Monday, November 19, 2012

Fungal Meningitis Outbreak Could Have Been Prevented by Department Tasked With Protecting Health

How would you like to be known as the company that brought Republicans and Democrats together in Washington? It sounds like a good thing, but it's not in this case. The setting is a Senate Health, Education, Welfare, and Pensions Committee hearing to look into the meningitis outbreak and the source of the illnesses, New England Compounding, which has since been shut down.

A year or so ago this could have been prevented, including all 461 cases that killed 32 people due to rare fungal meningitis linked to tainted steroid injections shipped by NEC. The U.S. Food and Drug Administration admitted during the hearing that it was a weak link in the communications chain; a smoldering crisis in which someone doesn't tell or someone doesn't take action.

The crisis annual report produced by the Institute for Crisis Management reveals that two thirds of all crises are of the smoldering variety, virtually all of which can be prevented. ( (http://crisisconsultant.com/download-the-annual-report/)

State inspectors in the Denver FDA regional office sent an e-mail to a colleague in Boston, detailing allegations that NEC, a Massachusetts drug compounder, was illegally shipping drugs to Colorado hospitals. They also passed concerns to the U.S. Food and Drug Administration. "But there the information stopped...."

"'I wish in retrospect that we had notified Massachusetts (Board of Registration in Pharmacy) at that time,' FDA Commissioner Margaret A. Hamburg told a congressional committee last week as the panel tried to dissect the ongoing outbreak."

Democratic and Republican lawmakers said they would change the regulation of drug compounding pharmacies in hopes of preventing more crises like this one, which has "led to public condemnation of the U.S. Food and Drug Administration and state pharmacy regulators for failing to act against known problems over the course of a decade.

A Thursday hearing ... brought the strongest signs so far of bipartisan willingness to approve legislation that could break down the current separation of powers between the FDA and individual state regulators charged with overseeing drug compounding. (http://www.reuters.com/article/2012/11/15/us-usa-health-meningitis-idUSBRE8AE13D20121115)

Senate Commerce Committee records show that in April 2011, a Colorado state inspector found evidence that NEC had shipped drugs to a medical center in Lone Tree, Colorado, without patient prescriptions, a requirement of state law. She took pictures of the vials and copied the records. That same month, the Colorado pharmacy board issued a cease-and-desist order against NEC, but didn't inform its Massachusetts colleagues of either the inspection report or the cease-and-desist order.

"Colorado officials did, however, inform the regional office of the FDA, which in turn sent the information on May 11, 2011, to its Boston office, where, congressional investigators determined, the trail ended."

A smoldering crisis can be even more devastating than a sudden crisis like an explosion or theft. Smoldering crises like NEC's can shutter windows, cost jobs, wreck careers, bring legal charges and jail terms, and lead to costly legal suits. To echo ICM's crisis research mentioned above: Two thirds of all crises are smoldering, and 100% of those can be prevented or at least minimized. Requirements include some form of Early Warning System and a crisis communications plan that has been practiced regularly.

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