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Helping to achieve safe 

medication use

ISSUE 3 VOLUME 3 MARCH 2013

 MEDICATION SAFETY NEWS 

FROM THE VA NATIONAL

PHARMACY BENEFITS 

MANAGEMENT SERVICES 

[PBM] AND THE FOOD AND

DRUG ADMINISTRATION

[FDA]........................ 1-3

 USE OF MULTI-DOSE PEN

INJECTORS ................ 3,4

Medication

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

NEWS YOU CAN USE

FROM THE VA NATIONAL PBM: BULLETINS, COMMUNICATIONS, & RECALLS

CARDIOLOGY

Dual Renin-Angiotensin Aldosterone System Blockade and Impaired Renal Function and Hyperkalemia – 02-12-2013 - National PBM 

Bulletin

 GLACIAL ACETIC ACID: 

PRODUCT CONFUSION AND

SEVERE BURNS ......... 1

GLACIAL ACETIC ACID: PRODUCT CONFUSION AND SEVERE BURNS

Health care staff have confused glacial acetic acid (the most concentrated form of acetic acid available), for diluted acetic acid 

(commonly known as vinegar), with inadvertent application of 

glacial acetic acid resulting in severe burns, scarring, and permanent damage to skin as well as mucous membranes. Acetic acid, 

in diluted formulations, has several uses which include identification of dysplasia of mucous membranes (3-5% solution); treatment of infections of the outer ear and ear canal (2% solution); 

and irrigation of wound areas (0.25% sterile solution). On the 

other hand, glacial acetic acid (> 99.5%) is a corrosive chemical 

and solvent used in laboratory settings, and has no applications 

medically.

 

Glacial acetic acid does not fall under the regulation of the Food 

and Drug Administration (FDA), and product labeling is not standardized with respect to 

warnings about the chemical’s corrosive nature. The 

Institute of Safe Medication 

Practices (ISMP) has reported 

product labeling inconsistencies as a contributing factor to product confusion in an effort to raise awareness and help the chemical industry to improve warning systems. In order to avoid future 

product confusion, health care staff should:

Eliminate the use and/or purchase of glacial acetic acid; and

Only use diluted acetic acid in patient. 

REFERENCES:

NAN ALERT. WARNING! Severe burns and permanent scarring after glacial acetic acid 

(>99.5%) mistakenly applied topically. National Coordinating Council on Medication Error 

Reporting and Prevention (NCCMERP): January 23, 2013.
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NEWS YOU CAN USE

FROM THE FOOD AND DRUG ADMINISTRATION (FDA)

DIABETES

FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic 

drugs for type 2 diabetes

3/14/2013 

Unpublished new findings from a group of academic researchers indicate a possible increased risk of pancreatitis and pancreatic duct 

metaplasia (pre-cancerous cellular changes) in patients with type 2 diabetes treated with incretin mimetics (exenatide [Byetta, Bydureon], liraglutide [Victoza], sitagliptin [Januvia, Janumet, Janumet XR, Juvisync], saxagliptin [Onglyza, Kombiglyze XR], 

alogliptin [Nesina, Kazano, Oseni], and linagliptin [Tradjenta, Jentadueto]. Data ensued from examination of pancreatic tissue specimens taken from patients following death from unspecified causes. Currently, drug labels and patient Medication Guides for incretin 

mimetics contain warnings about the risk of acute pancreatitis (fatal and serious nonfatal cases) associated with these agents. FDA 

continues to investigate pancreatic toxicity associated with incretin mimetics and will issue any recommendations or conclusions

upon completion. Health care professionals should continue to follow the prescribing recommendations in the drug labels for this 

drug class; and patients should continue to take their medicine as directed.

INFECTIOUS DISEASE

Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms

3/12/2013 

Azithromycin, a broad-spectrum macrolide antibiotic, increases the risk of QT-interval prolongation, torsades de pointes, polymorphic ventricular tachycardia, and sudden cardiac death as demonstrated in a study published last year by the New England Journal of 

Medicine (previously discussed in Issue 8; Volume 2; September 2012 of VA’s Medication Safety in Seconds newsletter) as well as 

a clinical QT study conducted by the manufacturer. Updated product labeling now includes this new information. FDA recommends that health care professionals should weigh the risks of torsades de pointes and fatal arrhythmia versus benefits when considering treatment options with azithromycin or alternative antibiotics, bearing in mind that other macrolide and fluoroquinolone agents 

may also potentiate QT interval prolongation as well as impart other serious side effects. Patients at higher risk of an adverse cardiac 

event include the elderly and those with pre-existing cardiac disease, including:

Known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, 

or uncompensated heart failure;

Concomitant drug therapy known to prolong the QT interval; and

Ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, 

and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic 

agents.

Note: One VA Medical Center added 

the following verbiage to the ordering 

template for AZITHROMYCIN: 

“*May Prolong QTc—use cautiously 

in patients at risk*”. This may serve 

as one option for how to inform providers at the site level within the VA of 

this safety risk. 

(continued on page 3)
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DON’T SHARE

Getting the most from our 

safety surveillance

USE OF MULTI-DOSE PEN INJECTORS

The VA National Center for Patient Safety has addressed the 

issue of multi-dose pen injectors on 2 occasions: previously in 

2008 due to an incident of use of the same multi-dose heparin 

syringe for intravenous line flushes on multiple patients; and 

more recently in January 2013 with the discovery in a VA facility of several insulin pen injectors not labeled for individual 

patients but instead used to administer doses of insulin to different patients by changing the needle between each patient. Multi

-dose pen injectors are intended for use by one patient only. 

Sharing the pen injector and cartridges may put patients at risk 

for exposure to blood-borne pathogens like Hepatits B Virus 

(HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency 

Virus (HIV). This resulted in an internal policy which prohibits 

the use of multi-dose pen injectors (Table 1) on all patient care 

units, with the following exceptions:

Patients being educated prior to discharge to use a 

patient-specific multi-dose pen injector. 

Eligible patients participating in the VA medical center’s Self-Medication Program (SMP) as established by 

VHA Handbook 1108.03. 

Patients requiring treatment with a medication delivered in a multi-dose pen injector, and no alternative 

formulation is available from the manufacturer for 

treating the patient while on a patient care unit (Table 

2).

Patients participating in a research protocol requiring 

a multi-dose pen injector while on a patient care unit. 

Pen injectors dispensed directly to the patient as an 

outpatient prescription. 

In these excepted instances, health care staff should ensure that:

BE AWARE

NEWS YOU CAN USE

FROM THE FOOD AND DRUG ADMINISTRATION (FDA)

(continued from page 2)

ENDOCRINE

FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death

2/26/2013 

FDA has put a stop to all pediatric clinical trials of cinacalcet hydrochloride (Sensipar®) following the death of a 14-year old patient 

during one of the trials. FDA continues to gather and evaluate information concerning the event and will communicate any final 

conclusions and/or recommendations upon completion of their review. Cinacalcet hydrochloride (Sensipar®) is a calcium-sensing 

receptor agonist indicated for:

Secondary hyperparathyroidism in patients with chronic kidney disease;

Hypercalcemia in patients with cancer of the parathyroid; and

Severe hypercalcemia in patients with primary hyperparathyroidism unable to undergo parathyroidectomy.

Cinacalcet hydrochloride (Sensipar®) currently does not have FDA approval for use in children.

PAIN MANAGEMENT

Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy

2/20/2013 *** UPDATE FROM 08/15/2012***

In August 2012, FDA reviewed codeine use and associated rare, but life-threatening, adverse events or death in certain children after 

tonsillectomy and/or adenoidectomy. FDA’s Adverse Event Reporting System (AERS) contained 13 cases of pediatric death or 

overdose associated with codeine use in patients ranging in age from 21 months old to 9 years old post-adenotonsillectomy or respiratory tract infection. Seven of these cases appeared in the medical literature where they were categorized as ultra-rapid metabolizers. FDA identified 2 additional cases of pediatric death associated with codeine use in autopsy-confirmed ultra-rapid metabolizers 

while conducting a review of a physician survey on morbidity and mortality following tonsillectomy and/or adenoidectomy conducted by the American Academy of Otolaryngology – Head and Neck Surgery. In light of these reports, FDA will update product 

labeling with the following:

A new Boxed Warning regarding the risks of codeine use in children following tonsillectomy and/or adenoidectomy;

A Contraindication applying to all children undergoing tonsillectomy and/or adenoidectomy due to difficulty in determining which children may be ultra-rapid metabolizers of codeine; and

Revised Warnings/Precautions, Pediatric Use, and Patient Counseling information sections.

(continued on page 4)
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Getting the most from our safety surveillance

USE OF MULTI-DOSE PEN INJECTORS

Multi-dose pen injectors shall be stored in the pharmacy and dispensed with an individual patient label 

consistent with the VA facility’s labeling requirements. 

Multi-dose pen injectors shall not be ward stocked. 

Multi-dose pen injectors are to be used by a single patient only and should never be shared with other patients, even when the needle is changed. 

Disposable safety needles with shield guards must be 

used to ensure OSHA compliance on patient care units. 

The needles should be promptly and properly discarded 

after each injection and a new safety needle attached 

prior to each additional injection. 

Education on facility policy and safe use of pen injectors must be provided to applicable current and new 

employees, and be a part of their annual competency 

assessment. 

REFERENCES:

1. Patient Safety Alert 08-02. Same syringe used for IV (intravenous) line heparin 

flushes for multiple patients. VA National Center for Patient Safety (NCPS): August 8, 2008.

2. Patient Safety Alert 13-04. Multi-Dose Pen Injectors. VA National Center for 

Patient Safety (NCPS): January 17, 2013.

3. Department of Veterans Affairs. VHA Handbook 1108.03. Self-Medication Programs 

(SMP). February 3, 2010. http://www1.va.gov/vhapublications/ViewPublication.asp?

pub_ID=2166

4. Internal Policy.

TABLE 1. Multi–Dose Pen Injectors Available in Alternative Formulations TABLE 2. Multi–Dose Pen Injectors Unavailable in Alternative Formulations

(continued from page 3)