New England Compounding Center meningitis outbreak

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Erzzn1989

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Written Project Requirements:

Choose you case study!

1.Scientific component (not less than 1 page)

•What was the compound used for;

•What caused the problem/tragedy (adverse reaction, drugs interactions, etc.).

2.Identify and describe the problem from public side. What happen? (not less than 1 page).

3.Describe the consequence of the steps that led to the problem/tragedy. Include information about both the company and the regulatory agency; (not less than 1 page).

4.Imagine, you are a Project Manager inside the company working on this project. What would you do differently? (not less than 1 page).

5.Imagine, you are a Project Manager at the FDA (other regulatory agencies). Your steps? (not less than 1 page).

Can you imagine this situation happening in 2015? Why?

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Explanation & Answer

Attached.

Running Head: NEW ENGLAND COMPOUNDING CENTER MENIGITIS OUTBREAK

New England Compounding Center Meningitis Outbreak
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NEW ENGLAND COMPOUNDING CENTER MENIGITIS OUTBREAK

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New England Compounding Center Meningitis Outbreak
Scientific Component
The New England Compounding Center Meningitis Outbreak started in September of 2012;
it affected over 700 people and killed about 76 people (Olaniran & Scholl, 2013). The scientific
component which happened to be Fungal Meningitis was caused by receiving contaminated
steroid injections, and this was done by the New England Compounding Center, found in
Framingham Massachusetts. The center was one of the compounding pharmacies located in the
United States of America and what this means is that the medicine was allowed to combine and
alter ingredients in need to make specific drug formulations that should meet individual patients.
Meningitis is an infection that affects the membrane around the brain, and in that order, the
spinal cord is also inflamed.
The outbreak of Fungal Meningitis infection was traced to the significant contamination of
fungi to the three lots of the medication methylprednisolone which was used for the epidural
steroid injections, and this was the medicine that was marketed by the New England
Compounding Center. It was later confirmed after testing by the Food and Drug Administration
which observed the foreign materials and identified it a fungal matter; the fungus was proved to
be the leading cause of fungal meningitis after traces of mushrooms was found in the
cerebrospinal fluid of several of the affected patients. The predominant fungus that as identified
is Exserohilum rostratum. The first cases of the infection were from three lots of steroid, this
included preservative-free methylprednisolone acetate, for the back pains and some of the said
patients developed symptoms which went with those of fungal meningitis (Olaniran & Scholl,
2013).

NEW ENGLAND COMPOUNDING CENTER MENIGITIS OUTBREAK

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Fungal meningitis is not contagious through physical contact and can be subsequently
caused through epidural administering medications. In another report by the Food and Drug
Administration, there was identified fungal contamination in the vials of unopened cardioplegia
and betamethasone solutions which were distributed by the New England Compounding Center.
The Problem from Public Side
The Fungal I...


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