Complying with Pharmacy Standards: USP 797/USP 800
Oncology practices, hospitals, and pharmacies are struggling to understand wide variations in the application of sterile compounding and safe handling of oncology hazardous drugs, and the costs and operating burdens of compliance with and adherence to current pharmacy standards. At the 2018 combined meeting of the Association of Community Cancer Centers and the Cancer Center Business Summit, 3 cancer centers shared their stories and experiences related to pharmacy standards compliance.
USP 797/USP 800 Still in Flux
Pharmacy standards are changing, and oncology practices and hospital pharmacies may soon be held accountable for compliance with standards for sterile compounding and safe handling of hazardous drugs. The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make elements of those chapters enforceable.
To date, most state Boards of Pharmacy have adopted their own standards based on USP 797. Fewer than 5 states have adopted safe-handling requirements; however, these are still in progress and not finalized, even after several months.
Many state Boards of Pharmacy are choosing not to implement or enforce USP 800, because it is not yet official; they are likely to consider enforcing their own standards related to the components addressed in USP 800.
These 2 chapters are in flux. USP 797 will be revised and sent out for public comment in the middle of 2018. The USP Expert Committee writing these chapters hopes to align USP 797 with USP 800, which has been presented but has not become official, because of its significant conflicts with the current official version of USP 797. A large public reaction is anticipated, with significant comments likely to be submitted on the revision of USP 797, and, by extension, the elements of USP 800.
Although the actual language of USP 797 and USP 800 will be in flux until the planned “official” date of December 2019, practices and hospitals are currently looking at the draft standards to identify existing gaps and prepare for their implementation. Regardless of whether the standards are legally enforceable, they provide a good outline of elements to consider for better practice. Some of the elements are likely to be challenged for supporting evidence, but many make sense, and gaps exist in most medical practices and pharmacies.
Frequently, discussions about pharmacy standards may be abbreviated to saying “USP 800,” but most stakeholders now understand that this nomenclature is short-form for a larger process of evaluating pharmacy standards in general, and not just the application of USP 800.
The areas of interest for compliance with standards encompass far more than a facility’s issues, which are often discussed because of the pharmacy standards’ effects on space and finances. Any discussion of gaps in pharmacy standards should also address compounding personal protective equipment; hazard communication programs; personnel training and competency; receipt and storage of drugs; deactivation, decontamination, cleaning, and disinfecting of facilities and equipment; and labeling, packaging, and transport of drugs.
Practical Steps to Consider
Steps that oncology practices will want to take include:
- Hazardous drug identification
- Risk assessment for managing use of drugs
- Review of the containment requirement for each drug
- Development of a plan of action for managing the risks of each drug.
Reviews of exposure will be needed across the many functions and activities of dispensing, compounding, administration, patient-care activities, spills, receipt, and transport.
Practices will want to review and plan designated facilities for receipt and unpacking of drugs, their storage, and nonsterile and sterile compounding. There may no longer be an exemption for low-volume hazardous sterile compounding, as is currently defined in USP 797, but practices may qualify for less-rigorous standards if all drugs are prepared for use within up to 12 hours.
Specific examples discussed at the meeting include caution that drug storage may not be directly on the same floor as the infusion chairs, and a suggestion to review your drug inventories to determine the volume of materials that will be prepared and stored in the nonhazardous- or hazardous-designated areas. Many practices have very small spaces for these designated areas, which can work well for meeting requirements regarding airflow and cleaning, but may also make it a struggle to divide existing areas into separate areas for different designations.
Marc Earl, PharmD, BCOP, Assistant Director of Pharmacy, Oncology Services, Cleveland Clinic Taussig Cancer Center, OH, is responsible for community-based and hospital sites ranging from 8 to more than 100 infusion chairs. Space and money are their biggest barriers for considering gaps and compliance.
“How will they fit everything in spaces that currently are as small as a closet, and how will they fund all these changes across 20 sites? Of the 20 sites, I think 18 will need renovation,” Dr Earl said.
New Mexico Cancer Center
Nina Chavez, MBA, FACMPE, Chief Operating Officer, New Mexico Oncology Hematology Consultants, New Mexico Cancer Center, Albuquerque, presented the perspective of a physician-owned private oncology practice with approximately 30 infusion chairs. Her practice started looking at USP 800 standards when they were first presented approximately 2 years ago, beginning with modifications of policy and procedures. They had projected an additional cost of approximately $100,000 annually for the personal protective equipment and closed-system transfer devices they would need to add for compliance with USP 800.
“We did our modifications in stages; the first thing was to train staff and change the culture. That was a barrier in and of itself. Last year we began modifications to our facility,” Ms Chavez explained.
The postponement timing of the official date of USP 800 was a challenge, because the practice had already started the renovation of their largest site. They are now postponing the renovation of another site until more clarity is provided about the final details of the standards, and how they are going to be applied.
“As a physician practice, you are mindful about the money, and about what you actually have to do to be compliant. In New Mexico, I already had the Board of Pharmacy in my office, because I have a dispensing clinic, and every time they came in, they would tell me that my mixing room was not compliant, and that I needed to work on that,” Ms Chavez told attendees.
Because the mixing of compounds is conducted under the auspices of a physician practice, the Board of Pharmacy has not yet taken any action, but it is monitoring the situation.
Ms Chavez’s practice began the journey of identifying what would need to be done, and planning space according to their internal risk assessment of the drugs they use. Then the new National Institute for Occupational Safety and Health list, which suddenly categorized hormone drugs as hazardous, came out. Operationally, Ms Chavez said, this is likely to require that her practice now get another hood, more space, and another technician to handle this new volume.
Novant Health Forsyth Medical Center
M. Jay Brown, PharmD, BCOP, Senior Director, Outpatient Pharmacy Support Services, Novant Health Forsyth Medical Center, Winston-Salem, NC, is part of their cancer service sites that have from 8 to 40 infusion chairs. He agreed with the challenges already presented, and added the change management requirements.
“Going in to these upfits and construction as well, you are taking down your normal mixing space for a period of time, depending on the level of changes needed, for 2 weeks or months. One of the biggest challenges we have seen is working with vendors to help us identify different spaces to be able to provide services to patients” during renovations, he said.
“That really takes a toll on scheduling, provider visits, nursing visits…the change management that you have to have for this is extensive, not just for the things we have already talked about, but simply the disruption you are going to have during the construction,” Dr Brown added.
Is compliance likely to be an issue based upon site size? How do you have the same levels of compliance across multiple sites?
Ms Chavez noted that in New Mexico, the state Board of Pharmacy is very stringent regarding pharmacy rules. She has one rural site, with 8 infusion chairs and very little space for the mixing facilities. She also has a technician and several nurses. However, in New Mexico, nurses cannot supervise or check a pharmacy technician, and the segregated containment area has to be 10 feet by 10 feet. So Ms Chavez is facing staff changes, possibly adding a pharmacist, and physical requirements that may not be possible to accommodate in that space. So far, her practice has not found a workable solution and is waiting to see what the changes are going to require.
Rural Oncology Practices
Barbara L. McAneny, MD, FASCO, MACP, President-Elect of the American Medical Association, Albuquerque, NM, is championing rural practices and seeking solutions that will allow rural oncology practices and rural patients to receive continued access to needed cancer services.
Rural patients will likely have to travel hours for treatment if the rural oncology practices close. It is also possible that new regulations will allow telehealth checking for remote oversight of pharmacy technicians.
State requirements vary across the different Boards of Pharmacy, which presents a challenge. Oncology practices will need to look carefully at their local regulations and at the authority of the Boards of Pharmacy and Boards of Medicine, as well as other entities that may choose to set enforceable standards.
The pharmacy standards do not directly address new therapies (eg, gene therapies), which may need additional rooms.
Some groups have estimated that compliance may add another 8 minutes to the current 4 to 5 minutes of the infusion preparation process. Others have looked at their hood efficiencies, predicting that they may become as much as 33% less productive under the new standards, which affect operations and equipment planning, especially for practices that may be close to capacity in the use of their current hoods.
Compounding and specialization of products for individual patient needs will add more challenges for balancing workflow and collaboration among the mixing staff, as well.
Review Your Practice Gaps
Many of these changes and standards are appropriate improvements, these experts suggest, but the variation in enforcement and selection of standards across states will be challenging. Oncology practices should already be reviewing their own gaps and start making changes.
Look at your National Institute for Occupational Safety and Health list, because the modifications that you choose to make will vary based on your own patient volume. Start with your policies and procedures, and look at your flow and operations carefully as you plan your physical modifications. Involve your staff in the planning, using a multidisciplinary team approach, even with scheduling staff. These changes affect everyone’s lives, and the team will help you realize where conflicts will happen.
Keep in mind that not every vendor that claims to be able to build compliant rooms is able to do so; do not delay making your plans for too long, so that you do not find yourself out of time and vendors, and at risk of being shut down until your practice is compliant. Very few consultants and vendors truly understand oncology practice issues and pharmacy standards, and all the relevant variables.
Despite the transitory nature of the pharmacy standards, USP 797 is now “official.” It may not yet be applied to medical practices in your state, but it serves as a good guide. For practices trying to decide where to start, look to the sterile compounding standards detailed in USP 797.
Many oncology practices are not compliant with staff training and competency standards, cleaning standards, facilities, or the existence of policies and procedures. Find help to identify and resolve those gaps, and that will be good preparation for any future changes.