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The Meningitis Scare- and How to React

By Rachael Yim posted 10-10-2012 13:43

  
If you've been following the news as of late, you've probably been noticing all the news articles that have been reporting the meningitis outbreaks. As of today, 11 people have been reported dead and 119 people sick. It is estimated that up to 13,000 people may have been injected with this contaminated steroid.

As a background for those who have not heard the news, methylprednisolone acetate injections were made at a specialty pharmacy, New England Compounding Center of Massachusetts, has caused an outbreak of meningitis across the country. The CDC has suspected that the vials were tainted with a fungus similar to that found in leaf mold, however, had already been distributed to 23 states. And slowly, the death toll increases and the sick number rises.

How do we react to such news? For compounding pharmacies like New England's Compounding Center, lawmakers are reacting by trying to impose stricter laws. However, these pharmacies compounding drugs that specifically do not go through the FDA process, and are prescribed by homeopathic physicians, what kind of laws are going to exist? Is it going to be harder for patients who choose for alternative treatments to receive the medications they desire, and will some pharmacies be closed by these future "stricter" laws?

As inpatient pharmacists, how do we react? Luckily, none of these vials came through the hospital I work at. But if it did, I'm not sure how I would feel, knowingly verifying, checking, a medication that is, future negative impacting a vulnerable patient. I'm not even sure what the right way to react is. For my non-pharmacy friends who have been asking me how I feel about it, I simply say, "well.. there was no way of knowing that the drug you checked was going to cause this...so if the patient gets meningitis, we try to handle it to the best of our ability.." And I really think that's the best we can do in this situation. Agree?
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10-23-2012 09:33

I thought I would comment being one of the hospitals currently dealing with the meningitis outbreak. I'm in Michigan and our hospital has had over 40 + cases of patients who's received the injections at an affiliated pain clinic. I don't think there would have been anything that could have been done to prevent it and I'm not sure necessarily that we would have verified it since it was distributed to the doctor's office for dispensing and administration. It really was luck of the draw and it is unfortunate that the pain clinic here received the contaminated lot.
However, I would say that I'm not sure how NECC managed to get their supplies to so many states. I can't recall my law, but it seems a little fishy that these products got sent to so many states. I would say that they should've been considered a manufacturer at that point and FDA should've been able to step foot and do QA, but it seems that the release of the news article today from the FDA investigation said that it wasn't the first time NECC had distributed faulty products but it was the Compounding society who was hindering the FDA from stepping in and it seems the Massachusetts State Board of Pharmacy has a lot of explaining to do.

10-22-2012 11:11

Thank you for your comments, Tim and Alex. And Alex, I totally agree- we have to work on improving the current practice rather than just stating that it happened and not improving from this incident.

10-18-2012 09:59

I remember my Law professor's quote all too well,
"Nothing happens in Washington until something goes wrong elsewhere"
When people ask me about the Meningitis Scare, I try to remind them, "Healthcare is not like any other industry. Our products and services are for treating humans. Other industries, say car manufactures, have processes and systems set in place on machines. When something goes wrong, they fix the car and improve the model. And the media sends its Hate Mail, and the company apologizes and improves."
When we have a problem in healthcare, the problem results in a person. That isn't easily forgivable to society. There are so many factors that complicate medicine. The solution isn't as easy as creating more laws to regulate processes. The solution lies in a calling to improve current practices from everyone. But sadly, we live in an imperfect world, and errors are going to slip thru the cracks."
And good point Tim, I'll remind them that there is a major difference between Pharmacy and Manufacturer

10-11-2012 14:12

Rachel,
Thank you for broaching this sensitive subject. I must say that I am appalled by the media treatment of this story. First of all, I think it's important to differentiate between "Pharmacy" and "Manufacturer" and we must be vigilant lest some of the negative opinions be levied on us. I think labeling NECC as pharmacy is an unfortunate name. My understanding is they fall more into the manufacturer category than pharmacy.
Secondly I feel that imposing stricter laws may not be the best way to handle the problem. Stricter laws will only complicate drug shortages that are already bad enough to begin with. I may show my complete lack of understanding here, but it seems to me that inspections of such facilities and increasing the frequency of said inspections would be a better solution.
In comparison, if the health department finds a restaurant not following cleanliness procedures, they shut down the restaurant, but they do not immediately run to the legislature to impose laws that you can't serve or make the same food elsewhere as long as guidelines are followed. Now if said legislature is to create those guidelines I'm all for it.
I agree wholeheartedly with your statement about how you feel. I too feel that I do the best I can for my patients and there was no way to know about the tainted medication until after the market withdrawal. As pharmacists we do our best to provide the safest and most effective care we can provide.