Safety Concerns At Compounding Pharmacies
http://thedianerehmshow.org/shows/2013-02-11/safety-concerns-compounding-pharmacies
A deadly meningitis outbreak last year drew attention to a relatively new segment of the drug industry: large-scale compounding pharmacies. The Food and Drug Administration is calling for new, stronger and clearer legislation to effectively oversee firms that mix custom drugs for specific patients. In the past two decades, compounding pharmacies have grown into a multimillion dollar business, making some of the highest risk drugs available. But they are not required to follow the safety rules that apply to commercial drug makers. State pharmacy boards have an uneven record of policing them. A panel joins Diane to discuss efforts to improve the safety and oversight of compounded drugs.
Guests
Lena Sun
reporter, The Washington Post.
Kasey Thompson
vice president of policy, planning and communications for the American Society of Health-System Pharmacists.
David Miller
executive vice president, International Academy of Compounding Pharmacists.
Carmen Catizone
executive director, National Association of Boards of Pharmacy.
Comments
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Topic: Crash Safety Model for Drug Testing?
Currently the FDA, as I understand it, inspects production of medication at the site of production It also has a reporting system, which most people are not aware of, to report adverse effects of medication.
Why not have the equivalent of crash safety tests? Sample the medications right off the shelf? This can be done for both prescription and non-prescription drugs. Tests can, at least, be done for compromises in hygiene and safety of these products.
This proactive model can be implemented for compounding pharmacies, as well. Experts can determine whether to determine the sampling of products by type of ingredient (including inactive ingredients, besides the obvious active ingredients) or type of medication or type of consumer population.
This is complicated, so details need to be worked out. There are expenses. But who would object to the potential benefits?
Manufacturers currently have such a program in place. For a substance that has been in commercial distribution for quite some time, this sort of testing is done annually. For newer entities, it is done quarterly for a period of 3 - 5 years.
It would be interesting to know how many compounding pharmacies are required to provide sterility, potency and pyrogen testing of compounded drugs.
Also, it is my understanding that compounding used to be a highly profitable practice for both the pharmacy and for the physician. Compounded drugs are not subject to the same price constraints of other drugs. Is that still true.
As a family physician in private practice, I am very fearful of the looming regulation of compounding pharmacies. I cannot emphasize strongly enough the value of the option of compounded medications in my practice and to my patients. Dosage adjustments, special preparations for those with allergies and insensitivities, liquid preparations for children, those with swallowing problems, and folks who need a medication that isn't available due to politics or just the realities of scale.
There is a big difference in the safety margins for injectable drugs and those taken by mouth. The medications that caused meningitis were injected and injected into the central nervous system.
I am concerned that the regulations designed to keep this tragedy from being repeated will have a much larger impact on small, local safe compounding pharmacies than it does on the actual pharmacies that caused the problem. (In the same way that the banking crisis seemed to have a larger impact on my community bank than on the big banks that upset the economy)
Elizabeth Allemann, MD
Columbia, MO
Margaret, I am not sure about profitability for the drugs I prescribe--oral, patient-specific, but they tend to cost about the same as equivalents commercially available, despite the fact that they take significant time from the pharmacist.
Great questions. I'm wondering about the injectable drugs and the profitability.
Elizabeth
I wonder what kind of training or certification is required of the individuals actually doing the compounding at these compounding pharmacies. My mother was a pharmacist during the 1950s and routinely compounded medications, and this was part of her training in college. Do pharmacy students get enough training in compounding, and are they required to demonstrate competence? Or are pharmacy TECHNICIANS -- who have minimal training and certification and might only have a high school degree -- doing the compounding?
Philip Onigman
Reading, MA
cell phone 617 688 0870
Individual pharmacists and physicians at hospitals and clinics can add additional preventive measures at the point of infusion or the point of injection to prevent infection by bacteria and fungi. Pre-sterilized, sterilizing grade, 0.22 micron pore size membrane filter devices that are FDA approved are available in the range of $2.00 per device from reliable medical device manufacturers such as Millipore Corp and Pall Corp. These devices have been available since the early 1970s. The Framingham compounding pharmacy related deaths and infections were mainly preventable if the injected drugs had been additionally filtered just before administration either by addition of a filter to the loaded syringe or to the inline catheter. In the case of meningitis, the clinicians should be thinking of multiple risk factors: The injection site of the drug, the immuno-suppression effect of the drug, and in the case of the mold contamination, even if the compounding pharmacy had done sterility tests, some molds are very slow growing.
Here in Florida Compounding pharmacies are no mystery. The big chains do not compound (CVS/Walgreens, etc) and mom and pops have gone out of business.
Thus, I have to take my script TO the compounding pharmacy because it can be filled no where else! These pharmacists qualifications can be verified. Procedures can be questioned. I have never had any problems. And trust these guys over the chains any day.
Oh, and my drugs are not cheap, nor does my insurance company cover ANY compounded drug unless it is pediatric.
Many of these compounding pharmacies are supplying medications that are in short supply due to national backorders and shortages. Many facilities are left with no alternative but to use these companies. From experience I know that my own facility's use has grown exponentially as the shortages have grown.
My health plan will not pay for my prescriptions that come from a local compounding pharmacy. If I get the same medicine from a national chain, they pay. The specific medicine is for my thyroid med, Amour (sp?).
Drug batches are supposed to get sterility tests on a lot by lot basis and are part of the release specification.
As a veterinarian, I am DELIGHTED at the increased scrutiny of compounding pharmacies.
Every research study of compounded medications in veterinary medicine has shown variable levels of active medication in compounded medications. Lest anyone dismiss this as a veterinary concern, that includes medications produced by compounding pharmacies whose primary business is the production of compounded medications for the humans. Remember those dead polo ponies in Florida back in 2009? Franck's Pharmacy was primarily a human compounding pharmacy. They closed in 2012, after yet another disaster: 33 human patients developed infections after intraocular injections of a contaminated medication produced by Franck's.
As a practitioner, I find this frightening. Not only do I have no assurance that my patient is receiving an adequate dose of a compounded medication I've prescribed, there is the looming fear that my patient may be overdosed. I select my compounding pharmacies carefully and hope for the best. Whenever possible I use FDA-approved generic or brand-name medications.
Compounding is highly profitable. That's why pharmacies are fighting for less regulation. While it's technically legal to use a compounded medication when that exact drug is not available, it's also almost always more profitable to do so. One example: I could prescribe flavored doxycycline powder vs. pills. It's more palatable, easier to administer and cheaper. The downside? I have no clue whether my patients are receiving an adequate dose of doxycycline.
The steroid disaster happened in Massachusetts, a relatively highly regulated state. Everyone who uses or prescribes compounded medications should be concerned.
The steroid drug in question was intended to be injected directly into the spine. This is procedure has risks that must be understood and addressed by physicians, clinics and manufacturers. That drug was available from major pharmaceutical manufacturers who have quality control processes in place. Compounding pharmacies may provide this type of injectable steroid and states that regulate the pharmacies allow compounding that drug.
However, a compounding pharmacy is to provide the medication on an individual prescription basis for and individual patient. The compounding pharmacy in question was manufacturing and selling the drug in bulk to physicians and clinics, not for individual patients.
If you are manufacturing drugs, you need to be regulated as a manufacturer. I work in a Wal-mart pharmacy. I compound things daily. I do "non-sterile" compounding. These are medications that are not injected. Usually liquids you drink or creams/ointments you put on your skin. This is done in nearly every pharmacy in the US.
Adding water to a powder and shaking it to make the suspension for your child's antibiotic is by definition "compounding" even when I am following the manufacturer's instructions. Do you as a parent have time for me to send this compound to be tested before giving it to your child? These medications expire in 14 days. Getting fresh ones shipped constantly will increase your child's penicillin prescription cost by over one hundred dollars; and people are complaining about drugs costs now.
Do I need to undergo massive regulation and require a sterile hood, which require a remodel of nearly every pharmacy in the US, to mix benadryl syrup and a FDA approved anti-fungal solution to make a "magic mouthwash" which instructions are to gargle and spit out, thus the infection risk is extremely low?
Don't throw the baby out with the bath water. Every pharmacy compounds and of the millions of magic mouthwashes and antibiotic liquids I haven't heard anyone die yet. Holding onto a sample of every penicillin liquid mixture is beyond ludicrous.
Manufacturing on a large scale and selling to doctors in huge batches is not compounding. Making little Timmy's antibiotic is. Once you define these huge companies as manufacturers then the regulations from the FDA can easily step in.
A small two person compounding pharmacy:
www.efn.org/~hkrieger/j0302.jpg
from the series, "Junction City Junction",
www.efn.org/~hkrieger/junction.htm.
"EAllemannMD wrote:
As a family physician in private practice, I am very fearful of the looming regulation of compounding pharmacies. "
Doc,
Thanks for your insightful post. There are many facets to this discussion. One is cost, and there are claims that compounders make big money on the practice. I'm not sure that's always true. We have to use compounded medication for our pooch. We have a compounding pharmacy that we love ... but, they suddenly dropped vetrenary. Why? No money in it.
"I am concerned that the regulations designed to keep this tragedy from being repeated will have a much larger impact on small, local safe compounding pharmacies than it does on the actual pharmacies that caused the problem. "
I also liked your analogy with the banks. Regulate all the banks and the little guy suffers. I think the same is true on proposed gun control regulations. Beef them up and it is the law abiding gun owners that will suffer. The individuals that cause most of the trouble (criminals) don't suffer, the law abiders do.
For the drugs, for the banks, for the guns ... there has to be a better way.
Compounded drugs made from unapproved chemical ingredients should be used only in rare circumstances where an FDA-approved medication cannot be used for medical reasons, primarily because the pharmacy standards under which they are produced are less rigorous than federal standards—> benefit risk assessments are minimal, and may not include risks associated with the chemicals, recipes and environments employed for their production. Compounded drugs should not be substituted in U.S. supply chains to:
Introduce unapproved new drugs to the market (novel hormone therapies, preservative-free spinal injections, “mesotherapy”)
Provide lower cost “copies” FDA-approved products (injectable drugs sold at a discount to medical offices)
Capture higher profit margins for the benefit of otherwise non-competitive pharmacies or medical clinics and where patients bear an added risk of harm
It is my experience that FDA has neither the resources, nor a public health interest, in preventing access to medically-appropriate compounded drugs. But in the last decade, medically necessary (traditional) compounding has become the outlier of the overall contemporary industry. FDA has a societal imperative, critically essential in today's complex global marketplace, to protect the public from unsafe and ineffective drugs. Clarification of current authorities and additional authorities are necessary, but, in the immediate, given limited state and federal resources, vigilance is necessary on the part of prescribers, patients and payers to prevent unintended exposures to substandard drugs that pose added risk of harm to patients.
I opened a community compounding pharmacy in our town 3 years ago, after 15+ years in retail, as a means to make a more meaningful contribution to wellness. Honestly, it would be much easier to take a salary from a chain pharmacy.
I appreciate concerns regarding safety and potency, and the only suggestion I can offer is to get to know your pharmacy and familiarize yourself with their practices. We undergo voluntary testing, as is strongly encouraged by organizations such as PCCA (Professional Compounding Centers of America) and have results demonstrating accuracy to the hundredth of a milligram/dose. Should regulations be altered to make this testing mandatory, pharmacies like ours who are already doing it voluntarily will welcome the change, as everyone will be operating on a level playing field.
As to profitability, when a compounding pharmacy is acting in its proper capacity, much time is involved in producing each formulation, which has been created pursuant to an individual prescription. The pharmacies who are acting more along the lines of a manufacturer are certainly realizing larger profit margins, but it is unfair to assume it is true for all compounders.
The difference between traditional compounding pharmacies and these large entities operating as manufacturers cannot be overstated. We offer a tremendous service to practitioners as well as patients.
You're absolutely right. The problem isn't compounding as it was originally intended to be done, as pharmacies such as yours do it.
The average client or patient filling a prescription out-of-pocket, however, doesn't understand that quality compounding can be expensive. Custom compounding from high-quality ingredients prepared for individuals costs money. In my experience, those who are paying cash for compounded medications aren't interested in the finer points of drug safety, at least until it affects them directly. They want a cheap pharmacy.
Worse, many physicians or veterinarians have a cavalier disregard for the distinction between compounded and FDA-approved. It's either ignorance or because using the former often improves one's clinic's profit margin. Combined with a lack of oversight and few consequences, we will continue to see disasters such as the contaminated steroid debacle on a regular basis. Unfortunately.