The New England Compounding Center
(NECC) has been under investigation since September due to its production and
dispersion of tainted steroids that have led to an outbreak of fungal
meningitis. The steroid injection was mainly used to treat chronic back pain.
According to the Centers for Disease Control (CDC), 338 people in the U.S. have
reported cases of meningitis in 18 states, and the death toll has now risen to
25, three in Florida alone.NECC shares ownership of a specialist company called
Ameridose LLC in Massachusetts that directly distributed the steroids which,We
recently added Stained glass mosaic Tile to our
inventory. according to The Huffington Post, has now been temporarily shut down
until further notice. The drugs sold to patients at this specialist pharmacy
have been directly linked to cases of fungal meningitis, an infection where
fungal membranes cover the brain and spinal cord, which can be fatal.
The CDC approximates nearly 14,000 patients may have received injections with medication from the three implicated lots of the steroid, 97 percent of which have been contacted since the discovery of the contamination. The lots, or batches, of the steroid were recalled on Sept.Western Canadian distributor of ceramic and ceramic tile, 25 after the first case of meningitis was reported in Idaho,Find detailed product information for Sinotruk howo truck. according to the official CDC website. Shortly after, the U.S. Food and Drug Administration (FDA) released a statement on Oct. 4 advising medical professionals that all products produced by NECC should be “retained, secured and withheld from use.” On Oct. 6, NECC announced a voluntary recall of all products produced and distributed from its Framingham, Mass. facility, according to the official FDA website.
The FDA, CDC and the Massachusetts Board of Pharmacy are performing a formal investigation of the New England Compounding Center on the cause of the meningitis outbreak. The investigation is still ongoing but according to The Baltimore Sun, the Massachusetts report says, “The facility released drugs before determining whether they were sterile, issued drugs without a prescription and, in general, did not follow proper sterilization guidelines.” The CDC and the FDA have both confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate from two out of three of the implicated lots from the NECC.
The FDA released a statement on Oct. 26, saying the Massachusetts pharmacy may have violated federal health law, as mold and bacteria were found in areas where drugs were mixed, according to The Baltimore Sun. This brings up questions such as how did this happen? Who was supposed to be in control of regulating the sterility of the company? And why was this not caught sooner,We have a wide selection of dry cabinet to choose from for your storage needs. before 25 people lost their lives? This seems to be a clear disregard of responsibility on someone’s part.We specialize in howo concrete mixer, It is yet to be determined who will be held responsible other than the NECC. It seems to me that the FDA would be in charge of regulating the sterility and safety of such drugs distributed to the public to prevent something of this exact nature from happening. According to The Huffington Post, the FDA is in fact required to regulate the ingredients and their suppliers but not the compounders which are subject to patchwork of state oversight. So the FDA is responsible for the safety of the ingredients that make up the drug, but not for the product after it is sent off to be mixed and packaged at these compounding companies such as NECC. Hopefully after this fateful event, this policy will change. With a company having mold and bacteria in the very area where drugs that will be injected into civilians’ bodies are being packaged, it was just a matter of time before deadly contamination occurred.
According to The Baltimore Sun, NECC officials have written an article stating, “All compounding pharmacies must take responsibility for the quality of what they produce.” Clearly this vow of responsibility has not fared well for the victims of the products from this particular compounding company whom are now either suffering or dead from meningitis. On Oct. 3, NECC is said to have ceased all operations and surrendered their license to the Massachusetts Board of Registration in pharmacy, according to the FDA.
From the investigation of this particular matter sprouts another cause for concern to be looked into as well. During the ongoing investigations, the FDA claims in a statement on their website that they have found “two patients that may have infections associated with other possibly contaminated NECC products.” It’s looking like this outbreak of meningitis is not the only case of contamination that has negatively affected recipients. The worst part of the situation may be that federal health officials say NECC was well aware that they had extensive contamination by mold in bacteria, but “failed to take corrective action,” including in the “clean rooms,” where sterile drugs are actually made, according to The Seattle Times. The FDA will not answer questions regarding the sterile condition of NECC in previous years.
The CDC approximates nearly 14,000 patients may have received injections with medication from the three implicated lots of the steroid, 97 percent of which have been contacted since the discovery of the contamination. The lots, or batches, of the steroid were recalled on Sept.Western Canadian distributor of ceramic and ceramic tile, 25 after the first case of meningitis was reported in Idaho,Find detailed product information for Sinotruk howo truck. according to the official CDC website. Shortly after, the U.S. Food and Drug Administration (FDA) released a statement on Oct. 4 advising medical professionals that all products produced by NECC should be “retained, secured and withheld from use.” On Oct. 6, NECC announced a voluntary recall of all products produced and distributed from its Framingham, Mass. facility, according to the official FDA website.
The FDA, CDC and the Massachusetts Board of Pharmacy are performing a formal investigation of the New England Compounding Center on the cause of the meningitis outbreak. The investigation is still ongoing but according to The Baltimore Sun, the Massachusetts report says, “The facility released drugs before determining whether they were sterile, issued drugs without a prescription and, in general, did not follow proper sterilization guidelines.” The CDC and the FDA have both confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate from two out of three of the implicated lots from the NECC.
The FDA released a statement on Oct. 26, saying the Massachusetts pharmacy may have violated federal health law, as mold and bacteria were found in areas where drugs were mixed, according to The Baltimore Sun. This brings up questions such as how did this happen? Who was supposed to be in control of regulating the sterility of the company? And why was this not caught sooner,We have a wide selection of dry cabinet to choose from for your storage needs. before 25 people lost their lives? This seems to be a clear disregard of responsibility on someone’s part.We specialize in howo concrete mixer, It is yet to be determined who will be held responsible other than the NECC. It seems to me that the FDA would be in charge of regulating the sterility and safety of such drugs distributed to the public to prevent something of this exact nature from happening. According to The Huffington Post, the FDA is in fact required to regulate the ingredients and their suppliers but not the compounders which are subject to patchwork of state oversight. So the FDA is responsible for the safety of the ingredients that make up the drug, but not for the product after it is sent off to be mixed and packaged at these compounding companies such as NECC. Hopefully after this fateful event, this policy will change. With a company having mold and bacteria in the very area where drugs that will be injected into civilians’ bodies are being packaged, it was just a matter of time before deadly contamination occurred.
According to The Baltimore Sun, NECC officials have written an article stating, “All compounding pharmacies must take responsibility for the quality of what they produce.” Clearly this vow of responsibility has not fared well for the victims of the products from this particular compounding company whom are now either suffering or dead from meningitis. On Oct. 3, NECC is said to have ceased all operations and surrendered their license to the Massachusetts Board of Registration in pharmacy, according to the FDA.
From the investigation of this particular matter sprouts another cause for concern to be looked into as well. During the ongoing investigations, the FDA claims in a statement on their website that they have found “two patients that may have infections associated with other possibly contaminated NECC products.” It’s looking like this outbreak of meningitis is not the only case of contamination that has negatively affected recipients. The worst part of the situation may be that federal health officials say NECC was well aware that they had extensive contamination by mold in bacteria, but “failed to take corrective action,” including in the “clean rooms,” where sterile drugs are actually made, according to The Seattle Times. The FDA will not answer questions regarding the sterile condition of NECC in previous years.
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