This is an official

CDC HEALTH UPDATE

Distributed via Health Alert Network
December 3, 2012, 16:55 ET (4:55 PM ET)
CDC HAN-0337

Update: Additional Contamination Identified in Medical Products from New England Compounding Center

Summary: As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass.  CDC and FDA are reporting today additional microbial contamination identified in NECC products, which updates the November 1, 2012 Health Alert Network advisory. This update includes the following key points:

• CDC and FDA have identified additional microbial contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC.
• These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species, and Penicillium species. 
• Although rare, some of the identified Bacillus species can be human pathogens. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically. 
• To date, although CDC has received reports of illness in patients who have received the medications listed in the table below, including some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products.
• The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
• CDC's recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings.
• CDC continues to recommend that clinicians remain alert for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as deemed necessary by treating clinicians.
• Clinicians should continue to report infections potentially related to NECC products to FDA's MedWatch and to state health departments.

Background
On September 26, 2012, NECC voluntarily recalled three lots of preservative-free methylprednisolone acetate (PF) 80mg/ml¹ associated with the multistate outbreak of fungal meningitis and other infections. As previously confirmed by CDC and FDA, the fungus Exserohilum rostratum was identified from two different lots of NECC-supplied, preservative-free methylprednisolone acetate (Lot #06292012@26 and Lot #08102012@51); testing on the third implicated lot of preservative-free methylprednisolone acetate (Lot #05212012@68) has yet to identify fungal growth.  Two types of fungus not known to be human pathogens were also identified from product from the two tested lots, namely Rhodotorula laryngis and Rhizopus stolonifer. Among these fungal organisms, only Exserohilum rostratum has been associated with human infections in this outbreak.

On October 6, NECC expanded its recall to include all products in circulation that were distributed from its facility in Framingham, Mass.  As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. Laboratory testing at CDC and FDA has found bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC, as shown in the table below.

Laboratory-Confirmed Organisms from Product Samples Associated with NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions
Medication	Lot Number	Bacterial and Fungal Contamination
Betamethasone 6 mg/mL injectable –5 mL per vial	08202012@141	Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea, Bacillus lentus
Betamethasone 6 mg/mL injectable –5 mL per vial	07032012@22	Bacillus niabensis, Bacillus circulans
Betamethasone 12 mg/mL injectable – 5 mL per vial	07302012@52	Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Betamethasone 6mg/mL injectable – 5 mL per vial	08202012@44	Bacillus lentus, Bacillus firmus, Bacillus pumilus
Betamethasone 6 mg/mL injectable – 5 mL per vial	08152012@84	Penicillium sp., Cladosporium sp.
Triamcinolone* 40mg/mL injectable – 1 mL per vial	06062012@6	Bacillus lentus, Bacillus circulans
Triamcinolone 40 mg/mL injectable – 2 mL per vial	08172012@60	Aspergillus tubingensis, Penicillium sp.
Triamcinolone 40mg/mL injectable – 10 mL per vial	08242012@2	Aspergillus fumigatus
Cardioplegia solution 265.5 mL per bag	09242012@55	Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

*Identification of other bacteria for this product is pending.

Recommendations to Healthcare Providers

FDA released a MedWatch Safety Alert on October 15 stating that the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC is of significant concern.  The safety alert further advised healthcare providers to follow-up with patients who were administered any of these products purchased from or distributed by NECC on or after May 21, 2012. A sample notification letter to assist with this process is available.

CDC’s recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of the laboratory findings reported here. CDC continues to recommend that clinicians remain vigilant for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as deemed necessary by treating clinicians.

There has been no prior systematic surveillance for adverse events following epidura
l steroid injections; however, infection is a known, although likely rare, risk that has been documented in the medical literature.  To date, although CDC is aware of reports of illness in patients who have received these medications, including some patients who had evidence of meningeal inflammation, CDC and other public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, or spinal or paraspinal infections caused by these products.  The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
However, because it is possible that some of the organisms listed in the table above can cause human disease, clinicians should continue to include bacterial and/or fungal infection in the differential diagnosis when evaluating symptomatic patients who were exposed to these medications, including consideration of empiric antifungal therapy.

Consultation with an infectious disease specialist is strongly encouraged to help make treatment decisions in these cases.  If the evaluation of these patients is suggestive of fungal infection, please consult existing CDC treatment guidance associated with this outbreak.

Physicians should continue to report infections potentially related to NECC products to FDA's MedWatch and to state health departments.

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NECC lots of methylprednisolone acetate (PF) 80mg/ml:
     Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
     Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
     Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

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Project Wildfire: A Community Approach to Surviving Wildfires

 

Project Wildfire: A Community Approach to Surviving Wildfires

Categories: General, Natural Disasters, Preparedness, Response

December 3rd, 2012 10:49 am ET  -  Blog Administrator

By Kate Lighthall

Project Wildfire in Deschutes County, Oregon has been recognized by CDC’s Office of Public Health Preparedness and Response’s (OPHPR) Learning Office and the CDC Foundation as a community effort that reflects and embodies FEMA’s Whole Community approach to emergency management.

Although central Oregon experiences other natural and man-made disasters, wildfires are by far the biggest threat here, especially during the summer months.  In an average year, we experience 450 fires that burn 50,000 acres and homes, threaten lives and impact the economy.  Following two devastating wildfires that burned in Bend, Oregon in 1990 and again in 1996, the Fire Chief of Deschutes County, Oregon, Gary Marshall, received a phone call from Safeco Insurance offering to contribute to the purchase of new firefighting equipment. Marshall politely declined Safeco’s offer because he had a more effective, long-term solution in mind that involved educating the public about the risks of wildfires.

Marshall asked Safeco Insurance if they would invest in an education program designed to teach people to help themselves prepare for wildfires. “A new piece of equipment might save one more home,” Marshall said. “But to really save homes, individuals have to take responsibility for their property before a fire.” His ultimate aim: To change the values and behaviors of citizens for generations to come. 

Safeco agreed and FireFree was born.  FireFree is a year-round educational program that was launched to promote 10 simple steps that homeowners can take to protect their homes from wildfires and reduce their risk of loss.  The number one FireFree tip, and the main focus of the behavior change campaign, is to create “defensible space,” a minimum 30-foot buffer zone around a house that can be created in one weekend, and easily maintained.  To encourage citizens to prepare for wildfires, FireFree partners with Deschutes County Department of Solid Waste and Deschutes Recycling to provide free collection and recycling of yard debris and waste during the spring.  Later in the fall, residents can recycle their yard debris at Deschutes Recycling for half price.  The program ran with the tagline, “It’s quick. It’s simple. It’s everybody’s responsibility.”  Sixteen years later, FireFree continues to effectively change attitudes and behaviors about wildfires.

This initial program became part of a larger endeavor.  County elected officials took notice of these efforts and passed a county ordinance that created Project Wildfire to help manage and support FireFree, as well as provide long-term wildfire mitigation strategies.  At the core of Project Wildfire’s organization is a community driven approach, with a diverse membership that provides a wealth of local knowledge and broad educational outreach.

The FireFree story is just one of Project Wildfire’s accomplishments.  Since the initial push in the late 1990s to educate communities in Deschutes County, Project Wildfire has become the local coordinating group that facilitates, educates, and disseminates efforts about the importance of wildfire safety across the community.  Project Wildfire is the facilitator and caretaker of seven Community Wildfire Protection Plans (CWPPs), coordinates a countywide Sweat Equity (FireFree based) Program, and Evacuation Preparedness program and is recognized as a wildfire mitigation resource across the state and the nation.
While Project Wildfire has accomplished much over the last decade, our achievement is due in no small part to our successful working relationships with our partners.  We continue to implement programs that encourage neighbor-to-neighbor education and understanding while leveraging opportunities for public/private partnerships. 

The Whole Community Approach

The “Whole Community” is FEMA’s philosophical approach on how to conduct emergency management in a way that integrates the needs, capabilities, and resources across the community. It attempts to engage the full capacity of the private and nonprofit sectors, including businesses, faith-based organizations, and the general public, in conjunction with the participation of federal, state, local, territorial, and tribal government partners. 

Project Wildfire has been identified as one of seven programs to continue their Whole Community work during the pilot program period October 2012 – March 2013. During this time, we will provide a learning opportunity for CDC and CDC Foundation staff to gather information on what works well in starting and maintaining community programs, identifying strategies to create and build partnerships, and techniques to empower local action. The project findings will outline recommendations for fostering a Whole Community approach to emergency management, sustainability, and program replication. 

We’re proud to be one of the seven community organizations selected as a promising example of FEMA’s Whole Community model.  We look forward to highlighting the progress we’ve made toward preparedness in Deschutes County, Oregon and contributing to a national effort to make sure America is prepared for emergencies.

To learn more about Project Wildfire, please contact Kate Lighthall at klighthall@bendcable.com or visit us on the web at www.ProjectWildfire.org or www.FireFree.org.

Follow #PromisingExample on Twitter to learn about the other six communities that embody a whole community approach to emergency management.