When we started thinking about how to improve the quality assurance and quality control of our compounded sterile products, we thought that a picture could be worth more than a thousand words, it could be worth a thousand lives.
At JCB, we have many ways to ensure that the products we compound are safe and efficacious for the patients receiving them. Some of the tools include electronic weighing and automatic electronic documentation of those weights, bar coding of all active and non-active chemicals, and tight controls over the environment in which we prepare compounded sterile products (CSPs). However, the one piece that has been difficult to verify is the liquids that are going into the CSPs. Clean room protocols prevent quick entrance and, therefore, inspection during the compounding process. Thus, most compounding pharmacies rely on unverifiable “empty syringe” inspection of the liquids being used. In other words, the compounder re-draws an empty syringe back to the amount that they think they put in the compound. It’s this empty syringe that is later verified by a pharmacist as the amount used in the compound. It’s a major cause of human error in liquid compounding. We knew there had to be a way to take the human element out of the process. So, 18 months ago we developed a camera verification process (CVP) that takes pictures of the product that is drawn into a syringe for use in the CSP. These pictures are recorded in high-resolution color and stored electronically for verification by a pharmacist today, tomorrow, or whenever a need arises. Additionally, the pictures print with each formulation worksheet for immediate verification.
JCB first introduced this concept in late fall of 2010 and it had overwhelming impact on clients who had experienced problems with compounded products from other providers. The fact that we could literally show that all products were compounded correctly was a key factor for working with these clients. Not only were we able to show that safety is our top priority, but also the clients feel the liability of using a compounded product is significantly reduced. This type of quality control development has gained much interest from our surgery center and hospital clientele. They recognize that JCB Labs is concerned first and foremost with the safety of their patients.
Is our CVP technology unique in the high-risk sterile compounding industry? Absolutely! We approached a company that supports over 3,500 compounding pharmacies to share this technology with their clients. They told us that we were the only pharmacy in the United States that had requested or built this type of technology and that they did not see a need for it. I find it alarming that compounding advocacy groups would not jump at the chance to offer this technology to their clients. Was it worth the development time and cost? At JCB we believe a picture really is worth a thousand lives; and that is priceless.