A Dyer County pharmacist and the pharmacy she works for have been disciplined by the Tennessee State Board of Pharmacy after an on-site inspection in November revealed several violations related to sterile and non-sterile compounding, out-of-date medication and prescription practices.
Christy R. Newbaker, D.Ph., and Main Street Family Pharmacy in Newbern were both listed on the Tennessee Department of Health's Disciplinary Action Report, released on Monday, April 16.
Newbaker was also disciplined in May 2012 for several violations of Tennessee pharmacy law, including allowing a nurse to work as a pharmacy technician in her facility without proper registration for four years and three months.
This March, the Tennessee State Board of Pharmacy placed Newbaker's license on probation for two years. The pharmacist was assessed $12,800 in civil penalties and must also meet certain terms and conditions throughout the probation.
Main Street Family Pharmacy in Newbern was also placed on probation. The pharmacy's license will remain on probation for three years, with $25,600 in civil penalties assessed per license. Main Street Family Pharmacy may also be responsible for other assessed costs.
A consent form, signed by Newbaker on Feb. 27 and approved by a majority quorum of Tennessee Board of Pharmacy on March 13, states Newbaker served as the pharmacist-in-charge at Main Street Family Pharmacy, located at 126 E. Main St., in Newbern.
On Dec. 6, 2011, board investigators inspected Main Street Family Pharmacy and observed the following violations to Tennessee pharmacy law:
* the condition of the laminar flow hood at the facility was not compliant with board regulations
* 89 expired medications were found on the pharmacy shelves
* 20 of these expired medications were used in drug compounding
* facility had shipped 11 compounded prescriptions directly to physicians' offices for use; however, none of these prescriptions were patient-specific as required by board rules
* a nurse had been working as a pharmacy technician in the facility without proper registration for four years and three months
The Tennessee Board of Pharmacy reviewed the facts concerning the violations on May 17, 2012. Civil penalties were assessed in the amount of $5,100 for the unregistered pharmacy technician and a letter of warning was issued pertaining to the compounding practices and the condition of the laminar flow hood. Newbaker signed the consent order on July 3, 2012 and the consent order was ratified by a majority quorum of the board on July 27.
In November, board investigators conducted an on-site inspection of Main Street Family Pharmacy in Newbern and discovered 109 out-of-date or deteriorated medications on the shelves.
Of these 109 medications, 107 were compounded drugs or drug powder materials including:
* 18 vials of expired estradiol pellets
* 56 expired powder and/or cream mixtures
* six powder and/or cream mixtures with no expiration date, lot or batch numbers indicated on the containers
* 19 bottles of expired medication in the facility's refrigerator and freezer
* eight expired vials of an injectable compound, Methione/Inositol/Choline B Complex with Lidocaine
In addition, investigators found 11 prescriptions dispensed by Newbaker that were not written on tamper-resistant paper and eight prescriptions dispensed by Newbaker that were emailed and unsigned.
These findings violated regulations concerning outdated and deteriorated drugs, medical and prescription orders, facsimile or electronic medical and prescription orders and tamper-proof prescriptions, constituting unprofessional conduct.
Newbaker's license was placed on a two-year probation effective March 13, 2013. The pharmacist is ordered to pay $12,800 in civil penalties.
At press time, the consent form for Main Street Family Pharmacy was not yet available through the Tennessee Department of Health website.
The pharmacy was listed on the Monthly Disciplinary Action Report for failing to comply with duly promulgated rules of the board. Its license was placed on probation for three years, with pharmacy officials ordered to meet certain conditions and assessed costs. Main Street Family Pharmacy was also assessed $25,600 in civil penalties per license.
Each month, the State Gazette receives a Disciplinary Action Report from the Tennessee Department of Health. The newspaper reports on all Dyer County cases.