Meningitis Outbreak Raises Compounding Questions

       A meningitis outbreak linked to contaminated steroid injections has resulted in a nationwide concern over compounding practices.  But in the aftermath of this developing story, we end up with more questions than answers. 

       The story began at the New England Compounding Center (NECC) pharmacy in Framingham, MA.  This compounding pharmacy sold thousands of vials of contaminated methyprednisolone acetate 80mg/ml injections to thousands of customers in 23 states. 

       Soon after there were cases of an uncommon fungal meningitis that began to appear.  As the cases spread and the outbreak became more severe, it was apparent the illnesses were linked to the injections compounded by NECC. 

       A recall was initiated by the pharmacy starting on September 26th to remove the suspected injections out of distribution.  NECC is now recalling all of its compounded products from the same facility as a precaution.

       The meningitis cases continues to rise nationally.  According to the CDC, there are 137 meningitis cases in 10 states including 12 deaths in 5 states as of October 10th that are associated with the injections.

        The result is a national media blitz that has focused attention on compounding pharmacies.  Concerns are being raised over drug safety as well as pharmacy oversight. 

        For the most part, compounding pharmacies are regulated at the state level.  But in the wake of a multi-state meningitis outbreak, politicians and consumer groups are questioning if more national oversight is in order. 

        For NECC, it appears they may have violated their Massachusetts permit stating they can only compound medications for a specific patient prescription.  Instead, it appears this pharmacy was mass-producing large batches of products for national distribution. 

        I’d caution lawmakers before drafting any new pharmacy regulation.  What may be a problem that affects a small percentage of large volume compounding pharmacies could translate into excessive oversight for every small town independent pharmacy that also compounds. 

       There is a huge difference between a mom-and-pop independent who compounds medications for local physicians and patients and the mass-producing compounding facilities such as NECC.  Many independent pharmacies provide compounding services to compete with larger retail pharmacy chains. 

        The question becomes do we need more regulation over compounding pharmacies?  And if so, who should oversee such an endeavor? 

         There is already a Pharmacy Compounding Accreditation Board (PCAB) that independently accredits pharmacies and certifies them according to a strict set of guidelines and rules.  But according to the PCAB, only 165 pharmacies in 38 states are certified under their criteria.

         The key word you will notice on PCAB’s website is voluntary. This quality accreditation organization is completely voluntary.  Prospective pharmacies must apply to be accredited, become certified, and pay yearly accreditation dues to become and maintain certification with PCAB. 

         There is no federal equivalent of PCAB.  The FDA has little oversight directly over the practice of compounding.  And I’m not sure another federal regulatory agency or an expansion of the FDA’s responsibilities is the answer to better oversight for all compounding pharmacies. 

        It appears there were lapses in the enforcement of state regulations already in place for NECC.   But can a state board of pharmacy effectively maintain quality control for all compounding pharmacies in their respective state? 

       I hope that everyone will cool off from the media campaign that has made this meningitis outbreak a national story before making regulatory decisions.  Is this situation serious?  Absolutely.  People have died and valid questions about safety and oversight have been raised. 

       But as Steve Airens has wisely pointed out, medication errors are a much bigger problem that somehow doesn’t get the media attention that an infection outbreak garners.   Thousands of deaths a year can be attributed to medication errors.  Why aren’t we discussing that public health threat with the same urgency we now have for compounding pharmacies? 

        I worry that in the heat of a serious public health threat, we will hastily pass new rules that will do more to hinder the efforts of small town community pharmacies rather than protect the public from future preventable illness outbreaks.  We should not control the larger compounding pharmacies at the expense of the small independents.

         Compounding is a vital service that is one of the core funtions of the profession of pharmacy.  I would caution anyone from regulating away a valuable service for patients and a way of life for many independent pharmacies. 

The Redheaded Pharmacist

4 Comments to “Meningitis Outbreak Raises Compounding Questions”

  1. By Pharmaciststeve, October 11, 2012 @ 3:44 pm

    IMO -The line can be easily drawn on this issue… when a entity is compounding a STERILE PRODUCT for injection from non-sterile ingredients.. which has always been labeled as “high risk”.. by the industry… there needs to be a different set of rules/regulations and oversight for those entities…

    Those pharmacies that are doing “bread/butter” compounding – oral meds , topical meds, supp and the like… the risk of problems are very little or maybe even non existent.

    using compounding pharmacies is rampant in the “pain clinic” community for the injectables and the medications that they put in implanted pain pumps… which goes directly into the spinal fluid and must be both sterile, and preservative free.

    Many of these “big player” have salesmen/detailmen that call on pain clinics…and you can find them with display booths at state/national medical conventions… They mimic the actions of the major Pharmas marketing programs….and the vast majority of them.. operate only under a state pharmacy license.. as a community pharmacy… If it walks/quacks like a duck… it is probably a duck… once again .. IMO .. the BOP’s have generally elected to turn a blind eye to what compounding they are doing and how much “manufacturing” they are really doing.

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  2. By Mike, October 11, 2012 @ 10:46 pm

    I once dated a girl for a while who was in vet school. At the time, I was working in a compounding pharmacy. Mostly oral capsules and topicals. One day she came home after an ethics class, having been taught that compounding was the devil.

    I had to remind her, among others, that even commercial product have errors. Almost can’t go a week without seeing a recall.

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  3. By jt, October 14, 2012 @ 3:45 pm

    There is a huge difference between compounding and manufacturing. In my opinion, necc is manufacturing.
    The media should make this distinction. Also, if they are only licensed to compound, then they are liable for more than just negligence.

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  4. By yourboarddidit, October 16, 2012 @ 2:58 pm

    this is what my friend said about it: “With all the news articles and reports about the alleged meningitis contamination of injectable products manufactured by the new England Compounding Center, I can’t help but wonder why no one has questioned the qualifications of those who performed the compounding. It’s obvious on its face that they were not pharmacists because the current standard of practice pretty much throughout the country, is that compounding is relegated to pharmacy technicians. That of course, is idiotic, but it’s the way things are. And worse, the public doesn’t know it, and the prescribers either don’t know it, or don’t care. The boards of pharmacy have been heavily lobbied by pharmacists and by the industry, and by and large, condone it. The Food and Drug Administration is aware of it, but has been largely acquiescent. It reminds me of a similar situation a few years ago (beginning 5-11-2001) at Doc’s Pharmacy in Walnut Creek, California, where injectable doses were compounded in batch form (similar to the New England case) and multiple patients were harmed. Those vials were prepared by technicians in a room which also contained a bubbling fish aquarium. And I hate to say it, but Doc’s Pharmacy was owned by a classmate of mine from UCSF. Why can’t pharmacists learn from their mistakes? Or as the old song says: “… When will they ever learn? …”

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