In The Clean Room

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The information, observations, and opinions in this report are

constantly evolving due to the authors ongoing research, thinking,
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2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to reproduce or share this report in whole or in part in a manner
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Report number 10.19.14.1 is licensed to Eric Kastango on October 10, 2014
1
CONTENTS
License Agreement 1
Preface by Christopher Jerry 3
Foreword by Eric Kastango 5
I. OBJECTIVE 6
II. PERSPECTIVE 7
III. OVERVIEW: PARADIGMS 18
IV. REVIEW: PRODUCTS 31
A. SEMIAUTOMATED-MANUAL SYSTEMS 31
1. BD Cato 32
2. DoseEdge 37
3. i.v.SOFT 44
4. Pharm-Q ITH 49
5. Phocus Rx 54
6. SP Central Pharmacy for Sterile Room
Medication Preparation 59
7. Verification 64
B. HIGHLY AUTOMATED ROBOTIC SYSTEMS 69
8. APOTECAchemo 70
9. INTELLIFILL I.V. 76
10. i.v.STATION 81
11. RIVA 86
Quick-Look Product Guides 91

Quick-Look Comparative Guide 103
Vendor Information 105
Authors 106
2
In February of 2006, my two-year old daughter, Emily Jerry, died
from an IV compounding error that could easily have been
prevented by using the kinds of technologies reviewed in this report.
In the fall of 2005, doctors found an exceptionally large yolk sac

tumor (YST) in Emilys tiny abdomen. Their diagnosis was shocking
PREFACE as, outwardly, Emily appeared to be a completely healthy and
vibrant toddlergiggling pretty much every minute of every day.
Emily was the youngest of three amazing siblings and was
absolutely adored by her older brother, Nate, and sister, Katherine.
Our oncology team recommended that Emily be admitted into a

leading pediatric facility in Cleveland for three days each month to
receive their prescribed chemotherapy regimen. We were told,
because the mass was the size of a grapefruit, that five or six
months after successful chemo treatments she would most likely
require surgery to remove residual scar tissue.
By February of 2006, the oncologists were beginning to think that

Emilys tumor might not be responding well to the etoposide being
used in her chemotherapy. She had not lost any weight, which was
rare. As a matter of fact, she had gained a pound, which they told us
was a first among their pediatric oncology patients. Emily also had
not exhibited many of the flu-like symptoms that typically
accompany chemotherapy. This prompted the ordering of an MRI
to see if a different course of treatment might be required.
By the grace of God, the MRI revealed that Emilys tumor had
completely disappeared. They couldnt even find residual scar
tissue, which normally follows chemotherapy treatment for tumors
of any size. Bottom line: we witnessed a miracle!
Even after this marvelous outcome, which every caregiver on the

planet dreams of experiencing (even once during the course of his
or her career), Emilys oncology team recommended one final
three-day round of chemotherapy. They wanted to make certain
that no residual cancer cells remained that could pop up later in life
and pose a threat.
3
With an amazing prognosis, Emilys mother and I decided to bring
our girl in for a final three-day round of chemotherapy, which
started February 24 on her second birthday. Everything went
extremely well on that Friday and Saturday. Then, on Sunday, for
what was supposed to the last dose before taking her home cured,
the worst imaginable IV compounding error occurred that took our
daughters life.
The technician preparing Emily's last IV, thinking she was doing the
right thing, took an empty compounding bag and filled it with three
vials of 23.4% sodium chloride instead of using the called for
premixed 0.9% sodium chloride. Before the day was over, our
darling girl was taken by an unintended and uncaught medication
erroran error, which could have been intercepted with the use of
simple, proven technology.
Today, with all my heart, I believe Emilys short life was meant to
save tens of thousands of precious lives going forward. And it can, if
we all join hands and truly learn from what happened.
As Emilys father, my life is now devoted to doing all I can to

prevent similar medical errors. I am convinced that had my
daughters hospital used common bar-code scanning technology to
verify containers and drugs when making sterile compound
preparations in its clean room that day, we would not have had to
say goodbye.
I encourage everyone to read the insightful report that you hold in

your hands and to encourage your hospital to implement such
safety systems in its pharmacy as soon as possible.
Christopher Jerry
President and CEO
Emily Jerry Foundation
www.emilyjerryfoundation.com
4
I am thrilled to be writing the Foreword for this body of work that
Jerry and Mark have written about the technology being deployed
in the cleanroom to improve the safety of compounded sterile
FOREWORD preparations (CSPs). You will be provided with some great
information from the authors. Jerry was my go to guy when I
needed help getting a handle on medication dispensing technology
while working on a project in the Middle East. His generosity was in
valuable and allowed me to be successful. But that story only
scratches the surface of his expertise. What can I say about Mark?
Although I havent worked directly with him, if you dont know his
name or his work, then you havent been paying attention to the
evolution and importance of patient safety based-technology.
It is good to see that this technology survey has been published,

providing the reader with an objective assessment of software and
hardware being marketed as the silver bullet to getting the
pharmacist out of the cleanroom and making every dose safe. As
the expression goes, trust but verify and it couldnt be truer about
the technology covered in this paper. It is important to also keep in
mind that this technology does not eliminate the need to train
employees or obviate the need for good aseptic technique. Again,
the opposite couldnt be truer.
So, sit back and let the Pros from Dover start you on your journey
of enlightenment. The more you learn, the more you realize you
dont know, so please dont stop learning and become complacent
because your patients health and well-being depends on you being
the best and the brightest!
Eric S. Kastango, MBA, RPh, FASHP

CEO & President
Clinical IQ
5
I. OBJECTIVE
Our objective in this report is to provide a review of technology-
assisted sterile compounding systems (paradigms and products)
currently available in the United States.
Herein, we offer triangulation points intended to help readers

pinpoint their organizations location in an expanding sea of options
while navigating their way toward safer IV-preparation.
En route, we will share observations and insights from our

experience intended to help readers select the right sterile-
compounding technologies for their hospitals.
We do not profess to provide everything in this report you will need

to know. We are prepared to dive deeper into the subtleties of the
various paradigms and products as they may apply to individual
institutions.
Finally, while we believe it is right to use sterile-compounding

technologies, we also believe they must be used the right way. In
future reports, we hope to go beyond selection to cover important
implementation and utilization factors as well.
Mark Neuenschwander
Jerry Fahrni, PharmD
Information about the authors here.
6
QUICK LOOK PRODUCT GUIDES
7
Quick-Look: Comparative Guide for Semiautomated-Manual
Systems
BD Cato DoseEdge i.v.SOFT Pharm-Q Phocus Rx SP for Sterile Verification

ITH Compounding
PhIS Integration Y Y Y Y Y Y Y
HL7 or XML HL7 or label- HL7, XML, ODBC HL7 HL7, label- HL7 or label- HL7 or label-
print feed print feeds or print feed print feed
direct scan
Web-based N Y (verification Y (via optional Y Y (verification N Y
only) module) only)
Remote Access Y Y Y Y Y Y Y
Formulary / NDC Y Y Y N N Y Y
Cross Reference
Recipe Catalogue Y Y Y N N Y Y
Compounding Y Y Y N N Y Y
Aids
Bar-code Y Y Y Y Y (limited) Y Y
scanning
Label printing Y Y Y N N Y (batch only) Y (product and
tracking)
Volumetric N Y Y Y Y Y Y
verification
Gravimetric Y Y (optional) Y N N N N
analysis
Image capture N Y Y Y Y Y Y
Implementation 4-8 weeks 12-14 weeks 6 weeks 2-4 weeks 1-2 weeks 6-12 weeks 1-2 weeks
time
Procurement Capital purchase Capital purchase Capital purchase Capital Capital Capital purchase Capital purchase
options Lease License fee Lease purchase purchase Lease
Rent
First Released 2013 2008 2012 2008 UNK 2006 2013
Live Installations 1 223 2 <5 <5 12 5-10
2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to reproduce or share this report in whole or in part in a manner that violates the licensing terms outlined on page 1 of this report
without the express written permission of The Neuenschwander Company.
8
Quick-Look: Comparative Guide for Highly Automated Robotic
Systems
APOTECAchemo INTELLIFILL I.V. i.v.STATION RIVA

PhIS Integration Y Y Y Y
HL7 HL7 HL7, XML, ODBC HL7 or flat file
Web-based N N Y N
Makes bags Y N Y Y
Makes syringes Y Y Y Y
Hazardous compounding Y N N N
Remote Access Y N Y Y
Formulary / NDC Cross Y Y Y Y
Reference
Recipe Catalogue Y Y Y Y
Compounding Aids Y Y Y Y
Bar-code scanning Y Y Y Y
Label printing Y Y Y Y
Volumetric verification N N N N
Gravimetric analysis Y Y Y Y
Image capture Y Y Y Y
Implementation time 12-16 weeks 7-14 weeks 12-24 weeks 12-24 weeks
Procurement options Capital purchase Capital purchase Capital purchase Capital purchase
Lease Lease Lease Lease
Rent Rent Per dose charge
First Released 2011 2001 2012 2008
Live Installations 3 20 3 31
2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to reproduce or share this report in whole or in part in a manner that violates the licensing terms outlined on page 1 of this report
without the express written permission of The Neuenschwander Company.
9
Vendor Information
AESYNT GRIFOLS USA LLC

Cranberry Township, PA Los Angeles, CA
800-594-9145 800-379-0957
inquire@aesynt.com hospitalusservice@grifols.com
http://www.aesynt.com http://www.grifols.com/
http://envision-rx.com/
INTELLIGENT HOSPITAL SYSTEMS INC
ApotecaUSA Winnipeg, Manitoba, Canada
Delray Beach, FL 204-943-0066
610-909-4447 info@intelligenthospitals.com
info@apotecausa.com http://www.intelligenthospitals.com
http://apotecausa.com
MEDKEEPER
BAXTER CORPORATION Denver, CO
Deerfield, IL 877-812-0100
800-4Baxter (800-422-9837) sales@medkeeper.com
http://www.baxter.com http://medkeeper.com
BD SCRIPTPRO LLC
Franklin Lakes, NJ Mission, KS
Phone: 855-489- 2286) 800-851-2364
BDCatoUS@bd.com http://www.scriptpro.com
http://www.bd.com/cato
ENVISION TELEPARMACY
Alpine, TX
432-897-0754
http://www.envision-rx.com
envision@envision-rx.com
10
AUTHORS
Mark Neuenschwander is the President of The Neuenschwander
Company, Cofounder of The TerraPharma Project, sponsor of The
unSUMMIT on Healthcare Barcoding. In addition to speaking and
consulting, he is the publisher/editor in chief and contributing
author for The Neuenschwander Reports. Mark is the recipient of
the ISMPs tenth Lifetime Achievement Award for his leadership in
promoting patient-safety technologies in healthcare over the past
two decades.
mark@hospitalrx.com
www.hospitalrx.com
Jerry Fahrni, PharmD has a background in hospital pharmacy and

pharmacy informatics. In addition to working in hospitals, he has
worked for technology companies and provided consulting services
for technology developers and hospital users independently and in
concert with The Neuenschwander Company. Jerry is the lead
researcher on this latest Neuenschwander Report: In the Clean
Room. He is also a popular blogger on the subject of pharmacy
automation and technology at jerryfahrni.com.
jerry@hospitalrx.com
www.jerryfahrni.com
11

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LICENSE

It is understood that this numbered copy of In the Clean Room has

Electronic Files: Licensee is permitted to download this PDF onto

Printed Copies: Licensee is entitled to produce one (1) printed copy

The information, observations, and opinions in this report are

While the authors have made reasonable efforts to ensure the

The Neuenschwander Company and the authors make no

Quick-Look Product Guides 91

In the fall of 2005, doctors found an exceptionally large yolk sac

Our oncology team recommended that Emily be admitted into a

By February of 2006, the oncologists were beginning to think that

Even after this marvelous outcome, which every caregiver on the

As Emilys father, my life is now devoted to doing all I can to

I encourage everyone to read the insightful report that you hold in

It is good to see that this technology survey has been published,

Eric S. Kastango, MBA, RPh, FASHP

Herein, we offer triangulation points intended to help readers

En route, we will share observations and insights from our

We do not profess to provide everything in this report you will need

Finally, while we believe it is right to use sterile-compounding

Jerry Fahrni, PharmD

Information about the authors here.

BD Cato DoseEdge i.v.SOFT Pharm-Q Phocus Rx SP for Sterile Verification

APOTECAchemo INTELLIFILL I.V. i.v.STATION RIVA

AESYNT GRIFOLS USA LLC

Jerry Fahrni, PharmD has a background in hospital pharmacy and

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