are meant for single use, it increases the overall cost of the medication,” he said. “The average price of a CSTD ranges from $8-$12 a dose.”

In addition to CSTDs, USP <800> requires nurses to double-glove and wear chemotherapy gowns, when administering chemotherapy drugs, which is consistent with ONS guidelines.

“NIOSH has provided best practice guidance for more than 2 decades. But USP <800> is an enforceable standard with far-reaching implications for all facilities that handle hazardous drugs,” Eisenberg says.

Meeting Enforceable Safety Requirements

Although guidelines for safe handling of hazardous oncology drugs aren’t new, USP <800> introduced safety standards that could be enforceable on a state level.

AnnMarie Walton, PhD, MPH, RN, OCN, CHES, FAAN

“USP <800> gave teeth and enforceability to safety practices that already existed,” AnnMarie Walton, PhD, MPH, RN, OCN, CHES, FAAN, assistant professor in the School of Nursing at Duke University in Durham, North Carolina, explained in an interview with Oncology Nursing News®. “Implementing USP <800> is still a work in progress for many oncology units. Some of the oncology units that weren’t already using CSTDs are adopting them now that suppliers are able to meet the demand. Enforceability of the USP <800> requirement is being decided and regulated at the state level.”

Walton said oncology nurses are in a good position to advocate for safety changes and encourage adoption of USP <800> if their unit hasn’t already implemented them. In addition, oncology nurses can educate patients and their caregivers on safety measures that should be followed while chemotherapy is administered in the hospital or at home after the patient is discharged.

Ensure Safety on an Outpatient Basis

MiKaela M. Olsen, DNP, MS, APRN-CNS, AOCNS, FAAN, clinical program director for oncology at The Johns Hopkins Hospital in Baltimore, Maryland, works at a hospital that began offering a curbside injection clinic to oncology patients in 2020, during the height of the pandemic.

MiKaela M. Olsen, DNP, APRN-CNS, MS, AOCNS, FAAN

“We had to find a way to ensure our patients could safely continue receiving chemotherapy while also protecting them from the coronavirus,” Olsen told Oncology Nursing News®.

Johns Hopkins initially conceived curbside injection clinics as a precaution during the pandemic. But Olsen said Johns Hopkins plans to continue these clinics for patients receiving chemotherapy, and other hospitals have taken notice. “For many oncology patients, the curbside injection clinic offers both increased safety and convenience,” Olsen said. “They still have the option of our indoor injection clinic, but for patients with transportation and mobility issues, the curbside clinic is easier. They can have a family member drive them or take an Uber or Lyft to their appointment.”

Nurses staffing the curbside injection clinic wear full PPE, follow safety protocols, and offer services including symptom assessment, port flushes, dressing changes, and chemotherapy. To date, the curbside injection clinic has seen over 7000 patients. Although large health systems such as Johns Hopkins have embraced USP <800>, Olsen acknowledged that some smaller community hospitals are still working to implement USP <800> safety requirements. One way for hospitals to do this is to request a Health Hazard Evaluation from NIOSH. This evaluation identifies potential health hazards and recommends ways to reduce exposure. There is no cost for the evaluations, but they pay off by providing peace of mind. “Compliance challenges vary from one health care setting to the next, but nurses can help identify areas in need of improvement,” Olsen said.

References

1. Bernabeu-Martínez MA, Ramos Merino M, Santos Gago JM, Álvarez Sabucedo LM, Wanden-Berghe C, Sanz-Valero J. Guidelines for safe handling of hazardous drugs: a systematic review. PLoS One. 2018;13(5):e0197172. doi:10.1371/journal.pone.0197172
2. Huff C. USP<800> Compliance: A Hazardous Drug Safe-Handling Quality Improvement Project for Ambulatory Care Infusion Nurses. Doctor of Nursing Practice thesis. University of San Francisco; 2020.https://repository.usfca.edu/dnp/218