ILLINOIS STATE BOARD OF PHARMACY agenda for November 13, 2012, indicates the board will discuss sterile compounding. To view the entire agenda, click here
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.
To view entire agenda click here
Iowa Board of Pharmacy November 8-9, 2012 Meeting Agenda Filled With Compounding Topics
To view agenda, click here
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:
- Order Summarily Suspending Permit #10410, Ameridose, LLC
- Order Summarily Suspending Permit #10411, Ameridose, LLC
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
Report Details Start of Steroid Meningitis Outbreak
More federal oversight needed to prevent repeat occurrences, expert says
November 7, 2012 RSS Feed Print
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
Read more here
Appropriate regulations: APhA provides feedback to Senate HELP Committee
November 05, 2012
Letter includes Association policies related to
pharmacy compounding
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
To read this article click here
More on FDA Drug Compounding Oversight Bill--Do Not Compound List
By Edward Lamb, 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:
Can you see any purpose in a Do Not Compound list?
Source found here
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.
Can you see any purpose in a Do Not Compound list?
Source found here
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