The quality of the Compounded Sterile Preparation you administer to patients is of the utmost importance. It’s critical that your hospital pharmacy adheres to all state boards of pharmacy and federal regulations, and that you do everything you can to ensure drug quality. A Compounding Management System helps with both.
Before we dive into the benefits of a Compounding Management System, let’s first reframe our thinking about the sterile compounding process. While sterile compounding has historically been thought of as a craft, sterile compounding is essentially a manufacturing process. Treating this process any other way can lead to critical failure points—especially when there are multiple, varied ways for technicians to arrive at the same result.
Here’s how a Compounding Management System helps to establish consistency and control to deliver high-quality sterile preparations.
Because drug compounding is a manufacturing process, you need a system that enforces:
Without a standardized, repeatable process for each and every sterile preparation, you run the risk of allowing a deviation from the approved preparatory workflow. This may not always result in a failure, but this unapproved workflow variation invites further deviation, increasing the risk that at some point you lose control of the system.
Traditionally, pharmacies have relied on experienced pharmacy technicians to train new technicians on how to compound drugs. It’s a craft, learned by observation and passed from one technician to the next.
Within this system, everyone trusts that the drug will be compounded correctly even though there are different methods for achieving the same result that vary by technician or department, or whether the compounding was patient-specific or batch.
Drug quality is assessed through visual inspection at the very end, without seeing the process. All evaluation and documentation occur after the fact. When there are multiple pathways to achieve a result, there is a lot of potential for variation/deviation, which can lead to lower quality.
A Compounding Management System can standardize these processes and ensure compliance with USP <797>, including:
With a Compounding Management System, you’re able to enforce consistent inspection, documentation, and auditing processes. Additionally, a Compounding Management System can even boost employee morale by helping them take pride in mastering the process themselves rather than emulating another technician (and not knowing whether/how a deviation occurred).
A Compounding Management System enforces consistent process controls, ensuring increased drug quality.
When using a Compounding Management System for compounding you’ll have a batch record: the single source of truth for everything that occurred with the batch. This batch record is a living document that captures what’s occurring with the compounding process, helping minimize the risk of a deviation or variation in real-time. Pharmacists can see every person that interacted with the batch, every document uploaded, and every time a technician scanned an ingredient, completed a preparation task, or took a picture.
With customizable workflows that include features like in-line verification checkpoints and Assure-Trak® Video Auditor for post-production quality assurance, a pharmacist can inspect drug compounding as it happens. There is increased visibility into each step of the process as it occurs. This shifts the emphasis from focusing on the outcome or the product to focusing on the process.
ConsortiEX’s Assure-Trak® Compounding Management System helps your hospital pharmacy achieve not only compliance but improved drug quality. Each step in the preparation and approval process is documented, creating an easily accessible single source of truth for auditing and process improvement.
To learn more about how Assure-Trak can benefit your health system or to schedule a consultation, contact us today.