Download Community/Ambulatory Care Edition January 2014 Vol. 13, Issue 1

Educating the Healthcare Community
About Safe Medication Practices
ISMP
Medication Safety Alert!
®
Community/Ambulatory Care Edition
Volume 13, Issue 1
January 2014
QuarterWatch™ (Special Report)
Adverse drug events in children less than 18 years old
QuarterWatch™ is an ISMP surveillance program that
monitors serious, disabling, and fatal adverse drug events
(ADEs) reported to the US Food and Drug Administration
(FDA) by manufacturers, healthcare professionals, and the
public. The goal of QuarterWatch™ is to improve
patient safety through the identification of signals that may
represent important drug safety issues. The term signal
means evidence judged to be substantial enough to warrant
publication but which requires further investigation to
determine its frequency of occurrence and establish a
causal relationship to the suspect drug. The latest
QuarterWatch™ examines ADEs in children less than
age 18 that have been reported to FDA during a 5-year span
between 2008 and 2012.
Reporting Totals
During these 5 years, 45,610 ADEs were reported in
children less than 18 years old. Of these, approximately
64% (29,298) involved reports of a serious injury. The
number of reports in children grew substantially over
time—from 6,320 in 2008 to 11,401 in 2012. The rate of
increase in pediatric reports (80%) was the same as the rate
of increase for adult reports during that time. The 5-year
totals included 2,935 (6%) deaths, 10,032 (22%) cases that
required hospitalization, 774 (2%) cases that required intervention, 1,430 (3%) cases considered life-threatening, and
816 (2%) cases of disability. A U-shaped curve of the data
revealed that the greatest number of cases occurred in the
first year of a child’s life, then declined and leveled off
until adolescence, when cases again rose rapidly.
Comparison of Reported and Actual Events
The 45,610 ADEs in children reported to FDA likely represent just a portion of the actual events, according to a 2009
FDA study.1 Data from various years and sources reveal that
a mean of about 586,000 children visit the doctor’s office
or other outpatient facility for treatment of ADEs, mostly
involving mild rashes or gastrointestinal (GI) distress.2
More severe ADEs account for an additional 160,000
emergency room visits per year, mostly to treat unintentional overdoses and allergic reactions.3 More serious ADEs
in children that cause hospital admissions are difficult to
estimate. Published data suggest that approximately 1 to 2
per 100 children experience an ADE requiring medical
treatment per year.1-3 Overall, improvements are needed to
expand active surveillance and spontaneous reporting of
ADEs in children.1
cont’d on page 2
Table 1. Most frequent suspect drugs in serious ADEs reported in children, 2008-2012
Rank Drug name
Brand name*
Cases
Medical use*
Psych**
Most frequent ADE
Second most frequent ADE
1
2
3
4
5
6
7
8
9
10
11
inFLIXimab
montelukast
somatropin
baclofen
ISOtretinoin
methylphenidate
lamoTRIgine
lisdexamfetamine
ARIPiprazole
ibuprofen
etanercept
Remicade
Singulair
Nutropin
Lioresal
Claravis
Concerta
LaMICtal
Vyvanse
Abilify
Motrin
Enbrel
1,772
944
606
579
447
418
335
314
297
242
231
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
No
No
atomoxetine
QUEtiapine
levETIRAcetam
risperiDONE
Strattera
SEROquel
Keppra
RisperDAL
227
210
206
195
Crohn’s disease
Suicidal ideation
Serious headache
Hypertonia
Suicidal ideation
Sudden death
Seizures
Suicidal ideation
Weight increased
Hypersensitivity
Serious injection site
pain
Suicidal ideation
Weight increased
Seizures
Aggression
Ulcerative colitis
Aggression
Seizures
Drug ineffective
Depression
Aggression
Stevens-Johnson syndrome
Aggression
Dystonia
Acute renal failure
Vomiting
12
13
14
15
Crohn’s disease
Asthma
GH deficiency
Muscle spasticity
Acne
ADHD
Epilepsy
ADHD
Bipolar disorder
Pyrexia
Juvenile idiopathic
arthritis
ADHD
Bipolar disorder
Epilepsy
Bipolar disorder
Yes
Yes
Yes
Yes
Chest pain
Tardive dyskinesia
Drug ineffective
Weight increased
ISMP Medication Safety Alert!
®
15 Most Frequently Reported Drugs
To identify signals of potential safety problems in children,
a subset of serious adverse event reports that resulted from
normal or expected use of the drugs was identified. These
more restrictive criteria captured 16,992 reports involving 741
different drugs between 2008 and 2012. Just 15 (2%) of the
741 drugs accounted for 41% of all reports in this category
during the 5-year period (Table 1 on page 1). Although only 6
of the 15 drugs have intended psychotropic effects, psychiatric adverse events were prominent for 10 of the 15 drugs.
They included suicidal ideation (n=714), aggression (n=686),
and abnormal behavior (n=580). Suicidal behaviors were not
limited to thoughts of suicide but also included 274
completed suicides, 159 attempted suicides, and 100 cases
labeled “self-injurious behavior.” Also reported were various
forms of psychosis, including hallucination (n=276),
psychotic disorder (n=124), and paranoia (n=74).
QuarterWatch™ (cont’d from page 1)
Highlights of the List
Three drugs used to treat ADHD. Psychiatric side effects,
particularly suicidal behaviors, aggression, hallucinations,
and other manifestations of psychosis, were predominant for
methylphenidate (CONCERTA, RITALIN), lisdexamfetamine (VYVANSE), and atomoxetine (STRATTERA), three
medications often used to treat attention deficit hyperactivity
disorder (ADHD). Atomoxetine shares a suicidal behavior
warning in official prescribing information similar to antidepressants. The two central nervous system stimulants, lisdexamfetamine and methylphenidate, are not required to warn
about suicidal behaviors, even though such events were
reported in 26% and 14% of all cases, respectively, in the
data we analyzed. Previously, FDA studied the incidence of
hallucinations and other forms of psychosis when taking the
stimulants and required a warning about these potential
adverse effects.4 FDA should also assess the need for a
warning for the more frequently reported suicidal thoughts
and behaviors.
Non-psychiatric adverse effects were also reported with these
three drugs. The most frequently reported adverse event for
methylphenidate was 37 cases of sudden death; the prescribing information currently contains a warning about this, but
the literature is mixed.5-6 Cardiac effects were also reported
for atomoxetine, including chest pain (n=16), syncope
(n=11), and prolonged QT interval (n=10). Movement disorders were reported for lisdexamfetamine, including dyskinesia (n=17), tics (n=16), and tremor (n=9). Weight loss or
arrested growth was also reported for all three drugs.
January 2014
page 2
Safety Briefs
Review your “bagging” procedures. A patient came
to the community pharmacy to pick up a completed
prescription; however, the patient’s bag could not be
located. Both the pharmacy computer system and the
pharmacy robot’s computer system confirmed that the
prescription had been completed. Pharmacy staff then
checked all the bags in the will-call area. The patient’s
medication was found in another patient’s bag. Both
patients had the same last name. This is certainly not the
first time we have heard of this type of error. We wrote
about a similar event in our February 2009 newsletter.
We have also seen this happen during observations in
pharmacies. This error prompts us to call on pharmacies
to review their current “bagging” procedures because,
once in the will-call area, the chances are high that a
bagging error will reach the patient. For example,
pharmacies should consider using baskets or trays to
keep labeled containers and receipts for one patient
together through the production process until final
verification. It is also important to strengthen strategies
at the point-of-sale to catch any bagging errors that
make it to the will-call area. Staff should consistently
use 2 patient identifiers at the point-of-sale. Ask the
person picking up the prescription to provide the
patient’s name and date of birth. Compare the answers
to the information listed in the computer system or
printed on the prescription receipt and vial. Also, staff
should check each prescription vial at the point-of-sale,
even if this requires opening the bag. Involving the
patient can provide an additional check. Present each
prescription vial to the patient to verify that each
medication is correct. While this will require some
additional time at the point-of-sale, this step can help
make sure the right patient receives the right medication. If your site is working to prevent bagging errors,
please share your ideas by emailing us at:
[email protected].
Unsafe frequency notation. Staff at a community
pharmacy told us that they are receiving prescriptions
from ophthalmologists that list administration times as
“1xd,” “2xd,” and “3xd” to indicate once, twice, and
three times daily dosing respectively. However, these
designations can be misinterpreted as 1 dose, 1 day, or
once daily. When the pharmacy receives prescriptions
with these designations, the pharmacist must contact the
cont’d on page 3
cont’d on page 4
Free customized medication safety alerts for consumers and caregivers. Details at: www.ConsumerMedSafety.org.
ISMP Medication Safety Alert!
®
Topical anesthetics for teething
infants
Lidocaine viscous is indicated for use as a topical anesthetic
for irritated or inflamed mucous membranes of the mouth and
pharynx and to reduce gagging when taking X-rays of the
mouth or performing dental impressions. The US Food and
Drug Administration (FDA) has not approved this product for
use in children who are teething. Nevertheless, we recently
learned about a tragic event involving twin 1-year-old infants
who were prescribed lidocaine viscous for that reason. The
first infant suffered a seizure at home, followed by cardiac
arrest. She was successfully resuscitated by emergency
medical services personnel and transferred to a hospital. Since
the infant had been playing with toy beads, the initial impression was asphyxiation. Just two days later the second twin
also had a seizure and arrested. Tragically, this twin could not
be resuscitated. Upon hearing of the demise of the second
twin, concern for toxic exposure and/or ingestion in the home
was raised. Toxicology results for the first twin indicated
toxic levels of lidocaine. It was learned that the infant’s
primary care provider had prescribed lidocaine viscous 2%
for teething/irritability. Toxic levels of lidocaine were also
identified in the second infant. It’s unclear how the infants
received an overdose of the medication.
Although parents may like to rub topical anesthetics on their
baby’s gums to treat teeting-related discomfort, the directions
for use and potential for toxicity with these products are often
not clear to parents and, sometimes, not even to their doctors.
One issue is that the anesthetic effects may be short-lived,
resulting in well-meaning parents using the product more
often than recommended by the doctor or the product label.
Parents have also been known to put the topical anesthetic
into the infant’s formula, or to soak a pacifier in the solution
and then put that in the baby’s mouth. This is a dangerous
practice since it is difficult to determine the amount of
medication the infant receives. Also, a portion of the medication often ends up being swallowed. When that happens, the
mucous membranes of the throat may become anesthetized,1
which can affect the gag reflex and make it difficult to sense
liquids during swallowing, increasing the risk of choking or
aspiration.
As for anesthetic products like ANBESOL and ORAJEL
that contain benzocaine, the same can occur, plus methemoglobinemia is a risk.2 Methemoglobinemia can occur within
minutes after exposure, even the first time the product is used.
It isn’t very common overall, but children under 2 years of
age appear to be at particular risk. In 2011, FDA issued an
January 2014
page 3
prescriber to clarify the order. Luckily, no errors have
been detected yet. It makes sense to avoid these administration time formats all together.
Safety Briefs (cont’d from page 2)
FDA compounding guidances. In response to the
2012 meningitis outbreak involving compounded drugs,
the US Food and Drug Administration (FDA) is taking a
more aggressive stance in regulating compounding activities, including those conducted at traditional pharmacies.
In December 2013, FDA issued three draft guidance
documents (www.ismp.org/sc?id=294) that carry out the
newly signed Drug Quality and Security Act (DQSA). A
key provision of one of the guidance documents,
Pharmacy Compounding of Human Drug Products
Under Section 503A of the Federal Food, Drug, and
Cosmetic Act (www.ismp.org/sc?id=295), is that a drug
product which is compounded should be in compliance
with the United States Pharmacopoeial Convention
(USP) chapters (i.e., USP Chapters <795> and <797>) on
pharmacy compounding. These USP standards provide
guidance for both non-sterile and sterile compounding.
FDA expects state boards of pharmacy to continue their
oversight and regulation of the practice of pharmacy,
including traditional pharmacy compounding. FDA also
intends to continue to cooperate with state authorities to
address pharmacy activities that may violate the Federal
Food Drug and Cosmetic Act. For more details about
USP Chapters <795> and <797>, consult the USP/NF.
alert (www.ismp.org/sc?id=292) about the risks of over-thecounter benzocaine gels and stated that these products should
not be used except under the advice and supervision of a
healthcare professional. The American Academy of Pediatrics
discourages topical anesthetic use (www.ismp.org/sc?id=293)
and instead suggests using a rubber teething ring that’s been
chilled in the refrigerator (not the freezer). One can also
gently rub or massage the child’s gums with a finger. Pain
medications like acetaminophen and ibuprofen can also be
useful when given in conjunction with advice from a healthcare professional. The bottom line is lidocaine viscous is not
approved by FDA for use as a treatment for teething. For
safety reasons, lidocaine viscous and benzocaine gels or
liquids should not be used for this purpose.
References
1) Cohen MR, Levinsky WJ. Topical anesthesia and swallowing. JAMA. 1976;
236(6):562.
2) Moore TJ, Walsh CS, Cohen MR. Reported adverse event cases of methemoglobi-nemia associated with benzocaine products. Arch Intern Med.
2004;164(11):1192-6.
ISMP Medication Safety Alert!
®
Three antipsychotic drugs. The full spectrum of antipsychotic adverse drug effects that occur in adults was also
reported in children for ARIPiprazole (ABILIFY),
QUEtiapine (SEROQUEL), and risperiDONE
(RISPERDAL). Suicidal behaviors were reported for all
three drugs, accounting for 25% of QUEtiapine cases, 19% of
risperiDONE cases, and 10% of ARIPiprazole cases. Reports
of dyskinesia, tics, weight gain, and sexual organ adverse
effects were seen for ARIPiprazole, QUEtiapine, and
risperiDONE. The reports occurred in children being treated
for a wide range of disorders but most frequently depression
or bipolar disorder.
QuarterWatch™ (cont’d from page 2)
Asthma and acne drugs. Montelukast (SINGULAIR) for
asthma and allergies, and ISOtretinoin (CLARAVIS) for
acne, are notable examples of drugs with numerous reported
psychiatric effects but no intended psychotropic action.
Montelukast produced a high number of serious adverse event
reports, predominantly psychiatric effects including suicidal
behaviors, aggression, and depression. Reports surged in
2008, and then tapered off substantially. For ISOtretinoin,
suicidal behaviors number among other prominent adverse
effects, including birth defects, warranting consideration prior
to use of this medication for severe and resistant acne. Other
major reported adverse effects included depressed mood
(n=101) and colitis (n=20).
Analgesic and anticonvulsant drugs. Among the over-thecounter (OTC) and prescription analgesics used in children,
ibuprofen produced an unexpectedly large number of cases
(n=32) of severe hypersensitivity and skin reactions, notably
Stevens-Johnson syndrome and toxic epidermal necrolysis.
These skin reactions were seldom reported for acetaminophen
and naproxen. Severe skin reactions were even more numerous for another top-15 drug, the anticonvulsant lamoTRIgine
(LAMICTAL) (n=66), which currently carries a warning
about this adverse effect in its official labeling. Its first-line
use as adjunctive therapy for seizures should be reevaluated.
Two anti-TNF agents. Reports for two anti-tumor necrosis
factor (anti-TNF) agents showed that adverse events occurred
in two different populations. InFLIXimab (REMICADE)
events (n=1,772) primarily affected the GI tract and occurred
in patients treated for GI tract disorders including Crohn’s
disease and ulcerative colitis. The largest group of adverse
events suggested treatment failures, which the manufacturer
attributed to disease flares despite an overall benefit of treatment. Etanercept (ENBREL) adverse events (n=231) were
primarily reported in patients treated for juvenile idiopathic
January 2014
page 4
arthritis and psoriasis and were frequently related to infection
and infusion site reactions. Because of differences in juvenile
patient populations and likely differences in exposure
(inFLIXimab has more indications for treatment in children),
the 7-fold difference in the number of reported serious ADEs
does not necessarily imply higher relative risks for
inFLIXimab compared to etanercept. However, the results in
both children and adults continue to show that anti-TNF
agents are high-risk treatments requiring vigilance.
Where Cases Were Few
Three of the most widely used drugs in children accounted for
few reported serious adverse events in our analysis. For
example, 28 million pediatric patients out of a population of
74 million were prescribed amoxicillin and/or azithromycin in
2010.7 However, azithromycin accounted for only 51 reports
over 5 years, and amoxicillin only 41 reports. Albuterol,
another drug often used with children, was prescribed to
about 7% of all children7 but accounted for only 56 serious
adverse events in our primary analysis group. The low
volume of reports for these medications may not only attest to
the safety of these widely used drugs, but also reflect shortterm or intermittent use as well as very low reporting rates.
Read the full report at: www.ismp.org/QuarterWatch.
References
1) Johann-Liang R, Wyeth J, Chen M, et al. Pediatric drug surveillance and the
Food and Drug Administration’s adverse event reporting system: an overview of
reports, 2003-2007. Pharmacoepidemiol Drug Saf. 2009;18(1):24–7.
2) Bourgeois FT, Mandl KD, Valim C, et al. Pediatric adverse drug events in the
outpatient setting: an 11-year national analysis. Pediatrics. 2009;124(4):e744–50.
3) Cohen AL, Budnitz DS, Weidenbach KN, et al. National surveillance of
emergency department visits for outpatient adverse drug events in children and
adolescents. J Pediatr. 2008;152(3):416–21.
4) Mosholder AD, Gelperin K, Hammad TA, et al. Hallucinations and other
psychotic symptoms associated with the use of attention-deficit/hyperactivity disorder drugs in children. Pediatrics. 2009;123(2):611–6.
5) Olfson M, Huang C, Gerhard T, et al. Stimulants and cardiovascular events in
youth with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc
Psychiatry. 2012;51:147–56.
6) Winterstein AG, Gerhard T, Kubilis P, et al. Cardiovascular safety of central
nervous system stimulants in children and adolescents: population based cohort
study. BMJ. 2012;345:e4627.
7) Chai G, Governale L, McMahon AW, et al. Trends of outpatient prescription
drug utilization in US children, 2002-2010. Pediatrics. 2010;130(1):23–31.
ISMP Medication Safety Alert! Community/Ambulatory Care Edition (ISSN
1550-6290) ©2014 Institute for Safe Medication Practices (ISMP).
Permission is granted for duplication only for internal distribution at your
practice site. Other reproduction is prohibited without permission by ISMP.
Report medication errors to the ISMP National Medication Errors Reporting
Program (ISMP MERP) at: www.ismp.org. ISMP is a federally certified
patient safety organization (PSO). Institute for Safe Medication Practices, 200
Lakeside Drive, Suite 200, Horsham, PA 19044. Tel: 215-947-7797; Fax: 215914-1492. Email: [email protected]. This is a peer-reviewed publication.
Three Unique Fellowship Programs
The Institute for Safe Medication Practices (ISMP) is now accepting applications for
Three
2014-2015 Fellowships
ISMP Safe Medication Management Fellowships (Two Positions)
FDA/ISMP Safe Medication Management Fellowship
ISMP Safe Medication Management Fellowships (Two Positions)
One Position Supported by Express Scripts
Location and Term: The 12-month Fellowship commences summer 2014 at the Pennsylvania (near Philadelphia) office of ISMP. Relocation to the
Philadelphia area is required.
Description: The Fellowship offers a nurse, pharmacist, or physician with at least 1 year of postgraduate clinical experience an unparalleled
opportunity to learn from and work with some of the nation’s experts in medication safety. Now in its 22nd year, the Fellowship allows the candidate to work
collaboratively with practitioners in various healthcare settings to assess and develop interdisciplinary medication error-prevention strategies.
FDA/ISMP Safe Medication Management Fellowship
Location and Term: The 12-month Fellowship commences summer 2014. The Fellow will spend 6 months at the Pennsylvania (near Philadelphia)
office of ISMP and 6 months at the Maryland (near Washington, DC) office of the US Food and Drug Administration (FDA). Relocation to the
Philadelphia and Washington, DC, area is required.
Description: The Fellowship, open to a healthcare professional with at least 1 year of postgraduate clinical experience, is a joint effort
between ISMP and FDA’s Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, and Division of Medication Error Prevention and Analysis. The Fellowship allows the candidate to benefit from ISMP’s years of experience devoted to medication error prevention. At FDA,
valuable regulatory experience is gained by working with the division focused on medication error prevention.
A competitive stipend, 2 weeks paid vacation, and full health benefits are provided with all Fellowship Programs.
How to Apply
Information and applications can be found at: www.ismp.org/profdevelopment/. Applications can also be requested by calling 215-947-7797.
Speak to ISMP’s Current Fellows
Please join us on February 5, 2014, at 2:00 p.m. ET for a special, live conference call about the Fellowship programs. Current and
past Fellows will describe their Fellowship experiences as well as plans for their post-Fellowship careers. They will also be available to
answer any questions you may have about the Fellowship. To attend, please send an email to [email protected].
The application deadline for all Fellowship Programs is March 31, 2014.
September-December 2013
ISMP AmbulatoryCare
ActionAgenda
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 September 2013 and December 2013. Each item includes a brief description of the medication safety problem, recommendations to reduce
the risk of errors, and the issue to locate additional information. The Action Agenda is also available for download in a Word format at: www.ismp.org/Newsletters/ambulatory/actionagenda.asp. To learn how to use the ISMP
Ambulatory Care Action Agenda at your practice site, visit www.ismp.org/newsletters/ambulatory/How_To_Use_AA.asp.
Problem
Issue
Recommendation
Organization Assessment
Action Required/Assignment
Date
Completed
Breath mints or melatonin
09/13
ISMP recently learned about an incident where
a child shared what were thought to be breath
mint film strips with other children at a school,
but they turned out to be melatonin film strips.
The packaging of these products are similar
making it easy to mix-up the products. Also,
both products are advertised in various flavors.
Pharmacies should evaluate their over-thecounter (OTC) inventory for these products
and consider not selling them. If these
products are sold, evaluate how and where
they are placed on the shelves and add a sign
to alert people that these are dietary supplements. Consider placing these products
behind the counter.
QuarterWatchTM 2012 Annual Report: Anticoagulants, anti-TNF drugs, fentaNYL patches and alendronate
©2014
10/13
ISMP
ISMP’s QuarterWatchTM 2012 Annual Report
identified adverse drug events (ADEs) frequently reported to FDA. Anticoagulants,
including dabigatran and warfarin, ranked
highest in serious or fatal adverse events. Antitumor necrosis factor (TNF) agents ranked
highest in regards to manufacturers’ expedited
reports. Safety issues were also identified with
fentaNYL patches including prescribing errors,
patient self-administration errors, and accidental exposure to the patch. It was also identified
that alendronate was 186 times more likely to
be associated with bone and joint injuries compared to all other drugs after adjusting for the
volume of reports.
For patients on anticoagulants, ensure that
proper follow-up monitoring is in place.
Ensure patients taking anti-TNF agents are
aware of the risks associated with taking
these medications. Provide proper counseling
to patients who are prescribed fentaNYL
patches, including education to keep patches
out of reach of children. If using alendronate,
confirm patients are aware the FDA warns
“optimal duration of use has not been determined. For patients at low-risk for fracture,
consider drug discontinuation after 3 to 5
years of use.” See the full QuarterWatchTM
report at: www.ismp.org/QuarterWatch/
pdfs/2012Q4.pdf.
ZERIT (stavudine) – ZYRTEC (cetirizine) mix-up
09/13
An error occurred when taking a patient’s
medication history. The antiretroviral agent
stavudine was recorded instead of the antihistamine cetirizine. The brand names Zerit and
Zyrtec are similar and when pronounced the
generic names stavudine and cetirizine can
sound similar.
January 2014
Confirm an HIV diagnosis for any patient
taking stavudine. When performing medication histories, ensure that all medications have
an appropriate indication.
ISMP MedicationSafetyAlert! Ò
Community/Ambulatory Care Edition
ACAA 1
September-December 2013
ISMP AmbulatoryCare
Problem
Issue
Recommendation
ActionAgenda
Organization Assessment
Action Required/Assignment
Date
Completed
Low health literacy, a Rx for error
09/13
According to an American Medical Association
report on health literacy, 50% of adults read at
or below the 6th grade level and only 20% of
adults can read at or above the 9th grade
level. Patients unable to understand the
instructions on how to properly take medications are more likely to experience unsuccessful management of treatment plans.
Use the health literacy tools (www.ismp.org/
sc?id=296) developed for pharmacy by the
Agency for Healthcare Research and Quality
(AHRQ). Included is an assessment for
pharmacies to use, a training program for
staff, a script to be used for automated
telephone prescription reminders, and a pill
card that patients can use.
Double-checking bingo cards
10/13
©2014
ISMP
A community pharmacy that serves retail
clients, assisted living facilities, group homes,
and rest homes recently delivered the wrong
medication to a group home patient. A
pharmacy technician inadvertently filled a
bingo card with propranolol 40 mg instead of
pantoprazole 40 mg. The patient received 4
doses of the wrong medication but did not
exhibit any negative outcomes.
Ensure the original medication stock bottle
accompanies the completed prescription all
the way to the verification pharmacist so a
visual comparison of the tablets in the bingo
card and the stock bottle can be made. Add a
description of the medication to the bingo
card label to better enable nurses or other
staff to serve as a final check and identify
when the incorrect medication has been
placed in the bingo card.
Influenza vaccine – shake well
12/13
An immunization-certified pharmacist was not
aware that all influenza vaccine products had
to be shaken before use. The vaccine cartons
are labeled “shake well.” But the vial and
syringe labels of influenza vaccine that we’ve
looked at are not so labeled.
Ensure staff who vaccinate patients with the
flu vaccine are aware that all influenza
vaccines need to be shaken before use,
whether packaged in a single dose or multiple
dose vial, or a prefilled syringe. Since most
pharmacies process vaccines as a prescription
and print a label, it may be helpful to include
“SHAKE WELL BEFORE ADMINISTRATION”
on the label.
Possible cross-contamination with insulin vials
10/13
A nurse accidentally injected a hepatitis C
positive patient with an empty insulin syringe
before she realized she hadn’t filled it with
insulin. She then used the same syringe and
needle to withdraw insulin from a vial. That
vial was later used to prepare doses for other
patients, exposing more than 70 patients to
hepatitis C.
January 2014
Keep this event in mind for education of staff
if you service nursing homes, prisons, or other
facilities. Using 3 mL insulin vials would
expose fewer patients if the vial becomes
contaminated. In institutional settings, preparation of patient-specific insulin doses by
pharmacy would greatly reduce the risk of
cross-contamination.
ISMP MedicationSafetyAlert! Ò
Community/Ambulatory Care Edition
ACAA 2
September-December 2013
ISMP AmbulatoryCare
Problem
Issue
Recommendation
ActionAgenda
Organization Assessment
Action Required/Assignment
Date
Completed
Identify your patients
11/13
A pharmacy dispensed prescriptions to wrong
patients who had the same first name but
different last names. Both patients were to
receive the same medication, metoprolol
tartrate 25 mg; however, the directions for use
were different. In a second report, a patient
received another patient’s amitriptyline and
ended up being treated in the emergency
department after taking upwards of 30 tablets
in an apparent suicide attempt. Both patients
had the same last name.
Standardize and monitor the processes in
place at the point-of-sale. Require pharmacy
personnel to ask the person picking-up the
completed prescription to supply the patient’s
name and date of birth. Open the prescription
bag at the point-of-sale so the medication can
be reviewed with the patient to verify that the
medication and directions for use are correct.
Also, consider employing technology at the
point-of-sale that would guide or “force” the
patient identification process.
Contamination of topical antiseptic products
11/13
©2014
ISMP
The US Food and Drug Administration (FDA) is
receiving reports of infections resulting from
antiseptic products labeled for preoperative or
preinjection skin preparation. Most often,
contamination of these products occurs when
organisms are introduced into the product by
users. Examples of affected antiseptic ingredients include alcohol, iodophors, chlorhexidine
gluconate, and quaternary ammonium.
FDA recommends healthcare practitioners use
the products according to the directions on
the label, apply the contents of single-use
containers only one time to one patient, avoid
diluting antiseptic products after opening
them, and discard applicators and any unused
solution after the single application. To read
the complete MEDWATCH Safety Alert, go to:
www.ismp.org/sc?id=275.
Caution! Error-prone dose designations
11/13
A pharmacist expressed a safety concern
regarding the labeling of ferrous sulfate tablets
distributed by Qualitest Pharmaceuticals. The
carton expresses the strength of each tablet in
three different ways—325 mg of ferrous
sulfate, 5 grains of ferrous sulfate, and 65 mg
of elemental iron. The unit dose blisters are
only labeled with 5 gr.
Check your inventory and consider removing
this product. Manufacturers should avoid
using the apothecary system and clearly
express dosage strengths in terms of both
elemental iron and the ferrous salt form on
package labels.
When questions arise, verify
09/13
A physician ordered LORazepam 2 mg/mL
injection for a hospice patient. However,
pharmacy staff immediately thought of the
oral concentrate; they were familiar with its
common use in hospice and the hospice
services’ preference for patient comfort to
avoid injections. The oral concentrate was
dispensed without consulting the prescriber.
January 2014
Educate staff to never make assumptions
when interpreting prescriptions. When
questions arise, the prescriber should be
contacted to verify what he or she intended.
ISMP MedicationSafetyAlert! Ò
Community/Ambulatory Care Edition
ACAA 3