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CUSTOMIZED NCPIE CAMPAIGN FOR SAFE USE OF ACETAMINOPHEN 

Helping to achieve safe 

medication use

ISSUE 6 VOLUME 2 JUNE 2012

 CUSTOMIZED NCPIE CAMPAIGN

FOR SAFE USE OF ACETAMINOPHEN ................. 1

 MEDICATION SAFETY NEWS 

FROM THE VA NATIONAL

PHARMACY BENEFITS 

MANAGEMENT SERVICES 

[PBM] AND THE FOOD AND

DRUG ADMINISTRATION

[FDA]........................ 2

 6% HETASTARCH IN 0.9% 

SODIUM CHLORIDE INJECTION [HESPAN®] AND

LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE

INJECTION: POTENTIAL

LOOK-ALIKE CONFUSION

............................... 3Medication

On May 7, 2012, the National Council on Patient Information and Education (NCPIE), a 

non-profit alliance of representatives from 

consumer and patient groups, voluntary health 

organizations, healthcare professionals, government agencies, and pharmaceutical manufacturers, developed an educational program 

to raise consumer/patient awareness about the 

safe and appropriate use of acetaminophen. 

Three online modules provide customized 

information regarding safe acetaminophen use 

for distinct populations across the age spectrum. Module 3 targets the elderly and their 

caregivers, and can be accessed with the following link: http://mustforseniors.org/

acetaminophen_safeuse.jsp . Content includes:

Acetaminophen: Know the Facts –

Safe and effective pain relief when 

used as directed; 

Be Medicine Smart -Tips for using 

medicines safely;

Older Adults and Medicine Use -

Important facts;

Caregiver Corner - How to help 

older adults manage medicines 

safely;

Resources - Useful external links for 

learning more about using acetaminophen safely.

This module can be combined with NCPIE's 

Medication Use Safety Training for SeniorsTM program site, located at 

www.mustforseniors.org , for additional learning materials and tools.

EDITOR-IN-CHIEF | Marie Sales, Pharm.D.

VA Pharmacy Benefits Management Services [PBM] & Center for Medication Safety [VA MedSAFE]

1st Avenue—1 Block North of Cermak Road | Building 37; Room 139 | Hines, Illinois | 60141

www.pbm.va.gov

safety in seconds

A M ONT H L Y P U B LI C AT IO N FRO M V A M E D S AF E: 

V A ’S CO M P R EH E N SI V E P H A R M ACO V IG IL A NC E C E NT E R
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NEWS YOU CAN USE

FROM THE FOOD AND DRUG ADMINISTRATION (FDA)

NEUROLOGY

Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

5/14/2012 

FDA’s evaluations of one fatal case report, as well as clinical trials and post-marketing data, cannot definitively associate death outcomes 

from any cause with the multiple sclerosis drug fingolimod (Gilenya®). However, data show that fingolimod (Gilenya®) can induce

bradycardia up to 20 hours post-initial dose, contraindicating its use in:

Patients with certain pre-existing or recent (within 6 months) cardiovascular conditions or stroke; OR

Patients taking certain cardioarrhythmic medications.

FDA recommends monitoring the following parameters in all patients starting fingolimod (Gilenya®) for at least 6 hours after first dose:

Heart rate for signs/symptoms of bradycardia; 

Pulse and blood pressure every hour;

Electrocardiogram (ECG) prior to dosing and at the end of patient’s observation period.

FDA recommends extending the monitoring period beyond 6 hours for high risk patients, including those with:

Severe bradycardia after initial dose (heart rate < 45 beats per minute within the first 6 hours of monitoring or lowest heart rate 

at 6 hours post-dose due to possibility of further depression);

Pre-existing conditions affecting bradycardia;

Concommitant use of medications that slow heart rate or atrioventricular conduction; 

Concommitant use of medications that prolong the QT interval;

QT interval prolongation before fingolimod (Gilenya®) administration or during the monitoring period.

ONCOLOGY

Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies

5/7/2012 

An FDA review of three clinical trials show an increased risk of developing new primary malignancies when patients receive maintenance therapy with lenalidomide (Revlimid®) compared to placebo after initial chemotherapy alone or after initial chemotherapy in combination with stem cell transplantation. FDA pooled data from 3 prospective randomized trials which demonstrated a nearly 3-fold increase in new malignancies among the groups receiving lenalidomide (Revlimid®) versus groups that did not receive lenalidomide 

(Revlimid®) [7.9% versus 2.8%, respectively; p<0.001]. The new malignancies include acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), Hodgkin lymphoma, B-cell malignancies, and other new malignancies, with a median time to development

for the new malignancy [from the start of lenalidomide (Revlimid®) until diagnosis of the second malignancy] of 2 years. No difference 

in incidence rates for non-melanoma skin cancer or solid tumors occurred between patients who received lenalidomide (Revlimid®) and 

those who did not. FDA performed an additional retrospective pooled analysis of data derived from 2 clinical trials supporting the initial 

approval for lenalidomide (Revlimid®) for relapsed/refractory multiple myeloma, and found no increased incidence of second primary 

cancers with use of lenalidomide (Revlimid®) in this setting compared to dexamethasone alone. Revisions to product labeling reflect 

these findings. FDA recommends that providers evaluate the risks and benefits when considering lenalidomide (Revlimid®) as a treatment option, and to monitor patients for secondary malignancies during use of lenalidomide (Revlimid®).

REMINDER

NATIONAL MUE

CLEARINGHOUSE: 

A LIFELINE FOR

LOCAL SITES

ATTENTION PHARMACISTS: Please remember to take advantage of this shared opportunity and exchange of information for ongoing and/or completed MUEs.

HOW TO ENTER LOCAL MUE INFORMATION

For VISN-Wide MUEs, visit:

http://vaww.national.cmop.va.gov/PBM/medsafe/VISNWide%20MUEs

For Local Facility MUEs, visit:

http://vaww.national.cmop.va.gov/PBM/medsafe/Local%20Facility%20MUEs

Post information in 3 quick and easy steps:

1. Click on the link

2. Upload document

3. Save and Close

Please ensure compliance with privacy and security rules.

For questions and suggestions regarding the MUE Clearinghouse, please contact 

Muriel.Burk@va.gov .
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Getting the most from our 

safety surveillance

6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION (HESPAN®) 

AND LIDOCAINE HCL AND 5% DEXTROSE INJECTION | POTENTIAL 

LOOK-ALIKE CONFUSION

One VA facility reported a close call involving the potential mix-up of 6% hetastarch in 0.9% sodium chloride injection 

(HESPAN®) with lidocaine HCl and 5% 

dextrose injection due to look-alike packaging with a similar color scheme (see 

Figure 1). HESPAN® bags are stored in 

the operating room. Lidocaine bags, 

while not stored in the operating room, 

may be administered to multiple patients 

as infusions for adjunct analgesia. Due 

to continuing drug shortages, pharmacy 

purchased HESPAN® product from a new 

manufacturer (B. Braun Medical Inc.) 

since others could not provide a supply. 

The packaging of B. Braun’s HESPAN® 

bears a strong resemblance to that of B. 

Braun’s lidocaine product, which the 

pharmacy also had in their stock. Inadvertently, one of these similarly-looking 

lidocaine bags ended up in the same location as the HESPAN®. A Certified Registered Nurse Anesthetist (CRNA) discovered the misplaced product while preparing to give HESPAN® to a patient. The 

lidocaine bag was neither opened nor administered, averting any patient harm. 

HESPAN®, an intravenous (IV) solution, 

treats hypovolemia via plasma volume 

expansion. On the other hand, lidocaine 

in dextrose solution for IV administration 

has anesthetic and antiarrhythmic effects. 

Both products occur in IV bags of similar 

size, shape, and color, and have use in 

acute care, posing a high likelihood of 

error if these two bags wound up in the 

same location during a crisis situation, 

such as in the operating room. A twogram lidocaine bag given rapidly to a patient by mistake in the place of an intended HESPAN® bag would result in 

lethal outcomes.

Unique packaging and color-coding serve 

as identifiers to help health care providers 

in differentiating between medication 

products. However, when circumstances 

necessitate the use of a different or new 

manufacturer for a routinely used and 

recognized medication (as in the event of 

a drug shortage), product shape, size, and 

color may also change. If the switch in 

manufacturers occurs suddenly and without notice, this may create an increased 

risk for medication error, especially in 

emergency situations where providers 

may partially rely on product appearance/

color for quick identification of medications.

REFERENCES:

1. Field Information Report.

2. HESPAN® (6% HETASTARCH IN 0.9% SODIUM 

CHLORIDE INJECTION) [package insert]. Irvine, 

CA: B. Braun Medical Inc.; April 2003.

3. LIDOCAINE HCL AND 5% DEXTROSE INJECTION [package insert]. Irvine, CA: B. Braun Medical Inc.; January 2011.

PROVIDER

RECOMMENDATIONS

Providers should be aware of 

the potential for look-alike confusion between 6% hetastarch 

in 0.9% sodium chloride injection (HESPAN®) and lidocaine 

HCl and 5% dextrose injection 

due to similar packaging and 

label color when manufactured 

by B. Braun Medical Inc.

Providers should carefully 

check the name on the IV bag 

when either 6% hetastarch in 

0.9% sodium chloride injection 

(HESPAN®) or lidocaine HCl 

and 5% dextrose injection is 

ordered and/or administered. 

Pharmacy should ensure that a 

process is in place to return 

unused stock of 6% hetastarch 

in 0.9% sodium chloride injection (HESPAN®) and lidocaine 

HCl and 5% dextrose injection 

to designated pharmacy or operating room area(s) when not 

ordered for a particular patient.

Pharmacy should review their 

stock for 6% hetastarch in 0.9% 

sodium chloride injection 

(HESPAN®) and lidocaine HCl 

and 5% dextrose injection, and 

ensure that a method is in place 

to distinguish between the two 

agents in order to avoid future 

look-alike confusion (i.e., warning stickers/labels). 

Pharmacy should ensure that a 

system is in place to notify providers regarding the use of new 

manufacturers and/or new product appearance/packaging to 

reduce the potential for medication error, especially for critical 

drug products used in acute or 

emergency care.

FIGURE 1. 6% Hetastarch in 

0.9% sodium chloride injection 

(HESPAN®) and lidocaine HCl 

and 5% dextrose injection, both 

manufactured by B. Braun Medical Inc., use IV bags of similar 

shape, size, and color, increasing 

the potential for look-alike confusion.