Ethics with Prescription drugs

[Peaches1206]

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Hey I am new to the forum and a first year. I just had a lecture on vet ethics with prescription drugs and was a little confused on some of the ethical considerations/obligations. In class we were given an example of the legality of the multiple uses of bulk compounded tubes. In the example an owner obtains compounded tubes of medicine from another doctor that doesn't list the ingredients- and this is a mixture of different types of medicine. The FDA prohibits the compounding of medicine for food animals.

My question is, other than the obvious legal issue with the FDA, what other ethical considerations are we supposed to see here? I am not familiar with FDA rules on food animal drugs and was trying to gain a little bit better of an understanding since these are incredibly important issues I will face.

Thanks!

 

[l2vet]

One of the main issues I see in using a compounded medication not specifically tested by the FDA is withdrawal times for meat and milk. They would be unknown in the case of compounded medications, and so would present serious issues with the safety of the food product produced from the treated livestock.

 

[sumstorm]

Compounding of meds without proper labeling doesn't enable follow up, as well (for any species.) Withdrawl times. Compounding suggests off-label use, which is particularly problematic in food animals.

BTW - are you a first year (brand new) vet? or a first year vet student? I'm assuming the later, but was looking at your status.

 

[Peaches1206]

Haha definitely a first year STUDENT!, I will get on that change 🙂

 

[Peaches1206]

Sunstorm- could you explain your answer more?

Unfortunately, I am extremely new to the food animal industry (with most of my experience coming from small animals/ exotics). Hence-my interest. From what I've read it seems that there are more definitive ethical guidelines for food animal prescription drug use.

 

[flyinggoat]

Kind of jumping in here- just speaking from my experience with my animals and off-label use in the food industry. For goats, pretty much everything is off label, and it's pretty annoying. We generally go by the withdrawal times listed for cows, and consensus from my limited research seems to be that goats tend to metabolize drugs faster than cows, so we should be fine. Plus our products are tested at the least, monthly, by the state and they would tell us if there was anything wrong. If we ever have any questions, we can send a sample. But, it does make us much less likely to use any kind of antibiotics if we don't absolutely have to. I, personally, do not like to jump to antibiotic use, and we try to maintain health and prevent problems, rather than deal with things reactively.

I'm sure there are more ethical guidelines and legal issues in food animals because people are going to be eating them, or something made from them. If there is, for example, antibiotic residue in the muscle or milk of an animal, and an allergic human ingests that product, that can be a big deal.

ETA: just using antibiotics as an example here because many are available OTC. Obviously, many kinds of medications, hormones, supplements, etc could have an effect on the product.

 

[sumstorm]

In food animal, you have to worry about the end product, particularly meat/egg/offspring/milk.

So anything you dose the animal with (no matter what route) you need to know how long it will be in the tissue of concern (milk, egg, offspring, meat.) That's withdrawl, which is a major concern.

When you combine drugs, or you deliver drugs through an alternative route (both reasons for compounding drugs) you can affect absorptoin and elimination from tissues; changing withdrawl times. IE a drug that affects renal elimination would impact the withdrawl time fro a drug that is cleared by the renal system.

When you compound drugs without a label (ie exactly what, how, and when mixed) you make it impossible for another vet (including state vets) to interpret care, calculate withdrawl, etc. It also means that tracking down errors could be impossible (polo horse massacre.)

Lots of drugs are used off label, even in food animal, but when you start combining drugs, you might not know all the pharmodynamics/pharmakinetics for the complete mixture. So off label use has to be very cautiously used in food animals.

Now, having said that, compounding can be very helpful for a lot of reasons (oversized animal where regular doses of, say, tablets, isn't sufficient, improve palatability, provide product without ingredients a particular animal is allergic to, etc) but compounding without a label is, in my opinion, never acceptable (neither is distributing non-compounded drugs without a label.) Also, a bulk tube is generally meant to treat multiple animals...which may encourage treatment without diagnostics/examination, which could mask an issue or an infectious disease (not even getting into super-bug concerns).

 

[Peaches1206]

Thanks for the reply. From what my teacher said, this is somewhat of a common thing to find in large animal medicine. Have you seen it...how would you be expected to handle this?

One of my classmates said she worked with a vet who did this all the time.

 

[eventualeventer]

You probably already know this, but just so we're on the same page:
From reading pharmacy discussions on VIN: it is illegal for a veterinarian to purchase a compounded drug and turn around and dispense it to a client. Period. You may write the client a prescription (or call, fax, whatever) and the compounding pharmacy may dispense the drug directly to the client. You may purchase a small amount of compounded drug for direct administration to patients in the hospital (or outpatients). You may not legally call up Big Name Compounding Pharmacy, order a metric crapload (industry term) of compounded tubes of flunixin meglumine paste, and resell them to clients as "generic Banamine". Yes, the vet who treats most of the horses at my barn (but not my friend's horses) periodically drops off (labeled) BNCP compounded flunixin paste, which comes in the same concentration and form as Banamine, and literally a case at a time of compounded phenylbutazone powder.

One issue with compounded drugs is informed consent. IME, most clients are not necessarily even told that the drug being given to their animal (or illegally dispensed) is compounded, let alone the higher risks inherent in using compounded drugs. Particularly for hobby animals and pets with a greater individual attachment, or breeding animals of some value, how many of them would ask for an alternative, approved drug/formulation if given information about the risks and benefits of compounding? This may be relevant more to horses than food animals, but I have seen compounded drugs often used for questionable justification where there IS an alternative, even if it's more expensive/not quite as convenient/etc. Sure, there are some drugs for which vets have no choice, like pergolide, which is no longer manufactured at all in the U.S. - the benefits for a Cushingoid horse clearly outweigh the risks. But what about compounded omeprazole suspensions (which are already of dubious legality since Gastrogard is a perfectly good orally dosed form, albeit expensive), which don't necessarily even work because of how finicky the molecule is (breaks down sitting on the shelf in aqueous media, has to be protected so it doesn't get degraded by stomach acid)?

Personally, when I see vets who buy compounded versions of existing drugs just because they're cheaper, and resell them to their clients for a markup, I start to wonder about their general moral character. It undermines the trust required for a healthy VCPR, since compounded drugs are NOT necessarily as safe as legally manufactured drugs. I'm not saying it makes them an axe murderer, but I wonder what other corners they might be cutting in the name of making money. It also, in my mind, calls into question the ethics of the compounding pharmacy involved. If they are willing to illegally manufacture large amounts of common drugs, what corners are THEY cutting which may jeopardize patient safety?

Just my .02 for now, I'm sure I'll think of more later.

 

[sumstorm]

One issue with compounded drugs is informed consent. IME, most clients are not necessarily even told that the drug being given to their animal (or illegally dispensed) is compounded, let alone the higher risks inherent in using compounded drugs.

True, to some extent, but some vets are very good at explaining the risks and gaining consent. In some cases, where allergies are involved, the risk of compounding is minimal compared to the risk of type I hypersensitivity.

Particularly for hobby animals and pets with a greater individual attachment, or breeding animals of some value, how many of them would ask for an alternative, approved drug/formulation if given information about the risks and benefits of compounding? This may be relevant more to horses than food animals, but I have seen compounded drugs often used for questionable justification where there IS an alternative, even if it's more expensive/not quite as convenient/etc.

One challenge is that there isn't always available drugs/formulations or they aren't available in viable quantities. I am not in large animal, but I know I had to calculate out a dose for a zoo species recently, and it would have involved giving the animal 37 tablets TID of a substance that wasn't very palatable. I'd take compounding a single dose palatable formulation over capture myopathy and risking injury to the animal and the staff. Also, apparently (I didn't know this till recently...and I think it may have been Whtsthefrequency who informed me) cost is a reason to go off label and/or compound.

Personally, when I see vets who buy compounded versions of existing drugs just because they're cheaper, and resell them to their clients for a markup, I start to wonder about their general moral character. It undermines the trust required for a healthy VCPR, since compounded drugs are NOT necessarily as safe as legally manufactured drugs.

All drugs are going to have to be marked up for vets to carry them. We have to cover carrying cost somehow, whether it's compounded, manufactured, over the counter, or off label. Should a vet not provide care if it is available if a client can't or won't pay for the current manufactured product? I know on my dogs I routinely use manufactured drugs off label (ie human versions when there is a canine version) because the cost difference is significant. The concern I have is that will lead to less research, but it allows me to cover other costs while I'm in vet school. While there may be some instances where ethics are questionable, in just as many cases there are doctors trying to provide necessary care for patients within the means of clients.

It also, in my mind, calls into question the ethics of the compounding pharmacy involved. If they are willing to illegally manufacture large amounts of common drugs, what corners are THEY cutting which may jeopardize patient safety?

I'm sorry, but I must be poorly informed about the legality of compounding. Here it isn't a hidden activity done in a dark back room; the compounding pharmacy is next door to the grocery store. And compounding is becoming common in major chains like Walgreens. And to some extent, this allows pharmacists and doctors to customize meds to the needs of their patients. I have a great deal of respect for the compounding pharmacist at the pharmacy we use where my husband lives....he really understands the pharmaceuticals and works with the vets to figure out what is best for the animals. Maybe my opinion is colored from working with exotics and allergic pets.

 

[alliecat44]

All drugs are going to have to be marked up for vets to carry them. We have to cover carrying cost somehow, whether it's compounded, manufactured, over the counter, or off label. Should a vet not provide care if it is available if a client can't or won't pay for the current manufactured product?

sumstorm, I'm not sure if you missed it, but as eventualeventer pointed out--it is absolutely 100% illegal in every state for a veterinarian to order compounded drugs and then sell those drugs to the client. The veterinarian can prescribe the compounded drug to the patient. The veterinarian can order a bunch for in-hospital use. However, the veterinarian cannot send home any of their "hospital stock" of compounded whatever or sell any directly to a client.

There's also the issue of compounding non-FDA approved drugs/supplements (remember the massive polo pony death? that was due to a mistake in compounding something that isn't even legal for sale here in the USA in the non-compounded form). Major ethical (and legal) issues there.

 

[NStarz]

VIN News:

http://news.vin.com/VINNews.aspx?articleId=17757

I found it pretty pertinent.

 

[sumstorm]

sumstorm, I'm not sure if you missed it, but as eventualeventer pointed out--it is absolutely 100% illegal in every state for a veterinarian to order compounded drugs and then sell those drugs to the client. The veterinarian can prescribe the compounded drug to the patient. The veterinarian can order a bunch for in-hospital use. However, the veterinarian cannot send home any of their "hospital stock" of compounded whatever or sell any directly to a client.

There's also the issue of compounding non-FDA approved drugs/supplements (remember the massive polo pony death? that was due to a mistake in compounding something that isn't even legal for sale here in the USA in the non-compounded form). Major ethical (and legal) issues there.

are you saying that you won't be charging when you dose an animal with a drug? won't you still need to cover the costs of that drug plus some algorithm of costs to you to obtain/carry that drug? I read 'resell' not just as distributing product, but as providing treatment (ie we go to X farm and give a dairy goat Y compounded pharmaceutical, we will still shift that cost to the consumer.) I can see how I may have misinterpreted what EventualEventer meant by resell. I actually didn't say anything about sending home stock, just that vets will have to cover carrying costs. At least where I am at, even drugs that wouldn't be handed out to clients, like euth solutions, still have a mark up.

I actually DID mention the polo incident earlier ("polo horse massacre") so apparently I did remember it. I'm not saying there aren't issues, but I am saying that I don't interpret compounding as automatic grounds for challenging the ethics or morality of a practitioner. I would be highly upset with the vet that EventualEventer noted as leaving large stocks of drugs at stables; I don't even think that is appropriate with manufactured drugs.

There are ethical and legal issues with microchips as well, but that doens't make vets that distribute and/or check for microchips automaticly of questionable moral/ethical fiber. I'm sorry I didn't articulate my interpretations and points better.

This might help the OP:

http://web.archive.org/web/20080115081805/www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html

 

[alliecat44]

are you saying that you won't be charging when you dose an animal with a drug? won't you still need to cover the costs of that drug plus some algorithm of costs to you to obtain/carry that drug? I read 'resell' not just as distributing product, but as providing treatment (ie we go to X farm and give a dairy goat Y compounded pharmaceutical, we will still shift that cost to the consumer.)

Yes, absolutely, charging the owner for drugs you administer in-house with a markup is completely and totally legal (whether they're compounded or not). However, the situation you describe--selling the goat's owner a bottle of compounded X, even though it is only intended to treat this one goat's condition this one time--is illegal for you as the veterinarian. You have to write/call in a prescription and they have to get it directly from the pharmacy. To do otherwise is illegal and (not to put words in anyone's mouth) what I *think* eventualeventer meant when she said that she questions the moral character of a veterinarian who buys and re-sells compounded medications--because it is illegal.

For example--we can use potassium bromide that is compounded by an outside pharmacy to load a patient during their hospital stay. However, the client has to buy their own bottle of potassium bromide directly from the pharmacy for their maintenance therapy. Hope that makes sense. 🙂

 

[sumstorm]

Yes, absolutely, charging the owner for drugs you administer in-house with a markup is completely and totally legal (whether they're compounded or not). However, the situation you describe--selling the goat's owner a bottle of compounded X, even though it is only intended to treat this one goat's condition this one time--is illegal for you as the veterinarian. You have to write/call in a prescription and they have to get it directly from the pharmacy.

Wow, we are talking around each other today!

Again, did NOT say 'sell the goat's owner a bottle' I said 'we go to X farm and give a dairy goat Y compounded pharmaceutical'

as in, much like I recently went to a farm and gave a whole bunch goats TB tests, I do literally mean we stuck the goat with a needle from our own hands, I meant literally gave the dairy goat Y compound....from our own hands.

As noted, I see that I may have interpreted EventualEventers term of resell differnetly than intended, much as I think you may have interpreted my 'give a dairy goat' as 'sell the goat's owner a bottle.'

Working in exotics, 90% of what I deal with is compounded. I do actually know what a pain it is to have to call the script in, and arrange for the delivery guys to meet the owner at the clinic or the owners to pick up the product and bring it to us. 🙂

 

[eventualeventer]

I'm sorry for causing confusion. I DID mean "buy and dispense" not "buy and administer". I have no problem with vets charging mark-up on medications.

I have no problems with veterinarians prescribing compounded formulations for exotic animals and other legal uses under AMDUCA, given informed consent. Compounding is actually quite important in equine practice; among other things, pergolide, the treatment of choice in Cushing's/PPID (which is VERY common in older horses and leads to crippling laminitis), is not manufactured anymore in the United States and so is generally compounded from imported bulk ingredients (one of the few cases where it is legal to do so).

I DO have problems with the ethics of both pharmacist and vet when existing medications are being duplicated or almost duplicated, usually for the purpose of cost. I have seen compounded "generic" cough cough Banamine/flunixin, phenylbutazone powder, ophthalmic preparations, etc. I have seen even so-called reputable pharmacies eagerly prepare compounded formulations that cost less per dose than the original form, implying in my mind that they are using cheap bulk ingredients from overseas instead of the commercial product that they are supposed to. I therefore do not believe that these pharmacies are at all interested in following the law unless it suits their needs.

I agree that dispensing large amounts of any prescription drugs for use at the owner's discretion does not exactly show good judgment.

 

[Armymutt25A]

I'll ask my wife to check out this thread tonight and give some feedback on the whole compounding thing. She's a second year pharmacy student and has done extensive compounding the past two years.

 

[david594]

For example--we can use potassium bromide that is compounded by an outside pharmacy to load a patient during their hospital stay. However, the client has to buy their own bottle of potassium bromide directly from the pharmacy for their maintenance therapy. Hope that makes sense. 🙂

Off-topic.... but is your potassium bromide example actually a valid one? Potassium bromide is not an FDA approved drug, and as such I would assume does not fall under pharmacy regulations.

 

[eventualeventer]

My general understanding is that all compounding from bulk ingredients (i.e., anything other than an approved product) is illegal, but the FDA has outlined certain situations in which they will turn a blind eye. From an FDA article on use of pergolide in horses - they use the term enforcement discretion:

Because of the severity of this disease in horses and the large population of horses affected by the syndrome, FDA is doing what it can to keep the drug available for use in horses. This effort includes trying to make the approved human product available through veterinary distribution channels and exercising enforcement discretion as appropriate with respect to pharmacy compounding of pergolide when done in response to a veterinarian's prescription.

More from the FDA website - green added for emphasis:

Compounding Under AMDUCA
FDA defines compounding as the manipulation of drugs to obtain products that differ from the starting materials in an approved dosage form drug. Under AMDUCA, compounding is considered to be extra-label drug use, and must be done from approved finished dosage form human or animal drugs only. Like any extra-label use, compounded drugs should not be used if an approved drug can be used at its approved dose and dosage form. AMDUCA does not permit veterinarians, or pharmacists, to compound unapproved finished new animal drug products from bulk drugs. Unless conditions set forth in 21 CFR 530.13(b) are met, the compounding of a new animal drug from an approved human or animal drug results in an adulterated new animal drug.
Conditions for Compounding

1. all relevant portions of the regulation have been complied with;
2. there is no approved new animal or approved new human drug that when used as labeled or in the available dosage form and concentration, will properly treat the condition diagnosed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for the compounding;
3. the compounding is performed by a licensed pharmacist upon the order of a veterinarian or by a veterinarian within the scope of their professional practice;
4. adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product;
5. the scale of the compounding operation is commensurate with the established need for compounded products (e.g., similar to that of comparable practices); and
6. all relevant State laws relating to the compounding of drugs for use in animals are followed.