Meningitis Outbreak Grows, Highlighting Dangers of Compounding Pharmacies

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Health officials are hunting for the source of a meningitis outbreak among dozens of people who received steroid injections to treat back pain.

So far, 35 people have fallen ill with fungal meningitis and five have died after receiving shots in the spine. Health officials expect the case count to rise, warning that hundreds, if not thousands of patients who received epidural steroid injections could be at risk. The fungus, Aspergillus, causing illness may have contaminated the steroid injections at some point in the manufacturing process, but investigators are still searching for the cause.

Officials say the drug associated with the outbreak is methylprednisolone acetate, made by New England Compounding Center (NECC) in Framingham, Mass. On Sept. 25 NECC voluntarily recalled three lots of the drug, and on Oct. 3 the company expanded the recall to include all lots of the medication, as well as other injectable drugs administered directly into the spinal fluid.

Health officials are also testing other medications used with the steroid injections, including lidocaine injections and antiseptic agents, as potential sources of contamination.

On Thursday, however, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) ramped up warnings, recommending that doctors and health care personnel remove from their inventories all methylprednisolone products from NECC, and contact any patient who has received an injection of the drug since July. There is no evidence that more than three lots of the medication may have been contaminated, but Ilisa Bernstein, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, told reporters during a briefing that “out of an abundance of caution, we are urging physicians and health care personnel at clinics and hospitals to check their drug supply for all product purchased from NECC and discontinue use at this time.”

(MORE: What’s Causing that Musty Smell in Recalled Pills?)

The first cases appeared in Nashville, Tenn., in September, but the outbreak has since involved patients in four other states to which New England Compounding delivered its products. The company has voluntarily shut down operations, but the recalled steroid has been shipped to 23 states since July. So far, illnesses have been reported in Tennessee, North Carolina, Florida, Virginia, Maryland and Indiana.

The outbreak renews concerns about the practice of “compounding,” or custom mixing. At so-called compounding pharmacies, pharmacists mix up batches of custom drugs, at various doses that are not standard from the manufacturer. Compounding pharmacies may use a variety of active ingredients — either from manufacturers or other ingredients sold in bulk — and can often offer medications to hospitals and doctors at lower prices than commonly available medications. The compounding industry has been growing in recent years as the cost of medications as risen, and while exact estimates are hard to confirm, a 2003 Government Accountability Office report estimates that anywhere from 1% to 10% of all U.S. prescriptions may come from compounding pharmacies.

Because they aren’t pharmaceutical manufacturers, compounding pharmacies and the products they make, are not regulated by the FDA. Instead, they are monitored by state pharmacy boards, which may not have the resources to ensure that all safety requirements are met. “FDA’s authority by law [over compounding pharmacists] is more limited than its authority over products made by non-pharmacists,” Kathleen Anderson, acting director of the FDA’s Office of Unapproved Drugs and Labeling Compliance, said. According to the Tennessean, the NECC has been cited by the FDA before for regulatory violations, including misbranding of drugs and promoting drugs for unapproved purposes — but not for issues related to compounding.

The Tennessean also reports that the connection between NECC’s steroid injections and meningitis was first drawn by a physician, Dr. April Pettit, at Vanderbilt University, who recognized the signs of meningitis in one of her patients, but was puzzled when the patients didn’t respond to antibiotics and tests didn’t show evidence of the usual bacterial culprit. A second round of tests came up positive for the Aspergillus fungus, and when Pettit learned the patient had had a spine injection, she immediately suspected it as a possible cause of the infection. When two other patients surfaced with similar histories, the state alerted the CDC.

(MORE: Possible Criminal Investigation for Tylenol Maker)

This is not the first time manufacturers have come under fire for such contamination. Because the injections associated with the current meningitis outbreak are delivered to the spine, which shares fluid with the brain, the medication is required to be sterile; but in recent years manufacturers of other types of sterile injections have been cited for outdated practices that have led to contamination incidents and national drug shortages — most notably with life-saving cancer drugs. These episodes have prompted the FDA to tighten its safety and manufacturing requirements.

According to the Associated Press, the same steroid involved in the current outbreak was also tied to five cases of a different fungal infection in North Carolina in September 2002. One of those patients died.

Patients who have received methylprednisolone injections since July should be wary of symptoms including new or worsening headaches, dizziness, nausea and swelling at the injection site, says the CDC’s Dr. Benjamin Park, medical officer in the mycotic disease branch in the National Center for Emerging and Zoonotic Infectious Diseases. He says this form of fungal meningitis is rare, and not transmissible from person to person. The disease can be difficult to diagnose because it may cause a stroke, and when a patient presents with stroke symptoms, doctors may not test for infections. The disease is also difficult to treat, requiring intravenous antifungal medications that may have to be administered for months.

MORE: Inside America’s Drug Shortage
Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME’s Facebook page and on Twitter at @TIME.

6 comments
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Healthcare Infection
Healthcare Infection

The provider of these tainted injection vials could be found negligent, in addition question need to be asked by patients and their families about the healthcare providers who prescribed, and administrated the steroid injections.

http://www.healthcareinfection...

mtnd0c
mtnd0c

One of the indirect causes no one is talking about, is the huge increase in drug shortages caused by federal manipulation of profit margins and pricing instability caused by the Medicare Modernization Act and Medicaid 340B discounting and rebates. Because of this price instability (made especially acute by stricter regulatory demands on parenteral medications and lower profit margins allowed for generic drugs like methylprednisolone) large manufactures are getting out of the business leaving smaller less accountable compounding and overseas pharmaceuticals to supply continuing need. One more unforeseen tragedy caused by Federal interference with free market forces.

mtnd0c
mtnd0c

One of the indirect causes no one is talking about, is the huge increase in drug shortages caused by federal manipulation of profit margins and pricing instability caused by the Medicare Modernization Act and Medicaid 340B discounting and rebates. Because of this price instability (made especially acute by stricter regulatory demands on parenteral medications and lower profit margins allowed for generic drugs like methylprednisolone) large manufactures are getting out of the business leaving smaller less accountable compounding and overseas pharmaceuticals to supply continuing need. One more unforeseen tragedy caused by Federal interference with free market forces.

TxPharm
TxPharm

This is a biased article serving the purposes of Big Phrma, which has engaged in a long and aggressive campaign against compounding pharmacists in an effort to corner the market on many drugs and charge exorbitant prices. And consumers wonder why Androgel costs $300 when it can be compounded for a fraction of that price.

Your article uses the typical Big Phrama argument that compounding pharmacies are not regulated by FDA, but by state boards of pharmacy. FDA has taken numerous actions that show it is the strong arm of Big Phrma, even raiding compounding pharmacies to intimidate pharmacists and destroy their businesses, when FDA had no legal authority to carry out such raids. Executives at drug companies gnash their teeth at their inability to use FDA to prevent pharmacists from compounding.

Your article makes no mention of the 20% of the generic drug supply that is manufactured in foreign countries, which FDA has inspected on a very limited basis or in most cases, not at all.

40% of bulk pharmaceuticals are imported from foreign countries, and FDA is spotty in it's inspection and regulatory duties. Compounding pharmacists have doctorate level education and additional compounding certifications. It is easy in situations such as this to scapegoat compounding pharmacies, but the more likely culprit is FDA in failing to inspect and regulate bulk products being brought in by drug companies. Pharmacists must trust drug companies to provide them with pharmaceutically pure bulk ingredients, and should NOT be subjected to knee-jerk scapegoating without investigation.

TxPharm
TxPharm

Ms. Park, one wonders if you have been influenced or even paid by Big Phrma, which has engaged in a protracted battle against compounding pharmacists so large drug companies can corner the market and charge exorbitant prices. Prior to WW2 , most drugs were compounded by pharmacists. As far as the familiar argument that compounding pharmaciies are not regulated by the FDA, which has taken actions that clearly show it is the strongnarm of Big PhRmA, be advised that about 20% of finished generic drugs in the US came from China or India. FDA in many cases has never set foot in the foreign factories producing these drugs. 40% of ingredients for bulk drugs are imported from foreign countries.

Pharmacists have doctorate degree education and compounding pharmacists have additional training specifically in compounding. It is entirely possible that the problems arising from this and other contaminations stem from contaminated BULK products imported from other countries, where FDA has inspected on a very limited basis or not at all.

Pharmacists are a convenient scapegoat in a situation like this. Your misleading article serves the purposes of Big Phrma so well that one would question your impartiality as a journalist.