Using drugs for indications not approved by the FDA or in species not listed on the label is a fine gray line many of us in the veterinary profession are uncomfortably forced to straddle.
That’s because way too many of our drugs are not economically significant enough for drug manufacturers to undertake the incredibly expensive approval process required to bring them to market for common animal species. And it’s even worse for the cavvys and cockatoos among us. I mean, who’s going to shell out hundreds of thousands of dollars for a medication that’ll only be applicable to rabbits...or reticulated pythons?
Then there’s the case of the many human and animal drugs made for just one problem, to be used at just one dose, and only for a certain amount of time or exclusively at certain specific intervals. Anything beyond this limited indication effectively means you’re using it “off label” or “extra label” (both terms mean essentially the same thing).
So if you choose to use the parasite-preventing Revolution, for example, to actually kill a parasite like ear mites (instead of prevent it), you’re engaging in an off label use of the product. Similarly, using Viagra to control blood pressure in humans (instead of for its erectile dysfunction indication) constitutes an off-label use of the drug, too.
According to the FDA, it’s OK to use products off label if there’s no other way of achieving the same effect...and if it conforms to the standard of care of your industry. Therefore, veterinarians who use the human drug Lipitor in dogs to reduce their cholesterol levels can do so––carefully, and with appropriately informed owners in tow (as all drug use should be).
But the FDA is careful about these innovative uses. And while it doesn’t want to stifle innovation at the level of basic research and clinical application, it certainly does NOT want docs using these drugs willy-nilly for whatever use, dose or frequency strikes his or her fancy.
Want a sense of the complexity of FDA policy on this? Here’s some explanatory testimony by the FDA’s William B. Schulz before a congressional committee back in ’96:
“Madam Chairman, I am here today to talk about uses that do not appear in a product's FDA-approved labeling and are not approved by the Agency. Such uses commonly are referred to as "off label," "unapproved," "unlabeled," or "extra-label" uses. The Food and Drug Administration (FDA)recognizes that, in certain circumstances, off label uses of approved products are appropriate, rational, and accepted medical practice. FDA knows that there are important off label uses of approved drugs. In this context, it is important that physicians have access to accurate information about drugs. But we also know that allowing the promotion of these kinds of uses can have negative public health consequences -- including exposing patients to unnecessary risks and destroying the incentive for companies to conduct the necessary research to demonstrate that products are safe and effective for these uses. Striking the proper balance between the need to regulate the promotion of unapproved uses for drugs and devices and the need for reliable scientific data and information on unapproved uses of approved products is a difficult and controversial challenge.”
In the last sentence here, the FDA refers to companies that would promote the off label use of their drugs, something the FDA finds wholly objectionable. The implication is that drug companies who engage in this practice do so by way of shirking their responsibility to appropriately investigate these uses and file proper FDA applications to expand their drug’s labeled use. Because, essentially, they’re using these off label patients as guinea pigs as they compile unpaid-for data on their drug’s cool new spinoff properties.
Now for the examples: Two things coincided this week to hammer home the point of off-label drug use and its pitfalls.
The first was all over the news: Pfizer was fined $3.2 Billion for using its drug representative army to promote off label uses for 13 of their drugs. Pfizer had engaged in this practice before, so I’d say the FDA was well within its rights to levy so high a fine. Yet because this sum represents only 3 weeks of revenues for a company Pfizer’s size, and because off label drug use is a huge consumer safety issue, there were plenty of complaints alleging that the fine was inadequate.
The next issue arose when I received a call from a North Carolina veterinarian unhappy over my use of Adequan in a cat. Said cat was one of my winter patients, a kitty with chronically intermittent bladder issues who responds to Adequan beautifully (here’s a post that discusses this indication). You can throw antibiotics and steroids her way all you want yet nothing alleviates her symptoms like Adequan does.
Problem is, Adequan’s use in this case is off label (it's not approved for use in cats). The NC vet did NOT want to relent on offering Adequan in his name––he required that I write a written prescription and a letter explaining why I was using this drug.
He also complained that the intramuscular injections were a big no no, implying that things in Florida must be a whole lot more lax than they are in North Carolina, since he would NEVER have allowed a client to administer IM injections of anything––much less an off label drug. ("Sub-Q is fine," I humbly agreed as I held my tongue.)
Not that I blame this veterinarian too much. In fact, I’d much prefer a careful soul such as him over the drug-happy kind of veterinarians we all know are out there. Nevertheless, I was taken aback by his lack of knowledge of this drug’s off label use in cats and by his unwillingness to employ ANY off label drugs in his practice unless they’d been in use for at least thirty-plus years.
So you know, this point of view is alive and well across the US. When it comes to steroids and antibiotics, anything goes, since many of these drugs have never been approved for use in dogs and cats. But when it comes to newer-fangled drugs, all bets are off. If there’s no veterinary version it’s a no-go. And if it’s only been approved for dogs you can forget it for your cat.
Never mind that veterinary specialists like oncologists, internists, cardiologists, dermatologists and exotics vets use drugs off label every single day. None of our chemotherapeutics are approved for pets. Not even diphenhydramine (Benadryl) is approved. The market is either too small to be worth anyone's while or the drugs have been commonly in use for so long that nobody cares anymore––so there’s no need for a drug company to go out of its way to make dogs, cats and conures any safer.
Then there’s this to consider: ARE your pets safer when these products are brought to market by way of a Pfizer or a Lilly? Or does it simply mean you’ll be paying more for the same drugs?
Consider the case of Prozac: It was expensive before it went off patent and was genericized into lowly fluoxetine. That’s when veterinarians discovered its profound benefits as an adjunct to behavior modification in highly stressed animals. In comes Lilly. It reorganizes the drug into a variety of non-human doses (8, 16, 32 and 62 mg instead of 10 and 20 mg), adds flavor, tests it for one indication (separation anxiety) and applies for FDA approval.
Now that Reconcile's been granted approval, veterinarians cannot use the off label human version without a darn good reason. Never mind that this is the exact same drug and that its off label use is all about whether we give a chewable or a capsule just a couple of milligrams different than the human formulation. It’s just marketing. But whenever I write a $4 fluoxetine script to help out a client with his finances, I know I do so at my own professional peril.
Same goes for meloxicam. Now that this drug has been approved for use in dogs as an oral liquid (as Metacam), there may be trouble in store for veterinarians who continue to write cheap scripts for the human generic (in a pill form).
Do I do it anyway? Sure I do. I just have to be extra careful to explain why I’m doing it and detail the client conversation in my medical records: “off label usage of X drug discussed.” Some veterinarians, like my NC colleague, will also ask another veterinarian to sign off on it and further distance themselves by asking the client to sign on a dotted line.
Despite my willingness to script out non-vet versions of chemically identical drugs, the truth is I believe drug companies deserve to be compensated for their investments, especially when they make drug use a safer prospect for my patients.
In fact, I still use Metacam (like water). I still carry Reconcile (and use it more than my other colleagues do). But when pet owners cannot afford these options (especially for very big dogs) or when they won’t take the medication in a pill or liquid (whichever the case may be), I’ll make adjustments to make things possible. And many veterinarians I know will do the same, despite the gloom and doom others among us may disseminate on the matter.
Is it uncomfortable? Does it add stress? Do I worry that one day my liberal use of off label drugs will come back to bite me in the butt? Of course I do. But it’ll never keep me from using drugs based solely on their labeling status––not while many pet health and welfare concerns are held captive by a drug paradigm that would otherwise limit my ability to care for animals to the best of my ability.
Add Comment48 Comments
So, my two kitties that have IBD and pancreatitis would be dead within this vet's practice. Glad I'm not seeing him. Bo, who suffers from acute vomiting when he is sick (think of vomiting once or twice an hour for 13-14 hours), would be dead without his dolasetron, and we relied on Cerenia for 3 days too the last time around. And what about the injectable famotidine (pepcid generic) that we use when he is so sick because we can't keep the oral meds down. I just looked and even the metoclopramide that was worthless on Bo isn't even approved!!
And Cougar relies on mirtazapine when he is sick, which is off-label too (using a human anti-depressant as an appetite stimulant and for nausea). Oh, and let's not forget the buprenex that both Bo & Cougar have used from time to time. And Cougar's ursodiol that he takes for pancreatitis every other day.
Oh, by the way, we give Bo SQ injections of Adequan - started weekly and now every othe week. This is for arthritis, not urinary issues. But it seems to be working fine SQ. My vet does a fair amount of research on VIN and other sites, and I asked her before we started to use it if it had to be IM and she said they use it SQ. I didn't ask any further as I wasn't looking forward to trying IM injections at home, and certainly didn't want to cart him to the vet on a regular basis. I have known others that have used it SQ as well.
But obviously if I was waiting for all my cats meds to be approved, I wouldn't have any cats alive anymore.
Jenny September 5th, 2009 02:15:52 PM
OMG. Metoclopramide? My vet was prescribing that for my cat in the early 1990's! It's not approved? What idiocy. I've had the good fortune to have a sensible vet willing to work with me and prescribe human equivalents where it would save me time and money, and as a result, I trusted him when he told me that we needed to use a veterinary formulation, or a strictly veterinary medication. For example, I understood that Clavamox and Augmentin were not necessarily equivalent; it depended on the ratio of amoxicillin to clavulinic acid (pardon if I misspelled that). So when we needed Clavamox, we got Clavamox.
Susan September 5th, 2009 03:40:20 PM
This is such a sticky subject, loaded with risks and benefits for both humans and animals. But once again, it is the animals that take the short end. As a veterinarian, it has to be extremely difficult to make thoughtful decisions regarding risks when applying human approved medications to animals. Just relying on big pharma to utilize "approved" animal medications/dosages is fraught with risk as in the NSAIDS many documented adverse reactions.
Sadly, medications are still given out without serious written OR verbal discussion of potential side effects. This is taken care of by a human pharmacy with labels, and attached (folded page-s). And how does one really know what is happening within the canine, feline, animal body? A human can verbalize long before overt physical symptoms are observed (for the most part) . And translation of dosages? We know metabolism is drastically different, right?
Over the past decade or so, I have developed big mistrust in the drug industry, as have many people. So, I would like the take the same care and err conservatively with my pets. And the only one that can aid me in making that informed and best decision is a Vet that is knowledgeable, thoughtful, and concerned taking into consideration the individual pet's health.
Barbara A. Albright/NH September 5th, 2009 04:35:10 PM
And I thought "high cholesterol" was no big deal , as it is in humans? At least that was what I was told many years ago, although possibly indicative of impaired thyroid.
Barb A./NH September 5th, 2009 04:43:15 PM
In my state (Pennsylvania), pharmacists are permitted to substitute generic equivalents unless explicitly prohibited by the prescriber. Thus, a pharmacist would be permkitted to dispense fluoxetine if Reconcile were prescribed; but, apparently, a veterinarian is not allowed to dispense generic fluoxetine. I suppose the same is true now with methimazole. I understand that the FDA does not intend to pursue such infractions of AMDUCA rules except in cases relating to animals that end up in the food chain. I think there is also a similar anomaly by which a pharmacist may compound veterinary dosage forms for a given patient, but not prepare a stock supply for dispensing nor yet to supply these to veterinarians except again for a specific patient at a time.
Dr. Steve Dubin September 5th, 2009 05:20:18 PM
I'm one of those folks who buys Advantage in the big sizes and breaks it down for her cats. This is also technically "off label" since the pkg is for dogs, but it makes me crazy to spend so much more to get the pre-measured cat size. I wish I could just buy it by the quart and be done with it.
Brooke September 5th, 2009 06:01:54 PM
Teva Animal Health sells medicines for dogs, cattle, horses, sheep, swine and cattle including flea and tick shampoos, ear washes and antibiotics. The company also markets the DVM Pharmaceuticals brand-name dermatologic products for animals. http://drugs-about.com/firms/teva.html
FDA NEWS RELEASEFor Immediate Release: July 31, 2009 Media Inquiries: Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.govConsumer Inquiries: 888-INFO-FDA FDA Takes Action Against Teva Animal Health Inc.Company fails to adhere to current Good Manufacturing Practice regulationsThe U.S. Food and Drug Administration announced a consent decree of permanent injunction filed today, that prohibits Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the defendants from manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain FDA approval.
Then there is the worry of approved products not being contaminated, it never ends!
Barb A./NH September 5th, 2009 07:15:25 PM
As an interesting aside, ondansetron is now available as a generic in a 4-mg. oral disintegrating tablet. Previously available only by brand-name as Zofran ODT, it is a great anti-emetic that doesn't need to be swallowed. It comes in a flavored tablet that dissolves in a few seconds and is absorbed through the oral mucosa. I'm pretty sure this would be off-label use, but my vet prescribed it when my 85-lb. Lab had been vomiting this summer. She got a dose of the injectable in the office, and I then asked about the ODT if more doses were needed. My vet hadn't heard of it before that, looked it up, and prescribed it at the 4-mg. dose. (I already knew how well it worked on humans, as I had been prescribed this myself before having my gallbladder removed this spring). The tablets could be split for a smaller dose if needed; I don't think they're scored, but a pill-cutter should do the job nicely. BTW, Gracie took only 2 doses, and it worked great for her.
Shellie September 5th, 2009 07:37:47 PM
Barb, I find the Teva matter interesting for a number of reasons. Apparently, the FDA has been giving them a "pass" on this same stuff for 2 years. Around pet circles, what Teva's been doing makes us cringe but I know that in FDA's world most of it isn't near the top of their list. I have a suspicion that another little investigation provoked this and that led to the flurry of inspections and ending in this decree. In this matter, I find FDA letting it slide for 2 years disturbing. If it warranted action, it should have been taken much sooner.
Of course, I just don't get the whole drug/war-on-drugs/people/pets thing. When I was young, we had a whole little pharmacy in our civil defense supplies, including morphine and codeine. The whole kit an caboodle was stored at the shelter, in a local Jr. High School. The whole community knew it was there and nobody ever touched any of it and it was simply behind a locked door. I know because I helped do the periodic inventories. Why can't we just go back to people having basic good sense instead of all these "drug" and "quasi-drug" restrictions that just beg for people to find a way around them.
PJBoosinger http://pjboosinger.viviti.com/ September 5th, 2009 08:17:10 PM
Advantage Multi is off label for demodectic mange in dogs and is now recommended by the dermatologists at Co. Stat Univ. Vet School.
Under a different name, it is ON label for that use (and the insert includes information on the clinical trials that demonstrated effectiveness.). The product in the US and in the rest of the world is exactly the same.
Just a data point...
EmilyS September 5th, 2009 08:40:05 PM
Thank you for this post. My staff worries about this a lot. I've read that indoor cats don't need the flea and tick, is this true?
www.romeothecat.com September 5th, 2009 08:58:11 PM
To me the whole drug thing has become crazy (and did you have to reference our age PJ?), vaccines, drugs, protocols all tested on laboratory animals, limited human trials---approved for the market, hurry up & do huge advertising targeted to the physicians and public media---make gazillions, have adverse events and death, then withdraw them to start all over again. Two years of FDA asking Teva to clean up , with no results for animal products. Sure, why not? Animals are at the bottom with no protection.
But back on point, sure I have utilized off-label drugs for my pets, with careful consideration. Piroxicam was one such drug, for a diagnosed Transitional Cell Carcinoma Scottie. Even if it did not extend his life, although I think it certainly did (25 months worth); it abated the horrible symptoms, as he regained bladder control and was able to urinate as needed. Some Scotties aren't so lucky and can not tolerate Piroxicam or any NSAIDs without severe consequences.
Shellie: Just curious, but did you find the reasonGracie vomited?
Barbara A./NH September 5th, 2009 10:14:40 PM
Yeah, the ondansetron gets mentioned too on the cat lists, but really when a cat is vomiting non-stop, any oral meds are difficult. We did manage to get the Cerenia down, but much prefer the injections of dolasetron/Anzemet, or others on the cat lists like the injections of ondansetron. Cerenia is also available as an injection (off-list) but not offered to us that way.
I was actually trying to think of what meds I have used that are actually on-list and they are usually things like heartworm meds. But on the other hand there are plenty of published articles that discuss the use of off-list meds for cats - including ondansetron, dolasetron, Cerenia, famotidine, etc.....So, I have a great vet that does research before she recommends medications and I do my own research too. Since so few serious meds for cats are on-list it becomes kind of a moot point. Dogs always seem to take priority - Cerenia and Adequan are perfect examples. So, most of the cat owners I talk to on the lists don't really consider whether a drug is on-list or off, but only whether there is a good reason to use the drug.
Jenny September 5th, 2009 11:00:27 PM
Tests on Gracie were somewhat inconclusive--CBC was minimally indicative of virus, chemistry showed only some early dehydration; fecals negative for any parasites, x-ray showed no obstruction. So maybe she would have been fine without the med, but it made it much easier to rehydrate her orally and not require hospitalization and IV's. If at all possible, I prefer to keep my animals at home in familiar surroundings and treat them. Of course if that had failed, or if dehydration had been more severe, I would not hesitate to hospitalize.
Shellie September 6th, 2009 01:49:38 AM
"trying to think of what meds I have used that are actually on-list" Having been a "cat lady" for years before dogs, me too. I will never understand why the FDA won't set up some better kind of after market tracking system of on and off label use so we'd at least have the data although I guess it would be difficult to get vets to participate if they're fearful of sanctions.
Barb, Sorry about the age inferences. With my Shiba's new complications, I'm doing a juggling act and really feeling my age at the moment. But I won't do a vet rant on Dr. K's blog :)
PJBoosinger September 6th, 2009 02:41:04 AM
Jenny: Sorry so late to the discussion (busy weekend) but let me just congratulate you on making my point so perfectly––and with such a wide variety of drugs!
Dr. Patty Khuly September 6th, 2009 07:40:09 AM
PJB: That was a joke, I reference it all the time! I'm going to do it again right now: in the 30+ years of pet ownership, I never got all these drugs to stop a vomiting episode.
It was usually thought to be due to an indiscretion and the simple course of action: withhold food for 24 hours, offer ice chips, restart with bland diet (boiled drained hamburg & rice) and your on your way to recovery. And never an episode that continued or needed IV fluids (until Pocket & death, of course)
But Anzemet? Working on the neurological vomiting reflex? Never heard of it, not too mention charged $100 a dose! I can certainly fathom stomach coaters like Reglan or Pepcid AC.
Barbara A./NH September 6th, 2009 11:26:50 AM
Anzemet (dolasatron) is a great antiemetic drug. It and ondansetron/Zofran are used by a lot of people on the feline IBD/pancreatitis lists - both are from the same family of drugs. I do see ondansetron mentioned a little more than dolasetron which I use, but I asked one of my vets why they use dolasetron and they said the local vet school uses it so they do too. They rarely use reglan/metoclopramide anymore - the problem is that it just isn't all that effective compared to the other meds. Bo actually got severe cramps from it, so I have it in his folder that he should never be given it.
Pepcid AC is an acid reducer which is also very helpful - one of my cats has been taking it since 2004, the other for almost 2 years.
Regarding cost of Anzemet, $100 sounds very steep but it is not a cheap medication. The problem is unless you get the huge vial (which is very expensive), it does not contain any preservatives. So, we were instructed by the pharmacy to draw all the medication into syringes and store up to 2 weeks in the refridgerator. We have relaxed a little on that, doing the draw maybe 2-3 times so we don't take a chance of wasting a lot of syringes if we don't need it all, and we probably stored up to 3 weeks. It wasn't cloudy so we felt it was OK. But still, the lack of preservatives may explain some of the cost - they can't keep it on hand forever once it the vial is open. We don't get the Anzemet from our vet as it was just too expensive that way - I think it was $23 for 3 syringes or close to that. We purchase the largest non-preservative vial when we use it for Bo from the pharmacy for $60. That provides enough meds to give him an injection twice a day for 2.5-3 weeks. Bo is a very large cat. A smaller vial was about $20.
Withholding food is fine - and we have done that briefly as obviously you can't feed a vomiting cat. But when this goes on for several weeks, you can't do without the nausea meds. Bo has been on dolasetron for several weeks at a time. This last time around we also did Cerenia for 3 days as the dolasetron was not working by itself, but our vet only likes to use it when she has to. I've been on the yahoo feline IBD list for about 2.5 years now, and these meds are very important for these cats.
Jenny September 6th, 2009 12:34:02 PM
Oh, one more comment :) Most of the time the vomiting (and diarrhea) seen with IBD is not simple indiscretion - same with pancreatitis and intestinal lymphoma. Until the inflammation is brought under control, vomiting, nausea, and diarrhea may continue for weeks at a time. For Bo we have to gradually reduce his nausea meds over several weeks or the vomiting will restart. One of the most frequently asked questions on the lists is "what should I feed my cat" - and it is one of the most difficult questions to answer because each cat is so different. Sometimes it can take weeks to find the right food. Sometimes you never do and you need steroids, etc.
So, I agree - if a cat is off because of simple indescretion, that drugs like anzement or zofran are probably not needed. But diseases are a different matter. I actually used pepcid on my non-IBD cat this week as he was showing some signs of nausea. But if he continues to need it, will need to have him checked out.
Jenny September 6th, 2009 12:46:07 PM
Jenny, I wasn't referring to chronically ill cats w/diagnosed IBD. I was thinking more of canines with a temporary period of vomiting.
Yes, a diagnosis of intestinal lymphoma is another matter alltogether too.
My point being, why would you ever jump to a powerful med, for hopefully a temporary problem. I have never done so, and have certainly not had it ever suggested or prescribed as a stopgap. Including my dog with diagnosed pancreatitis (Pearl)---that never vomited or had diarrhea anyways. Switching to lowfat dogfood permanently solved that!
I didn't realize it was an injectable until this post, let alone the obviously outrageous proce charged for such a small quantity, nor its mode of action. It didn't work anyways. My dog vomited stomach contents (not food, since she didn't eat anything for an entire week, unless you count a teaspoon of baby food, which wouldn't sustain life of a 5 lb. cat.)
I appreciate learning about all the feline treatments, I consider myself completely spoiled by the luck I had with mine.
Barbara A./NH September 6th, 2009 02:31:41 PM
I think that off label use has little to do with the price and my biggest objection is the 300% increase vets charge to make money off their RX...
Zofran in chemo patients is a wonder drug, but crazy priced supposedly to pay for the R&D. I do not know what it's price is now, but when my son was getting chemo, it was $2700.00 for a 30 day rx...we were lucky enough to have great pharmacy coverage, but I refilled that zofran every month even if we didn't need it and made sure those who did and couldn't afford it, were able to get it anyhow. (we paid a tiny copay in comparison).
the pharamceudicals have already tested every drug marketed on animals already, so in a way it is a sad commentary on the way things are that these drugs are used "off label"
LorriM1 September 7th, 2009 03:28:35 PM
LorriM1: I think you'll find that the markup on drugs varies widely from vet hospital to vet hospital. Right now, a huge percentage of vets is feeling the pinch of online pharmacy competition. Even those of us who never marked up our foods and drugs much (50%?) are reducing our margins to justify the "convenience sale."
Do some hospitals still keep the 300% markup going? Sure. But we don't all deserve to be painted with the same brush of "high prices because we know you'll pay." No, most of us would rather you paid for our operations through services. It only makes sense. (After all, I'm not a pharmacist nor do I feel veterinarians should be monetarily motivated to be "drug pushers.")
But consider that those of us who used to survive off the extras gained from drug and product sales will have to raise our service prices to survive––especially in this economy.
Dr. Patty Khuly September 7th, 2009 06:07:54 PM
Most vets in this area (southwestern PA) are now writing scripts, albeit grudgingly, to be filled in the local pharmacies, which compete with the $4-10 generics. The vets usually add a surcharge of from $6-10 just to write a script rather than dispense the meds. However, the savings can be enormous if you do your homework. A prescription filled at Walgreen's, for Clindamycin, for example, may cost me $4 for the generic, plus the $8 prescription surcharge, for a total of $12. So I am still saving around $60 by getting the drug from the pharmacy rather than buying it from the vet at a cost of $72. This is a substantial savings for someone who, with 6 animals in residence, is almost always spending a sizable chunk of change at the office. Of course, if it is a veterinary-only drug, or needed in a hurry for one-time use, I will buy from my vet; but for long-term administration, I'll take the savings where I can, and am happy to pay the surcharge for a script.
Shellie September 7th, 2009 09:52:40 PM
<<surcharge for a script.>>
that shouldn't even be legal...
Dr K...in this economy, we're all struggling. Raising prices will simply keep many from going to the vet. I am seeing pets dumped all the time now because people can't afford to feed them much less vet them. Many can't afford premium anything. I had no idea how bad it really was until I moved out of high rent district into the real world...and if our current government has it's way, we'll all be needing food stamps
LorriM1 September 7th, 2009 10:51:12 PM
On the one hand, I am disturbed by observing routine use of drugs in an off-label capacity without discussing this with owners explicitly explaining what that means and what the side effects may be.
On the other hand, there are times when they refuse to give a prescription for a drug even when you can demonstrate it is being safely used off label in animals. For example, insulin. Almost all insulin except vetsulin and PZI is off label, right? They never really explain that to you. Many vets are perfectly willing to tell you to go get humulin N ,which is a human insulin and its use in cats is off label, even knowing it is a very harsh and short-lived insulin in cats with a higher risk of hypoglycemia (if they've done reading).
But I remember getting a firm 'No' to my requst for levimir, even after being able to produce information on its successful use in many cats who had become poor responders to lantus.
(That's not the vet I go to now, though.)
Years later, my beloved diabetic cat is long gone, but I "watch" the diabetic cat owner community, and I see more and more cats doing well on levimir. Which isn't to say that its a "solution" it's just an option when things are getting wacky on lantus. Levimir takes longer to kick in, has typically a flatter, longer, curve, less of a dip, which can result in a very flat cycle (in a good way) if the caregiver is testing a lot and learns to use the overlap.
I hope that vet remembers all the materials I printed out for her, and keeps it in the back of her mind, and remembers where she first heard about it the first time she goes to a conference and gets a presentation on the use of levimir in diabetic cats.
Stefani September 8th, 2009 12:50:05 AM
Shellie: Seriously? A surcharge? That's SO wrong on so many levels. A veterinarian cannot legally refuse to write a script. Some do, citing the gray markets and poor regulation of veterinary pharmacies, among other reasons. But charging for it? Imagine if a physician did so. If they're losing revenue on outsourced Rx's, building the expense of their expertise into the office visit is the appropriate way. That's how the human medical profession does it.
Dr. Patty Khuly September 8th, 2009 07:33:09 AM
Dr. Khuly, I hate to remind you, but there are several states that have expressly given veterinarians the right to refuse to write prescriptions. Ohio is one of them. I think Stefani has a link to the other states where vets can (although most wont) refuse.
KateH September 8th, 2009 05:02:19 PM
Kate,
It's not on my sites but maybe it should be. The following info courtesy of the good people who maintain the CRF (chronic renal failure) supplies site:
http://members.verizon.net/~vze2r6qt/supplies/legal.htm
Shows which states do/do not require the vet to write an RX if asked and appropriate VCPR exists, etc. The date on it is 10/2008.
FWIW, subq supplies is one area where there is a huge difference between what a vets office will charge vs. what you will pay per bag. When I have purchased lactated ringers solution, I was typically charged more than $20 per bag at the vet hospital. You can get a case of 12 bags from Direct Medical for about $25, with shipping and other related supplies the cost goes up to nearly 80 bucks but that is 12 bags plus all the lines and needles. When you are in the long haul on a disease that requires daily subqs, that adds up significantly.
Stefani September 8th, 2009 05:25:38 PM
I can't find my last statement for which there is an Rx. charge--don't recall if they called it a "surcharge" or a "fee"--whatever, it amounts to the same thing; they are charging you for their writing a script. PA is one of the states where a vet is not required to provide a script for meds they are willing to dispense. My friend found that out the hard way when she took her newly-adopted shelter dog (with dry eye) to her vet for his first check-up after the adoption. She requested a script for his Optimmune (cyclosporine 2%) ointment to fill when the tube given by the shelter vet ran out. She had found it online at EntirelyPets.com for $23.95 for a 3.5 Gm tube (the local pharmacies didn't have that strength, except a compounding pharmacy who would sell it for around $40). Her vet flatly refused, told her that he never, ever writes scripts, and instead sold her the same tube for $65, on top of the $48 office visit. (My friend has since found another vet, who does write Rx's and also charges a "prescription charge").
Shellie September 8th, 2009 09:21:47 PM
Okay, so I am one of those people whose pet keeps the compounding pharmacies in business. My understanding is that the practice of medicine includes having to sometimes make things that aren't ordinarily used, or aren't used frequently enough to be commercially viable as a mass marketed product. Is some of this off-label? I have no idea. Things I've had either compounded or had to purchase through a human pharmacy for Louie included pentoxifylline for his ears (he couldn't tolerate it), tacrolimus topical ointment for his skin (from regular pharmacy) and tacrolimus ointment for his eyes (compounding pharmacy). And then there's the off label use of Atopica at 10x the normal dose for all of his autoimmune issues.
I guess my real wonder here is why vets would be afraid of practicing medicine. If there's a treatment for a problem, why not prescribe it, particularly if there's a track record of success?
Louie's Mom September 9th, 2009 01:55:13 AM
Louie's Mom: Yep. All off-label. Anything compounded is off label, too. But compounded versions of vet drugs typically get a pass if you're seeking it in another delivery method because your pet won't take it otherwise (liquid vs. pill, for example).
Dr. Patty Khuly September 9th, 2009 07:38:12 AM
I would estimate that >95% of the drugs I use (aside from heartworm and flea preventatives) are being used off label in some way, shape or form. Either I am using a human generic drug for a dog/cat or I am using a veterinary drug to treat a condition it is not specifically approved for. I can choose to practice veterinary medicine in one of two ways: 1) as an advocate for my patients, or 2) in fear of being sued. I choose to be an advocate for my patients and to use drugs that I see fit to best address their medical needs. Will that bite me in the butt? Perhaps one day, but the entire tone of my practice would change if I put my own legal protection above the needs of my patients. So far, I have had the good fortune of being able to practice without the government or HMO's looking over my shoulder all the time.
As for charging for a written Rx... Whether your state "requires" you to do it or not, denying a written prescription to a client is in violation of the Robinson-Patman Act of 1936. But I do have some stong opinions on internet pharmacies.
Dennis Leon, DVM
Dr. Dennis Leon September 9th, 2009 05:23:53 PM
Dr. Leon, I'm sure it doesn't hurt that it's highly unlikely you'd ever be sued (no doubt, you know this), and even if you were, given the way the law views animals, any client who would sue you would lose much more than they could ever gain. You also, I'm betting, have about $1 mill of insurance coverage for a few hundred bucks a year. So, you aren't really taking all that many risks. No offense, I know nothing about your skills as a vet, but it's easy to be a "risk taker" when the potential "bite in the butt" is little more than a mosquito bite.
Stefani September 10th, 2009 10:29:31 AM
I didn't realize that all compounded meds were 'off label'.
If it weren't for compounded Cisapride, my oldest cat would have had to been euthanized almost 2 years ago since I can't afford the surgery.
I thank God for compounded meds and the vets willing to prescribe them, and my Jack appreciates it too every time he goes potty on his own!!
cl September 10th, 2009 08:24:29 PM
Stefani: Believe it or not, the risk of litigation drives much of us to practice differently than we would otherwise like to. Though it's unlikely to be but a 'mosquito bite' in the long run (I agree), for a profession until very lately unused to the downside of litigation, it makes sense that we'd fear the bite far more than we'd actually feel it.
Dr. Leon: I totally agree on the written Rx issue. If this was ever legally challenged, the federal law you cite would doubtless come into play. Like you, I'm also very leery of internet pharmacies, which is why I'm liking the voluntary certification process newly available for veterinary pharmacies. Have any thoughts on this?
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