By: Tom Wilemon and Walter F. Roche Jr., The Tennessean
Six months after state officials found multiple violations at a West Tennessee compounding pharmacy but did not shut it down, the pharmacy is the apparent source of infections in two states.
Main Street Family Pharmacy LLC in Newbern recalled all its sterile products, the U.S. Food and Drug Administration said Friday, after methylprednisolone acetate it made was linked to seven cases of injection site inflammation in Illinois and North Carolina. One of the cases appears to involve a fungus, the FDA said.
The drug is the same steroid blamed for an ongoing fungal meningitis outbreak that has killed 55 patients nationwide, including 15in Tennessee.
State and federal health officials cautioned that they do not know the scope of the problem. The number of people exposed to the suspect medicine is not known.
State inspectors found issues at the pharmacy the month before the suspect medicine was shipped but allowed it to continue to operate.
"Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster, but still our hearts go out to those affected by this event," said Tennessee Health Commissioner Dr. John Dreyzehner. "It is very important to note that based on everything we know right now, this situation does not approach the severity of the fungal infections outbreak we encountered in the fall of 2012."
However, he noted that the information could change.
"This is very early in this rapidly evolving investigation," Dreyzehner said. "We expect that we will receive additional facts that will be very important to this investigation."
Clients haven't been identified
The primary focus at this point is sequestering all the sterile products shipped by Main Street Family Pharmacy and to contact patients who might have received injections with the steroid - a common treatment for chronic pain.
"We are working with clinics to do this," he said. "They have been very cooperative at this point, as has the pharmacy."
Among the company's clients are seven clinics in Tennessee, including two that received the preservative-free form of the medicine. State officials have not identified the clinics.
The medicine in question would have been received after Dec. 6.
Originally licensed as just a pharmacy in 1985, the company in 2010 obtained a Tennessee permit to operate as a manufacturer/wholesaler/distributor. It is licensed as a pharmacy in 29 states.
Joe M. Grillo, a Boston-based spokesman for Main Street Family Pharmacy, issued a statement on behalf of the company.
"As the FDA reported, an investigation into the exact source of the potential adverse effects from methylprednisolone acetate is inconclusive and ongoing," Grillo said. "The company is fully supportive and compliant with the FDA's recommendation that patients not be administered this compounded medicine until the investigation is complete. In its more than 17 years of operation, patient safety has always been and will always be Main Street Family Pharmacy's top priority."
109 outdated medications
Records of the Tennessee Board of Pharmacy show that state inspectors were at the pharmacy on Nov. 19, just weeks before the suspected lots of methylprednisolone acetate were shipped out. Terry Grinder, interim director of the Pharmacy Board, said the issues did not rise to the level that merited halting operations.
"The processes they were following at the time did not indicate there was any problem," Grinder said.
The inspection was one in a series that ultimately resulted in the license of Christy R. Newbaker, the person listed as pharmacist-in-charge, being placed on two years' probation and she was hit with a $12,800 fine. In signing the consent agreement, Newbaker did not admit to any of the violations but acknowledged that it was a formal disciplinary action and would be reported as such to federal regulators.
The violations found in the November inspection and cited by the state board in the March consent agreement included having 109 medications on the pharmacy's shelves that were outdated, and all but two of those drugs were "compounded drugs or drug powder materials."
Eleven prescriptions on file were not written on tamper-resistant paper as required under state law and regulations.
And the March consent agreement was not the first run-in with state inspectors.
In 2011, the pharmacy was cited for having 89 expired medications on its shelves, 20 of which were used for drug compounding.
Sterilization equipment was found out of compliance with state regulations, and records showed compounded drugs had been shipped directly to physicians' offices without having patient-specific prescriptions as required under state rules.
That same violation has been cited repeatedly in the ongoing investigation of the New England Compounding Center, the Massachusetts company blamed for a nationwide fungal meningitis outbreak.
The 2011 inspection also recorded that a nurse had been working in the pharmacy for more than four years without proper registration.
The 2011 inspection resulted in a consent agreement under which a $5,100 civil penalty was assessed. A warning letter also was issued relating to the equipment problems and the compounding violations.
The state records show Christy Newbaker was first licensed in Tennessee on Aug. 8, 1985. Her husband, David, also holds a pharmacist license, first issued in 1982.
Under a sales agreement in 2010, records show, Christy Newbaker was listed as the owner of the pharmacy when a sale was proposed to a publicly traded company called Capital Group Holdings for $300,000.
Though the sale was eventually called off, the agreement called for both Newbakers to be employed after the purchase.
Bill in the works
Legislation has emerged in the U.S. Senate to clarify the FDA's authority over compounding pharmacies that operate as medicine manufacturers, but it is uncertain whether the U.S. House of Representatives will follow suit.
The Tennessee legislature this year created a loophole around one safeguard to ensure vital medicines are available during drug shortages. Legislation sponsored by Sen.Ferrell Haile, R-Gallatin, removed a specific patient-prescription requirement when drugs are not readily available.
Haile, who is a pharmacist, defended the state law as needed in Tennessee, but said members of the U.S. House should follow the example set by Sen. Lamar Alexander, R-Tenn., in supporting better protection in federal law.
Patient advocates say this latest concern validates their calls for tougher laws and better regulation of compounding pharmacies.
"Nobody imagined that a company with the reassuringly named 'Main Street Pharmacy' could be shipping contaminated medical products to patients in 13 states," said Diana Zuckerman, president of the National Research Center for Women and Families. "Unfortunately, the public is at just as much risk now as we were when patients first started dying from contaminated medicines last year."
Terri Lewis, a volunteer advocate for people sickened by last year's outbreak, said the nation needs to properly grapple with a serious problem.
"Compounding pharmacies are highly risky operations that require controlled processes," she said.
Sue Manor of Hendersonville still worries about getting sick after being potentially exposed to contaminated medicine from last year's outbreak. In cases of fungal meningitis, symptoms may not appear until months after exposure.
Dreyzehner said he had no reason to believe that the medicine made by Main Street Family Pharmacy had not also been used in epidurals - the procedure that led to cases of fungal meningitis.
"Every day brings a new surprise," Manor said. "It's scary. Is there no end to this?"
Contact Tom Wilemon
at 615-726-5961 or firstname.lastname@example.org.
Contact Walter F. Roche Jr.
at 615-259-8086 or email@example.com.