2019 Fall Tips: USP, OSHA, and Practice Protection

Dawn Holcombe, MBA, FACMPE, ACHE
Editor-in-Chief
President, DGH Consulting, South Windsor, CT

Although our top priority is to provide high-quality care, we often encounter barriers and hurdles that can affect where, when, and how we interact with our patients and staff. Given the increased focus on the acquisition, handling, preparation, and administration of drugs in medical practices—especially oncology practices—we are now being challenged with existing and emerging restrictions and expectations, which are continually in a state of transition. In this article, I want to share 3 important tips that will help you be more prepared and protected this fall.

USP Applicability

On June 1, 2019, the US Pharmacopeia (USP) published chapters on Pharmaceutical Compounding – Sterile Preparations (USP <797>) and Hazardous Drugs – Handling in Healthcare Settings (USP <800>); both chapters were published with an official utility date of December 1, 2019. During the summer, there was a flurry of activity in the medical community as practices sought clarity regarding how and when these chapters will apply to their businesses. In response to rising challenges to the published chapters, the USP added to the confusion by “clarifying” and basically backpedaling from their former hard-line position.

On July 23, 2019, the American Society of Clinical Oncology published guidance suggesting that practices ask regulatory, licensing, and other organizations to determine if and how these standards may be applied in their states.1 This caused further confusion because there are many other directions from which these standards may be, and already are being, applied to medical practices. Any “clarification” provided by the USP in statements, interpretations, or even Frequently Asked Questions published on its website had no legal standing or effect. Until the actual published USP <797> and <800> are changed or rescinded from their current standing, any entity (public or private) can take the words in these chapters and subject them to whatever interpretation or application they so choose, and make them applicable to any medical practice in any state.

Chapter <797> addresses the protection of products from contamination. Chapter <800> addresses the protection of humans from contamination from products. These 2 concepts are related but not interchangeable. Practices must look at their compliance gaps from each standpoint separately.

Tip #1

Do not assume that USP <797> and <800> will not be held up as standards against your practice. If you have checked with a local regulatory agency and it indicated that it did or did not intend to seek compliance with these chapters, do not assume that is the end of the issue. Compliance with these chapters may still be compelled from another direction—a competitor, a network to which you belong, a staff whistleblower, or a litigious patient or caregiver. As long as they are published, these chapters present a risk for any medical practice that handles or touches drugs outside of a licensed pharmacy (which already must comply with the chapters).

USP Delays

The USP Bylaws have set forth specific timelines and processes for publication and making their standards official. Since the June 1, 2019, publication of USP <797> and <800>, several appeals were filed. Although denied by the USP Compounding Committee, some of those filers have now requested hearings of their appeals. The USP Bylaws (Article VII, Section 7.c of the 2015-2020 USP Bylaws)2 call for postponement of the “official” dates of the standards under appeal while the appeal is pending.

On September 23, 2019, the USP announced that it was postponing the official dates of Chapter <797> and other chapters indefinitely while keeping the “official” date of December 1, 2019, for Chapter <800>. During the postponement and pending resolution of the appeals, USP <800> is being identified as informational and not compendially applicable. Separation of the revised USP <797> from USP <800> by these postponements will lead to inconsistencies and confusion in the marketplace. Practices must stay on their guard.

Tip #2

The “official” date of December 1, 2019, for USP <797> has been postponed as multiple appeals are moved into hearings, and it is also likely that litigation will be brought into the mix. By leaving Chapter <800> as is, with the official December 1, 2019, date, the USP has left the door open for chaos, since the standing Chapter <797> conflicts with and contradicts Chapter <800>. The revised USP <797> that is now postponed offered some language that may have provided an avenue for redefinition of the applicability of this chapter to medical practices appropriately following specific guidance from FDA-approved drug indications, but the standing USP <797> does not. This postponement will only allow medical practices more time to adapt to portions of the Chapters, although they will want to enact some changes, regardless of the standing of the USP Chapters, which I discuss in more detail in Tip #3. These delays will buy you time, but not protection. As long as USP <800> is listed as “official” and the standing USP <797> remains in force, medical practices that are not in compliance are at extreme risk for tort and competitive challenges.

OSHA Hazard Communication

Occupational Safety and Health Administration (OSHA)’s Hazard Communication Standard (29 CFR 1910.1200)3 ensures the safety of employees who potentially come in contact with hazardous substances. This regulation requires employers to make Safety Data Sheets (formerly Material Safety Data Sheets) for any hazardous substances available to their employees. Since many oncology practices seem to be unaware of this requirement, compliance is widely variable. Although OSHA does not appear to make routine inspections of physician offices or pharmacies, it does respond to whistleblower complaints, and has levied substantial fines against healthcare provider organizations in response to such complaints, and has brought along other organizations during inspections.

Tip #3

If you do not have an annual hazard communication program and process for every employee, put one in place immediately. This is the first thing that OSHA will look for when given the opportunity to come into your office. OSHA fines are significant and immutable. Do your level best not to give this agency a reason to come into your practice.

How to Protect Your Practice

The horse is out of the barn. States, regulatory bodies, licensing bodies, networks (eg, clinical trials, payers, health systems, pharmacy, etc), accreditation bodies, and private groups, such as competitors, staff whistleblowers, and patients and staff with litigious leanings, are all going to be looking at the published USP <797> and <800> chapters and contrasting what they see in your practices against these “standards.” It will not matter if one of those many possibilities has given you an exemption, the rest are looming out there.

The best protection is a strong proactive stance. Review your regular practices against these “standards.” Take action to mitigate what gaps you can. At the very least, develop substantial standard operating procedures, staff training, competency, and tracking programs. Even aseptic techniques should be well-defined and practiced.

These actions should be taken now, no matter what transpires on a national level with USP <797> and <800>. If they are delayed, or even revised into noncompendial chapters rather than obtaining “official standards chapter” status, you are only gaining more time to prepare. It is inevitable that these chapters will exist in some form and your practices will be held up against them for comparison. Remember that the best defense is a good offense.

References

  1. American Society of Clinical Oncology website. Your Practice May Not Be Subject to USP <797> and <800> Standards; Check with Your Relevant Regulatory Body. www.asco.org/advocacy-policy/asco-in-action/your-practice-may-not-be-subject-usp-and-standards-check-your. Accessed September 13, 2019.
  2. USP. Excerpt from 2015-2020 USP ByLaws. www.usp.org/sites/default/files/usp/document/about/convention-membership/article7.pdf. Accessed September 13, 2019.
  3. United States Department of Labor website. Occupational Safety and Health Administration. www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=federal_register&p_id=13349. Accessed September 13, 2019.

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