HealthSeptember 06, 2024

Easing the regulatory burden: Leveraging technology for smarter USP compliance in pharmacy IV compounding 

Explore tech solutions for USP-compliant pharmacy IV Compounding amidst technician shortages and changing regulations.

Is it surprising to learn that 93% of hospitals are grappling with a shortage of technicians proficient in sterile compounding? This shortage is only escalated by the evolving regulations and the complexity of maintaining compliance with USP. Given the recent updates to the USP chapters’ compounding standards, and the prevailing confusion about some changes, many facilities are finding it hard to stay compliant and integrate best practices. For instance, a quarter of pharmacies have received citations or recommendations related to compounding compliance from accrediting authorities, as reported in PPPMag's State of Pharmacy Compounding report in April 2024. 

In the first three months of 2024, we witnessed an unprecedented number of drug shortages, with more than 300 instances, the highest since the American Society of Health-System Pharmacists started tracking them in 2001. This inevitably places more pressure on compounding pharmacies to bridge the gap, underscoring the urgent need for innovative solutions to optimize efficiency and ensure compliance in sterile compounding.  

In this installment of our multi-part executive insight series, our pharmacy clinical experts explore the latest innovations that will equip modern compounding pharmacies with tools to keep up with the complexities of USP standards and maintain compliance in sterile compounding which can be daunting, especially with ongoing technician and drug shortages.  

Navigating the complexities of USP standards 

USP standards are comprehensive but not necessarily universally applicable. They set base standards that might necessitate physical, operational, or workforce updates for compliance. The latest USP standards have led to continued renovation of pharmacies and cleanrooms to meet the updated facility and engineering controls. According to the recent PPPMag report, 51% of facilities have been renovated in the past five years, and 35% are planning renovations within the next 2-3 years. These recent changes demand a thorough review of facility policies, procedures, and workflows, along with adherence to new environmental monitoring and cleaning requirements. 

Harnessing pharmacy software systems for USP compliance 

Sterile compounding has inherent challenges, such as proper documentation, staff training and competencies, and environmental controls. The additions to the USP standards have only amplified these challenges, making it even tougher for hospitals grappling with technician and drug shortages.  

For example, recent revisions require compounding pharmacies to conduct a full review of policies and procedures, facilities, and workflows, as well as implement changes to the frequency of air and surface sampling, and cleaning requirements.  

In addition, the rigor and frequency of training and competency assessment requirements increased. Manual compliance with these standards can result in new documentation challenges, increased personnel strain, higher equipment and supply costs, and potential workarounds and points of failure throughout the workflow. 

Boosting efficiency and patient safety with integrated compliance solutions 

An integrated compliance solution can significantly streamline the compounding process. By implementing standardized USP-compliant templates and workflows, coupled with staff training, managing the system and minimizing compliance gaps becomes easier. Features like automated alerts, customized color labels, and master formulation records can enhance workflow and safety. 

Adopting industry best practices from organizations like ASHP, ISMP, and ThrIV, which recommend technologies with remote, in-process checks and video camera monitoring, can provide real-time oversight and approval, reducing the chance for error and enhancing patient safety. 

Consider systems with formulary management systems and global workflow templates which can help streamline the task list build. Many systems can also offer dedicated batch and patient-specific workflows, a format that can be more cost-efficient compared to manual workflow development. Systems with remote checks that do not require a pharmacist in the cleanroom free up personnel to focus on other tasks, ultimately enhancing productivity. 

Incorporating a system with these features not only simplifies tasks and reduces workload but also ensures compliance with the latest regulations and best practices. 

The future of pharmacy IV compounding: Embracing innovation and automation 

Technology will shape the future of sterile compounding, enabling pharmacists and technicians to practice at the top of their licenses. Real-time data and digital documentation will drive better compliance and operational decisions. Health systems' potential to automate their compounding processes will enhance safety, accuracy, repeatability, and efficiency. 

Looking forward, staying ahead of compliance requirements through pharmacy IV workflow innovation and automation will be vital. Using automated IV workflow systems to optimize workloads, reduce manual errors, save time, and ensure adherence to USP standards. Get ready for our next article, where we will outline what to look for in your pharmacy compounding workflow software to ensure it aligns with ISMP and THRIV guidelines to deliver safer, more efficient, and compliant sterile compounding. 

Simplifi+ IV Workflow
Annie Lambert
Clinical Program Manager for Compliance Solutions
Compliance Solution Clinical Program Manager Annie Lambert, PharmD, BCSCP is committed to providing up-to-date USP content and expert compliance guidance, and to work with you to optimize the use of our Simplifi+ pharmacy compliance solutions.
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