Adopting pharmacy compounding solutions like technology-enabled IV workflow management is becoming the gold standard for hospital pharmacies, streamlining operations, and promoting the highest patient safety standards. In the first segment of our multi-part series, we explore the challenges and pain points of IV workflows within healthcare institutions.
Sterile IV compounding—identified as one of the most high-risk areas in pharmacy operations—remains remarkably untouched by straightforward safety measures such as barcode scanning, volumetric or gravimetric analysis, and automation that align with the progressive Institute for Safe Medication Practices and the THRIV Coalition guidelines.
Today’s sterile compounding procedures, characterized largely by manual methods, present clear risks to patients. Even the smallest deviation can trigger a serious adverse event. A significant number of clinical leaders falsely presume that IV preparations maintain the same quality controls as other medications. However, stand-alone statistics paint a different picture:
- Barcode medication verification for sterile IV compounding is utilized by a fraction of hospitals.
- Compounding errors are reaching patients. Nearly one-third of facilities disclosed that a patient incident involving a compounding error had transpired within their institution in the last five years. That number has not changed in the last 17 years.* Pharmacy Purchasing & Products' State of Pharmacy Compounding 2024
- Data shared with the Institute for Safe Medication Practices consistently indicates that manual inspection of IV admixture components is inadequate in preventing dispensing errors entirely.
Consider this everyday scenario: Before beginning daily compounding tasks, the technician cleans and disinfects their workspace, documenting the cleaning steps. They then verify the environmental conditions, such as temperature, humidity, and pressure, of the compounding area. Upon completion of these tasks, they are finally ready to begin compounding medications.
A pharmacy technician starts by obtaining printed labels for specific administration times. These labels are sorted manually on a table or desk, organized by drug and time, with urgent orders prioritized accordingly. The technician then locates the correct recipe and gathers the necessary ingredients, which are documented in a compounding log. After all the IV doses are manually measured, prepared, and labeled, the technician provides a walkthrough of the process from memory. This manual process requires the pharmacist to either supervise or place their trust in the technician’s work, culminating in a sign-off from the pharmacist to ensure everything meets the necessary standards.
This method underscores the inherent patient safety risks associated with manual IV compounding procedures. Each step introduces the chance for human error. During audits, concerns often arise regarding missing documentation or potential errors. Manual processes can also undermine pharmacies' capacity to meet the complex requirements of USP <797> and USP <800> guidelines.
Despite the significant financial and reputational consequences of non-compliance, not all facilities are entirely compliant with USP <797>, with only about 80 percent claiming full compliance according to the Pharmacy Purchasing & Products' State of Pharmacy Compounding Update 2024. Common obstacles to USP compliance range from limited resources, expertise, and time to unsupportive leadership and dependence on manual, paper-driven workflows.
As expected, accreditors have increased citations and recommendations this year. Common areas of focus include cleaning training and documentation, remediation practices for out-of-spec events, and hand hygiene - particularly when moving in and out of the ISO 5 hood. *Pharmacy Purchasing & Products, April 2024
The time is ripe for a shift towards higher standards of practice that incorporates a comprehensive approach to safety, accuracy, and compliance through pharmacy compounding solutions. In the next installment, we will discuss the latest innovations that will equip modern compounding environments with sophisticated systems and tools.
