What Oncologists Need to Know About USP and the Recent Clarification

John Dodd, director of business and clinical consulting for ION Solutions, a part of Amerisource Bergen

John Dodd

Patients with cancer across the country rely on community oncology practices to provide them with high-quality, coordinated cancer care. This critical care is made possible by dedicated physicians and clinical staff. Unfortunately, oncologists and clinical staff make up part of the 8 million healthcare workers in the United States who may be exposed to hazardous drugs every year.¹ According to past studies, mishandling hazardous drugs can cause acute and chronic health effects, such as rashes, reproductive issues, and even cancer.² Therefore, it is crucial that throughout the care process, oncology practices prioritize safety for their staff and patients.

In 2016, the United States Pharmacopeial Convention (USP) published General Chapter <800> to reduce the dangers of handling hazardous drugs in healthcare settings and provide uniform guidance to protect patients and healthcare workers (Figure).³ The chapter consists of 18 sections, such as “List of Hazardous Drugs,” directing readers to criteria for identifying hazardous drugs provided by the National Institute for Occupational Safety and Health, and “Types of Exposure,” which outlines activities that could lead to potential harmful interactions with the drugs.

In addition to <800>, USP has developed several chapters intended to protect a practice’s staff and patients from hazardous materials in the healthcare setting. USP recently announced that it will delay the implementation of chapters on pharmaceutical compounding for nonsterile preparations (<795>) and sterile preparations (<797>), pending appeals of some sections in those chapters.

As initially planned, USP <800> was deemed official as of December 1, 2019. Generally, a chapter becomes federally enforceable once it is official, although organizations may delay enforcing USP <800> until the other chapters it is linked to become official. Nevertheless, practices should move forward with their plans to meet the requirements of USP <800>, depending on their state’s guidance and direction.

Figure. Facility Engagement With HDs Is Multifaceted³

It is important to understand that these regulations may require oncology practices to make significant capital expenditures and changes in process. For example, practices that prepare hazardous materials may need to install negative pressure rooms and anterooms. USP <800> also has very specific processes for delivering, unpacking, and moving hazardous drugs within a practice. Designated areas must be available for receiving and unpacking hazardous materials, and personal protective equipment must be worn during unpacking. Before they can understand if and how they will need to comply with USP <800>, practices must better understand the specifics of the guidelines and navigate the relevant state governance.

Understanding the Recent Clarification

USP recently revised its definition of drug compounding to better align with the official FDA definition. The initial version of USP <800> did not differentiate compounding from standard administration of a sterile medication and the preparation of drugs (mixing, reconstituting, and other acts) in accordance with the medication label.⁴ The initial version suggested that oncology practices exhibiting these standard actions need a negative pressure room and anteroom. With this revision, it is now clear that compounding means combining 2 or more drugs to create a new drug that is not FDA approved.⁵ For further clarification, organizations like the American Society of Clinical Oncology and Community Oncology Alliance also offer online resources outlining accessible examples of actions that fall under USP’s definition of compounding.

Determining State Governance

After gaining insight on this clarification and its business ramifications, cancer centers will need to determine how and if their state intends to enforce USP <800>. Although USP has no enforcement authority, the new chapter provides direction to states, which can choose to monitor and enforce the USP <800> recommendations, such as the stipulations for external venting.

State governance, as it relates to which parts of USP <800> are enforced, differs for each state. In California, New Jersey, Pennsylvania, and many other states, the decision is determined by a state board of pharmacy and/or medicine. In rare cases, states require a legislative mandate to enforce USP’s guidelines.

Searching a state’s website is typically the most efficient way to determine the state’s standards and if governance falls under 1 or both state boards. Also, a state’s approach can change over time. It’s possible that many states will delay any potential review of the USP <800> standards given the appeals of the other 2 chapters, but that is not guaranteed. It could be risky for a practice to rely on a delay. Therefore, it’s important that practices, especially those that are not yet fully prepared to adhere to UPS <800>, continue to monitor a state’s stance on the matter. In fact, I encourage physicians to reach out directly to a state’s governing body to determine its next actions and periodically check in with these contacts and the state website on any upcoming meetings related to these regulations.

Complying the Regulations

Cancer care destinations that are work-ing to comply with USP <800> standards can streamline the lengthy planning process and decrease added interruption to patient treatment and flow by familiarizing themselves with methods for implementing standards.

When working with oncology practices, I often discuss the potential for designat-ing a USP <800> champion to take the lead on executing procedures, onboarding staff, ensuring that staff document every-thing related to USP <800>, and applying the standard requirements. This champion should be an existing staff member, such as a nurse or pharmacist who is familiar with clinical and patient flow, understands the chemotherapy drugs, and grasps the practice’s entire operation. Given their familiarity with both the standards and the practice, the champion is in a great position to ensure that drafted policy and proce-dures are written properly and in detail.

It is important to remember that these standards were developed to protect a practice’s staff and patients from hazard-ous materials. Practices that decide not to move forward with USP <800> should still consider following the guidelines for personal protective equipment and closed system drug-transfer devices as an added safety precaution. These requirements aren’t as expensive or time-consuming as, for example, a full negative pressure room buildout or the external venting of a chemotherapy hood. Most important, these precautionary guidelines will ensure that staff and patients are better protected from hazardous substances.

References

1. USP publishes new and revised compounding standards [news release]. Rockville, MD: USP; June 3, 2019. usp.org/news/new-revised-compounding-standards. Accessed December 10, 2019.
2. Hazardous drug exposures in healthcare. Centers for Disease Control and Prevention website. cdc.gov/niosh/topics/hazdrug/default.html. Updated September 27, 2018. Accessed December 10, 2019.
3. Explore the hazardous drug lifecycle. B. Braun Medical Inc. website. wwww.readyfor800.com/getting-started-peo-ple-and-processes/. Accessed January 27, 2020.
4. USP issues clarification on general chapter. IntrinsiQ Specialty Solutions website. intrinsiq.com/insights/usp-issues-clarifica-tion-on-general-chapter-800. Published September 10, 2019. Accessed December 10, 2019.
5. Compounding and the FDA: questions and answers. FDA website. www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. Updated June 21, 2018. Accessed December 10, 2019.