Update on S. 959 and Vet Compounding

Back in July we wrote about a proposal coming before the U.S. Senate that, if passed, threatened to ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.

We examined why this would be so detrimental to family pets, and Dr. Sara Huber explained how
compounding medications might sometimes be the only way a veterinarian can accurately dose small breeds, puppies and kittens.

(click here to read more)

Now we'd like to update you on the status of that legislation, and if it still poses a threat to the medical care of our family pets.

snapshot of Amy's letter from Senator Roberts

A fellow blogger - Amy of Sebastian the Sensitive Soul -  has a pharmaceutical background and was particularly concerned about this.

So she decided to write her senator and let him know she opposed anything that would ban veterinarians from offering compounded medicines to family pets.

Senator Pat Roberts wrote her back and assured her that he has long been an advocate for local
pharmacies and referenced a "significant amount of misinformation" that was circulating about the proposed legislation.

Here is a direct quote from his response to her (used with permission):

"S. 959 makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the Food and Drug Administration. This legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation." (emphasis mine)

Hey, that all sounds pretty good to me. It is ethical and moral to ensure the safety of compounded medications, especially after the 2012 meningitis scare where tainted pharmaceuticals from a compounding manufacturer in Framingham, MA resulted in illness to over 700 people. 

But please note what he did not mention. Not once did he address her concerns with regard to animals and veterinarian-prescribed medications. I wanted to know why, so I dug deeper. 

So, are animals addressed 
in this legislation or not?

After hours of poring over the actual wording of the legislation itself, including strikethroughs from previous iterations of the proposed bill, I've found out a few things:

One: on May 22 this legislation, known as S. 959, was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee. It currently awaits consideration on the floor of the U.S. Senate.

Two: anyone who is brave enough, has the time, or is suffering from insomnia can read the progress of this proposed bill for themselves, online at a website called GovTrack.us. It includes previous wording as well as the final wording the HELP Committee passed on to the Senate floor.

Three: oh yes, animals are mentioned quite a bit in the wording of this bill, 41 times in fact. And it's interesting to note that they're almost exclusively in the parts of the proposed legislation that have been deleted.

Will pharmacies like this one continue to have the freedom
to compound prescriptions for our pets?

The organization that brought this to our attention, My Meds Matter, expressed a concern that big drug
companies were trying to add an unrelated amendment to this bill that would forbid veterinarians from writing compound prescriptions for family pets.

They urged people to write their congressmen and ask that these provisions be removed from S. 959.

I'd count this a win - it appears they were successful.

I have signed up to follow the progress of this legislation via email updates from the Gov Track web site. It will be interesting to see how the wording changes once it passes from the Senate to the House of representatives.

Currently, 39 of the 41 references to animals have been removed from the proposed legislation.
Here are the two that are left:

Reference #1:
In the definitions section of the bill, a "DISPENSER" is defined as a retail pharmacy, etc, etc... and "does not include a person who dispenses only products to be used in animals."

In most cities, this exclusion is meaningless, as most veterinarians use human compounding pharmacies to fill their prescriptions.

Reference #2:
"Not later than November 1, 2016, the Comptroller General of the United States shall conduct a study and submit to Congress a report on the safety of animal drug compounding and the availability of safe and effective drugs for animals." [S. 959, section 102 (d)]

This second one is worth keeping an eye on, for if it's true that big pharma is trying to eliminate a veterinarian's ability to compound drugs for family pets, here might be their next opportunity to try to restrict that.  

Whew! This was one of our more difficult posts to wade through, both from a writing and reading standpoint, we know!

Thanks for hanging with us because, although it's not exactly a fun blog post, we think it's an important one.

(We promise to balance it out with a terrific 'Toon Tuesday tomorrow, and an awesome Wordless Wednesday!)

gratuitous shot of Maxwell and his baby blues

Drug Companies Try to Ban Compound RX for Vets

Today's Medical Monday deals with a critical issue to pet health care.

My Meds Matter, a medical watchdog site with a specific interest in custom compounded medications, recently posted an alert about a proposal coming before the U.S. Senate. If passed, this proposal would effectively ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.

photo via GOKLuLe, Wikimedia Commons

According to My Meds Matter, "customized medications can make all the difference is the world when these animals have a health issue.

The most egregious provision under consideration would limit the bulk ingredients that can be used in compounded medications to treat dogs, cats and horses to a positive list developed by the FDA.

There are no similar restrictions for elephants, giraffes, hamsters, other minor species— not even humans!

This could mean the elimination of important drug therapies that dogs, cats and horses depend on."

What's behind this push to ban compounding drugs? Apparently it's sponsored by the Animal Health Institute (AHI), a group created and funded by the big drug companies. Their member directory reads as a Who's Who of the world's major pharmaceutical companies: Abbot Laboratories, Bayer, Merck, Boehringer Ingelheim, Novartis, Zoetis.

Will this proposal cause pharmacies like this one to be
a thing of the past? Photo: Sarah Smith

This feels like a clear conflict of interest if, by banning compounded medications, veterinarians are forced to use the very pharmaceuticals these companies produce.

But are compounded medications really that important? We asked Dr. Sara Huber of Leawood Plaza Animal Hospital to weigh in on the subject - and her answer was eye opening:

Dr. Sara Huber, DVM

Dr. Huber: "I use compounding pharmacies on a weekly basis for my clients and for my own pets! My cat Millie has hypertrophic cardiomyopathy and asthma.

"When I try to pill her, she gets so worked up that she has an asthma attack and needs her rescue inhaler. I get her medications compounded into a transdermal gel that she tolerates really well.

"Without these compounded medications, I don't know that I would be able to get the medication into her without:
1. compromising her health and risking a potentially fatal asthma attack
2. ruining the bond between us.

"The last thing you want is for your cat to run away when they see you coming!"

I found this next point to be a very important one:

Dr. Huber: "Aside from just ease of administration, compounded medications help us dose our puppies and kittens and our toy breeds much more accurately.

"Most of the medications that we use are formulated for "adult-sized" cats and small, medium, and large dogs. We often have to treat 2 pound kittens, full grown dogs that are 4 pounds, etc.

"With compounding pharmacies, we can get the proper dose in an appropriate amount of liquid/appropriate sized pill to treat these little guys.

"Lastly, cost is often a factor when trying to medicate pets (it stinks that it has to be, but even people who love their pets more than themselves sometimes can't afford to do everything for them). Often times, a medication through a compounding pharmacy is more cost effective than the name brand veterinary equivalent or even human equivalent. This allows us to treat problems that may otherwise go untreated if the client simply can't afford it.

"Again, I take the compounding issue very personally because losing the ability to compound certain drugs would compromise my own pet. But I love my patients dearly, and using compounded medications has helped me to treat them more efficiently."

After reading this, we went out immediately and signed the petition at My Meds Matter to block the passing of such a proposal. To me, the critical issues are these three points:

1. Sometimes the best, most accurate dosage can only be given through a compounded medication.
2. Compounded meds may be cheaper.
If we can keep the cost of pet health care down, we can help more people afford to adopt.
and...
3. Compounded meds can be far less traumatic to your pet when administered.

Please consider signing the petition also, and help keep compounded medications available to veterinarians across the USA.

Mister "I Refuse To Be Pilled."

 On behalf of my own persoal pilling nightmare, Faraday...I thank you.