Safety implications of USP 800 compliance in cancer care

Safe handling of chemotherapy drugs is challenging but essential for oncology centers

USP <800> provides standards for safe handling of hazardous drugs (HD) to minimize the risk of exposure to healthcare workers, patients, and the environment. But what are the real-world implications in clinical practice?

Maya Leiva, PharmD, BCOP, director of infusion services and lead advanced practice pharmacist for BASS Cancer Center in Walnut Creek, Calif., shared the challenges she has faced in driving USP <800> compliance in her facility, and steps she has taken to keep both caregivers and patients safe from unintentional exposure to chemotherapy agents.

When drugs made to heal cause harm

According to the National Institute for Occupational Safety and Health (NIOSH), approximately 8 million U.S. healthcare workers are potentially exposed to hazardous drugs (HD), including pharmacy and nursing teams, physicians, operating room (OR) teams, environmental services (EVS) staff members, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.[1]

By their very design, antineoplastic agents (cancer chemotherapy drugs, cytotoxic drugs) are harmful to healthy cells and tissues, and healthcare workers who work near or with these drugs are at risk for skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers.[2]


NIOSH points out how “pharmacists who prepare these drugs or nurses who may prepare and/or administer them are the two occupational groups who have the highest potential exposure to antineoplastic agents.”[3]

Dr. Leiva describes why chemotherapy drugs, intended to treat cancer patients, pose such significant risks to healthcare workers who handle them:

“We are giving these drugs to patients for therapeutic purposes to kill cancer cells that are causing illness. It’s targeted therapy with a specific drug (or mix of drugs) administered at therapeutic doses for a discrete period and the patient is monitored for adverse effects, such as toxicities. A patient may develop a secondary malignancy as a direct complication of being given chemo, but we monitor for that too.”

“On the other hand, pharmacy staff who prepare chemotherapy drugs and the nurses who administer them are exposed to low levels of various antineoplastic agents over the course of their careers. We know there are increased rates of bladder cancer and some hematological malignancies (cancers that affect the blood, bone marrow, and lymph nodes) among healthcare workers who handle chemotherapy agents. Because exposure varies and we don’t monitor healthcare workers as we do patients, it’s much harder to predict whether they will develop secondary malignancies and what organs, tissues, or systems will be impacted.”

Minimizing risk through USP <800> requirements

Published in 2016, the United States Pharmacopeial Convention (USP) General Chapter <800> (USP <800>) is designed to protect healthcare worker safety by minimizing their exposure to HDs, including chemotherapy. Its requirements include:

“Responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.” These standards “apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.”[4]

Revised USP <800> requirements standardizing the safe handling of HDs will go into effect on November 1, 2023. They include:[5]

  • Responsibilities of personnel handling hazardous drugs
  • Facility and engineering protocols
  • Procedures for deactivating, decontaminating and cleaning
  • Spill control
  • Documentation

While USP <800> is focused on protecting individuals who handle and administer HDs as part of their jobs, Dr Leiva, who leads USP <800> compliance for her cancer treatment center, said the measures she has put in place are intended to protect all persons at risk, including patients.

“As a director, I see myself being responsible not just for the local enforcement within office practices but also encouraging people beyond our walls to take their health and safety seriously,” she explained.

if you want to read full article on, click here.



[2] Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, NIOSH,


[4] USP General Chapter <800>, USP,

[5] USP General Chapter <800>, McKesson, September 11, 2023,<800>

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars