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Wednesday, May 29, 2013
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/
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.
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/
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.
Tuesday, May 28, 2013
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...
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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
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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
By: Kat Hernandez, 10/21/2012 10:10:18 am
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