Quest for IV Safety Leads from Clean Room to Capitol Hill

David Webster, RPh, MSBA

Sterile compounding is among the highest-risk activities performed by health-system pharmacies. The quest to reduce this risk led Dave Webster to become an early adopter of sterile compounding automation—as well as a noted author, lecturer, and advocate on the subject.

Webster leads sterile compounding operations across multiple sites for the University of Rochester Medical Center. To date, fully automated robots have produced over 170,000 doses for the medical center—including patient-specific oncology doses—with IV workflow devices producing an additional 3,000 doses per month.

Q: How have perceptions of sterile compounding technology changed among health-system pharmacists?

At first, I heard comments such as, “Do we really need technology in this space? How do you introduce technology in a clean-room setting?” The conversation evolved to become more supportive, but with some hesitancy. More recently, I’ve seen healthy debates about the technologies used. It is encouraging to see the debate move away from the question of need for technology to finding the best solution available.

Q: What debates about foundational technologies are you seeing?

I think everyone agrees that barcode scanning and digital image capture are helpful in assisting pharmacists in the clean room as far as improving safety. But there still is debate around gravimetrics. Some individuals question whether IV preps need to be weighed before and after: “Do we really need to go that far?” I’ve always been a proponent of all three technologies in sterile compounding. More pharmacy directors and leaders are moving in that direction to make this process as safe as possible. All three components are important.

Q: What are the arguments for insourcing vs. outsourcing?

If you’re outsourcing, you need to look at what you would save by bringing that in-house. You need to look at the financial and safety perspectives. Many institutions—and we were one of them—relied heavily on compounding pharmacies and 503B sites. The NECC (New England Compounding Center) situation exposed a lot of that overdependence, but there’s still a heavy reliance by many hospitals.

Some pharmacy leaders feel compounding pharmacies have put new quality controls in place and that the FDA is watching over them. But while some compounding pharmacies do an excellent job, there’s still a spectrum of issues among outsourcers related to quality control and adhering to regulations.

Q: Why have you been so active in meeting with regulatory agencies?

I’ve been working with pharmacy leaders and patient safety advocates from across the country to meet with government leaders and the FDA on sterile compounding technology.

We’re very supportive of the Drug Quality and Security Act (DQSA) and the 503A and 503B spaces. But a lot of avenues are available to make the system even safer.

Q: Why have you been so active in meeting with regulatory agencies?

I’ve been working with pharmacy leaders and patient safety advocates from across the country to meet with government leaders and the FDA on sterile compounding technology. We’re very supportive of the Drug Quality and Security Act (DQSA) and the 503A and 503B spaces. But a lot of avenues are available to make the system even safer. We want to guide hospitals and healthcare systems to the best possible solution to protect patients. We believe that adoption of technology in a smart way can be part of that solution.

Q: What has been your proudest moment?

I couldn’t be prouder of our IV compounding team and leaders. They’ve embraced the technology and want to make it even better.

The day we went live with the IV workflow devices was a really proud moment. The idea that we now have technology that can make almost any compound and still have the same robust patient safety checks is exciting to me. If I had a crystal ball to look into the future, I’d want to see an IV workflow system in every hospital that compounds sterile products.

Omnicell events

Subscribe to our popular newsletter today!

Omnicell's customer newsletter, The Capsule, delivers concise, practical articles. It is currently focused on information and resources to aid health systems as they navigate the COVID-19 crisis.

omnicell closing icon