Fungal meningitis outbreak has slowed but isn't over yet

While the nation's fungal meningitis outbreak has slowed, it hasn't ended, according to health professionals.

Patients continue to seek treatment for meningitis-related symptoms more than four months into the outbreak, which has been linked to contaminated steroid injections given to treat back pain.

"We're seeing about two patients in, two patients out a day," said Laura Blodgett, a spokeswoman for Saint Joseph Mercy Hospital in Washtenaw County's Superior Township, which is the treatment center for local cases. "It's been holding steady."

As of Monday, 23 patients remained hospitalized at Saint Joseph Mercy.

While no new cases of cases of full-blown meningitis were reported in Michigan over the past six weeks, patients continue to seek follow-up care.

Patients also seek treatment for epidural abscesses, infections near spinal areas where the contaminated steroids were injected.

The number of abscesses and meningitis-related joint infections has continued to grow even as the number of cases of full-blown meningitis have leveled off.

Last week, the Michigan Department of Community Health reported three new cases of epidural abscesses. Medical professionals consider the abscesses dangerous because they could spread meningitis through a patient's body if left untreated.

Last week, the Michigan Department of Community Health reported three new cases of epidural abscesses. Medical professionals consider the abscesses dangerous because they could spread meningitis through a patient's body if left untreated.

According to the department, one of the 13 Michigan-related meningitis deaths has now been linked to an epidural abscess.

As of Friday, the department reported 232 overall cases including 64 cases of full blown meningitis, including 38 cases of meningitis with abscesses and 146 epidural abscesses alone. Other cases include 21 joint infections, including one with an abscess, and one meningitis-related stroke.

Meningitis is an inflammation of the membranes surrounding the brain and spinal cord.

Michigan Pain Specialists in Genoa Township was one of four Michigan facilities to have received the contaminated steroids.

The contaminated steroids were mixed at the New England Compounding Center, a now-closed facility in Framingham, Mass.

Michigan accounted for one-third of all cases recorded during the 19-state outbreak, according to figures released by the federal Centers for Disease Control and Prevention.

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Year in Review: Meningitis Outbreak Still a Challenge

By Michael Smith, North American Correspondent, MedPage Today

Published: December 28, 2012

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened with the fungal meningitis outbreak since we published our first report.
The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.
What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.
It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.
"The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing," Kauffman told MedPage Today. "The huge morbidity and, for some, mortality, is enormous."
The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called "compounding pharmacies."
And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.
The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.
The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: "We're still in the middle of this thing."
Compounding Out of Bounds
The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.
Continue to read here

Should New Federal Legislation Similar to the Safe Drug Compound Act of 2007 Giving the FDA Authority to Regulate Compounding Be Enacted in Light of the New England Compounding Center Meningitis Outbreak

The Safe Drug Compounding Act of 2007 was drafted as a Senate bill.  Its purpose was to redefine oversight and regulation of the practice of pharmacy compounding by giving power to the FDA to inspect all retail pharmacies that made or dispensed compounded medications and to determine whether or not compounded medications were medically necessary or  "essentially copies" of existing FDA-approved medications. The draft bill also would have taken a number of steps to inhibit the distribution of compounded medications beyond state lines by requiring compounding pharmacies to provide detailed documentation on all intrastate orders and asking state pharmacy boards to "discourage the distribution of inordinate amounts of compound drug products in interstate commerce."  The bill never passed.

Pharmacists and pharmacy organizations opposed the draft bill, expressing concern that the Safe Drug Compounding Act of 2007, would restrain the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations--the American Pharmacists Association, National Community Pharmacists Association, International Academy of Compounding Pharmacists (IACP), American College of Apothecaries, American  Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas Pharmacists Association --  drafted a letter to the bill's expected sponsors. insisting that the draft legislation "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists" and urging that this draft legislation not be introduced.  The coalition of none pointed out the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised to work with Congress to address concerns about compounding.

Compounding critics, however, wanted the draft bill to pass, insisted that the act would clarify several issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA) dealing with compounding, and  claimed it would help correct the problems and dangers associated with pharmacy compounding.  The 2007  legislation was sponsored by Senator Ted Kennedy and co-sponsored by Senators Pat Roberts and Richard Burr.  The bill previously failed to become law.  Senator Richard Blumenthal (D-Conn.) called for stronger federal oversight of compounding pharmacies.  In a letter to the FDA, Senator Blumenthal states:

 “This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies. I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution."

To read the entire letter click here.  Is federal legislation already in the works?  What should the federal legislation cover?  What should it not cover?  How board should it be?

Rare meningitis cases at 26 in 5 states, 4 deaths

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More on the New England Compounding Center

The Wall Street Journal has an article regarding the New England Compounding Center entitled, Meningitis Tied to Pharmacy: Authorities Investigate Maker of Steroid Injections Linked to Deadly Outbreak.  To read the article click here.