Meningitis outbreak spreads; Mass. revokes Compounding Center's license

Oct 25 2012

Investigators found unsterilized and contaminated vials at the New England Compounding Center.

Politico: Massachusetts Facility Linked To Meningitis Outbreak Loses License
The Massachusetts Board of Pharmacy has permanently revoked the license of the New England Compounding Center, the facility implicated in a nationwide outbreak of fungal meningitis, Gov. Deval Patrick announced Tuesday. ... State Director of Healthcare Safety Madeleine Biondolillo said ... investigators witnessed "black particulate matter" in some vials of medicine returned amid the nationwide recall of NECC's products. That substance turned out to be a "fungal contaminant linked to the outbreak" (Cheney, 10/23).

WBUR: State Moves To Revoke License Of Pharmacy Linked To Meningitis Outbreak
[I]nspectors have finished the first stage of an investigation at the compounding pharmacy that produced the steroids, New England Compounding Center. ... The inspection that began one month ago paints a picture of a pharmacy poised for problems. Floor mats showed dirt and debris at the entrance to NECC's so-called "clean room," where pharmacists mixed medications. Equipment used to sterilize drugs was not regularly tested (Bebinger, 10/24).

The Wall Street Journal: State: Pharmacy Ignored Safety Rules
On 13 occasions, New England Compounding Center shipped products from two now-recalled batches of the steroid linked to the outbreak before receiving a report from an outside lab that tested them for safety, violating industry-backed guidelines the company said it followed, Massachusetts health officials said. Some medicines were sent 11 days before receiving a report, the state said (Martin, Rockoff and Maremont, 10/23).

Reuters: Before Meningitis Outbreak, Firm Avoided Sanctions
The pharmacy tied to a deadly U.S. meningitis outbreak escaped harsh punishment from health regulators several times in the years leading up to the health crisis that has raised questions about oversight of the customized drug mixing industry, newly released state records show. Problems at the New England Compounding Center (NECC) in Framingham, Massachusetts, date as far back as 1999, the year after it began operations (Clarke and McLaughlin, 10/23).

NPR: Meningitis From Tainted Drugs Puts Patients, Doctors In Quandary
Public health officials and physicians are trying to strike a prudent balance between alerting, diagnosing and treating patients who might be at risk of fungal infections -- and not over-alarming, over-diagnosing and over-treating those who aren't really at risk. ... The caution is warranted. This type of fungal infection can smolder for weeks and months before exploding into meningitis or causing massive strokes (Knox, 10/24).

Medpage Today: Meningitis Outbreak: 17 States Affected
Georgia, reporting a single case, has joined 16 other states affected by the fungal meningitis outbreak that has claimed the lives of 23 people, the CDC reported Tuesday. The tainted steroid at the heart of the outbreak was shipped to 23 states, but vials sent to Nevada were not used before the drugs were recalled. No cases have been reported in five other states -- California, Connecticut, Rhode Island, South Carolina, and West Virginia. The case total is now 308, up from 285 reported Sunday (Smith, 10/23).

CQ HealthBeat: Oversight Committee Democrats Ask GAO To Investigate Pharmacy Compounders
Two Democrats who serve on the House Committee on Oversight and Government Reform asked the Government Accountability Office on Tuesday to investigate federal and state oversight of the pharmaceutical compounding industry. ... John F. Tierney of Massachusetts and Elijah E. Cummings of Maryland asked ... asked that the GAO work with state boards of pharmacy to determine the size of the compounding industry, including the number of licensed pharmacists who do compounding (Norman, 10/23).