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A meeting in review:
7 trends on USP <797>

In September, BD had the opportunity to host nine compounding experts from many organizations in the inaugural Medication Management Solutions (MMS) Compounding Expert Committee (CEC).

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A meeting in review: 7 trends on USP <797> from September BD Compounding Expert Committee Meeting


Authored by: Craig Greszler, PharmD, MBA, BCSCP; Senior Manager, Medical Affairs


In September, BD had the opportunity to host nine compounding experts from many organizations in the inaugural Medication Management Solutions (MMS) Compounding Expert Committee (CEC). The meeting occurred at our Lakewood, Colorado office and was headlined with a keynote address by Med Safety Board (MSB) President Rita K. Jew, PharmD, MBA, BCPPS, FASHP, focusing on medication safety, technology implementation best practices, and compounding practice trends.

The goal of this advisory board was to promote collaboration among compounding key opinion leaders (KOLs) and advance compounding safety, regulatory compliance, and best practices. The day and a half event can be summarized into seven key trends impacting health-systems compounding practice: 

 

 

Given the 11/1/23 enforcement date of the new United States Pharmacopeia (USP) standards for <795> and <797>, and the corresponding compendial applicability of <800> and <825>, we spent a large portion of the meeting focused on adherence barriers and solutions.1,2 One of the largest barriers of revised standard implementation included staff education of new requirements. While attendees felt confident training pharmacy personnel on USP <797> and <800>, the providers were warier of the implications of <795> and non-pharmacy personnel education of <800>. One contributing factor is ambiguity regarding how regulating bodies (e.g., state boards of pharmacy and The Joint Commission) will enforce the new standards. While we expect this factor to be mitigated over time, possible solutions offered by the group included leveraging technology to manage and track personnel training, contracting with independent consultants to assist with education and competency creation, and standardizing assessment toolsets. The expert committee also elicited two calls to action: technology vendors must provide a more connected database to manage hazardous medications between electronic health records (EHRs) and automation, and IV workflow management solutions must provide customization to allow for nonsterile compounding guidance.

The other main topic related to updated USP standards was the burden placed on pharmacy with the new competency assessment requirements in <797>. The new standards increase the frequency in which each compounding personnel must be evaluated.1 The revised standard also increased how often environmental monitoring, such as surface sampling, must be completed.1 Attendees expect these new requirements to have a negative effect on labor and supply cost. Additionally, they are bracing for regulatory bodies to scrutinize their logs and records during routine inspections. Members offered that they are vetting and utilizing technology solutions with enhanced reporting capabilities to help manage and prepare for the changes. 

The committee had a lengthy conversation on new practitioner readiness to enter the workforce. It’s well documented that operational and management training is often insufficient or neglected during didactic pharmacy education.3 This was confirmed and solidified during our meeting, as members commented that advance practice pharmacy experience (APPE) students and post-graduate year one (PGY1) residents often had little understanding of the USP chapters, aseptic technique, or overall compounding workflows. This is especially true when technology is introduced into compounding environments. Making matters worse, the competency requirements necessary for garbing and gloving per USP <797>1 make it nearly impossible to provide compounding experiences to APPE students, as they typically only spend 4-6 weeks at each rotation.

While the group acknowledges there is no “silver bullet” to solve this problem, there was unanimous support that education needs to be provided earlier to new practitioners. Futuristic technology was mentioned as a possible solution, citing augmented or virtual reality as opportunities to introduce skills without compromising aseptic environments. There may also be possibilities to increase laboratory time during pharmacy school and incorporate technology at the college or university level.  

During the keynote address, attendees participated in a lengthy discussion on safety risks introduced through compounding technology implementation. The biggest takeaway was that technology implementation without also evaluating workflow could result in ineffective and potentially unsafe utilization.

Failure modes and effects analyses (FMEAs) have been shown as effective tools to help mitigate risk introduced by compounding technology.4 Attendees discussed the need to complete FMEAs before activating their technology in a live environment. Additionally, health-systems may benefit from involving technology vendors in their FMEA process, as the vendor representatives are the true subject matter experts of a particular product or workflow solution. Finally, involving human factors engineers can help identify error prone processes and design workflows that increase the usability of the technology.5

Since the revised USP <795> chapter becomes official at the same time as <797>, it’s important to understand what nonsterile regulatory implications will accompany official inspection and accreditation visits. Health-systems have started to utilize their sterile compounding technology to prepare nonsterile doses, increasing their compounding data availability and reporting capabilities.6 For these reasons, it was the opinion of the committee that the profession of pharmacy should consider a more encompassing name for IVWMS technology, such as Technology-assisted workflow (TAWF), and vendors should consider more flexibility for rightsizing features and functionality to support nonsterile compounding needs. 

End-to-end compounding safety involves more than just medication preparation. To fully follow a medication from component procurement to patient receipt, one must also consider the inventory management and administration workflows and technologies. While disparate automated inventory storage solutions, TAWF systems, and infusion pumps often interface with electronic health records (EHRs) today, the connections between the non-EHR technology is limited. This group felt best practices would be to further connect this data. Opportunities mentioned included:

  • Standardized hazardous designations throughout all electronic formularies
  • Sharing data such as beyond use date (BUD) and expiration date between TAWF and infusion pumps to help avoid medication delays and prevent workflow disruptions
  • Normalizing medication dose and volume significant figures across systems (e.g., volume is represented to the hundredths place and dose strength can go as far as the thousandths decimal place)
  • Visibility to continuous drip volume across TAWF systems, infusion pumps, and the EHR

As sites continue to automate their compounding practices, there will also be more data available. Revisions to USP <795> and <797> strengthened the need for enhanced reporting with additional documentation requirements for standard operating procedures (SOPs), detailed compounding records (CRs), and new criteria for master formulation records (MFRs).1,2 The expert committee requests that their automation and electronic documentation vendors help support these needs by simplifying reports and making data easier to access. The attendees also discussed the future, which they envisioned with complimentary proactive analytics to accompany simplified static reporting with the ability to customize columns and data fields. Proactive alerting could involve more advanced analytics offerings, including generative artificial intelligence (AI), machine learning (ML), and robust data visualization platforms. The ability to automatically update BUDs in a TAWF system if microbial surface sampling in a cleanroom surpassed allowable levels was one example of how proactive and actionable alerting could be used. The overall conclusion from this discussion is that compounding leaders want access to all available data but also need a way to quickly prioritize the most pressing needs. 

Futuristic compounding was an underlying theme throughout the seminar. While committee members were willing and eager to be on the “cutting edge” of new technology in healthcare, they were hesitant to implement it given lack of clear guidance on how this new technology would be regulated. This was especially true for two areas. The first was AI/ML. While the FDA continues to authorize a number of devices utilizing AI, there are no authorized devices employing some of the newer advancements, such as generative AI, as of October 2023.7 Until these devices are authorized and have suitable data to support their use in patient care, attendees were hesitant to explore use within their health-systems.

The other area heavily discussed was centralized pharmacy services. Health-systems continue to consider whether centralization of compounding services is both economically feasible and appropriate for patient care. Compounding robots and automated compounding devices provide opportunities to achieve economies of scale by mass producing commonly used medications.8 However, the 2021 revision to the FDA guidance on Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act saw the replacement of the “1- mile radius” with guidance that non-patient specific products should be used or discarded within 24 hours of leaving the pharmacy.9 The expert committee summarized that there is still too much ambiguity surrounding this guidance, especially as it relates to automated dispensing cabinet (ADC) storage. They feel compounding centralization will fail to expand until more clarity is provided, as health-systems will elect to leverage 503B outsourcing facilities to avoid potential regulatory scrutiny and inspections. 

 

 

This event was an excellent example of how a group of KOLs in medication compounding can meet and exchange ideas and workflows to arrive at key points and consensus opinions.  We would like to thank everyone who took time out of their busy schedules to attend and participate in this important event. The BD MMS CEC will meet again in Spring of 2024 to continue formulating best practices and advancing the safe utilization of compounding technology. 

References

  1. USP. Pharmaceutical Compounding- Sterile Preparations <797>. In: USP–NF. Rockville, MD: USP; Nov 1, 2022. DOI: https://doi.usp.org/USPNF/USPNF_M99925_07_01.html
  2. USP. Pharmaceutical Compounding- Nonsterile Preparations <795>. In: USP–NF. Rockville, MD: USP; Nov 1, 2022. DOI: https://doi.usp.org/USPNF/USPNF_M99595_06_01.html
  3. Mospan, Cortney M. “Management education within pharmacy curricula: A need for innovation.” Currents in pharmacy teaching & learning vol. 9,2 (2017): 171-174. doi:10.1016/j.cptl.2016.11.019
  4. Feemster, Agnes Ann et al. “Use of failure modes and effects analysis to mitigate potential risks prior to implementation of an intravenous compounding technology.” American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 78,14 (2021): 1323-1329. doi:10.1093/ajhp/zxab179
  5. Schneider, Philip J. “Applying human factors in improving medication-use safety.” American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 59,12 (2002): 1155-9. doi:10.1093/ajhp/59.12.1155
  6. Nester, Tina et al. “Utilization of a technology-assisted workflow to prepare controlled substance oral syringes.” American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 80,16 (2023): 1063-1070. doi:10.1093/ajhp/zxad112
  7. Center for Devices and Radiological Health. “Artificial Intelligence and Machine Learning (AI/Ml)-Enabled Medical D.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices#:~:text=As%20of%20October%2019%2C%202023,powered%20by%20large%20language%20models. Accessed 26 Oct. 2023.
  8. Pang, Bob et al. “Comparison of IV oncology infusions compounded via robotics and gravimetrics-assisted workflow processes.” American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 78,2 (2021): 122-134. doi:10.1093/ajhp/zxaa366
  9. Center for Drug Evaluation and Research. “Hospital and Health System Compounding under Section 503A of the Feder.” U.S. Food and Drug Administration, FDA, www.fda.gov/regulatory-information/search-fda-guidance-documents/hospital-and-health-system-compounding-under-section-503a-federal-food-drug-and-cosmetic-act. Accessed 26 Oct. 2023.
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