Tag Archives: USP 800

OPEN Pre-Conference Highlights

By Amanda Patton, ACCC Communications

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We’re in St. Louis for the ACCC 33rd National Oncology Conference this week. Events got underway on Wednesday, October 19, with dynamic pre-conference sessions focused on some of the most challenging and rapidly evolving areas in cancer care delivery. Read on for highlights from the Oncology Pharmacy Education Network (OPEN) pre-conference.

A morning panel discussion during the OPEN Pre-Conference focused on strategic planning for the oncology pharmacy. Zaven Norigian, PharmD, BCOP, Beth Israel Deaconess Medical Center, moderated a discussion with Steve D’Amato, BSPharm, New England Cancer Specialists, and Ali McBride, PharmD, MS, BCPS, BCOP, University of Arizona Cancer Center, that touched on some of the toughest challenges for oncology pharmacy today. Among these:

Cost of drugs. Pharmacy budgets continue to increase, the value of inventories in clinics is escalating, and if programs are not paid in a timely manner, cash flow problems will result. With the increase in immunotherapies and new oral agents, programs are wrestling with how to afford of these therapies and provide access to these for all of their patients. “The bank is going to break eventually,” said D’Amato.

Implementing genomic testing. Operationalizing this in the community setting is creating big challenges for the oncology pharmacy, panelists agreed. It requires a multidisciplinary approach providing integration and education for clinical pharmacists and nurses. There must be buy-in from everyone.

EHR and data issues. Programs need to be able to mine their data, understand their data, and reduce the staff time needed to collect and report data. Pharmacy is looking to technology to solve some of these important issues—without being “nickel and dimed to death” by their EHR vendors, panelists said.

USP 800. This is top-of-mind if you work in pharmacy, panelists agreed. Among the pressing challenges: How do you explain issues related to USP 800 compliance to the C-suite? Attendees were urged to act now—if they haven’t already—and at a minimum bring in a consultant to determine what it will cost to be compliant by 2018. “We know it’s going to be costly…it’s not something you can flip the switch one day and start it,” said Norigian.

Succeeding with Oral Oncolytics

An OPEN Pre-conference session tackling a critical current day challenge highlighted ACCC’s education initiative, Steps to Success: Implementing Oral Oncolytics. (The session was broadcast live, and will be available on the ACCC website on-demand soon.)

“One of the biggest challenges with oral oncolytics is that we put so much responsibility on the patient,” said presenter Niesha Griffith, RPh, MS, FASHP, West Virginia University Health System. Pharmacists need to be “on the frontlines” of taking care of oncology patients, she said.

Calling attention to the Steps to Success white paper developed as part of this ACCC initiative, Griffith focused on the project’s key programmatic recommendations for successful integration of oral oncolytics:

  • Take a multidisciplinary approach
  • Assign responsibilities; clearly identify who is responsible for what
  • Work collaboratively with specialty pharmacy (as needed)
  • Provide financial advocacy services
  • Develop a robust patient education program
  • Put in place effective processes for monitoring for adherence and toxicity
  • Maximize the use of technology

Griffith stressed the importance of developing robust case management platforms so that all providers can document information from patient visits. Where possible, develop methods to streamline processes. For example, devising a streamlined process for prior authorizations can help avoid pulling staff away from frontline care for this time-consuming task. Access more resources from ACCC on successful integration of oral oncolytics here.

Stay tuned for more from the ACCC 33rd National Oncology Conference from ACCCBuzz. Follow the conference highlights on Twitter #ACCCNOC.

USP Chapter <800> — Readiness is All

By Amanda Patton, ACCC, Communications

ThinkstockPhotos-180686516Last 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.