A Summer of Choices and Actions

Dawn Holcombe, MBA, FACMPE, ACHE
President, DGH Consulting, South Windsor, CT

Medical practices and hospital centers across the United States are facing important choices that will determine their fiscal and physical viability moving into 2020. Not only is the impetus behind these required changes unclear, many feel that there is a lack of purpose and justification for them, which has resulted in mounting frustration.

The issue at hand is pharmacy standards, and the choices that need to be made are related to compliance. 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, and can be downloaded as PDFs at no cost from the USP website. These downloads are individualized and may not be shared with, or used by, others. Every medical practice or entity that mixes, stores, or handles drugs should download its own copy of USP <797> and USP <800> immediately and read through them carefully.

For years, most medical practices, many of which do not employ pharmacists or pharmacy technicians, have functioned under the auspices of their medical license and common—if not formalized—operating practices and procedures. However, a growing chorus of voices is rising from many fronts, chanting that if full compliance with USP <797> and USP <800> does not happen by December 1, 2019, inspectors will be beating down the door with fines and citations, and that full compliance will cost hundreds of thousands to millions of dollars.

The reality is that practices do have choices other than going the most expensive, full-blown cleanroom route, although they will likely still need to make changes to their facilities, operations, policies and procedures, cleaning, training, supplies, and equipment, as well as to staff deployment and oversight.

In the April 2019 issue of Oncology Practice Management, we offered readers a self-assessment guide and checklist that can help them identify some of the gaps they may need to address. I encourage practices to use this valuable tool, which is available by e-mailing me at This email address is being protected from spambots. You need JavaScript enabled to view it..

Strategies for Making Cost-Effective Changes

Unfortunately, many practices have created plans—or have already completed physical changes—without proper advice or guidance from those who are well-versed in these pharmacy standards and who have the knowledge to integrate them into medical practice. These practices have spent—or have committed to spend—large sums of money on noncompliant or excessively compliant solutions. Although there is no one-size-fits-all answer to these compliance issues, I believe that walking medical practices through the realities of what they may actually do as an alternative to the absolute full-blown cleanroom suite, and examining comparative costs for equipment and construction, can ease some concerns.

It is important to keep in mind that there are numerous factors that can drastically change the number and design of dedicated rooms that practices and hospital centers will need. These include:

  • Whether all drugs are mixed and fully used within a 12-hour “Beyond Use Date” time frame;
  • Whether all drugs are handled as hazardous;
  • Whether drugs are handled and separated according to the definition of Hazardous Drugs found in USP <800>;
  • What the volume and handling requirements become for the hazardous drugs, nonhazardous drugs, and drugs being administered as defined in USP <797> and USP <800>;
  • Current and future staffing requirements;
  • Local building codes that may be more stringent than the recommendations in USP <797> or USP <800>;
  • Available space in the facility;
  • Current equipment compliance capability;
  • The flexibility, financial resources, and appetite for change of the facility and physicians.

Applying and Enforcing Pharmacy Standards in the Medical World is Still Unclear

For many, the purpose for the upcoming changes may be as clear as mud. These are pharmacy world standards that are suddenly being applied to the medical world. Physicians are wondering how other potential entities could now be allowed or authorized to inspect their operations and change their costs and workflow, or affect patient access to care. The answer may be as vague and unsatisfying as “because they decide to.”

The impetus for quick compliance transformation may be murky for many practices. I am frequently asked by clients, “Who is going to enforce this, and when?” Unfortunately, the answer is “it depends.” I suggest that practices become familiar with 4 general sources of enforcement, application, and referral to pharmacy standards. It is important to remember, however, that only 1 of these sources (or any combination up to all 4 sources) may affect a given practice in a given locale, and not in a predictable time frame.

  1. Legislative/regulatory at the federal and state levels
    Many authorities will be proactive whereas others may only respond to a complaint. However, when a complaint occurs, multiple authorities may get involved.
  2. Accreditation
    Review accrediting expectations carefully for reference to compliance with USP <797> and USP <800> since the June 1, 2019, publication date of the revised standards.
  3. Networks
    Any private network, manager, or affiliation in which a medical practice is involved may choose to hold forth compliance as an expectation, including, but not limited to, payers, pharmacy benefit managers, health systems, and clinical trials.
  4. Private/Individual
    Patients, caregivers, staff, and competitors are all potential sources of a complaint, whistleblowing, or legal action that relies on the mere publication of USP <797> and USP <800> as standards.

Good News and Bad News

For many physicians and administrators, the most frustrating aspect is the perceived lack of justification for this chaos and mayhem. The reality is that the USP received thousands of critical comments regarding their proposed USP <797> and USP <800> standards. The responses to most of those comments were basically that the USP is still keeping the chapters as originally planned.

The good news is that there is hope related to the standing of USP <797> and USP <800>. There is considerable backlash growing among many national disciplines and organizations, all of which are affected by the potential application of these standards. The dated and weak evidence justifying some of the more costly-to-implement standards is being challenged, particularly because of the added cost on a healthcare system already under extreme stress, and the number of patients who will find access to care disrupted or removed as the implications of compliance hit affected entities.

If you have concerns about disruptions in patient access or the financial burden of compliance with questionable evidenced standards, share them with me via e-mail. You can also request to be added to the roster of those who are expressing concern about these standards and seeking solutions.

The bad news is that although some of the USP <797> and USP <800> published standards overreach and create unjustifiable burdens that will adversely affect the healthcare delivery system and patients, there is a case to be made for creating consistency regarding approaches to drug handling by medical and pharmacy communities. Even if USP <797> and USP <800> are appropriately shifted to being references rather than enforceable standards, practices will modify some of their processes as a result of this discussion. Those medical practices deserve to have balanced and reasonable resources available to them as they move forward.

The clock is ticking toward December 1, 2019, and every medical practice, even those that do not specialize in oncology but offer infusions and injections of certain drugs, will have to take some action. As we simultaneously challenge the role and positioning of USP <797> and USP <800>, we cannot lose sight of the 4 potential sources that may well reference those chapters in ways that will affect our practices and patients sooner than later. This is indeed a summer of choices and actions.

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