Microsoft word - talking points_injection epidural 10 4 2012.doc

Medication Recall / Meningitis from Injection Investigation • The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), in partnership with state health departments are investigating a cluster of clinical meningitis cases following spinal injections. • Patients received epidural spinal injections and developed meningitis within 1 • As of noon today, the current case count is as follows: * Case Definition 1: A person with meningitis1 of sub-acute onset (1-4 weeks) following epidural injection after July 1, 2012. 2: A person, who has not received a lumbar puncture (LP), with basilar stroke 1-4 weeks following epidural injection after July 1, 20122. 3. A person with evidence of spinal osteomyelitis or epidural abscess at the site of an epidural injection diagnosed 1-4 weeks after epidural injection after July 1, 2012. 1clinically diagnosed meningitis meaning 1 or more of the following symptoms: HA,
fever, stiff neck, or photophobia and a CSF profile consistent with meningitis (elevated
protein/low glucose/pleocytosis)
2These people, if possible, should have an LP. • The source of the infections is unknown at this time however, it has been determined that a steroid medication (methylprednisolone acetate) was used for all of the infected patients. This is a medication commonly used for epidural spinal injections. • Early data suggest that all infected patients received infection with preservative- free steroid medication prepared by the New England Compounding Center (NECC), located in Massachusetts. The NECC has been shut down as of 10/3/12 and all methylprednisolone products are recalled. • Three lots of the medication have been recalled: o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot o Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot • The medication was shipped to healthcare facilities in 23 states across the country, including New Jersey. All facilities that received shipments are outpatient facilities and were notified by the pharmacy. The product has been recalled. NJDOH has also been in contact with all of the facilities that received the product. • Physicians are asked to contact patients who have had any injection (e.g., spinal, joint) using any of the three lots of methylprednisolone acetate listed above to determine if they are having any symptoms. • Patients who received a steroid injection and are experiencing symptoms such as new or worsening headache, fever, neck stiffness, or pain at the injection site, should contact the provider who administered the injection to determine if they may have received one of the recalled products and to receive further evaluation. • At this time, there are no confirmed cases in New Jersey. • The New Jersey Department of Health (NJDOH) is working with the facilities within NJ that received the recalled lots of the medication to assess patient outcomes. Facilities that received shipments of the medication should report patients who meet clinical criteria provided by the CDC. The NJDOH will continue to monitor the situation. Medication Recall / Meningitis from Injection Investigation
For the Public

What is Aspergillus?
• Aspergillus is a mold, which is a type of fungus. This fungus is common to the environment and is found in places such as soil and on plants. It is also found in household dust and building material. • There are many species of the Aspergillus fungus and Aspergillus fumigatus • Aspergillosis is the name of the condition when a person is infected with the Aspergillus fungus. Aspergillus usually causes illness in people with weakened immune systems. If this fungus is found in the environment, should I worry? • Normally the body can fight off disease and prevent infections. However, because the medication (which may include the mold) was injected directly into the body, the body may not be as effective in fighting germs. What is the treatment for Aspergillosis? • Antifungal medication is available to treat fungal infections. Your health care provider can determine the best treatment for you if you should develop an infection. How would I know if I am at risk for Aspergillosis? • If you received a methylprednisolone acetate epidural injection on or after July 1, 2012 from the medicine lots that were recalled, you may be at risk. If you are concerned, contact your health care provider to determine if you received medication from the implicated batches. What are the symptoms associated with this investigation? • Patients developed symptoms that included worsening headache, stiff neck, sensitivity to light and fever within 1-4 weeks following their injection. Some also experienced stroke symptoms including localized weakness (on one side of the face, drooping face), numbness, slurred speech. If I had a pain injection at my doctor’s office, should I be concerned? • This investigation focuses on medication that was shipped to six ambulatory care (outpatient) facilities in seven locations in New Jersey. Most of the medications used in these types of injections is safe and is not involved in the recall. What locations in New Jersey received shipments of the contaminated medication? • Facilities that received shipments of the implicated product have been contacted. The medication has been recalled. If you have any concerns, please contact the health care provider or facility that provided your care, as they should know if you might have received medication from the recalled batches. • This investigation is ongoing. The New Jersey Department of Health is working with our federal and local partners to evaluate the products and preparation practices. How do I know my doctor has been informed of the medication recall? • The pharmacy notified all facilities that received shipments of medication that were later recalled. The New Jersey Department of Health issued a notification to all public health and healthcare partners regarding the investigation. I just received a cortisone shot from my doctor, should I be concerned about a fungal infection? • Individuals receive injections for many reasons. This investigation is focusing on the medication methylprednisolone acetate only. If you are concerned, contact your health care provider to determine if you received medication from the implicated batches. Is there a difference between this meningitis and the one I hear about? • Meningitis is an inflammation of the covering of the brain and spinal cord. It is spread from person to person by saliva. Fungal meningitis is different. It is not spread from person to person. This investigation is looking at a contaminated product as the cause of the disease. • An epidural is an injection given into the back. The injection can be given for different purposes and contain different medications. I just gave birth and had an epidural, should I be concerned? • The type of medication used during an epidural during childbirth is different than the medication that was recalled with this investigation.
For Health Care Providers

I am a healthcare provider who received contaminated medication. What should I
do?
• The NJDOH will coordinate a pick-up of the affected vials with the CDC and What signs/symptoms am I looking for in an infected patient? • Infected patients have presented approximately one to four weeks following their injection with a variety of symptoms including: fever, new or worsening headache, nausea, and/or new neurological deficit (consistent with deep brain stroke). Some of these patients’ symptoms were very mild in nature. Cerebrospinal fluid (CSF) obtained from these patients has typically shown elevated white cell count (with a predominance of neutrophils), low glucose, and elevated protein. I am a provider and have a patient(s) who received spinal injections and meets case definition. What should I do? • Providers are advised to work with the regional epidemiologist in their county/jurisdiction. The NJDOH can provide you with their contact information. I am a provider and I have patient(s) of meningitis or basilar stoke. What further testing is needed? • For patients who received epidural injection and have symptoms of meningitis or basilar stroke, a diagnostic lumbar puncture (LP) should be performed, if not contraindicated. Because presenting symptoms of some patients with meningitis have been mild and not classic for meningitis (e.g., new or worsening headache without fever or neck stiffness), physicians should have a low threshold for LP. While CDC is only aware of infections occurring in patients who have received epidural steroid injections, patients who received other types of injection with methylprednisolone acetate from those three lots should also be contacted to assess for signs of infection (e.g., swelling, increasing pain, redness, warmth at the injection site) and should be encouraged to seek evaluation (e.g., arthrocentesis) if such symptoms exist. • For guidance on diagnostic testing that should be performed on patient specimens, refer to the diagnostic protocol developed by CDC for this outbreak, which will be posted on the CDC website on October 4, 2012. • Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch. I am a provider, what is the recommended treatment? • At present, the etiologic agent of this cluster of meningitis has not been clearly identified. However, a mold species has been isolated from CNS specimens from at least two patients linked to the outbreak, one of whom also had Propionobacterium acnes of unclear clinical significance isolated from a post-mortem CNS specimen. Two additional patients have preliminary histopathologic evidence of fungal infection. When treating patients with meningitis who meet the outbreak case definition,1 clinicians should continue to follow routine treatment protocols for meningitis of unclear etiology, including covering for potential bacterial causes of meningitis. In addition, until the etiology is better defined, clinicians are encouraged to add empiric antifungal therapy to the treatment regimen because of the severe adverse outcomes of untreated fungal meningitis. CDC has consulted with national experts on the following guidance; these treatment options for fungal meningitis in patients associated with this cluster are interim, and may change as new information becomes available.

Source: http://orthopedicnj.com/pdf/epidural-steroid-injections.pdf