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Educating the

©2009 Institute for healthcare community about A federally certified


Safe Medication Practices safe medication practices Patient Safety Organization

ISMP 

MedicationSafetyAlert! Acute Care

August 27, 2009 Volume 14 Issue 17


SafetyBriefs Ohio government plays Whack-a-Mole with pharmacist
Scan product, not storage On August 14, 2009, Ohio pharmacist The pharmacy was short-staffed on
HIGH-ALERT container label. A vial of generic Eric Cropp was sentenced to 6 months the day of the event
sulfamethoxazole and trimethoprim injection was in prison, 6 months of home confine- Pharmacy workload did not allow for
accidentally placed in a pharmacy shelf bin meant ment with electronic monitoring, 3 years normal work or meal breaks
for EPINEPHrine injection 30 mL multiple-dose of probation, 400 hours of community The pharmacy technician assigned to
vials. Sometime later, a technician went to remove service, a $5,000 fine, and payment of the IV area was planning her wedding
an EPINEPHrine vial from the bin as part of a court costs, for his role in a fatal medica- on the day of the event and, thus,
refill process for automated dispensing cabinets tion error. (Early last week, ISMP highly distracted
(ADCs) located on nursing units. The technician President Michael Cohen posted A nurse called the pharmacy to
scanned a drug identification label on the comments regarding the sentencing at: request the chemotherapy early, so
medication bin but did not scan the label on the www.ismp.org/pressroom/injustice-jail Eric felt rushed to check the solution
vial itself. The vial was placed in a ziplock bag with time-for-pharmacist.asp.) Eric made a so it could be dispensed (although, in
a barcoded label and then placed with other items human error that tragically led to the reality, the chemotherapy was not
for the surgery department ADCs. A death of a child—the fodder needed for several hours).
pharmacist checked the item by of nightmares that plague
scanning the barcode on the ziplock many health professionals We don’t have details regarding how
bag but, again, not the vial inside the who perpetually fear making verification of IV admixtures occurred in
bag. Later the technician placed the that one fatal error. During this hospital, but we have observed
item in the ADC, again scanning the manual inspection of a unsafe variations of the checking process
barcode on the ziplock bag, which compounded chemotherapy in other hospitals—from a jumble of vials
matched the ADC barcode where the solution, Eric failed to recog- and syringes pulled back to the supposed
product was stored. When nize that a pharmacy techni- volume of additives, to vials and syringes
performing a monthly ADC check as cian had made the base from different admixtures together on a
required by the pharmacy’s state solution using too much cluttered surface awaiting verification.
regulations, a pharmacist discovered 23.4% sodium chloride. The We also know little about why the
the error and removed the erroneous vial. The size, child received the chemotherapy technician made the compounding error,
shape, and colors of the vials, seen in Figure 1, are solution and developed severe hyperna- other than press reports stating she was
similar, especially when one vial among many is tremia, which led to her death. highly distracted that day. However, we
oriented in a bin where the drug name is not know that compounding a chemotherapy
visible. The hospital has now switched to a different Human factors research confirms that base solution from scratch is error-prone
manufacturer for the sulfamethoxazole- manual checking systems are not 100% and often unnecessary; such exactness of
trimethoprim product to help avoid mix-ups. reliable. Under ideal conditions, we— base solutions is frequently not required
meaning all human beings—fail to from a clinical standpoint.
perform a check correctly about 5%1,2 of
the time, and we fail to detect an error The price of this medication error was
during the checking process between ever so costly: a beautiful 2-year-old child
5%2 and 10%3 of the time. While under named Emily Jerry lost her life; Emily’s
moderate stress, our failure to detect an family will forever suffer the pain of her
error during an inspection or verification loss; healthcare practitioners who were
process increases to about 20%.4,5 involved in the error and/or Emily’s care
are forever changed by the event; and
Figure 1. Vials resemble each other, particu- According to news media6-8 and personal Eric Cropp, who will never practice
larly when the front of the labels face away
from the healthcare practitioner. conversations with Eric’s defense attor- again (the Ohio board of pharmacy
neys, conditions under which Eric was permanently revoked his license), will
Although bar-coding technology, automated working on the day of the event were far forever feel the weight of his human falli-
dispensing, and multiple checks can dramatically from ideal and outside his control: bility and how it played out on that
decrease the potential for product mix-ups, only fateful day—this while serving an
scanning the barcode on the product label itself The pharmacy computer system was undeserved term of incarceration and
when removed from bins, ADC pockets, or down in the morning, leading to a other criminal and civil penalties.
continued on page 2 backlog of physician orders continued on page 2

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August 27, 2009 [ Follow us on Twitter.com (ISMP1) ] Volume 14 Issue 17

SafetyBriefs continued from page 1 Whack-a-Mole continued from page 1


carousels can assure the correct product has been D a v i d M a r x , CEO of Outcome and the game is won. Problem solved.
selected. Drug storage bin labels should never be Engineering, likens such a punitive Mole whacked. As Marx writes, the “if
used to identify products. Incidentally, had the mix- response to human error to a child’s we all just do our jobs correctly and
up taken place the other way around (EPINEPH- game of Whack-a-Mole. The game is follow the rules” club tends to view
rine dispensed for sulfamethoxazole-trimethoprim), played by lying in wait until a mole (the all bad outcomes as blameworthy
and had a patient actually received the wrong drug, adverse event) pops up, and then trying incidents—even in the presence of
the error almost certainly would have been lethal. to whack the exposed mole with a poorly designed systems and perform-
hammer (to punish the person closest to ance shaping factors outside the control
Kapidex or Capadex? In our the event) before it retreats back into the of involved workers; even in the absence
August 13, 2009 newsletter, we warned safety of its hole. In his profoundly of an intent to harm or an evil-meaning
about mix-ups between KAPIDEX (dexlansopra- moving new book on this topic, Whack- mind.
zole) and CASODEX (bicalutamide). Since then, a-Mole: The Price We Pay for Expecting
we heard from a pharmacist who received a pre- Pe r fe c ti o n9 (available at Barnes & No matter how hard we try, human
scription from a doctor’s office via telephone for Noble), Marx notes that this child’s game endeavors carry inherent risks. We can
Kapidex. The office nurse had misspelled the drug is a telling depiction of how we set try to do everything possible to make it
as “Capadex,” probably because she heard the unrealistic expectations of perfection for safe for patients, but we often fail to plan
doctor pronounce the drug name and then tran- each other and then unjustly respond to for the unexpected—a computer system
scribed it phonetically. When the pharmacist tried our fellow human beings who inevitably that is nonfunctional when you arrive at
to enter the medication into the computer, he make mistakes. We play the game at work, causing a serious backlog of work;
could not find “Capadex.” The pharmacist asked work by writing disciplinary policies that an inadequate level of staff on duty
others in the pharmacy if the prescribed drug literally outlaw human error. Our legisla- because of unexpected absences; a
could be Casodex. Meanwhile, one of the pharma- tors play the game by writing laws that distracted technician working in a hectic
cists searched “Capadex” using Google to see if it make human error a felony punishable high-risk IV area—just a few of the
was an actual product. He saw many listings for by prison. We take the easy route with a unexpected conditions in Eric’s case on
“no harm (no visible mole), no foul (no the day of the event. As Marx notes in
“Capadex” as well as a listing for Kapidex. But
whack required)” policy. We turn a blind his book, civil, criminal, and regulatory
“Capadex” is a foreign product containing aceta-
eye to those imposing unnecessary risk systems are increasingly obscuring the
minophen and propoxyphene (similar to DARVO-
as long as the outcome is good (no mole differences between intentional, risky
CET) available in Australia and New Zealand, and
pops up). But we push our need for choices and inadvertent human fallibility.
online. At least one site advertises that no pre-
perceived “justice” to the point that every Thus, the net cast to catch criminals is
scription is needed. We’ve notified FDA about this harmful adverse outcome must have an now catching those whose only crime is
new issue associated with the brand name accompanying blameworthy person to that they are human. The criminal courts
“Kapidex.” Given that the name is being confused punish. are playing the most extreme version of
with Casodex and could lead to dangerous confu- Whack-a-Mole with the lives of all
sion with the foreign product Capadex, this might According to Marx, the Whack-a-Mole healthcare professionals, for who among
be a case where a name change is appropriate. game is simple and addicting: a health- us cannot say, “It could have been me”
care professional makes a harmful error when thinking about the plight of Eric
Arginine errors in pediatrics. and the healthcare system in which he Cropp and Emily Jerry?
Last month, an FDA Drug Safety Newsletter works fires him—w whack! The profes-
included information from a post-market safety sional licensing board takes his license Marx makes it clear in his book that
review of arginine hydrochloride injection (R-Gene away—w whack! The newspapers and playing the Whack-a-Mole game costs us
10), a drug used to evaluate pituitary function online news media demonize the dearly, in lives that will continue to be
(www.fda.gov/Drugs/DrugSafety/DrugSafetyNews dedicated professional who has made the lost due to our failure to learn from
letter/ucm167883.htm). FDA has received several mistake—w whack! The civil court mistakes, and in resources that could be
reports of errors and other adverse events with this demands payment from the professional put to better use. When we play the
drug. Reports from FDA’s Adverse Events Reporting for the bad outcome—w whack! The game, it does nothing to enable us to
System (AERS) include four fatal overdoses in criminal court sends him to jail—w whack! learn what we might do differently the
pediatric patients. One of these cases was reviewed Leaders in the healthcare system who next time to avoid a similar tragedy. In
in the January 31, 2008, ISMP Medication Safety employed him stand by silently, without fact, ISMP is unaware of steps to help
Alert! (www.ismp.org/Newsletters/acutecare/ uttering a single word about the system- other Ohio hospitals learn from this
articles/20080131.asp). A number of prevention based causes of the error to help defend event and redesign their systems accord-
suggestions were included in this newsletter and the individual—w whack-whack! Society is ingly. We have not heard about any visits
should be considered wherever and whenever poised to pounce, to swing the hammer by state surveyors to detail expectations
arginine hydrochloride is stored, prepared, or when someone is injured. Punish the regarding prevention strategies in all
administered. person most visibly involved in the error continued on page 3

Please encourage your patients and staff to visit www.consumermedsafety.org often. It may save a life!
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August 27, 2009 [ Follow us on Twitter.com (ISMP1) ] Volume 14 Issue 17

WorthRepeating... Whack-a-Mole continued from page 2


Valtrex (valacyclovir) and Valcyte Ohio hospitals. If nothing has changed in system because it is predominantly a
Ohio hospitals, as well as other hospitals human-based system despite our ever-
(valganciclovir) confusion
in the US, the death of this little girl is a increasing use of technology. Likewise,
In our June 26, 2002, newsletter we wrote about heartbreaking commentary on health- we cannot and should not expect perfec-
an error involving a mix-up between VALTREX care’s inability to truly learn from mistakes tion from each other, no matter how
(valacyclovir) and VALCYTE (valganciclovir), so we are not destined to repeat them. On critical the task may be. We are fallible
mentioning how easy it is to confuse the two a positive note, though, the Ohio legisla- human beings destined to make mistakes
drugs. Since then, other mix-ups have been ture passed and implemented Emily’s along the way, as well as to drift away
reported to the ISMP Medication Errors Reporting Law (http://lsc.state.oh.us/analyses/analy from safe behaviors as perceptions of risk
Program (ISMP MERP). The generic names for sis127.nsf/c68a7e88e02f43a985256dad0 fade when trying to do more in resource-
these two drugs are strikingly similar, and both the 04e48aa/443d752e6fc207bb852575050 strapped professions. Our real power to
brand and generic names of the products start with 053b835), which requires all pharmacy protect patients is in the systems we
the prefix “val,” contributing to look- and sound- technicians to be trained, tested, and certi- build around imperfect human beings.
alike confusion. Both have uses associated with fied via a state board of pharmacy approved
cytomegalovirus (CMV) and may be used in course, as they are in 26 other states. References:
1) The Institute of Petroleum. Human reliability
immunosuppressed patients with human immuno- analysis. Human factors no. 12 briefing notes.
deficiency virus (HIV) or transplant patients. Valtrex There is another insidious flip side to the London, England; 2003.
is used in the treatment of shingles (herpes zoster), Whack-a-Mole game; it prevents learning 2) Grasha A. A cognitive systems perspective on
cold sores (herpes labialis), genital herpes (herpes by driving errors underground and discour- human performance in the pharmacy: implications
for accuracy, effectiveness and job satisfaction.
genitalis), and as prophylaxis for prevention of CMV ages students from becoming healthcare Executive Summary Report, Report No. 062100.
in patients with advanced HIV or after transplan- professionals. Some will ask, “Why Alexandria, VA: National Association of Chain
tation. Valcyte is used in the treatment of CMV disclose errors and risk punishment, loss Drug Stores; Oct. 2000.
retinitis in patients with acquired immunodeficiency of a hard-earned license, going to jail?” 3) Lewis M. THERP: Technique for Human Reliabil-
ity Analysis. Pittsburgh, PA: University of Pittsburgh;
syndrome (AIDS) and also for prevention of CMV in Thus, some risks will not be addressed to 2002. www.pitt.edu/~cmlewis/THERP.htm
kidney, heart, and kidney-pancreas transplant prevent harm. College students may not 4) System Reliability Center. Technique for human
patients. Also, valacyclovir is metabolized to be drawn to legally “risky” healthcare error rate prediction (THERP). Rome, NY: Alion
acyclovir while valganciclovir is metabolized to professions, and professionals working in Science and Technology; 2005.
5) Gertman D, Blackman H, Marble J, et al. The
ganciclovir, all of which are drug names that are healthcare may try to avoid risky tasks, SPAR-H human reliability analysis method.
easily confused, too. such as compounding IV solutions. Prepared for The Division of Risk Analysis and
Applications, Office of Nuclear Regulatory
The June 26, 2002, report involved a doctor Marx makes a compelling argument that Research, US Nuclear Regulatory Commission
(NRC Job Code W6355); Washington, DC;
prescribing the wrong drug, but other error reports the Whack-a-Mole approach is ineffec- August 2005.
involve nurses and pharmacists who confused the tive, inefficient, unsafe, and wholly 6) McKoy K, Brady E. Rx for errors: drug error
drugs while transcribing and dispensing them, or unjust. There is a better way of dealing killed their little girl. USA Today February 2, 2009.
misinterpreted the drug name due to poor with human error and promoting the www.usatoday.com/money/industries/health/2008-
02-24-emily_N.htm
handwriting. For example, a pharmacist recently behavioral choices that best support 7) Sangiacomo M. Chris Jerry, whose daughter
notified us about a colleague who noticed that a safety. We spend far too much time Emily died from a pharmacy technician’s mistake,
heart transplant patient had received valacyclovir in reacting to the severity of the outcome starts foundation to push for national law. The Plain
error for 10 days. The drug had been chosen incor- and punishing the unfortunate soul Dealer June 13, 2009. http://blog.cleveland.com/
metro/2009/06/chris_jerry_whose_daughter_
rectly by the prescriber from a computer selection closest to the harm, and far too little emi.html
screen. time addressing the system design that 8) Atassi L. Former pharmacist Eric Cropp gets 6
got us to the bad outcome and the behav- months in jail in Emily Jerry’s death from wrong
For either of these drugs, we’d highly recommend ioral choices that might have contributed chemotherapy solution. The Plain Dealer August
15, 2009. www.cleveland.com/news/plaindealer/
using both the brand and generic names when to the outcome. A bad outcome should index.ssf?/base/cuyahoga/1250325193310800.xml
referring to them and determining their purpose never automatically qualify a practitioner &coll=2
when processing the orders. We also recommend for blame and punishment. We will never 9) Marx D. Whack-a-Mole; The Price We Pay for
using tall man letters when listing the drugs in be able to design a perfect healthcare Expecting Perfection. Plano, TX: By Your Side
Studios; 2009.
computerized inventories: consider using
valACYclovir and valGANCIclovir. You might also be ISMP Medication Safety Alert! Acute Care (ISSN 1550-6312) ©2009 Institute for Safe Medication Practices
able to configure a computer alert to warn of the (ISMP). Permission is granted to subscribers to reproduce material for internal communications. Other repro-
duction is prohibited without permission. Report medication errors to the ISMP Medication Errors Reporting
risk of mix-ups during order entry. We are consid- Program (MERP) at 1-800-FAIL-SAF(E). Unless noted, published errors were received through the MERP.
ering adding these drugs to our unofficial list of ISMP guarantees confidentiality of information received and respects reporters' wishes as to the level of detail
product names that should be expressed using tall included in publications. Editors: Judy Smetzer, RN, BSN, FISMP; Michael R. Cohen, RPh, MS, ScD;
Russell Jenkins, MD. ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044. Email: ismpinfo@ismp.org;
man letters (www.ismp.org/tools/tallman Tel: 215-947-7797; Fax: 215-914-1492. This is a peer reviewed publication.
letters.pdf).

Please encourage your patients and staff to visit www.consumermedsafety.org often. It may save a life!
ISMP
Medication Safety Intensive
A unique 2-day workshop that
will arm you with the tools you
need to establish an aggressive,
focused medication safety
program

Program Overview
This intensive workshop will help you look at your organization “through the eyes of
ISMP” medication safety experts, who will take you through their real-world experiences
in establishing and evaluating medication safety programs.

During The Workshop, You Will:


Engage in group discussions
Take part in hands-on practice in error and data analysis
Evaluate the root causes related to medication errors
Learn how to effectively select high-leverage strategies to sustain your safety
efforts
Earn 12 contact hours of pharmacy or nursing continuing education.

October 8-9, 2009


Scottsdale, AZ

For more information about the program and to register,


please visit: www.ismp.org/educational/MSI.

Fees and Registration


Early Bird: $950
Don’t miss out on the early registration discounts if you register up to 21 days before the program!

Supported through a grant from


Regular Registration: $1,095

The Hospira Foundation


Space is limited, so register today!

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