The Clinician and Patient Safety Implications of USP 800 Compliance in Cancer Care

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.

Compliance challenges

While there’s no doubt USP <800> requirements are critical to protecting against unintentional HD exposure, the necessary infrastructure and practice changes required to achieve compliance are complex, costly, and labor intensive. Dr. Leiva, described some of the challenges she has faced in her efforts to protect her team members and patients.

Costs

Under USP <800>, healthcare entities must handle HDs in designated areas that include: receipt and unpacking, HD storage facilities, sterile and non-sterile compounding areas (if performed by entity). Dr. Leiva explained there is a significant investment required to establish these areas:

“Cost in terms of primary and secondary facility and engineering controls are a huge factor. While hazardous drugs are just a portion of the pharmaceuticals we compound, to comply with USP <800> standards we had to build a USP 797/<800> compliant pharmacy mixing suite. This required some architectural changes and upgrades to our HVAC system to maintain negative air pressure when unpacking drugs to avoid particulate contamination.”

Comprehension

Another major challenge is comprehension according to Dr. Leiva, pointing to the “voluminous” nature of the USP <800> and its changing requirements. Facilities must also keep up with changes in formulary, determining whether any new agent or dosage form they prepare or administer is NIOSH classified as an HD and, if so, handling it in accordance with USP <800>. 

Adding to the complexity, because USP is not an enforcing body, it falls on the U.S. Food and Drug Administration (FDA), The Joint Commission (TJC) and state boards of pharmacy to enforce it, depending upon the type of healthcare organization compounding and administering hazardous drugs.

“One challenge for a facility like ours is that we are not under a pharmacy license but rather a physician license and it is murky as to who has absolute jurisdiction but likely it would be the FDA,” Dr. Leiva explained. “Other facilities are governed by state boards of pharmacy, which have slightly different iterations of USP <800> requirements, with some being stricter than others.”

Clinical staff burden

Under USP <800>, an entity’s health and safety management system must include competent personnel, safe work practices, and proper use of appropriate personal protective equipment (PPE). All personnel who handle HDs must be trained based on their job functions (e.g., receipt, storage, compounding, repackaging, dispensing, administering, disposing of HDs) and competencies regularly assessed.

“From both a cognitive and physical burden perspective there’s a lot of pressure on clinic staff members to make sure they are doing all the right steps because it is a multi-step process,” said Dr. Leiva. “And changing USP <800> requirements, such as those going into effect November 1, 2023, require additional staff training.”

Something that seems simple from a layperson’s perspective, donning and doffing of PPE, can present significant challenges to healthcare workers because of the extent of PPE required for different functions – gloves and gowns, head, hair, shoe, and sleeve covers, eye and face protection, and respiratory protection – and the need for frequent PPE changes (between tasks, between patients, etc.).

“It’s labor intensive and inconvenient especially with technicians having to wear two pairs of chemotherapy gloves when administering antineoplastic hazardous drugs,” Dr. Leiva explained. “It makes it hard for them to manipulate equipment. And for those with visible and invisible disabilities, its challenging to make frequent PPE donning and doffing requirements accessible for them. Just think about how exhausting it is to put on and take off multiple pairs of booties even for those without a disability.”

While use of Closed System Drug-Transfer Devices (CSTD) “offer enhanced protection against potentially hazardous exposures to healthcare workers during the compounding and administration of hazardous drugs,”⁶ Dr. Leiva said she has seen more repetitive stress injuries among staff member using CSTDs because of the force required to move them.

Best practices in USP <800> compliance

For practice directors like Dr. Leiva, putting into place and maintaining practice and quality standards aligned with USP <800> while also managing cancer center operations and patient care delivery can be overwhelming. When asked what advice she has for other leaders in her position, she offered the following best practices.

Streamline SOP content

Under USP <800>, entities must maintain standard operating procedures (SOPs) that include everything from hazard communication and occupational safety programs to spill control and medical surveillance. Given their comprehensive nature, SOPs are not typically “user friendly” tools for healthcare workers, especially when they need quick answers to questions regarding safe HD handling practices.

“A major best practice piece is making sure we are consistently educating employees,” said Dr. Leiva. “SOPs are great, but we can’t expect healthcare workers to stop what they are doing and read them through in their entirety while they are handling HDs. To make SOPs content more accessible, I recommend condensing them down into easy to reference checklists, such as steps to compliant donning and doffing of PPE.”

Keep up with staff training

Training on USP <800> requirements is not only important for those new to the field but also experienced healthcare workers who have been in practice for years, according to Dr. Leiva.

“You don’t know what you don’t know,” she stated. “And for people who have been practicing for a long time it’s easy to get into a confirmation bias mindset and think, ‘Of course I am doing this right because I have always done it this way.’ Another misconception I have come across is staff members believing use of CSTDs eliminate any risk for HD exposure, which is untrue. This belief can lead to risky behaviors that put people in danger.”

While Dr. Leiva admits that most people dislike competency assessments, personnel competencies for HD handling are required under USP <800>, and must be reassessed at least every 12 months. She stated:

“The more frequently we undergo competency assessments, the better we learn and retain the knowledge, which in the case of USP <800>, equates to safer practices. I recommend performing competency training every 6 months in alignment with another requirement, such as fingertip sampling, to make it a consistent process.”

Anticipate the scope of spills

Wherever chemotherapy is prepared, administered, or disposed, spills can happen, placing clinicians and patients at risk for unintentional exposure – and the risks are well documented.

One study, conducted in the ambulatory oncology department at an academic medical center, examined drug spill events (etoposide, cisplatin, pemetrexed, and docetaxel) during a 6-month period. All spills occurred in the patient care area, and all involved the use of a CSTD. Researchers found a single drug spill exposed multiple workers simultaneously, with “low, but quantifiable levels of the tested drugs are found in health care workers soon after a spill.”⁷

Recognizing the extent of the problem and the dangers, Dr. Leiva recommends healthcare facilities place HD spill kits in every area chemotherapy is present.

“For example, consider the movement of a patient with an ambulatory pump from one area to the next, such as in the infusion room, in medical oncology, and in radiation oncology in the cases where patients are receiving concurrent radiation/chemo treatments. Spill kits should be made available to staff members in all these care settings so they can safely clean and decontaminate the environment in the event of a spill.”

Extend safety resources out to patients

As with healthcare workers handling HDs, patients who receive chemo outside of care settings, including those equipped with ambulatory infusion devices, require safety education and training as well. That’s why Dr. Leiva stresses the importance of sending them home with spill kits, along with explicit instructions on handling spills. She stated:

“Even though it’s not covered in USP <800>, spills outside of the clinical care setting do happen. For example, I had a patient who was aggressively gardening after getting a Fluorouracil (5FU) pump. I had warned him of the risks, but he ignored them, and his chemo spilled. That’s why it is best practice to extend HD precautions to keep both patients and their loved ones safe.”

Don’t reinvent the wheel

While Dr. Leiva has implemented USP <800> safety protocols and practices designed specifically for her care setting, she acknowledges she has also leveraged existing resources and tools when available and encourages others to do the same.

“You don’t need to reinvent the wheel for everything related to USP <800> because it’s all been done before,” she explained. “There are a lot of great resources out there, so use them. McKesson does a great job of providing educational resources to support facility leaders and their teams. Also, reach out to colleagues at other facilities to learn what steps they have taken to achieve USP <800> compliance and share your own learnings and best practice tips with each other.”

Conclusion

“The fact is cancer is the second leading cause of death in the U.S. so a lot of people are getting treatment and that will only increase,” said Dr. Leiva.

Recent research has found cancer rates are rising among younger people. A study published in the August edition of JAMA Network Open reported cases of early onset cancers (people under age 50) increased substantially over the study period (2010-2019), with gastrointestinal cancers having the fastest-growing incidence rates among all early-onset cancers.⁸

“With increasing cancer cases, healthcare workers will be required to handle and administer more antineoplastic agents, which in turn increases the risk for unintentional exposure,” Dr. Leiva explained. “These trends should be driving healthcare leaders to build a USP <800> compliant culture and structure of protection today that can support safety as chemotherapy patient volumes grow. As practice leaders, it’s about recognizing the risks to our staff members and patients and being good stewards of safety.”