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

(1)

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, PGY1 Residency Program

(2)

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

(3)

Fee For Value

(4)

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

Overview

(5)

Clinical Pharmacy Practice

“Getting the Medications Right”

Medication Distribution System

Right Drug – Right Patient – Right Time

Dockside

Bedside

Procurement/Contracting

Technology/Workflow Management

Technicians

Pharmacists - Technology/Operations Specialists

BCMA

Smart Pumps

Systems Interoperability

Pre-Admission

Post-Discharge

Patient-Centered

Team-Based

Inter-professional

Authorization

Medication Reconciliation

Hand-offs

Transitional Care

Comprehensive Medication Management

Evidence-based Guidelines Accountability

(6)

Dispensing Models

H

ybr

id

•

~850 beds

•

Automated Storage

and Retrieval

•

Robotics for Central

Fill

•

ADCs for

Decentralized

Inventory

•

IV Robotics

•

IV Workflow and

Product Validation

•

TPN Compounder

D

ece

n

tr

al

iz

ed

•

~262 beds

Automated Storage

and Retrieval

•

ADCs for

Decentralized

Inventory

•

Automated UD

Packaging

D

ece

n

tr

al

iz

ed

•

125 beds

•

ADCs for

Decentralized

Inventory

Wilmot Cancer Center

IV Hazardous Production Robotics

IV Workflow and Product Validation

Central Sterile

Compounding

Off Campus Infusion

Centers (5) ~30%

Inpatients – ~8%

(7)

Dispensing Metrics – Strong Memorial Hospital

Total Doses

Dispensed

•

>17,000 doses/

day

Total Patient

Specific IV Doses

•

830 doses/day

•

~5% of doses

Total Pre-Mix IV

Doses

•

1150 doses/day

•

~550 are CSPs

Oncology Doses

•

190 doses/day

•

~8% inpatient

•

~25% off site

(8)

Current state of Sterile Compounding

(9)

Current State of Sterile Compounding

(10)

Pre-Check

Post-Check

(11)

(12)

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

(13)

Active Drug Name

12pt Font Bold

(Use ISMP tallMAN)

A ct ive in R o b o t Packaging (Syr vs Bag) Label Plus?Infusion Type

Box Around

Dose ?

Total Dose in Total Volume Final Diluent Fluid

12pt Font Bold (Total Dose or Content in

18 Font Bold) Box Around Concentration ? Final Concentration 10pt Font (18pt 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 12 pt Bold Font Intermittent Intermittent

Continuous Caution: High Risk

CardioPLEGIA Solution Intermittent Intermittent Intermittent Intermittent Intermittent

Yes Continuous Violet 256 EPINEPHrine

Continuous Pnd Continuous Continuous Blue 297 Continuous Continuous HYDROmorphone Yes Yes Pnd eRec Pnd eRec Yes Yes Pnd eRec 5 mg in D5W 250mL Bag Bag Bag Yes Yes Yes Yes Yes 4080-‐80840-‐01 4080-‐80835-‐01 Syr Yes Y Yes

20 mcg/mL

Y Bag Yes Yes N N

30 units/mL

Equiv approx 2 g Calcium

GLUCONATE Y Bag Yes Yes N N No Yes 4080-‐09493-‐51 Yes Y

1 mg/mL

Yes N

9.4 mEq

in Sod Chloride 0.9% Inj 100mL

Yes

2 g

in D5W Inj 100mL

Bag

4080-‐09492-‐51

Blue 297

Heparin for CELL-SAVER

fentaNYL

50 mcg/mL

Y

Syr Yes Blue 297

Blue 297

2 mcg/mL-0.0625%

Y Bag Yes Yes Yes

30,000 units in Sod Chloride 0.9% Inj 1000mL Yes Y

Bag Yes

calcium GLUCONATE calcium GLUCONATE

4.7 mEq

in Sod Chloride 0.9% Inj 50mL Equiv approx 1 g Calcium

GLUCONATE Y Bag Yes Y Y ceFAZolin Y

20 mcg/mL

Y fentaNYL-bupivacaine EpiDURAL/PeriNEURAL ONLY N N fentaNYL ceFAZolin

1 g

in 10mL

1 g

in D5W Inj 50mL 100 mg/mL Y Y Syr Bag ceFAZolin cefTRIAXone cefTRIAXone EPINEPHrine

fentaNYL-bupivacaine 2 mcg/ml-0.0625%in Sod Chloride 0.9% Inj Final Vol 250mL (C-II) fentaNYL 1250 mcg/25 mL (C-II)

fentaNYL 2000 mcg

in Sod Chloride 0.9% Inj Final Vol 100mL (C-II)

1 g

in D5W Inj 50mL

2 g

in D5W Inj 100mL

heparin

HYDROmorphone Yes

cardioPLEGIA Admixture

Solution Bag Yes

PlasmaLYTE-A with additional KCL

(52.8mEq/576.4ml) Y N

25 mg/25 mL (C-II)

(14)

(15)

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

Sara Wilke

Pharmacy Clinical Specialist

Rush University Medical Center

(16)

Central Compounding

What do the regulations and standards dictate (DQSA)?

Will we be able to supply other facilities within our health care network?

(17)

Medical Center

Hospitals

Infusion Centers

Other

“In Network”

Or Enterprise

“Out of Network”

Affiliated Centers

(18)

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

(19)

Savings from Insourcing

Year 1

Year 2

Year 3

Year 4

Year 5

TOTAL

SMH

$

1,590,297

$

1,622,103

$

1,654,545

$

1,687,636

$

1,721,389

$

8,275,969

HH

$

310,177

$

316,381

$

322,708

$

329,162

$

335,746

$

1,614,174

FFT

$

83,000

$

84,660

$

86,353

$

88,080

$

89,842

$

431,935

Total

$

1,983,474

$

2,023,143

$

2,063,606

$

2,104,878

$

2,146,976

$

10,322,078

Incremental Margin

$

466,587

$

479,077

$

491,545

$

503,982

$

516,381

$

2,457,573

Cummulative Margin

$

945,664

$

1,437,210

$

1,941,192

$

2,457,573

Annual Costs

$

1,516,887

$

1,544,066

$

1,572,061

$

1,600,896

$

1,630,595

$

7,864,505

Incremental Margin

$

466,587

$

479,077

$

491,545

$

503,982

$

516,381

Depreciation

$

109,596

$

109,596

$

109,596

$

109,596

$

109,596

TOTAL Sources Cash

$

576,183

$

588,673

$

601,141

$

613,578

$

625,977

Renovations/IT

$

1,560,164

$0

Inc/Dec Cash

$

(983,981)

$

588,673

$

601,141

$

613,578

$

625,977

Cummulative Cash Flow

$

(983,981)

$

(395,308)

$

205,834

$

819,412

$

1,445,389

Net Present Value (at 4%)

$1,171,536

(20)

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 1gm bag B 1728 $ 11,439.36 1 Aztreonam 2gm bag B 1296 $ 18,688.32 3 Calcium Gluconate 1gm 50ml B 9125 $ 37,686.25 1 Calcium Gluconate 2gm 50ml B 4563 $ 18,115.11 1 Cefazolin 1gm Frozen B 12736 $ 17,193.60 0 Cefazolin 1gm Syringe S 5940 $ 9,563.40 0 Cefazolin 2gm Syringe S 2804 $ 6,925.88 1 Cefepime 1gm Frozen B 3048 $ 13,228.32 1 Cefepime 2gm Frozen B 7476 $ 48,668.76 1 Ceftriaxone 1gm Frozen B 4920 $ 27,483.12 1 Ceftriaxone 2gm Frozen B 3936 $ 39,249.79 2 Clindamycin 600mg 50ml D5W B 2616 $ 27,394.75 2 Clindamycin 900mg 50ml D5W B 1824 $ 23,343.55 3

Ephedrine Sulfate 5 mg/mL in 0.9% NaCl, 10 mL S 10100 $ 36,360.00 1

Epinephrine 10 mcg/mL in D5W PF, 10 mL S 1296 $ -‐ 0 Epinephrine 5mg/250ml B 3968 $ 23,609.60 1 Esmolol HCl 10 mg/mL, 10 mL S 2200 $ 8,177.84 1 Famotidine 20mg 50ml B 7392 $ 12,788.16 0 Fentanyl 20mcg/ml 100ml Bag 100ml B 12198 $ 127,957.02 2 Fentanyl 2mcg/ml-‐Bupiv 0.0625% 150ml B 1800 $ 23,310.00 3

Fentanyl 2mcg/ml-‐Bupiv 0.1% 150ml B 0 $ -‐ #DIV/0!

Fentanyl 2mcg/ml-‐Bupiv 0.125% 150ml B 0 $ -‐ #DIV/0!

Fentanyl 50 mcg/mL, 2 mL, PF S 28500 $ 90,276.60 1

Fentanyl 50 mcg/mL, 5 mL, PF S 13300 $ 49,462.70 1

Fentanyl 50mcg/ml 25ml S 1836 $ 11,364.84 1

Glycopyrrolate 0.2 mg/mL, 5 mL S 13400 $ 37,486.50 1

Heparin 100units/ml in D5W 250ml B 9384 $ 36,503.76 1

Heparin 2 units/ml 500ml B 1728 $ 1,558.31 0

Heparin 30 units/ml in NS 1000ml B 1236 $ 14,367.26 2

Hydromorphone 0.2 mg/mL in 0.9% NaCl, 10 mL, PF S 18600 $ 51,626.90 1

Hydromorphone PCA S 11208 $ 70,498.32 1

Ketamine HCl 10 mg/mL in 0.9% NaCl, 10 mL S 700 $ 1,608.60 0

levetiracetam 1.5gm/100ml B 640 $ 15,797.12 5

levetiracetam 1gm/100ml B 2480 $ 48,984.96 4

levetiracetam 500mg/100ml B 1630 $ 20,099.53 3

Lidocaine 2% , 5 mL, PF S 6450 $ 19,873.10 1

Magnesium 1gm in D5W 50ml B 0 $ -‐ #DIV/0!

Magnesium 2gm in D5W 50ml B 24090 $ 70,101.90 1

Magnesium 40gm in LR 1000ml B 810 $ 1,782.00 0

Methohexital 10 mg/mL in SWFI, 10 mL, PF S 540 $ 935.28 0

Midazolam 1 mg/mL in 0.9% NaCl, 2 mL S 22500 $ 81,543.60 1

Midazolam 1mg/ml in NaCl 100ml B 4668 $ 120,574.44 6

Morphine PCA S 1350 $ 7,870.50 1

Neostigmine Methylsulfate 1 mg/mL, 5 mL S 11500 $ 30,187.50 1

Nicardipine 20mg in NS 200ml B 1680 $ 129,890.88 17

Oxytocin 30units in NaCl 500ml B 3991 $ 41,546.31 2

Penicillin 2MU FRZ B 1152 $ 7,570.94 1

Penicillin 3MU FRZ B 1752 $ 10,674.94 1

Phenylephrine 0.32mg/ml inNS 250ml B 1060 $ 15,338.20 3

Phenylephrine HCl 100 mcg/mL in 0.9% NaCl, 10 mL, PF S 11400 $ 57,186.96 1

Rocuronium 10 mg/mL, 5 mL, PF S 18700 $ 77,418.00 1

Succinylcholine Chloride 20 mg/mL, 5 mL S 9300 $ 25,039.32 1

Vancomycin 1gm Frozen B 9216 $ 34,209.79 1

Vancomycin 500mg B 2628 $ 7,361.03 1

Vancomycin 750mg B 3000 $ 11,869.50 1

Vecuronium Bromide 1 mg/mL in SWFI, 10 mL, PF S 5100 $ 34,228.65 1

Zosyn 2.25gm Frozen B 9336 $ 18,672.00 0

Zosyn 3.375gm Frozen B 28632 $ 66,139.92 0

Zosyn 4.5gm Frozen B 14364 $ 40,362.84 1

IV Room Workload Reduction

Financial Return/Productivity

(21)

(22)

Central Compounding - Design

Central

Compounding

Facility

Hospital

Batch CSPs

Oncology

Infusion

Centers

(patient

specific)

Ambulatory

Batch CSPs

(23)

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 100% of IV production include bar code verification

and gravimetric checks

(24)

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)

(25)

The Paradigm Shift in CSP production

Wait and see what regulations will dictate

Apply and anticipate evolution of regulations

From…

To…

Assume Quality and Safety of Compounding

Pharmacies under FDA regulation

Ensure and demonstrate Quality and Safety

(Who is best positioned to accomplish this?)

Our State Board will not allow that

Have the discussion with a patient safety focus

Wait for more sites to adopt technology

(adapters)

Be part of the early adoption (innovators)

Look for answers in Compounding Pharmacies

Look for answers within your organization

(26)

“We can’t change the human condition,

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