Why Haven't All States Where NECC Is Licensed To Do Business Revoked This Right?

I am still amazed at the number of state boards of pharmacies who have taken no action against NECC.  Even if there are no cases of meningitis in these states wouldn't taking some form of action as allowed by the state regulations and laws be the prudent thing to do?  Emergency meetings have been held in some states.  Others could do the same.  Some have placed the item on the agenda for their next meeting.  Others could do the same.  If states really want to show they are capable of handling some portion of regulation of compounding pharmacies, as I have said before States need to move quickly and take action. 

U.S. regulator needs new authority over compounding pharmacies: report

David MorganReuters

10:01 p.m. CDT, October 28, 2012

WASHINGTON (Reuters) - The U.S. Food and Drug Administration's power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.

The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner "the authority we need to help prevent tragedies like this from happening again."

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Compounding pharmacies face greater scrutiny in Ohio

By Peggy O'Farrell

Staff Writer

Ohio is cracking down on pharmacies that custom-mix individualized prescriptions in the wake of a deadly fungal meningitis outbreak tied to a Massachusetts compounding pharmacy.

Statewide, 17 pharmacies are now specially designated as compounding sites, said Jesse L. Wimberly, spokesman and pharmacy inspector for the Ohio State Board of Pharmacy. Inspectors check pharmacies at least every three years, though they will go more often if complaints are filed or violations are reported. “Now we’re going to every one of these pharmacies that are designated for compounding,” he said.

The state now requires pharmacies to spell out how much of their business is strictly retail sales and how much is mixing up custom preparations, Wimberly said. And when a state inspector comes to call, they have to be able to demonstrate both that their facilities meet cleanliness standards set out by the U.S. Pharmacopoeia, a kind of governing board for pharmacists, and to show that their products are being prepared for specific patients — not mixed up in advance and set aside so it’s ready when and if the order comes in.

“The issue we’re having now is are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person,” he said.

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Report faults states’ oversight of specialty pharmacies

byy Lena H. Sun, Sunday, October 28, 5:50 PM

State boards have failed to adequately regulate the safety of practices at specialty pharmacies like the one at the center of the deadly fungal meningitis outbreak, according to a congressional report to be released Monday.

The report by Rep. Edward J. Markey (D-Mass.) looked at enforcement actions against compounding pharmacies in all 50 states and found that only six states had records of taking action. The information was based on what was available on Web sites and through follow-up telephone calls.

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Indiana knew about meningitis outbreak a week before telling the public, documents show Read more: http://www.foxnews.com/health/2012/10/28/indiana-knew-about-meningitis-outbreak-week-before-telling-public-documents show

Published October 28, 2012

 INDIANAPOLIS – State health officials knew six clinics in Indiana had received a recalled back pain medication linked to an outbreak of fungal meningitis a week before they notified the public, according to documents obtained by The Associated Press.

A series of emails obtained Friday through an AP public records request indicate officials at the Indiana State Department of Health were racing to keep up with an evolving picture as the disease rapidly spread.
"A lot of new information was coming in regularly over the weekend of Sept. 29 and 30 from the Centers for Disease Control and Prevention as the situation began to take shape," Amy Reel, a spokeswoman for the state health agency, told The Associated Press.
"This is a fast breaking and fluid situation," Randy Snyder, acute care director for the agency, told other state health officials in an Oct. 3 email.
The emails indicate the CDC informed officials at the Indiana health agency on the night of Sept. 28 it was investigating a cluster of fungal meningitis cases in Tennessee and North Carolina that it suspected were connected with injections of a contaminated steroid. An email attachment identified the six Indiana health facilities that were known to have received the suspected medication from a specialty pharmacy in Massachusetts.
The CDC email urged state health agencies to contact clinics that received the tainted steroid and monitor their patients for signs of meningitis symptoms. The Indiana clinics that received the medication were located in Elkhart, Evansville, Fort Wayne, South Bend, Terre Haute and Columbus.
Snyder told officials in an email Sept. 29 that he had received no reports of meningitis cases. That morning, a Saturday, state epidemiologist Pam Pontones sent an email to CDC intelligence officer Rachel Smith saying, "We'll focus on contacting the facilities on the list first."
"We'll contact the patients," Kristi Williams, pharmacy director at Union Hospital in Terre Haute, told state health officials in an email the following Monday. That same day, Oct. 1, Snyder said in an email that the state health department had contacted by phone and email all six of the health facilities that received the tainted lots of medication. The agency also distributed a "script" for the clinics to read from when notifying patients who may have been exposed.
Reel said Indiana and other states didn't receive data defining how to recognize cases that would be considered part of the outbreak from the CDC until Oct. 2, and the state agency immediately alerted physicians.
"It's critical physicians are made aware of signs and symptoms prior to any public announcement so they can be prepared to discuss those signs and symptoms and appropriately treat patients," Reel said.
As of 6:30 a.m. Oct. 4, health officials weren't aware of any meningitis cases in Indiana, according to the documents. But by shortly after noon, they knew that one case had been confirmed and two more were suspected.
"One case has been identified in Indiana, and we probably have at least two more," Pontones said in an email.
That same day, the state health agency informed the clinics that the state epidemiologist would be contacting them for a list of the patients who had received the tainted injections, and to find out how many patients the clinics had already contacted.
In the same email, Snyder told the clinics that the agency intended to announce the outbreak to the public and planned to identify the facilities that had received the contaminated steroid.
Reel said the state health agencies coordinated the release of information with a CDC press conference on Oct. 4, the same day the first Indiana case was confirmed.
As of Sunday, the CDC meningitis website was reporting 44 cases and three deaths connected with Indiana.
The tainted steroids have been traced to the New England Compounding Center of Framingham, Mass., which has since recalled the contaminated lots and suspended production.


Read more: http://www.foxnews.com/health/2012/10/28/indiana-knew-about-meningitis-outbreak-week-before-telling-public-documents/#ixzz2AdHzvF9j

United States pharmacies facing growing drug shortage Drug shortages in American hospitals

October 28, 2012

By: Mary Bender

The latest reports about the United States healthcare
industry, show that it is the middle of one of the worst
drug shortages in American history. One of the biggest
causes of this are "compounding pharmacies". Also,
according to an article in the online publication,
FierceHealthcare, called, "Meningitis scare could
worsen drug shortage", by Alicia Caramenico,
the menigitis outbreak, is believed by some to have been
caused by contaminated steroids from compounding
pharmacies.
In a related October 15, 2012 article, by Alicia Caramenico,
called, "Hospital use of componding pharmacies under
fire", explains that compounding pharmacies were
begun to be used when it became evident there was
a growing shortage of drugs used for prescriptions
and in hospitals. "... despite policies and procedures
to insure the sterility of drugs, compounding pharmacies
have been linked to patient safety incidents, in the past
few years..."
Another reason for the higher amount of compound
pharmacies, is due to the increase in outpatient
surgeries, and ambulatory care areas. The
healthcare industry is also facing a shortage of anesthesiology
drugs for surgeries. Anesthesiologists have been turning to
compound pharmacies to relieve this shortage.
So, while the shortage of medications for hospitals and
pharmacies caused the growth and usage of
compound pharmacies, they are creating not only
safety problems, but worse than ever shortages.
Source found here

State closes another pharmacy, pushes board member to resign

State closes another pharmacy, pushes board member to resign

Mass. shuts down Waltham compounding pharmacy

Mass. shuts down Waltham compounding pharmacy

Texas Board of Pharmacy to Discuss Problems with Sterile Compounding at Out-of State Compounding Pharmacy at November 6, 2012Board Meeting

To view the agenda click here
GD D.3 Discussion Concerning Problems With Sterile Compounding at an
Out-of-State Compounding Pharmacy (Tab 36)

States Need To Move Quickly

Florida Department of Health entered an emergency order shutting down or as the order states "suspensi[ing] [ ] Rejuvi's permit to operate as a community and sterile products and special — parenteral enteral compounding pharmacy in the State of Florida."  See order here.  This is a terrific pro-active approach that should have been done long ago by the states.  More states need to be taking this approach and shutting down dangerous, non-complaint compounding pharmacies.  This needs to be done not only for public health reasons but also,  if the states have any interest at all in retaining at least some of the authority to regulate compounding pharmacies.  While it is true that the United States Congress has plans to introduce legislation granting the FDA more authority to regulate these entities, that legislation has not been introduced, it is unclear at this point how broad the legislation will be, and there is always a question of which version, if any, of a draft piece of legislation will pass.  This leaves states a chance to take action as Florida has done.

States should be inspecting compounding pharmacies, noting  whether those compounding pharmacies have been previously written up for violations, and taking the strongest action allowed under the state law.  For example, if allowed under the state laws, state boards should issue orders shutting pharmacies down that are a public health risk; if closure is not allowed then state boards should impose the maximum fine allowed.  In any event state boards should require the pharmacies to become compliant within so many days before they can begin operating again.  Also state boards should make compounding pharmacies that have such violations recall all drugs linked to any possible contamination or public health risk.    

If states do not already have strict compounding laws and regulations,  they should promptly adopted and enact the needed laws and regulation to deal with the problems.  The laws need to give the state boards (i.e., inspectors)  authority to immediately shut down compounding pharmacies that pose a public heath risk.  They also need to give the state boards authority to impose significant fines.  The fines need to be significant enough that the bad compounders would rather comply with the rules than pay the fines.  When the fine is a dollar amount that is merely a slap on the wrist and cheaper than actually complying  with most rules and regulations, then the bad pharmacies opt to pay the fine and continue to operate in an unsafe manner.  This also penalizes and is unfair to the good compounding pharmacies, and yes, there are some, who spend the money required to comply the rules and regulations.

One other key to fixing the compounding world that I have repeatedly stressed on this blog, is TRANSPARENCY.  The inspection reports, the orders and the fines need to be made readily available to the public.  While putting them on the Internet cost money--it is well worth the lives it could save.  Doctors, Veterinarians, Hospitals, Clinics, Consumers, . . .everyone can then look up the compounding pharmacy to see if their inspection report contained any violations, what corrections to the violations were made, etc.  For example, it was great that I could immediately go to the Florida Department of Health and download and read the emergency order as could any member of the public.  Reporters are reporting on it. Bloggers are blogging about it.  The public is becoming aware of it.   Florida has done a good job of making their disciplinary records for compound pharmacies transparent. Other states should follow Florida's lead.