Pharmacy compounding recently has come under the spotlight following the deadly meningitis outbreak caused by tainted steroids manufactured at the New England Compounding Center in Massachusetts. Consumers now are wondering why the Food and Drug Administration has not been regulating compounding pharmacies.
Pharmacy compounding expanded in the 1990s; when hospitals experienced shortages of medications, they began outsourcing to get the drugs they needed. Since then, compounding pharmacies have been regulated by the individual states. Congress wants to know why regulators failed to prevent this meningitis outbreak, but the Senate did praise Tennessee for its decisive actions.
Tennessee had a high number of the total fungal meningitis cases nationwide, 81, and led the nation in meningitis-related deaths, 14. The problem could have been worse in Tennessee if the Department of Health did not act as quickly as it did. According to reports, the Department first learned of a person suffering from an NECC steroid injection on September 18, 2012, and ordered all Tennessee health facilities to discontinue using medicines from the New England Compounding Center on October 4.
New Regulations to Strengthen Tennessee’s Policies Regarding Compounding
Although Tennessee reacted quickly to the recent NECC tainted steroids, the Tennessee Board of Pharmacy convened in response to the outbreak to review the state’s regulations regarding compounding. The Board conducted a survey at the end of last year to find out how regulations could be strengthened to protect the public. Of the 1,893 pharmacies that responded to the survey, 352 reported that they are active in sterile compounding. According to a report in the Tennessean, 65 of those are preparing over 100 doses per day.
Upon receiving this information and learning how extensive the practice of compounding is across Tennessee, the Board is considering amending the state’s pharmacy compounding regulations or proposing new state legislation to improve oversight of compounding in the state.
It appears that increased regulations of pharmacy compounding are in order for Tennessee in the near future.
If you were injured by a pharmacy error, or if your loved one died from complications of a pharmacy error, please call Kennedy Hodges, L.L.P., a nationwide pharmacy malpractice law firm, at 888-526-7616 for a free consultation and a FREE copy of our report, How to Make Pharmacies Pay for Injuries Caused by Medication Errors.