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Disclosure Information

I have no financial relationship to disclose.

AND

I will not discuss off label use and/or investigational use in my presentation.

IV Compounding Experience at King Faisal Specialist

Hospital & Research Centre: Manual or Robotics?

Learning Objectives

• At the completion of this activity, you will be able to:

• Explain the role of automation for intravenous (IV) medications.

• Identify bottlenecks in the preparation of IV medications by IV robotics.

• Describe the Pros and Cons of IV robotics in the preparations of IV medications.

• Assess the appropriateness of IV automation with regards to ROI.

IV Reconstitution Methods

Standards of IV medication preparations?

• International Organization for Standardization Standard allow syringe accuracy variance of ±4% or ± 5%, based on the percent of volume in the syringe, from the intended/prescribed dosage.1

• The US Pharmacopeia Chapter 795 standard for compounded preparations allows a variance of ± 10%.2

1. International Standards Organization. Sterile hypodermic syringes for single use – part 1: syringes for manual use. ISO 7886-1:1993.

2. Chapter 795: Pharmacy compounding—Physical tests, in United States Pharmacopeia (ed 27 ) United States Pharmacopeial

Convention,2003, p 2348

IV medication errors

• The practice of sterile compounding involves well-acknowledged risks.

• Parenteral medication errors were nearly three times as likely to cause harm or death (3.0%) compared with other errors reported to Medmarx(1.2%).

• The majority (79%) of harmful or fatal parenteral errors involved the i.v. route of administration.

Am J Health-Syst Pharm. 2008; 65:2367-79

• Overall, 29% of the evaluated syringes were found to contain drug concentrations

• outside the designated range of acceptability (±10% of the targeted concentration);

• 18% of preparations deviated from the declared dose by ±20%, 8% deviated by ±50%, and 4% deviated by ±100%.

Am J Health-Syst Pharm—Vol 70 Jan 15, 2013

J Oncol Pharm Practice 2014 0(0) 1–7


Primary outcome of accuracy of chemotherapy doses prepared via volumetric measurement.

71.7% of the prepared doses

were within 5% of and 87.4%

of the were within 10% of the

ordered doseNearly 13% of preparations failed to

meet the 10%

acceptable tolerance

threshold


Percent volume difference based on prescribed volume.

Increased percent volume

Pediatric population, mean 3.38%

Requiring reconstitution 3.61%


Percent volume difference of preparations based on syringe size used.

smaller volume were

associated with an increased

percent volume difference

Enhance processes in pharmacycleanrooms

• Rapid growth in the availability and use of automation in sterile compounding.

• Automated devices for compounding total parenteral nutrition is common

• Gravimetric measurement, and robotics are emerging technologies in the cleanroom.

• Increasing acceptance of technology’s role in creating safe medication practices.


Robotics

• The ASHP Section of Pharmacy Informatics and Technology’s SAG on Pharmacy Operations Automation defines robotics as “mechanical devices that perform programmed, complex, and repetitive manipulations which mimic human behavior without continuous input from an operator.”

American Society of Health-System Pharmacists. Robotics resources. www.ashp.org/

Paradigm shift in the practice of pharmacy

• The surge in technological advances in robotics offers the possibility of a paradigm shift in the practice of pharmacy, particularly in the preparation of IV medications;

• Improving

•safety,

•accuracy, and

•efficiency

Am J Health-Syst Pharm 2015 Jun 15;72(12):1036-45.

History - improvements

• Introduction of unit dose medication dispensing and IV preparation programs in the late 1960s.

• Introduction of pharmacy automation through pill counting machines in the 1970s

• Introduction of computer systems for processing medication orders and medication labeling in the 1980s.

• Medication-dispensing robot in the 1980s.• Using bar-code technology to dispense medication, the robot

improved dispensing accuracy, inventory management, and workflow in the pharmacy.

• Introduction of IVpreparation robots in the 21st century.• Ability to perform repetitive tasks efficiently and accurately,


ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2014

• Overall, 2.9% of hospitals used a stand alone robotic device for compounding flushes, syringe-based small-volume parenteral preparations, or minibags, excluding chemotherapy

• The use of a robot to compound products differed significantly by hospital size, with the largest hospitals (600 or more staffed beds) most likely to use such a device.

• Robotic chemotherapy-compounding devices were used in just 0.3% of hospitals, with only the largest hospitals (600 or more staffed beds)reporting their use.

Am J Health-Syst Pharm—Vol 72 Jul 1, 2015

Am J Health-Syst Sep 15, 2012

Factors for Selecting and Implementing Robots

Benefits Considerations

Assists in decreasing

compounding errors

Cost

Able to operate outside of

cleanroom

Size and weight

Minimizes exposure to

hazardous products

Consumable costs

Maintains sterile environment Service and maintenance costs

Staff redirection Downtime planning

Consistency Size and manufacturer restrictions on

bulk drugs or consumables

Available round-the-clock

Bar-coding capabilities

Accuracy of robot vs. syringe

Markings

Points to consider when evaluating IV workflow systems and IV robotics

King Faisal Specialist Hospital & Research Centre - Experience

Pre-Installation check list

• Floor load capacity, space available in clean room, and the workflow requirements.

• HVAC requirements for maintaining proper cleanroom temperature.

• Challenge-under estimation of the cooling capacity required to offset the heat generated by the robot.

• Cleanroom had to be retrofitted with additional air conditioning units, at considerable cost in order to maintain a buffer area temperature of 18-20 C

• Installation of new air handler unit with ductwork

• Electrical work.

• Refinishing of areas affected by construction.

Pre-Installation check list Standardized RIVA consumables

• RIVA consumables (17 items) standardized

• Stock items

• Staff responsibility to order at right time.• Secure items internally.

• Non Stock items• Request at least 3 months’ supply a head

of reaching zero stock

• Vendor to supply free of charge for 6 months only starting for the operation day


DESCRIPTION UOM ITEM TYPE

Monthly AMU

Note

NEEDLE FILL BLUNT 18G 40MM FOR RIVA ROBOTIC SYSTEM DISPOSABLE BX/100 (72)

BOX STOCK ITEM

300 BOX Internal Requisition; Zero stock in the warehouse. 50 boxes (100 needles/box) are available on the pharmacy shelf provided by vendor.

SYRINGE LUER-LOK™TIP GRADUATED NON LATEX PEEL PACK 1ML FOR IV STATION™ ROBOTIC SYSTEM DISPOSABLE STERILE (72)

BOX STOCK ITEM

30 BOX

Internal Requisition; Available in the warehouse. Requested quantities were received.

SYRINGE 3CC LUER-LOK™TIP GRADUATED NON LATEX PEEL PACK FOR IV STATION™ ROBOTIC SYSTEM DISPOSABLE STERILE (72)

BOX STOCK ITEM

60 BOX

Internal Requisition; Available in the warehouse. Requested quantities were received.


BOX STOCK ITEM

120 BOX

Internal Requisition; Zero stock in the warehouse. Zero stock in the IV room. Possible delivery in 2-3 weeks


BOX STOCK ITEM

150 BOX

Internal Requisition; Available in the warehouse. Requested quantities were received

SYRINGE 20CC LUER-LOK™TIP GRADUATED NON LATEX PEEL PACK FOR IV STATION™ ROBOTIC SYSTEM STERILE DISPOSABLE (72)

BOX STOCK ITEM

125 BOX


SYRINGE LUER-LOK™TIP GRADUATED NON LATEX PEEL PACK 30ML FOR IV STATION™ ROBOTIC SYSTEM DISPOSABLE STERILE (72)

BOX STOCK ITEM

90 BOX


LABEL BARCODE IV BAG 1/2" X 1-3/4" PK/800 FOR RIVA ROBOTIC SYSTEM DISPOSABLE (72)

PACK STOCK ITEM

10 PACK Internal Requisition; Zero stock in the warehouse. Needed only for LVPs for barcoding.

SYRINGE TIP CAPS FOR RIVA- ROBOTIC SYSTEM DISPOSABLE (72)

EACH STOCK ITEM

30 BOX

Internal Requisition; Zero stock in the warehouse. Some quantities are available from vendor. Syringes will not be part of phase I implementation.

STERILE WATER FOR INJECTION 1000 ML BAXTER BAG FOR RIVA- ROBOTIC SYSTEM

BAG STOCK ITEM

150 BAG Internal Requisition; Available in the warehouse. Requested quantities were received.


Medication Conc. Vial Size Status Manufacturer SavingsInflation (SR/YR)

Clindamycin150

MG/ML6 ML Available Hospira $

Clindamycin150

MG/ML60 ML Backorder Hospira $

Dexamethasone 10 Mg/ML 10 ML Available APP $

Dexamethasone 4 MG/ML 30 ML Backorder Mylan $$

Ondansetron 2 MG/ML 20 ML Available Hospira $

Ranitidine 25 MG/ML 40 ML AvailableCOVIS

Pharma$$

Piperacillin/

Tazobactam

36GM/

4.5GMBackorder Pfizer

$$$$$

Vancomycin1 GM

/VIALAvailable Mylan $$$


Drug Dose Preparation Batch type Comments

Piperacillin/

Tazobactam

4500mg/100ml D5W

IVPB3375mg/100ml D5W

2250mg/100ml D5W

Vancomycin

1000mg/100ml D5W

IVPB500mg/100ml D5W

1000mg/250ml D5W Current 250ml D5W not

compatible with RIVA750mg/250ml D5W

Omeprazole 20mg/50ml NS IVPB

40mg/100ml NS

Ceftriaxone

2000mg/100ml D5W

IVPB

1000mg/100ml D5W

Cefepime 2000mg/100ml D5W IVPB

RIVA Workload

•Initially, reviewed approximately 20 CSPs for possible IV robotic production,

• adult and pediatric drugs that were manually prepared to meet patient needs.

• Of these, seven drugs suitable for robotic production were identified.

RIVA-Batch Preparations

Medication Dose Vloume Type of Stability in Amount of medication/ Final conc.

Of Diluent Diluent Fridge Volume of diluent in the vialin the vial

Ampicillin 1000 mg 50 ml NS 48 hrs 1 gm/ 5 ml SWI 200 mg/ml

Cefazolin 2000 mg 100 ml D5W 7 days 1 gm/ 5 ml SWI 200 mg/ml

Cefipime 1000 mg 50 ml D5W 7 days 2 gm/10 ml SWI 200 mg/ml

2000 mg 100 ml D5W

Cefoxitin 2000 mg 50 ml D5W 7 days 1 gm/ 5 ml SWI 200 mg/ml

Ceftazidime 1000 mg 50 ml D5W 3 days 1 gm/ 5 ml SWI 200 mg/ ml

2000 mg 50 ml D5W

Ceftriaxone 1000 mg 50 ml D5W 7 days 1 gm/ 10 ml SWI 100 mg/ ml

2000 mg 100 ml D5W

Clindamycin 900 mg 100 ml D5W 7 days

600 mg 100 ml D5W 300 mg/ 2 ml 150 mg/ ml

450 mg 100 ml D5W

300 mg 50 ml D5W

Colistin 3000,000 U 100 ml NS, D5W 24 hrs

2000,000 U 100 ml NS, D5W 2 Million IU/ 4 ml SWI 500,000 IU/ ml

1000,000 U 50 ml NS, D5W

Dexamethasone 10 mg 10 ml in 10 ml NS 48 hrs 10 mg/ ml 10 mg/ ml

syringe

Diphenhydramine 25 mg 50 ml D5W 7 days 50 mg/ ml 50 mg/ml

50 mg 50 ml D5W

Technical Problems

Issue Reason Solution

D5 Water Rejected Scratched Barcode Check quality of barcode

Sterile Water rejected Port neck exceeded pre-

defined measurements

Check port neck

measurements

Magnesium Sulphate Plastic Vial Glass Vial

Ondansetron Ampoule Glass Vial

Potassium Chloride Ampoule Glass Vial

Teething Problems

• Water for injection 1 L bag still not available.• Riva will not operate/function if not available.

• Tazocin, vancomycin, and Heparin cannot be prepared by Riva at the present time.

• Tazocin vials are not bar-coded. • Vancomycin and Heparin vials are too long

and do not fit in the provided racks.• Densitometer still not available to start

setting up Riva.

• Codonics is used to generate bar codes for items not bar coded

• BD syringes 5 & 30 ml still not available.

Codonics will be used for generating the required barcodes for all non- barcoded items. However, requesting to barcode each vial from the current manufactures or to secure barcoded items from other manufacturers that would be a better solution.

Medication Recommended Source Container Batch Type

To be Prepared by RIVA

Comments

caspofungin caspofungin 70 mg/10 mL IVPB Yes No barcode

cefazolin cefazolin 20 g/100mL IVPB Yes No barcode

ceftriaxone ceftriaxone 10 g/ 100 mL IVPB Yes No barcode

omeprazole omeprazole 40 mg/ 5 mL IVPB Yes No barcode

piperacillin-tazobactam

piperacillin-tazobactam 4.5g/20mL IVPB Yes

No barcode

tigecycline tigecycline 50 mg/10 mL IVPB Yes No barcode

zoledronic zoledronic 4 mg/5 mL IVPB Yes No barcode

BAR CODE

Training is vital!

• Staff training with vendor-supported education.

• Select individuals who display an interest and an aptitude for the role

• Not all staff will show the same interest

• A dedicated team of pharmacists – Automation and Informatics team received special training.

• The super users assist in training new employees and help with trouble shoot.

• Installation completed 2 October 2014

• Go-LIVE Sunday 22nd March 2015.

RIVA Workflow

34

Load Inventory Start RIVA - Automatic

preparation of dosesCompleted Doses

Load items

5-10 minutes with on

screen instructions

Press “Start” on screen

Walk away

Automatically makes

syringes and bags

All preparations in ISO-

5 environment

compliant with USP-

797

Fully Automated

Fully labeled doses,

waiting in bin, ready to

go

Complete audit trail

Doses ready to use

• During loading, operators fills an entire rack in a single step without a wait state between placement of the each consumable.

• High capacity per rack:

• Syringes up to 27 per rack

• Bags up to 10 per rack

• Vials up to 20 per rack

• Finished products are automatically dispensed into a collection bin

35

RIVA Differentiators

Riva Production- 1 week

Tazocin

2.25 G

Tazocin

3.375G

Tazocin

4.5G

Vancomycin

1000mg

Ranitidine

50mg

Riva

Dispensed 258 134 379 20 276

ICIS orders 216 273 1307 88 1660

% prepared

by RIVA 116% 49% 29% 23% 17%

Average

time to finish

one que

(hh:mm)

1:16

20 bags /

que)

1:25

20 bags/

que

1:20

16 bags/

que

1:49

20 bags/

que

00:57

20 bags/

que

KFSH&RC data-29 Oct. – 4 Nov

RIVA production Vs orders 1 week data

258 134379 276

20

216273

1307

1660

88

0

500

1000

1500

2000

2500

Tazocin 2.25G Tazocin 3.375G Tazocin 4.5G Ranitidine 50mg Vancomycin 1000mg

ICIS

RIVA



7 9 8 9 10 9 815 14 12 15 15 12 15

0

20

40

60

80

100

120

140

160

180

200

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

No. of Ques

No. of orders

No. of preparations

No. of failed preparations

Time (hrs)



Tazocin

2.25G

Tazocin

3.375G

Tazocin

4.5G

Vancomycin

1000mg

Ranitidine

50mg

Riva

Dispensed 329 310 208 30 118

ICIS orders 436 536 1436 55 1747

% prepared

by RIVA 75% 58% 15% 23% 7%

Average

time to finish

one que

(hh:mm)

1:12

20 bags /

que)

1:27

20 bags/

que

1:15

16 bags/

que

1:49

20 bags/

que

00:47

20 bags/

que

KFSH&RC data 21-28 Oct

Riva Production- 6 months

3174 3743 4753

130 130 520 129 897 854 498 912

7012

9737

24338

34 60 419 232 1780 3094 718 1586

0.00

5,000.00

10,000.00

15,000.00

20,000.00

25,000.00

30,000.00

35,000.00

ICIS

RIVA

45 3820

382

217

124

56 5028

69 58

0

50

100

150

200

250

300

350

400

450

Percentage doses dispensed byRIVA

Percentage doses dispensed by RIVA in 6 months

Riva- Ave Que time (mins)

20 2016

20 20 20

5

20 20 20 20

7480

75

63

7380

24

80

57

76 75

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

No. Bagsper Que

Ave time tofinish Que(mins)

Downtime

• Tazocin batch –• Stock is from a different manufacturer.

• Vial size not fitting the rack

• Vancomycin batch• Fast movers doses are 1gram and 500mg in 250D5W

• Current available D5W is from another manufacturer

• Hospital network issues• Downtime

• Internal connectivity between the robot’s stations and subsystems

• Water for injection 1 L bag • Baxter bags only –

• will not operate/function if this item is not available.

Downtime

• Vancomycin• Vial pressure issues

• initial pressure is high before injecting the diluent• results in generating diluent droplets on top of vial stopper • a further pressure is generated after reconstitution• large amount of spills, affect the weight of the vial• failure to withdraw the correct dose

• Omeprazole• Rubber stopper

• rubber stopper inside the vial is very high• completely cover the vial neck• accumulation of around 0.2-0.5ml between stopper and vial

wall• failure to withdraw the correct fluid volume.

Down time –Days

0

5

10

15

20

25

Robotic Consumables Staff NetworkConnectivity

Days

Days

ROI-Automation

Potential cost advantage

from the implementation of

the automated system of

34,000 drugs prepared in

year


Comparison between the cost of manual preparation of 100 bags of Piperacillin/Tazobactam(4.5 g)/100 ml and Riva preparation

Manual

preparation

Riva preparation

Cost of 100 ml D5w $ $

Cost of 100 vials Tazocin 4.5g $$ $$

Cost of needle to prepare 100 bags $

1of 19g needle

100 of Blunt fill

needle $$$$$

Cost of 60 cc syringe to prepare 100

bags 1 syringe $ 100 syringes $$$$

Cost of 1 bag of 2000 ml Sterile

water

$ 4

Syringes issue in RIVADrug/ Product Concentration IB

stability

in REF

IB Exp after 1st

Puncture (SDV –

per USP 797) in

RT

Final product

stability in

REF per USP

797

Final product

stability in RT

per USP 797

Ceftriaxone IB 40 mg/mL 7 days 6 hrs

Ceftriaxone Syr

40 mg/mL

7 days 30 hrs

Clindamycin IB

18 mg/mL

7 days 6 hrs

Clindamycin Syr

18 mg/mL

9 days 30 hrs

Gentamycib IB

10 mg/mL

7 days 6 hrs

Gentamycin Syr

10 mg/mL

4 days 24 hrs (D5W)

30 hrs (NS)

Meropenem IB

20 mg/mL

1 day 6 hrs

Meropenem Syr 20 mg/mL 24 hrs 24 hrs

Piperacillin/Tazobactam

IB 100 mg/mL

7 days 6 hrs 7 days 24 hrs

CHOC hospital

Pediatric

• Batch mode is beneficial to aid in standardization of doses.

• High volume and making multiple additions.• Vancomycin• Tazocin• Meropenem

• Maximum throughput from the robot

• For example, when making doses of antibiotics that require reconstitution, using the robot increases safety.

• The robot is also ideal for patient-specific drugs, although the bulk of use at our facility is in batch mode for standardized drugs.

“Autonomation" or "automation with a human touch."

• Steps of Jidoka:•assigning work to humans and machines on the basis of their differing abilities, •adapting machines to the human work flow, and•monitoring the human-machine interaction.

•Jidoka offers opportunities for a smooth transition to new technology

Jt Comm J Qual Patient Saf. 2014 Aug;40(8):341-50.

Conclusions

• Adjusting workflow to best incorporate the robot into our daily operation.

• Bach vs. patient specific compounding in future.

• Beyond Use Dating- Reduce costs

• Significant cost savings through vial sharing.

• Return on investment.• Savings on inventory as a result of the RIVA.

• Automating the compounding process enabled to redeploy pharmacists.

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