Stephanie Jean from UNC Health’s Pharmacy Services is among a team of pharmacists who recently published a study evaluating the viability of remote checking of compounded sterile products (CSPs) in a hospital setting. This study has received a lot of attention in the pharmacy world, and in fact, the data produced from this study was influential in supporting the passing of the North Carolina Board of Pharmacy’s recent emergency waiver. This waiver allows for the practice of remote verification of compounded sterile products in response to COVID-19.
We got the chance to talk to Stephanie to learn more from her about how and why the study was conducted, as well as the results of the project.
Explain the basics of why and how this study was conducted.
The goal of this study was to evaluate remote sterile product pharmacist checks and study the accuracy, review time, workload sharing, cost savings, and pharmacist perceptions compared to traditional on-site pharmacist checks. We were looking to attain a proof of concept as this has not been a widely published topic and would serve as a starting point in conversations with the board of pharmacy on telepharmacy regulations in this setting.
For the most part, discussions around telepharmacy have been focused on the retail setting and remote order verification in hospitals. In our state, there is no stance yet on remote sterile product pharmacist checks, so we felt it important to conduct one of the very first studies on this. We examined existing literature on gravimetric systems, as well as the telepharmacy Yale New Haven Hospital implemented in their cancer centers. With this information in hand, we were motivated to build the study design and continue to provide more data on this subject.
In order to remain compliant with the current board of pharmacy regulations, which do not currently permit remote sterile product pharmacist checks, product checks were performed for all products by a remote and an onsite pharmacist. This also allowed us to compare results on accuracy and safety.
This was a four site, double-arm study that was conducted over a period of three months. Arm 1 included two sterile compounding sites located in the same building. At these sites, pharmacists performed remote verifications of CSPs from within the same building where the CSP was prepared by the technician, while a pharmacist in the IV cleanroom with the product performed their normal, non-remote checking process.
Arm 2 included two sterile compounding sites located approximately 25 miles apart. The remote process was conducted in this arm as well, wherein CSPs prepared at one site were verified remotely by a pharmacist at the other first, with a second check by an on-site pharmacist occurring back at the location where the CSP was physically located.
The primary outcomes we analyzed were accuracy and time data, with secondary outcomes including workload sharing, cost savings, and staff perceptions.
What system did this study use to perform the remote verification? Were there any limitations with the system?
Throughout the past few years, several pharmacy sites within our health system have implemented a gravimetric-based technology-assisted workflow (TAWF), called BD Pyxis IV Prep. The system has built-in hard stops, gravimetric measurements, and digital images of the preparation process and is currently used as an adjunct to physically verifying the CSP in hand. We have studied the use of this system with favorable results in regards to timeliness, accuracy, and efficiency compared to the manual volumetric preparation, so we wanted to further assess the use of a gravimetric-based TAWF system in a telepharmacy workflow to remotely check CSPs.1,2
One of the limitations we encountered with the study was consistency in the information provided in the digital images based on how pharmacy staff presented the drug for the image to be captured by the system. Pharmacists noted concerns about information, such as the lot number and expiration date of the drugs used to prepare a CSP, not being consistently visible in the digital images taken. If the remote process is operationalized, protocols should be developed with clear instructions for technicians on what to capture in the digital images.
Can you give an overview of the results of this experiment?
1. Error rate of the remote process compared to the local?
There was no statistically significant difference between the errors recorded with the local process compared to the remote process. We classified a “critical error” as an error documented by the local pharmacist that the remote pharmacist did not catch. A critical error would suggest that outside of this study, without the secondary check by a local pharmacist, a patient would have received a medication with an error. Fortunately, we had no instances of “critical errors” in any of the 2,609 remote pharmacist checks.
2. Difference in speed?
The remote process did in fact take more time to complete than the local pharmacist checks, which is something we expected. This was a complete change from the process the pharmacists are accustomed to, so it took a little longer for them to adjust to the new process and look at the protocol, the hard stops, and images to thoroughly ensure safety.
While it was a little slower overall, we did not take into consideration the time that was saved from pharmacists not having to garb in and out to enter and exit the cleanroom. It is reasonable to assume that especially at smaller hospitals and health systems where there may be only one pharmacist, it could take significant time out of the day for them to go in and out of the cleanroom several times. Just because the process of product checking was a little slower in the study, it could potentially be offset by the elimination of garb time in some settings, not to mention the speed that would come with optimization of the workflow, enhanced training for technicians, and simply more familiarity with the process and systems for all involved.
3. Cost savings?
We calculated the cost of the garbing materials, such as the mask, cap, gown, and shoe covers, for the two sites that currently have pharmacists garbing in and out of the cleanroom and found that the amount spent is nearly $12,000 per year for each location. These are costs that could be saved if the remote workflow was implemented and the on-site pharmacists no longer need to enter and exit the cleanroom multiple times a day.
4. Opportunities for workload sharing
A hypothesis we had coming into the study was this process could provide greater opportunities for workload sharing. Throughout the course of the study, it became clear to us, as well as our participants, that this could really open the door for workload sharing and the possibility for pharmacists to be freed up for other activities in the hospital away from the cleanroom, being more involved in patient care and clinical activities.
You surveyed the participants before and after the experiment. What were the results of the surveys and how did the participants’ perspectives change after the completion of the study?
The participants were asked to answer each question on a scale of 1-5; with 1 being the strongest disagreement, and 5 being the strongest agreement. There were three questions that came back as more positive after the conclusion of the study from our participants. Those questions were about safety, opportunity for workload sharing, and optimization of the current workflow. There were two questions that had a more negative response from our participants after the study, and those were questions about accuracy and impact on job security.
As I mentioned before, the checks and hard stops that are in place in the process really help to ensure the process is safe and accurate for patients. The participants felt this as well, and therefore their responses regarding safety were more positive after the conclusion of the study. It also became clear to us and to the participants that this remote process could open up opportunities for workload sharing, as well as workflow optimization.
The decrease in agreement with the accuracy of the process was due primarily to addressable components of the process, such as the standardization of information captured in the digital images and the utilization of lot management functions within the system. Though the data did show a statistically significant lack of accuracy, the perception of the participants was that minor improvements could be made to the workflow if it were operationalized.
Regarding impact on job security, there was a decrease in percent agreement from pre- to post-study. Because this is a significant workflow change, we expected there to be some skepticism. It’s really important to have candid conversations with pharmacist staff to ensure they understand the intent of the remote sterile product pharmacist check process is not to eliminate existing pharmacist positions but rather to support them in their roles by opening up more opportunities for workload sharing, optimization of current processes, and engagement in clinical activities away from the cleanroom.
As of yet, many states do not allow the use of telepharmacy preparations of compounded sterile products, how do you think this study can help advance the regulations?
Our hope in conducting this study was to gather the necessary data to show whether or not a remote process was as safe and accurate as the current process. A secondary goal was to be able to use this data to encourage our state to begin the discussion of this type of telepharmacy.
We finished the study last year and it was published last month. Within that time frame, our state pharmacist association created a telepharmacy task force consisting of stakeholders from retail and hospital organizations throughout the state to discuss a possible proposal for the board. COVID-19 has really sped up the conversation around this topic as pharmacies are looking for ways to increase the use of telehealth to keep our staff healthy while continuing to provide patient care during this time. It just happened to be fortunate timing that we conducted this study prior to all this happening, so we already have data on hand that helped us to prove the concept.
What components of a TAWF system would be required to ensure safety and accuracy?
When preparing CSPs in the current, onsite workflow, pharmacists are able to visually check for details like lot number and expiration date of the drug vials or i.v. bags because they are in-person reviewing the products. If the remote process is operationalized, clear instructions and training for technicians should be developed so that all necessary information is available for a pharmacist who cannot access the physical product and review it in-hand. It is also important to note that the TAWF system used in our study was gravimetric-based with built-in hard stops, gravimetric measurements, and digital images to perform the sterile product check.
What are your final thoughts about the project as a whole, and the implications of the future of this practice?
We are really happy with the results of this study and what it shows. Because all hospitals and health systems have unique workflows and technology infrastructure and capabilities, it’s important to understand that it may not be a one-size-fits-all solution. Overall, this study is really the first of its kind in this space, so our hope is that it can go a long way in promoting the practice of hospital telepharmacy in North Carolina and beyond.
1. Bucci TG, Hedrick T, Roberts PA, Lin K, South MD, Willoughby IR, Eckel SF, Hess ET, Eberwein S, Amerine LB. Evaluation of a gravimetric-based technology-assisted workflow system for nonhazardous sterile product preparation. Am J Health Syst Pharm 2019; 76:1071-8.
2. Roberts PA, Willoughby IR, Barnes N, Eckel SF, Paruscio A, Valgus JM, Amerine LB. Evaluation of a gravimetric-based technology-assisted workflow system on hazardous sterile product preparation. Am J Health Syst Pharm 2018; 75:1286-92.