Monday, December 3, 2012

IACP’s Recommended Changes to the State Practice Acts & an Update on the FDA’s Response to Meningitis Situation

 IACP will be formally announcing a robust list of state practice act change recommendations on Thursday, December 6, 2012 during a national town hall teleconference exclusively for IACP members, state pharmacy associations and state Boards of Pharmacy.
For more information on the teleconference, send an email to iacpinfo@iacprx.org.
IACP members, if you are unable to participate, the teleconference will be recorded and posted to the Member Center of the IACP website at www.iacprx.org.
 
Source IACP website

South Jersey lawmaker seeks to tighten customized-medication oversight

South Jersey lawmaker seeks to tighten customized-medication oversight

Meningitis Outbreak Sweeps Across America…But Where Did It Come From?

Submitted by Dr Marc Macera on Mon, 12/03/2012 - 15:40
In late September and early October, cases of fungal meningitis began to spring up, seemingly out of nowhere, across America. States such as New Hampshire, New York, New Jersey, Ohio, Michigan, Maryland and Tennessee reported case after case of fungal meningitis. Experts were baffled as to what was causing the outbreak…especially because the predominant fungus identified in patients was Exserohilum rostratum, which is a rare cause of fungal meningitis. As more states began to report cases of meningitis a pattern began to develop. All patients suffering from the identified fungal meningitis received an injection of preservative-free methylprednisolone, a steroid injection mainly used to control back pain. Once the steroid injections were implicated as the potential cause of the outbreak they were traced back to the New England Compounding Center pharmacy in Framingham, Massachusetts, where they were prepared. After government officials carried out an investigation, they concluded the steroid injections in question were contaminated during preparation and ultimately lead to the outbreak. As the findings of the report were made public one question began to surface…how could this have happened? The short answer is the New England Compounding Center prepared the steroid injections under conditions that were NOT sterile. The long answer is one riddled with controversy and implications towards pharmacy companies putting profit before patient safety. A compounding pharmacy typically prepares custom medications for individuals based on doctors’ prescriptions. In other words, a compounding pharmacy makes medication preparations for individuals that are different from the available mass-manufactured products on a case by case basis. Compounding pharmacies are not supposed to mass-produce medications and ship them out for resale. However, that is exactly what the New England Compounding Center did. They mass-produced a steroid injection and shipped more than 17,000 vials to pain clinics in 23 states. In essence, the New England Compounding Center turned a compounding pharmacy into a manufacturing company ignoring existing laws, sterility protocols and patient safety all for the speculated goal of profit. As of November 26, 2012, a total of 510 cases of fungal meningitis, including 36 deaths, have been reported in 19 states across America from the implicated New England Compounding Center’s steroid injection. Although the steroid injection has been recalled and the New England Compounding Center has been shut down the infection rate and death toll continue to rise. With that unsettling news in mind, many are wondering what will be done to prevent future tragedies like this meningitis outbreak from occurring again. Some individuals are calling for stronger state compounding laws while others are lobbying for more government led pharmacy inspections. Although the public is split on what they ultimately want done they do agree on one point…if the new laws and protocols do not address pharmacy companies placing profit before patient safety it will only be a matter of time before another health care crisis sweeps across America.
Source found here

Sunday, December 2, 2012

Basic Veterinary Compounding Course



ACA National Training Laboratory (map)
Basic Veterinary Compounding Course Basic Veterinary Compounding is a 15 hour course The overall goal of this practice based course is to introduce the pharmacist and pharmacy technician to veterinary pharmacy compounding.This program provides the fundamental techniques for compounding medications for animals, as well as establishing and marketing a veterinary pharmacy practice. For Additional Information and to REGISTER ONLINE - Click Here $1095 (Non Member price) * $995 (Membe...

Who Should Be Included on State Boards of Pharmacy Compounding Pharmacy Working Groups or Advisory Committees?


The following notice appears on the North Carolina State Board of Pharmacy:

COMPOUNDING PHARMACY WORKING GROUP. The Board decided at its October meeting to put together a small working group to review all aspects of North Carolina regulation of compounding pharmacy and to make a report and recommendation. North Carolina pharmacists with an interest in participating should communicate that interest to Jay Campbell, the Board’s Executive Director, by Friday, November 2. The Board will select the members shortly afterward.

How many other states had compounding pharmacy working groups or advisory committees before the meningitis outbreak.  How many have recently put together such groups or committees or plan to do so?  It would be a great idea if all state boards of pharmacy and perhaps even state veterinary and medical boards also established compounding pharmacy working groups or committees.   This would be another sign that states are being proactive in this area and want to retain jurisdiction over compounding regulations.

Who should be appointed to these working groups and committees?  Obviously, an expert compounding pharmacist needs to be appointed, but that does not mean that all members should be pharmacist.  To the contrary, the boards should not be stacked with all pharmacists. Nor should pharmacists who represent special interest or big manufacturers be allowed to sit on these working groups or advisory committees.  An example of where this can be a problem is the New England Compounding Case and the Massachusetts Board of Pharmacy.  Instead, the boards should include a diverse group of individuals.  How about including a physician and  a veterinarian who are experts in compounding and  know how the medications are used, what they are used for, etc. One of the most important people to include may be a marketing consultant or pharmaceutical representatives (one both on the human side and one on the vet side)-who knows the trenches and what really goes on in the compounding world but the one out there every day dealing with the pharmacist, the doctor, the veterinarian and possibly the public.  One must be careful because not all marketing consultants or pharmaceutical reps are knowledge of the rules and regulations relating to compounding.  Should the committee or group also include a member from the general public? an attorney?  No matter who the Board of Pharmacy decides to include on the compounding pharmacy working group or committee it should include a diverse, well-rounded group of individual who can bring a vast array of knowledge and expertise to the meetings.

OOS Representatives TO Meet With The Ohio Pharmacy Board To Discuss Enforcement Of Regulations Surrounding The Purchase Of Avastin From Compounding Pharmacies


11/28/2012

Last week the OOS made a formal meeting request to the Ohio State Board of Pharmacy to discuss the enforcement of current rules surrounding the purchase of Avastin from compounding pharmacies. We hope to hear back in the next several days regarding a proposed meeting date.

As you know, attention at the federal and state level regarding the regulation of drugs distributed from compounding pharmacies has increased dramatically since the deadly fungal meningitis outbreak linked to the New England Compounding Center. While Congress continues to investigate the current level of oversight and discusses developing legislation to create new regulations, state pharmacy boards are focused on enforcing current state level requirements.
The OOS has heard from several practices that have already been investigated or have questions about the current regulations. For a complete copy of the Ohio State Board of Pharmacy’s fact sheet Compounding in Ohio click here. The OOS has heard from several practices that are concerned that a number of the existing provisions make it extremely difficult for most practices to purchase and administer Avastin and potentially compromise what would be considered good patient care. The OOS is aware of these issues and will be articulating them to the Pharmacy Board.
We will update OOS members when we have a meeting date, and additional information to provide, from the Pharmacy Board. Should you have any questions now or in the future, please contact the OOS office directly at (614) 527-6799 or email us at tbaker@ohioeye.org.

Push on to consolidate meningitis lawsuits


Lawyers for the drug compounding firm blamed for a deadly nationwide outbreak of fungal meningitis are moving forward with a strategy to get the growing number of lawsuits consolidated in federal court and want a Boston-based judge to preside over all of them.
Federal court records show that 37 cases originally filed in state and county courts have been transferred to federal courts across the country at the request of lawyers representing the New England Compounding Center.
The lawyer for the company, with headquarters in suburban Framingham, Mass., says it wants the cases eventually to be consolidated in Massachusetts.
That would include six suits originally filed in circuit court in Nashville, Tenn., and subsequently transferred to U.S. District Court.
Forty other cases against the company were filed in federal courts to begin with, pushing the number of pending federal suits to more than 70. Dozens of additional suits still remain in local courts. Lawyers for the compounding firm have predicted that the final total will top 400.
In several of the transferred cases, New England Compounding’s lawyers have said that their ultimate goal is to have all of the cases consolidated in Boston before U.S. District Judge F. Dennis Saylor IV, who currently has a dozen cases assigned to him.
“Judge Saylor has the judicial experience needed to steer this anticipated massive litigation on a prudent course to an expeditious conclusion,” New England Compounding’s attorney wrote in a brief.
“That’s what their plan is,” said Nashville attorney Randy Kinnard, who represents Colette Rybinski of Smyrna, Tenn., the widow of Thomas W. Rybinski, who was the first patient to be diagnosed with fungal meningitis. Kinnard also represents nine other victims.
A panel of federal judges is scheduled to decide in January whether the cases should be consolidated and, if so, in what court. A move to have that decision issued on an expedited basis was turned down.
“Consolidating these cases to a single federal court will save time for all parties, save judicial resources by having one judge preside and streamline the discovery process,” said Fred Fern of Harris Beach, the lead defense firm for the drug compounder.
Continue reading here

Grand jury probing meningitis pharmacy


BOSTON--A grand jury is investigating the compounding pharmacy at the heart of a deadly meningitis outbreak, the Boston Globe reported on Saturday.
The grand jury has begun issuing subpoenas to people who worked for the New England Compounding Center, which closed after investigators determined it had produced the tainted injectible steroid that has killed 36 people, the newspaper reported, citing unnamed people who formerly worked for the company.
Grand jury investigations, which are conducted in secrecy, are a step prosecutors take before determining whether to press criminal charges.
Officials at the U.S. Attorney's office and NECC could not be reached for immediate comment on Saturday. The Globe reported that U.S. officials declined to comment.
After federal officials in October raided the Framingham, Massachusetts-based pharmacy, U.S. Attorney Carmen Ortiz confirmed her office was investigating the company.
U.S. District Court Judge Dennis Saylor, who is hearing the dozen civil lawsuits filed against NECC in federal court in Boston, said during a Wednesday hearing there may be a grand jury investigation into the company.
Source found here

Saturday, December 1, 2012

Health officials scale back efforts to identify new fungal meningitis cases


Related: Fungal meningitis patient's sickness started with a cure
The discovery of new cases in the fungal meningitis outbreak has slowed in Virginia, prompting state health officials to change the way they monitor those at risk for becoming ill.
This week, health officials will begin to reign in surveillance efforts aimed at identifying new cases in the outbreak, which was tied to tainted steroid injections and has killed 36 and sickened hundreds in 19 states. The change comes as data collected by the Virginia Department of Health show a 20-day average incubation period from when a person received the steroid injection and first developed symptoms of the fungal infection.
"We do expect that there may be additional cases, but in much smaller numbers and with a decreasing frequency," said Dr. David Trump, state epidemiologist for the health department. "Hopefully, everyone who was exposed knows what to look for and won't hesitate to seek medical attention."
In Virginia, only about 13 percent of people who received one of the recalled shots blamed in the outbreak developed a fungal infection.
But early in the outbreak, before officials knew the likelihood of developing an infection after receiving one of the shots, the state decided to take the rare — and time-intensive — step of calling anyone at risk of becoming ill.
Since October, health department nurses have made weekly calls to everyone who received one of the shots but had not yet had a lumbar puncture to test for meningitis.
In the Roanoke and Alleghany health districts, the process involved assigning about 25 employees to call about 260 people, said Dr. Stephanie Harper, director of the two districts.
"We directed a lot of resources to getting it done," she said. "It's manpower intensive."
The department also made home visits and sent certified letters to ensure that no person was missed, she said.
Many of those on the original list ended up being referred to the emergency rooms at Carilion Roanoke Memorial Hospital and LewisGale Medical Center for lumbar punctures, Harper said.
This week will mark the last time Harper's nurses make the weekly calls, she said. After that, her staff will be available to answer questions, but they will not actively check in with people, she said.
The decision follows the recommendation from Trump that the surveillance is no longer necessary, although he has left the ultimate decision up to the various health district directors in Southwest Virginia who have been coordinating the efforts.
So, for instance, the outreach will continue until Dec. 23 to the 94 affected people living in the New River Valley Health District, said Dr. Molly O'Dell, director of that district.
"We're considering going to once a month for three months after that," she said. "But we haven't decided."
Virginia identified 680 people who received a contaminated injection made by New England Compounding Center at one of two outpatient clinics in Southwest Virginia. In Virginia, most people received the shot at Insight Imaging in Roanoke, but 27 were exposed after getting an injection at New River Valley Surgery Center in Montgomery County.
O'Dell said none of the 51 cases identified in Virginia so far have involved patients who got the shot at the New River center.
The vast majority of people who developed meningitis began to have symptoms between the end of September and the middle of October, Trump said.
Source found here  

Subpoenas Handed Down In Meningitis Case


December 1, 2012 9:01 PM

FRAMINGHAM (CBS) – A federal grand jury has begun to hand down subpoenas in its investigation of the deadly meningitis outbreak linked to a Framingham pharmacy.

Continue reading here