A growing outbreak of fungal meningitis has claimed 7 lives and infected up to 64 people across 9 states. The rate that the outbreak is growing is also alarming:
The total number of cases has also grown to 64 people in nine states, the CDC said. That is 17 more cases and two more states than the day before.
Patients contracted the deadly meningitis after being injected in their spine with a preservative-free steroid called methylprednisolone acetate that was contaminated by a fungus. The steroid is used to treat pain and inflammation.
The steroid is manufactured by compound pharmacies. Compounding is used to create special blends of medications that aren't available on the market, as well as to custom tailor drugs to fit a certain patients needs. According to a 2003 GAO report, nearly 10% of all drugs administered in the Untied States are compound manufactured. But how safe are these drugs? Well it depends on the state they are manufactured in:
Drugs manufactured by compound pharmacies do not have to go through FDA-mandated pre-market approval. Instead, oversight and licensing of these pharmacies comes from state health pharmacy boards.
The steroid causing this outbreak was manufactured by The New England Compounding Center, a pharmacy based in Massachusetts. When federal inspectors did come in to the plant last week, they found unopened vials of the steroid that contained foreign particles. After testing one of these vials, the particle was determined to be the fungus causing this meningitis.
Reading about it, I can't help but think back to the healthcare debate. When the Affordable Care Act was being debated in Congress, one of the issues was allowing people to buy their prescriptions from Canada and other countries. The opponents to that argued that those countries don't have the same safety screenings that our country does. Ironically, I don't recall reading about such an outbreak happening in Canada.
So if we are going to prevent our citizens from getting their medications from Canada, simply because our safety standards are higher, then shouldn't we be sure that is the case? Shouldn't these compound pharmacies be regulated by strict federal standards and not just state regulations? It seems that should be the case. Institute tough oversight and regulations on the federal level, coupled with inspections of facilities, and maybe we wouldn't be talking about this deadly outbreak today.
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