TN State Pharmacy Board Strengthens Oversight of Drug Compounding

By: CINDY SANDERS

Posted: Monday, July 1, 2013 11:01 am

In the wake of another suspect drug case with reports of adverse patient events, the Tennessee Board of Pharmacy has announced actions to better assure the safe, sterile compounding of drugs by state-licensed entities.The latest incident found officials with the Tennessee Department of Health (TDH) and other state and federal agencies working through the Memorial Day weekend to investigate problems with methylprednisolone acetate (MPA) products produced by Main Street Family Pharmacy, LLC, in Newbern, Tenn.
Reports of adverse events first surfaced in Illinois and North Carolina from patients who received injections of preservative-free MPA (80 mg/mL) after Dec. 6, 2012. By May 24, seven reports of illness had been logged with no report of meningitis or other life-threatening infection. The suspect MPA was shipped to physicians and clinics in 14 states. In Tennessee, seven facilities received the questionable drug — Quality Care, Jackson; PinnaclePain Management Clinic, Union City; Getwell Family Clinic, Jackson; Walker Pain Management Center, Jackson; First Choice Clinic, Dyersburg; Christian Care Clinic, Newbern: and Axis Medical Clinic, White House.
The Tennessee Board of Pharmacy first licensed Main Street Family Pharmacy in 1985, with a license as a manufacturer/wholesaler/distributor being added in 2010. State officials reported the staff of Main Street Family Pharmacy had fully cooperated with the investigation and launched a voluntary recall of all its sterile products even though no known adverse effects have occurred from any other product. The pharmacy is currently on probation as a result of this investigation.
The new measures adopted by the Tennessee Board of Pharmacy collectively address the need for safe, effective medicines while preserving access for patients. “The board is working cooperatively to identify solutions to improve safeguards for public health while not placing unnecessary barriers on sterile compounding pharmacies that would hamper production of much-needed drugs already in short supply,” said Charles E. “Buddy” Stephens, DPh, president of the Board of Pharmacy. “We believe our actions enhance existing safeguards and offer new steps to ensure safe and effective medications are there when needed.”
The board has taken action to:

• Expedite suspension of sterile compounding by a pharmacy or manufacturer when a serious problem is discovered. With cause, a sterile compounder’s license can be suspended jointly by an officer of the Board of Pharmacy, its authorized executive director, and the commissioner of the Tennessee Department of Health without having to wait for a full Board of Pharmacy meeting.
• Enhance oversight and regulation of drug manufacturing operations in the state. The license for manufacturers will be a separate category. Prior to this move, manufacturers were included in a combined classification with wholesalers and distributors.
• Work more closely with the U.S. Food and Drug Administration. The new requirements call for drug manufacturers in Tennessee to show proof their operations are registered with the FDA.
• Add a sterile compounding registration to the regular pharmacy license, to the manufacturer license, and to the wholesaler/distributor license.

These initial actions are not expected to be the last. A workgroup from the Board of Pharmacy is collaborating with staff at the TDH to identify additional measures and improvements to address the manufacturing and distribution process. Items under consideration include more proactive inspection with additional emphasis on critical reviews of maintenance and quality control records, interim self-assessment and applicable reporting by the licensed entities, and adoption of applicable U.S. Pharmacopeia Standards. Additionally, three more licensed pharmacists are being recruited by the Board of Pharmacy to serve as inspectors and another administrative staff person will be added to facilitate the new self-assessment and reporting responsibilities.
“It’s a great challenge to strike a thoughtful, protective balance between addressing the daily drug shortages faced by patients and healthcare providers across Tennessee with the absolute need to assure safety and effectiveness in the compounded product,” said TDH Commissioner John Dreyzehner, MD, MPH. “While we wish the current situation associated with a Tennessee pharmacy had not happened and that patients had not been affected, the actions taken by the board, along with legislation passed recently, are moving us forward in assuring the safety and availability of important medications.”
 quoted from here