Article or Case Law Search HCS 430
Article or Case Law Search
HCS/430
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
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
HCS/430
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
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
References: Amednews (2013) Groundwork laid for lawsuits over deaths from tainted steroids, Retrieved from http://www.amednews.com/article/20130812/government/130819980/7/?utm_source=rss&utm_medium=&utm_campaign=20131007 Amednews (2013) New guidance issued for drug compounding after meningitis outbreak, Retrieved from http://www.amednews.com/article/20121217/profession/121219954/9/ Amednews (2013) AMA meeting: Compounding pharmacies need more oversight, Retrieved from http://www.amednews.com/article/20130701/house/130709960/7/ Amednews (2013) Groundwork laid for lawsuits over deaths from tainted steroids, Retrieved from http://www.amednews.com/article/20130812/government/130819980/7/?utm_source=rss&utm_medium=&utm_campaign=20131007 CDC (2013) Multistate Fungal Meningitis Outbreak Investigation, Retrieved from http://www.cdc.gov/hai/outbreaks/infographic.html CDC (2013) Notice to Clinicians: Continued Vigilance Urged for Fungal Infections among Patients Who Received Contaminated Steroid Injections, Retrieved from http://emergency.cdc.gov/HAN/han00342.asp FDA (2013) Multistate outbreak of fungal meningitis and other infections, Retrieved from http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/default.htm