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Do Regulations Need to Change After Fungal Meningitis Outbreak?

Unfortunately, those of us working on cases related to mass medical device errors or dangerous drugs appreciate that safety changes are usually only made in the aftermath of tragic problems. This is partly understandable, as in some cases it is difficult for anyone to know of a problem until some harm befalls someone. However, that does not mean that all mass problems are unavoidable or should not result accountability for those responsible.

The latest fungal meningitis outbreak–linked to tainted spinal steroid injections–offers a good illustration of these points.

As blog readers know, the outbreak has been traced to a pharmaceutical compounding company located in New England. Over 17,000 vials of contaminated product were shipped to at least 23 different states. Over 13,000 doses may have been given to patients between July and September of this year before the problem was identified and the injections were recalled. Thus far well over a hundred people have been infected, and at least twelve have died as a result.

Illinois was not spared, as at least three clinics in our state received the steroids from the compounding company and gave them to patients. Those include the APAC Pain Center located in the Thorek Hospital Professional Building, the APAC Lincoln Park, and the Westchester, Illinois’s APAC in the Prairie Medical Building. The IDPH reports that those patients should have already been notified and tested.

So did the problem come out of nowhere?

Not quite. In the last week news has surfaced of past concerns about the quality of the products coming out of this compounding pharmacy. A 2002 complaint led to state and federal investigations into the facility, with a 2006 consent decree. In 2004 a lawsuit was filed by a widow who argued that her husband died after developing meningitis which, she claimed was caused by a tainted epidural shot. The details of this previous suit, which settled confidentially in 2005, are eerily similar to what allegedly happened in this latest fungal outbreak.

In other words, there were clear warning signs that this sort of problem might occur–either stemming from this particular facility or similar compounding pharmacies

What can we do to ensure it does not happen again?

The only thing to do now is to move forward, helping those affected and ensuring similar problems are avoided. A recent Forbes article discussed how many have used this latest outbreak to point out the flaws in the compounding pharmacy regulatory scheme. Unlike larger pharmaceutical companies that actual produce the materials used, compounding pharmacies do not have tight FDA oversight. Instead, they are mostly regulated only at the state level.

Each state has very different ways to work with these facilities to ensure their products are safe–some far more stringent than others. Of course, the problem with this piecemeal approach is that companies can simply move operations to less onerous states while still shipping product across the country. In other words, it doesn’t matter what Illinois regulations are, because the material were made elsewhere. Local patients may therefore be affected by lax oversight by other states, and there is little that can be done about it. For this reason, many are calling for national regulations to ensure all of these companies abide by reasonable safety protocols.

See Our Related Blog Posts:

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Thousands May Be Affected By Meningitis Outbreak