Monday, September 22, 2014
FiercePharma Animal News
- Will Zoetis stand alone when Big Pharma's music stops?
- Work on the National Bio and Agro-Defense Facility continues
- EU gives nod to Merck's poultry vaccine to fight infectious bronchitis
- Phibro reports strong sales in animal growth and nutrition sectors
- Drug delivery company SiSaf to enter into animal health
Sunday, September 21, 2014
Look a the informaton on Wikipeda about ApotheCure Inc. and the companies and organizations it was tied to; Most know about the 2007 deaths, but how many know about the 2005 Chelation therapy to the five year old autistic boy case involving ApotheCure?
ApothéCure Inc.
From Wikipedia, the free encyclopedia
| Industry | Pharmaceutical |
|---|---|
| Headquarters | Dallas, Texas, U.S. |
| Website | http://www.apothecure.com/ |
ApothéCure Inc. is a Dallas, Texas-based compounding pharmacy that specializes in custom compounded formulas and nutritional supplements for both patients and physicians. The business began operations in 1991. ApothéCure is a sister corporation of theTexas Institute of Functional Medicines. It is regulated by the Texas State Board of Pharmacy.
ApothéCure's products include compounds such as bioidentical hormones, thyroid and adrenal, ophthalmic drops, podiatric, glandular, nutritional (vitamins, amino-acids, minerals, bioflavonoids, anti-oxidants), L-Gluathione for COPD, aesthetics, dermatology,mesotherapy, prolotherapy and chelation therapy compounds. ApothéCure was referenced in Natural Health magazine in an April 2004 article,[1] and in several books, such asDigestive Wellness by Brand and Lipinski and 8 Weeks to Vibrant Health by Hyla Cass, MD and Kathleen Barnes,[2] and Suzanne Somers' The Sexy Years. ApothéCure is affiliated with several organizations, including the American Academy of Anti-Aging Medicine, the International Academy of Oral Medicine and Toxicology, the American Academy of Aesthetic Medicine (AAAM) and the Professional Compounding Centers of America (PCCA).[3][not in citation given] Professionally, ApothéCure is a member of The International Association of Compounding Pharmacies and The International Academy of Clinical Nutritionists.
Controversy[edit]
In a later case in Pennsylvania, ApothéCure was one of several parties sued over the fatal administration of disodium EDTA to an autistic five-year-old boy in 2005.[4][5] Dr. Roy Kerry prescribed the drug for chelation therapy, which some people believe is helpful to treat autism.[4][5] However, this usage is not approved by the U.S. Food and Drug Administration (FDA).[4][5]
ApothéCure has been implicated in the March and April, 2007, deaths of three patients from the Pacific Northwest. The patients were each given intravenous colchicine, a substance commonly used in naturopathic medicine,[6] for treatment of back pain (an off-label use of the drug). Colchicine can be very toxic when given in high doses; due to incorrect labeling, the colchicine the patients received was ten times more concentrated than listed on the vials, resulting in toxic doses.[6][7][8] Over 3,500 vials of the drug, distributed nationwide, were recalled.[9][10]
Attorneys general in Oregon and Texas filed lawsuits against ApothéCure Inc. and the company's owner, Gary Osborn of Dallas, Texas.[11][12] The case is being jointly prosecuted between Oregon Attorney General Hardy Myers and Texas Attorney General Greg Abbott, asserting that "the company failed to follow standard safety practices and exceeded their authorized scope of practice as a compounding pharmacy".[13] According to Meyers, ApotheCure's error reflected a pattern of substandard care and was not an isolated incident.[13]The Texas suit alleges that the pharmacy "failed to use proper manufacturing practices, employed incorrect labels and made exaggerated claims about the benefits of its dietary supplements."[11]
In the 2007 deaths, there may have been several violations committed, including ApothéCure being unlicensed to sell drugs in Oregon.[14][13] In the year and a half prior, ApothéCure made 44 total sales of injectable colchicine to Oregon health professionals without a license to distribute in Oregon.[15] ApothéCure reached a settlement with the Oregon attorney general in April 2008. The settlement requires ApothéCure to pay $100,000 to the state, and a $500,000 civil penalty if the company wishes to sell products in Oregon again.[15][16] ApothéCure must also refund money from all of its 222 sales to Oregon consumers from 2004 through 2007.[15]
Wrongful death lawsuits were also filed against ApothéCure by the families of two of the colchicine victims; both families have reached confidential settlements with ApothéCure, while the third family is negotiating a settlement with the company.[15]
On February 10, 2012 the United States Department of Justice charged ApothéCure Inc. and its owner, Osborn, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act. These charges were in connection with the misbranding which led to the three deaths in the Pacific Northwest.[17] Osborn and his corporation pleaded guilty to these charges on April 24, 2012.[18] On October 3, 2012, the District Court for the Northern District of Texas made its judgement.[19] Osborn was sentenced to home detention, one year of probation, and a $100,000 fine.[19] Separately, the company was sentenced to five years of probation and a $100,000 fine.[19]
quoted from here
This Reader's Comment Is Right on Point regarding my IACP office use question!!
- Where medically necessary, a compounded drug intended for use in an office setting can and should be prescription-based; purchase-order-like transactions involving compounded, unapproved new drugs should be expressly forbidden.
Because compounded drug formulas are sold or otherwise made available without guarantee, and because components, including brokered, purchased, and repackaged active and inactive pharmaceutical ingredients are also sold without guarantee, the prescription is the foundation where fitness for intended use is constructed. This is not a trivial undertaking, given lack of scientific rigor backing formulas in conjunction with the current state of global supply chain security for chemicals reaching the U.S.
Where a medical decision to use an unapproved new drug is made prior to an office procedure and takes the form of medication problem-solving consistent with pharmaceutical care models, there is an opportunity for patients to be included in an informed decision-making process. In the absence of informed decision-making, patient autonomy is breached and patients are denied the basic human right to self-determination and to protect themselves from unnecessary harm involving compulsory treatment with a drug that does not meet national standards. - September 21, 2014 at 10:51 AM
Question of the Day September 21, 2014 Isn't IACP between a rock and a hard place on the office use question?
They didn't like the answer the FDA provided. If they go to court on the issue and win, Congress or states could turn around and pass very clear legislation overruling the case law and prohibiting office use unless compounds come from an outsourcing facility and they could make it apply to veterinary compounds. If they go to court and lose, they will have no arguments left. I don't see the majority of Congress amending the DQSA because it would make the outsourcing provisions meaningless. If Congress is going to amend it will be to include veterinary compounds in the DQSA or to give the FDA even more authority in light of more and more bad inspections, more and more information coming out showing the dangers of compounded medications and the lack of potency, fraud and abuse etc. in the industry. It will be interesting to see what IACP's next move is. I wonder if they have ever thought their next move should be compliance with the laws and clearning up the industry gone bad- rather than continuing down the same path. That might go along way toward fixing the bad reputation and image of compounding pharmacists. I don't see it happening, however, because of greed and the amount of huge profits compounding pharmacists stand to lose if they actually follow the law and do what is right.
FDA tells Nashville pharmacy to correct problems
The U.S. Food and Drug Administration has put a Nashville compounding pharmacy on notice to correct multiple safety hazards in a warning letter issued this month to its owner, John W. Hollis. The letter comes after the FDA last spring cited John Hollis Pharmacy on 11 rule violations, ranging from failing to maintain sterility safeguards to compounding drugs without having legally required individually identified patients. The FDA acknowledged that Hollis had agreed to recall drug products and verbally stated in May that he would cease sterile compounding. However, the pharmacy continues to fill and compound prescriptions that do not require sterility measures. “If you decide to resume production of sterile drugs, FDA strongly recommends your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials and systems,” the letter stated. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.” The Sept. 4 letter instructs Hollis to take prompt actions to correct the violations and to submit in writing within 15 days whether the pharmacy has taken specific steps to correct the violations. Reach Tom Wilemon at 615-726-5961 and on... |
A Facebook for Drugs? Regulators Want Help Building Database of What Every Drug Looks Like By Alexander Gaffney, RAC - Published 19 September 2014
A Facebook for Drugs? Regulators Want Help Building Database of What Every Drug Looks Like By Alexander Gaffney, RAC - Published 19 September 2014
A new government project is calling for help from the pharmaceutical industry to make what will be, in effect, a Facebook for drugs.
Categories: News, US, CDER, Drugs
- See more at: http://www.raps.org/SearchRegFocus.aspx?tag=drug#sthash.ObZzNICJ.dpufDA Affirms Office-Use Compounding Restrictions In Letter To Lawmakers
PDF - InsideHealthPolicy.com
insidehealthpolicy.com/sites/insidehealthpolicy.com/.../fda_current.pdf
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