Source of meningitis supplied many local hospitals

Dozens of Philadelphia-area health-care facilities, including some of the largest hospitals, were among the thousands nationwide that received products in the last five months from the Massachusetts compounding pharmacy at the center of the fungal-meningitis outbreak that has killed more than 20 people.

The U.S. Food and Drug Administration has issued a 73-page list of health-care facilities that received at least one drug from New England Compounding Center in Framingham, Mass., which has been shut down because of tainted products.

Taking advantage of a legal and regulatory gray area, "compounding manufacturers," as one hospital spokeswoman described them, produce medications without the same FDA oversight that other drugmakers are subject to, without prescriptions, and often at lower prices. (Originally, a compounding pharmacy amounted to a single pharmacist mixing drug ingredients after receiving a prescription from a doctor, who hoped the special formulation would meet the needs of an individual patient.)

The FDA announcement, which included a second and longer list of each medication that was shipped to each facility, followed a Tuesday evening preliminary report from the Massachusetts health department that provided troubling details about the operation that produced the drugs.

Among several concerns, investigators found a "leaking boiler" and pools of water near a supposedly "clean room" in which medicine was made, according to the report. The investigators were worried that procedures might not have been followed to ensure sterility of products; additional concerns were raised regarding a nearby recycling center operated by New England Compounding Center's parent company.

New Jersey has reported 18 cases of fungal meningitis, and Pennsylvania has reported one case, with no deaths in either state. Nationwide, 24 deaths were reported as of Wednesday night.

Only a few drugs have been associated with the meningitis outbreak, but the Centers for Disease Control and Prevention and the FDA have urged doctors and other health-care providers not to use products from NECC.

The drug associated with most of the meningitis cases is methylprednisolone acetate, a steroid injected into patients' backs and necks to treat pain.

The FDA said it also is concerned about an injectable drug used in eye surgery and a solution and injectable drug used in cardioplegia, part of stopping the heart during surgery.

According to the FDA list, regional facilities receiving NECC shipments ranged from individual doctors to hospitals including Pennsylvania Hospital, Thomas Jefferson University Hospital, and Hahnemann University Hospital in Philadelphia, and Cooper University Hospital and Our Lady of Lourdes Medical Center in South Jersey.

A spokeswoman for Thomas Jefferson University Hospital, Jefferson Hospital for Neuroscience, and Methodist Hospital said those facilities have never acquired methylprednisolone from NECC and have removed all of the NECC medications that they did receive.

Pennsylvania Hospital was the only Penn Medicine facility on the FDA's list. A spokeswoman said the hospital did not use the steroid in question, but because other injectables come in multi-dose vials, she could not say how many patients were treated with other NECC drugs.

A Hahnemann spokeswoman said in a statement that the facility has not ordered or used any NECC methylprednisolone.

"We have ordered and used cardioplegia, ophthalmic injectables and ophthalmic solutions used during eye surgery and other injectables from the NECC during the time period currently being investigated" by the FDA, she wrote. "We are no longer using NECC products, and they have been removed from our pharmacy inventory. None of the products previously used by our hospital has been linked to the outbreak of meningitis or other infections.

"Out of an abundance of caution, the FDA has asked all health-care providers to notify patients who may have received these medications. We are identifying all patients who may be impacted and are notifying them this week," the Hahnemann statement said. "Ensuring high-quality care and the safety of our patients is our highest priority, and we will continue to monitor the situation closely."

A spokeswoman for Cooper University Hospital said it has "inventoried and quarantined the products and [has] returned them to the company as instructed."

A Lourdes spokeswoman said that 26 patients received NECC drugs before the outbreak started, but that none of those were drugs identified as problematic and that no patients have indicated adverse side effects. Like the others, Lourdes has stopped using NECC medications.

Links to the two FDA lists are on www.philly.com/phillypharma.

Contact staff writer David Sell at dsell@ phillynews.com or 215-854-4506. Read his blog at www.philly.com/phillypharma and on Twitter @phillypharma.