The GeniusVets Show with Mickey O'Connor

Welcome to the GeniusVets Show for veterinary practice owners and industry pros. At GeniusVets, it's our mission to help veterinary practices thrive, and this webinar and podcast supports that mission by giving a platform to the best and brightest minds in the veterinary industry, where we identify challenges facing veterinary practices today, and discussing ideas, insights, and solutions that practice owners need to know about. If you like today's show, that's something we'd love to know. Feel free to send an email to [email protected]. And make sure to check the wealth of resources available to veterinary practices at GeniusVets.com/Pro. Now without any further ado, let's dive into today's show.

Hello, everybody. How are you doing today? Welcome back to another episode of the GeniusVets Show. I'm your host Davil Hall, co-founder here at GeniusVets. And today, we will be diving into a really interesting topic that I have found fascinating.

The pharmaceutical industry. We're talking about a really interesting aspect of the pharmaceutical industry that you know a lot about but maybe not enough. We are going to be talking about compounded medicine in the veterinary industry.

Guiding us through the conversation today and giving us some answers to our many questions is Mickey O'Connor. Mickey is the Director of Business Development for Epicur Pharma. He grew up in Philadelphia, graduated from Temple University School of Pharmacy, and worked as a sales representative for Merck and Co. for years.

He's licensed in five states and has now worked for Stokes Healthcare for 20 years. Over those 20 years, he's been a staff pharmacist, a sales rep, the Director of the Pharmacy, and now is the Director of Business Development. This man knows his stuff through and through. That's why he's the right guy to be answering our questions today.

Tell us a little about Epicur Pharma.

Epicur Pharma is a 503B FDA-registered outsourcing facility, part of Stokes Healthcare. Stokes Pharmacy is a 503A traditional compounding pharmacy.

Stokes Pharmacy started out as a small hometown pharmacy in Medford, New Jersey back in 1975. It grew into a compounding pharmacy that is known across the country and provides compounded medication for all states, including Hawaii and Puerto Rico.

In 2018, we got a 503B designation from the FDA. Then, in 2020, we announced the name Epicur for the 503B designated facility. Since then, Epicur has been providing high-quality medications across the United States.

Can you explain why it matters where you source compounded medications?

Traditional 503A compounding pharmacies started out with a simple idea of one doctor writing one prescription for one patient and being filled at one pharmacy. This worked out fine until the compounding industry started to grow on both the human and veterinary sides. The need for compounding grew, and so traditional compounding pharmacies started to make large batches to help out those hospitals and veterinary facilities that needed medication for their facilities.

This is where the challenge came in because those pharmacies were not made to do this. They follow the direct guidelines of USP, which are state boards of pharmacy, but they don't follow FDA guidelines. So, making large batches is not what they're meant to do.

In 2012, a New England compounding pharmacy had a sterile injectable medication that was contaminated and killed over 60 people, and over 700 were injured.

This is why the FDA decided to step in and create 503B outsourcing facilities. Once they were created, they were the ones making bulk batches for these hospitals and these veterinary hospitals. Which is how it's worked mainly on the human side. Human hospitals can only get compounded medication from a 503B facility, and now we are seeing this in veterinary hospitals.

What are your thoughts on the challenges veterinary hospitals have seen when working with compounding pharmacies and following regulations?

Regulations have caused a lot of challenges for veterinarians and their staff. Each state has its own regulations to follow. So a state like New York cannot get any medications for office use from a 503A compounding pharmacy. Everything for office use must come from a 503B outsourcing facility. There are several other states that do the same. The 503B category has been a positive change and was necessary as the FDA allows 503B facilities to make large batches for hospitals that can't get medications from compounding pharmacies.

You mentioned “office use” previously. Can you explain what office use means?

If you think about traditional compounding, you get a prescription from your veterinarian, take it to a pharmacy, and the pharmacy fills the prescription for your pet. That is one prescription for one patient. When we are talking about office use medication, this is ordering 10,50 or 100 bottles of something, depending on how large a practice is. Hospitals need these medications on hand to dispense to patients who need medications right away. So they stock these medications in their hospital. They directly dispense when the pet comes into the office. They also will send a prescription so they can use the medication right away on day one, getting the benefits right away. After the given script is done, they have a refill prescription on hand when needed so there is no waiting. It's a way for veterinarians to hold an inventory in-house.

How would a veterinarian know whether to use a 503A or 503B facility?

The way the system is supposed to work is for a veterinarian or purchaser to first search for a medication that is FDA-approved and comes from a commercial manufacturer. This is the best way!

If this doesn’t work or they can't find a medication from an FDA commercial manufacturer, then they want to search a 503B manufacturer. They have all their medications on their website, so you can go on their website and search for what you need. You can also call our facility as an individual if needed.

If it cannot be provided for a 503B facility, you will want to go to a 503A pharmacy to see what your next steps are. A 503A pharmacy product will not have the same amount of testing before coming to the market.

How do you know you are receiving a 503B FDA-enforced regulations?

503B facilities have to put their name on their label. If you receive a medication from a 503B facility like Epicur, it would say so on the label.

What sets Epicur apart from other compounders?

It’s really important to mention that there are three 503B facilities in the veterinary space. It gives options. There will be different medications made by different facilities. In this case, we are lucky to have multiple facilities so different products can be made for the veterinary space.

Stokes Healthcare has both a 503A and 503B facility. We can manufacture medications at Epicur, and we can also dispense them through Stokes Pharmacy. If a veterinarian wants to stock Epicur medications in their facility, they can have something in stock in-house, and then they can script out a refill for the same manufactured product. The consistency is there from start to finish. It’s the same product. The client will remain consistent throughout the treatment.

The other part is we have really great customer service. A lot of people will say this, but our customer service is trained well to solve issues and take orders. But the best part is we take time with the facility and doctors. We have a lot of relationships with these teams, and we understand the importance of their needs. We have fast delivery for these facilities. All of our products are shipped the same day they are ordered, and an office can receive it usually in 1 or 2 business days, depending on their location.

We have an online platform that is really easy to use. This platform will guide the person ordering to allow them to order the medication that is right for their facility. If a medication is not able to be sent to your facility, the software will give options on what to do next and help guide the client.

I challenge some of the veterinarians out there to call our facility to talk to our staff and ask questions. Let them walk through the process and see what the experience is like.

What is GFI 256, and why was it established?

There are a lot of technical parts to this, and I want to make sure everyone understands. So let me read this piece that I have written. “The GFI #256 was established to reinforce the FDA’s position that for safety and effectiveness reasons, FDA-approved or Indexed products should be a veterinarian's first choice over compounded medication. The guidance gives rules that the pharmacy must follow to avoid FDA enforcement. This is happening because the FDA wants documentation from veterinarians that proves why an FDA-approved or indexed product was not prescribed for their patient. They want to reduce the number of non-approved compounded items used in-house.

The FDA was saying there is a lot of compounded medication out there; is it really needed? They have now said if you want to prescribe a compounded medication for patients, we need you to provide acceptable reasons why you need that medication. For example, veterinarians may choose a compounded medication because a commercial drug is too expensive or because they want a 25 mg tablet compounded and don’t want to use the 50 mg commercially available tablet that can be broken in half. These are not acceptable reasons. The FDA wants you to use the commercial product whenever it is available.

The FDA wants all to use a commercial product first. If that isn’t available, we want you to use an FDA registered 503B facility to create this. This all comes back to the ability to track the drugs. Going back to the New England Compounding Pharmacy situation, there was no documentation or record of who had taken the medication.

How is this affecting veterinary hospitals?

I think what the veterinarians and purchasers are looking for are options. They may be having trouble getting medications they have used in the past. The regulations have changed what is available.

This brings us back to our online platform we offer, iFill, at Epicur Pharma. Our platform will guide you to medication alternatives if you can't get the drug you are trying to order. If you want a particular medication for your facility, the platform will allow you to see what you can and cannot order so you know you are being compliant with the regulations.

This makes it less confusing for veterinary hospitals. There are actually two versions of this. A doctor can order a prescription for a particular pet on our direct-to-client (V1) portal. The same thing will happen on our direct-to-office (V2) portal which is where you go to order medication for the hospital in bulk. Our team is always here to help, our customer service can assist with providing options and alternatives.

Do you have an example of a drug veterinary hospitals might be looking for that is on the “do not compound list” that Epicur can provide?

Buprenorphine injection is the one that comes to mind. It's used by pretty much every veterinary hospital across the country. You cannot get this for office use unless you get it from a 503B facility. If a clinic is ordering this drug and not getting this from a 503B facility, they are not in compliance.

What's Epicur doing to help veterinary hospitals and veterinary professionals demonstrate compliance?

Getting back to what we talked about earlier- we are offering guidance both live over the phone and through our online platform. When you go onto iFill, you will be compliant ordering for your pet owners. You can get the medication they need. This platform guides you and supports clinics to be compliant with regulations.

Is there anything else relevant now you want to alert the profession about?

It’s interesting because there is something that occurred in November, new USP guidelines. It kept being put off, but now in November 2023, USP guidelines went into effect. This means the guidelines that are set up which most states follow in full, some may take pieces. but those guidelines have now changed the way compounding pharmacies can create beyond-use dates for their prescriptions.

Mainly oral suspensions and sterile injections, items with water, will have shorter beyond-use dates. It will effect how much they want to prescribe for an individual because beyond-use dates can be as short as 4 days. In the past a pharmacy may have been able to give a 3 or 6 month beyond use date but not anymore as pharmacies are now limited on the beyond use date they can put on their products which will affect shelf life.

What is the difference between a beyond use date and an expiration date?

Beyond-use dates are followed by compounding pharmacies. They follow USP guidelines and there are different rules used to use to establish a beyond-use date. An expiration date is what is used by pharmaceutical and 503B outsourcing facilities and is much longer up to 365 days and are established and validated through current Good Manufacturing Practice regulations. All drugs are tested for potency and sterility.

How does a veterinary hospital set up an account with Epicur?

It’s really easy! If they call into the facility and talk to customer service, they will set them up with an account. Or go to iFill.com and sign up. They can then script out to patients or order for their facility.

Are there any incentives or offers for potential clients?

Yes! Any medication that they order from Epicur will be 20% off for 3 months, until March 31, 2024. All they have to do is call our facility at 888-508-5032, mention the podcast and the code GV23 and we will set them up so that every time they order over the next 3 months, they will get the discount.

Why not try it? You can’t lose getting 20% off. They will stay compliant and follow guidelines with us! They can stop at any time, but I promise they will be back!

We will be at all conferences; come and find our booth. We have a lot of great people with good information that can help you with any questions. 503B facilities are really important. In 2024, there will almost be no veterinary hospital that doesn’t use a 503B facility. Find the best one that works for you now.

Visit EpicurPharma.com to learn more.