Compounding pharmacies will feel the heat after death of polo ponies
By Gina Spadafori
April 23, 2009
I predict some regulatory or legislative action will come out of this tragedy. As always, there’s a chance it will be completely misguided or so overly punitive that it stops practices that are legitimately beneficial.
But clearly, there’s a problem here when a veterinarian can prescribe and a pharmacy fill a prescription for a compound that’s illegal in this country.
Check out this Palm Beach Post piece on compounding pharmacies:
Franck’s Pharmacy appears to have violated federal law when it produced its own version of a banned vitamin supplement that is now thought to be linked to the deaths of 21 polo ponies, experts said.
But the Ocala pharmacy and hundreds of other so-called compounding pharmacies – which produce made-to-order supplements and prescription drugs from raw ingredients – operate in a gray world of vague rules and little oversight.
Even government and industry leaders admit that the system leaves abundant opportunity for abuse.
“This is about as gray a gray area as you’re going to find,” said Tom Murry, executive director of the national Pharmacy Compounding Accreditation Board. “That’s part of the problem – that no one really knows who regulates compounding pharmacies.”
Although the U.S. Food and Drug Administration bans the sale of drugs it deems unsafe, federal law still allows compounding pharmacies to create their own versions of unapproved drugs if a veterinarian deems them necessary, officials say.
The FDA’s current stand on compounding pharmacies is one of caution.
Update: Dr. Peter Wedderburn, a veterinarian and blogger in Ireland, writes that because Europe doesn’t have compounding pharmacies, this sad incident wouldn’t have happened there:
It’s interesting that the series of events could not have happened in the UK for a simple reason: we don’t have the “compounding pharmacies” that are common-place in the USA. These pharmacies allow veterinarians to create made-to-order medications out of any list of active ingredients that they select. There’s no tradition for this type of prescribing in the UK, and vets are restricted to using products that are already on the market.
There are very tight regulations governing drugs used by vets in the UK and throughout Europe. Vets are primarily obligated to use products licensed only for the species under treatment – this is the safest route, because the drugs have been tested and approved for their purpose. Dog wormers must be given to dogs; cat wormers to cats.
I am pretty sure I remember Christie writing favorably about the existence of compounding pharmacies and the ways in which they can be useful at some point on this blog.
Comment by The OTHER Pat — April 23, 2009 @ 8:07 pm
She absolutely has. And that’s what I’m thinking of when I worry about misguided or over-the-top legislative or regulatory action.
Among other things, compounding pharmacies can save money (here’s a ref on Dolittler, see item No. 6), and put medication in forms more palatable for pets (such as a flavored paste).
But mark my words: This tragedy will mean changes for compounding pharmacies, and so, too, for the use of them by veterinarians.
Comment by Gina Spadafori — April 23, 2009 @ 8:12 pm
i love my neighborhood apothecary/pharmacy. I hope the knee-jerk reaction to this does not end up with ONLY pre-made dugs being legal.
Gahh
Comment by JenniferJ — April 23, 2009 @ 8:57 pm
Gina, the spam filter monster just narfed up my last comment
“nom nom nom, mmm… comments :-) “
Comment by JenniferJ — April 23, 2009 @ 8:59 pm
One of my dogs and I depend on a compounding pharmacy for his liquid potassium bromide, which helps to mitigate the severity and frequency of his epilepsy. It’s the only source we have. I would be devastated if the Nanny Law Contingent in this country screwed that up for us.
From what I have read, this tragedy wasn’t caused by deliberate abuse, this was human error.
Comment by Anne T — April 24, 2009 @ 2:48 am
Comment by JenniferJ — April 23, 2009 @ 8:59 pm
“nom nom nom, mmm… comments :-) “
Okay - now you made me giggle!
Comment by The OTHER Pat — April 24, 2009 @ 2:55 am
Oh boy, here comes the Congressional Nanny Law contingent to Save the Day! My epileptic dog and I depend on a compounding veterinary pharmacy for his potassium bromide. It’s our only source. Acupuncture and herbal remedies only augment the KBr. Without it, he seizes every 2-3 weeks, and experiences episodes of longer duration and greater severity. We lose that source, and he’s in trouble.
This tragedy was not caused by deliberate abuse, it was caused by human error. A better system of failsafes to minimize that error on the part of the individual pharmacy is in order, yes. Nanny laws? No!
Comment by Anne T — April 24, 2009 @ 3:25 am
my comments got nommed too. :) I thought I’d made the error. Ignore one and post the other if you wish. Or ignore them both and post neither.
Comment by Anne T — April 24, 2009 @ 3:32 am
Can you give me some key words? I can find the nommed comments. (And there are close to 8K spam comments to sift through …. impossible without being able to search for a word or two.)
Comment by Gina Spadafori — April 24, 2009 @ 6:24 am
Is there a bug in the comment box? It seems to be refusing to post my comments too - then when I try to repost them, it rejects the comment as a duplicate.
Comment by Janeen — April 24, 2009 @ 7:08 am
I suspect that Gina’s right about significant changes coming to the compounding industry. I just hope that - for once - the government manages to make reasonable, common-sense changes rather than instituting “sweeping reforms” designed more as PR machines for their sponsors than to do any real good.
IMO rules that prevent compounding pharmacies from producing their own versions of banned substances would be a very good place to start. I mean SRSLY - if I buy a compounding pharmacy, can I make my own crack or ectasy - or do I have to stick with the lightweight stuff like illegal steriods?
Comment by Janeen — April 24, 2009 @ 7:11 am
It’s the word “pharmacy” that’s triggering the spam filter. You know, as in Viagra, etc. Heck, I’ll had to de-spam THIS comment … and I run the blog.
I released the comments I found, deleted all the spam (7K-plus) to make future searching easier. We’ll keep an eye out for trapped comments, so if you lose one, let us know.
Comment by Gina Spadafori — April 24, 2009 @ 7:19 am
Obviously something went seriously wrong here for 21 horses to drop dead within 3 hours of receiving whatever it is they received. I really need to question anyway this practice of performance enhancing substances being used in both human and animal sporting events. Ultimately sports are entertainment events. Humans and animals are capable of exceptional performance without stimulants or endurance enhancers. This should be a huge wake up call not just business as usual in my opinion. Horses are beautiful and majestic animals so I’m not falling for the “these horses died for the sport” nonsense at this point either.
Not trying to get into an argument here just expressing my concerns.
Comment by Kate — April 24, 2009 @ 9:09 am
The UK regulations have had some unfortunate effects where human medicines were in common use for animals and the human use was banned. The most significant one is probably cisapride, which used to be used to treat rabbits with gut stasis.
The manufacturer never went through the process which would have been needed to get a licence to sell it as a drug for treating rabbits, so it became entirely unavailable here when its licence for sale as a human medicine was withdrawn.
http://en.wikipedia.org/wiki/Cisapride
http://tinyurl.com/catyvx
This is maybe an argument for better/different regulations on drug licensing rather than for or against letting pharmacies make up compound drugs from their components as I really can’t see why it wouldn’t have been possible to let the manufacturers license Cisapride for rabbits on the grounds that there was already a track record of use with no serious reported side effects. I can’t see that there would have been any possible danger of illicit sales of a rabbit drug in order to treat human constipation!
Comment by Rosemary Rodd — April 24, 2009 @ 9:34 am
YOur filter nommed my comment on the previous post on this topic.
The local compounding word-that-cannot-be-written was the only choice for, I think it was stilbestrol, which controls spay incontinence.
It’s not available for humans for the very good reason of, like, CERVICAL CANCER in the daughters of women who took it to prevent miscarriage.
Terrible drug, if you are a pregnant human. Great if you are a spayed bitch. No chance of any daughters to get cancer.
I’d hate to see such items be made unavailable because of this.
After all, a VET wrote the prescription, yes?
Will there be licensure action taken against the vet and the professional-that-cannot-be-written?
Comment by H. Houlahan — April 24, 2009 @ 11:01 am
Ok, so we need a sooper-sekrit code word for the word-hat-cannot-be-written….
Comment by JenniferJ — April 24, 2009 @ 11:46 am
that, not hat.
Sigh. Sleep, I neeeed you!!!
Comment by JenniferJ — April 24, 2009 @ 11:47 am