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practice R eport Photoemission spectroscopy
Am J Health-Syst Pharm—Vol 65 Jan 1, 2008 49
practice report
Yaman Kaakeh, Pharm.D., BCPS, is Clinical Assistant Professor of
Pharmacy Practice, Purdue University, West Lafayette, IN; at the time
of this study she was Pharmacy Practice Resident, Department of
Pharmacy Services, University of Michigan Health System (UMHS),
Ann Arbor. Hanna Phan, Pharm.D., is Pediatric Pharmacotherapy
Fellow, College of Pharmacy, The Ohio State University, Columbus;
at the time of this study she was Neonatal Intensive Care Unit Clinical/
Staff Pharmacist, Department of Pharmacy Services, C. S. Mott
Children’s Hospital, UMHS. Brian D. DeSmet, Pharm.D., M.S., is
Pharmacy Specialist, Henry Ford Hospital, Detroit, MI; at the time of
this study he was Pharmacoeconomics and Outcomes Fellow, Department
of Pharmacy Services, UMHS. Deborah A. Pask o, Pharm.D.,
is Adjunct Clinical Assistant Professor, College of Pharmacy; Clinical
Coordinator, C. S. Mott Pharmacy; and Clinical Pharmacy Specialist,
Pediatric Critical Care, UMHS. Denise K. Glenn, B.S.Pharm., is
Supervisor, C. S. Mott Pharmacy, Department of Pharmacy Services,
UMHS. James G. Stevenson, Pharm.D., FASHP, is Director of Pharmacy
Services, University of Michigan Hospitals and Health Centers,
and Professor and Associate Dean for Clinical Sciences, College of
Pharmacy, University of Michigan, Ann Arbor.
Address correspondence to Dr. Stevenson at the Department of
Pharmacy Services, UH B2D301, Box 0008, University of Michigan
Health System, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-
5008 ([e-mail]).
The contributions of John F. Mitchell, Pharm.D., Joshua Loveland,
Pharm.D., and the pharmacists and technicians of C. S. Mott Children’s
Hospital are acknowledged. Darrell Campbell, M.D., Mark
Pearlman, M.D., and Chris Dickinson, M.D. are recognized for their
support of medication-safety initiatives.
Copyright © 2008, American Society of Health-System Pharmacists,
Inc. All rights reserved. 1079-2082/08/0101-0049$06.00.
DOI 10.2146/ajhp060626
Enhanced photoemission spectroscopy
for verification of high-risk i.v. medications
Yaman Kaakeh, Hanna Phan, Brian D. DeSmet, Deborah A. Pask o,
Denise K. Glenn, and James G. Stevenson
Technology has provided an opportunity
to improve safety in
dispensing oral drug formulations
with robotic assistance and
bar-code systems. The checking of
compounded i.v. drug products, however,
has been more challenging. The
i.v. compounding area in the pharmacy
is high volume and high risk.

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Health Robotics Announces American Joint Venture With i.v.SOFT
BOZEN, Italy, July 27 /PRNewswire/ -- Health Robotics today announced that it has embarked in a joint venture with i.v.SOFT in order to market, implement, and support its I.V. Workflow Engine and related software automation modules to hospitals and infusion centers in North America. One of its software modules (OncoCube) has already been installed and is being currently utilized at the University of Colorado Hospital [Denver], in addition to all-digital and totally integrated I.V. installations at La Maddalena Cancer Center in Palermo and Campus Biomedico University General Hospital in Rome.

While significant investments have already been made by North American vendors and hospitals alike applying technology in an attempt to reduce I.V. (intravenous) medication errors, these efforts have largely focused on the stand-alone phases of prescription [CPOE] and administration [Smart Infusion Pumps], without an integrated approach to I.V. Workflow and Medication Management that includes Admixture phase preparation errors, and without the capability of tying together all phases of I.V. Medication Management.

The I.V. Room has been portrayed by some in the industry as a "dark hole in the hospital" where everything is "an impossible-to-differentiate clear liquid" and things are "out of control". Others have described the I.V.Room as the last frontier in Pharmacy Automation, or a place where patient labels are printed as output out of the Pharmacy System and then Sterile Compounding supervisors hope that nothing goes wrong afterwards due to lacking or inconsistent procedures and "tribal knowledge" cultures. Lost medications wandering around the hospital, no I.V. Admixtures' audit trails, "What is in that bag?" or "Who made that dose?" unanswered questions, costly repeat I.V. Admixtures, I.V. waste, and medication errors are commonplace at many institutions, and well documented in research studies throughout the world. While I.V. Robotics solutions such as CytoCare and i.v.STATION are successfully addressing many of these issues, Health Robotics believes that anywhere between 10 to 35% of I.V.s are not compatible with Robots, due to ampoules, non-standard elastomeric infusors, plastic bottles, sub-standard vial shapes, and the large variance in thousands of medical devices globally utilized for I.V. preparation and administration such as syringes, bags, bottles, tamper-evident caps, and needles.

"From the days of one mid-1990's-designed I.V. automation solution in the industry supporting only 1 brand & size of syringes, and one late-1990s robot supporting only 1 brand of bags and 1 brand of syringes, we have come a long way with CytoCare and i.v.STATION supporting multiple brands and syringe sizes, at least 7 brands of bags and bottles each with 5 sizes, and 95% of the vials available in the market. The i.v.SOFT Workflow Engine not only addresses the automation of I.V. preparation for patient doses not handled by Robots, but it also integrates the communication processes of all clinicians involved in all phases of I.V. Medication Management, from I.V. case planning all the way to Medication Administration monitoring, and whether the I.V. Admixtures are made by a Robotic Device or manually in a biological safety cabinet (BSC). i.v.SOFT Workflow Engine customers are continuously aided within the BSCs by electronic work-lists that guide them in the execution of each scheduled task, with touch-screen, Bar-Code, RFID, and image capture technologies that reduce the risk of errors, omissions, and delays in each phase of the I.V. Medication Management process, and consequently increase the time dedicated to caring for patients," stated Werner Rainer, CEO of Health Robotics.

About Health Robotics:

Health Robotics is the global leading supplier of life-critical intra-venous medication preparation, compounding, and dispensing Robots, providing healthcare facilities in four continents with robotics technology and software automation solutions. The world-leading solutions CytoCare [hazardous IVs], i.v.STATION [non-hazardous IVs], i.v.SOFT [workflow engine] and the future development of TPNstation, have and will greatly contribute to ease global hospitals' growing pressures to improve patient safety through the effective and efficient production of sterile, accurate, and ready-to-administer IVs, to eliminate life-threatening drug-exchange errors, to decrease other medication errors and sterility risks, and to work more efficiently, increase throughput, reduce waste, and contain costs.

About i.v.SOFT:

i.v.SOFT is a privately-held Delaware [USA] based corporation with the vision to fill the industry void of automating the control of I.V. Medications from the time the patient is scheduled for infusion to the point where IV Administration is completed in a closed-loop manner. i.v.SOFT Workflow Engine interfaces with Medical Devices [Smart Infusion Pumps, I.V.Robots], Automatic Dispensing Cabinets, and Clinical Information Systems, automating the Sterile Compounding phase of I.V. patient doses not handled by Robots, and tracking to completion all scheduled intravenous medications and other injectables throughout the medical facility until the patient's treatment is complete.


For additional information, please contact:
Health Robotics
Gaspar G. DeViedma
Europe: [phone]
USA: [phone]
[e-mail]

http://sev.prnewswire.com/health-care-hospitals/20090727/3942589en_iCrossing27072009-1.html

July 21, 2009
Robotics -Health Robotics Signs Agreement with German Hospital
By Nathesh
TMCnet Contributor


Health Robotics and Charite-Universitatsmedizin Berlin have entered into a definitive agreement through which Charite will install an i.v.STATION robot at its Centrum 14 during the second half of 2009.

Health Robotics is a supplier of life-critical intra-venous medication preparation, compounding, and dispensing Robots, providing healthcare facilities with robotic technology and software automation solutions. Charite is claimed to be one of the oldest hospitals in Germany and among the largest of university clinics in Europe today.

http://robotics.tmcnet.com/topics/robotics/articles/60352-health-robotics-signs-agreement-with-german-hospital.htm

Hospitals Tally Their Avoidable Mistakes

By Lisa Rein
Washington Post Staff Writer
Tuesday, July 21, 2009

These are among the hundreds of incidents of death or serious medical harm disclosed in the past year by hospitals in the Washington region, preventable errors that until recently have not required public reporting. Under laws that took effect last year in Virginia and a few years earlier in the District and Maryland, hospitals must report to health regulators many serious injuries that patients suffer in the course of treatment.

The laws are different in each jurisdiction. For example, Virginia's public records identify the hospitals by name, while Maryland's and the District's do not. But they all allow the public to glimpse the breadth of mistakes that health experts dub "never events" (because they should never happen): sponges left inside patients after surgery, operations on the wrong limb, medication errors,

http://www.washingtonpost.com/wp-dyn/content/story/2009/07/20/ST2009072002432.html

Jul. 11, 2009 10:15 PM
Medication errors harm millions of Americans each year

Medication errors — wrong drug, incorrect dose or improper use — harm at least 1.5 million people every year, according to the Institute of Medicine. Confusion caused by drugs with similar names accounts for up to 25 percent of the reported errors.

Premature infants with intravenous lines have received insulin instead of the blood thinner heparin.

http://www.kansascity.com/105/story/1318764.html

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Stevenson University of Michigan Enhanced Photoemission Spectroscopy

http://www.ajhp.org/cgi/content/abstract/65/1/49

American Journal of Health-System Pharmacy, Vol. 65, Issue 1, 49-54
Copyright © 2008. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

--------------------------------------------------------------------------------

Practice Report

Enhanced photoemission spectroscopy for verification of high-risk i.v. medications
Yaman Kaakeh, Hanna Phan, Brian D. DeSmet, Deborah A. Pasko, Denise K. Glenn and James G. Stevenson
YAMAN KAAKEH, PHARM.D., BCPS, is Clinical Assistant Professor of Pharmacy Practice, Purdue University, West Lafayette, IN; at the time of this study she was Pharmacy Practice Resident, Department of Pharmacy Services, University of Michigan Health System (UMHS), Ann Arbor. HANNA PHAN, PHARM.D., is Pediatric Pharmacotherapy Fellow, College of Pharmacy, The Ohio State University, Columbus; at the time of this study she was Neonatal Intensive Care Unit Clinical/Staff Pharmacist, Department of Pharmacy Services, C. S. Mott Children’s Hospital, UMHS. BRIAN D. DESMET, PHARM.D., M.S., is Pharmacy Specialist, Henry Ford Hospital, Detroit, MI; at the time of this study he was Pharmacoeconomics and Outcomes Fellow, Department of Pharmacy Services, UMHS. DEBORAH A. PASKO, PHARM.D., is Adjunct Clinical Assistant Professor, College of Pharmacy; Clinical Coordinator, C. S. Mott Pharmacy; and Clinical Pharmacy Specialist, Pediatric Critical Care, UMHS. DENISE K. GLENN, B.S.PHARM., is Supervisor, C. S. Mott Pharmacy, Department of Pharmacy Services, UMHS. JAMES G. STEVENSON, PHARM.D., FASHP, is Director of Pharmacy Services, University of Michigan Hospitals and Health Centers, and Professor and Associate Dean for Clinical Sciences, College of Pharmacy, University of Michigan, Ann Arbor.

Address correspondence to Dr. Stevenson at the Department of Pharmacy Services, UH B2D301, Box 0008, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-5008 ([e-mail]).



Purpose. The sensitivity and specificity of enhanced photoemission spectroscopy (EPS) for performing an automated final check of compounded i.v. admixtures at a pediatric hospital pharmacy were studied.
Methods. A tabletop EPS device was used to test samples of seven high-risk drug–diluent combinations compounded in the pharmacy; the drugs were vancomycin, lorazepam, morphine, insulin, hydromorphone, gentamicin, and epinephrine. Ten sets of samples were prepared for each drug. Typically, a sample set consisted of dilutions ranging from 10-fold above to 10-fold below the targeted concentration. Testing was performed twice weekly between November 2005 and March 2006.

Results. The EPS device detected errors departing from the targeted concentration by 20% or more with a sensitivity of at least 95%. Specificity in distinguishing among test medications at targeted concentrations was 100%. The percentage of passing samples with intermediate concentrations varied among the drugs.

Conclusion. A tabletop EPS device demonstrated acceptable sensitivity and specificity for validating the identity and concentrations of selected high-risk i.v. medications compounded for pediatric patients. The device may help prevent clinically important medication errors caused by inaccurate compounding.


Index terms: Aminoglycosides; Antibiotics; Anxiolytics, sedatives and hypnotics; Concentration; Control, quality; Diluents; Epinephrine; Errors, medication; Gentamicin; Hydromorphone; Injections; Insulin; Insulins; Lorazepam; Morphine; Opiates; Pediatrics; Spectrometry; Stability; Storage; Sympathomimetic agents; Vancomycin

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http://www.redorbit.com/news/health/1205943/improving_medication_safety_independent_18_month_study_of_valimedtm_medication/index.html

Improving Medication Safety: Independent 18 Month Study of ValiMed(TM) Medication Validation System By CDEX Published in American Journal of Health-System Pharmacists
Posted on: Monday, 7 January 2008, 09:00 CST

CDEX, Inc. (OTCBB: CEXI) announces publication of an 18 month independent study of the ValiMed(TM) Medication Validation System at the C.S. Mott Children's Hospital in the University of Michigan Health System in the American Journal of Health-System Pharmacists. "During the 18 months since [ValiMed] was implemented, five potentially serious medication errors have been detected and avoided," the report stated. "[ValiMed] consistently validated the correct solution, while dependably detecting as invalid the wrong drug or concentrations that departed substantially from the targeted standard." (Am J Health-Syst Pharm--Vol 65, pp 49-54, Jan 1, 2008, "Enhanced Photoemission Spectroscopy for Verification of High-Risk IV Medications.")

"Errors in compounding these types of medications are rare. However, when they occur they can have a significant negative impact on patients and staff," said one of the authors, Jim Stevenson, Associate Dean of Clinical Sciences at the University of Michigan College of Pharmacy and Director of Pharmacy Services at the University's Health System. "Our goal is to have zero tolerance for errors. We know from having ValiMed(TM) in place we've deterred five potentially serious errors that might have happened. I really believe having technology like this needs to be the standard around the country." (Stevenson's statements are drawn from a University of Michigan press release and are quoted with permission (see http://www.ns.umich.edu/htdocs/releases/story.php?id=6255).)

"This peer reviewed Study was a comprehensive analysis of our patented technologies and first generation ValiMed units," said Malcolm Philips, CDEX CEO. "Jim Stevenson and his Staff at the University of Michigan Health System are among the best and most forward thinking heath care organizations in the nation, with a zero tolerance policy for medication errors. They have stepped forward to tackle a significant problem facing the entire medical community and we look forward to working with them and other top rated national and international hospitals in our collective efforts to provide the best standard of care for patients."

ValiMed(TM) uses Enhanced Photoemission Spectroscopy to quickly validate high-risk medication admixtures, as well as returned narcotics, to provide an increased level of patient safety. ValiMed compares a medication's spectroscopic signature to its expected CDEX Library signature and returns an easy to understand "validated" or "not validated" result, requiring no user interpretation.

About CDEX, Inc.

CDEX, a technology development company currently developing products using its patented/patent pending chemical detection technologies, is focused on (i) identification of substances of concern (e.g., explosives and illegal drugs, for security markets); and (ii) validation of substances for anti-counterfeiting, brand protection and quality assurance (e.g., validation of compounded medication and detection of counterfeit or sub-par products, for the medical and brand protection markets). ValiMed(TM) and the Meth Scanner(TM) are CDEX solutions for the healthcare and security markets. Corporate headquarters and R&D facilities are located in Tucson, Arizona. For more information, visit www.cdex-inc.com and www.valimed.com or contact Malcolm Philips ([e-mail]) or Stuart Poteet ([e-mail]) at 520.745.5172 X 210 or 202.

Any Non-Historical statements are forward-looking, as defined in federal securities laws, and generally can be identified by words such as "expects,""plans,""may,""anticipates,""believes,""should,""intends,""estimates," and other similar words. These statements pose risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied. Such risks and uncertainties include, without limitation, the effectiveness, profitability and marketability of products, the Protection of intellectual property and proprietary information, and other risks detailed from time-to-time in filings with the Sec. There is no obligation to publicly update any forward-looking statements.


Malcolm Philips 520.745.5172 X 210 [e-mail] Stuart Poteet 520.745.5172 X 202 [e-mail] News Agent Angie Junell 214-461-3500
SOURCE: CDEX, Inc.

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practice R eport Photoemission spectroscopy
Am J Health-Syst Pharm—Vol 65 Jan 1, 2008 49
practice report
Yaman Kaakeh, Pharm.D., BCPS, is Clinical Assistant Professor of
Pharmacy Practice, Purdue University, West Lafayette, IN; at the time
of this study she was Pharmacy Practice Resident, Department of
Pharmacy Services, University of Michigan Health System (UMHS),
Ann Arbor. Hanna Phan, Pharm.D., is Pediatric Pharmacotherapy
Fellow, College of Pharmacy, The Ohio State University, Columbus;
at the time of this study she was Neonatal Intensive Care Unit Clinical/
Staff Pharmacist, Department of Pharmacy Services, C. S. Mott
Children’s Hospital, UMHS. Brian D. DeSmet, Pharm.D., M.S., is
Pharmacy Specialist, Henry Ford Hospital, Detroit, MI; at the time of
this study he was Pharmacoeconomics and Outcomes Fellow, Department
of Pharmacy Services, UMHS. Deborah A. Pask o, Pharm.D.,
is Adjunct Clinical Assistant Professor, College of Pharmacy; Clinical
Coordinator, C. S. Mott Pharmacy; and Clinical Pharmacy Specialist,
Pediatric Critical Care, UMHS. Denise K. Glenn, B.S.Pharm., is
Supervisor, C. S. Mott Pharmacy, Department of Pharmacy Services,
UMHS. James G. Stevenson, Pharm.D., FASHP, is Director of Pharmacy
Services, University of Michigan Hospitals and Health Centers,
and Professor and Associate Dean for Clinical Sciences, College of
Pharmacy, University of Michigan, Ann Arbor.
Address correspondence to Dr. Stevenson at the Department of
Pharmacy Services, UH B2D301, Box 0008, University of Michigan
Health System, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-
5008 ([e-mail]).
The contributions of John F. Mitchell, Pharm.D., Joshua Loveland,
Pharm.D., and the pharmacists and technicians of C. S. Mott Children’s
Hospital are acknowledged. Darrell Campbell, M.D., Mark
Pearlman, M.D., and Chris Dickinson, M.D. are recognized for their
support of medication-safety initiatives.
Copyright © 2008, American Society of Health-System Pharmacists,
Inc. All rights reserved. 1079-2082/08/0101-0049$06.00.
DOI 10.2146/ajhp060626
Enhanced photoemission spectroscopy
for verification of high-risk i.v. medications
Yaman Kaakeh, Hanna Phan, Brian D. DeSmet, Deborah A. Pask o,
Denise K. Glenn, and James G. Stevenson
Technology has provided an opportunity
to improve safety in
dispensing oral drug formulations
with robotic assistance and
bar-code systems. The checking of
compounded i.v. drug products, however,
has been more challenging. The
i.v. compounding area in the pharmacy
is high volume and high risk. Hospital
pharmacies may compound hundreds
of thousands of i.v. drug products annually,
and, in most institutions, checking
these products relies on human observation
alone. Typically, a technician
prepares a product and a pharmacist
visually checks the work. This process
has been in place in most institutions
since the advent of centralized i.v.
admixture services over 30 years ago.
Even if the human error rate in this
setting is extremely low, the high-risk
nature of many of the products being
prepared dictates that the pharmacy
must strive for an error rate of zero.
The Institute for Safe Medication
Practices has identified the following
drugs as high risk: adrenergic
agonists, epidural medications, ino-
Purpose. The sensitivity and specificity of
enhanced photoemission spectroscopy
(EPS) for performing an automated final
check of compounded i.v. admixtures at a
pediatric hospital pharmacy were studied.
Methods. A tabletop EPS device was
used to test samples of seven highrisk
drug–diluent combinations compounded
in the pharmacy; the drugs
were vancomycin, lorazepam, morphine,
insulin, hydromorphone, gentamicin,
and epinephrine. Ten sets of samples
were prepared for each drug. Typically, a
sample set consisted of dilutions ranging
from 10-fold above to 10-fold below the
targeted concentration. Testing was performed
twice weekly between November
2005 and March 2006.
Results. The EPS device detected errors
departing from the targeted concentration
by 20% or more with a sensitivity of at least
95%. Specificity in distinguishing among
test medications at targeted concentrations
was 100%. The percentage of passing
samples with intermediate concentrations
varied among the drugs.
Conclusion. A tabletop EPS device demonstrated
acceptable sensitivity and specificity
for validating the identity and concentrations
of selected high-risk i.v. medications
compounded for pediatric patients. The device
may help prevent clinically important
medication errors caused by inaccurate
compounding.
Index terms: Aminoglycosides; Antibiotics;
Anxiolytics, sedatives and hypnotics;
Concentration; Control, quality; Diluents;
Epinephrine; Errors, medication; Gentamicin;
Hydromorphone; Injections; Insulin;
Insulins; Lorazepam; Morphine; Opiates;
Pediatrics; Spectrometry; Stability; Storage;
Sympathomimetic agents; Vancomycin
Am J Health-Syst Pharm. 2008; 65:49-54
Practice R eport Photoemission spectroscopy
50 Am J Health-Syst Pharm—Vol 65 Jan 1, 2008
tropes, narcotics, heparin, insulin,
and sedative agents.1 Most of these
products are prepared in laminarairflow
hoods or sterile i.v. rooms,
after which the traditional human
verification occurs. Confirmation
bias may occur when a pharmacist
selectively supports what he or she
expects to see rather than what is actually
present.2 This may lead to failure
to detect errors in i.v. medication
preparation, even among very experienced
pharmacists.2 Many drug
vials look similar, with similar colors
and printing. These factors, coupled
with typical pharmacy distractions,
can promote an environment ripe for
medication errors.3 Therefore, a need
exists to improve the current system
of visual checking.
Rare incidents involving incorrectly
prepared sterile products that
resulted in patient harm contributed
to the development of the ASHP
Guidelines on Quality Assurance for
Pharmacy-Prepared Sterile Products,
which was published in 1993 and updated
in 2000.4 It was recognized that
the small number of reported errors
did not reflect the true frequency of
the problem, and in 1997 Flynn et al.5
identified a 9% mean error rate for
i.v. admixture compounding, excluding
ready-made products. More important,
the overall rate of potentially
clinically significant errors was 2%. A
dose in excess of 10% of the labeled
concentration was compounded in
3.1% of cases. The incorrect drug was
used for 0.6% of doses.
Enhanced photoemission spectroscopy
(EPS), an expanded version
of conventional fluorometry,
represents a potential means of
verifying the accuracy of i.v. drug
compounding. EPS is a proprietary
process for analyzing a composite
returned-energy spectrum. Using
EPS, the targeted material is interrogated
with light energy with a specific
range of wavelengths. The returnedenergy
spectrum is mathematically
converted to an alternative domain
and then analyzed in composite format
by multiple methods, including
fluorometry. This allows both drug
and concentration validation while
facilitating separation of drugs for
unique identification. A pilot study
we conducted showed that EPS was
successful at detecting doses more
than twofold above or below the targeted
concentration. We developed
a workflow process to prepare staff
for integrating the technology into
practice (Figure 1). However, further
study was warranted to better understand
the limits of the device.
The objective of this study was to
evaluate the sensitivity and specificity
of tabletop EPS for performing
an automated final check of compounded
i.v. admixtures at a pediatric
hospital pharmacy.
Methods
Instrument. The study was conducted
by the department of pharmacy
services at C. S. Mott Children’s
Hospital. A tabletop instrument
(ValiMed, CDEX, Inc.) was used to
validate high-risk i.v. medications that
are commonly compounded in the
pharmacy and used as bulk products
for additional compounding into
patient-specific doses. The instrument
generates ultraviolet light energy
through its fiberoptics; the energy is
directed at the medication sample to
excite sample molecules. The energy
returned by the medication, including
that associated with fluorescence, is
measured by a spectrometer.
To determine a drug’s unique
fingerprint,6-9 a combination of the
composite signature and the channel
values is used. The composite
signature is defined as the pattern
of wavelength-dependent intensity
resulting from emission of energy
by an excited molecule, combined
with scattered and specularly reflected
components. The degree of
photoemission and the wavelengths
at which it occurs are used to mathematically
validate the substance
being tested. The channel value is
defined as a point on the returnedenergy
curve that represents the intensity
strength of emitted energy at
a particular wavelength. The shape of
the curve is considered to be unique
for each drug.
Once the fingerprint was created
and ready for use, it was stored in the
device’s signature library. Two primary
evaluations were completed by
the device to validate a given sample.
First, the instrument compared the
scanned sample’s unknown signature
with that of the known signature
within the library. Comparison with
a known signature identified whether
the sample was the intended medication
defined by the properties and
acceptable variance for a known signature.
Second, signal strength was
used to validate its concentration.
The amplitude of signal intensity
was compared with set variables in
the device to identify the concentration
within predefined ranges. This
resulted in the sample being either
validated as matching the known
standard or not validated.
The EPS device was calibrated
daily with a control, which was a
specially designed cuvette that provided
a consistent spectral return.
The manufacturer periodically used
data from the control to determine
if any component degradation had
occurred and whether adjustments
were necessary.
Sample preparation. We chose
seven drug–diluent combinations
for the study. Selection of these
drugs was based on the literature
on medication errors,1 as well as on
institution-specific reports. They
were epinephrine hydrochloride
0.02 mg/mL in 5% dextrose injection
(D5W), gentamicin sulfate 10
mg/mL in D5W, hydromorphone
0.1 mg/mL in bacteriostatic 0.9%
sodium chloride injection, insulin
0.1 unit/mL in 0.9% sodium chloride
injection, lorazepam 1 mg/mL
in 0.9% sodium chloride injection,
morphine sulfate 1 mg/mL in 0.9%
sodium chloride injection, and vancomycin
10 mg/mL in D5W. Ten sets
practice R eport Photoemission spectroscopy
Am J Health-Syst Pharm—Vol 65 Jan 1, 2008 51
Figure 1. I.V. compounding workflow integrating enhanced photoemission spectroscopy (EPS).
Pharmacist reviews order
for appropriate dose
and use.
Order from
prescriber
Pharmacist
determines if product
qualifies for EPS.
1. Upon checking of setup, pharmacist
calculates concentration.
2. Pharmacist marks label with “V” to indicate
that product is to be tested.
3. Product
is completed.
Qualifies→ Technician or pharmacist
tests sample with EPS:
If syringe: Needle is attached to
syringe and 1 mL is injected into
cuvette.
If batch, bag, or bottle: 1 mL is removed
with new 3-mL syringe
for cuvette.
Product and sample are placed
on tray and on counter.
When sample is ready to test,
technician or pharmacist transports
tray to device.
Pharmacist enters order
into pharmacy information
system.
Technician receives label
and order and sets up
medication preparation.
Pharmacist checks
technician’s work before
completing preparation.
Product
is saved for lab
analysis, product
is remade,
and validation
process is
repeated.
Pharmacist
initials log.
Invalid
reading
Technician places
“invalid” label in log
for pharmacist review,
returns product to hood
for shaking and mixing,
and draws second
sample.
Invalid
reading
Technician places
“invalid” label in log
for pharmacist review,
then turns cuvette 180°
and reanalyzes sample.
Invalid
reading
Medication is
dispensed.
Pharmacist initials
log and sample sticker.
Technician places
“valid” label in log
for pharmacist review.
Final product is labeled
with sample sticker.
Valid
reading
Data to obtain: sample identifier,
technician and pharmacist, medication,
date, diluent, concentration expected,
reading by EPS device, first or second
attempt, redrawing of sample, remaking
of product, repositioning of cuvette
Valid
reading
Practice R eport Photoemission spectroscopy
52 Am J Health-Syst Pharm—Vol 65 Jan 1, 2008
of samples were prepared for each
drug. A sample set consisted of various
dilutions ranging from 10-fold
above to 10-fold below the targeted
concentration. With vancomycin 10
mg/mL as an example, the following
dilutions were prepared as a sample
set: 1, 5, 8, 9, 10, 11, 12, 25, 50, and
100 mg/mL. The only exception to
the sample-set dilutions occurred
if a drug could not be further concentrated
(e.g., gentamicin, which
is commercially available only as a
40-mg/mL solution, or four times
more concentrated than the standard
concentration of 10 mg/mL).
Testing was performed twice weekly
between November 2005 and March
2006. All sample sets were mixed by
the same person to eliminate any
interoperator variation. Each sample
was labeled with drug name, concentration,
and sample-set number to
track the sample through the testing.
Process validation. To provide a
process validation of the compounding
technique and ensure the validity
of the dilutions prepared, for each
drug we selected two sample sets at
random to send to the hospital laboratory
for analysis. A 5-mL volume
from each set at the targeted concentration
was labeled appropriately and
delivered to the laboratory. The results
for the two samples of each drug
were averaged. A 5% compounding
error was considered acceptable;
this also takes into consideration
bag overfill that is removed for bulkcompounded
items (e.g., vancomycin,
gentamicin).
Machine scanning and data collection.
After thoroughly mixing the
contents of each sample syringe, we
transferred a 1- to 2-mL portion to
an unused disposable cuvette. The
cuvette was then wiped with clean,
lint-free gauze on all sides to remove
any fingerprints or oils. Tests for all
dilutions of a given drug were performed
with the same test button on
the instrument, as though the sample
were actually at the targeted concentration.
Data from the sample scans
were recorded electronically in the
instrument, including date and time
of the scan, observed result of the
scan (validated or not validated), and
channel value of the scan in a text
file format. The channel values were
transferred to an Excel spreadsheet
(Microsoft Inc.) for analysis.
Cross-testing. To study the instrument’s
ability to distinguish among
the test drugs, a sample of each drug
at the targeted concentration was
scanned as though it were each of
the other drugs being studied. For
example, a 1- to 2-mL volume of
vancomycin 10 mg/mL was scanned
by using the signatures of each of the
six other drugs. These results were recorded
by the device and transferred
to an Excel spreadsheet.
Data analysis. The sample size
necessary was determined by the
assumed sensitivity and specificity
of the instrument, as well as by
the desired width of the confidence
intervals around the sensitivity and
specificity. We assumed that the device
was 95% sensitive at the targeted
concentration and 95% specific for
all dilutions other than the targeted
concentration. By using a sample size
of 10, we were able to conclude with
95% confidence that our assumption
was correct, as long as the percentage
of samples that passed testing
fell within 95% ± 13.5%. To measure
specificity, we assumed that concentrations
within 20% of the targeted
concentration (80–120% of goal
concentration) were acceptable.
Results
For all seven medications, the instrument
correctly did not provide
validation when the concentration
was 5- or 10-fold higher than the
targeted concentration or more than
50% lower. For samples at targeted
concentrations, the machine correctly
validated the samples in 100% of
cases (100% sensitivity). All the drugs
at 90% and 110% of targeted concentrations
were validated 80–100%
of the time. For gentamicin sulfate,
hydromorphone, and vancomycin,
all the samples were correctly validated.
Five of the seven medications
at 80% of targeted concentrations
were validated 80–100% of the time.
Six of the seven medications at 120%
of targeted levels were validated in
60–100% of cases. Eighty percent of
morphine and insulin sample sets at
50% of targeted concentrations were
validated; this result is outside the
20% range of acceptable error. Sensitivity
and specificity for lorazepam
were acceptable when compared with
other concentrations of lorazepam.
However, cross-testing found that
20% of lorazepam samples at the
standard concentration of 1 mg/mL
were validated as gentamicin. This
problem was communicated to the
manufacturer so that it could adjust
the signature, and the problem was
corrected.
Discussion
Our results indicate that EPS is
capable of validating the correct drug
and concentration when incorporated
into the i.v. admixture process
for the preparation of high-risk
agents. The technology consistently
validated the correct solution, while
dependably detecting as invalid the
wrong drug or concentrations that
departed substantially from the
targeted standard. A 20% range of
acceptable error was chosen, since it
would detect potentially catastrophic
errors and enhance patient safety
while minimizing false nonvalidations
that could have occurred because of
variations in compounding practice or
EPS technique. In most cases, such an
error would not have a serious clinical
impact. The goal was to protect the
patient from receiving the wrong drug
or doses severalfold different from
those intended. Further increasing
specificity could produce false nonvalidations
and potentially encourage
staff to bypass the machine.
In our pediatric hospital we currently
test 40–50 samples of patientspecific
high-risk products each
practice R eport Photoemission spectroscopy
Am J Health-Syst Pharm—Vol 65 Jan 1, 2008 53
day. Staff support and training were
provided throughout the trial, and
the program has been well received.
Training involved brief instruction
on drawing medication samples, using
screen functions, and inserting
cuvettes into the device. Designated
staff leaders addressed technical support
issues.
Overall workflow was not detrimentally
affected by the new verification
process. On average, 30–60
seconds is needed to perform all
the steps necessary to validate one
sample. This might be prohibitive
if the technology was applied to all
i.v. products, so we elected to use the
device only for high-risk medications.
Work processes were modified
during the trial to accommodate the
increasing numbers of samples that
were tested. The addition of a label
printer allowed pharmacy technicians
to run samples and have evidence
of validation for final review
by a pharmacist prior to dispensing.
This precluded the need for the pharmacist
to come to the machine to
verify each test result.
During the 18 months since the
technology was implemented, five
potentially serious medication errors
have been detected and avoided.
Two of the incidents involved bulk
vancomycin solutions that were
compounded with only half of the
required amount of vancomycin. The
device did not validate the samples,
and the pharmacist retraced the compounding
steps. In another incident,
an incorrect amount of morphine
was used to compound the final
product, resulting in a concentration
that was three times higher than
intended. Another potential overdose
was detected in the fourth incident, in
which 10 mL of lorazepam 2 mg/mL
was added to 20 mL of 0.9% sodium
chloride injection instead of 0.5 mL of
lorazepam 2 mg/mL. The fifth error
involved a mixup of dopamine and
dobutamine.
Several nonvalidations were initially
observed with lorazepam. After
investigation, it was noted that these
products were being prepared correctly
but that, because of lorazepam’s
high viscosity, the drug was not
evenly dispersed in the final product,
resulting in what appeared to be an
incorrect concentration. Thoroughly
mixing the admixtures helped to
avoid false nonvalidations. Awareness
of this variation has improved
the consistency of compounding
practice.
Because the amount of returned
energy is related to the concentration
of the substance being tested,
EPS is capable of validating that both
the desired drug and concentration
are present. Refractometry, another
technique that has been used to validate
liquid drug products, measures
the degree to which the compound
refracts light passing through it. Experience
at our institution indicated
that refractometry does not have
sufficient sensitivity and specificity
to distinguish among the many drugs
and concentrations that we sought to
test in the i.v. admixture setting. Refractometry
also has some deficiencies
in testing controlled substances
sent to the operating room, since
some critical drugs do not refract
light in a manner that can distinguish
them from water.
There appear to be several limitations
to testing with EPS. Medications
that do not fluoresce and those
with weak signals within the ultraviolet
spectrum, such as potassium
chloride, cannot be verified with this
technology. The instrument works
only for drugs for which reliable signatures
can be established. Heparin
sodium is one example of a heterogeneous
drug that has been difficult
to create a signature for. Signatures
differentiating various concentrations
of heparin—particularly low
ones—have not yet been established.
While testing has demonstrated acceptable
performance in distinguishing
among drugs and concentrations,
the technology may not be able to adequately
distinguish errors due to the
incorrect diluent (e.g., gentamicin
10 mg/mL in 0.9% sodium chloride
injection instead of in D5W). Signatures
have been established only for a
limited number of high-risk medications
at this point; work is ongoing
to develop more signatures and to
refine some of those that are currently
in test mode. The EPS device
is not an analyzer; it only provides
information about whether a sample
matches a programmed standard
concentration.
We are interested in using EPS to
verify chemotherapy drugs, as they
are certainly high risk. One of the
barriers to this is that most chemotherapy
doses are individualized on
the basis of body weight or body
surface area; EPS works best when
there is a standard concentration of a
product to compare against a known
signature. Also, there is currently no
way to maintain a closed system to
protect pharmacy personnel from
drug exposure.4 Despite these limitations,
many of the high-risk products
prepared today in hospital pharmacies
appear to be suitable candidates
for EPS.
More work is underway to test the
device further and additional drug,
concentration, and diluent signatures
are being developed. Problems
identified in this study for some of
the signatures were communicated
to the manufacturer for adjustments.
Those signatures are currently being
tested. The manufacturer is planning
to release a second-generation device
that has a larger library of signatures
and that will reduce the integration
times needed to run samples; a study
similar to this one will be needed to
verify sensitivity and specificity.
Conclusion
A tabletop EPS device demonstrated
acceptable sensitivity and
specificity for validating the identity
and concentrations of selected highrisk
i.v. medications compounded for
pediatric patients. The device may
help prevent clinically important
Practice R eport Photoemission spectroscopy
54 Am J Health-Syst Pharm—Vol 65 Jan 1, 2008
medication errors caused by inaccurate
compounding.
References
1. Institute for Safe Medication Practices.
List of high-alert medications. www.
ismp.org/tools/highalertmedications.pdf
(accessed 2005 Aug 20).
2. Institute for Safe Medication Practices.
What is confirmation bias? www.ismp.
org/pages/ismp_faq.htmL#question%208
(accessed 2005 Aug 20).
3. Kelly WN. Understanding and preventing
drug misadventures: pharmacy contributions
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4. American Society of Health-System
Pharmacists. ASHP guidelines on quality
assurance for pharmacy-prepared sterile
products. Am J Health-Syst Pharm. 2000;
57:1150-69.
5. Flynn EA, Pearson RE, Barker KN. Observational
study of accuracy in compounding
intravenous admixtures at five
hospitals. Am J Health-Syst Pharm. 1997;
54:904-12.
6. Agranovski V, Ristovski Z, Hargreaves M et
al. Performance evaluation of the UVAPS:
influence of physiological age of airborne
bacteria and bacterial stress. J Aerosol Sci.
2003b; 34:1711-27.
7. Eversole JD, Cary WK Jr, Scotto CS et al.
Continuous bioaerosol monitoring using
UV excitation fluorescence: outdoor test
results. Field Anal Chem Technol. 2001;
15:205-12.
8. Lakowicz JR. Principles of fluorescence
spectroscopy. New York: Plenum; 1986:1-
42.
9. Guilbault GG. Practical fluorescence. 2nd
ed. Boca Raton, FL: CRC; 1990 Oct.

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