Pet cares

Designing Hospitals for the Treatment of Cancer Patients: USP Regulations

Content submitted by Animal Arts, a dvm360® strategic alliance partner

During the COVID-19 pandemic, veterinary professionals have had a lot of worries. How to keep ourselves and our loved ones safe was at the top of the list. We’ve been forced to take a closer look at how the disease can be transmitted and what it’s like to do all we can to protect each other. This included our pets. Many people have adopted pets during the pandemic, and others have simply spent a lot more time with them at home than before. As a result, our veterinary teams were busier than ever on the front line diagnosing, treating and caring for our 4-legged family members.

Before the pandemic for non-healthcare workers, I probably should have defined what PPE stood for. Now, that’s common terminology. We are now thinking about how we touch things and how we can potentially transmit the disease, unknowingly, to someone else. We even think about how long we wash our hands. As we thought about designing safer spaces for our veterinary teams, we learned that they needed more space; touchless taps when functional; easy-to-clean, non-porous surfaces; and well-planned spaces for proper storage and placement of equipment to facilitate a safe working environment. Many of the best practices for safety in hospital design that we all instinctively knew about pre-pandemic have come back with a vengeance.

Just as the pandemic was beginning, I patiently awaited the appeal process for the revised 2019 General Chapters of the United States Pharmacopeial Convention (USP), Pharmaceutical Compounding – Nonsterile Preparations and Pharmaceutical Compounding – Sterile Preparations, to be comprehensive so that we can better understand their implications for designing the safest possible veterinary oncology area for our customers. At the beginning of January 2020, I published an article in dvm360® entitled “Handling dangerous drugs? Read this” which provided the general context and importance of these 2 chapters as well as their equivalent, the General Chapter Hazardous Drugs – Handling in Health Care Facilities.1 For more than a year before, we had started to implement the new standards in our designs. Then, on March 12, 2020, while we were all rightly focused on this new thing called COVID-19, the USP issued a decision on appeal of the Revised General Chapters and .

The decision was to allow appeals for these 2 general chapters and to refer the chapters to the Membership Expert Committee (CMP EC) with the recommendation for further engagement on the issues raised regarding the membership provisions. expiration date.2 The EC CMP is still under review and as such the latest revised chapters remain official. The catch here is that until the 2019 versions of these general chapters are adopted, the USP is not applicable compendially. One reason for this is that a general chapter numbered below 1000 becomes compendially applicable, and a required standard, when the chapter is referenced in another general chapter below 1000.

without the chapters and revised, the General Chapter has no regulatory weight. This chapter has been designed to create a public standard to minimize the potential risk of exposure and the information it contains is crucial to the safety of those who administer the medicines and the patients who receive them.3

It has been 2 years since the start of the pandemic and since the CMP EC began its review. The comment period officially ended on March 17, 2022 and it is expected that as early as early next year we will see the revisions go into effect. We must continue to focus on using this time to begin implementing the standards.

It is essential to trace the path of hazardous drugs (HD) from their arrival at the hospital to your receiving area, to your oncology department, then to a client or administered to a pet . Breaking this down a bit further to help you understand the flow, we’ve illustrated the process in Figure 1. The boxes in orange are the areas your architects should design with your input. The gray boxes are the areas for which members of the veterinary team handling these drugs will be responsible.

Let’s quickly review some highlights of these 3 General Chapters:

  • All antineoplastic drugs requiring handling must meet all containment requirements.
  • Technical controls are necessary. These controls are the primary containment technical control (C-PEC, for example, the hood itself), the secondary containment technical control (C-SEC) such as the room in which the C-PEC/hood is located) and additional levels of control.
  • Sterile and non-sterile Hazardous Drugs (HD) must be compounded in a C-PEC located in a C-SEC.
  • For sterile preparations, the C-PEC must be in a C-SEC, which can be either an unclassified containment separate staging area (C-SCA) or an ISO Class 7 buffer room with an ISO Class 7 anteroom. These configurations are illustrated in the following sample plans.
    • If the C-PEC is placed in a C-SCA, the expiry date (BUD) of all compounded sterile preparations must be limited as described in for CSPs prepared in separate preparation areas. (In depending on which version you are referring to, you will need to confirm that you will be able to operationally comply with the low or medium risk level or category 1.)
    • Volatile drugs can be compounded in a Type 2, Class II BSC. If you plan to use a CACI, you will need to check with the hood manufacturer for compliance.

Keep in mind that oncology wards require more than space to handle chemotherapy drugs. They need functional exam space, enough spaces for nursing and records, and enough additional treatment areas for non-chemo administration. Each full-time equivalent physician, space permitting, should have 2 examination rooms, a treatment table and 2 nurse stations dedicated to their department. Additionally, there should be animal housing to accommodate the larger physical size of most oncology patients, as well as different types and locations of housing to suit the needs of the patients and the procedures being performed.

In the example floor plan below (Figure 4), there is a running room nearby as well as cages in the treatment room. Surrounding departments should also help support oncology by providing flexible space for additional treatment tables and animal housing. Since many of the animals in this area of ​​the hospital are immunocompromised, you also want to minimize cross-traffic from other patients and people and keep the service close to the exam rooms and medical team. the reception to facilitate the support and transport of the animals.

Final Thoughts

As veterinary medicine continues to advance and provide more oncology services to more patients, it is essential that we design to incorporate the goals of these 3 important USP General Chapters as part of our recognition and our support for the safety and accommodation needs of people who work and pets who are cared for in these spaces.

References

  1. Pollard V. Handling dangerous drugs? Read it. dvm360. January 7, 2020. Accessed March 31, 2022. https://www.dvm360.com/view/handle-hazardous-drugs-read-this
  2. Appeal Panel Decisions on USP , and . USP. March 12, 2020. Accessed March 31, 2022. https://www.usp.org/sites/default/files/usp/document/our-work/compounding/decisions-appeals-fs.pdf
  3. Role and Applicability of the General Chapter of the USP on the safe handling of hazardous drugs. USP. March 12, 2020. Accessed March 31, 2022. https://www.usp.org/sites/default/files/usp/document/our-work/compounding/compendial-applicability-of-usp-800.pdf