Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, June 25, 2014
In his first television interview, compounding pharmacist Nima Alavi told the ABC's 7.30 program that a letter was discovered by ASADA investigators at Essendon which was purported to be written by him. It referred to a natural substance called Thymomodulin which is not banned by the World Anti-Doping Authority. It’s stronger synthetic version - Thymosin Beta 4 - is banned.
Pressure appears to be mounting on controversial sports scientist Stephen Dank, with a pharmacist and doctor he dealt with during his period at Essendon going public in forgery allegations against him.
Continue to read here
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Kareem Ahmed, Major Obama Donor Accused of Workers Comp Fraud, Has Assets Targeted
See the update at the end of this post on a hearing that just resumed concerning the freezing of the assets of Kareem Ahmed and 14 doctors, pharmacists and other medical professionals indicted for an alleged $25 million workers comp kickback scheme.
Read here
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CAPS Showcases its Broad Compounding Portfolio at ASHP
06/24/14
CAPS Showcases its Broad Compounding Portfolio at ASHP
CAPS News
Irvine, CA – June 24, 2014 – Central Admixture Pharmacy Services, Inc. (CAPS®) showcased its broad compounding portfolio at the American Society of Health-System Pharmacists (ASHP) Summer Meetings and Exhibition in Las Vegas, Nevada, May 31-June 3.
CAPS featured its comprehensive outsourcing admixture services at booth (#811) and its,“It takes both parts to complete the puzzle,” campaign that highlights the unique ability to offer customers both anticipatory compounding outsourcing services through its 503B FDA registered facility, as well as same day customized patient-specific compounding services through its regional 503A state licensed pharmacies.
Tuesday, June 24, 2014
Automated compounding technology proven to make medications safer
As automation technologies enhance a growing number of healthcare services – including imaging, surgery, radiotherapy and rehabilitation, among others – pharmacies remain largelyun-automated.
Despite its central role in healthcare, technicians in most pharmacies still compound medications manually, in much the same way it's been done for generations. Such a long history, combined with refinements in aseptic techniques and training, means manual IV compounding remains the accepted standard of care. But how much longer should it be?
Recent outbreaks of illness and adverse reactions linked to compounded medications, as well as numerous pharmacy product recalls, make the shortcomings of manual compounding increasingly hard to ignore. Last year, a Birmingham-based compounding pharmacy was forced to withdraw at least 10 products after the FDA raised concerns about the lab it used for sterility testing.
A subsequent inspection of the pharmacy itself found numerous deficiencies in procedures for making sterile drug compounds. Although no illnesses have been linked to products made by the pharmacy, such stories beg a simple but fundamental question: how can we ensure the safety of compounded medications?
Ongoing reliance on manual techniques would be understandable if there were no alternative. But automated IV compounding systems have existed for more than a decade. Moreover, the technology is proven to enhance the safety of compounded medications, reduce pharmacy costs and increase productivity. Still, some in the industry feel automated IV compounding technology is not yet sufficiently developed for widespread implementation. It's an unfortunate perception, and inaccurate.
Continue to read here
Despite its central role in healthcare, technicians in most pharmacies still compound medications manually, in much the same way it's been done for generations. Such a long history, combined with refinements in aseptic techniques and training, means manual IV compounding remains the accepted standard of care. But how much longer should it be?
Recent outbreaks of illness and adverse reactions linked to compounded medications, as well as numerous pharmacy product recalls, make the shortcomings of manual compounding increasingly hard to ignore. Last year, a Birmingham-based compounding pharmacy was forced to withdraw at least 10 products after the FDA raised concerns about the lab it used for sterility testing.
A subsequent inspection of the pharmacy itself found numerous deficiencies in procedures for making sterile drug compounds. Although no illnesses have been linked to products made by the pharmacy, such stories beg a simple but fundamental question: how can we ensure the safety of compounded medications?
Ongoing reliance on manual techniques would be understandable if there were no alternative. But automated IV compounding systems have existed for more than a decade. Moreover, the technology is proven to enhance the safety of compounded medications, reduce pharmacy costs and increase productivity. Still, some in the industry feel automated IV compounding technology is not yet sufficiently developed for widespread implementation. It's an unfortunate perception, and inaccurate.
Continue to read here
Question of Day June 24, 2014 If a transdermal preparation killed an infant then how many transdermals being used on animals have made humans sick or killed them? Studies of this type are not generally done on compounded preparations. If you suspect this has happened to you or a loved one contact the FDA and/or an attorney immediately.
PRESS RELEASE June 24, 2014, 8:00 a.m. EDT Imprimis Pharmaceuticals Go Dropless™ Video Interview Survey Reveals 95% of Leading Cataract Surgeons Surveyed Would Prefer Dropless Therapy -- Survey highlights interest in easing patient compliance issues associated with conventional post-cataract surgery eye drop regime --
Read here
Florida: office use
"Office Use" FDA 2014 Sterile Compounding Regulations
Due to this ever changing landscape the Florida board of Pharmacy has passed a rule making it unlawful for a pharmacy with a Florida license to fill an "OFFICE USE" sterile compounded prescription for human use
(rule 64816-27-700).
This means that any pharmacy located in the state of Florida, or any pharmacy that has a license to ship into the state of Florida, cannot fill an office use sterile compounded prescription for a human unless they have aspecific permit that requires they register with the FDA. We do not have that type of license.
We will still be able to ship a patient specific prescription.
As always if the patient specific prescription is a scheduled drug it must be shipped directly to the consumer.
If it is a non-schedule drug it can be shipped to either the patient or the clinic.
(rule 64816-27-700).
This means that any pharmacy located in the state of Florida, or any pharmacy that has a license to ship into the state of Florida, cannot fill an office use sterile compounded prescription for a human unless they have aspecific permit that requires they register with the FDA. We do not have that type of license.
We will still be able to ship a patient specific prescription.
As always if the patient specific prescription is a scheduled drug it must be shipped directly to the consumer.
If it is a non-schedule drug it can be shipped to either the patient or the clinic.
Continue to read here
Monday, June 23, 2014
Ninth Question of the Day June 23, 2014 What kind of contract does a compounding pharmacy have with its sales and marketing representations? These contracts could potentially show compliance with the law or lack thereof? Should the same attorney represent both the compounding pharmacy/pharmacist and the sales or marketing rep, or is this a conflict of interest?
French endurance vets’ open letter [official English translation]
Read more at http://www.horseandhound.co.uk/archives/french-endurance-vets-open-letter-english-translation/#0mpifKIlFHBDz0HQ.99
Eighth Question of the Day June 23, 2014 Is it enough to protect a pharmacy or pharmacist from liabilty if the doctor documents that a commerically available drug should not be used and that he or she wants a compounded drug? Does it matter if a commerically available has been tried on the specific patient? Does it matter, if as a general rule, the commerically available doesn't work? What if the commerically available works but the doctor prefers the compound preparation because it is easier to administer or take but there is no proof that it works any better? When, if ever, should a compounding pharmacy or pharmacist refuse or at least question a doctor's request?
MUST READ!! Breaking News!! Exclusive: Baby's death linked to alleged massive workers' comp scheme involving compounded medications--compound transdermal cream
A specialized skin cream prescribed by a local doctor for a woman's back and knee pain killed her 5-month-old baby after he came in contact with it, according to a Los Angeles coroner’s report.
The infant's parents are suing the mother's doctor, whose involvement in the case also led to his being charged with involuntary manslaughter in an indictment filed last week by the Orange County Grand Jury.
The parents of the baby, Andrew Gallegos, have filed a product liability and medical negligence lawsuit against Dr. Andrew Jarminski, physician assistant Joseph Gutierrez, Healthcare Pharmacy, Allied Medical Group and Industrial Pharmacy Management.
The lawsuit claims Gallegos' mother, Priscilla Lujan, went to Jarminski’s Long Beach office in February 2012 for treatment of injuries she suffered while working at Goodwill Industries.
Medical records show Jarminski prescribed Lujan a compound transdermal cream comprised of the antidepressant amitriptyline, the pain reliever tramadol and the cough suppressant dextromethorphan.
continue to read here
The infant's parents are suing the mother's doctor, whose involvement in the case also led to his being charged with involuntary manslaughter in an indictment filed last week by the Orange County Grand Jury.
The parents of the baby, Andrew Gallegos, have filed a product liability and medical negligence lawsuit against Dr. Andrew Jarminski, physician assistant Joseph Gutierrez, Healthcare Pharmacy, Allied Medical Group and Industrial Pharmacy Management.
The lawsuit claims Gallegos' mother, Priscilla Lujan, went to Jarminski’s Long Beach office in February 2012 for treatment of injuries she suffered while working at Goodwill Industries.
Medical records show Jarminski prescribed Lujan a compound transdermal cream comprised of the antidepressant amitriptyline, the pain reliever tramadol and the cough suppressant dextromethorphan.
continue to read here
Medimix Specialty Pharmacy Hiring Sales Representatives Across the United States
see job announcements on Linked In found here
Seventh Question of the Day June 23, 2014 Does any compounding sales or marketing representative tell the entire truth about the preparations he or she is selling? Why are sales or marketing representatives needed if most compounded preparations are suppose to be patient-specific? Doesn't having these representatives just increase the cost of the compounded medication?
Maryland Racing Commission adopts multiple medication violation points
by Frank Vespe
The Maryland Racing Commission took the next step in reforming its drug and medication rules yesterday, unanimously adopting the Association of Racing Commissioners International (ARCI) multiple medication violation point syste
continue to read here
The Maryland Racing Commission took the next step in reforming its drug and medication rules yesterday, unanimously adopting the Association of Racing Commissioners International (ARCI) multiple medication violation point syste
continue to read here
Jockey Club seeks support for Lasix study
LEXINGTON, Ky. – The Jockey Club has begun seeking support for a multi-million-dollar study that would assess the efficacy of the diuretic furosemide in treating bleeding in horses’ lungs when it is administered 24 hours out from a race compared with the current regulatory limit of four hours, opening up a new debate in a deeply controversial topic.
Jockey Club executive director Matt Iuliano introduced the idea for the study at a meeting of the Kentucky Equine Drug Council on Tuesday afternoon outside Lexington, where the proposal received a mix of lukewarm support and outright hostility from some council members, including an equine veterinarian and the president of the Kentucky Horsemen’s Benevolent and Protective Association.
continue to read here
Jockey Club executive director Matt Iuliano introduced the idea for the study at a meeting of the Kentucky Equine Drug Council on Tuesday afternoon outside Lexington, where the proposal received a mix of lukewarm support and outright hostility from some council members, including an equine veterinarian and the president of the Kentucky Horsemen’s Benevolent and Protective Association.
continue to read here
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