1

As of October 24, 2012, an outbreak of fungal meningitis associated with compounded steroid injections (for epidural and other 

joint administration) prepared and distributed by New England 

Compounding Center, Inc (NECC), in Framingham, Massachusetts, has resulted in 312 cases of fungal meningitis, stroke from 

presumed fungal meningitis, or other central nervous systemrelated infection, plus 5 peripheral joint infections (e.g., knee, hip, 

shoulder, elbow), as well as 24 deaths. No deaths have occurred in 

association with the peripheral joint infections. All infected patients received preservative free (PF) methylprednisolone acetate 80mg/ml injection from 3 lots voluntarily recalled by NECC 

on September 25, 2012. NECC has since voluntarily suspended 

operations, surrendered their license, and expanded its recall to 

include all methylprednisolone acetate prepared by their specialty 

pharmacy as well as all of their other drug products prepared and/

or sold. 

Department of Veterans Affairs (VA) has issued a 

National PBM Communication on October 5, 2012 with recommendations for facilities to:

Cease use and immediately remove from their pharmacy inventory ANY product produced by the NECC [not just 

methylprednisolone acetate (PF)]; and

Contact all patients who received methylprednisolone acetate 

(PF) injections from any of the three recalled lots to determine if they are having any symptoms.

Department of Veterans Affairs (VA) circulated an updated 

National PBM Communication on October 18, 2012 with additional actions for facilities to:

Contact patients who received ANY injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012, to 

determine if they are having any symptoms of meningitis or 

other possible infection(s).

(continued on page 2)

FUNGAL MENINGITIS OUTBREAK AND INJECTABLE PRODUCTS FROM 

NEW ENGLAND COMPOUNDING CENTER [NECC] 

Helping to achieve safe 

medication use

ISSUE 9 VOLUME 2 OCTOBER 2012

 FUNGAL MENINGITIS OUTBREAK AND INJECTABLE

PRODUCTS FROM NEW ENGLAND COMPOUNDING CENTER

[NECC]...................... 1-2

 MEDICATION SAFETY NEWS 

FROM THE VA NATIONAL

PHARMACY BENEFITS 

MANAGEMENT SERVICES 

[PBM] AND THE FOOD AND

DRUG ADMINISTRATION

[FDA]........................ 1-2

 OPPORTUNITIES TO PARTICIPATE IN VA SAFETY

INITIATIVES ................ 3Medication

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 

ADDENDUM: Fungal Meningitis Outbreak and Additional Patient Notification – 10-18-2012 - National PBM Communication

Compounded Epidural Steroid Injections and Meningitis Outbreak - 10-05-2012 - National PBM Communication
2

Department of Veterans Affairs (VA) facilities have removed any 

product from the New England Compounding Center, Inc. 

(NECC), based on the recall of all NECC products issued by the 

Food and Drug Administration (FDA). VA has found no evidence 

that any VA medical facility used the injectable steroid product 

from NECC identified as being contaminated. VA’s top priority 

is to ensure the safety of all patients. To date, a detailed review of 

data from the VA Adverse Drug Event Reporting System (VA 

ADERS) from May 21, 2012 until October 16, 2012 shows no 

reports of meningitis or any infection related to any injectable 

steroid use within the VA healthcare system. 

FDA continues to work with CDC and state health officials to 

investigate the source of contamination, scope of exposure, and 

impact on patient outcomes. As investigations unfold, new information can be accessed via the following links:

CDC updated case counts: http://www.cdc.gov/hai/

outbreaks/meningitis-map.html

CDC Map of Healthcare Facilities that received lots of 

Methylprednisolone Acetate (PF) recalled from New 

England Compounding Center on September 26, 2012: 

http://www.cdc.gov/hai/outbreaks/meningitis-facilitiesmap.html

CDC Health Alert for clinicians: http://www.cdc.gov/hai/

pdfs/outbreaks/HANAdvisory_Meningitis_and_Stroke_Associated_with_Potentiall

y_Contaminated_Product-10-4-12.pdf

CDC instructions for clinical teams regarding diagnostic 

testing: http://www.cdc.gov/hai/pdfs/outbreaks/Outbreakdiagnostic-protocol-cleared.pdf

CDC interim treatment options for patients: http://

www.cdc.gov/hai/pdfs/outbreaks/Treatment-Options-10-

3-2012-cleared.pdf

CDC website: http://www.cdc.gov/hai/outbreaks/

meningitis.html

FDA website: http://www.fda.gov/Drugs/DrugSafety/

ucm322734.htm

REFERENCES

1. Multistate Fungal Meningitis Outbreak Investigation. http://www.cdc.gov/hai/

outbreaks/meningitis-map.html . (Accessed 10/16/12).

2. FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification 

Advised. http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm . (Accessed 

10/16/12).

3. Internal VA data.

NEWS YOU CAN USE

FROM THE FOOD AND DRUG ADMINISTRATION (FDA)

NEUROLOGY

Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure

9/19/2012 

FDA suggests a potential risk for heart failure with pramiprexole (Mirapex®) based on preliminary evaluations of a pooled analysis of 

randomized trials and two epidemiologic studies, with further review underway. The pooled analysis (from randomized, placebocontrolled, parallel phase 2 and 3 clinical trials of pramiprexole [Mirapex®] submitted by the manufacturer to the FDA) showed a nonsignificant greater incidence of newly diagnosed heart failure occurring in patients taking pramiprexole (Mirapex®) compared to patients 

receiving placebo. One epidemiologic study showed a statistically significant increase in risk for heart failure (risk ratio [RR] = 1.58; 

95% confidence interval [CI]: 1.26-1.96) with use of any dopamine agonist compared to no use of a dopamine agonist. Another epidemiologic study looked at ergot dopamine agonists as a class, as well as non-ergot dopamine agonists as a class, and saw no increased risk of 

heart failure when compared to levodopa. However, of the non-ergot dopamine agonists, use of pramiprexole (Mirapex®) increased the 

risk of heart failure when compared to levodopa (odds ratio [OR] = 1.61; 95% CI: 1.09-2.38). Study limitations from these epidemiologic trials prevent FDA from reaching any definite conclusions. These limitations include the participation of patients using antiParkinson drugs for other uses (such as restless legs syndrome, treatment of hyperprolactinemia, and for unidentified reasons); limited or 

no validation of heart failure cases via medical record review; the appearance of risk factors more frequently in cases than in controls; 

and the presence of peripheral edema (even if adjusted for by sensitivity analysis).

PAIN MANAGEMENT

Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers

9/13/2012 

First- to third- degree chemical burns have occurred when applying over–the-counter (OTC) topical muscle and joint pain relievers 

(creams, ointments, and patches) containing menthol (>3% concentration), methyl salicylate (10% concentration), or capsaicin. Burns 

occurred after only one application, with severe blistering or burning occurring within 24 hours after initial use. Current product labelling for OTC muscle and joint pain relievers do not carry a warning regarding burns. Healthcare providers should counsel patients on 

appropriate use of OTC muscle and joint pain relievers in addition to care for the site of application, including:

Do not bandage affected area(s) tightly;

Do not apply local heat to affected area(s) [heating pads, lamps, hot water in bags or bottles];

Do not apply to wounds or damaged, broken, or irritated skin;

Do not allow contact with eyes or mucous membranes;

Discontinue use if experiencing pain, swelling, or blistering of the skin at the site(s) of application.

Helping to achieve safe medication use

FUNGAL MENINGITIS OUTBREAK AND INJECTABLE PRODUCTS FROM NEW ENGLAND COMPOUNDING CENTER 

[NECC] 

(continued from page 1)
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ATTENTION PHARMACISTS: CALL FOR PARTICIPANTS

• Multi-Site Medication Use Evaluation (MUE) of Pharmacological Treatment 

of Dementia

The purpose of this MUE is to collect information as a quality assurance and improvement (QA/QI) initiative to describe the current prescribing landscape of cholinesterase inhibitors (Ch-I) and memantine in relation to the VHA PBM Criteria for 

Use guidance. Aggregate data will be evaluated to determine rate of compliance to 

PBM National Criteria for Use of Ch-I’s with regards to indication, monitoring, management of adverse event, and timeliness of follow-up. Looking for 10-15 geographically dispersed sites. Sites with pharmacy 

residents are encouraged to participate; however, participation is open to all . If interested, or for more information, contact 

Muriel.Burk@va.gov .

• Allergy/Adverse Reaction Tracking System (ARTS) Multi-Site Validation

VA MedSAFE is currently recruiting Pharmacist Residents to participate in a multi-site validation of the observed and historical

classification of adverse drug reaction entries documented in the Allergy/Adverse Reaction Tracking System (ARTS) package, 

located in the Computerized Patient Record System (CPRS). This information will help evaluate the true incidence of Observed 

and Historical events as well as potential submission to the VA Adverse Drug Event Reporting System (VA ADERS) and the 

Food and Drug Administration’s (FDA) MedWatch. If interested, or for more information, contact Anthony.Au@va.gov and 

Von.Moore@va.gov .

Getting the most from our 

safety surveillance

OPPORTUNITIES TO PARTICIPATE IN VA SAFETY INITIATIVES