Pharmacy Guidance Document - himss
Pharmacy Guidance Document - himss
Pharmacy Guidance Document - himss
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<strong>Guidance</strong> <strong>Document</strong>:<br />
Costs, Benefits and Potential Unintended<br />
Consequences of Automating the <strong>Pharmacy</strong><br />
Medication Cycle in Acute-Care Settings<br />
Enterprise Information Systems Steering Committee<br />
Nursing Informatics Committee and<br />
<strong>Pharmacy</strong> Task Force<br />
January 2010<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Authors<br />
David Butler<br />
Yadim David<br />
Suzanne Enquist, RPh<br />
Chris Jellison, RPh<br />
Tara K Jellison, PharmD<br />
Martin Kappeyne<br />
Dennis A. Tribble, PharmD<br />
James Stewart<br />
Judy Van Norman<br />
President, Heartland Innovations LLC<br />
Biomedical Engineering Consultants LLC<br />
Asst. Professor, Baylor College of Medicine and University of Texas School<br />
of Public Health<br />
Sparrow Health System, MI EMR Project Team<br />
Parkview Hospital, IN <strong>Pharmacy</strong> Inventory Manager<br />
Parkview Hospital, IN <strong>Pharmacy</strong> Clinical Manager<br />
Green Leaves LLC, Principal<br />
Chief <strong>Pharmacy</strong> Officer, Chief Technology Officer<br />
AmerisourceBergen Technology Group, IL Director, Integration Engineer<br />
Banner Health, Sr. Director Care Transformation<br />
Contributors / Editors<br />
Christel Anderson<br />
Denny C. Briley, PharmD<br />
Janet Bochinski, MSN, PNP<br />
Edna Boone, MA, CPHIMS<br />
John Falkenholm, PharmD<br />
Pat Feehery RN, BS, CRNI, CLNC<br />
James J. Finley, MBA, RN-BC<br />
Kevin Glaza, RPh<br />
HIMSS, Senior Manager Clinical Informatics, Staff Liaison<br />
GE Healthcare IT, Enterprise Solutions Product Strategy, <strong>Pharmacy</strong><br />
Unisys Corporation, Manager<br />
HIMSS, Senior Director HIS, Staff Liaison<br />
Lutheran General Hospital, IL <strong>Pharmacy</strong> Manager<br />
Sparrow Health System, MI EMR Inpatient Clinical Project Manager<br />
Dearborn Advisors, Delivery Services Executive<br />
Sparrow Health System, MI EMR Project Team<br />
Melissa Glaza, RPh, MHA Sparrow Health System, MI Lead Application Coordinator EPIC Rx /<br />
Beacon<br />
Mike Hibbard, RN, MHSA, PMP<br />
Timothy R. Lanese, RPh, MBA,<br />
FASHP, CPHIMS<br />
Susan Lessani, RN<br />
Jane McNeive, RN-BC<br />
Nicole A. Mohiuddin, MS, RN-BC<br />
Cheryl D. Parker, RN, MSN, PhD<br />
Mercy Health Partners, Chief Information Officer, Clinical Informatics<br />
Officer, Central Division<br />
Eclipsys Corporation, Solutions Consultant - <strong>Pharmacy</strong><br />
CareFusion, Clinical Analytics Consultant<br />
Stormont-Vail HealthCare, IS Applications Manager<br />
Title? Independent, IL<br />
Motion Computing, Senior Informatics Specialist<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Susan Robertson, RN, MSN, CPHQ<br />
Darla S. Shehy, BSN, RN<br />
Portia Towns, LPN, BHA/HIS<br />
Mike Wisz, MBA<br />
Michael H. Zaroukian, MD, PhD,<br />
FACP<br />
North Shore Long Island Jewish Health Systems, Director, Clinical<br />
Information Systems<br />
Penn State Hershey Medical Center, Manager of Nursing; Quality and<br />
Informatics<br />
North Shore/LIJ Health Systems, Project Manager EMR - Operational<br />
Specialist<br />
Principal, Mike Wisz & Associates<br />
Michigan State University , Chief Medical Information Officer and Professor<br />
of Medicine, Director Clinical Informatics and Care Transformation Sparrow<br />
Health System, MI<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Table of Contents<br />
1. INTRODUCTION....................................................................................................... 5<br />
1.1. Purpose.......................................................................................................... 5<br />
1.2. Scope and Organization of <strong>Guidance</strong> <strong>Document</strong> ....................................... 5<br />
2. OVERVIEW: THE INPATIENT MEDICATION MANAGEMENT PROCESS .................. 6<br />
3. PRINCIPAL TECHNOLOGIES................................................................................ 9<br />
3.1. Auto-ID: .......................................................................................................... 9<br />
3.2. <strong>Pharmacy</strong> Inventory Management ............................................................. 14<br />
3.3. Drug Unit-Dose Packaging ......................................................................... 17<br />
3.4. <strong>Pharmacy</strong> Bar coding/Labeling.................................................................. 20<br />
3.5. IV Compounding Systems / Automated Bag & Syringe Fillers/Automated<br />
Infusion Compounding Robots.................................................................. 24<br />
3.6. Central <strong>Pharmacy</strong> Robotic Dispensing Systems ..................................... 32<br />
3.7. Decentralized Automated Dispensing Cabinets....................................... 38<br />
3.8. Electronic Medication Administration Record (eMAR) ............................ 41<br />
4. CONCLUSION ........................................................................................................ 44<br />
APPENDIX A - REFERENCES ....................................................................................... 46<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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1. INTRODUCTION<br />
1.1. Purpose<br />
This guidance document provides pharmacy and nursing professionals with concise,<br />
practical information on selecting and deploying available technologies for automating<br />
the movement of medications and the location tracking of pharmacy-related devices<br />
(e.g., automated infusion pumps) in acute-care settings. In so doing, we will emphasize<br />
the flow of medications and medication-related work processes from the receiving dock<br />
to the pharmacy, to the unit of care, and finally, to the patient’s bedside for<br />
administration. We will look at how these technologies help pharmacy and nursing<br />
professionals receive, process, distribute and administer medications in a safe, timely<br />
and efficient manner. Although data on cost-benefit and return-on-investment remain<br />
sparse and reports largely anecdotal, we will attempt to give the reader a sense of the<br />
strength of the current business case for investing in pharmacy-related automation in<br />
acute-care settings, while acknowledging the potential unintended consequences that<br />
may be encountered.<br />
1.2. Scope and Organization of <strong>Guidance</strong> <strong>Document</strong><br />
In accordance with the purpose of this guidance document and considering the very<br />
busy health professionals for whom it is intended, we have limited the scope of the<br />
document to provide a concise overview of the technologies and principles for effective<br />
pharmacy-related automation in acute-care settings. A corresponding executive slide<br />
deck is also available to facilitate communication about the potential business case for<br />
expanding pharmacy-related automation in the acute-care setting. Each technology<br />
section is structured to provide answers to the following practical questions:<br />
• What is this technology, how does it work and how has it been put to work in<br />
pharmacy-related automation activities?<br />
• In which stages of medication management in the acute-care setting can this<br />
technology be most helpful?<br />
• What benefits can I expect from the use of this technology? How strong is the<br />
evidence for such benefits?<br />
• What unintended, adverse consequences are associated with the use of this<br />
technology? How can the risks be mitigated?<br />
• How does this technology work with other pharmacy-related automation<br />
technologies, and do they need to be in place for this technology to work?<br />
• What is the cost to implement this technology in a typical 250-500 bed acute-care<br />
facility? Are there credible examples of published cost-benefit analyses that<br />
provide a strong business case for the use of this technology?<br />
• Where can I obtain more information about this technology?<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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This guidance document is organized according to pharmacy-related automation<br />
technology types, with each technology introduced and discussed in order of its<br />
appearance and relevance to the stages of medication management in acute-care<br />
settings—from arrival at the facility to patient medication administration at the patient’s<br />
bedside. In order of appearance, the technologies discussed include:<br />
1. Auto-ID technologies.<br />
2. <strong>Pharmacy</strong> inventory management.<br />
3. Drug unit dose packaging.<br />
4. <strong>Pharmacy</strong> bar coding/labeling.<br />
5. IV compounding systems/automated bag & syringe fillers/automated infusion<br />
compounding robots.<br />
6. Central pharmacy robotic dispensing systems.<br />
7. Decentralized Automated Dispensing Cabinets (ADC).<br />
8. Bar code Medication Administration-Electronic Medication Administration Record<br />
(BCMA-eMAR).<br />
2. OVERVIEW: THE INPATIENT MEDICATION MANAGEMENT<br />
PROCESS<br />
A typical example of the medication management process in an inpatient facility is<br />
shown in Figure 2-1. This guidance document focuses on the movement of medications<br />
from their arrival at the facility from the external supply chain, through medication<br />
processing, dispensing from pharmacy inventory, distribution to patient-care units and<br />
administration at the bedside. (Processes 3, 4 and 5 in Figure 2-1).<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Figure 2-1: Inpatient Medication Management Process<br />
Medication Cycle Phases<br />
Monitoring<br />
phase<br />
6<br />
multidisciplinary<br />
Ordering<br />
phase<br />
1<br />
Verifying<br />
phase<br />
2<br />
P<br />
Administration<br />
phase<br />
5<br />
HIMSS © 2008 <strong>Pharmacy</strong> Informatics Task Force: A. Flynn<br />
Distribution<br />
phase<br />
P<br />
core pharmacy<br />
4<br />
Dispensing<br />
phase<br />
P<br />
3<br />
P<br />
supply chain<br />
HIMSS <strong>Pharmacy</strong> Informatics Task Force 2007©<br />
For an acute-care facility with automated pharmacy and medication administration<br />
technologies, the on-site medication management process follows a progression<br />
through the three major phases, shown in Figure 2-2.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Figure 2-2: Inpatient Medication Management Processes—<strong>Guidance</strong> <strong>Document</strong><br />
Focus Areas<br />
The process typically starts with the arrival of medications in the receiving area of the<br />
acute-care pharmacy. Individual medications may arrive in bulk containers or unit<br />
doses, with or without bar code or other auto-identification labels that can be read by<br />
the facility’s pharmacy information system.<br />
Medications must be unboxed and processed for placement into inventory. Those<br />
medications that did not arrive with readable bar codes will require additional<br />
processing, either on arrival or sometime prior to interaction with other pharmacy<br />
automation technologies. Solid medications arriving in bulk containers can be loaded<br />
into unit-dose packagers to separate the medications into single-dose packages and<br />
add an internally recognized bar code to facilitate additional automated processing.<br />
Unit-dose packaged medications (solid and selected liquid medications) can then be<br />
presented to a central pharmacy robot (if available) that loads the medications into<br />
appropriate storage spaces within the robot. The robot subsequently dispenses the<br />
appropriate medications for individual patients at a specified time as part of a cart fill<br />
process.<br />
Meanwhile, other liquid medications and compounded solutions for intravenous (IV)<br />
administration can be processed using other pharmacy automation technologies and<br />
prepared for distribution to satellite pharmacies within the acute-care facility, or placed<br />
in decentralized automated dispensing cabinets (ADC) on care units. Finally,<br />
medications can be taken from the ADCs and administered to patients at the bedside,<br />
using pharmacy-related automation technology to verify compliance with the “five rights”<br />
of medication administration (right patient, right drug, right dose, right time and right<br />
route). Any medications not administered due to discharge or order changes after<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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distribution can then be returned to the pharmacy and placed back into inventory, a<br />
process that can also involve automated methods.<br />
3. PRINCIPAL TECHNOLOGIES<br />
3.1. Auto-ID:<br />
What is auto-ID, how does it work and how has it been put to work in pharmacyrelated<br />
automation activities?<br />
Auto-ID represents a broad family of technologies that enable automatic identification of<br />
people or things. Auto-ID technologies include bar codes, radio frequency identification,<br />
infrared and ultrasound-based identification systems, magnetic strip cards, optical<br />
character recognition, voice recognition and biometric authentication systems.<br />
Bar codes: Bar codes represent the most mature, cost-effective and commonly used<br />
Auto-ID technology. With the recent adoption of data rich, easily scanned 2-D formats,<br />
barcoding should be considered a critical element of system solutions targeted at<br />
reducing errors and improving operational efficiencies throughout the various<br />
medication handling and administration processes. Bar codes will be covered in more<br />
detail in section 3.4, “<strong>Pharmacy</strong> Barcoding/Labeling Technologies.”<br />
Voice Recognition and Biometric Authentication: Voice recognition and other biometric<br />
systems are typically used for health professional authentication to computers or room<br />
access control systems. Fingerprint biometric systems have become a common<br />
authentication technology in two-factor system sign-on protocols. They have even been<br />
used in lieu of written signatures for “signing off” on medication orders in some EHR<br />
systems. Fingerprint authentication provides some definite advantages to badge<br />
readers, both in terms of workflow enhancements and in eliminating the potential for<br />
sharing or inappropriately using another individual’s badge to authenticate computer<br />
access or electronic record approval.<br />
RFID: Radio frequency identification (RFID) has received significant press and<br />
discussion in healthcare, as well as other industries, including consumer packaged<br />
goods and the U.S. Department of Defense (DoD). Although the roots of RFID date<br />
back to World War II and the development of radar and “Friend or Foe” identification of<br />
aircraft crossing the English Channel, it is still considered an emerging technology. 1<br />
RFID uses radio frequency (RF) electromagnetic waves to identify people or things. Like<br />
an aircraft transponder, an RFID “tag” receives radio signals and responds with a<br />
unique identifier. An RFID “reader” sends out a radio signal and looks to receive<br />
identification information from RFID tags within range. Because radio waves do not<br />
require line of sight and can pass through walls and various substances, RFID enables<br />
the identification of every tagged item or person in range of the reader, regardless of its<br />
visibility (such as a patient’s identification wristband beneath bedcovers). Unlike bar<br />
codes that are read one at a time and require line-of-sight with the bar code reader,<br />
RFID can potentially identify the entire contents of a closed box or automatically identify<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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all of the infusion pumps in a given room. Additionally, because the tag is really an<br />
electronic device, it is possible to read and write information onto the tag throughout its<br />
life. 2<br />
RFID devices are designed to be active or passive. Active RFID uses battery-powered<br />
tags and enables longer read ranges and the potential for additional functionality. Active<br />
RFID tags can also be used for locating assets or people within hospitals and other<br />
healthcare facilities. This application is also referred to as Real Time Locating Systems<br />
(RTLS). Passive RFID tags do not have batteries but rather are powered by the energy<br />
of the radio waves sent by the RFID reader. Although limited in read range, passive<br />
RFID tags are significantly lower cost and are thin enough to be embedded in a label or<br />
easily attached to a small object. 3<br />
Proximity Cards: One form of passive RFID that is growing in use is the “proximity” card.<br />
Proximity cards have commonly been used in hospitals as employee badges for room<br />
access control or user authentication to computer systems and have become the new<br />
standard for subway access and credit card transactions outside of the United States.<br />
Proximity cards provide for more rapid read rates than magnetic strip cards; yet with<br />
their short read ranges, they ensure that only a single, closely aligned card is read.<br />
Wi-Fi/Ultrasound/Infrared: In addition to pure RFID-based systems, similar technologies<br />
have emerged to provide a means to automatically locate and identify mobile medical<br />
equipment and/or people. These include leveraging a WiFi network infrastructure to<br />
triangulate and locate devices communicating on the network, or installing infrared or<br />
ultrasound-based systems to enable “room level” location and association of people and<br />
equipment. These systems are included in the RFID-related discussion that follows.<br />
RFID and other emerging Auto-ID/location technologies will likely become common—<br />
even dominant—technologies for automatic identification over the next 10 to 20 years<br />
as the cost of the technologies declines and clear business cases for their integration<br />
into clinical systems are refined. Until then, bar codes, magnetic strip employee badges,<br />
proximity cards and fingerprint readers will remain the dominant strategies for automatic<br />
identification and authentication.<br />
In which stages of medication management in the acute-care setting can Auto-ID<br />
be most helpful?<br />
Auto-ID has the potential to enhance processes in a number of stages of medication<br />
management in the acute-care setting, from product delivery at the hospital loading<br />
dock to administration at the bedside. Bar codes provide a cost-effective and proven<br />
means to quickly and accurately enter information regarding medications (manufacturer,<br />
lot number, expiration, formulation, etc.), as well as the identification of staff members<br />
and patients. Bar coding systems also can provide a time stamp associated with each<br />
scanning event. As mentioned earlier, employee badges utilizing magnet strips, bar<br />
codes or proximity cards, fingerprint readers and other biometric sensors can also<br />
enable efficiencies in quickly identifying and documenting caregivers and other staff<br />
members involved with managing the storage, dispensing and administration of<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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medications. These also add a layer of security beyond using passwords to authenticate<br />
users.<br />
In the future, RFID tags may be used to detect and prevent counterfeiting and diversion<br />
of high-value drugs. 4 Although aimed at the supply chain prior to hospital receipt,<br />
hospital pharmacies could also use these RFID tags to speed up delivery of<br />
medications to clinical units and help reduce the risk of data entry errors. Some<br />
manufacturers are designing RFID technology into their systems to confirm that the<br />
appropriate cartridge or item has been connected to the medication delivery system,<br />
thereby helping ensure that the patient receives the right drug and dose during a<br />
procedure. 5<br />
Active RFID systems can be used as part of an RTLS to locate infusion and IV pumps<br />
and other mobile equipment critical to delivering and administering medications to the<br />
right patient, through the right route, at the right time. These RTLSs have been<br />
implemented in a number of hospitals to enhance the utilization and regulatory<br />
compliance of mobile medical equipment. A growing number of hospitals have found the<br />
value of RTLS to be greatest in ensuring that the right equipment is in the right place at<br />
the right time. Patient flow and operational efficiency in the emergency department<br />
(ED), operating room (OR) and patient bed areas can be greatly enhanced, with a<br />
beneficial effect on timely and efficient delivery of required medications. 6<br />
The visibility of pharmaceuticals at the item level becomes more challenging and laborintensive<br />
as drugs move from the central pharmacy and are staged in locations closer to<br />
the point of medication administration. RFID provides a potential way to track and<br />
manage drugs stored in cabinets or refrigerators in close proximity to patient care areas.<br />
Passive RFID tags on items or unit-dose packages could be read by “smart” cabinets or<br />
refrigerators with embedded RFID readers. RFID cabinets are beginning to be installed<br />
in cardiac catheterization laboratories and other areas where high costs and shelf life<br />
are critical factors.<br />
Similarly, medical devices are being tracked and managed by caregivers with the help<br />
of RFID to reduce costs associated with product outdating, management of lot recalls<br />
and inventory control, while ensuring appropriate charge capture and product<br />
documentation. 7 At least one pharmaceutical distributor is using RFID-enabled<br />
refrigerators to ensure appropriate control of costly specialty drugs consigned to acute<br />
care facilities. The refrigerator both monitors the contents and the temperature of the<br />
refrigerator to ensure compliance with temperature requirements and appropriate<br />
inventory management. 8 A refrigerator manufacturer recently announced an RFIDenabled<br />
refrigerator that utilizes industry-standard RFID reader technology “to store<br />
reagents, vaccines and other temperature-sensitive substances.” 9<br />
Finally, RFID may replace bar codes in the future for bedside medication administration.<br />
St. Claire Hospital in Pittsburgh, PA, developed a system using passive RFID-enabled<br />
patient wristbands, passive RFID-enabled staff ID badges and bar coded medication<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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unit-dose packaging and IV bags. The system employed a handheld device with a dual<br />
passive RFID/bar code reader attachment. The hospital felt that the RFID provided a<br />
faster and more accurate read of the patient and staff member than bar code<br />
technology available at the time. They also liked the fact that they could obtain an Auto-<br />
ID verification of patient identity in most instances without needing to physically touch<br />
the patient to rearrange the wristband or move blankets. 10<br />
What benefits can I expect from the use of Auto-ID? How strong is the evidence<br />
for such benefits?<br />
Common to all potential pharmacy-related Auto-ID applications in the acute-care setting<br />
is the benefit of leveraging the technology to speed up identification, authentication<br />
and/or location of the item or person of interest. Auto-ID use can improve<br />
documentation accuracy while also improving workflow speed and efficiency. It also<br />
helps reduce the amount of time that would otherwise be required to manually sign on<br />
and off the system, giving health professionals more time for direct patient care. The<br />
bulk of published studies documenting these benefits involve bar codes and bar code<br />
medication administration systems. 11,12<br />
In the future, RTLS that automatically locate mobile assets and people throughout the<br />
facility will increasingly be used to drive workflow improvements. RFID-enabled smart<br />
cabinets and refrigerators that automatically take inventory of their own contents will<br />
enhance inventory management of expensive, limited shelf life medications and<br />
supplies. RFID use at the bedside of the future also holds the promise of enabling a<br />
quicker read rate with less inconvenience to the patient, along with the ability to read<br />
and write information into the patient’s wrist band, providing patient safety enhancement<br />
opportunities beyond those available from the read-only technology upon which bar<br />
codes are based.<br />
What potential, unintended adverse consequences are associated with the use of<br />
Auto-ID? How can the risks be mitigated?<br />
All Auto-ID technologies are vulnerable to the possibility that inaccurate data will be<br />
associated with the bar code, proximity card, RFID tag or other auto-readable item.<br />
Original data entry accuracy is important to ensure that only correct information is<br />
automatically transmitted throughout each of the various processes associated with<br />
medication management and administration in the acute-care setting. Because a bar<br />
code or RFID scanner may give an audible response that a “read” was successfully<br />
completed, the caregiver may erroneously assume that all of the information associated<br />
with the bar code or RFID tag also was correct.<br />
For example, a bar coded wristband attached to the wrong patient could lead to<br />
medication administration errors if a second form of patient identification was not<br />
implemented (picture, verbal questioning, etc.).<br />
As mentioned above, RFID use in acute-care settings is still an emerging area for which<br />
potential adverse consequences are still under discussion. For example, concerns have<br />
been raised regarding potential RFID signal interference with implantable medical<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
12
devices. By elevating these concerns, vendors and end users can ensure that the<br />
systems designed and implemented do not adversely impact the health and well being<br />
of patients and caregivers. 13 Some hospitals have explored RFID-enabled employee<br />
badges that can be read from several feet to provide initial sign-on identification for<br />
shared computers. The concept can work well when only one caregiver is near the<br />
computer but when multiple staff members are in close proximity to a computer, the<br />
system may inadvertently sign in or sign out the wrong person. Programming to<br />
gracefully force out the second user improves the efficiency of using RFID. Another<br />
consideration in fine-tuning the “readable range” is to consider physical barriers as well<br />
as body shapes of the caregiver.<br />
Like other computer systems, Auto-ID enabled systems need to be designed and<br />
implemented with care to ensure that appropriate electronic security measures are in<br />
place to prevent theft of confidential patient or hospital information. Bar codes can be<br />
easily replicated and employee Auto-ID badges can be stolen or used by unauthorized<br />
personnel. RFID transmissions similar to WiFi broadcasts require consideration by<br />
vendors to ensure security measures are taken to prevent unauthorized RFID readers<br />
from capturing confidential information. 14<br />
Since RFID represents a broad family of technologies, it is important to understand the<br />
trade-offs of capabilities vs. limitations to ensure an appropriate “fit” for a given<br />
application. Nowhere is this more apparent than with RTLS. There is a broad range of<br />
RTLS technologies in use, from highly accurate but expensive Ultra Wide Band (UWB),<br />
to low-cost Wi-Fi-based systems, to infrared and ultrasound.<br />
All of these systems can mark a location of an asset or person on a floor plan map; but<br />
understanding the inherent precision and accuracy of each technology enables better<br />
selection of the appropriate technology. Some technologies can provide accuracies to<br />
within a few feet, while others are only good to within 20 feet or 30 feet in all directions.<br />
Some pioneering hospitals have implemented workflow systems that required<br />
automatic, real-time location of patients and staff members at a room level, only to find<br />
that the technology they implemented did not have sufficient accuracy, consistency and<br />
response time to accurately document care events or patient locations. New<br />
technologies and innovations are emerging each year, and the ability to capture patient<br />
location and care delivery events automatically will eventually be solved in an<br />
economical fashion.<br />
It is also important to note that while Auto-ID technologies can decrease the risk for<br />
errors, their use does not eliminate the need for or value of final verification/confirmation<br />
by the nurse at the bedside. Errors in bar codes and labeling can occur, and the nurse<br />
who carefully inspects the medication to be given and confirms the five rights prior to<br />
administering it remains the last, best defense against serious medication administration<br />
errors.<br />
How does Auto-ID interface with other pharmacy-related automation technologies<br />
and do they need to be in place for Auto-ID to operate?<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Auto-ID technology itself is an enabler of other solutions; they are not stand-alone<br />
systems. The ability to automatically identify, authenticate or locate medications,<br />
equipment, patients and staff members promotes quality, safety and efficiency. A<br />
cohesive strategy should be developed to maximize the use of technologies like bar<br />
codes and, in the future RFID, to drive quality and efficiency improvements throughout<br />
the entire medication management and administration process in the acute-care setting.<br />
What is the cost to implement Auto-ID in a typical acute-care facility? Are there<br />
credible examples of published cost-benefit analyses that provide a strong<br />
business case for the use of this technology?<br />
As mentioned above and in greater detail in section 3.4, there have been several<br />
published studies as to the costs and benefits of implementing bar code technology in<br />
the medication administration process. Due to the emerging nature of RFID technology<br />
in the healthcare setting, interested organizations should seek out the most current<br />
information available. 15-17 RFID and other Auto-ID technologies are not stand-alone<br />
systems, but rather tools that enable hospitals or vendors to automate less efficient<br />
manual or automated work processes. Sustainable cost-benefit models will only be<br />
attained when work processes and equipment are re-engineered to leverage the full<br />
capabilities and limitations of the appropriate technology that enhances the pharmacy<br />
mission of delivering the right drug at the right time to the right patient in the right dose<br />
and route.<br />
Where can I obtain more information about Auto-ID?<br />
Auto-ID technologies, like RFID, can be further researched by referencing the HIMSS<br />
Web site in the following areas:<br />
• Patient Safety and Quality Outcomes Committee<br />
• Management Engineering and Process Improvement Community<br />
• Clinical Informatics including:<br />
o <strong>Pharmacy</strong> Informatics<br />
o Nursing Informatics<br />
• HIMSS Store 18<br />
3.2. <strong>Pharmacy</strong> Inventory Management<br />
What is pharmacy inventory management technology, how does it work, and how<br />
has it been put to work in pharmacy-related automation activities?<br />
<strong>Pharmacy</strong> inventory management solutions take many forms in today’s pharmacy<br />
practice. One of the primary uses of an inventory management solution is the<br />
continuous monitoring of drug product quantities in the pharmacy. By establishing<br />
“MAXimum” and “MINimum” levels for the products stored in the pharmacy,<br />
appropriately configured inventory systems can generate and transmit electronic orders<br />
to vendors for additional medication deliveries when product inventories reach the<br />
MINimum, ordering only the amount needed to reach the MAXimum. Automated<br />
ordering of just the right amount of medication at just the right time allows for tighter<br />
control of inventory dollars and, assuming the minimum level is sufficient and delivery is<br />
timely, ensures adequate on-hand quantities at all times while optimizing inventory turns<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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and decreasing the likelihood of having medications reach their expiration dates before<br />
use. Inventory management systems also often serve as a point of electronic integration<br />
between pharmacy information systems, pharmacy drug vendors, and other pharmacy<br />
automation systems by receiving requests for drugs from the different systems and<br />
driving replenishment activities.<br />
In which stages of medication management in the acute-care setting can<br />
pharmacy inventory management technology be most valuable?<br />
A pharmacy inventory management solution is a key component of the hospitalpharmacy<br />
supply chain. By communicating directly with a drug wholesaler, inventory<br />
management systems ensure that the correct product is ordered and that the cost<br />
information stored in the system is accurate and up-to-date. As mentioned earlier, these<br />
systems are also valuable in driving the different medication replenishment cycles,<br />
including automated drug cabinet (ADC), cart fill and others.<br />
What benefits can I expect from the use of pharmacy inventory management<br />
technology? How strong is the evidence for such benefits?<br />
One benefit of using a pharmacy inventory management solution is that it can bring<br />
improved consistency and efficiency to many processes. As various systems interface<br />
with the inventory management system, the picking processes are the same for cart fill,<br />
first fill (cart fill update), and ADC replenishment. This process consistently allows for<br />
easy training and fewer errors.<br />
Another benefit pharmacy inventory management technology brings is the opportunity<br />
to accurately report drug expense. Because the system tracks inventory and cost<br />
information, the pharmacy department can take purchasing information and reconcile<br />
the data with fluctuations in inventory value to get a more complete and accurate view<br />
of expenses.<br />
Additionally, the pharmacy department’s ability to generate activity reports is enhanced<br />
because replenishment data from multiple systems are aggregated in a single<br />
database. This also allows for identification of products that are rarely used and should<br />
be considered for removal from the hospital formulary.<br />
<strong>Pharmacy</strong> inventory management systems can also help reduce the manual labor<br />
needed to maintain the pharmacy inventory. The automatic monitoring feature of such<br />
systems can replace much of the traditional human workflow process of “walking the<br />
shelves” to update inventories and make re-order timing decisions.<br />
What potential, unintended, adverse consequences can be associated with the<br />
use of pharmacy inventory management technology? How can the risks be<br />
mitigated?<br />
Like any technology, a pharmacy inventory management system is only as good as the<br />
information it contains. Monthly cycle counts must be performed to ensure the inventory<br />
report is accurate. Accurate and timely backups of the system must be performed and<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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several days’ backups should be archived to ensure that corrupt data do not overwrite<br />
the only good backup.<br />
The ability to generate meaningful information from a pharmacy inventory management<br />
system also depends on the ability to easily integrate data from multiple systems into a<br />
single database (i.e., doses dispensed vs. doses administered). This can often be a<br />
challenge as data exports can be difficult and vendors are not always forthcoming with<br />
their data dictionaries.<br />
Inventory management systems are usually interfaced to another “picking” solution (i.e.,<br />
re-packager, carousel, robot, etc.). When a problem arises with the interface between<br />
the pharmacy inventory management system and one or more “picking” solutions, the<br />
normally interfaced data will need to be added manually, which can have a significant<br />
negative impact on workflow efficiency and introduce the risk of data entry errors.<br />
While the pharmacy inventory management system may serve as an excellent solution<br />
for most medications, there will likely remain at least a few critically important but<br />
inconsistently used drugs that will require manual monitoring. Such medications cannot<br />
be allowed to be “out of stock” for patient safety.<br />
How does pharmacy inventory management technology work with other<br />
pharmacy-related automation technologies? Do they need to be in place for<br />
pharmacy inventory management technology to work?<br />
<strong>Pharmacy</strong> inventory management systems are often interfaced to a pharmacy<br />
information system, a drug wholesaler, and ADCs. Additionally, within the pharmacy,<br />
these systems often facilitate the replenishment cycle by providing data to re-packaging<br />
and picking systems. These systems can also be linked to automated inventory control<br />
equipment, such as a carousel.<br />
However, to provide benefit to the pharmacy department, only one system needs be<br />
present to track decrements in the inventory and one system to track increments in the<br />
inventory. This is most often provided by a pharmacy information system and a drug<br />
wholesaler system, respectively. The remainder of the systems mentioned (repackager,<br />
ADCs, etc.) are not prerequisite technologies for the pharmacy inventory<br />
management system to be effective, although they can bring additional efficiencies to<br />
medication management processes.<br />
What is the cost to implement pharmacy inventory management technology in a<br />
typical acute-care facility? Are there credible examples of published cost-benefit<br />
analyses that provide a strong business case for the use of this technology?<br />
Purchasing a pharmacy inventory management system can cost $100,000 or more<br />
depending on the scope of products included and the degree of integration or<br />
interfacing with other pharmacy-related technologies. Annual software maintenance<br />
fees typically run between 15 and 20 percent of the initial licensing costs.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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While there are few data in the peer-reviewed literature on the costs and benefits of<br />
pharmacy inventory system implementations in acute-care settings, there are a number<br />
of case studies and white papers available from the companies who market these<br />
systems. For example, following the implementation of a pharmacy inventory<br />
management system, a health system in Lexington, KY, identified an increase in<br />
inventory turns of 21 percent and a reduction in inventory value of 18 percent, resulting<br />
in a first-year savings of more than $300,000. 19 Additionally, a health system in Fort<br />
Wayne, IN, realized a $600,000 reduction in inventory after implementation of a<br />
pharmacy inventory management system. 20<br />
Where can I obtain more information about pharmacy inventory management<br />
technology?<br />
Several vendors currently market inventory management systems. Most are marketed<br />
in conjunction with other technology solutions. These vendors include Cardinal Health,<br />
McKesson Corp., AmerisourceBergen ® , Omnicell ® , Talyst ® Inc., Swisslog ® , and others.<br />
More information can be found by visiting the respective vendor Web sites, searching<br />
the Internet or researching pharmacy or nursing trade magazines.<br />
3.3. Drug Unit-dose Packaging<br />
What is drug unit-dose packaging technology? How does it work, and how has it<br />
been put to work in pharmacy-related automation activities?<br />
Unit-dose packaging technology allows a pharmacy to re-package bulk medications into<br />
single-use doses. These medications include tablets, capsules and liquids. The<br />
medications are loaded either onto or into the machine (depending on the packager)<br />
and result in a fully USP-compliant unit-dose package.<br />
Packagers with the capability to interface with pharmacy information systems have been<br />
used in pharmacies since the 1990s. Unit-dose re-packagers can facilitate patientspecific<br />
cart fills. A re-packager can create multiple unit-dose medications sequentially<br />
from the device. Between each medication is a perforation creating a final strip of<br />
medications specific to the needs of each individual patient; the medications can then<br />
be separated by the dispensing pharmacy or the administering nurse. Re-packagers<br />
may also package multi-dose packages that can be useful in long-term care facilities.<br />
Unit-dose packaging technology is important because many medications are currently<br />
not manufactured in unit-dose form. For hospitals, unit-dose medication dispensing is<br />
required by The Joint Commission as part of medication management standard<br />
03.01.01 EP 10 and is considered a best practice by the American Society of Health<br />
System Pharmacists (ASHP). 21,22 Even without an interface to the pharmacy information<br />
system, the devices can facilitate unit-dose medication creation.<br />
Following initial use for cart fills, these re-packagers began to be interfaced with<br />
automated dispensing cabinets (ADCs) to create cabinet-specific refill strips. Repackagers<br />
can now provide packages with bar codes that are specific to the institution’s<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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information system. As will be mentioned in section 3.4 on bar coding and labeling, not<br />
all bar codes work with all systems, so the re-packagers provide value by ensuring that<br />
the bar codes created and dispensed are compatible with the facility’s information<br />
system. Some re-packagers are also able to create “robot ready” unit-dose packages.<br />
Re-packagers can also interface to pharmacy inventory management systems.<br />
In which stage of medication management in the acute-care setting can drug unitdose<br />
packaging technology be most helpful?<br />
Re-packagers are generally used as part of the dispensing phase, although they can<br />
also be used as part of the receiving phase when bulk items can be re-packaged before<br />
being placed in inventory Having medications re-packaged as unit doses is also helpful<br />
in the medication administration phase to facilitate safe practices. The creation of unitdose<br />
packages that contain medication-specific bar codes also supports safety by<br />
facilitating bar code scanning-enabled medication administration at the bedside.<br />
What benefits can I expect from the use of drug unit-dose packaging technology?<br />
How strong is the evidence for such benefits?<br />
Vendors state that these devices can process up to 60 doses per minute for oral solid<br />
medications and 15 to 32 doses per minute of liquid medications. 23-26 Compared to the<br />
time required for manual re-packaging, it has been claimed that oral solid packaging<br />
labor is reduced by 65 percent. 27 By providing ADC-specific medications, it has been<br />
estimated that the re-packagers can reduce ADC fill time by 70 percent. 28 The dollar<br />
value of such reductions depends on the volume of re-packaging and the extent of ADC<br />
use at the institution.<br />
When used in combination with inventory carousels, re-packagers can facilitate<br />
inventory control measures. By preferentially using items stocked in the carousels that<br />
were previously packaged over those created in real-time by the re-packager,<br />
medication waste is reduced.<br />
There may also be financial benefits to the purchase of bulk medications re-packaged<br />
in-house over manufacturer supplied unit-dose medications. Manufacturer supplied<br />
products may be more expensive and/or require additional work to be recognized by an<br />
internal bar code scanning application. In 2006, Lanwood Regional Medical Center in<br />
Fort Pierce, FL, was able to save $15,000 by purchasing bulk products. 29 This benefit<br />
must be weighed against the organization’s existing inventory, cost of packaging<br />
supplies, impact on expiration dating and technician time involved in using and<br />
maintaining the re-packager. According to a 2008 survey by the American Society of<br />
Health-System Pharmacists® (ASHP) on dispensing practices in hospitals, only 31<br />
percent of hospitals re-packaged medications, primarily motivated by a desire to<br />
achieve cost savings. 30<br />
What potential, unintended, adverse consequences are associated with the use of<br />
drug unit-dose packaging technology? How can the risks be mitigated?<br />
Unit-dose packaging devices must be well maintained. Without proper maintenance,<br />
package integrity and printing quality may be compromised and render products unsafe<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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for dispensing. Frequent cleaning and calibration of the system, and adequate training<br />
of personnel in loading the packaging and ink can dramatically decrease the likelihood<br />
of such problems. Proper inspection of the product prior to dispensing is important to<br />
ensure that no compromised product leaves the pharmacy.<br />
Although the automated re-packager is far more advanced than its manual predecessor,<br />
medication mix-ups can still occur. For canister-based packagers, safeguards are<br />
provided with the system to prevent mix-ups when refilling. For oral solid medications<br />
packaged using a special tablet system tray, human error is a risk, much as it is with<br />
manual re-packaging. “The ASHP Technical Assistance Bulletin on Repackaging Oral<br />
Solids and Liquids in Single Unit and Unit-dose Packages” advises that an individual<br />
other than the packaging operator verify the packages, with ultimate responsibility for<br />
the integrity of the process being with the pharmacist. 31<br />
How does drug unit-dose packaging technology work with other pharmacyrelated<br />
automation technologies and do they need to be in place for the unit-dose<br />
packaging technology to operate?<br />
As mentioned above, it is not essential that a re-packager be interfaced with other<br />
technology, but the benefits of the product are greatly increased when used as part of a<br />
comprehensive medication management and administrative solution. Interfaces with the<br />
institution’s pharmacy information system and ADCs can occur at implementation or in<br />
subsequent stages.<br />
What is the cost to implement drug unit-dose packaging technology in a typical<br />
acute-care facility? Are there credible examples of published cost-benefit<br />
analyses that provide a strong business case for the use of this technology?<br />
Cost of an oral solid re-packager is approximately $200,000, plus $30,000 for annual<br />
device maintenance. Packaging supplies generally range from $0.02 to $0.04 per dose.<br />
Review of existing inventory and determination of canister medications are additional<br />
implementation costs. Cost of a liquid re-packager is approximately $17,000 to $22,000.<br />
Packaging supplies generally cost $0.05 to $0.08 per dose.<br />
In using a 500-line item re-packager, JFK Medical Center in Atlantis, FL, was able to<br />
stock 95 percent of its oral solid inventory in the device. By having 80 percent to 90<br />
percent of its ADC inventory in the re-packager, JFK Medical Center was able to reduce<br />
the time spent selecting refill medications by 75 percent, from eight hours to two hours.<br />
This reduction in staff technician time was converted to a packaging technician who<br />
streamlines the packaging process. This technician supports the quality assurance of<br />
their bar coding process. 32 Overall, these changes would suggest a net decrease in<br />
technician time needed for the pharmacy operation when implementing oral solid repackaging<br />
in coordination with bedside bar code scanning of medications.<br />
Where can I obtain more information about drug unit-dose packaging<br />
technology?<br />
Several vendors currently market oral solid re-packagers. Vendors include<br />
AmerisourceBergen ® , CareFusion ® , Cardinal Health ® , McKesson ® , Omnicell ® ,<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Swisslog ® and Talyst ® . KLAS ® , an independent research company that conducts<br />
interviews with healthcare providers regarding various technologies, has also published<br />
information in this area. In September 2008, Talyst ® Inc. released their report on “High<br />
Volume Unit-dose Packaging”. 33 This report focuses primarily on AmerisourceBergen ® ,<br />
McKesson Corp ® and Talyst ® Inc. It provides user feedback on various aspects of the<br />
technology.<br />
Vendors for liquid re-packagers include EUCLID ® , Spiral Paper Tube Corp ®, and<br />
Medical Packaging ® Inc. More information can be found by visiting the vendors’<br />
respective Web sites, searching the Internet, or researching pharmacy or nursing trade<br />
magazines.<br />
Figure 3.3 <strong>Pharmacy</strong> Unit-Dose Packaging Footnote 34<br />
3.4. <strong>Pharmacy</strong> Barcoding/Labeling<br />
What is barcoding/labeling technology, how does it work and how has it<br />
been put to work in pharmacy-related automation activities?<br />
Barcoding has been commercially available since 1974, and is now available in different<br />
formats (one-dimensional and two-dimensional) that can be read with a scanning<br />
device.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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A typical 1-D bar code<br />
A typical 2-D bar code<br />
The scanning software reads the code. The code format determines the amount of data<br />
encoded in the bar code. This information can then be used to check against a<br />
database to obtain additional information about the bar code-labeled item. The simplest,<br />
1-D bar codes contain the least amount of data, usually a number, while 2-D codes can<br />
embed more and different types of data. Over the decades, bar codes have become<br />
more sophisticated and have incorporated more error-checking features, tolerance to<br />
damage to part of the label and in some cases design features that allow the label to be<br />
read independent of the bar code orientation relative to the scanner/reader. However,<br />
unlike RFID tags, bar code technology can be less efficient than RFID because it<br />
requires establishing a clear “line of sight” between the bar code and the reader, 35 which<br />
may require repositioning the patient, the reader and the health professional.<br />
It has been estimated that up to 38 percent of inpatient medication errors occur at the<br />
medication administration stage 36,37 Bar codes can be used to identify patients (i.e.,<br />
wristbands), equipment, locations and most items that are in some form of container, or<br />
those that can accept a label. As acute care environments become more computerized<br />
and automated, these codes are being used to track every aspect of medication<br />
handling such as receipt of bulk lots, unit-dose packaging, filling orders (central<br />
pharmacy, decentralized cabinets), and bedside medication administration. However,<br />
according to a 2008 survey, bar code technology has been implemented in only 25<br />
percent of hospitals. 38 At this time, there is no accepted standard format for<br />
manufacturer bar codes. Different companies may include different information as part<br />
of their barcoding processes.<br />
Unless the bar codes from the supplier conform to and are integrated with the code<br />
used in the acute-care setting, a second, hospital-specific bar code may need to be<br />
generated and applied to the item (packaging, wristband, etc.). This requires specialized<br />
printers at various locations, or an extra printing tray that only prints label/wristband<br />
sheets.<br />
In which stages of medication management in the acute-care setting can<br />
barcoding/labeling technology be most helpful?<br />
Bar code technology is an enabling technology that can be used at every major step of<br />
medication handling, including:<br />
• <strong>Pharmacy</strong> inventory management, including supply chain. 39<br />
• Stocking of floor supplies (carts and dispensers).<br />
• Filling of orders.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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• Identification of healthcare professionals and patients involved in the handling<br />
and administration of medications.<br />
• Bar code medication administration (BCMA), 40 which is also referred to as bar<br />
code point of care (BPOC), 41 and is generally implemented in conjunction with<br />
electronic medication administration (eMAR) applications.<br />
• Electronic medication administration (eMAR; provider, patient, drug, dose,<br />
delivery method being identified), which can be implemented along with or prior<br />
to BCMA.<br />
Properly implemented bar code identification can reduce adverse drug events (ADE)<br />
and support quality assurance measures required or recommended by the Joint<br />
Commission 42,43 , the Food and Drug Administration (FDA) 44 and others such as the<br />
Leapfrog Group, the Ambulatory Quality Alliance (AQA), the National Quality Forum<br />
(NQF), and others. For best results, a comprehensive plan for implementation and<br />
rollout of bar coding should be implemented within the organization. 45<br />
What benefits can I expect from the use of barcoding/labeling technology? How<br />
strong is the evidence for such benefits?<br />
Barcoding is an established technology that has proven itself in the pharmacy and<br />
hospital environment. 46 Bar code technology helps healthcare professionals fulfill the<br />
“five rights of medication administration,” 47 including the right patient (bar code), right<br />
medication (bar code), right dose (bar code), right time (eMAR) 48 and right route (CPOE<br />
and eMAR). Though using a barcoding system does not necessarily cut down on the<br />
number of steps to perform, it can reduce typing and populate an electronic record with<br />
detailed information as well as rapidly perform crosschecks, thereby increasing the<br />
overall safety of the medication administration process.<br />
Reduction of dispensing errors can be achieved when a bar code system is integrated<br />
into hospital systems to identify the person administering the medications, the patient,<br />
the drug, the dose, the route and the timing of administration. These data can then be<br />
fed into an eMAR system, which can check all the parameters against a prescribers<br />
order.<br />
Comparative metrics from before and after an implementation are difficult to obtain,<br />
because often the necessary data were not collected prior to adoption of the digital<br />
systems. Additionally, the adoption of barcoding systems in healthcare is a rapidly<br />
evolving field with usability of the systems improving rapidly. 49 Overall, users who have<br />
implemented digital systems do not want to go back. 50<br />
Barcoding/labeling technology improves tracking and accuracy at every stage of the<br />
medication management process, as well as allowing for faster medication inventory<br />
updates, particularly in the inpatient setting. When bar coding/labeling technology is<br />
used in combination with other technologies (e.g., eMAR), additional benefits may be<br />
seen. One large study showed that the incidence of potential and real adverse drug<br />
events decreased by more than 63 percent after the implementation of a bar code<br />
system. 51 When staff was required to scan all drug doses, the incidence decreased 93<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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percent or more. Some health systems are tying scanning compliance rates to<br />
performance goals of nurse managers.<br />
What potential unintended adverse consequences can be associated with the use<br />
of bar coding/labeling technology? How can the risks be mitigated?<br />
In a computerized environment, users may incorrectly assume that all data within the<br />
system are always correct. Users of bar code-enabled systems may assume that the<br />
database linking the bar code to information is always correct, or that the correct label<br />
was applied to a given object or that the patient is wearing the correct wristband. When<br />
scanning, the operator must still verify the patient’s name and ensure that the five rights<br />
of medication administration have been satisfied. In the example of the patient ID, many<br />
hospitals require two data points to identify a patient, such as the patient’s name, plus<br />
birth date; or bar code, plus the patient’s photograph. Similarly, the process flow that<br />
leads to building a bar code database and labeling all the items linked to that database<br />
should use “inherently safe” methods. An inherently safe process is one that has<br />
incorporated safety from the beginning and creates an environment where it is easier to<br />
do the right thing. 52<br />
When an implemented BCMA/BPOC system does not adequately address workflow and<br />
ease of use, providers may substitute workarounds that introduce new sources of<br />
errors. An example would be affixing patient-identification bar codes to computer carts<br />
for easy access, rather than reading the bar code attached to the patient’s wrist. Koppel,<br />
et al, have examined this issue in some detail, identifying over 30 workarounds to bar<br />
code system problems and making some practical recommendations. 53 One risk can be<br />
mitigated by ensuring the patient ID bar code is of a different symbology (type) than<br />
other labels printed on the nursing unit. Another way of mitigating certain risks and<br />
workarounds is to only allow certain areas to print patient bar coded patient wrist bands.<br />
Other less anticipated consequences include underestimating the costs to maintain the<br />
systems (hardware, software, consumables, user training), time and resources needed<br />
to apply patches and system upgrades, response to system downtime or maintaining<br />
policies and quality improvement measures to monitor and ensure best practices. As<br />
with all complex software, software and security patches can also cause unexpected<br />
failures in integrated systems unless the institution has a clear-cut and enforced policy<br />
to deal with the testing and release of changes.<br />
It should be noted that due to the plethora of bar code formats, there should be no<br />
assumption that because a product carries a bar code, it is usable without modification<br />
in the local environment. Computers only recognize bar codes that they have been<br />
programmed for, and the system could otherwise potentially misinterpret a code,<br />
generating incorrect results if the bar code is placed for a different purpose and linked to<br />
a different system.<br />
How does bar coding/labeling technology work with other pharmacy-related<br />
automation technologies, and do they need to be in place for bar coding/labeling<br />
technology to work?<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Bar coding is an interconnecting technology for other applications within and outside the<br />
pharmacy environment. Bar codes are core components of automated inventory<br />
management, tracking, robotic dispensing systems, preparing single-unit medication<br />
doses, IV compounding systems, automated bag and syringe fillers and automated<br />
infusion-compounding robots. Additionally, use of bar coding or other auto-ID<br />
technology is an essential component of effective closed-loop medication systems. 54,55<br />
What is the cost to implement bar coding/labeling technology in a typical acutecare<br />
facility? Are there credible examples of published cost-benefit analyses that<br />
provide a strong business case for the use of this technology?<br />
The financial cost of implementing bar coding/labeling systems within the pharmacy and<br />
the health organization can vary widely, depending on how the system is integrated into<br />
the overall healthcare IT architecture of the institution. Calculation of the financial<br />
benefits of bar coding/labeling technology should include the averted cost of ADEs and<br />
time efficiencies gained during ordering, stocking, distribution, administration and billing<br />
processes. 56 Even so, results may be ambiguous because it can be difficult to capture<br />
all parameters affecting costs.<br />
Cost depends on the size of the organization, the applications in which the technology is<br />
used, where in the acute-care setting the technology is deployed, and how many<br />
interfaces are required for support of legacy systems. The licensing costs can range<br />
from tens of thousands to hundreds of thousands of dollars. The total cost to implement<br />
bar coding/labeling technology (software, hardware, infrastructure, personnel) averages<br />
between one and three times the cost of licensing the technology and may exceed $1<br />
million if linked to robotic systems. The annual maintenance cost (software, hardware,<br />
infrastructure, personnel) averages between 15 percent and 30 percent of the total cost<br />
of implementation.<br />
Where can I obtain more information about bar coding/labeling technology?<br />
There are multiple vendors manufacturing and selling bar code systems, bar code<br />
printers or other technologies that rely on bar codes. HIMSS has also developed a white<br />
paper that looks at the selection process of BCMA/BPOC 57 and published a book on<br />
implementing bar coding and auto identification in healthcare. 58 Searching trade<br />
magazines as well as the Internet can yield much information (on the Internet, search<br />
under both “barcode” and “bar code.”). Most large vendors active in electronic health<br />
records (EHR), pharmacy systems and medication administration have information<br />
pertaining to bar coding and labeling. Reviewing the HIMSS list of exhibitors attending<br />
such events as the HIMSS Annual Conference & Exhibition, will yield a lengthy list of<br />
prospects. If you have a pre-existing EMR/EHR, consult with your vendor to see which<br />
bar code systems are already integrated into the application.<br />
3.5 IV Compounding Systems/Automated Bag & Syringe Fillers/Automated<br />
Infusion Compounding Robots<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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What is IV compounding, filling and automated infusion robotics technology?<br />
How does it work? How has it been put to work in pharmacy-related automation<br />
activities?<br />
Recent technological innovations and the ability to compound new, customized<br />
chemical components and drug research preparation have rejuvenated the<br />
administration of drug mixing and dispensing operations. Attaining better outcomes in<br />
patient and work environment safety; lowering costs through automation and resource<br />
pooling; and better shelf-life management of costly drugs significantly impact healthcare<br />
delivery. Adding accurate drug delivery tools and more efficient workflow processes to<br />
those that are already deployed to reduce medical errors, challenges pharmacists to be<br />
better informed about the deployment and integration of these innovations.<br />
Intravenous medication therapy is an integral part of in-patient acute care, as well as<br />
outpatient treatment and home care programs. Pharmacies that provide medications for<br />
IV administration are responsible for preparing medications that are safe, accurate,<br />
sterile, stable, labeled appropriately and placed in a container consistent with the<br />
anticipated mode and route of administration to the patient. In addition, it is necessary to<br />
comply with industry standards for sterile-product compounding and disposition, such as<br />
those of the United States Pharmacopeia (USP), 59 and the Food and Drug<br />
Administration’s Good Manufacturing Practices (FDA, cGMP) and Institute for Safe<br />
Medication Practices (ISMP).<br />
The medication safety movement has prompted healthcare facilities to employ<br />
technology as a means for preventing medication errors and to eliminate preventable<br />
ADEs. Bar-coded medication administration, improved patient identification and<br />
administration and the use of software-embedded medication safety feature in infusion<br />
pump devices assure achieving the five rights of intravenous medication administration.<br />
However, even the most advanced and integrated IV infusion software application<br />
cannot detect an IV medication that has not been manually compounded appropriately<br />
or sterilized, or is not chemically stable. While technologies that automate the<br />
preparation of medications for IV administration are available—such as centralized IV<br />
compounding systems; bag and syringe fillers; and decentralized IV compounding<br />
satellites—it is the pharmacist's oversight that is as critical as ever to ensure quality and<br />
safety.<br />
IV Compounding Systems. Within the last 30 years a resurgence in pharmacy<br />
compounding of customized drug preparations has occurred. 60 <strong>Pharmacy</strong> compounding<br />
is the preparation and mixing of drugs according to a prescription of a licensed clinician<br />
(pharmacist, physician or veterinarian) to fit the unique needs of the individual patient.<br />
Examples include changing the form of the medication from a solid to a liquid; removing<br />
non-essential ingredients from the medication; or to obtain the exact dose needed. It<br />
may also be done for voluntary reasons, such as adding favorite flavors to a<br />
medication. 61 There are standards published by the United States Pharmacopeia and<br />
National Formulary (USP-NF) for compounding. Compounding pharmacies are licensed<br />
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and regulated in the 50 states and the District of Columbia by their respective state<br />
boards of pharmacy. 62<br />
Total parenteral nutrition (TPN) compounders are the oldest of these technologies. With<br />
companion order entry software, a TPN compounder can perform complex TPN<br />
calculations and provide clinical alerts for safety issues associated with parenteral<br />
nutrition, such as osmolarity limits, electrolyte concentrations, lipid content and<br />
precipitation. After the formula is entered and verified in the software program, it’s sent<br />
via interface to the compounder. There, the compounder operator accesses the formula<br />
and initiates the automated compounding. Automated calculations and compounding of<br />
TPN are done in a fraction of the time required by a manual process. Additionally,<br />
automated systems allow for consistent and accurate documentation that can be stored<br />
electronically. With or without integrated software, a compounder can be manually<br />
programmed to pump desired quantities of stock solutions into a final container. Nonnutritional,<br />
automated IV compounding uses include batched preparation of cardioplegic<br />
solutions, electrolyte replacement solutions and base solution for use in epidural or<br />
intravenous patient-controlled analgesia (PCA) preparation.<br />
Automated Bag & Syringe Fillers. 2003 saw the introduction of table-top syringe filling<br />
devices that automatically fill, cap, weigh, verify and barcode label sterile syringes with<br />
accuracy of +/- 0.2 mL and speed of up to 100 syringes in eight minutes.<br />
Automated IV Compounding Robots. Intelligence-embedded automated systems that<br />
use precise electromechanical robotics and special environments are now deployed as<br />
part of the core pharmacy cycle. The progenitor of the IV automation process is a<br />
relatively simple clean hood space and pharmacy pump. Most people would probably<br />
identify TPN compounders as the first real robotic process. Remote IV Automation<br />
(RIVA) was first demonstrated at an ASHP meeting in 1989 and has a single articulated<br />
robotic arm that moves each dose through a preparation process. IV stations with a<br />
small, low-cost IV compounding device intended to provide just-in-time admixture at the<br />
nursing station have subsequently been introduced.<br />
These technologies can be categorized into three basic classes:<br />
1. Programmable, manually operated, table-top compounders. Their common element<br />
is simplicity and they are designed to be operated within a standard laminar air-flow<br />
hood.<br />
2. Automated robotic syringe-filling systems .<br />
3. Automated, programmable enclosed system for filling virtually any package—their<br />
common element is sophisticated electromechanically articulated arm and clean<br />
environment.<br />
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The compounding preparation and production cycle is described in the following flow<br />
chart that was adapted from Intelligent Hospital Systems, robotic IV automation—RIVA<br />
product.<br />
Table 1: Robotic IV Automation Flow Chart (adapted from www.intelligenthospitals.com.)<br />
The RIVA robotic IV automation system is an integrated system designed to automate<br />
the process of preparing IV admixtures in the hospital pharmacy in the process flow<br />
chart described in Table 1. The process highlights the issues of safety, efficiency,<br />
effectiveness and regulatory compliance. The pharmacist can interact with the process<br />
through a workstation screen or remote order entry and control.<br />
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The production process begins with inventory item validation. Items can be identified by<br />
a variety of systems, including image and bar coding recognition, as well as height and<br />
weight verification. To assure sterility of final preparations, a port disinfection system<br />
sterilizes both vial stoppers and IV bag ports. After inventory items are verified, several<br />
fluid transfers occur within the compounding area. Vials can undergo reconstitution and<br />
syringes or bags receive final product based on order requirements. Final weight and<br />
verification checks ensure that every dose is accurate. When a dose is complete, it<br />
receives a label with bar code and print information. RIVA then checks the ID to ensure<br />
the information is correct, and the robot moves the dose to an output chute so that it can<br />
be verified by pharmacy staff and sent to the appropriate patient unit. RIVA increases<br />
the safety of admixtures for the patient by improving dose accuracy, reducing the<br />
chance of cross contamination and reducing medical errors.<br />
Safety features improve dose accuracy, reduce the chances of cross contamination and<br />
use verification to reduce medical errors. Efficiency and effectiveness are achieved<br />
through reduction in overall waste, reduced need for pre-filled items—filling both IV<br />
bags and syringes in the same system—and integrating into the pharmacy processes<br />
and information systems. Regulatory compliance is achieved by meeting USP 707,<br />
NIOSH and OSHA requirements, and the ability to provide an electronic audit trail of all<br />
orders prepared by the system. When used for compounding of chemotherapy drugs,<br />
additional closed system transfer and outside venting hood are included. IV<br />
compounders are classified as Class II Exempt devices under the FDA Risk and Quality<br />
System Regulations (21CFR820).<br />
IV Station has some interesting features:<br />
• Face-recognition login.<br />
• Vial identification based on a vision system.<br />
• Low price point (~250-300K).<br />
• The ability to daisy-chain several systems to make a large, relatively high<br />
throughput product.<br />
In the acute-care setting, during which stages of medication movement can IV<br />
compounding, filling and automated infusion robotics technology be most<br />
beneficial?<br />
Pharmacies providing admixed IV medications for inpatient acute care, as well as<br />
outpatient and home care would use automated compounding or robotic preparation in<br />
the pharmacy medication preparation stage. One robot is available for use by nurses at<br />
the point of care. However, all of these devices provide mechanical dose production<br />
assistance.<br />
What benefits can I expect from the use of IV compounding, filling and automated<br />
infusion robotics technology? How strong is the evidence for such benefits?<br />
Automated compounding devices provide quick, consistent, accurate, aseptic delivery of<br />
product into a final container. When used in combination with partner software for<br />
calculations and clinical screening, medication safety can be enhanced. Evidence is<br />
strong in regards to the expected benefits of a compounding machine, such as a TPN<br />
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compounder. However, inappropriate use of the software or compounder,<br />
misinterpretation of the device warnings or clinical flags, or inconsistent usage<br />
procedures, can contribute to adverse outcomes as a result of using this technology.<br />
Automated, robotic IV compounding provides independent preparation inside an ISO<br />
Class-5 enclosed environment. The self-contained ISO Class-5 environment of the IV<br />
robot ensures product sterility without requiring staff to wear sterile garb or stay in a<br />
special preparation area. Staff is protected from exposure to hazardous substances and<br />
physical ailments associated with performing repetitive admixture manipulations for long<br />
periods of time. Cost savings are achieved through the reduction or elimination of sterile<br />
garb for staff, cleaning materials and special supplies required to maintain a USP-797-<br />
compliant compounding operation. Possible re-allocation of IV compounding staff may<br />
allow for reassignment of staff to clinical activities to further enhance medication safety.<br />
Bar code verification, specific gravity measurement, picture verification and weight<br />
measurement are methods robots employ to ensure accuracy, thereby decreasing the<br />
potential for a medication error or adverse drug events. There is strong evidence that<br />
the benefits of sterility, stability, accuracy and minimized employee exposure are<br />
associated with use of even the basic functionality of this technology. Feedback from<br />
hospital pharmacy directors suggests that ROI for this technology is still a complex<br />
issue that must be individually calculated and analyzed.<br />
What potential, unintended adverse consequences are associated with the use of<br />
IV compounding, filling and automated infusion robotics technology? How can<br />
the risks be mitigated?<br />
An automated compounder must reside in a laminar airflow hood within an ISO Class-5<br />
clean room. An automated compounder requires a significant amount of operator<br />
programming and participation during admixture, such as manual input of a formula into<br />
the software program, manual load of stock solutions onto the compounder, manual<br />
labeling of the final containers and manual addition of ingredients with a volume too<br />
small for the pump to accommodate. Each manual step in the compounder process<br />
introduces the potential for contamination, calculation error or medication error. 63 To<br />
mitigate the risk of an unintended adverse consequence due to manual steps<br />
incorporated into the automated compounder workflow, rigorous aseptic standards and<br />
operating procedures must be introduced, monitored and enforced.<br />
Implementation of automated technology, especially the more complex robotic systems,<br />
is associated with a significant staff learning curve. Staff must learn how to properly<br />
operate, clean and stock the technology, as well as incorporate use of the new<br />
technology into to revised workflows, policies and procedures. Emphasis placed on user<br />
training of the technology and additional staffing during the initial phase of automated<br />
technology implementation may help with throughput during this challenging time.<br />
How does IV compounding, filling and automated infusion robotics technology<br />
interface with other pharmacy-related automation technologies, and do they need<br />
to be in place for IV compounding, filling and automated infusion robotics<br />
technology to operate?<br />
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Automated IV compounding devices and robots may be programmed to interface with<br />
pharmacy computer systems or may work as stand-alone products. In a stand-alone<br />
configuration, the compounder or robot would be instructed to run batches of commonly<br />
used IV admixtures. Batched product must be labeled appropriately, including<br />
information such as final concentration and/or volume, ingredients, date and time of<br />
compounding and expiration, bar code and an internal lot number. Batched products<br />
would then be used by the pharmacy staff to fill physician orders. In an interfaced<br />
configuration, the automated compounding device would receive data directly from the<br />
pharmacy computer system and fill patient-specific orders. Multiple times throughout the<br />
day, the operator would send information from the pharmacy system to the robot, and<br />
the robot would then compound what is needed during the specified timeframe. IV<br />
robots are capable of placing patient-specific, bar-coded labels.<br />
Where can I obtain more information about IV compounding, filling and<br />
automated infusion robotics technology?<br />
There is clear need for up-to-date information, ranging from space preparation and<br />
conditioning (space size, height, venting, cooling and security) to maintenance of<br />
software and hardware to operation and training issues. Sources included user groups,<br />
publications and conferences, , review agencies and vendors. 64,65<br />
Figure 3.5 Drug preparation station (2009).<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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3.6 Central <strong>Pharmacy</strong> Robotic Dispensing Systems<br />
What is a central pharmacy robotic dispensing system, how does it work and how<br />
has it been put to work in pharmacy-related automation activities?<br />
A robot automates the pharmacy dispensing process using bar code labeling<br />
technology. This process includes dispensing medications to a patient, a cart to be<br />
exchanged or an automated dispensing cabinet (ADC). The robot is usually located in<br />
the central pharmacy and automates storage, dispensing, returning, restocking and<br />
crediting of unit-dose medications. McKesson’s Robot-Rx ® and Swisslog’s PillPick ® are<br />
two examples of systems that streamline the processing of cart fill and first doses.<br />
The pharmacy robot can dispense both initial doses and all doses required over a 24-<br />
hour period. When new medication orders are processed into a pharmacy information<br />
system, the information is transferred across an interface to the robot. The robot<br />
dispenses first doses by selecting the appropriate number of the correct unit-dose<br />
medications. The automated cart fill process dispenses a 24-hour supply of patient<br />
medications after the initial doses have been dispensed. Fill lists for patient-specific<br />
medications are generated in the pharmacy information system for each nursing unit.<br />
The fill lists are sent through the interface to the robot.<br />
Depending on the type of robot and whether it is a first dose or a cart-fill situation, it will<br />
dispense medications into a labeled envelope or bin, or arrange them on a fastened,<br />
labeled ring. In each scenario, the label includes the patient's name and bar code. The<br />
medications are then transported to the nursing units. Charges for medications are<br />
generated either at the point-of-administration or as fill lists are generated, depending<br />
on system set-up.<br />
Medications are transported from the pharmacy to the nursing units and placed into<br />
patient-specific medication bins. During medication administration, nurses scan the barcoded<br />
medications to verify the five rights at bedside.<br />
Medications dispensed, but not taken by the patient are returned to pharmacy. The<br />
robot restocks returned medications to the appropriate pegs or station within the robot<br />
picking area. Depending on system set-up, return credits and billing information may or<br />
may not have to be provided to the pharmacy information system.<br />
A robotic system can also perform multi-site filling operations as well as restocking of<br />
unit-based ADCs.<br />
In which stages of medication management in the acute-care setting can a central<br />
pharmacy robotic dispensing system be most helpful?<br />
<strong>Pharmacy</strong> robotic dispensing systems automate the repetitive and otherwise laborintensive<br />
task of dispensing medications from central pharmacy inventory, thereby<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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decreasing medication handling mistakes that can contribute to noncompliance with the<br />
five rights of medication administration, with harmful or potentially fatal consequences.<br />
Combining the use of bar codes with central pharmacy robotic dispensing technology<br />
ensures accuracy and allows detailed information tracking, such as lot numbers,<br />
expiration dates and unique-dose identifiers. Together, these technologies aid in<br />
preventing medication selection errors, help manage unit-dose inventories and prevent<br />
dispensing of expired medications.<br />
What benefits can I expect from using a central pharmacy robotic dispensing<br />
system? How strong is the evidence for such benefits?<br />
Using a robot to dispense both initial doses and cart fills frees pharmacists and<br />
technicians from error-prone and repetitive manual tasks. Labor can be redirected to<br />
higher value-added activities instead. Information about the benefits of deploying bar<br />
code-based automation can be found through the Internet and in journals, such as the<br />
American Journal of Health System <strong>Pharmacy</strong> and the Journal of the American Medical<br />
Association.<br />
With a reduction in pharmacy technician labor requirements for manual medication<br />
dispensing and checking, technicians can be used to support other important pharmacy<br />
activities. Maintenance of the robot also provides new employment opportunities for<br />
technicians, including positions as unit-dose packaging and automation (robotic)<br />
specialists.<br />
Pharmacist labor required to check the accuracy of medication dispensing is also<br />
reduced with robust central pharmacy robotic dispensing systems. Pharmacists no<br />
longer have to manually check first doses or all cart fill doses. In many states, the board<br />
of pharmacy allows reduced pharmacist quality checks for robot-dispensed medications;<br />
5 percent to 10 percent random checks are allowed in some cases. With the high<br />
reliability of pharmacy robotic dispensing systems, pharmacists can shift more of their<br />
time to overseeing clinical activities that may have a broad impact on patient safety.<br />
Medication selection errors are reduced significantly with a robot, improving patient<br />
safety. The accuracy of a dispensing robot is 99.9 percent. While the majority of the<br />
medication errors result from incorrect orders and transcriptions, almost half of the<br />
medication errors in manual dispensing environments occur because of dispensing or<br />
administration errors. 66 A 2006 study by Cina, et al., found that although pharmacy<br />
technicians accurately filled more than 96 percent of the medication doses, pharmacists<br />
intercepted only 80 percent of the pharmacy technician errors. 67 Medication dispensing<br />
errors increase in work environments with heavy workloads and high levels of<br />
interruption, distraction and noise. 68-70<br />
<strong>Pharmacy</strong> robotics technology improves charge capture and billing accuracy for<br />
hospitals that have not fully implemented a BCMA system with billing-upon-medication<br />
administration. In a centralized distribution system, typically 20 percent to 30 percent of<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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all medications dispensed are returned to the pharmacy. This is a result of discontinued<br />
medications or order revisions, as well as patient discharges and transfers.<br />
In the absence of pharmacy robotics technology and billing only upon administration,<br />
the return process is generally time consuming and labor intensive. A technician must<br />
sort through all returned medications and manually credit each patient’s profile in the<br />
pharmacy information system before physically returning each medication to stock. After<br />
implementing robotics, the technician instead scans the bar code on the returned<br />
medications and places them on a return rack. A transaction is automatically created to<br />
tell the pharmacy information system that the appropriate patient account should be<br />
credited for specific medications. When all scanning is completed, the return rack is<br />
placed into the robot, and the robot returns the medications to the appropriate place in<br />
stock.<br />
The return process is streamlined when medications are billed upon administration.<br />
Scanning medications to issue credit is not necessary. Unused medications are simply<br />
placed on the return rack for the robot to put back into stock. In addition, an automated<br />
system utilizing bar code technology decreases the number of missing patient<br />
medications, trims inventory and decreases expired medication costs.<br />
What potential unintended, adverse consequences can be associated with the<br />
use of a central pharmacy robotic dispensing system? How can the risks be<br />
mitigated?<br />
Mislabeled medications can cause harmful medication errors. Unit-dose re-packaging is<br />
largely a manual process, and for hospitals that utilize bar coding, bar codes must be<br />
added to the package, adding another manual step and source for error. The nextgeneration,<br />
high-volume re-packaging machines, such as Swisslog’s ATP ® System and<br />
McKesson’s ® PACMED ® , include bar code verification during the re-packaging process.<br />
Bar code verification prevents improper loading of high-speed packagers and allows<br />
batch-specific information, such as expiration dates, to be tracked. 71<br />
Selecting a pharmacy robot with limited capacity is less expensive, but can lead to a<br />
higher-than-desired amount of manually picked medications, or “manual picks.” Most<br />
hospitals have 2,500 to 3,500 medications on the formulary. The average robot capacity<br />
is 400-600 of the pharmacy’s top-moving medications. Robots with larger capacities are<br />
more expensive.<br />
In addition, the expectation that pharmacy robotic dispensing technology will reduce the<br />
need for other resources is not always valid. Instead, technology may shift rather than<br />
decrease staffing allocations. Failure to allocate resources needed for ongoing<br />
maintenance and system optimization can lead to inefficient or inaccurate robot<br />
performance, a higher-than-desired number of manual picks and point-of-care<br />
administration issues. Optimization of robotic dispensing systems after implementation<br />
too often falls short because required resources are underestimated or not provided.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Manual picks occur frequently when high-use items are not part of the robot online<br />
inventory. The number of manual picks increases as new medications are added to the<br />
pharmacy information system formulary, prescribing habits shift and robot formulary<br />
updates lag. The robot formulary must be maintained to reflect changes made to the<br />
formulary in the pharmacy information system. If the systems are not kept in step, bar<br />
code scanning issues arise, workarounds emerge and safety is compromised.<br />
The key to using technology most efficiently is to devote full-time employees to routine<br />
maintenance tasks and system optimization. Train enough subject matter experts to<br />
assume responsibility for operational tasks and troubleshooting across all shifts and all<br />
systems. Proper training could also alleviate employee concerns, such as a fear of<br />
technology or potential for job loss.<br />
Failure to recognize and redesign flawed processes uncovered in the existing manual<br />
system can cause unintended adverse consequences in the automated system.<br />
Scrutinize workflow processes and procedures for risks and inefficiencies and resolve<br />
these issues prior to any technology implementation. Include all stakeholders, whether<br />
they are clinical, technical or administrative to help identify and resolve these issues. 72<br />
What if the interface between the robot and the pharmacy information system goes<br />
down? Should downtime procedures include using the robot independently to fill carts?<br />
If so, then plan for order entry to be completed in the robot system. However, remember<br />
that the order information entered into the robot may not interface back to the pharmacy<br />
information system. In such cases, once the pharmacy information system is<br />
operational again, backlog order entry must be completed.<br />
The pharmacy information system and robot can operate independently; if one is down,<br />
the other remains operational. When the robot goes down, paper medication<br />
administration records (MAR) can be generated and used to complete cart fills.<br />
Similarly, when the pharmacy information system is down, the robot and automated<br />
dispensing cabinets may still operate. While new orders will not cross the interface to<br />
the robot, the robot and automated dispensing cabinets can dispense medications for all<br />
existing orders. Downtime procedures should provide guidelines to continue with<br />
pharmacy operations in the event that either or both systems experience downtime.<br />
Mechanical problems with the robot conveyer or other parts can make the system<br />
inoperable. Avoid downtime disasters by performing recommended routine maintenance<br />
and replacing worn parts.<br />
Software issues can also cause the robot system to go down. Look for a system that<br />
has a backup drive to keep the system operational in the event of hardware failure.<br />
Under-utilization of this type of technology is something that must be noted. It is crucial<br />
to have a firm understanding of how a pharmacy robot performs. Inadequate knowledge<br />
can lead to inefficient workflows, incorrect reporting and potential problems with<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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Figure 3.6.1 <strong>Pharmacy</strong> Robotic Dispensing System Footnote 34<br />
Figure 3.6.2 <strong>Pharmacy</strong> Robotic Dispensing System Footnote 34<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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3.7. Decentralized Automated Dispensing Cabinets<br />
What are decentralized automated dispensing cabinets, how do they work and<br />
how have they been put to work in pharmacy-related automation activities?<br />
ADC technology is popular in the healthcare industry, particularly in hospitals. ADC<br />
technology has increasingly been accepted as integral to medication inventory<br />
management, administration and distribution processes. Since 2007, more than 80<br />
percent of hospitals use some type of ADC technology. 73 ADC technology provides a<br />
mechanism for moving medications out of the central pharmacy and closer to the point<br />
of care. Secure distribution and storage of medications throughout the hospital reduces<br />
the time and labor involved in the medication administration process, as well as<br />
providing a means for controlling medication costs through electronic inventory<br />
management functions.<br />
Using ADC technology is quite simple. The cabinets typically reside near nursing<br />
stations. After electronically accessing the cabinet through biometric, badge reader or<br />
login and password authentication methods, the nurse is presented with a list of patient<br />
names on a touch screen. Next, the nurse selects a patient name and is presented with<br />
a list of pharmacist-approved patient medication orders. The nurse’s last step is to<br />
select the available medication based on the scheduled time. The cabinet drawers open<br />
one at a time, prompting the nurse to remove the medication. The medications are<br />
secured by limiting the nurse to only the medications needed for the selected patient. All<br />
user transactions are logged to a central database for reporting, charge capture and<br />
auditing.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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In which stages of medication management in the acute-care setting can<br />
decentralized automated dispensing cabinets be most helpful?<br />
ADCs are prevalent in the processing/distributing and medication administration phases<br />
of the medication management process (Figure 2-2). However, with wholesalers<br />
offering services that provide pre-packed totes for cabinet replenishment, ADC<br />
technology has also started to expand into the receiving medication phase.<br />
After totes are delivered to the hospital by the wholesaler, a pharmacist checks the<br />
order and the totes are delivered right to the nurse floor and placed into the cabinet<br />
inventory; bypassing central pharmacy inventory. However, not every wholesaler offers<br />
this service, so the process is not yet in wide use, and most acute-care pharmacies opt<br />
to store medications in a centralized location or in a storage and retrieval system.<br />
What benefits can I expect from the use of decentralized automated dispensing<br />
cabinets? How strong is the evidence for such benefits?<br />
Some of the reported benefits include a reduction in ADEs and medication costs,<br />
increases in charge capture, pharmacy and nurse productivity and assistance in<br />
meeting The Joint Commission standards and National Patient Safety Goals.<br />
Increased awareness of the impact of ADE in the media is a compelling reason to<br />
consider adopting ADC technology. Saudi Aramco Medical Services Organization<br />
reported a decrease in ADE of 27 percent after implementing ADC technology. 74 They<br />
also realized a 43 percent reduction in medication restocking costs and an overall<br />
medication cost reduction of 42 percent. 75<br />
A Shore Memorial Hospital study 76 found similar benefits associated with nursing<br />
productivity. After ADC implementation, nursing productivity increased by reducing the<br />
time required to reconcile narcotics by 93 percent, and data reflected an 80-percent<br />
reduction in medication stock stored on nursing units. 77 In a separate study, Parkview<br />
Health (Fort Wayne, Indiana) reduced their medication inventory by $600,000 and<br />
saved 20 percent in labor costs using ADCs. They also improved order delivery time<br />
from 90 minutes to 60 minutes; reduced medication confirmation and authorization time<br />
by 30 percent; reduced medication administration errors by 75 percent; and essentially<br />
eliminated the time it took to order and manage medication inventory after integrating<br />
their ADCs with the pharmacy information system, packaging, storage and inventory<br />
management software. 78<br />
Lastly, ADCs help hospitals and health systems meet regulatory requirements. For<br />
example, ADC technology facilitates compliance with The Joint Commission Medication<br />
Management Standards by preventing unauthorized individuals from accessing<br />
medications and providing secure access to medications when the pharmacy is<br />
closed. 79 ADCs are used in many different ways. The two basic modes are first<br />
dose/PRN medications only (the rest are supplied by traditional cart fills) and “cart-less,”<br />
where as many of the medications as possible are included in the cabinet. Which<br />
process is used will impact the number of cabinets needed, as well as the labor needed<br />
to keep them filled.<br />
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What potential, unintended adverse consequences are associated with the use of<br />
decentralized automated dispensing cabinets? How can the risks be mitigated?<br />
As with the implementation of any technology, workflow changes associated with ADC<br />
implementations can introduce new risks. ADC technology disrupts traditional<br />
pharmacy, nursing and medical work systems, forcing a redesign of services and<br />
requirements. Careful consideration should be given to the planning, execution and<br />
overall management of the ADC system. The risk of users rejecting the technology<br />
increases if effective implementation design principles are ignored. 80<br />
While planning for ADC technology, consideration must be given to cabinet footprint,<br />
drug capacity and location. The ADC should fit in its intended space with minimal<br />
structural changes to limit construction related charges. Further, the size of the ADC<br />
should be large enough to accommodate sufficient quantities of the medications<br />
typically given at the nursing unit. Lastly, the location of the ADC should be somewhere<br />
that optimizes and supports efficient nurse workflow.<br />
Another unintended consequence is the incorrect assumption that ADC technology will<br />
eliminate medication errors, leading to behaviors that increase the risk of adverse drug<br />
events. Inefficiencies in the system, inadequate training and lack of guidance have<br />
contributed to the misuse of the ADC “override” function which permits the dispensing of<br />
a medication prior to pharmacist review of the medication order. 81 Moreover,<br />
maintaining the organization of your inventory is the first key to safe stocking<br />
practices. 82 Medications and their packaging often look alike. For this reason, similar<br />
looking medications and medications with “sound alike” names should not be stocked<br />
alongside each other in an effort to decrease the likelihood that a technician will place a<br />
medication in the wrong location. To mitigate the risk of medication placement errors,<br />
some systems use a “look-alike, sound-alike” approach to printing drug names called<br />
“TALLman” lettering. The goal of TALLman lettering is to make it more obvious that two<br />
similar looking or sounding drugs (e.g., hydrALAZINE, hydrOXYzine), are different.<br />
A strong policy and procedure practice should be followed to maximize the patient<br />
safety features of ADC technology. More information on the safe use of ADCs can be<br />
found in the cover story of the July 2008 issue of <strong>Pharmacy</strong> Purchasing and Products<br />
magazine 83 and the Institute for Safe Medication Practices (ISMP) <strong>Guidance</strong> on the<br />
Interdisciplinary Safe Use of Automated Dispensing Cabinets. 84<br />
How do decentralized automated dispensing cabinets work with other pharmacyrelated<br />
automated technologies, and do they need to be in place for decentralized<br />
automated dispensing cabinets to work?<br />
To maximize efficiency and patient safety, an interface between a pharmacy information<br />
system and ADC technology is required so that patient movement, medication orders<br />
and patient billing can be tracked. To further expand patient safety features, ADC<br />
technology should be integrated with other pharmacy automation, such as a dispensing<br />
robot, carousel or packaging device. Working together utilizing interfaces and bar<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
40
codes, the technologies increase patient safety by ensuring the correct medication is<br />
packaged, picked, delivered and put away in the ADC accurately. Moreover, operational<br />
efficiencies are gained when there is automation present throughout the medication<br />
administration process. Shore Memorial reported an ROI of 28 percent and a net<br />
present value of $700,000 after its implementation of ADC technology, along with<br />
carousels and pharmacy software technology. 85<br />
What is the cost to implement decentralized automated dispensing cabinets in a<br />
typical acute-care facility? Are there credible examples of published cost-benefit<br />
analyses that provide a strong business case for the use of this technology?<br />
The cost associated with ADC technology is fairly high. New Elm Medical Center, part of<br />
Allina Health System, utilized one Pyxis ® cabinet before implementing 10 others at a<br />
total cost of $600,000. 86 There is very limited research with regard to return on<br />
investment of ADC technology alone. However, most of the documented savings<br />
associated with pharmacy automation did include ADC technology as part of the overall<br />
technology solution.<br />
Where can I obtain more information about decentralized automated dispensing<br />
cabinets?<br />
There are not many ADC technology vendors in the market. A few of the dominant<br />
vendors for ADC technology include AmerisourceBergen ® , Cardinal Health (now<br />
CareFusion ® ), McKesson Corp. ® , Omnicell ® Corp. ® and Talyst® Inc. More information<br />
can be found by visiting their respective Web sites, by searching the Internet or<br />
researching pharmacy or nursing trade magazines.<br />
3.8.Bar code Medication Administration-powered Electronic Medication<br />
Administration Record (BCMA-eMAR)<br />
What is BCMA-eMAR, how does it work and how has it been put to work in<br />
pharmacy-related automation activities?<br />
The combination of BCMA and eMAR uses bar code reading technology to facilitate and<br />
electronically record the bedside administration of medications. BCMA-eMAR<br />
technology helps ensure that the five rights of medication administration—drug, patient,<br />
dose, time and route—are all accurately assessed prior to bedside medication<br />
administration,and then accurately recorded in the patient’s chart. A wired or wireless<br />
bar code reader is used to scan the caregiver’s name badge, the patient’s wrist band<br />
and the medication being administered, electronically verifying the information related to<br />
an individual dose of medication. Advanced clinical decision support (CDS) can be<br />
coupled with electronic health record (EHR) and computerized provider order entry<br />
(CPOE) to simultaneously check for other potential errors such as duplicate therapies,<br />
potential drug interactions and drug-lab, drug-food or drug-diagnosis contra-indications.<br />
In which stages of medication management in the acute-care setting would<br />
BCMA-eMAR be most helpful?<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
41
BCMA-powered eMAR technology facilitates the administration and documentation of<br />
medications at the point-of-care. Utilizing BCMA-eMAR enables nursing medication<br />
documentation to be available to all healthcare practitioners in real-time. If the BCMAeMAR<br />
system detects a problem during the medication administration process, a<br />
warning message can be issued and displayed for the person administering the<br />
medication and recorded in the eMAR. The caregiver can then determine any further<br />
actions that are needed before proceeding. Electronic data collected related to the five<br />
rights can also be monitored for quality and performance improvement initiatives.<br />
Incorporating clinical decision support into BCMA-eMAR during medication<br />
administration can enhance patient safety and minimize adverse drug events (e.g.,<br />
displaying the latest INR when preparing to administer sodium warfarin and then<br />
alerting the physician as to the potential adverse drug/result interaction).<br />
What benefits can I expect from the use of BCMA-eMAR? How strong is the<br />
evidence for such benefits?<br />
The overriding benefit of implementing a BCMA-eMAR system is to ensure patient<br />
safety and reduce medication errors at point-of-care. The greatest potential benefit of<br />
bar code functionality during the bedside medication administration process is the<br />
reduction of preventable adverse drug events (PADE). According to one study, a bar<br />
coded medication administration process reduced errors from 0.19 percent prior to<br />
implementation to a rate of 0.07 percent post-implementation. 87 The added costs of<br />
treating medication errors can be very high. 88,89 One study found 2 percent of<br />
admissions were associated with a PADE, with an added cost per patient of $4,700. 90<br />
Sometimes, the potential adverse drug events will appear to have increased shortly<br />
after implementation of a BCMA-eMAR system. This is due to prior under-reporting of<br />
“near misses” and medication errors.<br />
What unintended adverse consequences can be associated with the use of<br />
BCMA-eMAR? How can the risks be mitigated?<br />
The major driver for utilization of bar code medication administration is to enhance<br />
patient safety, not as an efficiency strategy. Numerous workarounds have been<br />
described to address workflow efficiency problems and issues, or deal with problems<br />
encountered in the use of BCMA-eMAR systems. 91 <strong>Document</strong>ed examples include<br />
unreadable medication bar codes, malfunctioning scanners, unreadable or missing<br />
patient identification wristbands, non-bar coded medications, unreliable wireless<br />
connectivity or patient care emergencies.<br />
An example of a workflow efficiency workaround would be to scan a patient’s ID label<br />
placed on paperwork outside the room instead of directly scanning the patient’s<br />
wristband. This increases the risk that a nurse will walk into the wrong room and<br />
administer the wrong medications to the wrong patient. A strategy for monitoring and<br />
reporting frontline caregiver compliance with desired workflows related to the bar code<br />
medication administration process can help mitigate the risk of undesirable workflow<br />
adoption.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
42
Change management strategies and communications to ensure caregivers’ awareness<br />
of issues the technology is intended to address, as well as the current rate of<br />
medication errors in the acute-care setting, the successful adoption of the intended<br />
workflows. Adequate training and support for frontline caregivers are additional<br />
prerequisites to successful implementation. Medication errors can appear to increase<br />
when first using BCMA-eMAR systems because the technology captures more accurate<br />
data, such as medications missed or medications that are given late.<br />
How does BCMA-eMAR work with other pharmacy-related automation<br />
technologies, and do they need to be in place for the BCMA-eMAR system to<br />
work?<br />
Current best practice for bar code-enabled medication administration at the bedside<br />
requires that bar coded caregiver badges, bar coded patient identification (wristbands),<br />
individually bar coded medications and scanning technology be in place and<br />
consistently used. This provides the functionality necessary to verify that the five<br />
medication rights are met at the time of medication administration.<br />
Bar coded patient identification, individually bar coded medications and scanning device<br />
technology (wired or wireless) must be in place for the BCMA process to automatically<br />
and properly populate the eMAR. Caregiver bar code identifier scanning is preferred but<br />
not required. Alternatives include caregiver sign-in with user ID and password, or use of<br />
other auto-ID technology like biometric thumbprints or RFID proximity badges.<br />
What is the cost to implement BCMA-eMAR technology in a typical acute-care<br />
facility? Are there credible examples of published cost-benefit analyses that<br />
provide a strong business case for the use of BCMA-eMAR?<br />
One study evaluated the costs and benefits of a bar code medication administration<br />
system and found a positive ROI after one year of being fully operational. Total five-year<br />
costs of $2.24 million ($1.31 of capital and $342,000 per year of recurring costs) were<br />
offset by a net benefit at the end of five years, of $3.49 million. 92 In another study, the<br />
authors concluded that the combination of CPOE and BCMA-eMAR yielded a good<br />
return on investment because of reduced transcription errors, improved medication turnaround-times<br />
and timely result reporting. 93<br />
Where can I obtain more information about BCMA-eMAR systems?<br />
Additional information about the use of bar coded medication administration and eMAR<br />
processes may be obtained by accessing the HIMSS <strong>Pharmacy</strong> Informatics Task Force<br />
white paper entitled “The Ideal Bar code Point-of-Care System for the <strong>Pharmacy</strong><br />
Informaticist.” 94 Another useful source of information on the topic is the HIMSS book<br />
Implementation Guide to Bar Coding and Auto-ID in Healthcare: Improving Quality and<br />
Patient Safety, edited by Ned J. Simpson and Kenneth A. Kleinberg. 95<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
43
4. CONCLUSION<br />
The movement of medications from the receiving dock, to the pharmacy, to the unit of<br />
care and finally to the patient’s bedside for medication administration, requires a<br />
complex set of processes carried out by a multidisciplinary healthcare team to ensure<br />
the right medication is delivered to the right patient at the right dose, via the correct<br />
route and at the designated time.<br />
If implemented properly, pharmacy-related automation technologies have been shown<br />
to increase efficiencies in medication management workflow processes, maximize<br />
resource allocation and productivity, and help reduce adverse drug events. These<br />
advantages are increased when technologies interface with other systems, such as<br />
pharmacy information systems; or used in conjunction with other pharmacy automation<br />
enabling technologies, such as the use of bar code readers with eMARs, inventory<br />
management systems and unit-dose packaging systems.<br />
However, the risk of unintended consequences and adverse events needs to be<br />
considered and a mitigation plan generated as part of any pharmacy-related technology<br />
purchase. As indicated throughout this guidance document, potential technology-related<br />
adverse events can arise if systems are not carefully deployed and maintained, if<br />
human interactions with the system produce workarounds, or if those selecting and<br />
approving new systems fail to consider and mitigate the potentially adverse impact that<br />
disruptive new technologies can have on healthcare processes, workflow and safety. 96<br />
The chance of technology-related adverse events can be reduced by providing<br />
adequate resources prior to system selection and implementation, as well as<br />
appropriate monitoring and optimization after go-live. It is important to assess current<br />
medication management workflow processes and scrutinize workflow risk points and<br />
inefficiencies in each process when designing or changing the medication<br />
administration process. Additionally, once systems have been properly implemented,<br />
on-going evaluation of the workflow processes should be evaluated to ensure policy<br />
compliance and identification of potential human-computer interface risks.<br />
While independent, peer reviewed studies confirming a positive cost-benefit ratio for<br />
investing in pharmacy-related automation technologies remain sparse, case studies are<br />
emerging that provide anecdotal evidence of substantial cost-savings for the<br />
implementation of bar code medication administration, pharmacy inventory<br />
management and unit-dose packaging systems.<br />
As with any cost-benefit analysis, consideration needs to be given to key areas that may<br />
affect the net benefits an organization can expect from implementing medication<br />
management technologies. These include organizational culture issues; how the<br />
pharmacy-related automation systems are to be integrated with other systems; savings<br />
associated with averted errors and ADEs; expected time and efficiency gains; the<br />
possibility that technology may shift rather than reduce the need for resources; and the<br />
need for initial and ongoing training, system upgrades and maintenance.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
44
In closing, we believe there is an increasingly strong case to be made for greater use of<br />
pharmacy-related automation technologies to improve the quality and safety of<br />
medication management processes in acute-care settings. We also believe there are<br />
sufficient product choices to support organizations wanting to move forward in this area.<br />
Finally, we hope this guidance document helps pharmacy professionals, nurses and the<br />
healthcare executives they work with make more informed decisions about which<br />
technologies to implement in acute-care settings—and when.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
45
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Hospital Environments. Hospital Topics. Summer 2006. 84(3), 3-8.<br />
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Kleinberg, 2009.<br />
©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
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©2010 by the Healthcare Information and Management Systems Society (HIMSS)<br />
47
33. Klaus. High-Volume Unit Dose Packaging. Klaus Online Newsletter. September,<br />
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