Meningitis outbreak linked to lax oversight of ‘compounding pharmacies’

In a Drug Linked to a Deadly Meningitis Outbreak, a Question of Oversight.

The nation’s growing outbreak of meningitis, linked to spinal injections for back pain, was a calamity waiting to happen — the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment used by millions of Americans a year.

The outbreak, with 5 people dead and 30 ill in six states, is thought to have been caused by a steroid drug contaminated by a fungus. The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center. Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration.

On Monday, federal inspectors at the New England center found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye, Food and Drug Administration officials said Thursday. Under the microscope, the particles were a fungus.

This is the first I’ve heard of “compounding pharmacies”. What are they?

A compounding pharmacy is like your old-fashioned “chemist” – they actually prepare the treatment in addition to dispensing it.

Compounding has been called an ancient art, something practiced long before medicines were premixed and sealed in bubble packs. The practice goes on today, allowed by states and the federal government, but it is supposed to provide custom-made products for individual patients with special needs. It is frequently done in hospital pharmacies, and an estimated 2 to 3 percent of prescriptions in the United States are compounded prescriptions for individual patients, according to the International Academy of Compounding Pharmacists.

These pharmacies are not held to the same safety standards as big drug companies. Some doctors say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or at better prices. Some compounding pharmacies volunteer to abide by the same high standards as other pharmacies but they don’t have to. That’s a problem. Would the patient know that the drug comes from a potentially less safe source? Would they have a choice?

Here is more on compounding pharmacies:

More than 7,500 compounding pharmacies operate in the US, up from 5,000 in 2009, and account for $3 billion in sales and 3 percent of all prescriptions filled.

Only 162 compounders have applied for voluntary industry accreditation of the 3,000 or so compounding pharmacies around the country, according to the International Academy of Compounding Pharmacies.

The fact that they shipped this product over state lines is an impetus for the FDA to become involved. This is an example of why a free market isn’t always consumer friendly, why regulation and oversight is essential.

Here is more on the Misuse of Compounding at Quackwatch.

Tip: @pharmacistScott via Twitter (Scott Gavura)

  4 comments for “Meningitis outbreak linked to lax oversight of ‘compounding pharmacies’

  1. October 5, 2012 at 6:56 PM

    You won’t find cough syrup with codeine at your local chain pharmacy–compounding pharmacies to the rescue!

  2. G
    October 6, 2012 at 2:53 PM

    Hmm. Hrm. This is distressing. My vets have sent me to compounding pharmacies for various meds that my pets needed that didn’t come in the right mixtures or dosages as a mass manufactured medication. They’ve never suggested that the compounding pharmacies weren’t as reliable as a regular pharmacy.

    I know there have been problems with compounded medications (or supplements) from compounding pharmacies before (for example: http://www.washingtonpost.com/wp-dyn/content/article/2009/04/28/AR2009042803482.html ), but thought it was an accident at that pharmacy–you know, like a bad batch of something could be made at a big pharma manufacturer, as well, which does happen from time to time (for example, that one batch of flu vaccine in Australia in 2010).

    How does one determine if a particular compounding pharmacy is voluntarily holding itself to the more stringent standards? One of the medications I got from a compounding pharmacy was an inhalable medication for a horse with chronic obstructive pulmonary disorder; the Quackwatch page says to avoid inhalable drugs. But if that’s the only way to *get* the medication, what does one do?

    I had no idea compounding pharmacies weren’t held to the same standards as a regular pharmacy. That’s disappointing. And I see that in looking up a link for that polo pony incident, the same pharmacy (in Florida, not the one in the original post) made the news again this past May with a fungal contaminant in an eye medication.

  3. G
    October 6, 2012 at 3:11 PM

    I’m also attempting not to have mild hysterics because I was about to have another round of spinal injections. How do I know if my doctor is using safe injectables? Insert swearing here.

  4. October 11, 2012 at 7:00 PM

    This has been getting a lot of heat in the regulatory sense. Nothing like DEATH to make lawmakers do something.
    http://thehill.com/blogs/healthwatch/public-global-health/261573-senator-calls-for-criminal-probe-of-meningitis-outbreak

    “In a letter to U.S. Attorney General Eric Holder, Blumenthal noted Thursday that the national death toll from tainted steroid injections has reached 14 and that thousands of patients are “still at risk.”

    “Obviously, I have reached no conclusion as to criminal liability, but there seem to be sufficient, credible factual allegations and harm to warrant this [investigation] request,” Blumenthal wrote.

    The New England Compounding Center (NECC) recalled all of its products and surrendered its state license after its steroid injections were tied to the outbreak.”

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