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Wednesday, November 7, 2012

Illinois State Board of Pharmacy to Discuss Compounding at November Meeting


ILLINOIS STATE BOARD OF PHARMACY agenda for November 13, 2012,  indicates the board will discuss sterile compounding.  To view the entire agenda, click here

Oklahoma Board of Pharmacy Discusses NECC at Board Meeting Today (November 7, 2012)


FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Evidentiary Hearing on Complaints OSBP vs. New England Compounding Center, #99-722 – Case No. 1143
Proposed Executive Session pursuant to 25 O.S. Supp 2008, § 307 (B), (8); possible Board action.

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Iowa Board of Pharmacy November 8-9, 2012 Meeting Agenda Filled With Compounding Topics

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NC Board of Pharmacy summarily Suspended Ameridose Out-of-State Pharmacy Permit


WEDNESDAY, OCTOBER 31, 2012
AMERIDOSE INSTITUTES RECALL OF ALL PRODUCTS: Ameridose, which holds out-of-state pharmacy permits #10410 and #10411, announced today that it is recalling all products. Ameridose is affiliated by ownership with New England Compounding Center, whose permit was summarily suspended by the Board of Pharmacy on October 3, 2012. Ameridose ceased operations in early October pending inspections by the Massachusetts Board of Pharmacy and the Food and Drug Administration. According to press reports, FDA has reported potential problems with sterility control at the Ameridose facility. More information may be found here: http://www.boston.com/whitecoatnotes/2012/10/31/ameridose-recalls-all-drugs-after-fda-finds-problems-with-its-sterility-testing/Yno31L2Aw7LeAjOElo0DnO/story.html Reports state that no Ameridose product has been linked to a patient injury or illness. The recall is being instituted as a precautionary measure. Forms and instructions for any health-care facility who has Ameridose products in its inventory may be found here: http://www.ameridose.com/news/. Ameridose will be notifying each facility to which it has shipped products of the recall by fax. ALL HEALTH CARE FACILITIES IN NORTH CAROLINA ARE URGED TO DETERMINE IF THEY HAVE ANY AMERIDOSE PRODUCTS IN THEIR STOCK AND RETURN THOSE PRODUCTS AS DIRECTED IN THE LINKED INSTRUCTIONS. Board staff will communicate further information to pharmacists and health-care providers as it becomes available.
UPDATE: On November 1, 2012, the Board of Pharmacy summarily suspended out-of-state pharmacy permits 10410 and 10411 held by Ameridose, 201 and 205 Flanders Road, Westborough, Massachusetts. The suspension orders may be found here:
Source found here

Washington State Board of Pharmacy To Discuss Compounding Practice Tomorrow


1:50 p.m. DISCUSSION
5.1 Pharmacy Compounding Practice. The board will discuss the scope of pharmacy practice in compounding pharmaceutical products and consider a response to the Ther-Rx Corporation letter reviewed at the September meeting. Information/Action
Source found here

David Miller Speaks at ASCP Today


Compounding and Preserving Patient Safety: An Update from the International Academy of Compounding Pharmacists [+]


Wednesday, November 7
Non-CE Program
8:15 am - 8:45 am
Location: Potomac C
Speakers:
David G. Miller, RPh
Executive Vice President
International Academy of Compounding Pharmacists
David G. Miller, RPh, will discuss the recent tragic events surrounding the fungal meningitis outbreak due to contaminated compounded drugs distributed by the New England Compounding Center. This discussion will include updates on investigations, activities of legislators and regulators, and the pharmacy profession’s response. Miller will talk about how evolving policy discussions could impact LTC practices including LTC pharmacies and the consultant pharmacist. Miller will also discuss potential policy solutions for all of pharmacy.

Report Details Start of Steroid Meningitis Outbreak


More federal oversight needed to prevent repeat occurrences, expert says

November 7, 2012 RSS Feed Print
By Steven Reinberg
HealthDay Reporter
WEDNESDAY, Nov. 7 (HealthDay News) -- 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.
Investigators quickly linked the outbreak to contaminated products made by a single company, the New England Compounding Center in Framingham, Mass. The company began a recall of its products and eventually it was shut down.
When the Tennessee Department of Health compiled data on the cases, it found that the age of patients ranged from 23 to 91, and it generally took about 18 days from the steroid injection until symptoms appeared.
Symptoms included headache, new or worsening back pain, nausea, stiff neck and neurological symptoms, such as sleep problems and sensitivity to light, the report said.
The investigators were able to trace the tainted products to specific lots of a steroid, preservative-free methylprednisolone acetate. Patients particularly at risk were those whose injections came from older vials or those who were given high doses or multiple injections, the investigators found.
Among these 66 patients, eight died -- seven from strokes, the report said.
Effective collaboration between public health officials and physicians were essential to this investigation, the authors said. "An aggressive public health response to a single report of an unusual infection resulted in the identification of a multistate outbreak of fungal infections and the rapid recall of the implicated product involved," they concluded.
According to the CDC, as many as 14,000 people were exposed to the contaminated steroids.
While praising the Tennessee Department of Health and the CDC for their swift action, Siegel said the lesson from this outbreak is the need for more oversight of compounding pharmacies like the New England Compounding Center.
These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the U.S. Food and Drug Administration. Such customized drugs are frequently required to fill special needs, such as a smaller dose or removal of an ingredient that might trigger an allergy in a patient.
Currently, these pharmacies are regulated by each state's Board of Pharmacy. The FDA has limited regulatory power over these companies, Siegel noted. Several members of Congress have called for greater FDA oversight of compounding pharmacies in the wake of the outbreak.
"This is a situation where something is made in one state but administered in another state. This is a federal problem," Siegel said. "This is not supposed to happen. This loophole needs to be closed."
"From the point of manufacture to the point of injecting a person's body, the amount of surveillance should not diminish," he added.
More information
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Appropriate regulations: APhA provides feedback to Senate HELP Committee


Letter includes Association policies related to pharmacy compounding
Addressing the fungal meningitis outbreak, APhA sent a letter dated November 1 to the U.S. Senate Committee on Health, Education, Labor, & Pensions (HELP Committee) regarding appropriate regulations of pharmacy compounding.
“Despite news stories that continue to blame ‘compounding,’ the tragedy that continues to unfold from the apparent large scale unauthorized and unlicensed manufacturing in Massachusetts was not the result of poor compounding,” the Association wrote in response to an October 26 set of questions for stakeholders from the HELP Committee. “Rather, the manufacture and distribution of large quantities of sterile products to non-patient recipients for resale or administration in multiple states is just that—manufacturing. The pharmacists of America are prepared to support legislators and regulators in our collective desire to promote enhanced public health and safety.”
The Association’s 14-page letter described 2008 policies established through its House of Delegates process that address the differences between compounding and manufacturing. The majority of the letter consisted of responses to a series of questions posed by the HELP Committee.
In response to a HELP Committee question on “what state or federal laws or regulations could have and should have been used to prevent the New England Compounding Center tragedy from happening,” APhA wrote, “While not all the facts have been established, based on our understanding of the situation, both the Massachusetts Board of Pharmacy and FDA had the respective regulatory authority to act on compliance concerns and previous warning letters. From all reports the New England Compounding Center (NECC) was in violation of a myriad of existing laws and regulations. These violations are the apparent cause of the cascade of issues that resulted from distribution of products created by NECC.”
Continued APhA, “As evident in reports in this case, it appears that the company crossed the line from traditional compounding pharmacy (regulated by boards of pharmacy) into manufacturing (regulated by FDA) but clear and existing regulations were not invoked and enforcement options may not have been pursued.”
The Association supported increased resources for state boards of pharmacy and FDA to enforce existing laws. “While it does not diminish the magnitude of the transgressions by NECC in this case, we are concerned that the lack of resources related to staff, inspectors and inspector education/training for either FDA or the Board of Pharmacy authority to act on such concerns and perform follow-up inspections contributed to lack of enforcement and patient safety issues,” the letter added. “Due to budgetary constraints, we see many state boards without the resources to conduct even cursory inspections of pharmacies, let alone having the expertise to inspect specialized facilities that prepare sterile products.”
“APhA is committed to our longstanding work with state boards of pharmacy, FDA, Congress, our colleague pharmacy organizations, physicians, and other stakeholders in ensuring good compounding practices and standards are enforced to ensure patient safety and patient access to appropriately compounding products,” APhA wrote. “We support the Committee’s efforts to address compounding oversight and regulatory authority and would appreciate the opportunity to be a resource for the Committee as compounding discussions evolve.”

The HELP Committee has scheduled a hearing, Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak, for November 15 at 10:00 am. Represented will be CDC, FDA, and the Massachusetts Department of Public Health on Panel I; the New England Compounding Center on Panel II; and International Academy of Compounding Pharmacists and American Society of Health-System Pharmacists on Panel III.
The U.S. House of Representatives Energy & Commerce Committee today announced a hearing, The Fungal Meningitis Outbreak: Could It Have Been Prevented?, on November 14 at 10:00 am.

Source found here

Federal judge denies stay of execution for Hubert Michael, who killed York County girl in 1993---whMichael's attorneys argued that Pennsylvania's three-drug execution protocol could be unconstitutional because the state uses drugs from a compounding pharmacy and such pharmacies have a history of supplying drugs that are not of the required potencyere

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More on FDA Drug Compounding Oversight Bill--Do Not Compound List

By , About.com GuideNovember 7, 2012

Commenting yesterday on the proposed Verifying Authority and Legality in Drug (VALID) Compounding Act, I neglected to mention one of the bill's major provisions.

I apologize for this oversight in describing possible changes to pharmacy compounding oversight. My only real explanation for doing so is that I can hardly believe the draft of the VALID Compounding Act calls on the U.S. Food and Drug Administration to "create and maintain a 'Do Not Compound' list of drugs that are not safe or effective when compounded and make the list available to the public and state regulators."

The problem with requiring such a thing is that the list already exists in the form of Schedule I maintained by the U.S. Drug Administration under the Controlled Substances Act.

Here's what I mean:

  • Drug compounding is literally the making of medication doses.
  • Any medication dose that would be unsafe to make by compounding would, therefore, be unsafe to make in any manner.
  • A drug would be defined as unsafe almost exclusively on the grounds that it causes harm to users without producing health benefits.
  • Schedule I controlled substances are, by law (though not consensus), drugs and other chemicals determined to cause harm without producing recognized health benefits.
  • Pharmaceutical manufacturers are already barred by law from making products containing Schedule I drugs, as are compounding pharmacists or pharmacy technicians.
I normally temper my criticisms in these blog posts for fear of overstating my case. But I can see no need for, nor logic in, asking the FDA to draw up and publicize a Do Not Compound list. The contents of any such list are already widely available to anyone with knowledge of, and commitment to, making safe medications on industrial or individual scales.

Can you see any purpose in a Do Not Compound list?


Source found here

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


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.
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.”

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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.
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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