To read an interesting blog post on Big Pharma in India click here
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
Sunday, December 30, 2012
Counterfeit Prescription Drugs: How to Protect Yourself
by Rhona Finkel
on
December
5, 2012
The World Health Organization defines a counterfeit medicine as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."
Counterfeit medicines are defined broadly throughout the world by the World Health Organization. On April 1-3, 1992, experts from the world over met in Geneva for the first international meeting which gathered together member states and other organizations, such as INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16)."
The number of counterfeit drugs continues to grow. According to SafeMedicines.org, counterfeit drugs have killed an estimated 700,000 people from malaria and tuberculosis alone.
Up to a third of all anti-malarials are suspect, and around 10% of all essential drugs in emerging markets fail basic quality tests.
No country is safe. India is the world’s largest manufacturer of generic drugs, but it’s estimated that from 12-25% of their supply might be contaminated with substandard or counterfeit medicines. The WHO reports that many of those medicines find their way to Africa, where some nations may have up to 40% of their drug supply contaminated.
Cardiovascular Medications
Cardiovascular drugs are for a serious need, one which many Americans turn to foreign drug-makers for. But, points out Haiken, the danger isn't that the Americans won't get the medications--rather it's that they will get a dangerous counterfeit instead.
Antibiotics
Of course a counterfeit version might very well not heal you--but it could also make you sicker, as fake meds can be tainted with heavy metals or some other dangerous ingredients.
Cancer Drugs
Fake cancer drugs have been found in both Israel and China--and just February of this year in the U.S. In fact it's possible that doctors' offices and clinics might have bought counterfeit Avastin, containing no real drug, but rather acetone and water.
ED Medications
The Pharmaceutical Security Institute reports that 37% of all fake medicines seized are ED drugs. ED drugs are offered for sale via thousands of fake online pharmacies without prescription requirements. Writes Ms. Haiken, "The real danger of buying these drugs from a non-VIPPS approved pharmacy is that there is a very good chance they will not just be counterfeit, but poison."
Treatments for Chronic Ailments Like HIV, Diabetes & Alzheimer’s
Because chronic ailments respond slowly to treatment. it's hard to know if the drugs are really fake.
Psychiatric Medications
A Google search for Xanax, Ativan, Adderrall, or Ambien reveals hundreds of websites offering these powerful drugs without a prescription.
It is a dangerous world out there, and one where you have to keep your senses about you, since the matter can very easily be the difference between life and death.
Dr Sneh Khemka, Bupa International's medical director, notes that so many of the world's counterfeit medicines come from Asia, particularly China, that it is a dangerous area when you're searching for medical purity. Khemka writes that across the country between 50-85% of some drugs are fake and kill up to 300,000 people per year, which is the equivalent of wiping out the entire population of Iceland every year.
Don't think you're safe if you buy your drugs in any other country, however.
According to the CBS news, the FDA found in April 2012 that a counterfeit version of Roche’s Altuzan (bevacizumab), an injectable cancer medication, contained no active ingredient.
In an article entitled “Fake pharmaceuticals: Bad medicine,” in October 13, 2012's, issue of Economist, the authors determined that Pfizer found 20 counterfeit versions of their drugs in 81 countries in January 2009, and by July 2012, Pfizer reported finding 60 of their counterfeit drugs in 106 countries.
Create.org in a whitepaper on health and safety risks of counterfeits asserts that up to 40 million U.S. prescriptions are filled each year with counterfeits.
"Pharmaceutical counterfeiting is a low-risk, high-profit criminal enterprise that attracts entrepreneurs and organized criminals," says John P. Clark, vice president and chief security officer for the drug company Pfizer. "What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune."
In September/October, Computer World reported, an Interpol operation involving 100 countries seized $10.5 million worth of counterfeit drugs. Nearly 18,000 websites selling fake drugs were shut down during the operation, and 3.7 million doses of counterfeit drugs were seized.
Despite the way counterfeit drugs have encroached upon the U.S., CBS news points out that most of the ingredients in fake American medicines still come from other countries, including China and India, which are known to have weak regulatory systems. The FDA only inspects about 12% of overseas facilities a year.
"Criminal organizations manufacture these counterfeits, not in quality-controlled laboratories, but in hidden rooms with unsanitary conditions. And instead of patented ingredients, these meds can contain a haphazard mix of chemicals and fillers like highway paint, floor wax and boric acid — ingredients and doses that can actually harm you and your family."
It is a serious problem, one which the Department of Justice recognizes poses great danger, and the government recognizes that they need help--our help.
Attorney General Eric Holder launched a massive public education campaign, calling for help from all corners, from the TV, the radio, the newspapers, and blogs."
Because the government can't stop the onslaught alone, in his public campaign, Holder has asked that all Americans be proactive when buying their medications.
He strongly encouraged online-prescription-buyers to follow these tips to avoid counterfeit and possibly harmful products, and these are his warnings verbatim:
A new technology may aid in tracking down counterfeit medications. This September, the Food and and Drug Administration unveiled the Counterfeit Detection Device #3 or CD3.
Battery-operated, the machine can emit up to 10 different wavelengths of ultraviolet and infrared light and can be used on capsules, tablets, powders, and packaging like inks, papers and covert markings. It's also capable of detecting products that have been tampered with, re-labeled, or re-glued. It has already analyzed nearly 100 counterfeit products, finding counterfeits masquerading as Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singular, Plavix, and Wellbutrin.
Despite the threats posed by counterfeit medicines, it is possible to safely purchase legitimate, FDA-approved prescription medicines online if you keep your eyes open. For example, one way to purchase your meds if you have a valid prescription is to ensure that you are buying from a legitimate site. All legitimate sites receive VIPPS® (Verified Internet Pharmacy Practice Sites) accreditation from NABP, which indicates one can find there FDA-approved medications for purchase. A list of VIPPS-accredited pharmacies can be found on the NABP website, www.AWARERx.org.
Dr. Sneh Khemka, publishing on Bupa International, runs through some clues to a counterfeit pill:
Source: Counterfeit Prescription Drugs: How to Protect Yourself - Drugsdb.com http://www.drugsdb.com/blog/counterfeit-prescription-drugs.html#ixzz2GXn3Z6VG
The World Health Organization defines a counterfeit medicine as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."
Counterfeit medicines are defined broadly throughout the world by the World Health Organization. On April 1-3, 1992, experts from the world over met in Geneva for the first international meeting which gathered together member states and other organizations, such as INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16)."
The number of counterfeit drugs continues to grow. According to SafeMedicines.org, counterfeit drugs have killed an estimated 700,000 people from malaria and tuberculosis alone.
Up to a third of all anti-malarials are suspect, and around 10% of all essential drugs in emerging markets fail basic quality tests.
No country is safe. India is the world’s largest manufacturer of generic drugs, but it’s estimated that from 12-25% of their supply might be contaminated with substandard or counterfeit medicines. The WHO reports that many of those medicines find their way to Africa, where some nations may have up to 40% of their drug supply contaminated.
Which drugs are most commonly counterfeited?
Here in the U.S., certain drugs are more likely to be counterfeit.Cardiovascular Medications
Cardiovascular drugs are for a serious need, one which many Americans turn to foreign drug-makers for. But, points out Haiken, the danger isn't that the Americans won't get the medications--rather it's that they will get a dangerous counterfeit instead.
Antibiotics
Of course a counterfeit version might very well not heal you--but it could also make you sicker, as fake meds can be tainted with heavy metals or some other dangerous ingredients.
Cancer Drugs
Fake cancer drugs have been found in both Israel and China--and just February of this year in the U.S. In fact it's possible that doctors' offices and clinics might have bought counterfeit Avastin, containing no real drug, but rather acetone and water.
ED Medications
The Pharmaceutical Security Institute reports that 37% of all fake medicines seized are ED drugs. ED drugs are offered for sale via thousands of fake online pharmacies without prescription requirements. Writes Ms. Haiken, "The real danger of buying these drugs from a non-VIPPS approved pharmacy is that there is a very good chance they will not just be counterfeit, but poison."
Treatments for Chronic Ailments Like HIV, Diabetes & Alzheimer’s
Because chronic ailments respond slowly to treatment. it's hard to know if the drugs are really fake.
Psychiatric Medications
A Google search for Xanax, Ativan, Adderrall, or Ambien reveals hundreds of websites offering these powerful drugs without a prescription.
It is a dangerous world out there, and one where you have to keep your senses about you, since the matter can very easily be the difference between life and death.
Common Sources of Counterfeit Drugs
India and China are most commonly the source of counterfeit drugs. Havocscope, which keeps track of counterfeit medicines worldwide, found that genitourinary medicines, anti-infective drugs, and central nervous system drugs are the most frequently counterfeited kinds of medications. Just this August, according to Scientific American, "$182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China."Dr Sneh Khemka, Bupa International's medical director, notes that so many of the world's counterfeit medicines come from Asia, particularly China, that it is a dangerous area when you're searching for medical purity. Khemka writes that across the country between 50-85% of some drugs are fake and kill up to 300,000 people per year, which is the equivalent of wiping out the entire population of Iceland every year.
Don't think you're safe if you buy your drugs in any other country, however.
According to the CBS news, the FDA found in April 2012 that a counterfeit version of Roche’s Altuzan (bevacizumab), an injectable cancer medication, contained no active ingredient.
In an article entitled “Fake pharmaceuticals: Bad medicine,” in October 13, 2012's, issue of Economist, the authors determined that Pfizer found 20 counterfeit versions of their drugs in 81 countries in January 2009, and by July 2012, Pfizer reported finding 60 of their counterfeit drugs in 106 countries.
Create.org in a whitepaper on health and safety risks of counterfeits asserts that up to 40 million U.S. prescriptions are filled each year with counterfeits.
"Pharmaceutical counterfeiting is a low-risk, high-profit criminal enterprise that attracts entrepreneurs and organized criminals," says John P. Clark, vice president and chief security officer for the drug company Pfizer. "What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune."
In September/October, Computer World reported, an Interpol operation involving 100 countries seized $10.5 million worth of counterfeit drugs. Nearly 18,000 websites selling fake drugs were shut down during the operation, and 3.7 million doses of counterfeit drugs were seized.
Despite the way counterfeit drugs have encroached upon the U.S., CBS news points out that most of the ingredients in fake American medicines still come from other countries, including China and India, which are known to have weak regulatory systems. The FDA only inspects about 12% of overseas facilities a year.
How to know Whether Your Prescription Drugs are Counterfeit
The World Health Organization estimates that over half the drugs sold online via websites that hide their physical address are counterfeit. Writes the WHO:"Criminal organizations manufacture these counterfeits, not in quality-controlled laboratories, but in hidden rooms with unsanitary conditions. And instead of patented ingredients, these meds can contain a haphazard mix of chemicals and fillers like highway paint, floor wax and boric acid — ingredients and doses that can actually harm you and your family."
It is a serious problem, one which the Department of Justice recognizes poses great danger, and the government recognizes that they need help--our help.
Attorney General Eric Holder launched a massive public education campaign, calling for help from all corners, from the TV, the radio, the newspapers, and blogs."
Because the government can't stop the onslaught alone, in his public campaign, Holder has asked that all Americans be proactive when buying their medications.
He strongly encouraged online-prescription-buyers to follow these tips to avoid counterfeit and possibly harmful products, and these are his warnings verbatim:
- Don’t buy drugs from sites that sell prescription drugs without a prescription from your own physician.
- Consult the National Association of Boards of Pharmacy, which maintains a list of accredited online pharmacies" [to be sure that the pharmacy from which you're buying the medication is valid].
- If using an online pharmacy, make sure it has a legitimate brick-and-mortar street address, as well as a pharmacist on duty and available.
- Discard the medication if it is of a different size or color, or if it has a different or odd-looking brand insignia from the medication you are used to taking.
- Discard the medication if it dissolves differently or badly or has a strange or bitter taste that you are not accustomed to.
- If you suspect a website is selling counterfeit meds, report it here.
- And for more info on buying medicine on the Internet, go to fda.gov/ForConsumers/ConsumerUpdates or nabp.net/programs/consumer-protection/buying-medicine-online/counterfeit-drugs/.
A new technology may aid in tracking down counterfeit medications. This September, the Food and and Drug Administration unveiled the Counterfeit Detection Device #3 or CD3.
Battery-operated, the machine can emit up to 10 different wavelengths of ultraviolet and infrared light and can be used on capsules, tablets, powders, and packaging like inks, papers and covert markings. It's also capable of detecting products that have been tampered with, re-labeled, or re-glued. It has already analyzed nearly 100 counterfeit products, finding counterfeits masquerading as Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singular, Plavix, and Wellbutrin.
Protecting Yourself
Huffington Post has a few ideas. Know that Pfizer has partnered with the National Association of Boards of Pharmacy® (NABP) and several other organizations on a YouTube channel, SpotFakeMeds, that allows consumers to hear firsthand from anti-counterfeiting experts about what to look out for and how to buy online safely.Despite the threats posed by counterfeit medicines, it is possible to safely purchase legitimate, FDA-approved prescription medicines online if you keep your eyes open. For example, one way to purchase your meds if you have a valid prescription is to ensure that you are buying from a legitimate site. All legitimate sites receive VIPPS® (Verified Internet Pharmacy Practice Sites) accreditation from NABP, which indicates one can find there FDA-approved medications for purchase. A list of VIPPS-accredited pharmacies can be found on the NABP website, www.AWARERx.org.
Dr. Sneh Khemka, publishing on Bupa International, runs through some clues to a counterfeit pill:
- Spot the difference. Is the lettering on the packaging hazy and printed flat (rather than raised), or is the expiry date missing?
- Read carefully. Are the labeling and patient information in a language you understand? If there are misspelled words, contact the manufacturers – it can be a telltale sign.
- Use your senses. Is the medicine the same size, shape, texture, colour and taste as your previous prescription?
- Feel for consistency. When you handle the drug does it fall apart easily? If so, it could signal a fake.
- Do a price check. Does the cost of the drug seem very cheap in comparison with your official provider? If it’s much lower, it could be a scam.
- Prescriptions. Make sure the website you buy from requires a prescription and has a pharmacist you can contact for questions.
- Licensing. Only buy from certified online pharmacies. Search the website for a declaration of authenticity or certification and double- check this with your country’s official drug regulatory agency. For example, pharmacies in the UK that are registered with the Royal Pharmaceutical Society of Great Britain can display a logo on their website.
- Security. Don’t supply any credit card numbers unless you are sure the website has policies in place to protect your information and has a secure online payment system.
- Promises. Statements such as ‘no risk’ and ‘money-back guarantees’ can be key giveaways of a counterfeit website.
Source: Counterfeit Prescription Drugs: How to Protect Yourself - Drugsdb.com http://www.drugsdb.com/blog/counterfeit-prescription-drugs.html#ixzz2GXn3Z6VG
K-V Pharmaceutical Receives Court Approval of Hologic Settlement
Clears Path Forward for K-V's Pursuit of
Chapter 11 Reorganization Plan
ST. LOUIS, Dec. 28, 2012 /PRNewswire/ -- K-V Pharmaceutical
Company ("K-V" or "the Company") today announced that the U. S. Bankruptcy Court
for the Southern District of New York, the Honorable Judge Allan L. Gropper presiding, approved
the Company's settlement agreement with Hologic, Inc. ("Hologic Settlement"),
and authorized the Company to enter into an $85 million debtor-in-possession ("DIP") financing to,
among other things, fund the settlement.
"The resolution of the Hologic litigation
is a major milestone in our restructuring. Now that it is resolved, K-V can
focus on completing all other necessary steps for confirmation of a plan of
reorganization and timely emergence from Chapter 11," said K-V President and CEO
Greg Divis. "We
are committed to our core women's health care business and continue to work
closely with our customers to advance the care of the patients we serve."
18th Annual North Carolina Veterinary Conference! November 1–3, 2013 at the Raleigh Convention Center!
More information will be posted at the site located here as it becomes available
CA court rules pet owners can sue for more than market value
A California appeals court recently sided with pet owners in two cases where the owners were attempting to sue for damages beyond the animals’ market value. The decision sets another precedent in the legal system’s efforts to legally and monetarily define a pet’s value. The Second District Court of Appeals wrote in its opinion filed Oct. 23: “We hold that a pet owner is not limited to the market value of the pet and may recover the reasonable and necessary costs incurred for the treatment and care of the pet attributable to the injury.” Instead of tackling the subject of sentimental value, which has been a thorny issues for courts in other states, the appeals court based its decision on the actual costs paid by owners to treat their pets following an injury. Case summaries In the first case considered by the Second District Court of Appeals, a woman took her dog to have a small liver lobe removed. According to the court documents, the veterinarian allegedly “nicked and cut” the dog’s intestine during surgery, causing internal bleeding. The veterinarian also reportedly left a piece of surgical gauze inside of the dog. The woman spent $4,836.16 on the initial surgery, and then paid an emergency hospital $37,766.06 to stop the resulting internal bleeding and remove the gauze. She filed her lawsuit after the veterinarian reportedly offered to refund the $4,836.16 but refused her requests for money related to the emergency hospital fees. The second case involved a dog that escaped into a yard next door and began barking at the neighbor’s dog. The neighbor shot the dog in the leg and claimed it was self-defense even though the dogs were still separated by a gate. Veterinarians were eventually forced to amputate the leg, and the dog’s owner sued the neighbor for $20,789.81 in veterinary bills. In those two cases, trial courts ruled that the owners could only sue for market value, which prompted them to bring their cases to appeals court. Ruling details The ruling from the appeals court reversed the previous decisions and allowed the owners to sue for more than market value â?? as long as the amount is based on “reasonable and necessary” costs related to the animal’s treatment. In the court’s written opinion, the judge explained that a previous case â?? Kimes, supra, 195 Cal.App.4th 1556 â?? heavily influenced the court’s ruling. In the Kimes case, the owner of an adopted stray cat sued his neighbors after they allegedly shot the pet with a pellet gun and left it paralyzed. The owner’s lawsuit asked for $6,000 for the emergency surgery as well as $30,000 for costs incurred while caring for the cat. According to the appeals court, the opinion in the Kimes case stated: “In this case, plaintiff is not plucking a number out of the air for the sentimental value of damaged property; he seeks to present evidence of costs incurred for [the cat‘s] care and treatment by virtue of the shooting — a ‘rational way’ of demonstrating a measure of damages apart from the cat‘s market value.” The Second District Court of Appeals further explained its position by referring to animals using the terms “sentient beings” and “distinct and specially protected form of property,” which are terms that many courts have historically refrained from using. The article was provided by the American Animal Hospital Association. The court stated: “In California, the Legislature has recognized since 1872 that animals are special, sentient beings, because unlike other forms of property, animals feel pain, suffer and die. Civil Code section 3340 provides that â?? [f]or wrongful injuries to animals being subjects of property, committed willfully or by gross negligence, in disregard of humanity, exemplary damages may be given. Laws criminalizing animal abuse underscore the Legislature‘s view that animals are a distinct and specially protected form of property.” Source found here |
2013 OVMA 98th Annual Convention & Expo Sunday, January 27, 2013 - Tuesday, January 29, 2013
Oklahoma Veterinary Medical Association 98th Annual Convention will be held in Tulsa, Oklahoma, Sunday, January 27, 2013 - Tuesday, January 29, 2013, with a wide list of topics and speakers. For more information, click here
2013 Midwest Veterinary Conference Features Compounding Topics
February 21-24, 2013 at the Greater Columbus Convention Center, Columbus, OhioTopicOhio Pharmacy Laws; Compounding Topics Mr. Kyle Parker For more information click here |
Saturday, December 29, 2012
FDASIA-Mandated Drug Labeling Work Group To Hold First Meeting Next Month
Saturday, December 29, 2012
A working group mandated by the FDA Safety and Innovation Act to outline, in the coming months, best practices for communicating drug labeling information to blind or visually impaired patients will hold its first meeting next month.
Source found here (subscription required)
FDA Budget Cuts Could Mean Fewer Drug Inspections, Stakeholders Say
December 29, 2012
Stakeholders are questioning how FDA, in the face of possible sequestration and the fiscal cliff, will be able to meet inspection requirements under both the FDA Safety and Innovation Act and the Food Safety Modernization Act, and a former FDA official said the food law's mandate for a specific number of prevention-based inspections every two years could lead to fewer drug inspections, which Congress requires FDA do only when there is a perceived risk.Source found here (subscription required)
Hamburg: FDA's Compounding Plan Averts 'Dislocations' Within Healthcare System
December 29, 2012
FDA's plan to create a tiered oversight system for traditional and non-traditional compounding would address a growing area of risk without creating “huge dislocations” within the healthcare system, which has become increasingly dependent on outsourcing certain functions to large-scale compounders, said FDA Commissioner Margaret Hamburg as she met with regulators from 50 states last week.
Source found here (subscription required)
Reminder: Mandatory Survey of all NH Licensed / Registered in-State & Non-Resident Pharmacies Regarding Compounding Are Due Immediately
All NH licensed in-state pharmacies and all registered
non-resident / mail-order pharmacies are required to submit responses to an
online survey regarding compounding practices. The survey
can be started by clicking here - you will need to enter your pharmacy's NH
license / registration number to complete the survey. Notices regarding this
mandatory survey were mailed out to all registered non-resident pharmacies and
faxed to all licensed in-state pharmacies on Monday, December 10th. The deadline
for answering the survey was Wednesday, December 19, 2012
- if you have not yet responded to the survey, please do so immediately.
Pharmacies / pharmacists-in-charge that fail to respond to this mandatory survey
are subject to disciplinary action by the Board.
|
Friday, December 28, 2012
Revised USP Standards Guide Prescription Container Labels
Revised USP Standards Guide Prescription Container Labels
The US Pharmacopeial Convention (USP) has released standards that provide a universal approach to organizing labels for prescription containers dispensed by pharmacists. The new standards aim to eliminate the variability that currently exists between pharmacies across the US and improve patient understanding of medication instructions by giving direction for optimal format, appearance, content, and language.
The standards include detailed instructions for how to:
Emphasize instructions and information important to patients
Improve readability
Give explicit instructions
Include purpose for use
Address limited English proficiency
Address visual impairment.
The standards are contained in General Chapter <17> Prescription Container Labeling (November 2012). For more details, see USP.
Year in Review: Meningitis Outbreak Still a Challenge
By Michael Smith, North American Correspondent, MedPage Today
Published: December 28, 2012
As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened with the fungal meningitis outbreak since we published our first report.
The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.
What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.
It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.
"The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing," Kauffman told MedPage Today. "The huge morbidity and, for some, mortality, is enormous."
The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called "compounding pharmacies."
And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.
The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.
The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: "We're still in the middle of this thing."
Compounding Out of Bounds
The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.
Continue to read here
Salem woman files $25 million lawsuit over meninigitis outbreak
» Comments | Post a
Comment
ROANOKE, VA --
As more and more people were diagnosed with fungal meningitis in the Roanoke
Valley lawsuits began to pop up against the two companies believed to be
responsible, Insight Imaging in Roanoke which gave the epidural steroid
injection and New England Compounding Pharmacy which created the drug.
But now we're learning more about the extent of the allegations thanks to a $25 million lawsuit filed in Roanoke City Circuit Court on Thursday.
The 35 page lawsuit details alleged neglect and fraud by both companies.
In one of the more serious allegations the lawsuit claims Insight Imaging told patients they were receiving Depo-Medrol, a FDA approved steroid injection.
Instead patients received a different injection produced and distributed by the New England Compounding Pharmacy that was not FDA approved, this is according to the lawsuit.
"That's extremely troubling because it's just completely false," said Scott Sexton of Gentry Locke Rakes & Moore, the law firm representing 20 victims and their families. "It doesn't provide the right information to the patient or to the patient's insurer."
Sharon Wingate filed the $25 million lawsuit after her husband died of meningitis.
He received the epidural steroid injection from Insight Imaging in Roanoke earlier this year.
"It's rare to have those facts line up as they do in this case where you have a patient receiving one thing but he's being told it's another," Sexton said.
The lawsuit also alleges the Boston based New England Compounding Pharmacy, which is located next to a garbage dump, used unsanitary methods to produce the drug.
WSLS contacted Insight Imaging for their response to the lawsuit but our call was not returned.
Six more lawsuits were filed against the company on Friday and Sexton said more could be on the way next week.
It's the beginning of what will likely be a long legal process.
Source found here
But now we're learning more about the extent of the allegations thanks to a $25 million lawsuit filed in Roanoke City Circuit Court on Thursday.
The 35 page lawsuit details alleged neglect and fraud by both companies.
In one of the more serious allegations the lawsuit claims Insight Imaging told patients they were receiving Depo-Medrol, a FDA approved steroid injection.
Instead patients received a different injection produced and distributed by the New England Compounding Pharmacy that was not FDA approved, this is according to the lawsuit.
"That's extremely troubling because it's just completely false," said Scott Sexton of Gentry Locke Rakes & Moore, the law firm representing 20 victims and their families. "It doesn't provide the right information to the patient or to the patient's insurer."
Sharon Wingate filed the $25 million lawsuit after her husband died of meningitis.
He received the epidural steroid injection from Insight Imaging in Roanoke earlier this year.
"It's rare to have those facts line up as they do in this case where you have a patient receiving one thing but he's being told it's another," Sexton said.
The lawsuit also alleges the Boston based New England Compounding Pharmacy, which is located next to a garbage dump, used unsanitary methods to produce the drug.
WSLS contacted Insight Imaging for their response to the lawsuit but our call was not returned.
Six more lawsuits were filed against the company on Friday and Sexton said more could be on the way next week.
It's the beginning of what will likely be a long legal process.
Source found here
Doctor pleads not guilty to illegal weight-loss meds 2 Bucyrus patients were on the physician's client list
COSHOCTON — Dr. David A. Velasquez, accused of illegally selling weight-loss medication, pleaded not guilty Thursdsay to charges brought by indictment of a recent grand jury.
While he’s lived in the United States as a permanent resident with a green card, Velasquez retains his citizenship with El Salvador, said Jill Del Greco, spokesperson for the Ohio Attorney General’s Office.
Therefore he has the right to notify the El Salvador Embassy of the felony charges against him, according to the Ohio Attorney General’s Office. If Velasquez chooses to notify the embassy of his status, a consular officer has the right to visit him and arrange for legal representation, according to the U.S. State Department.
Continue reading here
NECC lawsuits-years of litigation and looking for deep pockets
"It will likely take years for federal and state lawsuits over a meningitis
outbreak tied to the New England Compounding Center to make their way through
federal and state courts. The chance of recovering damages from NECC is
extremely low," which means attention will turn to clinics and providers who
gave the shots, said John Day, an attorney in several of the suits." The
Tennessean (Nashville)/The Associated Press (12/14), ttp://www.tennessean.com/article/20121214/NEWS07/312140091
Once Again, "Pharmacy" is Evolving; Pharmacy Isn't Pharmacy Any More
From PharmQD written by BarbaraMorris in Pharmacy Isn't Pharmacy Any
More on 12.27.12 - 5:55 pm in response to Harold E. Cohen's "Straight
Talk" editorial in U.S. Pharmacist, December 2012
Way back in the dark ages, (circa 1940s) pharmacy graduates had to take grueling state board exams to get a license to practice what Professor Cyrus Cox at Rutgers College of Pharmacy called “the ancient and noble art of the apothecary”. Gradually, that hard won training to qualify as such a pharmacist has become worthless; pharmacist duties gradually have been taken over by a new class of health care workers, the “certified licensed technician.” How lovely.
When I was trained as a pharmacist, “compounding” (now a suspect activity) is what we did, and we didn’t kill anyone with questionable complex compounds often with dangerous side effects. Big pharma had not yet co-opted the term “pharmacy,” to use as a cover to promote and sell pharmaceutical industry nostrums that are the fourth leading cause of death in this country.Continue reading here
Veterinary Malpractice
On November 14, 2012, in PetPro, blog John Thompson, wrote a very good blog on the fast developing area of veterinary medical malpractice law. While his blog post does not specifically mention errors relating to compounded drugs this type of error could clearly fit within a veterinary medical malpractice claim under the appropriate facts and circumstances. John Thompson's blog begins:
Veterinary medical malpractice is becoming a topic that is being discussed and debated more and more as time goes by. This has been exacerbated by the fact that some states are beginning to treat pets as members of the family rather than property of the family in malpractice lawsuits. This change essentially means that families suing for veterinary malpractice won’t be limited in the monetary awards for the market value of the pet, but for sentimental value which exceeds the payouts of market value by a vast margin.To continue reading this blog entry click here
Wheaton Animal Hospital Blog Warns About the Problem With Online Pet Pharmacies
That blog entry dated December 27th, 2012, begins:
You may be asking yourself, “Why shouldn’t I order my pet’s prescription online? Good prices, direct shipping, what’s to lose?” Be aware that it may not be as good as it sounds though. Take the following into account before choosing where to purchase your next veterinary prescription:
To continue reading this blog click here
- When your veterinarian prescribes a medication, he or she can dispense it in a safe manner, ensuring your pet has had any recommended screening performed, looking out for drug interactions, and keeping the product in an appropriate manner. This does not always happen with online pharmacies.
Article Cites 6 Causes for Decline In Veterinary Visits
By Marissa Heflin and Brian Hutchins
A major national study has found that the decline in the number of veterinary visits over the past decade is rooted in six major factors having a common theme: Relatively few pet owners fully appreciate the value of professional veterinary services.
The Bayer Veterinary Care Usage Study was commissioned by Bayer Animal Health and conducted by Brakke Consulting and the National Commission on Veterinary Economic Issues. It identified the six causes as the economic impact of the recession; fragmentation of veterinary services; the Internet, primarily healthcare research; feline resistance; a perception among pet owners that regular medical checkups are unnecessary; and the cost of care.
Continue reading here
A major national study has found that the decline in the number of veterinary visits over the past decade is rooted in six major factors having a common theme: Relatively few pet owners fully appreciate the value of professional veterinary services.
The Bayer Veterinary Care Usage Study was commissioned by Bayer Animal Health and conducted by Brakke Consulting and the National Commission on Veterinary Economic Issues. It identified the six causes as the economic impact of the recession; fragmentation of veterinary services; the Internet, primarily healthcare research; feline resistance; a perception among pet owners that regular medical checkups are unnecessary; and the cost of care.
Continue reading here
Thursday, December 27, 2012
FDA: Pet medication errors on the rise Agency issues warning to all pet owners
Updated: Thursday, 27 Dec 2012, 9:38 PM EST
Published : Thursday, 27 Dec 2012, 9:37 PM EST
Published : Thursday, 27 Dec 2012, 9:37 PM EST
- By Susan Hogan
- By Shaun Towne
(WPRI) -- You've most likely heard about devastating medication errors
happening with people, but now the Food and Drug Administration is issuing a
warning to pet owners because investigators are finding an increased number of
mistakes with pet prescriptions.
All Sarah Schuck has left of her beloved 8-year-old Labrador, Rafter, is a collar, pictures, and fond memories.
"It was really hard," she said.
Hard, because it shouldn't have happened. Sarah tells Call 12 For Action that the drug store that filled Rafter's prescription made an error. His medication bottle label said to give him "two and one-fourth teaspoons." The problem was that the dosage her vet called into the pharmacy was for much less medication - "two and one fourth cc."
The overdose, combined with Rafter's health problems, was too much for the dog, and she was forced to put him to sleep.
"It was a tough realization," Schuck said.
Just days after Rafter's death, the FDA issued a warning about a pattern of pet prescription mistakes. Investigators discovered errors stemming from simple issues such as look-alike packaging, drugs with similar names, and simple penmanship errors.
"The consequences can be completely devastating," said veterinarian Dr. Howard Silberman.
Dr. Silberman said he takes prescription precautions at his office. All medications and dosages are typed into a computer, only vets or vet techs fill the prescriptions, and pictures of each pet are printed on the labels so there are no mix-ups.
"We do a tremendous amount to make sure that those things don't happen," he added.
The FDA said that while mistakes do happen at vet-based pharmacies, when pet prescriptions are filled in human pharmacies, different systems may be to blame. Abbreviations are a common cause of errors because prescription shorthand taught in veterinary schools differs from shorthand taught in medical schools, and some pharmacists may not be familiar with vet abbreviations.
"Don't be afraid to ask questions," she said.
FDA investigators also found pet medication errors stemmed from pet owners misinterpreting labels and accidentally giving pets human drugs.
All Sarah Schuck has left of her beloved 8-year-old Labrador, Rafter, is a collar, pictures, and fond memories.
"It was really hard," she said.
Hard, because it shouldn't have happened. Sarah tells Call 12 For Action that the drug store that filled Rafter's prescription made an error. His medication bottle label said to give him "two and one-fourth teaspoons." The problem was that the dosage her vet called into the pharmacy was for much less medication - "two and one fourth cc."
The overdose, combined with Rafter's health problems, was too much for the dog, and she was forced to put him to sleep.
"It was a tough realization," Schuck said.
Just days after Rafter's death, the FDA issued a warning about a pattern of pet prescription mistakes. Investigators discovered errors stemming from simple issues such as look-alike packaging, drugs with similar names, and simple penmanship errors.
"The consequences can be completely devastating," said veterinarian Dr. Howard Silberman.
Dr. Silberman said he takes prescription precautions at his office. All medications and dosages are typed into a computer, only vets or vet techs fill the prescriptions, and pictures of each pet are printed on the labels so there are no mix-ups.
"We do a tremendous amount to make sure that those things don't happen," he added.
The FDA said that while mistakes do happen at vet-based pharmacies, when pet prescriptions are filled in human pharmacies, different systems may be to blame. Abbreviations are a common cause of errors because prescription shorthand taught in veterinary schools differs from shorthand taught in medical schools, and some pharmacists may not be familiar with vet abbreviations.
The
American Veterinary Medical Association said that communication is key in
avoiding a pet medication mix-up. Make sure your pharmacist speaks to your vet
if they have any questions. The FDA also advises pet owners to verify the name
and dosage of your pet's drug with your vet.
Schuck says she hopes Rafter's legacy lives on to help other owners to avoid
these types of mistakes."Don't be afraid to ask questions," she said.
FDA investigators also found pet medication errors stemmed from pet owners misinterpreting labels and accidentally giving pets human drugs.
For more information on how to prevent pet
medication errors, visit the FDA's
website.
Copyright WPRI
12
Russia to Decriminalize Some Veterinary Drugs
MOSCOW, December 25 (RIA Novosti) -
Russia's Federal Drug Control Service said on Tuesday that it does not oppose
expanding the list of narcotic substances permitted for veterinary use.
“The Agriculture Ministry and the Health
Ministry may introduce changes into the list of narcotic and psychotropic
substances allowed for use in veterinary medicine, and the FDCS has never
objected to that,” the service said in a statement posted on its website.
One of the most controversial drugs
currently banned for veterinary use is ketamine. It is used primarily for the
induction and maintenance of general anesthesia and for putting down sick
animals.
It was deemed illegal as an attempt to stem
the use of it as a recreational drug.
The increase in illicit use prompted
ketamine's placement in Schedule III of the United States Controlled Substance
Act in August 1999.
There have been numerous reports of
veterinarians being prosecuted for using ketamine. In September, a
St. Petersburg based veterinarian, Alexander Shpak, was sentenced to eight years
in jail.
The agriculture and health ministries have
long been pushing for its legalization in veterinary medicine.
“Prompt resolution of that issue will help
take the edge off the problem and ensure humane treatment of animals in need of
veterinary aid,” the FDCS said.
Source found here
K-V Pharmaceutical Approved to Access Loan to Pay Hologic
Joseph
Checkler,
December 27, 2012,
(c) 2012 Dow Jones &
Company, Inc.
A judge on Thursday
said K-V Pharmaceutical Co. could take out an $85 million loan that will help it
pay off a debt to competitor Hologic Inc., a crucial moment for K-V as it inches
toward restructuring itself in Chapter 11. ...
Continue reading here
Next Assignment: Researching Which Compounding Pharmacy/Pharmacist to Do Business With
Coming soon will be a blog devoted to how to research which compounding pharmacy and pharmacist to do business with whether you are a doctor, a veterinarian or an average citizen. The article will give you examples of where to find valuable information on the Internet, by writing your state boards of pharmacy and by checking with the Food and Drug Administration. In the article, we will look at several actual compounding pharmacies and look at what information is readily available on those pharmacies. Then we will explode where to look for information that might not be readily available. Ultimately, the decision of which compounding pharmacy and pharmacist to use is that of the consumer--whether it be a doctor, a veterinarian, or an average citizen. While this information might be helpful in preventing some tragedies such as the NECC meningitis outbreak, ultimately enforcement of laws and regulations is the key. Only through strong enforcement of the rules and regulations will bad compounders be shut down and tragedies such as the meningitis outbreak be prevented. Not doing business with compounders who are not in compliance with the rules and regulations is at least a step in the right direction.
More Transparency in and Easier Access of Discipline Records Needed: Tennessee Case Fails to Name Pharmacy and Pharmacists
By Doletta Sue Tuck
Originally Posted July 12, 2012
Reposted December 27, 2012
More transparency of disciplinary records is needed regarding violations of compounding rules and regulations. Right now one must go to each individual state board of pharmacy to determine if a pharmacy or pharmacist that compounds drugs has been disciplined. In same states, the records are not available online. In other states, one maybe able to see that a pharmacist or pharmacy has been disciplined but it cannot be seen what the discipline was for. In most states, you can obtain the information by writing the state board. Some states require the requestor of the information to pay to have the information copied. In other states, you can see that a compounding pharmacy or pharmacist was disciplined but you cannot determine the name of either. An example of this is found in the board minutes of the Tennessee Department of Health Board of Pharmacy for Jan. 2012. The minutes contain the following enter:
Jan. 2012--Tennessee
5. Case No.: L11-PHR-RBS-20100093
Complaint generated from period inspection of Respondent’s compounding pharmacy. Periodic inspection found 20 partially filled compounding drugs which had expiration dates going back to 2009 and a hood which had not been recertified since 2007. At time of initial inspection Respondent stated that routine checks are conducted relating to expiration dates, however the shelf where the expired medication were found was inadvertently missed. A subsequent inspection was conducted which found that all expired drugs had been removed and that the non sterile hood had been recertified.
Prior discipline: none
Recommendation: Letter of Warning
Dr. Stephens made the motion to issue a Letter of Instruction to the pharmacy for the expired drugs. Dr. Smothers seconded the motion. The motion carried.While this entry lets the public know that Tennessee is taking disciplinary action against pharmacies and pharmacists who break the compounding regulations and rules, it is not helpful to consumers who want to make informed decisions about which pharmacies and pharmacists to use. Easier access to disciplinary actions is greatly needed in the compounding world. Such public access could encourage more compliance with the rules and regulations.
Posted by Doletta Sue Tuck at 7/12/2012 04:08:00 PM
Georgia Proposed Rule Discussed Board of Pharmacy at December 12, 2012 meeting.
If readers know status please update us. That proposed rule provides:
SYNOPSIS AND DIFFERENCES OF THE PROPOSED RULE OF
THE GEORGIA STATE BOARD OF PHARMACY,
PURPOSE: The purpose of this amendment is to change the requirements for distribution of compounded drugs.
MAIN FEATURES: The main feature of this proposed amendment is the removal of “inordinate amounts of” in paragraph 1(d) and the removal of “except in the course of professional practice for a prescriber to administer to an individual patients” in paragraph 1(f).
RULE 480-11-.02 COMPOUNDED DRUG PREPARATIONS
(1) Compounded drug preparations -Pharmacist.
(a) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order or in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug preparations that are commercially or not commercially available in the marketplace.
(b) Pharmacists shall receive, store, or use drugs that have been made in a FDA-approved facility. Pharmacists shall also receive, store, or use drugs in compounding prescriptions that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment to procure alternatives.
(c) Pharmacists may compound drugs prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such preparations compounded at the pharmacy. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing which requires a manufacturer’s license.
(d) The distribution of inordinate amounts of compounded preparations without a prescriber/patient/pharmacist relationship is considered manufacturing.
(e) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order, pharmacists may compound, in reasonable quantities, drug products that are commercially or not commercially available in the marketplace.
(f) Pharmacists shall not offer compounded drugs to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient.
(g) Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable state laws and rules regulating the practice of pharmacy.
(2) If low, medium, and/or high risk sterile preparations are being compounded, they must be in accordance with USP 797 and/or Georgia regulations.
(3) Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board’s rules for nuclear pharmacists and pharmacies must be followed.
(4) Special precaution preparations. If drug preparations with special precautions for contamination are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its return to inventory, must be utilized in order to prevent cross-contamination.
(5) Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved.
(a) All cytotoxic drugs should be compounded in a vertical flow, Class II, biological safety cabinet or an appropriate barrier isolator. Other preparations should not be compounded in this cabinet.
(b) Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH.) in addition to appropriate compounding attire as described in USP 797.
(c) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile preparations.
(d) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.
(e) Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.
(f) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and delivered in a manner to minimize the risk of accidental rupture of the primary container.
(g) Disposal of cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of cytotoxic and/or infectious waste in a manner so as not to endanger the public health.
Authority O.C.G.A. Secs. 26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.
SYNOPSIS AND DIFFERENCES OF THE PROPOSED RULE OF
THE GEORGIA STATE BOARD OF PHARMACY,
PURPOSE: The purpose of this amendment is to change the requirements for distribution of compounded drugs.
MAIN FEATURES: The main feature of this proposed amendment is the removal of “inordinate amounts of” in paragraph 1(d) and the removal of “except in the course of professional practice for a prescriber to administer to an individual patients” in paragraph 1(f).
RULE 480-11-.02 COMPOUNDED DRUG PREPARATIONS
(1) Compounded drug preparations -Pharmacist.
(a) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order or in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug preparations that are commercially or not commercially available in the marketplace.
(b) Pharmacists shall receive, store, or use drugs that have been made in a FDA-approved facility. Pharmacists shall also receive, store, or use drugs in compounding prescriptions that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment to procure alternatives.
(c) Pharmacists may compound drugs prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such preparations compounded at the pharmacy. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing which requires a manufacturer’s license.
(d) The distribution of inordinate amounts of compounded preparations without a prescriber/patient/pharmacist relationship is considered manufacturing.
(e) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order, pharmacists may compound, in reasonable quantities, drug products that are commercially or not commercially available in the marketplace.
(f) Pharmacists shall not offer compounded drugs to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient.
(g) Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable state laws and rules regulating the practice of pharmacy.
(2) If low, medium, and/or high risk sterile preparations are being compounded, they must be in accordance with USP 797 and/or Georgia regulations.
(3) Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board’s rules for nuclear pharmacists and pharmacies must be followed.
(4) Special precaution preparations. If drug preparations with special precautions for contamination are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its return to inventory, must be utilized in order to prevent cross-contamination.
(5) Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved.
(a) All cytotoxic drugs should be compounded in a vertical flow, Class II, biological safety cabinet or an appropriate barrier isolator. Other preparations should not be compounded in this cabinet.
(b) Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH.) in addition to appropriate compounding attire as described in USP 797.
(c) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile preparations.
(d) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.
(e) Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.
(f) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and delivered in a manner to minimize the risk of accidental rupture of the primary container.
(g) Disposal of cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of cytotoxic and/or infectious waste in a manner so as not to endanger the public health.
Authority O.C.G.A. Secs. 26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.
FDA warns doctors of counterfeit Botox NY Times Wed, 26 Dec 2012 11:00 CST
Federal regulators have warned more than 350 medical practices that Botox they
may have received from a Canadian supplier is unapproved and could be
counterfeit or unsafe.The Food and Drug Administration said in a letter sent
last month, a letter released publicly last week, that batches of the wrinkle
treatment shipped by suppliers owned by pharmacy Canada Drugs have not been
approved by the FDA and that the agency cannot assure their effectiveness or
their safety.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.
In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.
A request for comment from the drug distributor was not immediately returned.
Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.
In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.
A request for comment from the drug distributor was not immediately returned.
Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.
In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.
Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made
by Roche Holding AG's Genentech unit.
The FDA's warning letter, plus a list of doctors who received it: http://1.usa.gov/R7jKiR
The FDA's warning letter, plus a list of doctors who received it: http://1.usa.gov/R7jKiR
Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States
Dec 26th, 2012
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The State of Massachusetts has closed three more compounding pharmacies in
the wake of its ramping up of oversight of those making sterile injectables.
The Mass. Board of Pharmacy (MBP) has completed more than a dozen unannounced inspections of sterile compounders en route to an across-the-board evaluation of all 25 of those that have been identified in the state.
The inspections are part of a state crack down on compounders that ensued in the wake of the fungal meningitis outbreak caused by the Mass.-based New England Compounding Center. Both NECC and its affiliate Ameridose have been shut down and all products compounded at the two companies recalled. NECC filed for Chapter 11 bankruptcy in late December.
The new regulations require sterile compounding pharmacies in Massachusetts to report, for the first time, volume and distribution figures to the state. That data will be monitored to detect a pharmacy that is acting more like a drug manufacturer, which requires inspection and licensing from FDA. They are also required to attest that they are meeting all state laws and regulations.
Source found here
The Mass. Board of Pharmacy (MBP) has completed more than a dozen unannounced inspections of sterile compounders en route to an across-the-board evaluation of all 25 of those that have been identified in the state.
The inspections are part of a state crack down on compounders that ensued in the wake of the fungal meningitis outbreak caused by the Mass.-based New England Compounding Center. Both NECC and its affiliate Ameridose have been shut down and all products compounded at the two companies recalled. NECC filed for Chapter 11 bankruptcy in late December.
The new regulations require sterile compounding pharmacies in Massachusetts to report, for the first time, volume and distribution figures to the state. That data will be monitored to detect a pharmacy that is acting more like a drug manufacturer, which requires inspection and licensing from FDA. They are also required to attest that they are meeting all state laws and regulations.
[Editor’s Note: See the IPQ “Special Report” November 2012 for an in-depth analysis of the far-reaching implications of the pharmacy compounding quality control breakdown that stretch across the regulatory, political, legislative and health policy arenas.]The broader inspection initiative was announced by the Mass. Department of Health at the beginning of November along with a series of emergency regulations to bring greater scrutiny to the compounding industry (IPQ “The News in Depth” Nov. 27, 2012).
Source found here
PA lacks patient protection against sterile compounding errors
Filed Under: Michael Cohen
POSTED: Thursday, October 25, 2012, 10:38
AM
By Michael R. Cohen, R.Ph. Pennsylvania is one of only 5 states in the US that lacks regulations for compounding pharmacies to follow when preparing and dispensing sterile medications. The state also has no regulations to protect patients when sterile products are prepared by out of state pharmacies and shipped here.
In the wake of 24 deaths and over 300 people who’ve been harmed from contaminated steroids made by a Massachusetts compounding pharmacy, questions have been raised about the lack of regulatory oversight of such pharmacies by state and federal officials.
The pharmacy in the current case, New England Compounding Center (NECC), is being investigated for crossing the line into full-scale manufacturing by taking bulk orders for injectable medications without proof of an individual prescription as required in state regulations, then shipping large batches of drugs nationwide. Such compounding requires registration with FDA as a manufacturer, which was not the case with NECC. Thus oversight was up to the Massachusetts Board of Registration in Pharmacy.
While it’s difficult to understand how the transition to full-scale manufacturing could have been overlooked by authorities, the pharmacy has been accused of misleading state regulators who licensed NECC as a pharmacy.
For sterile compounding, Massachusetts regulations spell out requirements for pharmacies to follow standards set forth by the US Pharmacopeia in Chapter <797>, entitled Pharmaceutical Compounding: Sterile Preparations. The chapter 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.” The standard has the force of law in states that include mention of it in their regulations, as Massachusetts does.
Continue reading here
Wednesday, December 26, 2012
Nevada State Board of Pharmacy Sterile Compounding Larry L. Pinson, Pharm.D. Executive Secretary
has put together a great powerpoint with examples of cases where Nevada has taken disciplinary action. To view this powerpoint, click here
Confused About Compounding?--in the Vet World
May 10, 2012
Tips on avoiding illegal imposters of brand-name drugs.
From AQHA Corporate Partner Merial
Dr. April Knudson is an equine specialist with Merial Veterinary Services. She has a special interest in sport horse lameness and internal medicine. She holds a doctor of veterinary medicine from the University of California-Davis. Below, she answers a question about compounded equine drugs.
Q. Some of my friends at the barn were talking about compounded drugs and whether or not they are safe to use. What are they? Should I ever use them?
A. I’m glad you asked that question because the equine drug marketplace can be overwhelming. There are websites offering drugs for sale, products being sold at equine events around the country and opinions available from everyone who has ever owned a horse. It’s really important to sort through all of the information and consult with your veterinarian, if needed, before giving anything to your horse.
First, let’s clear up any confusion about what is meant by a “compounded drug.”
The American Association of Equine Practitioners defines a compounded drug as one that is created by manipulating an existing U.S. Food and Drug Administration-approved drug.¹ Examples include crushing a tablet to make a paste or gel or adding a flavor to a drug to make it more palatable.²
For a drug to be legally compounded:
- It must be compounded by a licensed veterinarian or pharmacist for a single horse to meet a specific need,²
- The horse owner must have a valid client-patient relationship with the prescribing veterinarian,²
- There must be no FDA-approved, commercially available drug that will appropriately treat the patient,¹ and
- The product must be made from an FDA-approved commercially available drug.¹
While the use of legally compounded drugs is recognized as an occasional necessity in equine health care, AAEP cautions veterinarians to “limit the use of compounded drugs to unique needs in specific patients.” Because of the time and financial investment required to bring a new equine drug to the marketplace, there are times when a legally compounded medication could be a veterinarian’s only option.
Unfortunately, some FDA-approved equine drugs are illegally manufactured, then advertised and/or sold to horse owners who are led to believe that they are the same as those legitimately on the market. These drugs have not been through the stringent FDA approval process, so they have not been demonstrated to be safe or effective for their intended use.³ Illegal manufacturers often make claims about how well the drugs work, but are not required to prove them. Consider these claims carefully and, if in doubt, ask the manufacturer for proof that the product works and that the manufacturer can back up its claims.
COMPOUNDING DRUGS FOR EXOTIC SPECIES
Was presented at the proceedings of the North American Veterinary Conference in January 7-11, 2006 in Orlando, Florida. To view these materials click here
Guidance on Veterinary Compounding:
Veterinary Compounding
2012 Editor’s Note: Veterinarians occasionally use compounded preparations to meet a specific patient’s medical need. The purpose of this content, created jointly by the Animal Health Institute (AHI), the American Veterinary Distributors Association (AVDA), and the American Veterinary Medical Association (AVMA), is to explain the Food and Drug Administration (FDA) requirements for compounding preparations for veterinary use and the distinction between drug products approved by the U.S. FDA and compounded preparations.
What is compounding?
Compounding that is consistent with the FDA Extralabel Drug Use regulations is the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding. Be aware, however, that products are being promoted to veterinarians under the guise of compounding that do not fit this definition. According to the FDA, legal compounding is not the formulation of preparations from bulk or raw active ingredients. Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug.
Federal regulations to follow
The FDA regulations and Compliance Policy Guide 608.400 “Compounding of Drugs for Use in Animals” describe specific circumstances under which FDA will either permit compounding for use in animals or may exercise its enforcement discretion where:
• A valid veterinarian-client-patient relationship exists.
• The health of an animal is threatened, or suffering or death may result from failure to treat.
• Compounding is performed by a licensed veterinarian or a licensed pharmacist on the order of a veterinarian within the scope of professional practice.
• There is no approved animal or human drug that, when used as labeled or in conformity with the extra-label drug use regulations, will, in the available dosage form and concentration, appropriately treat the condition diagnosed.
• Preparations are compounded from FDA-approved animal or human drugs. Nothing in the regulations permits compounding from bulk (raw pharmaceutical ingredient) drugs.
• Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for the compounding.
• For animals produced for human consumption, the veterinarian institutes procedures to assure the identity of treated animals, establishes a substantially extended withdrawal interval for the compounded preparation supported by appropriate scientific information, and ensures food safety. Compounding is not permitted if it results in violative food residue, or any residue that may present a risk to public health.
• No drug may be compounded for food animals from drugs listed on the prohibited list (go to www.fda.gov/AnimalVeterinary/ and enter “530.41” in the search engine).
• Veterinarians comply with all aspects of the federal extra-label drug use regulations including record-keeping and labeling requirements.
• Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product.
• The scale of compounding in advance of receiving prescriptions is limited and commensurate with the established need for compounded products.
• All relevant state laws relating to the compounding of drugs for use in animals are followed.
Compounding from unapproved substances
Federal regulations describe specific circumstances under which veterinarians, or pharmacists upon veterinarians’ prescriptions, are legally permitted to compound drugs for extralabel use in animals. Under these regulations, compounding for non-food animals may only be performed using
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