Evaluation of Cost, Workflow, and Safety of Implementing a Vial Transfer Device for Ready-to-Mix Drugs at an Academic Medical Center

Objective: To evaluate the cost, workflow, and safety of implementing a vial transfer device system. Methods: In this retrospective analysis, pharmacy systems and electronic health record reports identified high-volume and high-cost medications prepared by a Vial2Bag® (V2B) system from July 2017 to June 2018. The major outcome was the extrapolated yearly cost avoidance (EYCA) from utilization of a V2B system, calculated by subtracting total costs of the V2B system from total cost of ready-to-use products and locally compounded sterile products. Secondary outcomes included a workflow and safety analysis. Results: Implementing a V2B system led to a total EYCA of $2 295 261. A total of 283 209 potential V2B units were available for dispensing from automated dispensing systems and 41 082 yearly sterile product room units were avoided. A 0.02% safety report incidence per V2B administration was calculated at our institution. Conclusion: Use of a V2B system resulted in a substantial cost avoidance compared to purchasing commercial products and preparing locally compounded sterile products. The V2B system appears to be a safe addition to further optimize workflow but may require further investigation in prospective analyses.

Barrier Technologies proposed text from PHSS Annex 1 focus group for revision of clauses/ section in version 12 of Annex 1 through the targeted consultation process.

The PHSS are one of the eleven EC appointed commenting platforms in the targeted consultation process on Annex 1, with version 12 how in the process of review and commenting. Two sections of Annex 1 are considered by the PHSS to need significantly more clarity and differentiation of technologies and approaches to qualification. This article has a focus on Barrier technologies with a follow up article and Webinars also planned for the section on Qualification of Cleanrooms and clean-air devices (that includes classification). It is considered the current section in Annex 1 version 12 does not fully differentiate Isolators and Restricted Access Barriers (RABS) and their set-up for use in sterile product manufacturing. The following is recommended replacement text (in draft) that a PHSS Annex 1 Focus group have prepared to put forward to the EC/EMA as part of overall commenting on Annex 1 version 12 that has a deadline for submission on 20 July 2020.

4324 Phase 1 Sterile Product Formulation and Manufacturing at Academic Medical Centers: An Introduction for Translational Researchers

OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and pharmacy training in the areas of sterile product production, testing, and environmental controls, that can be used to support production of phase 1 clinical trial supplies METHODS/STUDY POPULATION: Searching and organizing relevant data and information from web portals and databases in the following: areas: FDA, EMA, USP regulations, regulatory science, pharmaceutical formulation and analytics, supply vendors, analytical testing laboratories, and product testing laboratories. Present the information using a user friendly format including flow charts and development timelines, taking the perspective of the translational investigator. RESULTS/ANTICIPATED RESULTS: Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possibleQualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO)Bringing together the deliverables for the IND CMC sectionWhere and how to leverage available products and science to simplify safe and reliable productionDISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.

Evaluation of telepharmacy and the use of a gravimetric technology–assisted workflow system for remote sterile product pharmacist checks

Purpose To evaluate the impact of remote sterile product pharmacist checks when used with a gravimetric-based technology-assisted workflow (TAWF) system on product checking accuracy, pharmacist review time, workload sharing, cost savings, and staff perceptions. Methods A double-arm, prospective study was conducted at 4 pharmacy locations for a 90-day period. Each compounded sterile product (CSP) checked by a remote pharmacist was also checked by a local pharmacist at the site of CSP preparation. An anonymous, online survey was emailed to staff before and after implementation to evaluate perceptions of the accuracy, timeliness, safety, potential impact, and value of the remote process. Results There was no statistically significant difference in the numbers of errors detected through the remote process and through the current, nonremote process (P = 0.177). The median pharmacist review time in the local process was significantly lower (P < 0.001). Remote pharmacists in the study workflow verified 30.4% of the total number of CSPs verified in the 90-day period. Annualized cost savings were calculated to be $23,770.08. Percent agreement increased from the preimplementation to the postimplementation period for survey questions about the safety of the remote process, opportunity for workload sharing, and optimization of current workflow. Percent agreement decreased for questions about the accuracy, timeliness, and value of the remote process and its impact on job security. Conclusion The study demonstrated that with use of a gravimetric-based TAWF system, there was no difference in the accuracy and safety of sterile product pharmacist checks performed remotely and those performed at the product preparation site. In addition, the remote process allows for opportunities for workload sharing and cost savings.

Development of Guidelines for Accurate Measurement of Small Volume Parenteral Products Using Syringes

Background: Syringes are commonly used in pharmacy compounding for the measurement of small volumes, especially in the preparation of sterile products for injection and infusion. However, there are no current official guidelines for the proper use of syringes in measuring small volumes. Objective: The purpose of this project was to determine the accuracy and precision of commercially available syringes in measuring small volumes during sterile product preparation to make recommendations for syringe size selection. Methods: To assess precision and accuracy of syringes, 3 separate investigators measured 5%, 10%, or 20% (n = 30 each) of the volume of a 1-, 3-, 5-, 10-, or 20-mL syringe with an attached 18G, 1½” needle by drawing sterile water for injection from a vial. Delivered volumes were measured gravimetrically using an electronic balance and converted to volume using the specific gravity of water (1.0). Accuracy is represented as the mean and standard deviation, while precision is represented as percent relative standard deviation. Differences were assessed using a 1-way analysis of variance with Bonferroni adjustments and significance set at P < .05. Results: Precision and accuracy were highly variable and often significantly ( P < .05) different compared to the theoretical volume delivered both within and between investigators. An increased likelihood of unacceptable error (>5%) was observed when less than 20% of the labeled capacity of a syringe was measured. Mean percent error ranged from 1.4% to 18.6%, despite manufacturer specification of ±5% accuracy, suggesting proper technique as a major factor in small-volume measurements. Conclusion: In addition to proper, validated training of syringe users, we recommend that users measure no less than 20% of the indicated volume of the syringe while choosing syringes as close as possible to the desired measurement. When possible, very small volumes should be diluted to meet the minimum volume of the smallest syringe available. Implementation of these recommendations will improve accurate dosing and, ultimately, patient safety.