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.