Showing posts with label ApotheCure. Show all posts
Showing posts with label ApotheCure. Show all posts

Saturday, February 23, 2013

Apothecure's Voluntary Relinquishment in Florida, Reprimand from Texas, New Pharmacy at Same Address--Thank you Dr. Kenneth Woliner for the Research, Information and Your Comments


Here is Apothecure's voluntary relinquishment. (If anyone needs a copy that is easier to read, email me at stuckrichmond@gmail.com and I will email you the information).


APOTHECURE, INC
LICENSE NUMBER: PH21213Printer Friendly Version  


Profession
PHARMACY
License/Activity Status
DISCP-RELINQ/Click here for more information
Qualifications
Special Non-Resident
License Expiration DateLicense Original Issue Date
2/28/201503/28/2005
Discipline on FilePublic ComplaintClick here for more information
YES  Link To DisciplineYES  Link To Complaint
Address of Record
If further information is needed, please contact the Department of Health at (850) 488-0595.



Here is the "reprimand" Gary Osborn, the owner of Apothecure, got from Texas:  


Now that was before he plead guilty to violating the FFDCA, perhaps they'll go back and do something similar to what the Feds did against Thomas Bader of College Pharmacy (revoke his license, make him sell all his shares in the pharmacy to a non-family member): http://www.fda.gov/ICECI/CriminalInvestigations/ucm200282.htm (note well: his conviction was upheld, but the $4.8 million forfeiture was reversed due to an instructional error by the judge). 


Saturday, February 9, 2013

REPOST: ApothéCure Compounding Pharmacy loses Florida License my apologies to Kenneth Woliner, MD www.holisticfamilymed.com who wrote the post; Here is his entire post (I missed posting some of it the first time).



On Tuesday, February 5, 2013, ApothéCure Inc, a compounding pharmacy based in Dallas, Texas, voluntarily relinquished its Florida pharmacy license and ability to mail prescription medications into the State of Florida. http://ww2.doh.state.fl.us/irm00praes/prasindi.asp?LicId=13503&ProfNBR=2205&Lookup=TRUE  Voluntarily relinquishing your license, while under disciplinary proceedings, is considered the equivalent to REVOCATION.  Why such drastic discipline?
ApothéCure (and its pharmacist owner, Gary Osborn) can't blame the fallout from the NECC-fungal meningitis outbreak or anyone else for its fate.  ApothéCure's wounds were all self-inflicted.  It was a combination of bad pharmacy practices, a history of having introduced adulterated drugs in the past, and most of all, arrogance, that it could do whatever it wanted, including operating as a manufacturer and wholesale distributor without having licenses to do so, violating the Federal Trade Commission and Federal Food, Drug, and Cosmetic Acts by advertising drugs for purposes not approved by the FDA, and for aiding and abetting the unlicensed practice of medicine.  When the pharmacy was told what it was doing was not just dangerous, but also illegal, it ignored those warnings, and continued to operate business as usual.  At least until now.
INTRAVENOUS COLCHICINE
ApothéCure is a compounding pharmacy.  As a pharmacy it is allowed to fill prescriptions for specific patients based upon individual prescriptions which are based upon a valid doctor-patient relationship.  As a compounding pharmacy, it often reformulated certain medications into other dosage forms.  There is a protocol using intravenous colchicine to treat low back pain and herniated discs created by Michael R. Rask, M.D. (1930-1994), a Las Vegas Orthopedic Surgeon who specialized in neurological orthopedic surgery. http://www.ncbi.nlm.nih.gov/pubmed/509824http://drmanso.com/patient-education-guide/colchicine/   Intravenous colchicine has been available in the United States since 1950, and was grand fathered in before the 1962 Kefauver Harris Amendment to the Federal Food, Drug and Cosmetic Act (FFDCA) that required medications to be proved safe and effective before being approved for sale in the United States.
Colchicine can be very toxic when given in high doses, with deaths being reported with cumulative doses as low as 5.5 mg.  The colchicine produced by ApothéCure was labeled as 0.5 mg/mL, but instead, each vial contained 4 mg/mL.  When an intended dose of 2 mg was administered, the patient actually received 16 mg!  That compounding error (making the drugs mislabeled and adulterated) lead to three deaths of patients who were treated at a Portland naturopathy clinic (Oregon allows naturopaths to prescribe and inject prescription drugs).  What was more galling, however, was that ApothéCure did not even have a license to operate in Oregon, even though it sent 43 batches of colchicine to Oregon clinicians over a one and a half year period.   Over 3,500 vials of the drug, distributed nationwide, were recalled. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5640a3.htm
The Oregon attorney general sued ApothéCure, alleging, among other things, that ApothéCure used low-quality water for its products, which could increase the possibility of contamination, and did not properly test its products for contamination or potency.  ApothéCure and the state of Oregon reached a settlement agreement in which ApothéCure agreed to pay a $100,000 fine and to pay a $500,000 civil penalty if it ever wanted to do business in Oregon again. http://portlandtribune.com/component/content/article?id=66040  This settlement was characterized as "not sufficient to protect Oregonians" by Larry Sasich, spokesperson for the public watchdog group Public Citizen, and chairman of the department of pharmacy practice at the Lake Erie College of Osteopathic Medicine in Pennsylvania.  With ApothéCure's annual sales were estimated by the Oregon attorney general's office at roughly $6 million, one could accurately describe a $100,000 fine, with no jail-time, as a "slap on the wrist".  (In addition, at least 2 of the 3 families who died due to adulterated colchicine reached confidential settlements with ApothéCure.)
CRIMINAL CONVICTION
On February 10, 2012, the United States Department of Justice charged ApothéCure Inc., and its owner, Gary Osborn, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act in relation to the misbranded injectable colchicine.  Apothecure pleaded guilty to those charges on April 24, 2012. On May 15, 2012, in the United States District Court for the Northern District of Texas, Dallas Division, in case number 3:13-CR-047M(01), Osborn entered a plea of guilty to two (2) counts of introducing or causing the introduction or delivery for introduction into interstate commerce of ay food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, a misdemeanor in violation of 21 United States Code 331(a).  Osborn was placed under house arrest (home detention) and probation for one year, while ApothéCure was placed on probation for five years.  Both were ordered to pay a $100,000 fine.
Violating the FFDCA by adulterating and misbranding drugs is a crime related to the practice of pharmacy, and, Section 465.023(1)(f), Florida Statutes, provides that the Board of Pharmacy may revoke or suspend the permit of any pharmacy permittee, ad may fine, place on probation, or otherwise discipline the pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under s. 465.022(3), has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy. http://ww2.doh.state.fl.us/DocServiceMngr/GetImage.aspx?documentid=MTY2NTMwNDY=&enc=1
DRUG FIRM HAS HISTORY
This was not the first time Apothecure has been cited for violations. http://portlandtribune.com/component/content/article?id=86341  In 2004, the Pennsylvania Department of Health sent out a statewide alert after what appeared to be reactions in three Pennsylvania patients following intravenous injections of the drug phosphatidylcholine, supplied by ApothéCure.  According to the alert, the patients suffered nausea, vomiting and abnormally slow heart rate; two developed a condition that resulted in a loss of kidney function.
In response to the Pennsylvania alert, FDA officials and investigators from the Texas pharmacy board undertook an inspection of ApothéCure's facility in Dallas.  The inspection revealed a number of deficiencies in the company's operation, according to inspection reports. And at least one of those deficiencies might have a connection to the Portland and Washington deaths. The August 2004 inspection cited the company for six violations ranging from refrigerators lacking adequate thermometers and temperature logs, to a lack of documentation of training for pharmacy personnel.  But the potentially most significant citation, in the context of the Oregon deaths, was for the pharmacy not having properly registered the balance scales used to weigh substances.  An ApothéCure spokesman told The Associated Press that the batch of colchicine responsible for the Oregon and Washington deaths was the result of a weighing error.  'This is significant,' Sasich of Public Citizen said. 'What it means is that there is no quality control within this organization.'
In 2007, the FDA seized 17 vials of injectable DMPS that ApothéCure was illegally compounding.  http://www.casewatch.org/fda/court/apothecure/inspection_warrant.pdf
COMPOUNDING PHARMACY OR DRUG MANUFACTURER?
At the heart of the latest investigation into ApothéCure is the company's status as a compounding pharmacy. That status means that, unlike a drug manufacturer, it does not have to submit its products for sample tests to any government agency.  In addition, federal law prohibits compounders from selling drugs that are available in the same form and dosage from manufacturers. Injectable colchicine was available from manufacturers.
State boards of pharmacy, which oversee compounding pharmacies, do not routinely test products.
Authorities have suggested that, in supplying a large batch of colchicine (without patient-specific prescriptions) to the Portland Center for Integrative Medicine, ApothéCure may have broken a number of laws, and may have been acting more as a manufacturer than as a compounding pharmacy.
In addition to the rules that ApothéCure may have broken in its distribution of colchicine, medical practitioners at the Center for Integrated Medicine also may have acted improperly by purchasing colchicine from a compounding pharmacy rather than a manufacturer.  Another possible violation may have occurred with colchicine that the center supplied to another medical practitioner.  The two Portland deaths attributed to the bad batch came after the patients were injected at the center, according to a physician there. But the Yakima, Washington death, according to the same physician, occurred with colchicine supplied by the center. This amounts to re-dispensing, which is not allowed.

ApothéCure is among the largest compounding pharmacies in the country, and sells its products in virtually every state. It also has been a leader among compounding pharmacies that have battled the FDA in court to fend off federal regulation as manufacturers.

 
ADVERTISING HCG DIET TREATMENTS -  A BIG NO-NO
ApothéCure, through its website, as well as through its sister company, the Texas Institute of Functional Medicine, advertises drugs for purposes not approved by the U.S. Food and Drug Administration.  One of the most glaring examples is its blatant advertising of diet treatments utilizing Human Chorionic Gonadotropin (hCG).  http://www.tifm.com/?id=10066  Not only has HCG been disproven as having any role in weight loss, the FDA requires each bottle of HCG to include in its labeling the following disclaimer, in all-caps, "
HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION. 


HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE RESTRICTED DIETS.


In addition, in the 1970's the U.S. Federal Trade Commission sued various diet clinics, winning a verdict (affirmed on two appeals) that it was false, misleading, and deceptive to advertise HCG diet treatments without a similar disclaimer. 

It gets worse.  HCG is a big molecule, weighing approximately 30,000 daltons, about 6x bigger than insulin.  ApothéCure advertised that it could compound HCG into topical creams, sublingual drops, and slow-dissolving tablets, that could be absorbed through the skin, under the tongue, or even orally.  Really?  If ApothéCure has the technology to absorb big peptide hormones sublingually, then there are 20 million insulin-dependent diabetic patients that want to know about it.

AIDING THE UNLICENSED PRACTICE OF MEDICINE

In 2011, I alerted Jarvis Savage of ApothéCure that they were aiding the unlicensed practice of medicine, by taking prescription orders from Wendy Lazar, a massage therapist (who calls herself a naturopath), sending those compounded medications to her office, and allowing her to dispense these compounded medications to patients.  The response from ApothéCure was that, even though it was obvious that Ms. Lazar was just "renting the license" of other physicians (and not based upon a valid doctor-patient relationship), they felt their hands were clean, and they would continue to dispense compounded drugs to her.

FLORIDA BOARD OF PHARMACY TAKES ACTION

ApothéCure's blatant disregard for the safety of its patients, or for the rules of the State of Florida or that of the Federal Government, lead to its license being voluntarily relinquished (revoked).  Pleading guilty to a misdemeanor might just put the pharmacy on probation (as the Texas Board of Pharmacy did).  Having a track record of engaging in manufacturing and wholesale distribution of drugs without a license to do so, of adulterating and misbranding drugs causing three (3) deaths, and multiple pieces of evidence of lack of ethical behavior (scamming patients with HCG Diet treatments; aiding the unlicensed practice of medicine), sealed its fate.  When this action gets reported to the National Practitioner Data Bank, it is very likely other states will follow suit.

ApothéCure Compounding Pharmacy loses Florida License


by Kenneth Woliner, MD www.holisticfamilymed.com


On Tuesday, February 5, 2013, ApothéCure Inc, a compounding pharmacy based in Dallas, Texas, voluntarily relinquished its Florida pharmacy license and ability to mail prescription medications into the State of Florida. http://ww2.doh.state.fl.us/irm00praes/prasindi.asp?LicId=13503&ProfNBR=2205&Lookup=TRUE  Voluntarily relinquishing your license, while under disciplinary proceedings, is considered the equivalent to REVOCATION.  Why such drastic discipline?
ApothéCure (and its pharmacist owner, Gary Osborn) can't blame the fallout from the NECC-fungal meningitis outbreak or anyone else for its fate.  ApothéCure's wounds were all self-inflicted.  It was a combination of bad pharmacy practices, a history of having introduced adulterated drugs in the past, and most of all, arrogance, that it could do whatever it wanted, including operating as a manufacturer and wholesale distributor without having licenses to do so, violating the Federal Trade Commission and Federal Food, Drug, and Cosmetic Acts by advertising drugs for purposes not approved by the FDA, and for aiding and abetting the unlicensed practice of medicine.  When the pharmacy was told what it was doing was not just dangerous, but also illegal, it ignored those warnings, and continued to operate business as usual.  At least until now.
INTRAVENOUS COLCHICINE
ApothéCure is a compounding pharmacy.  As a pharmacy it is allowed to fill prescriptions for specific patients based upon individual prescriptions which are based upon a valid doctor-patient relationship.  As a compounding pharmacy, it often reformulated certain medications into other dosage forms.  There is a protocol using intravenous colchicine to treat low back pain and herniated discs created by Michael R. Rask, M.D. (1930-1994), a Las Vegas Orthopedic Surgeon who specialized in neurological orthopedic surgery. http://www.ncbi.nlm.nih.gov/pubmed/509824http://drmanso.com/patient-education-guide/colchicine/   Intravenous colchicine has been available in the United States since 1950, and was grand fathered in before the 1962 Kefauver Harris Amendment to the Federal Food, Drug and Cosmetic Act (FFDCA) that required medications to be proved safe and effective before being approved for sale in the United States.
Colchicine can be very toxic when given in high doses, with deaths being reported with cumulative doses as low as 5.5 mg.  The colchicine produced by ApothéCure was labeled as 0.5 mg/mL, but instead, each vial contained 4 mg/mL.  When an intended dose of 2 mg was administered, the patient actually received 16 mg!  That compounding error (making the drugs mislabeled and adulterated) lead to three deaths of patients who were treated at a Portland naturopathy clinic (Oregon allows naturopaths to prescribe and inject prescription drugs).  What was more galling, however, was that ApothéCure did not even have a license to operate in Oregon, even though it sent 43 batches of colchicine to Oregon clinicians over a one and a half year period.   Over 3,500 vials of the drug, distributed nationwide, were recalled. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5640a3.htm
The Oregon attorney general sued ApothéCure, alleging, among other things, that ApothéCure used low-quality water for its products, which could increase the possibility of contamination, and did not properly test its products for contamination or potency.  ApothéCure and the state of Oregon reached a settlement agreement in which ApothéCure agreed to pay a $100,000 fine and to pay a $500,000 civil penalty if it ever wanted to do business in Oregon again. http://portlandtribune.com/component/content/article?id=66040  This settlement was characterized as "not sufficient to protect Oregonians" by Larry Sasich, spokesperson for the public watchdog group Public Citizen, and chairman of the department of pharmacy practice at the Lake Erie College of Osteopathic Medicine in Pennsylvania.  With ApothéCure's annual sales were estimated by the Oregon attorney general's office at roughly $6 million, one could accurately describe a $100,000 fine, with no jail-time, as a "slap on the wrist".  (In addition, at least 2 of the 3 families who died due to adulterated colchicine reached confidential settlements with ApothéCure.)
CRIMINAL CONVICTION
On February 10, 2012, the United States Department of Justice charged ApothéCure Inc., and its owner, Gary Osborn, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act in relation to the misbranded injectable colchicine.  Apothecure pleaded guilty to those charges on April 24, 2012. On May 15, 2012, in the United States District Court for the Northern District of Texas, Dallas Division, in case number 3:13-CR-047M(01), Osborn entered a plea of guilty to two (2) counts of introducing or causing the introduction or delivery for introduction into interstate commerce of ay food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, a misdemeanor in violation of 21 United States Code 331(a).  Osborn was placed under house arrest (home detention) and probation for one year, while ApothéCure was placed on probation for five years.  Both were ordered to pay a $100,000 fine.
Violating the FFDCA by adulterating and misbranding drugs is a crime related to the practice of pharmacy, and, Section 465.023(1)(f), Florida Statutes, provides that the Board of Pharmacy may revoke or suspend the permit of any pharmacy permittee, ad may fine, place on probation, or otherwise discipline the pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under s. 465.022(3), has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy. http://ww2.doh.state.fl.us/DocServiceMngr/GetImage.aspx?documentid=MTY2NTMwNDY=&enc=1
DRUG FIRM HAS HISTORY
This was not the first time Apothecure has been cited for violations. http://portlandtribune.com/component/content/article?id=86341  In 2004, the Pennsylvania Department of Health sent out a statewide alert after what appeared to be reactions in three Pennsylvania patients following intravenous injections of the drug phosphatidylcholine, supplied by ApothéCure.  According to the alert, the patients suffered nausea, vomiting and abnormally slow heart rate; two developed a condition that resulted in a loss of kidney function.
In response to the Pennsylvania alert, FDA officials and investigators from the Texas pharmacy board undertook an inspection of ApothéCure's facility in Dallas.  The inspection revealed a number of deficiencies in the company's operation, according to inspection reports. And at least one of those deficiencies might have a connection to the Portland and Washington deaths. The August 2004 inspection cited the company for six violations ranging from refrigerators lacking adequate thermometers and temperature logs, to a lack of documentation of training for pharmacy personnel.  But the potentially most significant citation, in the context of the Oregon deaths, was for the pharmacy not having properly registered the balance scales used to weigh substances.  An ApothéCure spokesman told The Associated Press that the batch of colchicine responsible for the Oregon and Washington deaths was the result of a weighing error.  'This is significant,' Sasich of Public Citizen said. 'What it means is that there is no quality control within this organization.'
In 2007, the FDA seized 17 vials of injectable DMPS that ApothéCure was illegally compounding.  http://www.casewatch.org/fda/court/apothecure/inspection_warrant.pdf
COMPOUNDING PHARMACY OR DRUG MANUFACTURER?
At the heart of the latest investigation into ApothéCure is the company's status as a compounding pharmacy. That status means that, unlike a drug manufacturer, it does not have to submit its products for sample tests to any government agency.  In addition, federal law prohibits compounders from selling drugs that are available in the same form and dosage from manufacturers. Injectable colchicine was available from manufacturers.
State boards of pharmacy, which oversee compounding pharmacies, do not routinely test products.
Authorities have suggested that, in supplying a large batch of colchicine (without patient-specific prescriptions) to the Portland Center for Integrative Medicine, ApothéCure may have broken a number of laws, and may have been acting more as a manufacturer than as a compounding pharmacy.
In addition to the rules that ApothéCure may have broken in its distribution of colchicine, medical practitioners at the Center for Integrated Medicine also may have acted improperly by purchasing colchicine from a compounding pharmacy rather than a manufacturer.  Another possible violation may have occurred with colchicine that the center supplied to another medical practitioner.  The two Portland deaths attributed to the bad batch came after the patients were injected at the center, according to a physician there. But the Yakima, Washington death, according to the same physician, occurred with colchicine supplied by the center. This amounts to re-dispensing, which is not allowed.

ApothéCure is among the largest compounding pharmacies in the country, and sells its products in virtually every state. It also has been a leader among compounding pharmacies that have battled the FDA in court to fend off federal regulation as manufacturers.

 
ADVERTISING HCG DIET TREATMENTS -  A BIG NO-NO
ApothéCure, through its website, as well as through its sister company, the Texas Institute of Functional Medicine, advertises drugs for purposes not approved by the U.S. Food and Drug Administration.  One of the most glaring examples is its blatant advertising of diet treatments utilizing Human Chorionic Gonadotropin (hCG).  http://www.tifm.com/?id=10066  Not only has HCG been disproven as having any role in weight loss, the FDA requires each bottle of HCG to include in its labeling the following disclaimer, in all-caps, "
HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION. 

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE RESTRICTED DIETS.


In addition, in the 1970's the U.S. Federal Trade Commission sued various diet clinics, winning a verdict (affirmed on two appeals) that it was false, misleading, and deceptive to advertise HCG diet treatments without a similar disclaimer. 

It gets worse.  HCG is a big molecule, weighing approximately 30,000 daltons, about 6x bigger than insulin.  ApothéCure advertised that it could compound HCG into topical creams, sublingual drops, and slow-dissolving tablets, that could be absorbed through the skin, under the tongue, or even orally.  Really?  If ApothéCure has the technology to absorb big peptide hormones sublingually, then there are 20 million insulin-dependent diabetic patients that want to know about it.

AIDING THE UNLICENSED PRACTICE OF MEDICINE

In 2011, I alerted Jarvis Savage of ApothéCure that they were aiding the unlicensed practice of medicine, by taking prescription orders from Wendy Lazar, a massage therapist (who calls herself a naturopath), sending those compounded medications to her office, and allowing her to dispense these compounded medications to patients.  The response from ApothéCure was that, even though it was obvious that Ms. Lazar was just "renting the license" of other physicians (and not based upon a valid doctor-patient relationship), they felt their hands were clean, and they would continue to dispense compounded drugs to her.

FLORIDA BOARD OF PHARMACY TAKES ACTION

ApothéCure's blatant disregard for the safety of its patients, or for the rules of the State of Florida or that of the Federal Government, lead to its license being voluntarily relinquished (revoked).  Pleading guilty to a misdemeanor might just put the pharmacy on probation (as the Texas Board of Pharmacy did).  Having a track record of engaging in manufacturing and wholesale distribution of drugs without a license to do so, of adulterating and misbranding drugs causing three (3) deaths, and multiple pieces of evidence of lack of ethical behavior (scamming patients with HCG Diet treatments; aiding the unlicensed practice of medicine), sealed its fate.  When this action gets reported to the National Practitioner Data Bank, it is very likely other states will follow suit.



Thursday, February 7, 2013

Washington Post Article: Compounding pharmacies have been linked to deaths, illnesses and safety failures for years

Founded in 2003, PharMEDium has four plants and annual sales of more than $100 million, officials said. The company says it uses only sterile, FDA-approved ingredients for the intravenous and epidural medications it supplies to more than 2,000 hospitals, including Johns Hopkins Hospital.
Company President Rich Kruzynski said the incidents are a fraction of the “tens of thousands of batches” provided to hospitals. The record, he said, demonstrates PharMEDium’s commitment to be the industry’s “gold standard” for quality, patient safety and regulatory compliance.
 
Continue reading here

Tuesday, November 27, 2012

State closes deadly drug shipment misbranding case


Published 2:00 p.m., Tuesday, November 27, 2012
AUSTIN, Texas (AP) — The Texas attorney general's office has resolved its case against a Dallas-based mail-order compounding pharmacy over a shipment of a misbranded drug ingredient blamed for three Pacific Northwest deaths.
An attorney general's office statement Tuesday says pharmacist Gary Osborn and his companies, Apothecure Inc. and SpectraPharm Inc., will pay $200,000 to the state, including $100,000 in civil penalties. They also agree to compound drugs to order and in a legal manner.
Osborn and ApotheCure received probation and $100,000 fines after pleading guilty to two misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act.
The cases center on a February 2007 shipment of a gout drug containing some vials with dosages more than seven times stronger than shown on the label. Autopsies showed three Oregon patients suffered fatal overdoses.


Read more: http://www.sfgate.com/news/texas/article/State-closes-deadly-drug-shipment-misbranding-case-4071164.php#ixzz2DTGehD3Y

Tuesday, July 31, 2012

Additional Briefs That Have Been Filed in U.S. v. Gary D. Osborn and Apothecure

To view Gary D. Osborn's Brief Relating to Apprendi/Fine argument click here.
To view Government's Response Brief to Osborn's Apprendi/Fine argument click here.
To view Government's Reply Brief click here.

Thursday, May 24, 2012

Judge Accepts Gary Osborn and Apothecure Pleas of Gulity

The judge in the Northern District of Oklahoma has accepted Gary Osborn and Apothecure plea of guilty.  The orders accepting the plea can be viewed here and here.

Monday, May 14, 2012

JUDGE IN NORTHERN DISTRICT OF TEXAS SETS SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc

SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc:

Presentence Investigation Report due by 7/6/2012.
Objections to Presentence Investigation Report due by 7/20/2012.
Presentence Investigation Addendum due by 7/27/2012.
Objections to Presentence Investigation Addendum due by 8/3/2012.
Sentencing set for 9/21/2012 01:30 PM before Judge Barbara M.G. Lynn.
Motions for Downward Departure due by 9/12/2012.
Sentencing Memoranda and Character Letters due by 9/12/12.

Thursday, May 3, 2012

The Need for Reform in Compounding Laws: The Alabama Accident


The Need for Reform in Compounding Laws

The article below appeared on the Institute for Safe Medicine Practice(ISMP) website.  It addresses the Alabama Total Parenteral Nutrition (TPN) bags that were contaminated, infected 19 patients and resulted in 9 patients' deaths.  The article addresses the lack of enforcement of laws, regulations and pharmacy board standards relating to compounding.  For example, any sterile activity should be undertaken with great care and in compliance with the United  States Pharmacopeia (USP) Chapter 797, Pharmaceutical Compounding: Sterile Preparations. The National Association of Boards of Pharmacy (NABP) has incorporated the 797 requirement into its Model State Pharmacy Act and Model Rules. As the article points out the NABP does not have authority to enforce its recommendations. State boards of pharmacy, who could enforce such laws, vary as to their position on 797.  Some states have adopted the entire chapter into laws, regulations or board policies and procedures, some have incorporated only portions of 797, and some have not taken any action and do not require compliance with 797. Another point made in the article is that most state boards have insufficient funding to send experienced and trained inspectors to pharmacy operations to ensure compliance with 797.  Deaths such as those resulting in Francks, ApotheCure, and the Alabama case, show that change in enforcement of compounding standards needs to occur before anymore deaths occur.  The question is how to best implement the reforms needed.


TPN-related deaths call for FDA guidance and pharmacy board oversight of USP Chapter <797>

From the April 7, 2011 issue
Last week, the Alabama Department of Public Health (ADPH) reported an ongoing investigation of an outbreak of Serratia marcescens bacteremia associated with contaminated total parenteral nutrition (TPN) bags in six Alabama hospitals.(1-4) The outbreak was identified after two of the six hospitals reported an unusual number of cases of Serratia marcescens bacteremia to the ADPH and the Centers for Disease Control and Prevention (CDC). An investigation was immediately started.
A total of 19 patients from six hospitals were adversely affected after receiving the contaminated TPN. The CDC determined that all six hospitals had received TPN produced by a single compounding pharmacy, Meds IV. Nine of the 19 affected patients have died, although the CDC has not confirmed that the deaths were directly caused by the contaminated TPN.(3) Meds IV was notified about the contaminated TPN and is fully cooperating with the investigation.
To date, the investigation has uncovered traces of Serratia marcescens in the compounding room at Meds IV, although genetic testing will be required to determine whether the organisms found in the pharmacy caused the TPN contamination. Health officials also reported that seven newborns received TPN supplements from Meds IV in March, along with 41 adults. While 19 of those 41 adults got sick, none of the babies became ill.(4) Thus, the investigation is focusing on differences between compounding TPN for adults vs. neonates.
At this time, Meds IV has discontinued all production and has recalled all of its compounded preparations.
USP Chapter <797>
Any type of sterile compounding activities must be undertaken with great care and in compliance with the United States Pharmacopeia (USP) Chapter <797>, Pharmaceutical Compounding: Sterile Preparations. It is tragic events like this that compelled USP to first establish <797>, which was initially published in 2004 and revised in June 2008. Chapter <797> describes a network of systems and processes “to prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations (CSPs).”(5)
Increased use of compounding pharmacies for sterile preparations
In the past, most sterile compounding was completed in-house in hospital pharmacies. However, this trend has shifted over the years,(6-7) particularly after the 2008 revision of <797>, as many pharmacies found it difficult to meet all the requirements of the standard. A recent (1st quarter of 2011) survey conducted by Pharmacy Purchasing & Products showed that 66% of pharmacies outsource at least some portion of their sterile compounding. Reliance on compounding pharmacies has continued to rise due to an unprecedented escalation in shortages of parenteral drugs, including recent shortages of vitamins, electrolytes, and other pharmaceutical components of TPN.
From a safety perspective, it makes sense to outsource the compounding of CSPs. It is difficult and costly for hospitals to comply with all of the <797> standard if they prepare just a few parenteral CSPs each day. As a general rule, compounding pharmacies that prepare large quantities of CSPs may be better equipped to employ, enforce, and monitor ongoing compliance with all of the <797> standard. But should hospitals be wary of using a compounding pharmacy in light of this latest infection outbreak?
While it’s true that contamination of CSPs from a compounding pharmacy can result in large and serious outbreaks, ISMP believes the use of compounding pharmacies should not be summarily dismissed as a result of this tragic outbreak. However, we must state unequivocally that the real issue to be learned from this event is that better oversight and licensing and/or registration requirements for compounding pharmacies are required.
Enforcement of <797>
Compounding pharmacies frequently prepare very complex CSPs, many with high-alert medications intended for parenteral administration. Jay Mirtallo, A.S.P.E.N. president elect, noted in a March 30, 2011 press release on this latest infection outbreak (www.nutritioncare.org/Index.aspx?id=6174) that, “Parenteral nutrition by nature is one of the most complex sterile preparations to prepare, relying on a specific order of mixture as well as method of preparation to assure sterility, compatibility, and stability.” Thus, one might expect the Food and Drug Administration (FDA) to subject compounding pharmacies to the same strict current good manufacturing practices (cGMPs) that are routine for drug manufacturers. Or one might expect all state boards of pharmacy to hold compounding pharmacies accountable for meeting the <797> standard in its entirety. However, there is often little or no required regulatory or licensing/registration oversight of compounding pharmacies to ensure and enforce compliance with <797>.
Chapter <797> is enforceable by the FDA; the agency clearly has the authority to inspect pharmacies and enforce the standard in the interest of public health.(5) However, FDA defers to the individual states to regulate the practice of pharmacy and to perform inspections.5 In the 1970s, the National Coordinating Committee on Large Volume Parenterals (NCCLVP) of USP emerged to ensure high quality CSPs. But with the dissolution of this group in the 1980s, FDA turned to the profession of pharmacy to address problems with sterile preparation. Since the early 1990s, FDA has been aware of multiple problems with compounded preparations that have resulted in recalls, patient injuries, and deaths.(5) However, when we communicated with the FDA recently to discuss this event, no one could clearly articulate how the agency regulates compounding pharmacies.
The National Association of Boards of Pharmacy (NABP) has incorporated the <797> requirement into its Model State Pharmacy Act and Model Rules, noting that, “The board’s Good Compounding Practices Applicable to State Licensed Pharmacies, and the current USP-NF chapters on compounding and sterile pharmaceutical preparations” are to be adhered to by compounding pharmacies and pharmacists.(6) However, the Model Rules or requirements of the Model State Pharmacy Act are only enforced to the extent that they are adopted by individual states, as the NABP does not have authority to enforce its recommendations.
Individual state boards of pharmacy vary in regard to the position taken with respect to <797>. Some states have adopted the chapter in its entirety, but most have chosen to incorporate only portions of <797> into laws, regulations, or board policies and procedures.(5) Some states have taken no action and do not require compliance with <797>. In addition, most state boards have insufficient funding to send experienced and trained surveyors to actually inspect pharmacy operations to ensure compliance with <797>.
While The Joint Commission (TJC) requires organizations to comply with portions of <797> that are similar to its standards, TJC views <797> as a best practice and expects organizations to review best practices for the purpose of improving systems (MM.08.01.01). Thus, surveyors may expect an improvement plan based on <797>, but it is left to the accredited organization as to what they need to improve. TJC expects organizations to comply with <797> in states that require such compliance. However, most surveyors have not been adequately trained regarding <797> and would simply ask to see the latest state inspection results.
Lessons learned: Need for future oversight
As we move forward and learn from the most recent outbreak, we are calling upon all state boards of pharmacy to expect compounding pharmacies to comply with all aspects of <797>, and to survey these pharmacies regularly to enforce compliance. To do this, state pharmacy boards must be provided with additional resources to adequately train and deploy surveyors to assess compliance. Today, many pharmacy boards are ill equipped to take on this responsibility; without additional resources, the assignment of responsibility will not result in improved oversight. The pharmacy boards that choose a limited set of criteria from the <797> standard for enforcement in their states are ill-advised regarding its benefit to public safety; partial compliance will not even partially protect patients from the risk of infection from contaminated CSPs. The <797> standard is not set out as an incremental improvement plan; it’s a bundle that must be implemented in its entirety and on an ongoing basis to be effective. Each of the state boards of pharmacy must demand and expect their licensees to comply with <797>.
We are calling upon FDA to work collaboratively with the state boards of pharmacy to provide them with the necessary support and training to survey compounding pharmacies for compliance with <797>. Further, we believe compounding pharmacies that distribute sizeable quantities (to be defined by FDA) of preparations, and those operating interstate, should be registered with FDA and subject to periodic inspections. We also encourage FDA to move forward with plans to publish guidances on Good Pharmacy Compounding Practices for Sterile Drug Products, and Outsourcer Pharmacy Operations Compliance Policy Guide (www.ismp.org/sc?k=ucm079647), to clearly articulate requirements for registration with FDA, periodic inspections, support available to the state boards of pharmacy, and expectations regarding the state boards’ role in regulating compounding pharmacies.
We are calling upon TJC to consistently survey compliance with applicable parts of the <797> standard as it relates to the type of CSPs being prepared in accredited facilities in all states.
We are calling upon all pharmacies and pharmacists/technicians who compound sterile preparations, regardless of where they work, to know and comply with <797> to the fullest extent possible. Pharmacy staff should use commercially available ready-to-use products when available, or start with sterile products whenever possible if preparing CSPs. This applies to the smallest hospitals up to the largest compounding pharmacies. We also recommend establishing an internal quality surveillance and review team to regularly monitor compounded preparations, the environment, compounding equipment, and personnel for compliance with key aspects of <797>, much like an internal peer-review process. An April 2011 supplement to Pharmacy Purchasing & Products on the state of pharmacy compounding is an excellent resource to help guide the surveillance and improvement process.(8) Any problems uncovered during surveillance require immediate stoppage of compounding, investigation, corrective action, and revalidation before resumption of activities. All pharmacy staff have a moral and legal obligation to compound preparations using the least risky processes while adhering to the highest standards possible.
We don’t have all the details about this recent outbreak, but a crucially important lesson we can take away from this tragedy is that we all need to make improvements based on the outcome of this investigation. Unfortunately, there are too many in healthcare who feel that, if it hasn’t happened to them, the adverse experiences of others do not apply. If investigation into this event uncovers some aspect (e.g., frequency of testing staff samples and environmental samples) of compounding that was overlooked in either the <797> standard or in staff practices, then let’s learn from it, incorporate necessary changes, and provide leadership and oversight to assure our patients are kept safe.
ISMP thanks Eric S. Kastango, MBA, RPh, FASHP, CEO of ClinicalIQ, for his contribution to this article.
References
1) US Food and Drug Administration (FDA). Meds IV pharmacy, IV compounded products recall: outbreak of Serratia marcescens bacteremia in Alabama hospitals. March 30, 2011. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249099.htm
2) US Food and Drug Administration (FDA). CDC and ADPH investigate outbreak at Alabama hospitals; products recalled. March 29, 2011. www.fda.gov/Safety/Recalls/ucm249068.htm
3) Watkins T. Contaminated IV solution suspected in 9 patient deaths in Alabama. CNN Health. March 29, 2011. www.cnn.com/2011/HEALTH/03/29/alabama.hospitals.deaths/index.html?hpt=T2
4) Wolfson H. Investigators piecing together tainted IV puzzle after deaths in Alabama hospitals. The Birmingham News. April 3, 2011. http://blog.al.com/spotnews/2011/04/investigators_piecing_together.html
5) American Society of Health-System Pharmacists (ASHP). The ASHP discussion guide on USP Chapter <797> for compounding sterile preparations. www.ashp.org/s_ashp/docs/files/DiscGuide797-2008.pdf
6) National Association of Boards of Pharmacy. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Mount Prospect, IL. August 2007.
7) Seres D, Sacks GS, Pederssen CA, Johnson D, et al. Parenteral nutrition safe practices: results of the 2003 American Society for Parenteral and Enteral Nutrition Survey. J Parenteral and Enteral Nutrition. 2006;30(3):259-65.
8) Pharmacy Purchasing & Products (PP&P). 2011 state of pharmacy compounding; PP&P’s 4th annual national survey. April 2011.

Wednesday, April 25, 2012

DOJ Press Release: Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Tuesday, April 24, 2012
Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with
Misbranded Drug Shipment, Shipment Led to Three Deaths in Pacific Northwest
Gary D. Osborn and his corporation, ApothéCure Inc., pleaded guilty today in the U.S. District Court for the Northern District of Texas to two misdemeanor criminal violations of the Food, Drug and Cosmetic Act (FDCA). The pleas are in connection with ApothéCure’s interstate shipment of two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.
ApothéCure, which is located in Dallas, is a compounding pharmacy. Compounding Pharmacies create particular pharmaceutical products to fit the unique needs of patients by combining appropriate ingredients.
Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults, and to relieve the pain of gout attacks when they occur.
The government’s charges were based on ApothéCure’s February 2007 shipment of 72 vials of compounded colchicine to a now-defunct medical center in Portland, Ore. On March 19, 2007, a patient in Yakima, Wash., who received colchicine from this shipment, died after receiving the infusion. The medical examiner determined that the cause of death was multiple organ failure and acute colchicine toxicity.
On March 30, 2007, colchicine from ApothéCure was administered to two other patients who were suffering from back pain. Within hours of receiving the colchicine injections, both patients became seriously ill, were taken to local hospitals, and died shortly thereafter. The medical examiner in Oregon determined colchicine toxicity to be the cause of death for both patients.
FDA testing of vials selected from the lethal shipment revealed that some of the vials were super-potent, containing 640 percent of the level of colchicine declared on the label. Other vials were determined to be sub-potent, and contained less than 62 percent of the declared levels on the labels.
“This plea shows that the Department of Justice will enforce the Food, Drug and Cosmetic Act against responsible corporate officers of companies that fail to control the quality of their products,” said Stuart F. Delery, Acting Assistant Attorney General of the Civil Division of the Department of Justice. “The drugs mixed by Mr. Osborn’s company were not merely misbranded, but lethal. Drug makers of all sizes, from large corporations to small compounding pharmacies, have a duty to ensure their products are safe.”
Sentencing is scheduled for July 27, 2012.
This case was investigated by Food and Drug Administration’s Office of Criminal Investigations, which referred this matter to the Justice Department. The case is being prosecuted by Trial Attorneys John Claud and Patrick Runkle of the Civil Division’s Consumer Protection Branch.

Previous State Court Proceedings and Other Pending Civil Court Proceedings against Gary D. Osborn and ApotheCure

Before the federal government brought criminal charges against Gary D. Osborn and ApothéCure, there were state proceedings in Oregon and Texas.  The Pharmacy Board of the State of Oregon filed a Notice of Proposed Civil Penalty. The board reviewed the case and voted unanimously in 2007 to issue a civil penalty not to exceed $1,000 per violation. Click here to see press release.

Oregon's Attorney General filed a complaint in Marion County Circuit Court.   ApothéCure, Inc., was not registered with the Oregon Board of Pharmacy as required by law. Oregon's lawsuit alleged that the unlicensed company unlawfully sold dangerous prescription drugs in Oregon including Colchicine, a highly toxic drug that must be used with great care to avoid injury and death.  In this Oregon case, Osborn and ApothéCure entered into a Stipulated General Judgment, which provided that ApothéCure was out-of-business in Oregon until all necessary licenses were obtained and a $500,000 penalty was paid.   

In November 2010, the Texas State Board of Pharmacy reprimanded Osborn's pharmacist license because he had failed to ensure that an error did not occur during the making of the compounded preparation of colchicine.  The board fined ApothéCure $125,000 and placed its license on probation for one year with the condition that the pharmacy develop and implement a continuous quality improvement program for preventing and handling dispensing errors.  The Texas States Attorney General also filed a lawsuit against ApothéCure and Osborn. Click here to see petition and here for press release.

The families of two of the colchicine victims filed wrongful death lawsuits and reached confidential settlements with ApothéCure.  The third family is negotiating a settlement with the company
On February 19, 2008, Hartford Lloyds Insurance  Company filed a civil action against Osborn and ApothéCure in the Northern District of Texas in case number 3:08-cv-00288-P.  This case is still pending. 
Cheryl A. Thompson has written an article posted on the The American Society of Health-System Pharmacits' website entitled Criminal Charges Not Necessarily Criminalization of Medication Error. Click here to read this article.

Tuesday, April 24, 2012

Gary D. Osborn's Plea in Criminal Case

Today, a magistrate judge in the Northern District of Texas recommended that the district court accept Gary D. Osborn's guilty plea to a two-count information, charging violations of  21 U.S.C. Section 331(a)352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. Click here to see Report and Recommendation of magistrate judge.  As noted in previous blogs three people died because of misbranded colchicine injectable solution compounded at ApothéCure, Inc., where Osborn was a pharmacist.  Osborn was released on conditions that are typical of this type of case.  The next step is that the district court will most likely accept the magistrate judge's report and recommendation, thus accepting Osborn's guilty plea and then impose sentence.

Readers feel free to comment on whether pharmacists and companies that compound medications should be held criminally responsible in these types of cases?  Should criminal charges be brought only in cases where death or serious bodily injury results?  Does it matter if the death or serious bodily injury is that of an animal instead of a human?  Should a company be shut down if a death or serious bodily injury results?

Plea Hearing in ApothéCure and Gary D. Osborn Criminal Case

A hearing in the criminal case of ApotheCure and Gary D. Osborn is scheduled for 10:30 a.m. today.  It is expected that ApothCure and Gary D. Osborn will plead guilty to the two-count information, charging violations of  21 U.S.C. Section 331(a)352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. The defendants were responsible for introducing into interstate commerce two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.  Updates on the hearing will be posted as soon as the information is available.

Sunday, April 22, 2012

Gary Osborn and Apothecure are Scheduled to Plead Guilty in Compounding case Charging Misbranded Drug Violations

On April 18, 2012, the United States, Gary D. Osborn and Apothecure filed a plea agreement and factual resume in the Northern District of Texas. Pursuant to the plea agreement, Osborn and Apothecure have agreed to plead guilty to the two-count information, charging violations of  21 U.S.C. Section 331(a)352(a) and 333(a)(1)--all criminal, class A misdemeanors.   ApothéCure and Gary D. Osborn are admitting that they introduced into interstate commerce a misbranded drug with a false and misleading label.  The defendants face up to a year of imprisonment.  Most likely, the defendants will receive probation and be ordered to pay a fine of $100,000.  The parties, while not agreement on the amount of the fine, have agreed that $100,000 would be a reasonable fine in this case.  Nevertheless, the United States' position is that the maximum fine can be imposed up to $250,000 for each count in the information.  The defendants have also agreed to pay restitution to the victims or community, which is mandatory under federal law.  The rearraignment and entry of the plea of guilty are scheduled for April 24, 2012, at 10:30 a.m.

Tuesday, April 17, 2012

FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 Draft Targets Illegal Compounding

A draft of the FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 indicates that a new enforcement strategy to address illegal compounding of new animal drugs may be a top priority of the FDA in the future.  Cases such as Franck's and ApothCure (although not a case involving animal drugs) suggest that illegal compounding of drugs has already become a key initiative of the FDA.  The draft reads:

The FVM Program is concerned about the number of unapproved animal drug products
that are being sold and marketed to animal owners and veterinarians. To reduce the risk of
harm from substandard and illegally marketed animal drugs, the program will identify new
regulatory frameworks and enforcement strategies to combat this growing area of
concern.
Key Initiatives
7.2.1: Develop risk‐based frameworks that assure quality and safety for products
that are currently being marketed without FDA approval
7.2.2:  Develop and implement an enforcement strategy that addresses the illegal
compounding of new animal drugs and removes unsafe, ineffective or copycat
animal drugs from the market

To read the entire FDA Foods and Veterinary Medicine Program Strategic Plan for 2012-2016 click  here.