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.
