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Health care facilities on ‘suspect material’ list did not necessarily receive tainted drugs

October 25th, 2012 11:02 pm by Rex Barber

Health care facilities on ‘suspect material’ list did not necessarily receive tainted drugs

The recent Food and Drug Administration list of health care facilities that received “suspect material” from the New England Compounding Center basically is a list of any place that received any product from that pharmacy and not necessarily an indication the drugs were tainted.
Mountain States Health Alliance facilities were on that list, including Franklin Woods Community Hospital, Johnson City Medical Center, Indian Path Medical Center in Kingsport and Sycamore Shoals Hospital in Elizabethton.
Access this list, which names all health care facilities that received products from the pharmacy in question since May 21, online at www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf.
The Johnson City Press reported Oct. 17 MSHA was notifying 63 patients of JCMC they had received medications obtained from the New England Compounding Center, though there was no indication those medications were tainted with a fungus that was found in steroid injections blamed on the national fungal meningitis outbreak that has killed 24 people and sickened hundreds of others.
These drugs were methacholene (an inhaled medication used to diagnose bronchial disorders), vancomycin beads (an antibiotic capsule implanted directly into a surgical site), tobramycin beads (another antibiotic capsule implanted directly into a surgical site), and cardioplegia solution (a drug used during heart surgery to prevent damage to the heart muscle).
The inclusion of the other MSHA facilities on the FDA list released this week was due to a substance called LET gel they received. This is a topical solution that would be used as a numbing agent prior to suturing or injection.
Rebecca Bartles, MSHA director of infection prevention, said the FDA originally said it could not confirm anything in the New England Compounding Center to be sterile and so, really, anything from there is “suspected” to be contaminated.
Regardless, all these products were pulled from MSHA stock shelves Oct. 4, when the original recall of tainted New England Compounding Pharmacy products was announced.
Shortly after that the FDA notified MSHA that four drugs it received from the compounding pharmacy were given to 63 patients and the health care provider should notify those individuals to be ware of any meningitis symptoms despite those drugs not being directly tied to the meningitis outbreak.
It was not recommended by the FDA that MSHA tell anyone who received the topical solution/gel.
“The reason they (officials at the FDA) have not requested that we notify patients about the gel products or these topical solutions is because the risk (of infection) is very low,” Bartles said. “The fungus that has been found in the steroid solution is, you know, very risky and potentially infectious if it’s injected into the body, but it’s also very common in the environment.”
Bartles said people should not be worried.
“Certainly if FDA had any evidence that these drugs (the topical gels), or if (Centers for Disease Control) you know, if they had any evidence that these drugs were contributing to infections we would have already started notifying patients,” she said. “They have not requested that we do that.”
Bartles said she was not aware of any infections reported from use of the topical solutions.
These five products were the only items MSHA facilities received from the New England Compounding Center.

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