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

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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

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

  1. 1. 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.
  2. 2. 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.
  3. 3. 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.
  4. 4. 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.
  5. 5. 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.
  6. 6. 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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