Complaint filed against pharmacy
State investigating firm responsible for national meningitis outbreak
Sunday, October 28, 2012
SEATTLE -- None of the recalled drugs from a Massachusetts pharmacy linked to the deadly meningitis outbreak were shipped to Washington state, according to state Department of Health officials.
But the state is now investigating a complaint it received against the company, the New England Compounding Center in Framingham, Mass., the Seattle Times reported.
The nature of the complaint was not disclosed, as is customary at this stage, the newspaper reported. The company is licensed in Washington as an out-of-state pharmacy.
The complaint was filed after an outbreak of fungal meningitis that has sickened those who received spinal injections of a steroid made by the company. The U.S. Food and Drug Administration officials confirmed last week that the black fungus found in the company's vials was the same fungus that has sickened 338 people across the U.S., causing 25 deaths.
Washington has compounding pharmacies, but Donn Moyer, spokesman for the state Department of Health and Board of Pharmacy, told the Times none are doing the volume that the New England Compounding Center was doing, "which would qualify as 'manufacturing.'"
In general, state pharmacy boards license pharmacies and their workers, but the federal Food and Drug Administration takes over when it can be determined that a company has become a manufacturer, the Times reported.
Any licensed pharmacist can compound ingredients. For example, it might be that a child needs a medication in a liquid form, but the drug only comes as a capsule. Or several ointments might be combined for a patient with a skin condition of unknown or multiple causes.
Kelley-Ross pharmacy, in business since the 1920s, compounds ingredients in one of its four pharmacies. Ryan Oftebro, a pharmacist and co-owner of the company, said the ethical and legal standards are clear.
"Making diaper cream to be used at a hospital bedside is one thing. Doing a mass production of an intrathecal (spinal) injection is another," he told the Times.
"I don't think there should be a facility in the United States anywhere that is not an FDA-regulated facility that pumps out 17,000 doses of anything," said Craig Toman, the managing member of Sound Prescriptions, which does business as Custom Prescriptions in Bellevue.
Both Kelly-Ross and Custom Prescriptions are accredited by the Pharmacy Compounding Accreditation Board. The board does on-site evaluations, requires that pharmacies obtain ingredients from FDA-registered and/or licensed sources and reviews the pharmacies' programs for testing compounds, among other requirements.