Sentara Virginia Beach General Hospital is a 282-bed, acute care facility with clinical services including a level III trauma center, a neonatal intensive care unit, the Costal Cancer Center, and the Sentara Heart Center. The pharmacy operation runs 24/7 and we are staffed with 40 FTEs, split into approximately 18 technicians and 20 pharmacists. Our pharmacy dispenses a variety of compounded doses as well as outsourced products to support our level III trauma center, NICU, and other departments within the hospital.

After a recent analysis of our compounding processes, we began seeing a trend of certain products wasted because we could not effectively reconcile beyond-use-dates (BUDs) with proper usage forecasting. We determined that our main improvement goal would be to find a way to extend the BUD for as many compounded products as possible, while still controlling inventory levels, reducing waste, and remaining cost effective. These were our initial reasons for looking into purchasing an automated compounding device. As with any cost justification, we needed to determine not only the overall cost of our compounding options, but also what the burden would be on staffing, workflow, and patient and employee safety.

Identifying Need and Justifying Cost
Prior to implementing the Gri-fill system from Grifols in 2008, we did not batch many compounded sterile products for placement in our automated dispensing cabinets (ADCs), choosing instead to outsource these products. We felt this was not an efficient use of time and resources, however, and once we realized we could exert more control over some of the products we were outsourcing, we decided to research whether it would make more sense to compound those in-house. At that time, we performed a fairly comprehensive cost analysis comparing the cost, per bag, of a medication preparation done in-house vs. outsourced. Our aim was to include as many variables as possible, including waste production, labor, transit time, and BUD.

We never really considered total devotion to either out- or in-sourcing, as our analysis directed us toward a hybrid process—compounding some products in-house, and outsourcing others, based on volume of use. Many of the drugs we compound using the automated compounding device are placed in our ADCs, and we now have much greater flexibility when it comes to BUDs, mitigating our concern for those medications expiring too quickly. In addition, we wanted to have greater control over our controlled substance compounding, so we now compound many of these in-house rather than outsourcing them.

Adjusting to a New Process
As our initial cost analysis factored in our inability to add FTEs to our staff, we knew early on that whatever combination of in-house vs. outsourced compounding we decided on would need to take this into account. We also wanted to be certain our technicians could perform the tasks associated with in-house compounding without sacrificing safety. Ultimately, we did alter our workflow to accommodate this hybrid process. During implementation, representatives from our vendor came in and trained a few core users on the device. Those core users then trained other designated techs, and also perform periodic performance evaluations. Currently, six of our 18 technicians are trained on the automated compounding device.

In order to make the process as efficient as possible, we perform the bulk of our in-house compounding during the evening shift, as it is less busy and therefore less distracting to the compounding process. It can take up to several minutes to process a single compounded medication, depending on the make-up, and we did not want our technicians to be exposed to frequent interruption while working with the compounder. Previously, there was always the risk that during busy times, a technician would start a new compound, and have to leave it to attend to other processes. We felt this posed an unnecessary risk and decided to perform these tasks during off-peak hours.

Conclusion
Like any cost justification project, the first step in determining whether an automated compounding device is a good fit for your facility is to qualify your needs. In our case, the impetus was to find a way to safely extend our beyond use dating. While we were not able to perform a cost comparison for every single compounded product we use, we did evaluate our most-used products. When performing a similar analysis, be sure to include as much cost information as possible, including expected materials, labor, and time—both the time it would take to compound in-house, and the time it would take an outsourcer to both compound and deliver the product. For our facility it made the most sense to have a combination of compounding processes, and we were able to make this process highly cost efficient without sacrificing safety.

Rich Grasmick, RPh, is the pharmacy manager at Sentara Virginia Beach General Hospital in Virginia Beach, Virginia. A graduate of the University of Nebraska School of Pharmacy, Rich has served 13 years as a pharmacy manager at four hospitals in the Sentara hospital network.

4Baxa Corporation
www.baxa.com

ExactaMix Compounders

The ExactaMix 2400 automated compounder from Baxa Corporation provides a solution for automating complex and critical compounding. For multi-source fluid mixing of both macro and micro ingredients down to 0.2 mL, the EM 2400 produces total parenteral nutrition (TPN) and continuous veno-venous hemofiltration (CVVH). With its operating software, bar code verification, and ability to mix 24 separate ingredients, the EM2400 brings safety, accuracy, and flexibility to multi-ingredient solution compounding.

The most recent addition to the Baxa automated compounding device product line is the ExactaMix 1200 compounder (EM1200). Using the same technology as the EM2400, the EM1200 prepares specialized therapies such as cardioplegia, dialysis solutions, and epidurals.

Both automated compounders can increase pharmacy productivity and reduce labor costs. A typical three-liter bag can be prepared on a Baxa compounder in approximately four minutes. System features of both compounders include:

• Touchscreen display
• Volumetric delivery and gravimetric check
• Low flush volume
• Air and occlusion detection
• Integrated load cell and user interface display
• Bar code verification
• Software networking capabilities

Baxa automated compounders can be configured to meet the specific requirements of large urban hospitals, smaller community hospitals, or home health care facilities.

B. Braun Medical Inc
www.bbraunusa.com

PINNACLE TPN Management System
The PINNACLE TPN Management System streamlines functional areas of operation and manages all aspects of the TPN process to help improve compounding efficiency and safety. Used for pharmacy admixture, the PINNACLE system controls the precise, individualized creation of IV formulations using dextrose, amino acids, electrolytes, and lipids for patients unable to tolerate oral intake of nutrients or who rely on tube feeding for sustenance. The system reduces transcription errors and expedites patient care via direct electronic communication from physician to pharmacist. Built-in safety check software and bar coding features help ensure that the right nutrition solution reaches the right patient. The system also helps enhance compliance with USP Chapter , American Society for Parenteral and Enteral Nutrition, and ASHP guidelines.

Grifols USA
www.grifolsusa.com

The Gri-fill System
In accordance with USP Chapter , the Gri-fill system is designed to:

• Achieve compounding accuracy and sterility
• Ensure the safety of patients
• Minimize waste by extending BUD to up to 60 days room temperature when chemical stability is supported

When used in conjunction with Gri-fill
System bags, Gri-fill maintains sterility via sterile filtration and subsequent integrity tests. The Gri-fill 3.0 system can be placed inside a standard isolator or biological safety cabinet when extra protection is needed (eg, with antineoplastics). In-sourcing with Gri-fill can be an effective complement to outsourcing.
The Gri-fill System bags have the capability to filter every dose, offering
increased confidence in the delivery of sterile preparations to patients. The
integral 0.22 micron filter on Gri-bag containers assures the maintenance of sterility in a closed system backed by an integrity test. The Gri-bag AP (with Additive Port) offers the flexibility to use multiple set spike sizes or to introduce another additive just prior to administration.

WHERE TO FIND: Automated Compounding Devices

• Baxa Corporation
• Baxter International Inc
• Grifols USA