Fungal meningitis lawyers at Pintas & Mullins Law Firm confirm that at least one patient has relapsed one full year after the outbreak of fungal meningitis. Medical officials in Tennessee are currently contacting other original victims to chick on their health status.
Fortunately, the relapsed patient was admitted to the hospital in time and is now receiving appropriate treatment. The 2012 fungal meningitis outbreak was caused by contaminated steroid injections from the New England Compounding Center (NECC), which has since been closed. The contaminated injections killed 64 patients throughout the country and sickened at least 750 others.
Many are now concerned, and rightfully so, that the fungus will return and attack their immune systems again. Unfortunately, doctors cannot guarantee that the infection won’t return, and many are still experiencing health problems from the mold-infested steroids. What’s worse is that many of their health problems are actually after-effects of the powerful anti-fungal medication they had to take to counteract the meningitis. About one-third of meningitis patients currently remain on the treatment drugs.
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Since the fatal outbreak, the FDA has made concerted efforts to change how compounding pharmacies throughout the country are regulated. The agency recently gained approval from Congress for a bill (titled the Drug Quality and Security Act) that will increase federal oversight of compounding pharmacies like the NECC. These facilities are supposed to manufacture drugs on a patient-by-patient basis, mixing and producing individual drugs per-prescription rather than en masse, such as Pfizer for example, which are federally regulated.
Previously, compounding pharmacies were subject only to regulation by each state’s Department of Health or Pharmacy Board. As the country grew more and more dependent on pharmaceuticals, however, compounding pharmacies became increasingly necessary, and states no longer had the man-power to adequately oversee them. Among its provisions, the bill calls for new national tracing systems to track the sales and manufacturing of prescription drugs from pharmacy to patient.
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It will also allow the FDA to monitor compounding pharmacies in much the same way it does for larger, more traditional drug manufacturers like Johnson & Johnson. Individual states are also refocusing their efforts on improved pharmaceutical regulation and oversight. California, for example recently approved a bill that requires pharmacies that produce sterile drugs to apply for specialized licensed from the State Board of Pharmacy. The law will go into effect in July 2014.
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The California Board plans to inspect and license about 700 new compounding pharmacies and 250 other facilities not in California when the law is enacted. Pharmacies will have to report to the board within ten days if it is subject to any disciplinary action, and provide the state with all recall notices of sterile drugs within 12 hours of release. This will help ensure that patients and physicians are aware of all recalls.
The Massachusetts House of Representatives passed a similar bill recently, which would require compounding pharmacies to obtain specialized licenses and undergo inspections at least once a year. The watchdog group Public Citizen requested last month that Specialty Compounding LLC, a pharmacy in Texas, be shut down by federal regulators.
At least 15 people have been sickened by contaminated sterile medications from Specialty, occurring less than nine months after the NECC outbreak. Fortunately, this bacterial infection affected patients on a much smaller scale, at two hospitals in Texas. Further aggravating this is that the FDA inspected Specialty Compounding in March 2013, five months before the recall.
During that inspection federal agents noted that Specialty was in violation of several manufacturing practices, witnessing pharmacists touching the floor and other unsterile surfaces and failing to switch their gloves before returning back to “clean rooms.”
Hundreds of lawsuits have been filed in connection to the NECC outbreak, which were recently consolidated in federal court as part of multi-district litigation. If you or a loved one was seriously sickened or killed by a supposedly sterile drug from a compounding pharmacy, you have important legal rights, and may be entitled to significant compensation. Contact a skilled compounding pharmacy lawyer who can inform you of your legal rights and options, free of charge.
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