Managing Outsourced Compounding Volumes

June 2020 - Vol.17 No. 6 - Page #12
Category: Outsourced Compounding Services (503B)

Q&A with Glenn Huth, RPh
Director of Pharmacy Operations
Summa Health
Akron, Ohio

Pharmacy Purchasing & Products: What is your current outsourcing strategy?

Glenn Huth, RPh: Summa Health in Akron, Ohio, currently focuses on outsourcing drugs that are on shortage, as the 503Bs typically have increased access to these medications. For example, during the ongoing lidocaine and labetalol shortages we were not able to access these medications through the typical channels such as wholesaler or via direct purchase, but our 503B partners were able to provide them in the same concentration and volume that we currently utilize.

In addition, we outsource many products used in the OR. For example, we outsource nerve blocks used both in the OR and in labor and delivery. Utilizing nerve blocks in the OR prior to and/or during the procedure, along with our Enhanced Recovery After Surgery (ERAS) protocols, is part of our strategy to control pain and subsequently reduce opioid consumption post procedure; nerve blocks that we outsource include a bupivacaine-dexamethasone combination syringe. We utilize between 10,000 and 15,000 nerve blocks per year; the 503Bs are able to keep up with our volume, whereas we could not handle that volume internally. Moreover, many of the products for OR use that we outsource are ready to use, such as ketamine, phenylephrine, and lidocaine, which frees up technician time for pursuits other than compounding.

Working with our GPO has allowed us to outsource medications without the need to vet each individual 503B separately, as our GPO takes care of this by providing us a list of approved vendors.

PP&P: How do you determine which products should be outsourced?

Huth: Data tracking is key to identify high-volume medications, which forms the basis for many of our outsourcing decisions. Because anesthesia utilizes an ERAS protocol that dictates the products used in every case, this provides clear volume usage data. For example, a ketamine syringe is used in almost every OR case. Because we are unable to compound a high volume of syringes internally with our current staffing levels, we determined that outsourcing was the best option.

Close communication with anesthesia is critical to determining which medications to outsource. While cost is always a factor, we find that outsourcing high volume anesthesia syringes is extremely beneficial and thus the cost is justified. It is also important to note that because many of the drugs used in the OR are older generics (eg, more affordable drugs like ketamine and phenylephrine), we find they are not price-prohibitive for outsourcing.

PP&P: How often do you revisit which products or quantities are outsourced?

Huth: Reviewing the medications and quantities outsourced is a continual pursuit. Robust dialogue is required to ensure our outsourcing proceeds smoothly and that we avoid supply interruptions. Thus, we continually communicate with our outsourcers regarding the availability of medications. Are they anticipating any delays, shortages, or manufacturing issues? In addition, it is important to keep lines of communication open to discuss any business decisions that might impact medication availability—for example, if the outsourcer is establishing a relationship with a new customer. Building strong relationships with our outsourcing partners is crucial to ensuring regular communication regarding product availability.

PP&P: What steps do you take to optimize your outsourcing quantities and volumes?

Huth: We evaluate the total number of cases each year and then work with the anesthesia and labor and delivery staff to identify appropriate volumes moving forward. For instance, we use approximately 15,000 bupivacaine-dexamethasone syringes each year. We have found that patients experience less pain using the blocks, which allows us to decrease opioid usage. Therefore, we estimate we will need at least 15,000 bupivacaine-dexamethasone syringes next year.

In labor and delivery we use ropivacaine syringes, rather than fentanyl, for spinals. We have had success with this strategy, so we anticipate using a similar number of ropivacaine syringes next year. Ketamine quantities are based on OR usage data; because almost every OR patient receives a dose of ketamine prior to their procedure, it is simple to determine approximately how many syringes we will need moving forward.

PP&P: How have drug shortages impacted your outsourcing?

Huth: Shortages have caused us to increase our reliance on outsourced compounders. As a result of the ongoing labetalol shortage, we switched completely to outsourcing that drug. We found that the manufacturer was unable to supply it in sufficient quantities, so outsourcing was the prime option. Of course, we could have used a multidose vial for nursing, but as this introduces infection control and compliance concerns, it was determined not to be an option.

Managing drug shortages often requires adjustments to ADCs and automated anesthesia cabinets, which can be time consuming. Anytime a new product is required, the new NDC code must be loaded into and managed in the technology. Reconfiguring an ADC to store a vial rather than a syringe significantly impacts the number of medications that can be stored in the drawer. Across the health system we use approximately 30+ anesthesia carts, which are identically configured. If we change one item, it must be changed in every anesthesia cart, which is simply time-prohibitive. Avoiding this challenge requires proper shortage planning and close communication with outsourcing vendors.

PP&P: What are your future outsourced compounding plans?

Huth: Our future plans include continuing to look for opportunities to stay ahead of shortages. Moving forward, health systems will likely need to routinely utilize 503Bs as an alternate solution when typical procurement channels are not a viable option. Our 503B partners play an important role in maintaining adequate stock levels of medications in the concentrations and volumes we are accustomed to, which helps us prevent any disruption in services, and more importantly, helps reduce medication errors, as there is no change in product size or concentration.

Glenn Huth, RPh, is the director of pharmacy operations for Summa Health in Akron, Ohio. He attended the University of Toledo and obtained his BS Pharmacy degree in 1996.


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