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Saturday, December 29, 2012
FDASIA-Mandated Drug Labeling Work Group To Hold First Meeting Next Month
Saturday, December 29, 2012
A working group mandated by the FDA Safety and Innovation Act to outline, in the coming months, best practices for communicating drug labeling information to blind or visually impaired patients will hold its first meeting next month.
Source found here (subscription required)
FDA Budget Cuts Could Mean Fewer Drug Inspections, Stakeholders Say
December 29, 2012
Stakeholders are questioning how FDA, in the face of possible sequestration and the fiscal cliff, will be able to meet inspection requirements under both the FDA Safety and Innovation Act and the Food Safety Modernization Act, and a former FDA official said the food law's mandate for a specific number of prevention-based inspections every two years could lead to fewer drug inspections, which Congress requires FDA do only when there is a perceived risk.Source found here (subscription required)
Hamburg: FDA's Compounding Plan Averts 'Dislocations' Within Healthcare System
December 29, 2012
FDA's plan to create a tiered oversight system for traditional and non-traditional compounding would address a growing area of risk without creating “huge dislocations” within the healthcare system, which has become increasingly dependent on outsourcing certain functions to large-scale compounders, said FDA Commissioner Margaret Hamburg as she met with regulators from 50 states last week.
Source found here (subscription required)
Reminder: Mandatory Survey of all NH Licensed / Registered in-State & Non-Resident Pharmacies Regarding Compounding Are Due Immediately
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All NH licensed in-state pharmacies and all registered
non-resident / mail-order pharmacies are required to submit responses to an
online survey regarding compounding practices. The survey
can be started by clicking here - you will need to enter your pharmacy's NH
license / registration number to complete the survey. Notices regarding this
mandatory survey were mailed out to all registered non-resident pharmacies and
faxed to all licensed in-state pharmacies on Monday, December 10th. The deadline
for answering the survey was Wednesday, December 19, 2012
- if you have not yet responded to the survey, please do so immediately.
Pharmacies / pharmacists-in-charge that fail to respond to this mandatory survey
are subject to disciplinary action by the Board.
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Friday, December 28, 2012
Revised USP Standards Guide Prescription Container Labels
Revised USP Standards Guide Prescription Container Labels
The US Pharmacopeial Convention (USP) has released standards that provide a universal approach to organizing labels for prescription containers dispensed by pharmacists. The new standards aim to eliminate the variability that currently exists between pharmacies across the US and improve patient understanding of medication instructions by giving direction for optimal format, appearance, content, and language.
The standards include detailed instructions for how to:
Emphasize instructions and information important to patients
Improve readability
Give explicit instructions
Include purpose for use
Address limited English proficiency
Address visual impairment.
The standards are contained in General Chapter <17> Prescription Container Labeling (November 2012). For more details, see USP.
Year in Review: Meningitis Outbreak Still a Challenge
By Michael Smith, North American Correspondent, MedPage Today
Published: December 28, 2012
As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened with the fungal meningitis outbreak since we published our first report.
The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.
What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.
It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.
"The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing," Kauffman told MedPage Today. "The huge morbidity and, for some, mortality, is enormous."
The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called "compounding pharmacies."
And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.
The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.
The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: "We're still in the middle of this thing."
Compounding Out of Bounds
The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.
Continue to read here
Salem woman files $25 million lawsuit over meninigitis outbreak
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ROANOKE, VA --
As more and more people were diagnosed with fungal meningitis in the Roanoke
Valley lawsuits began to pop up against the two companies believed to be
responsible, Insight Imaging in Roanoke which gave the epidural steroid
injection and New England Compounding Pharmacy which created the drug.
But now we're learning more about the extent of the allegations thanks to a $25 million lawsuit filed in Roanoke City Circuit Court on Thursday.
The 35 page lawsuit details alleged neglect and fraud by both companies.
In one of the more serious allegations the lawsuit claims Insight Imaging told patients they were receiving Depo-Medrol, a FDA approved steroid injection.
Instead patients received a different injection produced and distributed by the New England Compounding Pharmacy that was not FDA approved, this is according to the lawsuit.
"That's extremely troubling because it's just completely false," said Scott Sexton of Gentry Locke Rakes & Moore, the law firm representing 20 victims and their families. "It doesn't provide the right information to the patient or to the patient's insurer."
Sharon Wingate filed the $25 million lawsuit after her husband died of meningitis.
He received the epidural steroid injection from Insight Imaging in Roanoke earlier this year.
"It's rare to have those facts line up as they do in this case where you have a patient receiving one thing but he's being told it's another," Sexton said.
The lawsuit also alleges the Boston based New England Compounding Pharmacy, which is located next to a garbage dump, used unsanitary methods to produce the drug.
WSLS contacted Insight Imaging for their response to the lawsuit but our call was not returned.
Six more lawsuits were filed against the company on Friday and Sexton said more could be on the way next week.
It's the beginning of what will likely be a long legal process.
Source found here
But now we're learning more about the extent of the allegations thanks to a $25 million lawsuit filed in Roanoke City Circuit Court on Thursday.
The 35 page lawsuit details alleged neglect and fraud by both companies.
In one of the more serious allegations the lawsuit claims Insight Imaging told patients they were receiving Depo-Medrol, a FDA approved steroid injection.
Instead patients received a different injection produced and distributed by the New England Compounding Pharmacy that was not FDA approved, this is according to the lawsuit.
"That's extremely troubling because it's just completely false," said Scott Sexton of Gentry Locke Rakes & Moore, the law firm representing 20 victims and their families. "It doesn't provide the right information to the patient or to the patient's insurer."
Sharon Wingate filed the $25 million lawsuit after her husband died of meningitis.
He received the epidural steroid injection from Insight Imaging in Roanoke earlier this year.
"It's rare to have those facts line up as they do in this case where you have a patient receiving one thing but he's being told it's another," Sexton said.
The lawsuit also alleges the Boston based New England Compounding Pharmacy, which is located next to a garbage dump, used unsanitary methods to produce the drug.
WSLS contacted Insight Imaging for their response to the lawsuit but our call was not returned.
Six more lawsuits were filed against the company on Friday and Sexton said more could be on the way next week.
It's the beginning of what will likely be a long legal process.
Source found here
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