The Impact of IV Automation on Improving Safety, Efficiency and Workflow

The Impact of IV Automation on Improving Safety, Efficiency and Workflow David Webster, RPh, MSBA University of Rochester Medical Center Department of Pharmacy Associate Director of Operations Director, PGY Residency Program

Objectives Overview of URMC and Strategic Plan Compounded Sterile Products (CSPs) risks and changes required at URMC Specific strategies to decrease risk, increase efficiencies and reduce costs for CSPs. Current and projected impact of IV room automation Lessons learned and future plans

Overview Fee For Value

Overview http://www.ashpmedia.org/ppmi/overview.html

Overview Supporting a Clinical Practice Model Team-Based Pre-Admission Medication Reconciliation Clinical Pharmacy Practice Getting the Medications Right Patient-Centered Comprehensive Medication Management Hand-offs Evidence-based Guidelines Authorization Inter-professional Accountability Post-Discharge Transitional Care Medication Distribution System Right Drug Right Patient Right Time Dockside Pharmacists - Technology/Operations Specialists Procurement/Contracting Technology/Workflow Management Technicians Smart Pumps Bedside BCMA Systems Interoperability

University of Rochester Medical Center Dispensing Models Hybrid ~850 beds Automated Storage and Retrieval Robotics for Central Fill ADCs for Decentralized Inventory IV Robotics IV Workflow and Product Validation TPN Compounder Decentralized ~262 beds Automated Storage and Retrieval ADCs for Decentralized Inventory Automated UD Packaging Decentralized 25 beds ADCs for Decentralized Inventory Central Sterile Compounding Wilmot Cancer Center IV Hazardous Production Robotics IV Workflow and Product Validation Off Campus Infusion Centers (5) ~30% Inpatients ~8%

Dispensing Metrics Strong Memorial Hospital Total Doses Dispensed Total Patient Specific IV Doses Total Pre-Mix IV Doses Oncology Doses >7,000 doses/ day 830 doses/day ~5% of doses 50 doses/day ~550 are CSPs 90 doses/day ~8% inpatient ~25% off site

Current state of Sterile Compounding State of Pharmacy Compounding. Pharmacy Purchasing and Products. 204; 4: S-S40

Current State of Sterile Compounding http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding

Current State of Sterile Compounding Pre-Check Post-Check

Future of IV Room Production

Future of IV Room Production Decision path at URMC to IV Room Technology System needs to deliver core needs All sterile compounded products must incorporate bar code scan verification of correct ingredients All sterile compounded products must incorporate gravimetric checks for accuracy (robotic and human production) Workflow must be managed through a central hub for distributing tasks Must have integration to erecord (Epic) Space constraints and expandability Diverse product line including incorporation of high-hazard production

Future of IV Room Production Active Drug Name 2pt Font Bold (Use ISMP tallman) calcium GLUCONATE calcium GLUCONATE cardioplegia Admixture Solution cefazolin cefazolin cefazolin ceftriaxone ceftriaxone EPINEPHrine fentanyl fentanyl fentanyl-bupivacaine heparin Active in Robot Pnd erec Pnd erec Syr Bag Pnd erec Packaging Label Box Around Infusion Type (Syr vs Bag) Plus? Dose? Bag Bag Bag Bag Intermittent Intermittent Continuous Intermittent Intermittent Intermittent Total Dose in Total Volume Final Diluent Fluid 2pt Font Bold (Total Dose or Content in 8 Font Bold) Box Around Concentration? Final Concentration 0pt Font (8pt Bold Font for Cont Inf Conc) HR IV Station Control # erecord NDC Code (to generate barcode) ASTM Anesthesia Class Color Code ISMP Hi-Alert Rx? Y/N Class Warning Statement 2 pt Bold Font Caution: High Risk CardioPLEGIA Solution Bag Bag Intermittent g in D5W Inj 50mL Y 4080-09492- 5 Intermittent 2 g in D5W Inj 00mL Y 4080-09493- 5 N N Continuous Violet 256 EPINEPHrine Bag 5 mg in D5W 250mL 20 mcg/ml Y 4080-80840- 0 Continuous Syr 250 mcg/25 ml (C-II) Blue 297 Pnd Bag Bag Bag No Continuous Continuous 2 mcg/ml-0.0625% Blue 297 2 mcg/ml-0.0625% Y in Sod Chloride 0.9% Inj Final Vol 250mL (C-II) Continuous 4.7 meq in Sod Chloride 0.9% Inj 50mL Equiv approx g Calcium GLUCONATE 9.4 meq in Sod Chloride 0.9% Inj 00mL PlasmaLYTE-A with additional KCL (52.8mEq/576.4ml) g in 0mL g in D5W Inj 50mL 2 g in D5W Inj 00mL 2000 mcg in Sod Chloride 0.9% Inj Final Vol 00mL (C-II) Equiv approx 2 g Calcium GLUCONATE 00 mg/ml Y 50 mcg/ml Y 20 mcg/ml Y 30 units/ml 30,000 units in Sod Chloride 0.9% Inj 000mL Y Y Y Y Y Y 4080-80835- 0 Blue 297 N N N N N Y N fentanyl fentanyl fentanyl-bupivacaine EpiDURAL/PeriNEURAL ONLY Heparin for CELL-SAVER HYDROmorphone Continuous Syr 25 mg/25 ml (C-II) Y mg/ml Blue 297 HYDROmorphone

Future of IV Room Production

Central Compounding Fred Bender, team leader Director, Pharmacy Services Greenville Health System Brian Cotter Director of Pharmaceutical Services UM Baltimore Washington Medical Center Brad Ludwig Assistant Director, Pharmacy Services University of Wisconsin Hospital and Clinics Christopher Murray Manager, Perioperative: Pharmacy Services Duke University Hospital Andrea Nedved Supervisor, Pharmacy Services Mayo Clinic in Rochester Matt Parker Supervisor, Pharmacy Services Greenville Health System, Greenville Memorial Hospital Erinn Rowe Manager, Pharmacy Services UNC Health Richard Taylor Pharmacy Supervisor Beaumont Hospital, Royal Oak Dave Webster Associate Director of Pharmacy University of Rochester Medical Center Sara Wilke Pharmacy Clinical Specialist Rush University Medical Center

Central Compounding What do the regulations and standards dictate (DQSA)? Will we be able to supply other facilities within our health care network? How will USP standards evolve (USP 800)?

Central Compounding - Regulations Hospitals Other Infusion Centers Medical Center Affiliated Centers In Network Or Enterprise Out of Network

Central Compounding - Justification To our Board of Directors Background on the dangers of CSP production Rationale Primary Goal - Insource CSP production to meet patient care needs and safety expectations within the URMC network Outsourcing to Compounding Pharmacies is not currently an option Our current clean room capacity is not able to meet our needs Insourcing allows us to control Q/A for a safe supply chain of CSPs. The costs of outsourcing (once an option) are likely to increase significantly due to new requirements We can reduce our operating costs compared to outsourcing

Central Compounding - Justification Savings from Insourcing Year Year 2 Year 3 Year 4 Year 5 TOTAL SMH $,590,297 $,622,03 $,654,545 $,687,636 $,72,389 $ 8,275,969 HH $ 30,77 $ 36,38 $ 322,708 $ 329,62 $ 335,746 $,64,74 FFT $ 83,000 $ 84,660 $ 86,353 $ 88,080 $ 89,842 $ 43,935 Total $,983,474 $ 2,023,43 $ 2,063,606 $ 2,04,878 $ 2,46,976 $ 0,322,078 Annual Costs $,56,887 $,544,066 $,572,06 $,600,896 $,630,595 $ 7,864,505 Incremental Margin $ 466,587 $ 479,077 $ 49,545 $ 503,982 $ 56,38 $ 2,457,573 Cummulative Margin $ 945,664 $,437,20 $,94,92 $ 2,457,573 Incremental Margin $ 466,587 $ 479,077 $ 49,545 $ 503,982 $ 56,38 Depreciation $ 09,596 $ 09,596 $ 09,596 $ 09,596 $ 09,596 TOTAL Sources Cash $ 576,83 $ 588,673 $ 60,4 $ 63,578 $ 625,977 Renovations/IT $,560,64 $0 $0 $0 $0 Inc/Dec Cash $ (983,98) $ 588,673 $ 60,4 $ 63,578 $ 625,977 Cummulative Cash Flow $ (983,98) $ (395,308) $ 205,834 $ 89,42 $,445,389 Net Present Value (at 4%) $,7,536

Central Compounding - Justification Drug Item Bag/Syr Annual Usage Cost Savings Annual Low Volume/High Return Atropine 0.4 mg/ml in 0.9% NaCl, 2.5 ml S 4800 $ - 0 Aztreonam gm bag B 728 $,439.36 Aztreonam 2gm bag B 296 $ 8,688.32 3 Calcium Gluconate gm 50ml B 925 $ 37,686.25 Calcium Gluconate 2gm 50ml B 4563 $ 8,5. Cefazolin gm Frozen B 2736 $ 7,93.60 0 Cefazolin gm Syringe S 5940 $ 9,563.40 0 Cefazolin 2gm Syringe S 2804 $ 6,925.88 Cefepime gm Frozen B 3048 $ 3,228.32 Heparin 30 units/ml in NS 000ml B 236 $ 4,367.26 2 Cefepime 2gm Frozen B 7476 $ 48,668.76 Hydromorphone 0.2 mg/ml in 0.9% NaCl, 0 ml, PF S 8600 $ 5,626.90 Ceftriaxone gm Frozen B 4920 $ 27,483.2 Hydromorphone PCA S 208 $ 70,498.32 Ceftriaxone 2gm Frozen B 3936 $ 39,249.79 Ketamine HCl 0 mg/ml 2in 0.9% NaCl, 0 ml S 700 $,608.60 0 Clindamycin 600mg 50ml D5W B 266 $ 27,394.75 levetiracetam.5gm/00ml 2 B 640 $ 5,797.2 5 Clindamycin 900mg 50ml D5W B 824 $ 23,343.55 levetiracetam gm/00ml 3 B 2480 $ 48,984.96 4 Ephedrine Sulfate 5 mg/ml in 0.9% NaCl, 0 ml S 000 $ 36,360.00 levetiracetam 500mg/00ml B 630 $ 20,099.53 3 Epinephrine 0 mcg/ml in D5W PF, 0 ml S 296 $ - Lidocaine 2%, 5 ml, PF 0 S 6450 $ 9,873.0 Epinephrine 5mg/250ml B 3968 $ 23,609.60 Magnesium gm in D5W 50ml B 0 $ - #DIV/0! Esmolol HCl 0 mg/ml, 0 ml S 2200 $ 8,77.84 Magnesium 2gm in D5W 50ml B 24090 $ 70,0.90 Magnesium 40gm in LR 000ml B 80 $,782.00 0 Famotidine 20mg 50ml B 7392 $ 2,788.6 0 Methohexital 0 mg/ml in SWFI, 0 ml, PF S 540 $ 935.28 0 Fentanyl 20mcg/ml 00ml Bag 00ml B 298 $ 27,957.02 2 Midazolam mg/ml in 0.9% NaCl, 2 ml S 22500 $ 8,543.60 Fentanyl 2mcg/ml- Bupiv 0.0625% 50ml B 800 $ 23,30.00 3 Midazolam mg/ml in NaCl 00ml B 4668 $ 20,574.44 6 Fentanyl 2mcg/ml- Bupiv 0.% 50ml B 0 $ - Morphine #DIV/0! PCA S 350 $ 7,870.50 Fentanyl 2mcg/ml- Bupiv 0.25% 50ml B 0 $ - Neostigmine #DIV/0! Methylsulfate mg/ml, 5 ml S 500 $ 30,87.50 Fentanyl 50 mcg/ml, 2 ml, PF S 28500 $ 90,276.60 Nicardipine 20mg in NS 200ml B 680 $ 29,890.88 7 Fentanyl 50 mcg/ml, 5 ml, PF S 3300 $ 49,462.70 Oxytocin 30units in NaCl 500ml B 399 $ 4,546.3 2 Fentanyl 50mcg/ml 25ml S 836 $,364.84 Penicillin 2MU FRZ B 52 $ 7,570.94 Glycopyrrolate 0.2 mg/ml, 5 ml S 3400 $ 37,486.50 Penicillin 3MU FRZ B 752 $ 0,674.94 Heparin 00units/ml in D5W 250ml B 9384 $ 36,503.76 Phenylephrine 0.32mg/ml inns 250ml B 060 $ 5,338.20 3 Heparin 2 units/ml 500ml B 728 $,558.3 Phenylephrine HCl 00 mcg/ml 0 in 0.9% NaCl, 0 ml, PF S 400 $ 57,86.96 Rocuronium 0 mg/ml, 5 ml, PF S 8700 $ 77,48.00 IV Room Workload Reduction Succinylcholine Chloride 20 mg/ml, 5 ml S 9300 $ 25,039.32 Vancomycin gm Frozen B 926 $ 34,209.79 Vancomycin 500mg B 2628 $ 7,36.03 Vancomycin 750mg B 3000 $,869.50 Vecuronium Bromide mg/ml in SWFI, 0 ml, PF S 500 $ 34,228.65 Zosyn 2.25gm Frozen B 9336 $ 8,672.00 0 Zosyn 3.375gm Frozen B 28632 $ 66,39.92 0 Financial Return/Productivity Zosyn 4.5gm Frozen B 4364 $ 40,362.84

Central Compounding - Design

Central Compounding - Design Hospital Batch CSPs Ambulatory Batch CSPs Central Compounding Facility Oncology Infusion Centers (patient specific)

Next Phases in IV Automation at URMC Ø Interface to erecord system Ø High hazardous automated production Ø Semi-automated human CSP production Ø Goal to have 00% of IV production include bar code verification and gravimetric checks Ø Smart Pump integration

Lessons Learned " Focus of business plan must be patient safety " Site visits are critical sharing information " Drug shortages anticipate the unanticipated " Contingency planning " Be flexible in your design " Evaluate technology support (efficiency and safety factors) " Logistics (impact on BUD and testing)

The Paradigm Shift in CSP production From Wait and see what regulations will dictate Our State Board will not allow that Look for answers in Compounding Pharmacies To Apply and anticipate evolution of regulations Have the discussion with a patient safety focus Look for answers within your organization Assume Quality and Safety of Compounding Pharmacies under FDA regulation Wait for more sites to adopt technology (adapters) A financial model that improves safety Ensure and demonstrate Quality and Safety (Who is best positioned to accomplish this?) Be part of the early adoption (innovators) A safety model that have financial support

We can t change the human condition, but we can change the conditions under which humans work. -James Reason