Download ISMP Medication Safety Alert! Community/Ambulatory Care Edition

ISMP
Educating the Healthcare Community
About Safe Medication Practices
Medication Safety Alert!
Community/Ambulatory Care Edition
¿Comprende? Not Necessarily
Many people who are acutely ill or require ongoing therapy
for a chronic condition have trouble adhering to a prescribed
plan of care. Some limits occur as a result of emotional
distress, clinical condition, or socioeconomic factors. But
pharmacists should also consider the possibility that poor
health literacy—the ability to read, understand, and act on
healthcare information—is a barrier to adherence for many
patients. Older patients, people with chronic diseases, recent
immigrants, and patients who do not speak English as their
primary language, or at all, are especially likely to exhibit
low health literacy. ISMP recently received a report from a
community pharmacist who works in a setting where 90%
of her patients are Spanish-speaking. An elderly man, who
did not speak or read English, returned to the pharmacy for
more information after having taken a portion of a
methylprednisolone dose pack. He had not received appropriate instructions about how to administer this complicated
dosing regimen, and he was not taking the medication
correctly. Fortunately, the gentleman was not harmed, but he
didn’t receive the full intended benefits of the drug either.
®
E-mail: [email protected]
Hotline: 1 800 FAIL SAF(E)
Volume 7, Issue 1
January 2008
Safety Briefs
A 2004 study among Spanish-speaking Latino parents with
limited English proficiency who where given prescription
Anonymous patches. Nurses and pharmacists have
reported that CATAPRES (clonidine) patches present
problems because the manufacturer does not print the
name or strength of the drug on the patch itself. The
patches are available in a variety of strengths and are
worn for a week at a time. Problems are often
reported, especially if the dose of a drug delivered via
patch is changed, or if the patient requires multiple
patches. Long-term care settings seem to be particularly vulnerable to problems using this product.
Because the Catapres patch does not contain the name
of the drug, caregivers can determine only that
something is on the skin. They cannot determine the
drug, the dose, or, in some cases, even distinguish it
from adhesive bandages
and specialty dressings.
This can lead to errors. For
example, a nurse could
receive a new order for a
clonidine patch or an oral
dose of clonidine, and
Figure 1. The BI 33 code on
proceed to administer
this Catapres TTS 3 patch
additional medication not
indicates it contains 0.3 mg.
realizing that the patient
already has a clonidine patch affixed. Or, if the patient
has a clonidine patch along with another unlabeled
drug patch (e.g., LIDODERM [lidocaine]), the wrong
patch can be removed and replaced with the same
patch that remains on the patient. Thus, the patient
would receive a double dose of one medication and
none of the other. Another error-prone feature is the
ability of Catapres’ cover to be mistaken for the actual
drug patch and applied to the skin. We contacted the
manufacturer, Boehringer Ingelheim, about this longstanding problem and learned that they have no
immediate plans to print the drug name and dose on
the patch. We were also advised that the patch should
not be written on because it is not known if volatile
chemicals contained in ink might affect delivery of
the drug. However, the manufacturer did note that the
patch cover could be labeled and placed over the drug
patch to protect it. There’s also a code on each patch
cont’d on page 2
cont’d on page 2
Studies have shown that 36% of Americans function at the
basic health literacy level or lower.1 It is even more significant (66%) for Americans of Hispanic race/ethnicity.
Another study from a national managed care organization
described the literacy of 54% of Spanish-speaking Medicare
enrollees to be inadequate or marginal.2
Pharmacists should not assume that Spanish-speaking
patients who seem comfortable speaking English will understand a prescription label written in English. It is also wrong
to assume that patients who speak Spanish can understand
medication instructions written in Spanish. This fact has not
gone unnoticed by the pharmacist who reported the error
described above. She has observed that in the Hispanic community she serves, of which she is a member, it is common
for patients to indicate they understand what a healthcare
provider has said, even when they don’t fully understand the
instructions or how to access the information independently.
ISMP Medication Safety Alert!®
January 2008
page 2
¿Comprende? (cont’d from page 1)
labels in English and corresponding medication information
leaflets in Spanish exemplified this.3 The parents were asked
to read the medication label and the information sheet and
then answer questions regarding the medication and proper
dosing. Of the 100 participants in the study, only 22%
would have given a correct dose of medication to their child
and only 29% were able to answer questions regarding the
medicine dosage and proper use as a result of having access
to written information in Spanish. Also noteworthy in the
study was the fact that even among subjects who selfdescribed themselves as being comfortable speaking
English, only 50% were able to demonstrate knowledge that
would allow them to accurately prepare a dose of their
child’s medication.
SAFE PRACTICE RECOMMENDATIONS: In order to help
members of this patient population use medications safely, a
number of interventions must be employed. Here are some
suggestions that can make your patient education sessions
more successful.
Assess a patient’s level of comprehension. A new screening tool, which takes a few minutes to administer, has been
developed to assess comprehension levels of common
medical terms amongst Spanish-speaking people. The Short
Assessment of Health Literacy for Spanish-speaking Adults
(SAHLSA) identifies Spanish-speaking adults with low
health literacy.4 Notations should be made in these patients’
profiles and charts to alert practitioners and foster supplemental education for these patients at each follow-up visit.
You may obtain the SAHLSA by emailing University of
North Carolina at Chapel Hill’s professor Dr. Shoou-Yih D.
Lee at [email protected].
Offer supplemental counseling. Low health literacy
patients can receive supplemental patient education that is
tailored to meet their needs. When pharmacists understand
the special healthcare needs of Spanish-speaking people
with low health literacy and consistently offer customized
patient education, medication errors due to dosage and
indication confusion can be prevented.
Supply language-appropriate patient information.
Consider placing Spanish-speaking pharmacists in areas
with a high percentage of Spanish-speaking patients. In
practices with fewer Spanish-speaking patients, forge a
working relationship with a pharmacist who is fluent in
Spanish to assist in patient counseling. One of our reviewers
cont’d on page 3
Safety Briefs (cont’d from page 1)
(see figure 1) that can be used to identify the strength:
BI 33 designates a 0.3 mg patch, BI 32 is 0.2 mg, and
BI 31 is a 0.1 mg patch. Share these codes when
dispensing these patches. Educate patients about this
issue. Inform them of the need to keep an accurate, upto-date list of their medications, including the date each
patch was applied. Long-term care pharmacies and
facilities should consider attaching a notation about the
code designation along with the inventory item so that
dosing information appears on computer-generated
medication administration records.
“4 QD”, a sure thing for a daily overdose. A
psychiatrist wrote a prescription (see figure 2) for
lithium carbonate, used to manage bipolar disorder, as
“LiCO3 300 mg 4 QD.” The pharmacy technician interpreted it as take 4 capsules
once daily and entered it
into the computer as such.
When the pharmacist
reviewed the prescription,
Figure 2.
she made the same interpretation but then questioned the daily dosing of the
immediate-release product. The pharmacist checked the
patient’s profile and noted the patient was previously
taking 300 mg three times daily. The pharmacist called
the prescriber’s office, and the nurse verified the
prescription was written as “4 QD,” which in their
practice meant “take 1 capsule four times a day.”
Given the potential for confusion and risk for patient
harm, healthcare practitioners should stop using the
abbreviation “QD” in all forms of communication. In
the case above, not only was “QD” used but it was
used incorrectly. Instead, use the word “daily” in place
of “QD.” When expressing the directions “four times a
day,” it is best to use the complete English words,
although the abbreviation “QID” is acceptable.
OTC cough and cold medicines. FDA recommends
that over-the-counter (OTC) cough and cold drugs not
be used to treat children less than 2 years of age
because serious and potentially life-threatening side
effects can occur. FDA has not completed its review of
information about the safety of OTC cough and cold
medicines in children 2 through 11 years of age. For
more information visit: www.fda.gov/medwatch/safety/
2008/safety08.htm#cough.
ISMP Medication Safety Alert!®
January 2008
page 3
¿Comprende?(cont’d from page 2)
has been able to do this in his ambulatory care practice with
good success. Also, the National Library of Medicine and
the National Institutes of Health have produced easy-to-read
medication information leaflets in both English and Spanish.
They are available on-line at: www.nlm.nih.gov.
Provide small amounts of verbal information at one
time. First, in simple everyday language, tell patients what
they truly need to know to take their medications safely and
to identify important side effects. Emphasize desired behavior, not the medical facts. Leave extensive overviews of
interactions and side effects for later encounters. Avoid
using medical terminology and jargon.
Use multi-media visuals. Another strategy to consider for
patients with low health literacy is the use of multi-media
visuals aids, such as video, audiotapes, and CDs, preferably
in the patient’s primary language. Supplementing written
instruction sheets with drawings and simple pictograms can
also help patients understand how to take their medication.
Many simple black and white pictograms are available from
the U.S. Pharmacopeia at: www.usp.org/audiences/
consumers/pictograms.
Verify the patient’s understanding. Use the Teach-Back
Method to counsel patients. Avoid asking “yes” or “no”
questions. Instead, ask patients to show you and tell you
how they would take their medicine so that you can correct
knowledge gaps. Pharmacy personnel can assess comprehension by having patients repeat instructions in their own
words. Listen for accuracy. The preferred way to assess
knowledge, though, is to have the patient or caregiver
actually demonstrate how they will measure the dose and
administer the drug using the actual product, drug delivery
devices, or a sample product.
The Institute for Safe Medication Practices is an independent nonprofit agency.
ISMP accepts no advertising. The contents of this newsletter are copyrighted.
©2008 Institute for Safe Medication Practices. Law strictly prohibits redistribution, reproduction, or republication by recipients through any means, including
print, e-mail, or fax, without written permission by ISMP. Contact ISMP for subscription rates.
For more information regarding low health literacy and
resources to promote effective learning among low health
literacy clients, please visit www.npsf.org/askme3 or
www.ohiopatientsafety.org. Please note that Medication
Safety Brochures written at the 2nd-3rd grade level are available at the latter website in both English and Spanish.
References: 1.) Kutner M., et al. The Health Literacy of America’s Adults:
Results From the 2003 National Assessment of Adult Literacy (NCES
2006–483). U.S. Department of Education.Washington, DC: National Center
for Education Statistics. 2006. Available on the Internet at: http://nces.ed.gov/
pubsearch/pubsinfo.asp?pubid=2006483; 2.) Gazmararian JA, et al. Health literacy among Medicare enrollees in a managed care organization. JAMA. 1999;
281:545-551. Available on the Internet at: http://jama.ama-assn.org/cgi/content/
ful/281/6/545; 3.) Leyva M, Sharif I, Ozuah PO. Health literacy among
Spanish-speaking Latino parents with limited English proficiency. Ambulatory
Pediatrics. 2005;5:56-59; 4.) Lee SY, et al. Development of an easy-to-use
Spanish health literacy test. Health Services Research. 2006;41(4p1):
1392–1412.
Announcements
Now accepting applications for the 2008-2009
ISMP Safe Medication Management Fellowship!
The Fellowship, sponsored by Cardinal Health
Foundation, offers an experienced healthcare provider
an unparalleled opportunity to learn from and work
with some of the nation’s experts in medication safety.
The 12-month Fellowship commences in Summer 2008
at the suburban Philadelphia office of ISMP. Please
join us on February 18, 2008, at 1:00 p.m. ET for a
special, live conference call about the Fellowship.
Current and past Fellows will describe their experiences during their Fellowship as well as discuss their
post-Fellowship careers. They will also be available to
answer any questions about the Fellowship. To join the
call, please email Barbara Olson, the current ISMP
Fellow, at: [email protected].
Subscription Information
Individual subscription rates are $48 per year for 12 monthly
issues. Discounts are available for organizations with multiple
sites or multiple users. For more information, contact ISMP at
215-947-7797 or e-mail to [email protected].
ISMP Medication Safety Alert! Community/Ambulatory Care Edition (ISSN 1550-6290) ©2008 Institute for Safe Medication Practices (ISMP). ISMP® is an FDA
MEDWATCH partner. Call 1-800-FAIL-SAF(E) to report medication errors to the USP-ISMP Medication Errors Reporting Program (MERP) or report on-line at
www.ismp.org or www.usp.org. Unless noted, published errors were received through the MERP. ISMP guarantees confidentiality and security of information received
and respects reporters’ wishes as to the level of detail included in publications. Editors: Michael J. Gaunt, PharmD; Michael R. Cohen, RPh, MS, ScD; Judy Smetzer, RN,
BSN. Reviewers: ISMP staff and Tabitha Carreon, PharmD, RPh; Eddie Dunn, PharmD; Richard A. Feifer, MD; Charlotte Huber, RN, MSN; Stan Illich, RPh, MHA; Crystal
Lennartz, PharmD, MBA; Patrick McDonnell, PharmD; Andrew Seger, PharmD; Kelly J. Stanforth, PharmD, FISMP; Hermine Stein, DO; Kimberly Tallian, PharmD, FCSHP,
FASHP; Chuck Young, RPh, CFE. Institute for Safe Medication Practices, 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006. Tel. 215-947-7797; Fax 215-9141492; E-MAIL: [email protected]. This is a peer-reviewed publication.
Copyright © 2008 ISMP. Duplication is permitted only for internal distribution at your practice site. Duplication by any means for distribution outside your site is strictly prohibited.
©2008
ISMP
ActionAgenda
The numbers visible in the dose indicator
window in Pulmicort Flexhaler (budesonide
inhalation powder) provide confusing information to patients. The dial is labeled in increments of 20, and actual movement of the
dose-counter may not be discernable. Patients
may have difficulty telling if a dose has been
received.
10
January 2008
Confusion regularly occurs when patients must
convert SYMLIN (pramlintide acetate)—dosed
in micrograms—into units in order to administer Symlin using a manufacturer-recommended U-100 insulin syringe. Recently, a
patient nearly administered a 6-fold overdose
of Symlin before consulting his community
pharmacist for dose confirmation. Failure to
validate patient learning contributed to the
near miss.
A labeling mistake that would have resulted in
a significant under-dose of VICODIN
(hydrocodone and acetaminophen) was
discovered during a patient counseling session.
Poor penmanship on the part of the prescriber
contributed to “q6h” being interpreted as “qd.”
Problem
7
7
Issue
No.
Organization Assessment
ISMP MedicationSafetyAlert! ®
Community/Ambulatory Care Edition
Patients who use Pulmicort Flexhaler should
receive explicit instructions about how to
actuate the device, the slow-moving design
of the dose counter, and how to tell when
the device is empty. The manufacturer will
provide tear sheets and updated information
on the Pulmicort Flexhaler website once
patient instruction revisions are approved by
FDA.
Dose countdown misleading
When complex dose conversion is necessary,
patients must receive thorough instructions
and provide healthcare providers with a
“teach back.” Symlin teaching should include:
the prescribed dose; information about how
and when to adjust Symlin doses; converting
a dose from mcg to units; how to use an
insulin syringe to draw up the correct dose;
administration times; how to administer a
dose; when to measure blood glucose levels;
and blood glucose values to report to the
prescriber. The newly approved Symlin peninjector device may eliminate this problem.
Is this how I administer my Symlin?
Use patient counseling sessions as a final
check of prescription accuracy. Knowledge of
typical Vicodin dosing and the practice of
patient counseling using the original prescription allowed a second pharmacist to discern
this error and take corrective action before
the prescription was dispensed.
Patient counseling with original Rx
Recommendation
Action Required/Assignment
QAA 1
Date
Completed
One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent similar problems at your practice site. To
promote such a process, the following selected agenda items have been prepared for you and your staff to stimulate discussion and collaborative action to reduce the risk of medication errors. These agenda topics
appeared in the ISMP Medication Safety Alert! Community/Ambulatory Care Edition between July 2007 and December 2007. Each item includes a brief description of the medication safety problem, recommendations to reduce
the risk of errors, and the issue number to locate additional information as desired.
ISMP AmbulatoryCare
July - December 2007
©2008
ISMP
Two formulations of BYETTA (exenatide) are
distributed in pen injectors, one delivering
5 mcg/injection and one delivering
10 mcg/injection. The wrong strength may be
dispensed because both pens have similar
NDC numbers. Only the final two digits of the
NDC numbers are different which may not be
read by certain barcode scanning programs.
9
ISMP has received reports that indicate
different manufacturers are using identical or
very similar product codes (the middle four
numbers in the NDC number) for different
products. This has resulted in numerous
dispensing errors.
ISMP receives regular reports of erroneous
orders for insulin U-500 instead of the
intended U-100. The way insulin products are
listed on computerized order-entry screens
often causes confusion. Ready access to
concentrated insulin increases the likelihood of
inadvertent overdose if clinicians are not
aware that various concentrations exist.
8
8
January 2008
Organization Assessment
Manual double-checks of Byetta products, to
include the entire NDC number, are
warranted to ensure the correct strength is
dispensed, especially in community settings
where erroneous dispensing could lead to
repeated dosing errors.
Scanning inconsistencies
Patients who are accustomed to using insulin
syringes need to be educated when insulin
pen devices are prescribed. Nurses who
provide diabetes education, and dispensing
pharmacists, should verify the patient understands how to use insulin pen devices and
should observe a return demonstration to
validate learning. An instructional video
describing SoloStar is available at
www.ismp.org/sc?k=lantus.
Patient confused by insulin pen design
Recommendation
ActionAgenda
Action Required/Assignment
ISMP MedicationSafetyAlert! ®
Community/Ambulatory Care Edition
Evaluate how insulin is listed on order entry
and product selection screens. Partner with
your software vendor to determine the best
way to distinguish insulin products (adding
“CONCENTRATED” to U-500 insulin entries
has been proposed to major vendors).
Consider adding a hard stop on U-500 insulin
orders and require prescriber and pharmacist
verification before proceeding. Segregate
insulin products and ensure that front-line
staff knows about the potential for mix-up.
Humulin R Concentrate U-500
Pharmacies should: ensure the complete NDC
number is used when product selection is
verified and include NDC numbers as part of
a pre-purchase failure modes and effects
analysis when adding new products to stock.
NDC Product Codes: The same “middle four” does not mean equal
A patient received a three-fold overdose of
insulin (which resulted in an emergency
department visit) when he misunderstood how
to use the SoloStar insulin delivery device.
Pen devices may not have features—such as
the ability to see the plunger moving—that
patients rely on to tell if a dose has been
given.
Problem
11
Issue
No.
ISMP AmbulatoryCare
July-December 2007
ACAA 2
Date
Completed
©2008
ISMP
During a patient counseling session, a
pharmacist realized that he had nearly
dispensed PROGRAF (tacrolimus) instead of
PROZAC (fluoxetine). Sound-alike drug
names communicated over the telephone
contributed to the near-miss.
12
January 2008
A tragic case was reported in the news in
which MATULANE (procarbazine), used to
treat Hodgkin’s disease, was dispensed to a
pregnant woman instead of the ordered
prenatal vitamin, MATERNA. Matulane is the
only brand name drug in the U.S. that begins
with “MAT” so confusion may arise whenever
Materna queries are entered into pharmacy
systems.
HUMIRA PEN (adalimumab) is an existing
product used to treat immune-system disorders. A sound-alike product, HUMAPEN, used
to administer Lilly’s insulin HUMALOG (lispro
injection [rDNA origin]), has been introduced
recently.
9
10
A patient reported an error in which he
inadvertently administered rapid-acting
APIDRA (insulin glulisine [rDNA origin])
instead of the intended long-acting LANTUS
(insulin glargine [rDNA origin]). The similar
appearance of the vials contributed to the
error.
Problem
8
Issue
No.
Organization Assessment
ActionAgenda
ISMP MedicationSafetyAlert! ®
Community/Ambulatory Care Edition
Repeating and verifying drug information
communicated by telephone may help
prevent this type of error. Patient counseling
sessions that include reviewing the indication
for therapy and the prescribed medication
give pharmacists the opportunity to catch
errors before harm occurs.
Sound-alike names
Materna is no longer available in the U.S., but
pharmacy personnel should be alert for
prescriptions written for this product as it
may be considered a generic term for
prenatal vitamins. Consider requiring the full
drug name (“Matulane”) to be typed into the
system before this choice is displayed. Check
the indication for new prescriptions with the
patient profile or the patient and maximize
patient counseling when high-alert drugs are
dispensed.
Materna – Matulane mix-up
Communicate these potentially confused,
sound-alike products to frontline pharmacy
staff. Before dispensing these drugs and
devices, personnel should match the indication for use with the patient’s condition as a
double check.
Humira Pen and HumaPen
ISMP notified sanofi-aventis, the manufacturer of these products, and asked them to
investigate ways to better differentiate these
insulin products. In the meantime, patients
should consider applying a distinctive mark—
such a bold black line—to one bottle of
similarly packaged insulin products or
purchase one product of a look-alike pair
from a different manufacturer.
Lantus – Apidra Mix-up
Recommendation
ISMP AmbulatoryCare
July-December 2007
Action Required/Assignment
ACAA 3
Date
Completed
©2008
ISMP
A patient reported being very dissatisfied with
the way his community pharmacist responded
when a dispensing error resulted in nearly 30
days of erroneous therapy. Unfortunately, this
pharmacist’s sense of infallibility contributed
to the original error, and the perception that
she was uncaring impeded an appropriate
apology and service recovery actions when the
error was discovered.
Use of electronically-generated prescriptions
may lead to unintended consequences that
impair prescribing safety. Problems with
misspelled drug names, the use of error-prone
abbreviations, and pre-programmed “sigs” that
conflict with manually entered special instructions must be addressed.
FENTORA (fentanyl transmucosal buccal
tablets) use has been linked to serious
adverse outcomes when prescribed for
patients who are not already opiate-tolerant.
Patients must be selected carefully and
prescribed doses customized to ensure safe
use.
8
12
9
January 2008
An error that could have resulted in a significant harm-causing opioid overdose was
reported. The use of “IR” ( to mean
immediate release) was added to OPANA
(oxymorphone). The pharmacist interpreted
the “IR” to be “ER,” the common suffix used
to indicate the extended-release product.
Problem
7
Issue
No.
Organization Assessment
ActionAgenda
Action Required/Assignment
ISMP MedicationSafetyAlert! ®
Community/Ambulatory Care Edition
Prescribers, and pharmacists who double
check dosages, are cautioned that mcg-tomcg conversions are not appropriate when
converting patients from other fentanyl
products, including ACTIQ (fentanyl transmucosal lozenges).
FDA and Cephalon issue warnings about FENTORA
Pharmacists should communicate deficits—
such as trailing zeros, Latin abbreviations,
and confusing information—found in electronically-generated prescriptions with
prescribers, vendors, and ISMP so we can
inform others and advocate for change by
vendors. Seeing prescription problems that
arise through real-time use of the system
allows prescribers to adapt how they use the
system and can drive software changes.
Electronically-generated prescriptions: An Rx for E-rror?
Investigate patient concerns when prescriptions
are picked up; use patient counseling sessions
as a final check of prescription accuracy.
Schools and employers should provide education to pharmacists to ensure they possess
requisite knowledge and skills to respond when
errors occur. Conveying sympathy, preserving
relationships, and fostering trust should be
seen as appropriate professional actions in the
aftermath of an error.
We can do better
Prescribers should use a suffix to differentiate a product only when this designation is
linked to a specific product and represents
the FDA-approved name for the prescribed
agent. When confronted with a non-standard
or unrecognizable suffix, pharmacists should
verify the intended product and dose with the
prescriber.
Using suffixes where suffixes don’t exist
Recommendation
ISMP AmbulatoryCare
July-December 2007
ACAA 4
Date
Completed