SUPPLY CHAIN CENTER ACUTE CARE PHARMACY

Transcription

1 SUPPLY CHAIN CENTER ACUTE CARE PHARMACY FIVE YEARS EXPERIENCE IN A CENTRALIZED STERILE COMPOUNDING SERVICE WITH THE RIVA IV AUTOMATION SYSTEM

2 INTERMOUNTAIN HEALTHCARE THE VISION FOR STERILE COMPOUNDING Intermountain Healthcare is a Utah-based, not-for-profit system of 22 hospitals, a Medical Group with more than 1,600 physicians and advanced practice clinicians at about 180 clinics, a health plans division called SelectHealth, and other health services. Helping people live the healthiest lives possible, Intermountain is widely recognized as a leader in clinical quality improvement and in efficient healthcare delivery. Intermountain Healthcare facilities are serviced by the Intermountain Healthcare Supply Chain Center. The Supply Chain Center Acute Care Pharmacy (SCC ACP) is one division of the award-winning Supply Chain Center. In addition to oral drug prepackaging and distribution of pharmaceuticals, the SCC ACP also provides a highly controlled sterile compounding service. Because of constant drug shortages and the annual cost increases for acquiring sterile drugs, the facility enables better control over inventory carrying costs for these items and gives the ability to adapt to a changing supply chain. Another key driving factor for centralizing sterile compounding was to enable a small group of highly trained individuals to perform sterile compounding with engineered process controls and rigorous attention to accuracy and aseptic technique, which minimizes variation and potential harm to patients. Intermountain Healthcare had prior experience with automated sterile compounding technology at the health system s Primary Children s Hospital, and three ARxIUM RIVA units were selected for the new facility. The facility was conceptualized in 2010 and began services in fall During the planning and construction of SCC ACP, a number of market and regulatory changes occurred that further emphasized the need for a controlled sterile compounding process. The New England Compounding Center tragedy called into question the By conducting sterile compounding at a centralized facility, Intermountain Healthcare could establish internal processes that make quality audits straightforward and transparent for the health system. Intermountain Healthcare topped Gartner's 2016 and 2017 Healthcare Supply Chain Top 25 for "companies across the value chain that demonstrate leadership in improving human life at sustainable costs." quality of products obtained from outsourcing compounders and the risk of relying on a third party to provide sterile compounding services over which the health system has no control. Additionally, use of the RIVA Automated Sterile Compounding Systems enables a high degree of confidence that the preparations are both accurate and sterile, and removes risk of human error or touch contamination during the compounding process.

3 For Intermountain Healthcare, the highest quality for the patient is paramount. The SCC ACP supports the quality mission by increasing the control over sterile compounding processes. The facility exceeds the minimum regulatory standards for sterile compounding within hospitals through a tightly controlled sterile compounding area, well-designed manual compounding processes, and the use of RIVA for automated compounding. The combination of these programs enables Intermountain Healthcare to deliver custom pharmaceutical preparations to the patients served in the most cost-effective and safe manner possible. START UP AND FIRST TWO YEARS OF OPERATION The SCC ACP started with four primary goals for anticipatory compounding that they would provide to customer facilities in the Intermountain Healthcare System: 1. Standardization of batch compounding processes to reduce risk of errors and provide a transparent, consistent process for all patients served 2. Reduce the number of FTEs used by the system as a whole for sterile compounding services and move these personnel into higher value tasks 3. Use automation to reduce human error and contamination risks 4. Reduce the costs associated with purchasing ready to dispense sterile compounds from third party outsourced compounding providers The facility commenced operations to meet these goals by first establishing high-quality manual and automated compounding processes and a robust cleaning, disinfection, and material handling program. The first group of sterile preparations included manually compounded items that were historically prepared in small batches at individual facilities and then frozen or refrigerated. These items could be prepared in advance and centrally stored at the SCC ACP until requisitioned by a serviced facility. This enabled an economy of scale for the compounding processes and eliminated overproduction at each facility to reduce waste. Within the first year, the facility achieved its initial compounding operational goals and passed regulatory compliance measures. During the first two years of operation, the RIVA systems were gradually ramped up to produce a variety of refrigerated and frozen sterile compounds. The sterile compounding processes were validated through a systematic protocol run on each machine every day to assess the ability of the cleaning process to consistently provide a sterile compounding environment. More than 9,000 media fill simulations were conducted and demonstrated the effectiveness of the cleaning and disinfection program, and that the compounding cell was remaining in a state of control over an extended period.

4 The system leadership identified a number of process and automation issues to be addressed for the continued success of the facility. Among the challenges identified were lack of a robust software system to manage inventory, place orders, and track deliveries; hardware-software problems with the RIVA systems that reduced efficiency of operations; supply problems with the diluent solutions needed for RIVA compounding of the highest-use products; and process design flaws impairing turn-around time on the system customer s orders. To address these challenges, a joint steering committee of Intermountain Healthcare Pharmacy Leadership and ARxIUM Consultants was formed. The group was charged with identifying problems in the current processes and then designing solutions that would improve efficiency, productivity, and customer satisfaction. A one year time frame was established for the program. It was recognized at the end of the second year that the facility was not yet fully meeting the financial or customer service level goals, and the RIVA systems were not optimally utilized. YEAR 3 - RIVA OPTIMIZATION PROJECT The ARxIUM Consulting group was charged with addressing the RIVA-related issues. Examination of system performance yielded certain patterns of software or hardware issues that could be improved. On the usage design side, the RIVA units were not being optimally utilized to provide compounding of products that were part of the original plan. Changes in usage patterns and supply problems contributed to the latter issue. In addition, the Steering Committee decided to proceed with a conversion of all RIVA systems to use a different diluent bag vendor that was able to provide a broader portfolio of available product sizes. This also allowed all three systems to be identically configured and in the event of an unplanned downtime, production could be moved among machines to maintain the needed output for items scheduled on that day. A three phase plan was created to improve the RIVA program. The ARxIUM Service and Product Development groups were engaged to look at hardware and software issues. Data analysis of system logs showed that certain hardware and software errors occurred with a high incidence and accounted for more than half of the problems. Using a root cause analysis methodology, three principal areas were identified for the initial system adjustments: Software issues triggering system faults Mechanical issues with system components Performance characteristics of vials and bags Phase 2 Optimize automated compounding processes Phase 1 Address mechanical & software issues Phase 3 Execute a ramp-up plan to expand sterile compounding offerings

5 Two metrics were implemented to measure the success of the issues being addressed: mean time between halts (MTBH) and rejected (failed) doses. MTBH was measured as the number of minutes that RIVA would actively compound doses until a hardware or software issue was encountered that caused compounding to stop (this is termed a halt ). This metric is measured over an extended period of time (usually 1-2 weeks) by totaling the running minutes for that period and then dividing by the number of halts. Rejected doses and the reason for rejection were also collected over the same time period. Each of the areas identified for improvement was addressed in a systematic manner. First, the latest release of the RIVA software was installed on each machine to address software bugs. This eliminated known problems so that effort could be focused on areas that were not related to the older software release. Second, the mechanical systems on each machine were exhaustively tested and adjusted, then monitored and tweaked to obtain the best possible performance. One machine that was dedicated to a particular product and so had very few process variabilities to manage, saw a greater than fourfold improvement in the MTBH. Figure 1 shows the dramatic change in reliability before and after the software and mechanical system improvements. The result of the improvements was a doubling in the MTBH, meaning that the machines would run twice as long before encountering a mechanical or software halt.

6 Adjusting vial parameters and pressure management resulted in a dose weight reject rate reduction to less than 0.2% (2 rejects per 1,000 doses attempted). The third performance improvement area addressed was re-training each vial used in the systems. This project focused on checking the density of each drug vial and adjusting where needed, ensuring that the maximum amount of fluid draw could be performed without drawing air, and that the pressure management parameters were correctly set to eliminate any drips detected. Advanced tweaks were used to address vials with very low overfill and drugs requiring reconstitution to allow the maximum amount of fluid to be withdrawn. Figure 2 shows the comparison before and after the RIVA optimization period. FIGURE 2 - Rejected Doses Before/After Optimization Nov Mar 2014 Nov Mar 2015 Bags output Rejected bags Bag weight reject rate 1.5% 0.2% Syringes output Rejected syringes Syringe weight reject rate 1.8% 0.1% YEARS 4 and 5: VALUE DELIVERED AND GROWTH Following the completion of the RIVA optimization, the third phase was planning for the continued growth of the facility capacity. One approach will be to use RIVA to prepare bags of diluted drug solution stock bags and then use a rapid-fill syringe pump to prepare doses. This process is consistent with the quality goals of the SCC ACP because RIVA would ensure the more risk-prone step of preparing the dilution is conducted in a highly accurate manner, and the high-speed pump aids in the efficiency of the operation. The ongoing goal is to run the three RIVA systems with minimal interruptions and simultaneously conduct manual or automationassisted manual compounding. Over the last two years, the SCC ACP has expanded the number of compounded sterile preparations routinely prepared for system facilities from six to fourteen. Additionally, the number of facilities serviced has expanded and the SCC ACP is now the exclusive provider of certain sterile preparations, completely eliminating the dependence on an outsourced compounder for these items. Figure 3 shows the growth in doses delivered following the completion of the optimization project. This rate of growth is expected to continue as new sterile preparations are added to the service offerings.

7 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 June -17 July-17 August-17 Sept-17 Oct-17 Nov-17 Dec-17 Jan-18 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 June -17 July-17 August-17 Sept-17 Oct-17 Nov-17 Dec-17 Jan-18 # of doses/month The SCC ACP sterile compounding service has returned significant value to the Intermountain Healthcare system both clinically and financially. The compounding processes have direct oversight and control by the pharmacists, which is a degree of transparency not possible when an outsourcer is used. In addition, the financial value of centralized insourcing returns significant acquisition cost savings to each of the Intermountain Healthcare customers that SCC ACP services. Figure 4 shows the monthly savings returned to customers when compared to the cost of outsourcing, totaling over $2 million dollars during the tracking period shown in the figure Figure 3- Doses Delivered $90,000 $80,000 $70,000 $60,000 $50,000 $40,000 $30,000 $20,000 $10,000 $- Figure 4- Monthly Savings to Intermountain Healthcare

8 During the five years that the SCC ACP has operated, a number of valuable lessons have been learned. The original goal to provide a quick turn-around, on-demand service was found to be difficult to operationalize and meet customer expectations, while still maintaining the strict quality standards that are required. Understanding the inventory supply chain for both the supply and demand sides were quickly found to be vital. In addition, planning and execution needed to be dynamic; the SCC ACP changed both procurement and fulfillment processes so that they could respond to changes in market conditions and supply chain interruptions. Knowing in advance what to make, how much to make, and the logistics of ordering and delivery are key components of the smooth operation and became the standard for daily operations. Finally, working with the ARxIUM experts to optimize the system and provide guidance on efficient use of the technology was recognized as yielding additional value in addition to the production capabilities of RIVA itself. LOOKING TO THE FUTURE Intermountain Healthcare has realized significant value from the centralized sterile compounding service through the use of RIVA and ARxIUM consulting services. An important consideration is the ability to respond to changing market needs while maintaining the high quality standards and regulatory compliance that is needed to ensure the safety of these preparations. As drug costs continue to rise, gaining control over these expenses is paramount to ensure health care dollars are spent in the best manner possible. Centralization and standardization of batch processes and elimination of expensive outsourced sterile compounding products are two avenues that have proven successful for Intermountain Healthcare, and the SCC ACP will continue to explore new sterile compounds that the service can prepare. The success of the SCC ACP sterile compounding service is expected to continue as new sterile preparations are added. A number of areas that are being actively examined include centralized preparations of the alreadystandardized pain control medications, such as patient-controlled analgesia or continuous infusions of controlled substances. These require additional vigilance to prevent diversion and ensure accountability during the storage, compounding, and distributions processes. Implementation of a robust software system is planned to meet the regulatory documentation and reporting requirements. Other medications under consideration for expansion of the sterile compounding service include paralytics, vasopressors, and other medications used in surgical areas throughout the health system. The combination of RIVA automation and highly controlled manual processes has increased the safety, quality, transparency, and control over this risk-prone process, and reduced the total cost of providing these compounded sterile preparations to Intermountain Healthcare patients.