In the Clean Room: A Review of Technology-Assisted Sterile Compounding Systems in the US

Jerry Fahrni
Jerry FahrniPharmacy Expert and Informatics Consultant

An objective review of technology-assisted sterile compounding systems (paradigms and products) currently available in the United States. Information intended to help readers pinpoint their organization’s location in an expanding sea of options while navigating their way toward safer IV-preparation. Includes observations and insights from our experience intended to help readers select the right sterile-compounding technologies for their hospitals. Only the first few pages of the report are presented here. The full report can be found at http://hospitalrx.com/inthecleanroomcover.html

In the Clean Room: A Review of Technology-Assisted Sterile Compounding Systems in the US
CONTENTS 
License Agreement 1 
Preface by Christopher Jerry 3 
Foreword by Eric Kastango 5 
• OBJECTIVE 6 
• PERSPECTIVE 7 
• OVERVIEW: PARADIGMS 18 
• REVIEW: PRODUCTS 31 
• SEMIAUTOMATED-MANUAL SYSTEMS 32 
A. BD Cato 33 
B. DoseEdge 37 
C. i.v.SOFT 44 
D. Pharm-Q ITH 49 
E. Phocus Rx 54 
F. SP Central Pharmacy for Sterile Room Medication 
Preparation 59 
G. Verification 64 
• HIGHLY AUTOMATED ROBOTIC SYSTEMS 69 
A. APOTECAchemo 70 
B. INTELLIVILL I.V. 76 
C. i.v.STATION 82 
D. RIVA 86 
Quick-Look Product Guides 92 
Quick-Look Comparative Guide 103 
Vendor Information 105 
Authors 106 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.
PREFACE 
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 Emily’s tiny abdomen. Their diagnosis was shocking 
as, outwardly, Emily appeared to be a completely healthy and 
vibrant toddler—giggling 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 
Emily’s 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 Emily’s tumor had 
completely disappeared. They couldn’t 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), Emily’s 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. 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.
With an amazing prognosis, Emily’s 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 
daughter’s 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 
error—an error, which could have been intercepted with the use of 
simple, proven technology. 
Today, with all my heart, I believe Emily’s 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 Emily’s father, my life is now devoted to doing all I can to prevent 
similar medical errors. I am convinced that had my daughter’s 
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 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.
FOREWORD 
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 
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 haven’t worked directly with him, if you don’t know his 
name or his work, then you haven’t 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 couldn’t be more true 
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. In 
fact the opposite couldn’t be more true. 
So, sit back and let the “Pro’s from Dover” start you on your 
journey of enlightenment. The more you learn, the more you 
realize you don’t know, so please don’t stop learning and become 
complacent because your patient’s health and well-being depends 
on you being the best and the brightest! 
Eric S. Kastango, MBA, RPh, FASHP 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.
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 organization’s 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 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.
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 ISMP’s tenth Lifetime Achievement Award for his leadership in 
promoting patient-safety technologies in healthcare over the past 
two decades. 
mark@hospitalrx.com 
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 
jerryfahrni.com 
© 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in 
any way for dissemination to anyone outside licensee’s company without the express written permission of The 
Neuenschwander Company.

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In the Clean Room: A Review of Technology-Assisted Sterile Compounding Systems in the US

  • 2. CONTENTS License Agreement 1 Preface by Christopher Jerry 3 Foreword by Eric Kastango 5 • OBJECTIVE 6 • PERSPECTIVE 7 • OVERVIEW: PARADIGMS 18 • REVIEW: PRODUCTS 31 • SEMIAUTOMATED-MANUAL SYSTEMS 32 A. BD Cato 33 B. DoseEdge 37 C. i.v.SOFT 44 D. Pharm-Q ITH 49 E. Phocus Rx 54 F. SP Central Pharmacy for Sterile Room Medication Preparation 59 G. Verification 64 • HIGHLY AUTOMATED ROBOTIC SYSTEMS 69 A. APOTECAchemo 70 B. INTELLIVILL I.V. 76 C. i.v.STATION 82 D. RIVA 86 Quick-Look Product Guides 92 Quick-Look Comparative Guide 103 Vendor Information 105 Authors 106 © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.
  • 3. PREFACE 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 Emily’s tiny abdomen. Their diagnosis was shocking as, outwardly, Emily appeared to be a completely healthy and vibrant toddler—giggling 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 Emily’s 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 Emily’s tumor had completely disappeared. They couldn’t 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), Emily’s 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. © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.
  • 4. With an amazing prognosis, Emily’s 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 daughter’s 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 error—an error, which could have been intercepted with the use of simple, proven technology. Today, with all my heart, I believe Emily’s 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 Emily’s father, my life is now devoted to doing all I can to prevent similar medical errors. I am convinced that had my daughter’s 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 © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.
  • 5. FOREWORD 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 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 haven’t worked directly with him, if you don’t know his name or his work, then you haven’t 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 couldn’t be more true 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. In fact the opposite couldn’t be more true. So, sit back and let the “Pro’s from Dover” start you on your journey of enlightenment. The more you learn, the more you realize you don’t know, so please don’t stop learning and become complacent because your patient’s health and well-being depends on you being the best and the brightest! Eric S. Kastango, MBA, RPh, FASHP © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.
  • 6. 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 organization’s 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 © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.
  • 7. 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 ISMP’s tenth Lifetime Achievement Award for his leadership in promoting patient-safety technologies in healthcare over the past two decades. mark@hospitalrx.com 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 jerryfahrni.com © 2014 THE NEUENSCHWANER COMPANY, INC. All rights reserved. It is illegal to share this report or reproduce this report in any way for dissemination to anyone outside licensee’s company without the express written permission of The Neuenschwander Company.