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April 20, 2022

Reverse Your Reliance on 503Bs for Compounded Sterile Products

Joseph J. DiCubellis, RPh, MPH
Senior Director of Pharmacy Services for the University of Maryland Medical System and Senior Director of Pharmacy, University of Maryland Medical Center

Healthcare systems are under increasing pressure to ensure IV solutions are prepared safely and accurately while adhering to increasingly stringent regulations. Many often rely on 503B outsourcing pharmacies for their pre-mixed compounded sterile products. But as product shortages and price fluctuations increase in the supply chain, 503Bs may place more strain on pharmacy staff and budgets.

At the University of Maryland Medical Center, we reduced our need for 503B vendors by implementing an IV robotics insourcing program for compounded sterile products (CSPs). With better CSP services across the organization, CSP operations became more efficient, cost-effective, and safer. It also relieves us of scheduling and personnel tasks but leaves us in charge of signing off on the final products.

Our IV insourcing program has come a long way since it began. We deliver various medications, from syringes to bags of different sizes, and cover multiple services, from pediatrics to critical care to operating rooms. We've evolved and learned quite a bit since the program's inception. Throughout our growth, we have continued to see the value in this program.

Four IV robots produce non-hazardous medications 15 hours a day, Monday through Thursday, outsourcing technician manpower through Omnicell's IV Compounding Service. We insource about 50 percent of our non-hazardous adult sterile products, producing about 750 doses per day and 3,000 per week.

We achieved significant financial success by insourcing IV robotics. In year one, we set a target of saving $1 million above and beyond all program expenses, exceeding that goal in 15 months.

Savings are calculated by comparing what we would have spent on compounded products with 503Bs versus what we spent on our insourcing program. In addition, we consider the savings from optimizing inventories stored in cabinets and elsewhere in the hospital. This combination represents the net savings for the hospital.

We can forecast demand for specific goods using our dynamic inventory system, and only make what is needed; thus, we can reduce waste. As a result of this investment, we spend less on medication and supplies.

By managing inventory in this way, we can anticipate shortages better, which shields us from the market's uncertainties. If you are caught by surprise, you may be forced to make on-the-fly decisions that are not always the best choice.

Our patients received seamless care, and the staff didn't even notice a difference. It's a stellar example of how an insourcing program can adapt and change to support a constantly evolving environment.

From a supply chain perspective, IV robots also have the advantage of using components from several vendors. We can readily change to another company's product if one firm goes short since we're capable of switching suppliers quickly. This has made the shortages more bearable as we have better control.

Reducing dependence on 503Bs has been one significant benefit of our insourcing program. Now we're using 503B companies to a much lesser extent. We consolidated into two companies with about 80 percent of our business. It's made our services more manageable by insourcing products, shipping times, cost basis, and more.

Hear more about how we successfully insourced sterile compounding through IV robotics and services in episode 16 of the Future of Pharmacy Podcast, presented by Omnicell.

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The views and opinions expressed in this blog are those of the authors and do not necessarily reflect the official policy or position of any other agency, organization, employer, or company. Assumptions made in the analysis are not reflective of the position of any entity other than the author(s). These views are always subject to change, revision, and rethinking at any time and may not be held in perpetuity.