The article chosen is about New England Compounding Center in Framingham, Massachusetts, who provided an injectable steroid that was contaminated. The injectable steroid caused an outbreak of fungal meningitis in 20 states (amednews, 2013). The “FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC” (FDA, 2013, p. 1). The injectable steroids have infected many people in the United States. The American Medical Association House of Delegates adopted a “report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety” (Amednews, 2013, p. 1). Fungal Meningitis Outbreak

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On May 21, 2102 the New England Compounding Center produced injectable steroids that were contaminated. On September 18, 2012 was the first case of meningitis reported to the Tennessee Department of Health because of a patent receiving an injection of steroids. On September 26, 2012 the New England Compounding Center recalled three lots of steroids injections and by October 6, 2012 the company recalls everything made by the company in Framingham, Massachusetts, facility.

State and local health department’s help the facilities who administered the injections contact the individuals who were exposed (CDC, 2013). “As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states” (CDC, 2013, p. 1). The “FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC” (FDA, 2013, p. 1). The American Medical Association House of Delegates had a meeting and in the meeting they adopted a “report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety” (Amednews, 2013, p. 1). The report also encourages state boards of pharmacy to require those pharmacies to adhere to sterile compounding practices (Amednews, 2013). The recommendations of the report are to have large compounding companies to be regulated by the U.S. Food and Drug Administration (Amednews, 2013).

The Institute for Safe Medication Practices put

Page 2 Article or Case Law Search HCS 430 Essay

in place new guidelines on safely producing sterile compounded medications. The guidelines introduced were “how to compound sterile drugs, prepare bulk containers and label products” (Amednews, 2012, p. 1). After the outbreak came about the company recalled the product and filed for bankruptcy. A judge declared the New England Compounding Center’s products that were linked to meningitis deaths as insolvent because the judge declared the company insolvent, this “allowed third-party suits against physicians and others” (amednews, 2013, p. 1). The nature of the contamination show negligence, the introduction of tainted material has caused multiple fatal cases of fungal meningitis. The company failed integral quality checks to ensure a safe product for the consumers.

The source of the contamination was found when the facility was audited and the FDA found the rooms used to produce the product were not sterile. The FDA found bacteria and mold in the rooms. This case opened the clinics facilities and doctors to liability suet when the judge released a verdict of insolvency where the company has so few funds that they are unable to pay normal debts, let alone the costs of the liability lawsuits filed for wrongful death, negligence, and damages for those who were simply injured from the use of the tainted product. This allows the families to sue the facilities and doctors for restitution allowing them to find at least a small financial reimbursement for the damages. Conclusion

In 2012, there was an outbreak of fungal meningitis. The fungal meningitis was caused by the injectable steroids produced by the New England Compounding Center. “As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states” (CDC, 2013, p. 1). The American Medical Association House of Delegates had a meeting and in the meeting they adopted a “report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety” (Amednews, 2013, p. 1). ]

The Institute for Safe Medication Practices put in place new guidelines on safely producing sterile compounded medications. The guidelines introduced were “how to compound sterile drugs, prepare bulk containers and label products” (Amednews, 2012, p, 1). The nature of the contamination show negligence, the introduction of tainted material has caused multiple fatal cases of fungal meningitis. The source of the contamination was found when the facility was audited and the FDA found the rooms used to produce the product were not sterile. The judge released a verdict of insolvency, and this allowed the families to sue the facilities and doctors for restitution.

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