More light shed on health violations
Mass. health department releases meningitis outbreak documents
The Massachusetts Department of Health released hundreds of pages of documents Monday detailing a history of violations at the New England Compounding Center, whose tainted medicine has caused a nationwide meningitis outbreak. The documents include dozens of complaints from as early as April 1999, less than a year after the company began as a compounding pharmacy in Framingham, Mass.
Among the most frequently cited problems was the company’s habit of allowing doctor’s offices to fax orders for medicine without names of specific patients, a practice that is prohibited under state law. The company was also repeatedly cited for not providing the appropriate data to support its medicines’ expiration dates. All violations were eventually corrected.
The documents, released in response to requests from journalists, provide a window into regulators’ attempts to crack down on problems at the company, and the company’s efforts to correct them.
The reports were released as the number of meningitis cases related to the spinal injection of a steroid drug from the pharmacy that was contaminated with mold rose to 294. Three joint infections have also been linked to the shots, and 23 people have died.
State officials inspected the company at least three times in 2004, finding a variety of violations. The records show that a lawyer for the company pleaded with officials, saying that if they brought disciplinary action, the consequences “would be fatal to the business” and trigger a “catastrophe.” An outside auditor was assigned to see that the company corrected its procedures, and eventually the company was cleared by the state.
In January 2006, the company and the Massachusetts Board of Registration in Pharmacy signed a consent agreement in which the company and its chief pharmacist and co-owner, Barry J. Cadden, were to be placed on a one-year probation. However, the board agreed to delay the start of the probation for one year to give the company a chance to undergo two inspections and make improvements.
A few months later the state-appointed inspector said that the center had made significant progress. It does not appear it was placed on probation. Also Monday, the Food and Drug Administration posted on its website lists of the customers of the New England Compounding Center and of the products they bought. The customer list is 28 pages long and shows hospitals and clinics in every state except Missouri, and in the District of Columbia and Puerto Rico.
The facilities include an array of small clinics and surgery centers, but also some major hospitals. In New York, for instance, the Beth Israel Medical Center, Montefiore Medical Center and Long Island Jewish-North Shore University Hospital appear on the list. Also on the list are Brigham and Women’s Hospital and Boston Children’s Hospital, in Boston; a hospital in Eau Claire, Wis., that is part of the Mayo Clinic system; Yale-New Haven Hospital in Connecticut, and the Naval Medical Center in Portsmouth, Va.