HealthNovember 14, 2017

IV Workflow: The Challenges of Manual Sterile Compounding Processes

Hospital pharmacies have long embraced automation and technology-enabled workflows as a best practice for streamlining operations and promoting the highest safety standards. 

In this first installment of a two-part series, we explore the challenges and pitfalls of IV workflows in today's healthcare organizations. Stay tuned for our second installment, where we will uncover best-practice solutions and announce a next generation IV Workflow solution for enhanced accuracy and patient safety.

Yet, one of the riskiest aspects of pharmacy operations—sterile IV compounding—remains largely untouched by basic safety measures such as barcode scanning, gravimetrics and automation to promote compliance with evolving United States Pharmacopeia (USP) guidelines.

Characterized by largely manual processes, today's sterile compounding environments present hazards to both patients and staff, as even the smallest percent discrepancy can result in a serious adverse event. Many clinical leaders assume IV preparations are safeguarded by the same level of quality assurance as other medications, but the statistics speak for themselves:

  • The majority of hospitals do not use barcode medication verification for sterile IV compounding.
  • Well conducted studies point to IV error rates in the range of 1 percent to 9 percent.
  • Data submitted to the Institute for Safe Medication Practices has repeatedly shown that manual inspection of IV admixture ingredients is not a totally effective deterrent to preventing dispensing errors.

Consider this common scenario highlighting some of the patient safety risks associated with manual IV compounding processes—each step opening the door to human error. A pharmacy technician prints out labels representing patient IV needs for a specific time period. Labels are manually sorted on a table or desk and organized by drug and time. Once IV bag solutions are manually measured, prepared and labeled, a technician provides a simulated overview of what occurred based on memory. Then the lead pharmacist signs off.

Manual processes also plague the ability of pharmacies to comply effectively with complex USP <797> and USP <800> guidelines—the industry-accepted minimum practice standards for compounded sterile preparations and hazardous drug handling. Both enforceable federal guidelines, USP standards are increasingly adopted by national and state regulatory bodies to raise the bar on compounding practices.

Yet, despite the significant financial and reputational consequences that can occur from nonadherence, overall USP 797 compliance remains low with only 38 percent of facilities reporting full compliance, according to Pharmacy Purchasing & Products' 10th annual survey of compounding practice. Typical challenges creating barriers to USP compliance include a lack of resources, competency, time and leadership support, and the prevalence of manual, paper-based workflows.

In the Pharmacy Purchasing and Products survey, three out of 10 facilities reported that a patient incident involving a compounding error had occurred in their institution over the past five years. Larger facilities reported a higher rate of these incidences.

It's time to move towards a higher standard of practice—one that reflects a comprehensive approach to safety, accuracy and compliance. In our next installment of this series, we'll share with you a better way forward and a new partnership that will equip today's compounding environments with the most advanced systems and tools available.

Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.