By Sen. Buddy Carter (R-Pooler) and Rep. Ben Watson (R-
Savannah)
*Sen Carter has served his community as a pharmacist since 1980, while
Rep. Watson has served as a primary care physician in Savannah since
1988.
During the past few weeks, we have learned of a growing number of fungal
meningitis cases linked to a batch of contaminated epidural steroid injections
created by the New England Compounding Center. Meningitis refers to inflammation
of the meninges, which are the membranes covering the brain and spinal cord.
Common types of meningitis are viral and bacterial meningitis which can be
highly contagious and begin with flu-like symptoms. Often these types of
meningitis may go undiagnosed as patients will simply write it off as a seasonal
flu. Unlike viral and bacterial meningitis, fungal meningitis is not contagious
and cases currently under investigation by the CDC are limited to those who
received the affected steroid shot.
The CDC estimates that as many as 14,000 patients may have been given the
tainted product tied to the outbreak. Since last week, the outbreak has been
connected to 205 infections spread throughout 15 states and 15 reported deaths.
So far no cases have been indentified in Georgia but it is important to note
that the CDC has marked Georgia as a state that received the affected
product.
In this case, the contaminated product, created by compounding center,
tested positive for strains of fungus- including one that is present in wood
rot. You may not be familiar with how a compounding pharmacy differs from your
local pharmacy, or how each is individually regulated by the FDA. Compounding
centers create custom formulations of medications in order to fit patients’
needs that may not be able to be met with a manufactured drug product.
Currently, more than half of the nation’s 56,000 community-based pharmacies
provide some level of basic compounding services and one to three percent of all
prescriptions dispensed in the U.S. are compounded.
Compounding pharmacies are licensed and regulated by individual states, but
the final products created by a compounding pharmacy are not subject to FDA
regulations that manufacturers of drugs must follow. The New England Compounding
Center has voluntarily recalled products related to the outbreak, but the CDC,
recommends all products from the center be avoided while the investigation
continues.
The Georgia Drug and Narcotics Agency recognizes Georgia’s compounding
rules as among the strictest in the nation. Under rules established by the Georgia
Board of Pharmacy, Georgia pharmacists may compound, for an individual patient,
drug preparations based on the existence of a
pharmacist/patient/prescriber relationship and a valid prescription drug order.
The rules on compounding also include requirements related to pharmacy
proficiency, facilities and equipment, control of components, and quality
assurance, among other stipulations.
Our regulations also prohibit compounding pharmacies in Georgia from
engaging in the very actions that the NECC was engaged in- selling bulk compound
drugs to physicians and pharmacies. Instead, all
compounding of medication in
Georgia must be patient-specific. Additionally, Georgia law prohibits persons or
businesses, whether located in or out of state, from selling or distributing
drugs at wholesale without first registering with the Board of Pharmacy.
Though we serve as legislators, we serve our communities first and foremost
as dedicated members of the medical field. We are dedicated to making laws and
tightening regulations in order to ensure our citizen’s safety.
As we approach flu season, vaccinations are important to the health and
safety of all Georgians. We want you to be comfortable in the product you are
receiving and confident that we are taking additional precautions to protect our
citizens. While tragic and avoidable, the outbreak of meningitis caused by this
compounding center is a rare incident and shouldn’t dismay anyone from receiving
important, life-saving vaccinations in the future.
Senator Buddy Carter can be reached at Coverdell Legislative Office Building (C.L.O.B.) Room 301-A, Atlanta, GA, 30334.
His Capitol office number is 404-656-5109. You can connect with him on Facebook at facebook.com/buddycarterga or
follow him on Twitter @Buddy_Carter.
Source found here
No comments:
Post a Comment