Alert to Tennessee Providers on Meningitis Outbreak
Update: Dec. 19 - FDA, States Meet on Regs for Compounding Pharmacies
FDA officials conferred with public health officials from 50 states on Wednesday about the best way and the best agency to oversee compounding pharmacies. The TMA has said it favors regulation at some level.
Read more in the New York Times.
Update: Dec. 18 - Death Toll Now at 14 in Tennessee
Tennessee still leads the nation in deaths from the fungal meningitis outbreak, with a 14th patient death reported. Nationally, deaths stand at 39. State health officials have identified 107 patients with illness associated with tainted drugs from the New England Compounding Center (NECC), 23 of them with new, localized infections.
Read the full story in the Tennessean.
Update: Dec. 6 - Fungal Infections Rising in TN
Fungal infections in Tennessee have soared since Thanksgiving. Illnesses now total 107 with 23 new ones since the holiday. The surge is due to the secondary wave of localized infections at the injection site, said Tennessee Health Commissioner John Dreyzehner, MD. He urged heathcare clinicians to continue to be on the lookout for infections.
“The end of the risk period is frankly unknown,” Dreyzehner said. He could not say how long the risk window is for the localized infections, which are not considered as life-threatening as fungal meningitis.
Read the full story in the Tennessean.
Update: Dec. 5 - Meningitis Legislation Introduced
Two U.S. House Democrats introduced legislation on Wednesday aimed at bolstering federal oversight of compounded drugs like the tainted steroid injections blamed for a deadly fungal meningitis outbreak.
The outbreak, linked to steroid injections from the Massachusetts-based New England Compounding Center, has sickened 541 people, 36 of whom have died, according to the U.S. Centers for Disease Control and Prevention.
Read about the legislation from Reuters.
Update: Dec. 4 - More Contaminants Found in NECC Drugs
An alert was issued Monday night to healthcare workers that more contaminants have been found in drugs from the New England Compounding Center. Lab tests confirmed contamination in cardioplegia, a drug used in heart surgeries, and in the steroid medications betamethasone and triamcinolone.
Read the full story in the Tennessean.
State health officials continue to investigate the fungal meningitis outbreak; they have also contacted a number of healthcare facilities across the state that received materials from NECC not related to the current outbreak. So far, no Tennesseans are known to have been affected by newly-recalled medications.
Read more from the Tennessee Department of Health.
Update: Nov. 29 - FDA Asked to Reinspect Compounding Pharmacies
Public Citizen on Thursday called on the U.S. Food and Drug Administration to reinspect the 16 compounding pharmacies that received formal warning letters over the past decade in light of the failure to prevent the fungal meningitis outbreak this year.
Five of those pharmacies have licenses to sell drugs in Tennessee: Hopewell Pharmacy in Hopewell, N.J.; PharMedium Services in Lake Forest, Ill.; Wedgewood Village in Swedesboro, N.Y.; Reliant Pharmacy Services in Clearwater, Fla.; and Custom Compounding Centers in Little Rock, Ark.
Read the full story in the Tennessean.
Update: Nov. 26 - Two More TN Cases
Tennessee Department of Health is now aware of 84 patients who have been diagnosed with meningitis, epidural abscess or posterior stroke and 13 deaths in Tennessee, associated with epidural steroid injections in a major joint using NECC products.
Nationally the outbreak has topped 510 cases.
Read the latest from TDH.
Update: Nov. 21 - TDH On Lookout for New Fungal Infections
Tennessee health officials are again contacting 1,009 patients who received injections in Tennessee from three tainted lots of methylprednisolone acetate from the New England Compounding Center, warning them of potentially dangerous injection site infections that may still develop. Read the TDH update.
As of November 16, 82 patients in Tennessee have been diagnosed with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections or steroid injections in a major joint using tainted NECC products. Of those cases, 13 have resulted in death.
Read more in the Tennessean.
Update: Nov. 15 - TMA Submits Comments to Sen. Alexander
The TMA has submitted comments on the fungal meningitis outbreak to U.S. Senator Lamar Alexander, for inclusion in ongoing hearings in Washington. The TMA calls on Congress to authorize appropriate oversight and effective regulation of compounding pharmacies to ensure another deadly outbreak from tainted drugs never happens again.
Read the comments.
Update: Nov. 14 - Hearings Convene; TN Pharmacy Board to Investigate Compounding
Separate hearings are underway this week in Congress on the meningitis outbreak, with the House Energy and Commerce (E&C) Committee's oversight subcommittee taking up the issue November 14, followed by a November 15 hearing before the full Senate Health, Education, Labor, and Pensions (HELP) Committee.
The Tennessee Board of Pharmacy said it will survey the state’s roughly 1,900 pharmacies to gauge how prevalent the practice of compounding is. The board also said it will appoint a task force to study the issue and make recommendations, both short-term and long-term.
Read more on the Tennessean website.
Update: Nov. 13 - Senate Meningitis Outbreak Hearing Agenda Set
On Wednesday, November 14, 2012, at 10:00 a.m. in room 2123 of the Rayburn House Office Building in Washington, DC, the U.S. Senate Subcommittee on Oversight and Investigations will hold a hearing entitled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
This hearing will examine the facts surrounding the recent outbreak of fungal meningitis and other infections linked to contaminated injectable products made and distributed by the New England Compounding Center (NECC) in Framingham, Massachusetts. This hearing will also examine the history of complaints associated with NECC and its affiliated entities as well as related inspections and actions taken by the U.S. Food and Drug Administration (FDA) and the Massachusetts Department of Public Health (MDPH).
Read the full memorandum on the hearing.
Update: Nov. 8 - 80 Patients; TMA Testimony Requested on Outbreak
The Tennessee Department of Health is aware of 80 patients with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections or steroid injections in a major joint using NECC products. The number of deaths remains at 13.
The TMA is among organizations invited to submit testimony to a U.S. Senate committee that is examining state and federal oversight of the New England Compounding Center (NECC), the source of the contaminated steroid injections that have caused a meningitis outbreak nationwide and led to 13 deaths in Tennessee. U.S. Senator Lamar Alexander announced his participation in a November 15 hearing by the committee entitled “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.” He invited comment from the TMA, the Tennessee Department of Health, the Tennessee Board of Pharmacy, the Tennessee Pharmacists Association, the Tennessee Hospital Association, and the Tennessee Board of Medical Examiners.
Update: Nov. 6 - TDH Authors NEJM Article on Outbreak
The Tennessee Department of Health has co-authored with CDC officials an article on its investigation of the outbreak of illnesses in Tennessee associated with contaminated methylprednisolone acetate. The article will appear in the New England Journal of Medicine this week.
Access the article online.
“The process of researching, writing and publishing an article in the New England Journal of Medicine can take months, but due to the importance of sharing information about the outbreak quickly, this was completed in three weeks,” said TDH Commissioner and TMA member John Dreyzehner, MD, MPH. “The piece will be beneficial to clinicians who want and need more technical information to assist them with treating current patients infected by contaminated methylprednisolone. It should also be a valuable resource for future clinical work.”
Update: Nov. 5 - TN Infection Rate at 79, Deaths at 13
The Tennessee Department of Health is aware of 79 patients with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections or steroid injections in a major joint using products from New England Compounding Center. Of those cases, 13 have resulted in death of the patients. Read the latest.
Update: Safety Guide Issued for Epidural Steroid Injections
With the recent outbreaks of meningitis due to tainted corticosteroids, the Tennessee Society of Interventional Pain Physicians has issued a patient safety and effectiveness guide to epidural steroid injections for back pain.
In response to the recent national and state-wide meningitis crisis, TNSIPP is emphasizing the long safety history of epidural steroid injections for back pain relief and has created an educational guide for patients. This guide – in the form of “Frequently Asked Questions” – provides background on spinal injections for back pain that will help both patients who have had an injection and those who are considering one.
To date, 338 cases of meningitis and 25 deaths have been recorded due to a tainted corticosteroid produced by a compounding pharmacy in Massachusetts, according to the Centers for Disease Control and Prevention. Of these cases, 78 have been in Tennessee, resulting in 11 deaths.
“This situation is tragic, and it is incumbent upon all of us in the field of interventional pain management to ensure that the people of Tennessee have the information they need and that this does not happen again,” says Graf Hilgenhurst, MD, a TMA member and president of TNSIPP. But he emphasized that, with proper diagnosis and under the direction of a qualified physician, “an epidural steroid injection is a safe, effective treatment. They allow millions of people around the country to live more productive lives, despite chronic, sometimes debilitating, pain.”
TNSIPP members have been advocates for ensuring that only qualified physicians be permitted to perform epidural steroid injections. Just this past year, the Tennessee General Assembly passed legislation that prohibits practitioners without proper training from performing spinal injections; the law takes effect on July 1, 2013. Many other states, however, have no such regulations, he says.
“As with any procedure, there are risks and potential side effects, but contaminated corticosteroids on such a wide scale is surprising,” said Dr. Hilgenhurst. “However, compounding pharmacies produce special drug formulations that are not always available through traditional pharmacies. We must be as diligent in finding ways to ensure drug safety as we have been with providing training and qualification standards for those performing the procedures.” He said TNSIPP will continue to play a leadership role in both important areas.
Read the TNSIPP resource guide, Epidural Steroid Injection Safety & Effectiveness: Frequently Asked Questions.
Update: Ameridose Recall
The Tennessee Department of Health has received news that Ameridose, LLC, has issued a voluntary recall of all its products. At this time, the TDH and the Food and Drug Administration are not aware of any health issues caused by any Ameridose products in Tennessee or elsewhere.
The FDA, in announcing the recall, said healthcare professionals do not need to follow up with patients who received Ameridose products, but that clinicians should stop using the Ameridose products and return them to the firm.
Ameridose is licensed in Tennessee; it has a Manufacturing/Wholesaler/Distributor license in addition to a pharmacy license. According to the Massachusetts Board of Registration in Pharmacy, Ameridose “voluntarily ceased all pharmacy operations and any dispensing, manufacturing or wholesale distribution of any products as of 3:00 p.m. on October 10, 2012.” See the agreement.
Ameridose has provided the following information:
“Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo... A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com.”
Read the FDA news release for additional information.
Update: 74 Infections, 11 Deaths in TN
As of 11:00 a.m. Central on October 30, the Tennessee Department of Health is aware of 74 patients with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections or steroid injections in a major joint using products from New England Compounding Center. Of those cases, 11 have resulted in death of the patients. Read the full update on the TDH website.
Update: TDH Releases NECC Facility Shipment List
The Tennessee Department of Health today released a list of 74 health care facilities across the state that received suspect material from the New England Compounding Center after May 21, 2012. The material includes injectable medications used in some eye and heart surgeries at the facilities.
See the list.
Update: NECC Customer List Posted
The FDA has posted two versions of a list of customers who received the concerned NECC product, shipped on or after May 21, 2012:
Visit the FDA Meningitis web page for information on viewing the list and accuracy of the information provided.
Update: Monday, Oct. 22 - Cases Rising
The Tennessee Department of Health is aware of 69 patients with meningitis, epidural abscess or posterior stroke associated with epidural steroid injections or steroid injections in a major joint using products from New England Compounding Center. The number of confirmed deaths in this situation remains at nine.
TDH has supplied updated reporting protocol:
After appropriate evaluation and testing, if you believe your patient likely has a fungal infection associated with a NECC product, please call the Department of Health at 1-866-327-9102 to report it. Healthcare Associated Infections program staff will request information on the infection and exposure.
Please provide the following information:
1. A copy of the actual lab report.
2. The facility name (if not clearly identified on the lab report form).
3. The name, email address, and phone number of a contact person in the laboratory.
4. If readily available, whether or not the patient was exposed to a New England Compounding Center product
A. Isolates of Candida spp. are not reportable
B. Normally sterile sites include: blood, CSF, pleura, pericardial, peritoneal, joint, bone, surgical aspirate
Update: Friday, Oct. 19 - Additional Sample Patient Letter
Another patient sample letter has been provided by the Tennessee Hospital Association, edited to make it easier for patients to understand. See the letter.
Update: Thursday, Oct. 18 - Sample Patient Notification Letter
The FDA has provided a sample letter with standardized language for notifying patients about the meningitis outbreak. See the letter.
Wednesday, Oct. 17
Federal and Tennessee health officials report new concerns about all sterile products from the New England Compounding Center (NECC), cited in the current meningitis outbreak nationwide.
In addition to spinal injection products, health officials are investigating more cases involving cardiac, ophthalmic, transplant and deep surgical irrigation products; there are no concerns about topical or suppository products.
All Tennessee healthcare providers and facilities are being asked to:
- Halt the use of all NECC products, especially lot numbers back to May 21, 2012. See the full list of NECC products sent to Tennessee.
- Contact all patients who may have been exposed to NECC sterile products since May 21, 2012. Inform them of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms. Signs and symptoms include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).
- Report any injection site fungal infections seen/treated to State Health Operations Center (SHOC), 866-327-9102; fax 615-253-1563; Shoc.firstname.lastname@example.org. Please classify your reports as:
- Patient WAS exposed/treated with NECC products in the three months prior to fungal isolate/adverse event
- Patient WAS NOT exposed/treated with NECC products in three months prior to fungal isolate/adverse event
- Cannot confirm / Unknown exposure to NECC products in three months prior to fungal isolate/adverse event
- Report adverse events suspected related to NECC (non MPA) to the SHOC and to FDA Medwatch, 800-332-1088 or www.fda.gov/medwatch.
Read the FDA Medwatch Alert.
See the latest from the Tennessee Department of Health.
FDA Meningitis updates here.
CDC Meningitis updates here.
CDC Clinical Guidance is here.
State Health Operations Center
866-327-9102; fax 615-253-1563
800-332-1088; fax 800-FDA-0178
FDA Drug Information Line - 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.