Pre-Conferences Kick Off ACCC National Oncology Conference

by Amanda Patton, ACCC, Communications

OPEN Pre-Conference attendees listen to session on biosimilars

Cancer care professionals from across the country are gathering in Portland, Oregon, this week for the ACCC 32^nd National Oncology Conference.

Yesterday’s pre-conferences set the stage with sessions on oncology pharmacy issues and a program designed for administrators new to oncology.

One hot topic under discussion at the Oncology Pharmacy Education Network (OPEN) pre-conference: Institutional Review of Biosimilars. Jim Koeller, MS, PharmD, of the University of Texas at Austin, told attendees that “nationally, what we hope to create…we’re really trying to get to is a national standard on how biosimilars should be reviewed [by institutions].”  Until that time, what can P&T Committees do to be ready for institutional review? Setting up a subcommittee or working group for biosimilars is an important first step, Koeller  said.

While biosimilars will be less expensive, they will still be costly and reimbursement for biosimilars will “take a long time to figure out,” Koeller warned.

Key takeaways for oncology pharmacists and the oncology pharmacy:

• Biosimilars are not generics: Use of biosimilars will require clinical review by a multidisciplinary team through the P&T Committee or other mechanism
• A systematic review process will be necessary, looking at product, manufacturing, and institutional factors
• Interchangeability is generally a state issue; keeping up with state laws will be essential.

A common theme across both pre-conferences: Oncology today requires multidisciplinary leadership.

“Almost everything in oncology practice is interdisciplinary,” said presenter John Hennessy, MBA, CMPE, in a New to Oncology session on Leadership and Organizational Structure. To succeed, oncology programs must have processes in place for identifying and training future leaders and aligning incentive across all team members, he said.

Stay tuned for more from the ACCC National Oncology Conference.  Follow the conference on Twitter at #ACCCNOC.

USP Chapter 800–Round Two

By Maureen Leddy, JD, Policy Coordinator, ACCC

Recently, ACCC submitted comments on the U.S. Pharmacopeia (USP) draft Chapter <800>, proposed standards for handling hazardous drugs in healthcare settings. The comments are in response to USP’s latest draft of Chapter <800>.

As you likely recall, USP released a first draft of Chapter <800> in March 2014. In response to comments by ACCC and other stakeholder groups, USP issued a revised Chapter <800> draft in December 2014.

In responding to the initial draft, ACCC and other stakeholder groups expressed concern about the difficulties providers would face implementing the proposed Chapter <800> standards, in large part due to the financial investment they would require. Many, including ACCC, anticipated that if USP Chapter <800> was adopted as first drafted, some cancer facilities would no longer be able to offer compounding services to patients or might even close altogether.

ACCC is pleased that USP’s revised Chapter <800> draft provides more flexibility, but concerns remain. We continue to request additional pathways to comply with the new USP standards and to ask for more clarity on specific requirements. ACCC supports USP’s ultimate goal of ensuring healthcare worker safety; however, we believe that in several instances there are more cost-efficient protective measures that would provide more certain safety enhancements.

USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP standards, such as Chapter <800>, are generally adopted by states and enforced by state Boards of Pharmacy or other regulatory entities. USP has indicated that the earliest likely effective date for Chapter <800> is August 2016; however, the many structural and procedural changes in the current draft would make compliance by that date a stretch for oncology programs.

The ACCC policy team is watching closely for a further revised or final draft of Chapter <800>; we will keep you posted.

Why USP Should Reconsider Chapter 800

by Sydney Abbott, JD, Manager, Provider Economics & Public Policy, ACCC

The US Pharmacopeial Convention (USP) recently released draft guidance on the containment of hazardous drugs (HDs) to “as low as reasonably achievable” in order to ensure the safety of personnel handling these drugs.  According to the Centers for Disease Control (CDC), about 8 million people every year could be exposed to HDs, so USP developed Chapter 800 to protect this population in the transporting, receiving, compounding, and dispensing of these products. While ACCC’s Oncology Pharmacy Education Network (OPEN) supports USP’s aim to increase personnel safety, we remain concerned that implementation of these proposed standards would result in reduced access to care for patients with cancer.

USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.

The guidelines outlined in the proposed Chapter 800 call for any facility compounding or mixing HDs, no matter how infrequently, to undertake a series of precautions, including separate storage locations for sterile and non-sterile drugs. For many ACCC members, adherence to Chapter 800 would not only pose a major financial concern, it would present a challenge in terms of having enough physical space to comply with guidelines—especially for those in urban settings or with facilities located within a cancer center. Ultimately, if the chapter is adopted, it could cause some cancer facilities to either stop offering mixing services for their patients, or in extreme cases, to close altogether.

However, it is important to understand that USP Chapter 800 presents guidelines—states individually adopt Chapter 800 for these to become mandatory. Still, even if a state has already adopted USP Chapter 795 and/or Chapter 797, it does not preclude that state from adopting Chapter 800, as well.  This is because Chapter 800 addresses containment matters and is designed to build on 795 and 797, not replace them.

ACCC’s Oncology Pharmacy Education Network (OPEN) and the Oncology State Society Network (OSSN) recently submitted comments to USP on proposed Chapter 800.  In addition, ACCC joined with representatives from other cancer organizations in a group letter to USP expressing common concerns regarding proposed Chapter 800.

ACCC will continue to keep members informed on this issue.