Is it True: Pharma Trying to put Vet Compounding Pharmacies Out of Business?

ig Pharma Trying to put Vet Compounding Pharmacies Out of Business

0			0

Proven ingredients mixed to create effective medicines to become illegal if big pharma gets it's way. These money hungry sluts want to control everything related to the drug market. No doubt medication for people will be next!

................................................................................​...........................................

You have used compounded medications for your pet, and those medications are under attack by the big drug companies.

The big drug companies are trying to intrude on your relationship with your veterinarian and your pets. Last month, a provision they proposed was temporarily removed from a Senate bill (S.959) that would have greatly limited your vet’s ability to prescribe compounded medication for dogs, cats and horses.

This provision allowed the FDA to severely restrict compounded medications for dogs, cats and horses. Treatment options for elephants, giraffes, hamsters and other “minor species” were not limited. Yes, you are reading this correctly. The proposal actually targets family pets and horses. Why? Because that’s where the money is.

The proposal is the work of the Animal Health Institute (AHI), a group created and funded by the big drug companies. They want your money. You and your vet want the best possible care for your pets.

We know that many pet owners rely on compounded medication to treat serious and chronic conditions in your pets. They can be literally lifesavers. But now, we hear those corporate interests who would put profits before pets are hoping to insert this provision back in as early as late June when S.959 is debated on the Senate floor. As one AHI lobbyist was quoted in the trade press: “We hope our absence from the bill is temporary.” What’s more, the same drug company lobbyist criticized the “permissiveness” of the original language restricting treatment options for your pets. Have they no shame? 

We can’t let that happen. The consequences are too severe. Please take action today to tell Congress to leave medical decisions about dogs, cats and horses to you and your veterinarian.

http://www.mymedsmatter.com/?vvsrc=/Camp...95/Respond


Animal Health Institute - Big Pharma lobby group. Located 1000 feet from the White House.

This post is quoted from here

http://www.ahi.org/about/member-directory/

http://maps.google.com/maps?client=safar...IgBEPwSMAA

Update: Texas Board of Pharmacy Is Seeking Pharmacits to Assist in Disciplinary Proceedings??? Are there Going to Be So Many Their Lawyers Can't Handle Them? Are Maybe so Complex and Relating to Compounding That It Makes More Sense for Pharmacists to Handle Them?

1. TX Pharmacy Board ‏@txpharmacyboard 15h

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for... http://fb.me/U8JMmgiQ 
   
   Here is what the FB link says:
   
   

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for non-therapeutic dispensing and negligent practice cases. To learn more about this opportunity to advance professional care and concern for the practice of pharmacy, contact Caroline Hotchkiss at 512/305-8046.

KUDOS--This Article MAKES AN EXCELLENT POINT THAT HAS BEEN MADE SEVERAL TIMES ON THIS BLOG: Make pharmacy regulations meaningful May 28, 2013 10:12 PM

OUR VIEW

How much clearer does it have to be? The laws that are meant to ensure compounded medications are safe are not getting the job done.
Last year’s outbreak of fungal meningitis caused by contaminated medicine killed 55 patients, including 15 people in Tennessee. Hundreds more were sickened.
And yet, another compounding pharmacy, this one in West Tennessee, has been identified as the likely source of a new spate of infections in North Carolina and Illinois.
Facilities in 13 states overall received supplies of the medicine.
Main Street Family Pharmacy LLC in Newbern has now recalled all its sterile products. Tennessee health officials on Tuesday released the names of seven Tennessee facilities that received the drug.
Main Street shipped the medications about two weeks after state inspectors found violations at the pharmacy in November. Inspectors concluded that “the processes they were following at the time did not indicate there was any problem,” says Terry Grinder, interim director of the Tennessee Pharmacy Board.
How can that be, since the inspection helped lead to Main Street’s top pharmacist being fined and placed on two years’ probation; 109 medications on the pharmacy’s shelves were found to be outdated, and 11 prescriptions were not written on tamper-resistant paper as required under state law?
Main Street also was cited in 2011 for having expired medications used for drug compounding; sterilization equipment out of compliance; and shipping compounded drugs directly to physicians’ offices without patient-specific prescriptions, a direct violation of state law.
The state did not shut down the pharmacy then, either.
So maybe these dangerous problems continue because compounding pharmacies know that the consequences for breaking the rules are minor, if they are imposed at all.
And let’s not pretend that health officials and pharmacies do not understand the risk to patients’ safety if their medications are not compounded under strictly controlled conditions and made for specific patients. The deadly outbreak caused by the New England Compounding Center unfolded before Main Street was inspected in November.
Then, early in 2013, the Tennessee General Assembly acted irresponsibly by approving a loophole in the specific-patient prescription requirement. It was suggested that the risk of shortages outweighs the risk of contamination.
That is an important discussion to have, but why are the only options ample supply or lax safeguards? Shouldn’t compounding pharmacies ensure that they are adequately staffed and supplied without resorting to shortcuts?
Pharmacists are not physicians, but they are their partners in care. Shouldn’t they also adhere to the key tenet, “First, do no harm”?
quoted from here

NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing May 29, 2013 6:15 pm

May 29, 2013 6:15 pm Topics: Compounding

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony (PDF) presented at a United States House subcommittee hearing on May 23, 2013. The hearing, “Examining Drug Compounding” was held to provide US Committee on Energy and Commerce Health Subcommittee members an opportunity to hear testimony from Food and Drug Administration (FDA) and health care experts regarding the importance of drug compounding to patients and the current regulation of compounding on the federal and state levels. In its testimony, NABP noted that the clarifications in the proposed Pharmaceutical Compounding Quality and Accountability Act (S 959) regarding the distinction between compounding and manufacturing “provide a safe and equitable environment for both compounding and manufacturing to occur in the best interest of the patient.” The Association stressed that the distinction between compounding and manufacturing is “critical to maintain the present authority of the states and address one of the contributing factors to the NECC [New England Compounding Center] crisis, specifically, the ambiguous authority between the states and FDA.”  The proposed legislation also specifies that a “compounding manufacturer” cannot be licensed as a pharmacy, and NABP notes that this provision is “essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.”
continue reading here

News Release: FLORIDA DEPARTMENT OF HEALTH PROVIDES UPDATE ON MULTISTATE EPIDEMIOLOGICAL INVESTIGATION ASSOCIATED WITH STEROID INJECTIONS

Link to press release can be found here 

Thank you to Kenneth Woliner, MD, ABFM, www.holisticfamilymed.com, for providing the link to the press release.

13 new illnesses linked to TN drug compounder May 29, 2013 5:45 PM

Written by

Walter F. Roche Jr.

The Tennessean

The number of adverse events suspected of coming from steroid medications from a Tennessee drug compounder has nearly tripled with 13 new cases reported by the Florida Health Department.

In a statement released Wednesday, Florida officials said adverse reactions were limited to skin abscesses and did not involve any life-threatening conditions. The disclosure boosts the total number of cases in the growing cluster to 20, including five in Illinois and two in North Carolina.
According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.
No adverse reactions have been reported in Tennessee, where seven clinics got the drugs. Among them was Axis Medical Clinic in Robertson County.
Dr. Paul Yim, who has been operating the clinic in White House for 15 years, said in a telephone interview Wednesday that he is contacting an estimated 200 patients who were injected with the steroids.
“We’ve not had any complaints or reports of infection,” Yim said. “None at all.”
The drug is the same one blamed for a nationwide fungal meningitis outbreak that has taken the lives of 15 Tennessee patients and 55 nationwide. Those tainted spinal steroids were shipped around the country by the now-bankrupt New England Compounding Center in Massachusetts.
Yim said Axis Medical is contacting any patients who got shots with methylprednisolone acetate over the past six months. He said he has been working with the state health department to collect information on the patients, including their age, the date of the shots and the date of the last visit.
He said Main Street Family Pharmacy was suggested to him by a medical supply firm and he has been buying drugs from the firm for about two years without any problems. He described Main Street sales staff as “pleasant and professional.”

continue reading here

American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act

WASHINGTON, May 29, 2013 /PRNewswire-USNewswire/ -- As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.

(Logo: http://photos.prnewswire.com/prnh/20130405/MM89329LOGO)

"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II , M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."

continue to read here

New Compounding Pharmacy Scandal in TN May 29th, 2013 // 1:01 pm @ jmpickett

Last month, Tennessee passed a law that eased the restrictions on the state’s compounding pharmacies. Now FDA is looking into seven cases of patients suffering adverse events after they were injected with possibly contaminated drugs that were compounded by a TN pharmacy.
That is why Main Street Family Pharmacy is doing a recall of all of its sterile drug products. Most of them are injectable drugs. It appears that the drugs that are related to the adverse events have methylprednisolone acetate, which is the drug that led to the killer outbreak of fungal meningitis last year.
That outbreak has 740 cases and led to 55 deaths so far. It is the most grave public health crisis in the US in 40 years, and was traced to the New England Compounding Center. That scandal has led FDA to scrutinize drug compounders more closely.
For example, in 2013, FDA started an aggressive effort to do inspections of dozens of drug compounders in many states. There have been some product recalls, too. FDA wants Congress to give them more oversight authority, as well.

• May 30 – Audit Your Lab Like an FDAer
• June 12 – Avoid Warning Letter Disasters with a Strong cGMP Quality Agreement

However, Tennessee last month passed a law to cut down on drug shortages by letting compounders make more drugs and also avoid reliance on compounders out of state. This law also would allow compounders in TN to make/dispense drugs without a specific prescription for a patient. Some experts think this is dangerous.
Records show that Main Street Family Pharmacy shipped product to AL, AR, CA, FL, KY, IL, LA, MS, NM, NC, SC, TN, and TX. So far, patients in NC and IL have infections.
It is not clear how many patients got injected with the tainted drugs, but the TN Department of Health says that the firm had a license as a manufacturer, wholesaler and distributor in 2010.
quoted here

Press Announcements FDA announces import of injectable nutrition drugs

Press Announcements FDA announces import of injectable nutrition drugs

Meet the career con man who made a fortune selling illegal pharmaceuticals online—and pulled off a federal sting that forced Google to pay $500 million.

read the story here

Contaminated injections traced to IL clinic

Contaminated injections traced to IL clinic

Question of the Day: May 29, 2013 What are the differences between "traditional Mom and Pop" compounding and "non-traditional manufacturing" compounding? (Thank you Dr. Woliner for the detailed and indept answer you wrote)

Written by:

Kenneth Woliner, MD, ABFM
Boca Raton, FL
www.holisticfamilymed.com

BACKGROUND

Traditional compounding is done every day, to some extent, at regular chain pharmacies. One example is that FLAVORx is added to liquid medicines (often given to children who can't swallow tablets) to make them taste better (http://flavorx.com/). Another is the various versions of "magic mouthwash" (combinations of viscous lidocaine, maalox, mylanta, benadryl, tetracycline, nystatin, prednisolone, etc) used to treat mouth sores from cancer chemotherapy, apthous ulcers, and even the "burning tongue syndrome" (http://www.drotterholt.com/magicmouthwash.html).


MAINSTREAM PHARMACIES

Admittedly, "big chain pharmacies" such as Walgreens, CVS, Target, Costco, WalMart, etc - aren't efficiently set up to do compounding on a regular basis, preferring to do a "volume business" of using their "pill counting machines" and registered pharmacy techs to take stock bottles of 1,000 pills and transfer them into individual pill bottles of 30 or 60 pills each, handing them to the patient, and having patients sign the form that says "pharmacy counseling offered but refused by patient". From speaking with pharmacists who work in these big chain pharmacies, I understand that this "mill-like atmosphere" makes it very difficult for the pharmacist to have any interaction with the patient, and has turned many pharmacists into "clerks" that fill orders, where they will "hit the green button" verifying that the prescription written is actually the one being dispensed.  When they do get a "magic mouthwash" compounded-type prescription, it slows them down from their clerk-like responsibilities. Hence, a lot of pharmacists do not like to do compounding.


MOM AND POP PHARMACIES THAT DO COMPOUNDING

Not every pharmacy is "part of the corporate machine". There are quite a few "mom and pop" pharmacies out there, and they do thrive by providing great customer service - e.g. they know their patients by name, they're friendly, they might do deliveries (especially for home-bound senior citizens), etc.  Some of these pharmacies are "franchisees" (but locally owned) with a familiar name (e.g. Rexall, The Medicine Shoppe, etc.). Others have a friendly name of the owner pharmacist or town the pharmacy is located in (e.g. "Arthur's Drugs", "Boca Apothecary", etc.).  Part of their "customer service" is to do compounding for their patients, based upon individual prescriptions. They rarely do "anticipatory compounding", of making things up ahead of time. The volume for each type of medicine isn't there for that. It is expensive to do things this way, but because the pharmacy runs low overhead in other ways (no corporate profits), or charges more for each compounded prescription, these mom and pop pharmacies stay in business, and seem to do quite well. What is more important for the pharmacist is the quality of their job (the ability to interact with patients, to use their brain rather than being just a clerk), rather than their paycheck and 401K matching retirement plan the chain pharmacy would have paid them.


SPECIALIZED COMPOUNDING PHARMACIES THAT SERVE THE "LOCAL AREA"

It is a niche market to do compounding, and to "do it right" and to do it efficiently. Pharmacists that love to do compounding go to conferences and read journal articles specifically to learn how to do compounding. They frequent bulletin boards on-line and "trade recipes" of how to safely make different to compound different medicines. They speak with their prescribing physicians and veterinarians, and help "trouble-shoot" solutions with patients with particular problems that are difficult-to-treat such as Multiple Sclerosis, Fibromyalgia, and Chronic Fatigue Syndrome. They realize that allergies to food dyes and other inactive ingredients in medications is a problem for many patients, and they compound allergy-free formulations. They may focus on a niche such as veterinary compounding (small animal, large animal, or both), menopause management (with bioidentical hormone replacement therapy), or pain (topical compounded creams that don't have systemic side effects if sedation, low dose naltrexone, etc).

These pharmacies "may occasionally" mail a prescription across state lines. A patient may be a snowbird, and doesn't want to transfer a prescription from one pharmacy to another. A patient may move away, but like the pharmacy so much, he/she may prefer to use that pharmacy rather than find a local pharmacy. But for the most part, their business is a local one, serving local prescribers and their patients.


NON-TRADITIONAL COMPOUNDING SERVING PATIENTS IN STATES FAR AWAY FROM THE PHARMACY

There is a demand for compounded drugs. Most of it is generated by patients that "do better" with a compounded prescription that is customized to the patient. However, a lot of the demand is generated by the pharmacies themselves. These "larger scale" compounding pharmacies aggressively market themselves nationally by sponsoring exhibit hall booths at conferences that teach "anti-aging" and "alternative medicine" type courses. Some offer to sell these compounds to the physician at a "wholesale price" and then have the physician sell these drugs to the patient at a retail price, even though this is illegal in multiple aspects (patient-brokering, split-fee/kickbacks, etc). Some will let a physician/veterinarian dispense these drugs to the patient for the patient (or its owner) to administer to themselves at home, even though this is also illegal (doing so would make the pharmacy a manufacturer, manufacturing an unapproved new drug).

These "non-traditional" compounders, in part due to their marketing activities, do have enough volume to do "anticipatory compounding" before a prescription is received. This is good and bad. The good: turn-around time from when a prescription is received and when it can be filled is shortened, the cost of the prescription could be less (though not necessarily, especially if there is "restriction of the patient's choice of pharmacy due to the split-fee/kickback/patient brokering agreements mentioned above), and perhaps, quality control could be better because, with batch production, samples can be independently tested for potency and sterility.  The bad: "anticipatory compounding" is for all practical purposes, a loophole to do manufacturing without a manufacturer's license (or the patient-protection regulation that goes along with it). Hence we have "manufacturers in pharmacy clothing" such as NECC, Franck's, and ApotheCure that have operated beyond the scope of pharmacy practice, made mistakes because they were not following all the rules/procedures a manufacturer is supposed to be doing, and patients have died (or been blinded, or suffered other complications) as a result.


SUMMARY

I'm not saying that all "non-traditional" compounders are evil. I do prescribe compounded medications, and, with the patient's choice of pharmacy intact, often call/fax prescriptions to these non-traditional compounding pharmacies. I sometimes even recommend one pharmacy over another (e.g. one pharmacy is well known to do ophthalmic preparations well; another pharmacy is well known for its ability to service patients with Lyme disease, etc). However, I don't dispense compounded drugs from my office, and I don't make a dime off the medications themselves.

I am also more cautious than ever of which pharmacies I recommend and those I don't recommend. If a pharmacy offers me a kickback (overt or covert, directly or indirectly), I will refuse to use them. If a pharmacy is willing to manufacture a prescription in a form that is not bioavailable (such as compounded oral Sporanox/itraconazole; sublingual HCG), I consider the supervising pharmacist to be someone who doesn't care about the welfare of the patient, but merrily someone who wants to sell product (Restore Health Pharmacy in Wisconsin just got disciplined for that exact reason). And a pharmacy that is willing to scam patients with fraudulent treatments, whether it be HCG Diet plans or Laetrile cancer remedies, again, I have no respect for them. I would hope that other prescribers would have the same sense to refuse to do business with these types of pharmacies, but unfortunately, too many physicians don't do their due diligence when looking at the pharmacies they use.

Compounding is important to patients. Compounding should be allowed to continue. But these pharmacies that do "anticipatory compounding" and/or routinely ship prescriptions across state lines, should have a manufacturing license and follow those regulations as well. Going to national conventions and seeing which pharmacies are advertising their wares is perhaps the biggest tipoff and easiest way for the FDA to identify which pharmacies need to be looked at more closely.

2013 NABP Meeting brochure--Talk Scheduled on Compounding-"Compounding the Situation"

2013 NABP & AACP District 6, 7 & 8 brochure (DOC)

Alaska Board of Pharmacy Minutes for February 28-March 1, 2013 Meeting Contains Lot of Discussion On Compounding Issues

view here

Pharmacist Salaries Hit $117K and Keep Climbing

Pharmacist Salaries Hit $117K and Keep Climbing

How the Pharmacy Industry Ch-ch-changed in 2012

How the Pharmacy Industry Ch-ch-changed in 2012

Armada 2013: Specialty Pharmacy Gets More Competitive

Armada 2013: Specialty Pharmacy Gets More Competitive

New Drug Trend Forecasts: Express Scripts vs. CVS Caremark

New Drug Trend Forecasts: Express Scripts vs. CVS Caremark

The Cynical Pharmacist: Pharmacy Compounding And The Public

The Cynical Pharmacist: Pharmacy Compounding And The Public: There's a very good reason why early 20th century laws, like the Pure Food and Drug Act , the Federal Food, Drug, and Cosmetic Act , and...

Wow--201 Doctors Named in Scheme to Defraud--Involving Compounded Drugs--Not Sure the Current status but will Follow Up on It

By Greg Jones, Western Bureau Chief

A whistleblower complaint alleging a scheme to defraud the federal government, State Compensation Insurance Fund and other workers' compensation carriers by billing for compound drugs that were not dispensed names as defendants 201 California doctors, many of whom are also qualified medical evaluators.

The doctors, including one who is a suspect in a 2008 murder in...

Back to article

post a comment

Comments (2):

“Quite an impressive list of Docs. All but a handful are from SoCal. Wonder what happens once they are named in the lawsuit. ”
By: Bob Taber, 10/19/2012 06:10:17 pm

post to thread

“This whole debacle started to unwind with Uwaydah and with the prosecutors focus it will be interesting to see where it leads. The drama plays long-- all the way back to the fishy days of the last decade. Now we have different actors but same game, it’s in there dna. Sobold is this group sailing into the storm; soon they will be screaming S&S floundering in a boat on an Ocean of trouble as more unravels. ”
By: Kat Hernandez, 10/21/2012 10:10:18 am 

Markey Proposed Federal Legislation v. Senate HELP Committee Version

The two bills are compared in this news article, U.S. lawmaker would give FDA more oversight of drug compounding

Iowa Administrative Code Relating to Pharmacies and Compounding

new link to the code updated as of 5/28/2013 found here

Interesting post about the FDA Inspecting the Room and Not the Product

read the post here

Disturbing Parallels Seen in New Compounding Pharmacy Warning

Disturbing Parallels Seen in New Compounding Pharmacy Warning

Public Warms to FDA in Recent Gallup Poll

Public Warms to FDA in Recent Gallup Poll

Falsified Data, Study Deviations Focus of New Warning Letter to Investigator

Falsified Data, Study Deviations Focus of New Warning Letter to Investigator

A prolonged stay: The reason behind the slow pace of executions

By Raymond Bonner, special to ProPublica

States that impose the death penalty have been facing a crisis in recent years: They are short on the drugs used in executions.

In California, which has the country's largest death row population, the chief justice of the state supreme court has said there are unlikely to be any executions for three years, in part due to the shortage of appropriate lethal drugs. As a result, state prosecutors are calling for a return of the gas chamber.

Ohio, which is second only to Texas in the number of executions carried out since 2010, said it will run out of the drug it uses in executions, pentobarbital, on Sept. 30. The state has two men scheduled for execution in November, and eight more set to be killed after that. Every state's supply of pentotbarbital, which has been the principal execution drug, expires at the end of November.

The shortage has forced death penalty states to scramble on two fronts: They are hunting for new suppliers or different drugs to use, and enacting changes to public records laws to keep the names of suppliers and manufacturers of those alternative drugs secret.

continue to read here

A Day in the Life of this Blog: Where The Blog Is At Today

Entry	Pageviews
United States	609
China	82
France	52
Ukraine	38
Poland	30
Hong Kong	20
Indonesia	15
Iran	12
Philippines	11
Russia	11

Above is what today's view looked like as of 6:49 p.m.

Entry	Pageviews
United States	46
China	6
France	3
Poland	3
Ukraine	3
Belgium	1
Spain	1
United Kingdom	1
Indonesia	1
Iran	1

Above is what the views this moment on the blog looks like at 6:50 p.m.

The blog has now reached over 127,000 views.  The blog is close to having folks in 100 countries reading it.  And soon the 4000th blog entry will be added.  The blog has been called the "gold standard" in compounding resources.  Pharmacy board members have written to tell me they suggest all the board members read the blog and some have implemented some of the suggested   changes such as adding people other than pharmacists to their boards.