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Strict regs help keep citizens safe

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POSTED: October 23, 2012 7:00 p.m.

NOTE: 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 simply will write it off as a seasonal flu. Unlike viral and bacterial meningitis, fungal meningitis is not contagious, and cases currently under investigation by the Center for Disease Control and Prevention 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 at least 205 infections spread throughout 15 states and 15 reported deaths. So far, as of Wednesday, no cases have been identified 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 a 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 Food and Drug Administration. 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 1 to 3 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 voluntarily has 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.
  
Sen. Buddy Carter can be reached at 404-656-5109. Rep. Ben Watson can be reached at 404-656-0109.

 

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