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.”

Read entire article here

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.

Source found here

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.”

Continue reading here

Iowa Board of Pharmacy to Vote on Amendments Relating to Compounding

IOWA

The Board of Pharmacy will meet 11/8/2012 to 11/9/2012 and will vote on rule amendments which affect compounding and sterile compounding practices.  Carter Alleman at ca@stateside.com

Report Details Start of Steroid Meningitis Outbreak

WEDNESDAY Nov. 7, 2012 -- The first reports of serious fungal infections from tainted steroid injections for back pain came in September from Tennessee and quickly became a national health crisis.

As of Monday, 30 people had died and 419 had been sickened in 19 states during the outbreak of fungal meningitis, with Tennessee and Michigan hit the hardest, according to U.S. health officials.

"Tennessee really got inundated with this," said Dr. Marc Siegel, an associate professor of medicine at NYU Langone Medical Center in New York City.

Now, a report published online Nov. 6 in the New England Journal of Medicine explains how the outbreak began and gives details on 66 cases in Tennessee. The state is now reporting a total of 78 cases of infection and 13 deaths.

This is rare fungal infection, Siegel said. "What's important about this report is that it documents an unusual way of transmitting this fungus," he explained.

The crisis started when a Tennessee doctor reported a single case of fungal meningitis to the state Department of Health on Sept. 18, and the agency began an investigation. Two days later two more cases were identified in Tennessee and authorities notified the U.S. Centers for Disease Control and Prevention.

By Sept. 25 there were eight cases of meningitis, which is inflammation of the lining surrounding the brain and spinal cord. All of the patients had been injected with a steroid compound in hopes of relieving neck or back pain.

Continue reading here

Meningitis outbreak: Report shows who's most at risk

8:12 PM, Nov 6, 2012 

A combination of gender, age and frequency put some people at greater risk of developing fungal meningitis after they were treated with potentially moldy medicine, state health officials said in a paper published Tuesday.

Those at greatest risk included women at least 60 years old, those who received multiple epidural injections, and those treated with vials of medicine more than 50 days old from one lot of recalled steroids, Tennessee health officials said.

Continue reading here

House presses meningitis probe after Cadden indicated through his lawyer that he would not voluntarily attend a congressional hearing scheduled for Nov. 14 - Washington Times

House presses meningitis probe - Washington Times