Part I: Mendocino County Medical Center on Watch List for Non-FDA Regulated Drug
–Cases and Deaths Rising–
Skippy Massey
Humboldt Sentinel
A national fungal meningitis outbreak linked to epidural steroid injections has affected the eastern half of the
United States and is continuing to grow, according to the
Center for Disease Control and Prevention. The CDC, which
is coordinating the investigation into the outbreak,
said the infected states include Florida, Indiana,
Maryland, Michigan, Minnesota, North Carolina, Ohio,
Tennessee and Virginia.
State and federal officials said 75 health care facilities in 23 states received the contaminated product. As of Monday, 105 meningitis cases and eight deaths had been reported. On Wednesday afternoon, those numbers rose to 137 cases and 12 deaths in 10 states linked to the outbreak. It is believed that 13,000 patients may have been exposed by injection nationwide.
No cases or deaths have occurred so far in California– but about 600 California patients were treated with steroid shots from the recalled batches of the pain medication used as an epidural injection for chronic pain.
According to CDC, four California facilities that received the recalled batches of medication are:
- Ukiah Valley Medical Center
- Cypress Surgery Center in Visalia
- Encino Outpatient Surgical Center
- Universal Pain Management in Palmdale
Health officials are continuing to monitor patients in the North Coast
region who received the steroids. None of the facilities or patients
appear to be in Humboldt County.
The outbreak has been linked to batches of methylprednisolone acetate used to make injectable steroids and manufactured by the New England Compounding Center, which federal officials suspect was contaminated with the fungus.
Unlike drug manufacturers, which are regulated by FDA, compounding pharmacies are licensed by states and not subject to federal oversight. California officials are now eyeing tougher restrictions and considering ways to strengthen the regulation of medical products shipped from out-of-state compounding pharmacies due to the outbreak.
The California Board of Pharmacy is responsible for licensing pharmacies in California, as well as out-of-state pharmacies that ship products into California.
Virginia Herold — executive officer of the California Board of Pharmacy — said state regulators are working on proposals that would strengthen licensing requirements for out-of-state compounding pharmacies that ship products into California. Proposed regulations could require that accrediting agencies use California inspection standards for out-of-state manufacturers that ship to California, according to Herold.
“If we’re going to accept their accreditation, it should be to our standards,” Herold said.
New England Compounding Center located in Framingham, Mass., began a voluntary recall of the steroid drugs on Sept. 26. Among those receiving the infected batches was the Ukiah Valley Medical Center, which last week sent out letters to patients notifying them of the issues of fungal meningitis, a swelling of the protective covering of the brain and spinal cord.
The CDC said infected patients have developed a variety of symptoms approximately one to four weeks following their injection. The symptoms include fever, new or worsening headache and nausea. Some also have suffered strokes.
The CDC investigation thus far has revealed that the meningitis linked to the steroid injections was caused by a fungus that is common in the environment but rarely causes meningitis. The source of the fungus, however, hasn’t been identified. Officials said the fungal meningitis in this outbreak is not contagious.
Anyone who has had one of the epidural steroid injections since May 21 should talk to their doctor immediately if they experience a worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, according to the CDC.
In a released statement earlier this week, the Ukiah Valley Medical Center said it selected the New England Compounding Center in spite of a 75 percent higher cost for the compounded medication because the center is a specialized “compounding-only pharmacy” dedicated to providing medications and services to patients and prescribers.
“The product was selected because it contains no preservatives or buffers that other pharmaceutical manufacturers offer that may cause higher risk of infection or other complications,” a Ukiah Valley Medical Center spokesperson said on Monday.
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This is part I of a two-part Sentinel series on the national meningitis outbreak and compounding pharmacies. Part II: “What a Failed Vegas Sex Pill and the Meningitis Outbreak Have in Common” may surprise you– and can be found here.
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