Photo Credit CDC
# 7317
Yesterday the FDA announced that they were conducting an investigation into reports of adverse reactions to steroid injections produced by another compounding pharmacy, this time in Tennessee.
First the press release, then I’ll return with a bit more.
For Immediate Release: May 24, 2013
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDAFDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.
The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus.
An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of 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
For more on this story, we turn to NBC’s Maggie Fox, who writes:
FDA warns of infections tied to Tenn. pharmacy
By Maggie Fox, Senior Writer, NBC News
Health officials fear they have another outbreak of infections linked to pain injections -- this one because at least seven people in two states developed abscesses after getting injections of steroid drugs. They're all linked to a single pharmacy: Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
Tennessee state officials say the facility distributed the products to 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
"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," Tennessee state health commissioner Dr. John Dreyzehner told reporters in a telephone briefing.
As this case is just now under investigation, and we don’t know all the facts, I’ll confine my remarks to earlier compounding pharmacy incidents.
Compounding pharmacies were originally designed to provide customized medications - often for use in hospice or other specials needs situations – for individual patients. In many cases they provide an important, and difficult to replace service.
But in recent years, some of these compounding pharmacies have expanded their operations beyond this intended role, becoming – in effect – small scale drug manufacturing companies.
They fall into a gray area of the law - where the FDA has little oversight - and the industry has little regulation.
Last year’s Multistate Fungal Meningitis Outbreak - which resulted in more than 700 infections and 55 deaths – was linked to contaminated steroid products distributed by the New England Compounding Center (NECC).
For more on that story, you may wish to revisit:
CDC Update & Infographic On Fungal Meningitis Case
CDC Update/HAN Message On Fungal Meningitis Outbreak
MMWR: Multistate Outbreak Of Fungal Meningitis
Although this has been the worst fungal meningitis outbreak linked to a compounding pharmacy, it isn’t the first. Last October in Revisiting An Earlier Fungal Meningitis Outbreak, we looked at a similar, albeit smaller, outbreak in 2002 involving a pharmacy in South Carolina.
In April of this year the FDA targeted 31 compounding pharmacies, inspecting them for sterility or other deficiencies that could affect the safety of their product.
They cited safety issues in 30 of them.
FDA Commissioner Dr. Margaret Hamburg’s blog post in April: Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding described some of what they found.
During the course of both our proactive and reactive inspections over the past few months, we observed concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination. As of this week, we have issued to all but one pharmacy that we inspected an inspection observation report (called an FDA Form 483, or just a “483”) that lists objectionable conditions observed at the facilities. The one firm not receiving a FDA Form 483 was not producing sterile drugs.
As noted on some of these 483s, select FDA observations during the inspections include: unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in “clean rooms” where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats.
And lastly, Congress is considering ways to improve the regulation and oversight of this growing industry, but as this Washington Post Article shows, not everyone is in agreement over how this should be accomplished.
Senate panel approves tighter oversight of compounding pharmacies, but bill is under fire
By Lena H. Sun, Published: May 22
Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
The bill, approved Wednesday by the Senate Health, Education, Labor and Pensions Committee, would create a new category of regulation by the Food and Drug Administration for these companies. The bill now heads to the full Senate.
