In the US, IV medication errors are estimated to result in 1.2 million hospitalizations annually, equating to $2.7 to $5.1 billion in payer costs.1 To ensure safety when preparing compounded sterile preparations (CSPs), the Institute for Safe Medication Practices (ISMP) recommends an independent verification of each individual ingredient prior to addition into the final container (ISMP Best Practice #11).2 Complementing this recommendation are the United States Pharmacopoeia (USP) Chapter <797> standards, which detail practices, processes, and facility controls to ensure safety and sterility when handling CSPs.3 To ameliorate the potential for error, safer and more efficient compounding practices, including use of IV workflow management software (IV WFMS), are essential.

The adoption of IV WFMS introduces strong safety features including bar code scanning of ingredients, gravimetric analysis, and electronic image capture, while also improving tracking and documentation. Despite the safety benefits associated with implementing IV WFMS, according to Pharmacy Purchasing & Products’ 2020 State of Pharmacy Automation survey, only one-third of facilities have adopted IV WFMS.4 Implementing and maximizing the utility of IV WFMS are critical to ensuring the safety of CSPs.

IV Workflow Management Software at UNCMC

The University of North Carolina Medical Center (UNCMC) is a public, not-for-profit, academic medical center and the flagship hospital of UNC Health. The pharmacy department at UNCMC services over 900 acute care beds and both onsite and offsite outpatient clinics and infusion centers. IV WFMS has been deployed in two onsite pharmacies at the medical center, at the UNC Hillsborough campus pharmacy, and at two offsite infusion center pharmacies.

At the medical center, the cancer hospital infusion/inpatient pharmacy compounds the majority of hazardous sterile products for onsite inpatient and outpatient needs, with over 230 patient-specific hazardous sterile compounds made daily. The sterile products area pharmacy operates 24/7 and prepares the vast majority of non-hazardous compounds for both inpatients and outpatients located onsite. UNCMC pharmacy services extend to the UNC Hillsborough campus, which has one main pharmacy that operates around-the-clock to provide centralized coverage of hazardous and non-hazardous sterile compounding needs for the 83 beds, emergency department, operating and procedure rooms, and outpatient clinics and infusion center located on the campus. The two offsite UNC infusion center pharmacies utilizing IV WFMS are located within their respective clinics and provide all sterile non-hazardous (primarily) and hazardous IV infusion compounds needed in the infusion clinic.

The Implementation Process

The initial evaluation of IV WFMS options began with system reviews and vendor selection. The key selection features were system utility and gravimetrics, as this was deemed the fundamental safety component for this technology. To prepare for implementation, key stakeholders and front-line users, including oncology pharmacy leadership and staff, were brought in for administrator training. This initial training period was also coordinated with the internal pharmacy informatics team to address data interfacing and medication builds correlating with the electronic health record (EHR) medication list at the point of initiation.

The cancer hospital pharmacy was the first to implement IV WFMS. To ensure a smooth process, we adopted multiple testing phases, including end-user testing. The cancer center pharmacy used a phased approach, beginning the implementation with four commonly used hazardous medications (ie, docetaxel, oxaliplatin, paclitaxel, and pemetrexed). After 2 weeks, additional products were incorporated, for a total of 10 hazardous medications being prepared using the IV WFMS. To date, 93% of hazardous compounds prepared in the cancer center pharmacy are made using the IV WFMS.

Preparations that are not compounded via IV WFMS include intrathecal medications, individual drugs requiring patient-specific order preparation, and medication doses requiring reconstitution of more than 10 vials for preparation. This was decided upon by pharmacy leadership and end-users due to the intricate and varying workflows involved in compounding. Preparations that are less than 2 mL in volume are compounded through the IV WFMS, but with modified functionality that bypasses the gravimetric weight requirement. Given the small volume, very minor fluctuations in the actual weight of the preparation from the expected weight deemed the preparation outside of acceptable gravimetric limits, and put a halt on compounding until corrected. Therefore, these smaller preparations are still prepared utilizing IV WFMS, but do not require gravimetric analysis.

Following the rollout in the cancer center pharmacy, a similar phased roll-out process was conducted in the sterile products area. This process was subsequently repeated for hazardous compounding at the UNC Hillsborough pharmacy, and within the two offsite infusion center pharmacies. Implementation at these sites required replication of UNCMC’s gravimetric medication list within the EHR, with adjustments made based upon medication and area-specific requirements, which allowed for expedited rollout timelines.

Benefits of IV WFMS

Increased safety is one of the primary benefits of using IV WFMS, compared to the traditional pull-back compounding method. In a study at Boston Children’s Hospital, IV WFMS was able to detect 23% of errors that were considered undetectable prior to IV WFMS implementation.5 Safety features associated with the use of IV WFMS include:

• Bar code scanning: Serving as an additional check, bar code scanning facilitates detection and confirmation of all ingredients before they are used for compounding.
• Gravimetric analysis: Gravimetric functionality utilizes the known specific gravity or density of the ingredient to provide an expected weight, which is compared to the measured weight of the CSP. Further, an acceptable margin of error can be set such that anything measured outside of this range will alert the compounder. If the IV WFMS provides this capability, confirmation of CSP accuracy can occur in real time.
• Electronic image capture: Electronic image capture allows for identification and verification of ingredients, providing an additional confirmation of the ingredients and amounts used. This feature also facilitates remote verification of CSPs.
• Tracking and documentation: In an effort to maintain compliance with compounding regulations, IV WFMS can capture product-specific lot numbers, beyond-use dates (BUDs), manufacturer expiration dates, and product images throughout the compounding process. Images and compounding logs are recorded and stored electronically.

Early in UNCMC’s adoption of IV WFMS a major error was caught by the software during the preparation of a docetaxel compound. A concentration that had never been utilized before, 20 mg/mL, was mixed in with the usual 10 mg/mL concentration inventory and selected for compounding. The bar code scan recognized that a different concentration of docetaxel was selected for compounding and modified the preparation steps before allowing compounding to continue. This highlighted the safety benefit provided by the IV WFMS, as this error could have been easily missed using the traditional compounding method. The pharmacy department shares situations like these during regular meetings and continually identifies opportunities for quality improvement and safety.

Gaining Buy-in

Implementation of IV WFMS dramatically impacted the CSP workflow at UNCMC. A comparison of the two workflows is available in Figure 1. Whenever major workflow changes occur, it is imperative to engage frontline staff in workflow evaluation and design of the new system in order to facilitate a smooth implementation.

Click here to view a larger version of this Figure

A pre-implementation/post-implementation study of the IV WFMS was performed at UNCMC to assess for differences in production time, as well as staff perception of safety.6,7 Preparation time and median time to pharmacist review was shorter at 90 days post-implementation vs pre-implementation for hazardous sterile products.6 For the non-hazardous sterile products, there was an increase in preparation time initially, but a decrease in time of pharmacist review.7 Most importantly, there was an increase in the error detection rates following implementation of the IV WFMS. These studies assisted with gaining staff buy-in and helped address concerns regarding workflow changes.

Implementation Challenges

Challenges will arise with any new automation or technology implementation. An initial hurdle to implementation of the IV WFMS at UNCMC was interfacing with our EHR and gaining buy-in from the IT department to assist with the automation harmonization. Issues that needed to be considered included eliminating product overfill, use of split syringes, and products requiring a custom fluid volume that was not commercially available. To address these implementation challenges, we worked closely with the IT department and the vendor to build new logic and to provide continual feedback for improvement. A bi-monthly stakeholder call is held to discuss new issues and identify mitigation strategies for resolution.

System Maintenance

Continual updating of product-specific gravities and densities is a key maintenance component of IV WFMS. At UNCMC, dedicated team members, designated as system administrators or super-users, perform the required maintenance and updates during an established weekly project time.

A gravimetric IV WFMS implementation team was established to prevent local practice silos, standardize the process across our pharmacy department, and coordinate improvement opportunities across each pharmacy utilizing IV WFMS. The team, which comprises managers and super-users in each area utilizing the system, meets monthly via telecommunication software. Updates are provided regarding the IV WFMS, and the team works to address any deficiencies or challenges that have arisen.

Mitigation Strategies for Workarounds

ISMP has identified several potential workarounds associated with the use of IV WFMS8:

• New inventory assignment: When entering a new product, the receiving employee inputting the lot number and expiration date must place the product in “quarantine” to await pharmacist review. This process is essential as each new lot of product must be entered into the IV WFMS before compounding can commence. Some organizations have noted staff citing this workflow change as an excuse to bypass the IV WFMS process. Because the actual workflow impact is minimal, it is important to share this information with staff and train them to follow the simple steps within the IV WFMS.
• Reluctance to scan the bar code: ISMP recognizes that a common concern among compounding staff is the workflow adjustments that accompany IV WFMS implementation, including the potential for increased preparation processing times. Our department at UNCMC took the approach of having staff evaluate pre- and post-time studies in order to fully recognize the improvements to the overall process. Furthermore, note that the compounding process cannot proceed without the proper scans being conducted.
• Decoy image capture (ie, scanning just one vial): When multiple vials of the same medication are required for product preparation, there is the potential for a workaround wherein just one vial is scanned in place of the other vial, thus increasing the risk of missing an error prior to preparation. At UNCMC, compounding personnel must scan each product vial used throughout preparation as a part of a stepwise preparation process. Additionally, the IV WFMS utilized at UNCMC requires image capture of the vial prior to volume withdrawal, which serves as an additional layer of safety. Moreover, the gravimetric weight recording after each step also prevents this from occurring.
• Reverting to the syringe pull-back method: ISMP indicates that there is the potential for staff to utilize the syringe pull-back method prior to image capture, rendering the benefits of IV WFMS ineffective. At UNCMC, the volumetric method is only permitted for small volume preparations that prohibit efficient gravimetric processing. In an effort to further maximize the utility of IV WFMS, the preparation requires bar code scanning, automated workflow guidance, and image documentation prior to injection into the final vehicle fluid. This prevents disruption in the technicians’ workflow while facilitating pharmacist verification via the software.
• Blurry images: For smaller syringes (eg, 1 mL, 3 mL) it can be difficult to clearly see the volume via image capture. This issue has been noted to be one of the most frequent causes of rejected CSPs, with one study noting that 36% of rejected and reworked medications were due to blurry images.5 To remedy this challenge, syringes with clear scoring should be chosen, and they should be tested prior to being used for compounding.8 At UNCMC, the IV WFMS zooming capabilities allow for clear identification of volumes. Furthermore, in most cases, the pharmacists are provided the physical product for review.
• Lapses in technique: Sterile technique is critical to avoiding contamination, especially with hazardous medications. At UNCMC, workflow analyses were performed to identify how to maintain sterility and patient safety. Of note, the pharmacies that utilize IV WFMS at UNCMC use both vertical and horizontal laminar airflow. Cleaning practices should be adjusted to address routine cleaning of IV WFMS devices within the sterile environments.
• Scale limitations: Utilizing the gravimetric analysis process for low volume syringes can be challenging due to the inability to detect the change in weight for small volume liquids. At UNCMC, if the syringe is too small to be detected on a gravimetric scale (eg, certain pediatric doses), the IV WFMS process is still completed with all other functionalities outside of the gravimetric component.
• Other human errors: While implementation of IV WFMS can amend the potential for error that exists in sterile product preparation workflow, the process is not 100% automated and human error can still produce a medication error. The best practice for evaluating the potential error with IV WFMS is to conduct a failure modes and effects analysis (FMEA) to most effectively plan for a safe implementation. Furthermore, continuous quality improvement should be performed and reported in regularly occurring intervals.

Future Considerations

UNCMC plans to continue to expand use of our IV WFMS. Additionally, we are working on developing real-time reporting, including data on turnaround times, status, and productivity reporting, which would allow for greater transparency for internal stakeholders.

IV WFMS provides insight into the sterile product preparation process that did not previously exist with the syringe pull-back method. The safety implications of IV WFMS are positive and well documented. Nevertheless, it is important to recognize that implementation is environment-specific and must be tailored to the workflows of that institution. We recommend a gap-analysis of your current workflow prior to implementation, to assess where IV WFMS can be beneficial from a safety and compatibility perspective.

References

1. Lahue BJ, Pyenson B, Iwasaki K, et al. National burden of preventable adverse drug events associated with inpatient injectable medications: healthcare and medical professional liability costs. Am Health Drug Benefits. 2012;5(7):1-10.
2. 2021 ISMP Targeted Best Practices for Medication Safety. Institute for Safe Medication Practices. 2020:1-20.
3. USP <797> Pharmaceutical Compounding - Sterile Preparations. www.usp.org/compounding/general-chapter-797. Accessed March 16, 2020.
4. IV Workflow. IV Safety Supplement. Pharm Purch Prod. 2020;17(3):12.
5. Moniz TT, Chu S, Tom C, et al. Sterile product compounding using an i.v. compounding workflow management system at a pediatric hospital. Am J Health-Syst Pharm. 2014;71(15):1311-1317.
6. Roberts PA, Willoughby IR, Barnes N, et al. Evaluation of a gravimetric-based technology-assisted workflow system on hazardous sterile product preparation. Am J Health-Syst Pharm. 2018;75(17):1286-1292.
7. Bucci TG, Hedrick TL, Roberts PA, et al. Evaluation of gravimetric-based technology-assisted workflow for nonhazardous sterile product preparation. Am J Health-Syst Pharm. 2019;76(14):1071-1077.
8. Maximize benefits of IV workflow management systems by addressing workarounds and errors. Institute for Safe Medication Practices. September 7, 2017. www.ismp.org/resources/maximize-benefits-iv-workflow-management-systems-addressing-workarounds-and-errors.

Conor Myers, PharmD, is a first-year health system pharmacy administration and leadership resident at UNCMC. He earned his Doctor of Pharmacy degree from the University of South Carolina and is currently pursuing an MS with an emphasis in health system pharmacy administration from the University of North Carolina Eshelman School of Pharmacy.

Elissa King, PharmD, MS, BCPS, is the clinical manager of pharmacy for infusion services at UNCMC. She earned her Doctor of Pharmacy degree from the University of Maryland School of Pharmacy and her MS degree with an emphasis in health-system pharmacy administration from the UNC Eshelman School of Pharmacy while completing a 2-year health system pharmacy administration residency at UNC Health.

Nathan E. Barnes, PharmD, is the clinical manager for oncology pharmacy operations at the UNCMC. He received his Bachelor of Science and Doctor of Pharmacy degrees from the University of North Carolina Eshelman School of Pharmacy in Chapel Hill and is currently pursuing a Master’s of Healthcare Administration from the University of North Carolina Gillings School of Global Public Health.