Mass. pharmacy board chief fired after meningitis outbreak Director allegedly ignoring complaint from CO about Framingham compounding pharmacy: Board's Attorney Placed on Administrative Leave

By Kay Lazar

Globe Staff November 07, 2012


The director of the state pharmacy board, James D. Coffey, has been fired and the board’s attorney, Susan Manning, has been placed on administrative leave for allegedly ignoring a complaint in July that New England Compounding Center was distributing bulk shipments of drugs to hospitals in Colorado, in violation of its state licenses.
New England Compounding is the Framingham pharmacy blamed for a national outbreak of fungal meningitis caused by contaminated steroids it produced between May and August of this year.
The Colorado Board of Pharmacy alerted the US Food and Drug Administration and also contacted Coffey on July 26 about the problem, and Coffey forwarded the information to Manning and department inspectors, but failed to order an investigation, according to a source close to the investigation.
Coffey also failed to  alert officials at the state Department of Public Health, the agency that oversees the state pharmacy board, the source said. And there is no evidence that Coffey or Manning alerted the board itself.

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Recent Tainted Injections Catastrophe Sheds Light on Compounding Pharmacies Regulation

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Pharmacies Fought Controls

Industry at the Focus of Meningitis Outbreak Beat Back More Federal Oversight

By THOMAS M. BURTON, JAMES V. GRIMALDI and TIMOTHY W. MARTIN

In 1996, David Kessler, then the commissioner of the Food and Drug Administration, warned Congress that tiny drug-compounding pharmacies would spawn a “shadow industry” of unapproved drugs that “could result in serious adverse effects, including death.”
Today, Dr. Kessler, who worked for Republican and Democratic administrations, seems eerily prophetic. A painkilling steroid from the New England Compounding Center has exposed as many as 14,000 patients to fungal meningitis, sickened 203 people and killed 15 people. The center has shut down, and health officials warn that the number of cases is expected to rise.
How these firms escaped closer regulation shows how little happens in Washington absent an emergency. Top lawmakers and federal officials tried for years to increase regulation. A countereffort by the industry and a series of court decisions helped beat that back. Federal agencies debated about who should crack down on the industry. Lawmakers eventually abandoned their push after deciding the issue wasn’t important enough.
From 2001 to this year, the International Academy of Compounding Pharmacists spent about $1.1 million on lobbying, according to disclosure reports filed with Congress. In a newsletter to members, the academy described how it defeated a 2007 bipartisan draft bill that would have given the FDA more authority to regulate compounding pharmacies after hundreds of its pharmacists canvassed Capitol Hill urging lawmakers to abandon the proposed legislation.
It isn’t known whether tighter regulations would have stopped the outbreak tied to the New England Compounding Center. Lawmakers in that 2007 bill proposed restricting distribution of compounded drugs across state lines, which could have prevented the steroid injections from reaching clinics in 23 states. They also proposed giving the FDA more power to inspect facilities.
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Texas Board of Pharmacy Looking to See if There is Anything It Needs to Change: Meningitis Outbreak Highlights Need For Compounding Pharmacy Oversight « CBS Dallas / Fort Worth

Meningitis Outbreak Highlights Need For Compounding Pharmacy Oversight « CBS Dallas / Fort Worth

Meningitis Outbreak Fallout: Whom Can You Trust?

Although the clinical fallout from the largest outbreak of illness ever tied to a pharmacy compounder is alarming, in many ways it is the most straightforward part of the crisis to document. By mid-October, nearly 350 patients treated with an injectable steroid prepared by the New England Compounding Center (NECC) had been infected, with 24 fatalities reported in the 18 states affected, according to health officials.
But those numbers haven’t helped clear up several far more challenging questions. How, for example, could the Framingham, Mass., facility have been allowed to continue to produce massive amounts of compounded drugs and ship them across state lines, seemingly in violation of state pharmacy laws prohibiting such large-scale manufacturing? And why was NECC allowed to continue to operate despite a history of safety violations—some involving the same steroid that has been implicated in the current outbreak?
State boards of pharmacy, the FDA and compounding pharmacy trade associations have been cast variously as villains in allowing this regulatory morass to persist. With no concrete fixes likely to emerge anytime soon—aside from NECC ceasing operations and Ameridose, a company with shared ownership, still shuttered at press time due to an ongoing investigation of its manufacturing facilities—a more immediate, practical question now looms for pain clinics and health systems that still need to buy compounded medications:
Whom can you trust?
“That’s certainly one of the key questions we have been asking” during ongoing conference calls between pharmacy directors in Massachusetts and state health officials, according to the director of a multihospital health-system in the northeast who asked to remain anonymous due to the sensitive nature of the discussions. The consensus, the director said, was this: If you can purchase compounded drugs from an FDA-approved and inspected facility, “that’s who you should go with; it’s really the safest bet.”

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BREAKING NEWS: State fires pharmacy board director; allegedly ignored complaint against New England Compounding Story metadata: Submitted Nov. 7, 2012, 7:56 p.m. GMT from twitter.com by editor

Case Count: 424* States: 19* Deaths: 31*

Consumer Updates Medication Errors Happen to Pets, Too

Consumer Updates Medication Errors Happen to Pets, Too

Pet Medications Through Retail Pharmacies – What You Need to Know Date: November 6, 2012 Author: karen

Many retail pharmacies are now offering prescription pet medications.  National chain pharmacies such as Costco, Target, Walmart and Walgreens  can provide pet prescription and non-prescription medications at reduced costs, thereby saving the consumer money.  Like all pharmacists, they will not prescribe the medications themselves; they only work from prescriptions written by a licensed veterinarian.

From the consumer’s point of view this can be beneficial both from a cost savings perspective and a convenience factor.  However take some precautions if you do switch from a pet pharmacy to a retail pharmacy.   According to each state’s  Pharmacy Practice Act, pharmacists are not allowed to change a prescription without consulting the prescriber first (in this case the veterinarian).   But according to an article from the VIN News Service, there have been rare, anecdotal accounts of retail pharmacists changing the dosage or substituting another medication without consulting the original veterinarian.  So if your retail pharmacist contacts you with a suggested medication change, be sure they have consulted with your veterinarian beforehand.

Not all retail pharmacists are trained in veterinary pharmacology; this does not mean they are not qualified to dispense pet medications.  It’s more a matter of consumer comfort level.  Stacy Mantle of Pets Weekly says, “I haven’t had too many problems using regular pharmacies to fill pet medications. Most of them do compounding/reformulation (i.e., to add taste like beef or chicken flavors or to reformulate say a pill to a topical paste). For reformulation, I use specific animal pharmacies since they understand animals better. ”

According to Costco’s Senior Vice-President of Pharmacy Vic Curtis, from an article inDrugstorenews.com, Costco offers a ‘continuing education program for pharmacists dispensing pet meds, as well as a veterinary drug handbook shipped to stores and access to veterinarians who can answer pharmacists’ questions.’

Bottom line: If you do decide to use a retail pharmacist, stay on top of possible changes to your pet’s prescriptions.   And I recommend getting more information by speaking with your local pharmacist and your veterinarian.

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Fungal Meningitis Risk Period Over But Threat Remains

By SYDNEY LUPKIN

Nov. 7, 2012

The 42-day risk period for contracting fungal meningitis from tainted steroid injections ended on Wednesday, since the drugs were recalled on Sept. 26, but new case reports will probably continue to trickle into the Centers for Disease Control and Prevention for at least a few months, said Dr. Tom Chiller, a fungal disease expert at the CDC

With 18 new cases reported last Friday, and abscesses causing even fungal meningitis survivors to go back to the hospital with new symptoms, sighs of relief could be premature.

“Forty-two days is not a magic number by any sense of the word,” said Chiller, who is the deputy chief of the CDC’s Mycotic Diseases Branch. “This is a moving target. The outbreak is evolving.”

The CDC publicized the 42-day period as a way for individual physicians to determine whether putting all at-risk patients on anti-fungal medications was a good idea, Chiller said. Since anti-fungal medicine can cause liver and kidney damage, there was a risk it could do more harm than good. The long risk period would mean a long anti-fungal regimen.

A CDC analysis revealed that while preemptive anti-fungal prescriptions reduced patients’ risk of death or stroke from meningitis by .1 percent, they increased the risk of other adverse health problems by up to 14 percent, Chiller said.

Chiller said this kind of fungus, exserohilum rostratum, can have a very long incubation period. Although the median incubation period so far has been 20 days, the longest incubation period went beyond 100 days, he said.

“One of the important things to add is that we do feel pretty confident that the further out you are from injection, the lower the risk,” Chiller said. “When that risk becomes zero, we don’t know.”

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