USP Chapter < 800 > Readiness is All

Last week, on February 1, the United States Pharmacopeial Convention (USP) announced publication of the new standard general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings. USP approved an extended official implementation date of July 1, 2018. This gives healthcare facilities a little more than two years to conform to the standard’s requirements.

With Chapter 800, for the first time a USP standard addresses hazardous drug administration, bringing nurses—and not just pharmacists—under its purview. The standard covers all medications specified in the National Institute for Occupational Safety and Health (NIOSH) list of antineoplastic and other hazardous drugs.

“If there is chemotherapy in your organization, then it applies to you. So you better know about USP 800,” says Martha Polovich, PhD, RN, AOCN, Assistant Professor, Georgia State University. “It applies to all healthcare personnel and all entities in which these drugs are present.” In a session on March 4 at the ACCC Annual Meeting, CANCERSCAPE, Dr. Polovich will provide an in-depth look at final USP Chapter 800, what cancer programs need to know about compliance, and why time is of the essence. Dr. Polovich served on the expert panel that helped to write Chapter 800.

Although the implementation is July 2018, “You can’t wait until early 2018 and expect to meet the standard,” Dr. Polovich warns. While some organizations are already in compliance, it may take others that long to get up to speed, according to Dr. Polovich. Some will need to make capital improvements. And because Chapter 800 requires the use of closed-system transfer devices (CSTD) for hazardous drug administration, some will need to acquire CSTD and ensure that staff is fully trained.

USP 800 is an enforceable standard meaning that state boards of pharmacy and other regulatory entities may require compliance with the new standard.

Readiness is All

What should healthcare facilities be doing to prepare for compliance? As a first step, Dr. Polovich suggests a baseline assessment to find out where the organization is not meeting the standard. Using the baseline assessment results, organizations can then prioritize next steps. For example, if major capital improvements are needed, ensure that these are added into the budget planning cycle. Another key piece is identifying a champion who will be responsible for the organization’s safe handling program and be in charge of USP 800 compliance, she says. This individual should be an expert who is knowledgeable about hazardous drug management and prevention of exposure to hazardous drugs. Healthcare facilities also need to identify the drugs in their organization that should be handled as hazardous.

Join us at the ACCC Annual Meeting to hear from Dr. Polovich and other thought leaders on issues impacting quality oncology care delivery today and tomorrow. View the meeting agenda and learn more here.