Disclosures. Objectives 9/16/2015. Pharmacy Sterile Compounding: Quality, Technology and Robots..Oh My!

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1 Disclosures Pharmacy Sterile Compounding: Quality, Technology and Robots..Oh My! Caryn Belisle declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings and honoraria. Caryn Belisle, RPh MBA Director of Pharmacy Regulatory Compliance, Quality and Safety Brigham and Women s Hospital Objectives Evidence Demonstrating Concerns about Compounded Sterile Products Prepared by Healthcare Workers Describe the current state of compounding sterile products Identify the current metrics of compounding sterile products in the pharmacy department Evaluate the use of technology to assist with upholding USP regulations Demonstrate the use and need for an ongoing Quality Assurance Program Parshuram CS, et al. Occurrence and impact of unanticipated variation in intravenous methotrexate dosing. The Annals of Pharmacotherapy. 2006;40(5):805. Anton C, et al. Medication errors detected in infusions. Arch Intern Med. 2003;163(8):982. Parshuram CS, et al. Discrepancies between ordered and delivered concentrations of opiate infusions in critical care. Critical care medicine. 2003;31(10):2483. Hayes BD, et al. Frequency of medication errors with intravenous acetylcysteine for acetaminophen overdose. The Annals of Pharmacotherapy: 2008;42(6):766. What s in these bags? Where s the Heparin? Heparin 10,000 units in 500mL NS for use via circuit for procedure in Cath-Angio Tested bag Did NOT contain HEPARIN! Patient lost 300 cc of blood 1

2 Fatal Medication Error We need to change! Medication Error Consequence Visual verification without any safety checks should be a thing of the past! We need to use technology to our advantage and do our due diligence to research and utilize resources to make the safest compounds possible! Volumetrics vs. Gravimetrics Manual Batch Verification A gravimetric measurement process utilizes Specific Gravity to weigh and verify the accuracy of all components used to prepare a Compounded Sterile Product (CSP) Technology using gravimetric assessment can have accuracy parameters set for each specific drug depending on accuracy needed. A volumetric measurement process relies on the ability of a pharmacy technician to accurately reconstitute, measure and draw up all components used to prepare a CSP. Precision accuracy in a manually prepared CSP is impacted due to the variability in the products used: IV bags are frequently overfilled by 10% Medication vials have an accuracy range of +/- 10% Syringes are accurate +/- 5% Human variability Robots Galore! i.v. Station How is it resourced 1 Pharmacy Technician 2 shifts, 7 days per week Batch production PAR level based Scheduled production runs Pros/Cons + Versatile in final product containers (syringe/bag sizes) + Expansive degree of safety features (gravimetric, barcode scanning, visual recognition) - Speed and accountability - Drug shortages = suboptimal operation due to availability 2

3 i.v. Station Product Variances! i.v. Station Cleaning BWH CPhT Twice Daily Weekly Sporklenz Update vendor P&P UV light Robotic technology can provide which of the following below? Bar code verification and Optical scanning Efficient work flow Central Data Storage All of the Above Answer D. All of the above and more! Bar code verification Specific gravity and gravimetrics Optical scanning Central data storage High degree of accuracy and precision Efficient work flow Workload tracking Interfaces Removes part of the human element when compounding we are the primary source of contamination! i.v. Workflow Assist Devices What do we want to see an i.v. workflow device? Bar code verification Specific gravity and gravimetric verification Remote pharmacist verification Optical scanning Central data storage High degree of accuracy and precision Workflow prioritization 3

4 i.v. Soft Assist Remote Pharmacist Verification Checks human preparation process at each step using Optical scanning Bar code verification Gravimetric checking Interface with CPOE system Patient specific doses Centralized Electronic Data Storage and Database Management Changing the Work Flow We need the capability to electronically store all data associated with the preparation of CSPs Date/time Source of preparation (Device and Operator) All ingredients with lot numbers and Exp. Date Accuracy of final product Production time for efficiency We need the capability to analyze and utilize the data to continuously improve the process and staff proficiency Can be very difficult and can be upsetting to staff. I can do it faster! Don t you trust me? Do not underestimate the time and effort required to do this right! How We Dealt With It.. Lean concepts STAFF DRIVEN Tabletop exercises STAFF DRIVEN Time and Motion Studies Potential Concerns with Changing to New Processes for CSP Preparation Technology is relatively new and is still developing We are in the early adopter phase The technology is not proven as yet with a multitude of evidenced based studies Potential exists for new kinds of errors to occur due to the introduction of the new technology, new processes and new roles for staff Staff will need additional training to adapt to the additional steps of workflow devices Staff may over-rely on the technology and vigilance may be reduced 4

5 Quantity Metrics: Robot vs. Manual Metrics: Robot vs. Manual 400 i.v Station Made Vs. Made by Hand Jan-15 Made by Robot (Day) Made by Hand (Day) Made by Robot (Evening) Made by Hand (Evening) Total made Total made by Robot by Hand Grand Total Totals 3, ,287 1,663 7,130 2,631 9,761 Averages Percentage 79.88% 20.12% 66.40% 33.60% 73.05% 26.95% % Mar-15 Made by Robot (Day) Made by Hand (Day) Made by Robot (Evening) Made by Hand (Evening) Total made Total made by Robot by Hand Grand Total Totals 2,436 2,039 1,729 3,077 4,165 5,116 9,281 Averages Percentage 54.44% 45.56% 35.98% 64.02% 44.88% 55.12% % i.v Station Made Made by Hand Financial Concerns Space Ventilation Hood space for workflow devices Need to plan for the costs Capital Leasing Monthly Rental Outright Purchase Key Lessons Learned Set expectations early & mobilize commitment Identify your Super-Users early and get buy-in! Daily huddles during implementation and weekly check-in during sustain phases Encourage input from all SPR staff All ideas will be considered Some parts of the process are negotiable, others are not speak up proactively Focus on the positive Key Lessons Learned Incorporate QA measures directly into daily workflow Ensure operators, not just super-users continually work with the robot and/or workflow device Adaptation of processes & change management. Techs must be first line for improvement recommendations with new technologies What works and what doesn t work A face-to-face Thank You is unquantifiable! Additional Lessons Learned It takes time to add and validate new products to the database patience is key Product shortages can greatly impact output volume New problems can arise unexpectedly and can be related to: vial sizes drug product composition Hardware Software Human interface issues 5

6 Additional Lessons Learned You must have clearly written implementation and validation protocols You must also have clear change management protocols for when hardware or software are upgraded Training of both the pharmacist and technical staff is a key success driver Establish a partnership with your vendor to keep in constant contact during implementation and expansion and upgrade periods What are potential concerns when changing from a manual process to using a workflow or robotic device? The technology is in the late majority of the technology adoption phase Staff may over-rely on the technology and vigilance may be reduced Staff will not need additional training You have nothing to worry about! Answer BWH Quality Assurance Program B. Staff may over-rely on the technology and vigilance may be reduced *The technology is in the early adoption of the technology adoption lifecycle *Staff WILL need additional training BWH Quality Assurance Program USP<797> Requires sterile product preparation to be completed in a sterile environment Dictates maximum expiration date of sterile products based on risk level and storage The Joint Commission and State Boards of Pharmacy use USP <797> guidelines during pharmacy inspection Product expiration is limited without evidenced based literature or Beyond Use Date Certification BWH Quality Assurance Program Beyond Use Dating Increase expiration dating to decrease cost of waste and increase operational efficiency End product testing of robot preparations Testing performed by outside lab at designated time points with customer receipt of certified results Stability - potency/purity via HPLC Sterility <USP 71> Endotoxin <USP 85> Particulate matter <USP 788> ph testing 6

7 BWH Quality Assurance Program Monthly Reporting BWH PHARMACY QUARANTINE PROGRAM Theoretical Actual Drug/Concentration Weekly Monthly Yearly Quarantined Released Total on Hand IV BAGS Acyclovir 200mg/100ml D5W Calcium Gluconate 2gm/100ml NS Furosemide 200mg/100ml D5W PENDING QUARANTINE Oxytocin 30u / 500mL NA NA NA Promethazine 6.25mg/50mL NA NA NA CONTROLLED SUBSTANCES Ketamine 100mg / 50mL NA NA NA Dilaudid PCA 250mg/25mL NA NA NA Dilaudid 50mg / 250mL NA NA NA Technology does NOT replace the need for Quality Assurance! Environmental Monitoring Contracted with outside testing agencies Robots are tested exactly like BSC Every other week: Microbiology sampling viable/non-viable particles Every 6 Months: Certified as ISO Class 5 devices Air volume and velocity profile HEPA filter integrity/leak test Airflow patterns and pressure differential Particle count monitoring Temperature and relative humidity monitoring What is the appropriate beyond use date for a medium risk product that is not tested per USP <71>? 30 days refrigerated 14 days refrigerated 9 days refrigerated 48 hours room temperature Answer C. 9 Days refrigerated Also.. 30 hours room temperature 45 days Frozen 7

8 Conclusion It s time for the old process of compounding and visual checking to be retired Innovative technology is now available that will allow for precise and accurate sterile product preparation Pharmacy leaders need to embrace the change and lead their departments into the future DON T FORGET ABOUT YOUR STAFF! 8