Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
[UPDATE 06/07/2013] FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials form Main Street Family Pharmacy. The microbial growth was seen in samples from two separate lots (batches). Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, FDA is not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with this or any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the FDA Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353953.htm

Meningitis outbreak linked to steroid injection; expanded drug recall

The CDC and FDA in a joint telebriefing held on October 4, 2012 stated, “Out of an abundance of caution, CDC and FDA recommend that all healthcare personnel cease use and remove from their pharmacy inventories any product produced by the New England Compounding Center.”  Information regarding the expanded recalled products and notification by NECC may be accessed at  http://www.neccrx.com/

More information:

• Update March 4, 2013: Notice to Clinicians:  Continued Vigilance Urged for Fungal Infections among Patients Who Received Contaminated Steroid Injections
• December 19, 2012 Virginia Clinicians' Letter: Meningitis Investigation Update
• November 1, 2012: Update on NECC Products: Samples of injectable betamethasone and cardioplegia solution test positive for bacterial contamination
• Oct. 31, 2012: FDA reports voluntary recall of all Ameridose drug products; product list released
• Oct. 22, 2012: FDA Update on Fungal Meningitis Outbreak; NECC Customer List; Advice to NECC customers, patients, and healthcare professionals
• CDC advisory letter
• Letter from the Virginia State Health Commissioner
• Order of Mandatory Suspension against New England Compounding Center, Framingham, MA
• CDC’s website at http://www.cdc.gov/HAI/outbreaks/meningitis.html

New Requirement for Obtaining ACPE-approved Continuing Education - Pharmacists and pharmacy technicians must now obtain an NABP e-Profile ID in order to receive credit from ACPE-approved continuing education providers. Click here for background and instructions.

Information on prescription drug abuse and medication safety (AWARxE)

Instructions for Obtaining a Pharmacist License through Examination or Reciprocity;
Study Guide (Examination Handbook) for Virginia Federal and State Drug Law Exam (Word .doc)

Buying medicine online -For information about buying medicine online, visit the Consumer Protection section of the National Association of Boards of Pharmacy® (NABP®) Web site.
For more information:
Buying Medicine and Medical Products over the Internet from the FDA

Drug Disposal - How a consumer may properly dispose of unwanted prescription drugs.
Guidance from Office of National Drug Control Policy (pdf)
Campaign from U.S. Fish and Wildlife Service, the American Pharmacists Association, and the Pharmaceutical Research and Manufacturers of America
Guidance from the FDA

Extension of renewal requirements for deployed military and spouses
Virginia law allows active duty service people or their spouses who are deployed outside the U.S. to have an extension of time for any requirement or fee pertaining to renewal until 60 days after the person’s return from deployment.  The extension cannot last beyond 5 years past the expiration date for the license.  For more information, please read attached policy and contact the applicable board for your license.