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Showing posts with label 2013. Show all posts
Showing posts with label 2013. Show all posts
Wednesday, October 23, 2013
Tuesday, October 22, 2013
Eighth Question of the Day October 22, 2013 While I have been very tough at times on pharmacists who compound, I know there are still a number of great pharmacists out there with very good hearts and intentions who became pharmacists to help not hurt or kill people. Pharmacists are now experiencing what lawyers deal with all the time: A Profession With a Negative Image and an Appearance That it is More about the Money Than Anything Else. What can Pharmacy schools do to prepare future pharmacists for this type of image they may face in the future?
Is there anything Pharmacy schools can do to help correct this negative image? Do you think less people will be less likely to choose pharmacy as a profession in the future because of the high stress involved? Will more pharmacists like attorneys choose to leave the profession because of the stress and pressure involved?
Monday, October 21, 2013
IACP Regional Meeting Novembr 9, 2013, in Tulsa, Oklahoma
2013 Regional Education Meetings
- November 9, 2013 - Tulsa, Okla.
5:00 - 7:30 p.m.
Hyatt Regency Tulsa, Diplomat Room, 2nd Floor
100 East 2nd Street, Tulsa, OK 74103
Click Here to View the Event Flyer for More Details!
100 East 2nd Street, Tulsa, OK 74103
Click Here to View the Event Flyer for More Details!
This meeting is held in conjunction with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. For more information, please click her
Thursday, October 17, 2013
Friday, October 11, 2013
Compounding pharmacists create medications to fit the needs Pharmacists create custom medications to meet individual needs October 11, 2013
Written by
Sarah Eddington
Monroe pharmacist Kay Chandler, who has been compounding medications for more than a decade, says she has seen her work help countless people when other methods have failed.
“When you’re a compounding pharmacist, you reap the reward of helping a patient who was otherwise very distraught and didn’t know what else to do or where else to go,” she said. “Oftentimes, we’re not the first line of care. We’re the people patients go to when the first line of care didn’t work.”
Pharmacy compounding is the mixing, combining or altering of ingredients of a prescription drug to create a medication tailored to the medical needs of an individual patient. Traditional compounding is typically used to prepare medications that are not available commercially.
For example, if a child can’t swallow a pill and needs a medicine in a liquid form not otherwise available, compounding would serve an important role.
Or if a person is allergic or can’t tolerate an ingredient in a manufactured drug and needs a medication to be made without that ingredient, compounding would come into play.
Compounded drugs are not approved by the Food and Drug Administration, but each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary responsibility for oversight.
continue to read here
ACA Will host Compounding--What's Happening? November 1-2, 2013
ACA will host new Specialty Conferences in 2013
Compounding - What's Happening?
November 1 - 2, 2013Millennium Knickerbocker Hotel
Chicago, IllinoisRegister Online Today!
Thursday, October 10, 2013
Fourth Question of the Day October 10, 2013 Do Compounding Pharmacies that advertise short-dated compounds for sale provide evidence to the FDA and states boards of pharmacy that they are manufacture-ing drugs in excess of previous patient demand and compound drugs without prescriptions?
Wednesday, October 9, 2013
Second Question of the Day October 9, 2013 Will we see US Attorney's office's around the country file civil complaints against most if not all of the compounding pharmacies and pharmacists who the FDA issued 483 for and/or will it be limited to just those who are dispensing and manufacturing controlled substances?
Tuesday, October 8, 2013
A year later, fungal meningitis patients worry: Will fungus return? Oct. 7, 2013
William Wertz wonders whether the fungus will attack his body again — and what it would feel like to die.
“If I have fungal meningitis, how would my body shut down?” said the 68-year-old Howell man. “(Would I be) in a lot of pain, or would I go to sleep? Would I be like a dementia patient?
“They told me there’s no guarantee that it’s not going to be back.”
Wertz is among the hundreds of patients devastated by a deadly national fungal meningitis outbreak that exploded last fall and was caused by steroid injections that came tainted with fungus from a Massachusettspharmacy .
continue to read here
FDA cites labs that tested tainted drugs 5 labs test most of the compounded drugs in U.S. October 8, 2013 | By Eric Palmer Read more: FDA cites labs that tested tainted drugs -
One of the selling points that many large drug compounders lean on is that their drugs are tested by independent laboratories. But FDA inspections have found issues with many of those laboratories, leading the agency to seek recalls for products that compounders were selling nationally.
According to The Washington Post, many drug compounders started using outside labs for testing after a compounder in Kansas City was convicted in 2001 of diluting cancer drugs to up his profits. But the FDA has now cited 5 outside testing labs for more than 70 observations, including one in which bacteria was repeatedly found in a clean room. Those 5 laboratories handle the testing for about 90% of the nation's large-scale compounding pharmacies.
An FDA inspection found issues with the procedures used by DynaLabs in St. Louis, MO. The lab tested the calcium gluconate solution made by Texas-based Specialty Compounding that authorities now believe was contaminated with bacteria. The compounder recalled the drug in August after the Centers for Disease Control and Prevention (CDC) linked it to two deaths and 13 illnesses at two Texas hospitals.
The agency also cited Oklahoma-based Analytical Research Laboratories (ARL), which did testing for the now-closed New England Compounding Center (NECC). It was NECC drugs that were tied to the bacterial meningitis outbreak that sickened more than 680 people, 64 of whom died.
The agency also cited Oklahoma-based Analytical Research Laboratories (ARL), which did testing for the now-closed New England Compounding Center (NECC). It was NECC drugs that were tied to the bacterial meningitis outbreak that sickened more than 680 people, 64 of whom died.
Read more: FDA cites labs that tested tainted drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-cites-labs-tested-tainted-drugs/2013-10-08#ixzz2h9pUjYCM
Subscribe at FiercePharma Manufacturing
On October 4, 2013, California signed into law SB 294 relating to compounding
| Senate Bill No. 294 |
| CHAPTER 565 |
An act to amend the heading of Article 7.5 (commencing with Section 4127) of Chapter 9 of Division 2 of, and to amend, repeal, and add Sections 4127, 4127.1, 4127.2, and 4400 of, the Business and Professions Code, relating to pharmacy.
[ Approved by Governor October 04, 2013. Filed with Secretary of State October 04, 2013. ]
LEGISLATIVE COUNSEL'S DIGEST
SB 294, Emmerson. Sterile drug products.
(1) The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. Existing law requires the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime.
This bill, commencing July 1, 2014, would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill, commencing July 1, 2014, would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. The bill would require the board to adopt regulations to implement these provisions, and, on and after July 1, 2014, to review formal revisions to specified national standards relating to the compounding of sterile preparations to determine whether amendments to those regulations are necessary, as specified. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program.
Sunday, October 6, 2013
Letter: Lax oversight of compounding pharmacies, medicine can be deadly; Write Congress and Demand They Add Teeth to Legislation October 6, 2013
By
on October 06, 2013 at 3:15 AM
on October 06, 2013 at 3:15 AM
To the Editor:
I am writing about the editorial“Put teeth back in pharmacy bill,” in the Oct. 1 Times. I concur with the editorial. There has not been enough emphasis on the topic of regulating “compounding pharmacies” in the media, except for one “60 Minutes” segment.
As the editorial stated, “the (Sept. 28) U.S. House session resulted in passage of a bill for more oversight” of these pharmacies, tainted medicine from one of which reportedly caused 750 cases of fungal meningitis last fall.
“The sites are subject to spotty state licensing andregistration ,” the editorial added.
The Food and Drug Administration currently has no real authority to inspect or regulate or any of these pharmacies. Even though the House did pass new legislation, it makes reporting by these companies voluntary.
After doing some research I found the following: Naltrexone, approved for certain addiction therapy, but prescribed “off-label” in lower doses for diseases likemultiple sclerosis , has not been found to effective for symptoms.
The FDA has recalled numerous medications as problems were reported, including injectable and inhalable products that were not sterile. Among drugs and supplements that have been recalled are lidocaine, magnesium sulfate, ascorbic acid, acetylcysteine inhalation products and Vitamin B12.
We have no idea how many other such medications have been produced and dispensed to doctors’ offices, hospitals and clinics by compounding pharmacies, where the items tend to be cheaper to purchase.
Because this problem is so widespread, readers should check the FDA website for recalled products, hearings before Congress etc. Feel free to ask your physician, if he or she purchases any products from these pharmacies, and do not be hesitant to ask hospitals, either. Certain medications may be deadly, and the exact death toll, and the number of illnesses caused may be unknown.
With the government shutdown, this will mean the FDA will be even more overburdened, and reporting slow.
Contact the White House and your representatives and demand that something be done before a loved one becomes ill or dies.
I am writing about the editorial“Put teeth back in pharmacy bill,” in the Oct. 1 Times. I concur with the editorial. There has not been enough emphasis on the topic of regulating “compounding pharmacies” in the media, except for one “60 Minutes” segment.
As the editorial stated, “the (Sept. 28) U.S. House session resulted in passage of a bill for more oversight” of these pharmacies, tainted medicine from one of which reportedly caused 750 cases of fungal meningitis last fall.
“The sites are subject to spotty state licensing and
The Food and Drug Administration currently has no real authority to inspect or regulate or any of these pharmacies. Even though the House did pass new legislation, it makes reporting by these companies voluntary.
After doing some research I found the following: Naltrexone, approved for certain addiction therapy, but prescribed “off-label” in lower doses for diseases like
The FDA has recalled numerous medications as problems were reported, including injectable and inhalable products that were not sterile. Among drugs and supplements that have been recalled are lidocaine, magnesium sulfate, ascorbic acid, acetylcysteine inhalation products and Vitamin B12.
We have no idea how many other such medications have been produced and dispensed to doctors’ offices, hospitals and clinics by compounding pharmacies, where the items tend to be cheaper to purchase.
Because this problem is so widespread, readers should check the FDA website for recalled products, hearings before Congress etc. Feel free to ask your physician, if he or she purchases any products from these pharmacies, and do not be hesitant to ask hospitals, either. Certain medications may be deadly, and the exact death toll, and the number of illnesses caused may be unknown.
With the government shutdown, this will mean the FDA will be even more overburdened, and reporting slow.
Contact the White House and your representatives and demand that something be done before a loved one becomes ill or dies.
Edna Birch
Carneys Point
quoted from here
Saturday, October 5, 2013
Woodlands Compounding Pharmacy Demands Texas Return Execution Drugs for Refund By admin On October 5, 2013
The Woodlands Compounding Pharmacy letter to TDCJdemanding Texas return execution drugs for a refund.
more information found here
Arkansas Board of Pharmacy Meeting Scheduled for October 8-9, 2013
| itle | October Board Meeting |
| Date | 10/08/2013 - 10/09/2013 |
| Time | 8:00 AM - 04:30 PM |
| Address | 322 South Main Street Suite 600 Little Rock, AR 72201 |
| Location | ASBP Board Room |
| Event Contact | John Kirtley |
| Event Phone | 501-682-0190 |
| Event Email | asbp@arkansas.gov |
| Description | Reciprocity applicants will meet at 8:30 on the 8th and may leave once completed. |
| Additional Info |
This meeting will be held in the new ASBP Board Offices - note the new address.
|
AP News Ohio clears specialty drug-makers in executions By By Julie Carr Smyth And Andrew Welsh Huggins October 04, 2013
COLUMBUS, Ohio (AP) — Ohio could begin executing inmates with doses of a lethal injection drug prepared by specialized pharmacies under a change in its execution process prompted by difficulties securing the powerful sedative last used by the state.
New Ohio prisons department execution rules allowing compounding pharmacies were filed in federal court Friday, just days after the state's last supplies of pentobarbital expired. Such businesses custom-make drugs but aren't subject to federal scrutiny.
The new policy also establishes an alternative intravenous drug combination — the sedative midazolam with the opiate hydromorphone — if expired pentobarbital is deemed unusable or if new supplies of the drug are unavailable.
continue to read here
Thursday, October 3, 2013
State officials investigating charges of fraud at Pace pharmacy Oct. 2, 2013
A Pace pharmacy is under investigation after complaints of improper billing practices.
Officials searched Burklow Pharmacy, 4880 Woodbine Road, on Wednesday to investigate allegations that customers may have been overcharged for prescriptions, said Cpt. David Lindsey of the Department of Financial Services Division of Insurance Fraud.
“It’s an ongoing investigation to try and prove, or disprove, that there has been improper billing here,” he said.
Lindsey said the search is part of a yearlong criminal investigation into the pharmacy, which reopened Wednesday afternoon. No charges have been filed.
The pharmacy, owned by Stephen Burklow, has been in business about 15 years.
Todd LaDouceur, an attorney representing Burklow, said that the investigation came as acomplete surprise to his client.
“It’s an ongoing investigation to try and prove, or disprove, that there has been improper billing here,” he said.
Lindsey said the search is part of a yearlong criminal investigation into the pharmacy, which reopened Wednesday afternoon. No charges have been filed.
The pharmacy, owned by Stephen Burklow, has been in business about 15 years.
Todd LaDouceur, an attorney representing Burklow, said that the investigation came as a
continue to read here
Wednesday, October 2, 2013
State House in Mass to Debate Tougher Pharmacy Regulations October 2nd, 2013
BOSTON (AP) — Massachusetts House lawmakers are planning to debate a bill that would clamp down on compounding pharmacies like the one blamed for a nationwide meningitis outbreak last year.
House lawmakers released the latest version of the bill on Monday and are scheduled to meet in formal session on Wednesday to debate the measure.
It’s not the only legislation aimed at increasing oversight of the pharmacies that mix customized drugs.
The U.S. House on Saturday approved legislation that would give the federal Food and Drug Administration clearer oversight of the pharmacies.
continue to read here
Tuesday, October 1, 2013
Fourth Question of the Day October 1, 2013 Does having a degree in interior design, nursing and culinary arts and being the owner of a boutique qualify someone to own a veterinary compounding pharmacy or to make veterinary compounded medications? Should animal owners be more aware of who the makers and owners of veterinary compounding pharmacies are? Should there be requirements as has been suggested on the blog before that veterinary compounding pharmacies be a speciality in pharmacy schools and special licenses be required to make these types of compounded preparations?
- Linda Obele
- Phoenix Business Journal
Bold businesswoman builds ode to girliness
Sabrina Eaton always has enjoyed wearing different hats -- which makes sense, considering she owns a north Phoenix boutique that features more than 3,000 square feet of accessories and fashion items. But when she talks about wearing many hats, she could just as easily be discussing her varied business interests.
"I've always been very curious about a lot of things," said Eaton, owner of Sabrina's Boutique at Seventh Street and the Carefree Highway. "And I've always loved a challenge. If something interests me, I just go for it."
Her formal education includesdegrees in interior design , nursing and culinary arts. She's worked as an interior designer, a nurse and owner of a medical lab/pharmacy.
In 1995, Eaton and her husband, Robert, decided to capitalize on her medical training by founding Eaton Labs and Road�Runner Pharmacy, which customized medications for people and animals. She still runs both the lab and the pharmacy, and is working to secure a patent for a medication that treats dry eyes in pets.
Three years ago, realizing they had outgrown their quarters, the Eatons designed and built Tuscani Pointe, a 90,000-square-foot retail center that houses the lab, the pharmacy and Sabrina's Boutique, her ode to girliness.
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