Q&A with Jennifer Hillman, PharmD, RPhIV
University Health System
Pharmacy Purchasing & Products: What are the main challenges in managing IV compounding workflow at your facility?
Jennifer Hillman: Perhaps the most common challenge is managing the large amount of bulk batching that becomes necessary as a result of frequent manufacturer back orders for ready-to-use (RTU) products. Anytime a regularly used manufacturer-produced IV product becomes scarce, the pharmacy experiences a spike in IV room activity, and demand for compounded sterile products (CSPs) intensifies. At the same time, we must initiate workflow changes to accommodate the lack of RTU products, as well as take on the added burden of compounding more pharmacy-produced products and communicate these changes to staff in a limited amount of time.
PP&P: What are some primary safety concerns during CSP production?
Hillman: One issue we have seen lately is that a significant number of products used in sterile compounding that are ordered by our purchasing department actually arrive in the pharmacy in varying total volumes, concentrations, and presentations. For example, we will ask our purchasers to place an order for heparin, and while we were used to receiving the drug in 4 mL vials at 10,000 units per mL, the next shipment arrives in 1 mL vials at 5,000 units per mL. So, the concentration and volume is different from what we had been working with, and we have to adjust our operations, policies, and procedures to accommodate this change. Unfortunately, frequent product shortages require our purchasing staff to acquire whatever form they can get and this can cause confusion among staff when they are asked to locate specific additives and prepare compounded pharmaceuticals using new versions. Furthermore, the pharmacy must stock and monitor these varying forms, creating more work for inventory management.
When this situation presents itself and we are made aware that our purchasers cannot acquire our usual product, we will remove any leftover stock of the previous concentration from our IV compounding room so that we only have one product type available at any given time. This does leave us with some leftover stock that we keep in a separate storage area, but our main concern is to avoid intermingling drugs of different volumes and concentrations in the IV room. Beyond this, we have to produce and approve a new procedure and disseminate it to all relevant staff. The problem with this process is that it is often a last minute situation, and uncertainty among multiple shifts and practitioners creates risk for potential errors.
PP&P: How do your automated systems influence batch production and extended BUD?
Hillman: Clearly, automation enables a level of standardized scheduling for production that is difficult to mimic in entirely manual processes. In our case, labels for patient-specific IV batches auto-print at specific times—03:00, 07:30, 10:00, 16:00, and 21:00—in the cleanroom, thereby initiating the production process. Our standard operating procedures require every bulk batch product label to include expiration dating. These dates are programmed into label templates, which are printed and placed on each batch item indicating the time to expiration under room, refrigerated, and/or frozen temperatures.
A warning indicating short stability prints on batch labels for compounds that have been pre-identified as such. Our current set point for short stability indicates those items that expire in less than 24 hours at room temperature/refrigeration and the expiration information for short stability items is programmed to print on the label. For example, ampicillin continuous infusion labels include the following, additional expiration information: Expires—8 hours (room temp) or 48 hours (refrigeration). Sterile compounds that expire in less than six hours also include an additional preprogrammed comment—Call before mixing (short stability). So, if we receive an order for IV bactrim with a stability of six hours or less (depending on the final concentration), we would not mix that dose until a cleanroom staff member has spoken with the nurse to ensure the patient is ready for medication administration.
The number of short stability preparations requiring additional triage in the cleanroom varies, but in general, we produce between zero and five short stability compounds per eight-hour shift. The effort required to contact nursing staff to determine the anticipated medication administration time per item usually consists of a short, 30-second phone call, which is equivalent to, or less than the time required to credit and waste or return the drug to stock if unneeded.
PP&P: How do you manage IV compounding in order to reduce wasted doses?
Hillman: In order to address this very issue, we conducted an analysis to determine the times of day when the majority of compounded orders were adjusted or discontinued resulting in waste. Unsurprisingly, the analysis revealed the majority (43%) of discontinued orders that resulted in waste occurred between 09:00 and 15:00. To mitigate these losses, we inserted a batch at 07:30 to cover doses to be administered from 10:00 to 12:00 and shortened the fill duration of the 10:00 batch to cover doses from 12:00 to 16:00. In addition, we increased the total number of batches from three to the five mentioned above. Since these changes were put into place, we have seen a significant reduction in IV credits and waste as a result of order adjustments or discontinuations.
PP&P: Have your facility’s CSP preparation policies changed after the outsourced compounding tragedies of last year?
Hillman: The issues that arose from the compounding tragedies of last year did encourage us to review our processes for internal IV compounding quality assurance and we have since enhanced that program. We have increased the number of compounded items submitted quarterly for sterility testing, as well as increased surface samplings and random employee glove finger tip testing done throughout the year. Furthermore, we limited the number of outside companies from which we obtain outsourced CSPs to only those with which we have an established history of quality and reliability. Trusting an outsourcer is not enough; you must have access to data and regulatory qualifications that substantiate the good manufacturing processes of any outsourced provider. Fortunately, the outside compounding companies that we do utilize post their product quality assurance and monitoring programs online, which are readily accessible by our staff.
PP&P: What are your processes for managing the transition from IV to PO?
Hillman: Identifying timely opportunities to switch patients from IV to oral medications is a priority for our facility and we have designated, decentralized pharmacists who are responsible for reviewing patient profiles daily to identify opportunities for IV to PO switch. This is a process that also intensifies in times of injectable product and ingredient shortages. Furthermore, our facility has dedicated time to establishing internal hospital guidelines through interdisciplinary collaboration in order to increase the use of oral medications when the injectable form is limited or unavailable.
PP&P: What are your processes now for the following activities?
Hillman: When doses are dispensed from pharmacy via pneumatic tube, lift, window, or runner, a manual log is used to record the patient name, drug, time dispensed from pharmacy, location the item was sent, and the initials of pharmacy staff member making the record.
Pharmacist Check and Verification:
Hillman: A designated pharmacist staffs the sterile processing lab 16 hours per day and manually checks all compounds. Double checks are performed for all high alert, high-risk populations. High alert compounds are identified via a policy developed by an interdisciplinary group, and this policy is reviewed and updated annually.
Hillman: Mix check reports are filed chronologically and are kept on site for archiving. In addition, our automated compounding device contains an electronic list of all ingredients processed through the machine and manual compounding logs also are maintained chronologically and kept on site for archiving. These documents are maintained based on our state board of pharmacy’s retention requirements.
PP&P: How has the introduction of automation into IV workflow impacted safety and efficiency in your IV cleanroom?
Hillman: We currently use an automated compounding device that features prebuilt templates for any repetitively compounded products, which are programmed into the device’s database. These templates assist with the accuracy and speed of CSP production, and the ports on the device are maximized with ingredients to limit the number of manual additions.
We also generate an ingredients usage report, which is reviewed daily so we can adjust the vial and syringe sizes loaded on the compounder in order to minimize waste. The report is also used to facilitate drug inventory review and product ordering. Additional safety features include institutional warning limits and pop-up alerts that are tailored for adult, pediatric, and neonatal populations.
PP&P: What guidance would you give other pharmacies looking to automate IV workflow?
Hillman: Due to the nature of IV compounding and the inherent risk potential for error or contamination, all efforts should be made to minimize this potential and maximize quality. When properly implemented, maintained, and operated, IV automation provides increased safety and quality for compounded sterile preparations. Due to the variety of IV automation products on the market, it is essential to include, at minimum, the hospital IT department and key members of the pharmacy department when researching a possible automated workflow solution. Ensuring the IV workflow system is compatible with the hospital’s current IT system is a first step to consider for possible product implementation. In addition, never underestimate the importance of training and ease-of-use for pharmacy staff. These concepts, along with software maintenance, are equally important considerations when approaching an automation implementation and workflow change.
In some cases, it may make sense to break down the specific utilization needs when looking at IV automation. Focusing on providing automated IV workflow to certain drug categories, including hazardous preparations or those used by particularly vulnerable populations, such as pediatric or neonates, might prove most beneficial for facilities with limited financial and/or staff resources. In addition to the safety and quality levels expected with automated IV management and workflow systems, the ability to capture and easily review documentation, as well as provide measureable and meaningful metrics should also be investigated.
Jennifer Hillman, PharmD, RPh, is the IV lab supervisor for University Health System in San Antonio, Texas. She received her PharmD from Texas Tech University and completed a one-year general practice residency at the Dallas VA Medical Center, followed by a one-year primary care specialty residency at the University of Maryland.