Veterinary Today Podcast: How GFI 263 Impacts Veterinarians and the Public Beginning in June

The US Food and Drug Administration Guidance for Industry #263, or GFI 263, goes into effect nationally in the US in early June 2023. The new mandate changes the approved marketing status of certain antimicrobial drugs from over the counter to prescription status. Drugs that were commonly found on retail shelves and through online sources will no longer be available for purchase by the public and will only be accessible by veterinarian prescription.

In this episode, Dr. Michael Costin, Associate Director in the Division of Animal and Public Health at the American Veterinary Medical Association (AVMA), explains the background and reason for GFI 263's enactment. Dr. Costin also talks about how it impacts not only the veterinary profession but also consumers who raise, breed and care for companion and large animals. Dr. Joanne Carlson, ISVMA President, hosts the conversation.

Transcript

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Hello and welcome to the veterinary today podcast produced by the Illinois State Veterinary Association, commonly known as the ISVMA veterinary today has been created for veterinary professionals, but can also be informative for anybody interested in veterinary medicine and practice. Its goal is to share the latest trends and developments in the veterinary profession from individuals making news in the veterinary profession. This podcast shows information that allows veterinary professionals to better serve clients and their pets livestock, manage their practice and to establish a more informed, knowledgeable and engaged clinic staff. I'm Kelley McLaughlin, your podcast moderator Glad to have you here. Join Carlson is the owner and operator of loving care animal clinic in Palatine and president of the is VMAs. Board of Directors and your veterinary today podcast host and joins me once again. Hello, Dr. Carlson. I Joey so great to be back with you. I'm excited to share the pertinent information once again about the veterinary profession in Illinois with our listeners. Absolutely. For this podcast. We're looking ahead into June when a nationwide law goes into effect affecting the way customers have access to over the counter medications that could previously buy online or at retail stores but starting in June will only have access to those meds by veterinary prescription. Correct Joey. It's the guidance for industry number 263 or GFI 263 issued by the US Food and Drug Administration that changes the approved marketing status of certain antimicrobial drugs from over the counter to prescription drugs. Approximately 91 different antibiotics are going to be transitioning from over the counter to prescription. Once this change goes into effect. These popular drugs can only be used with animals under the care and control of a licensed veterinarian and impacts mostly animals intended for food production. But also some small animal situations. Yeah, certainly could affect a lot of people who are currently rely on the convenience of purchasing the drugs from you know, just from over the counter retailer Dr. Carlson for this podcast. We've invited Dr. Michael Costin, Associate Director of the Division of animal and public health at the American Veterinary Medical Association or the AVMA to help us understand how GFI 263 will impact not only veterinary professionals but also consumers who raise and breed and care for companion animals and large animals to welcome to veterinary today. Dr. Costin. Good afternoon. Thank you for the invitation. I'm excited to be here today. We're so glad you could join us Dr. Costin. To really establish an understanding of what we're discussing today. Can you please give us a little intro into what GFI 263 is and why it's being implemented? Sure. So back on June 10 of 2021 The US Food and Drug Administration finalized guidance for industry 263, or as you stated earlier, gfi 263. Now what GFI 263 does is an outline of the process that animal drug sponsors or pharmaceutical companies do to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over the counter or OTC to prescription or RX. Now once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian. Now even if the animals are not intended for food production, so everything from pet dogs and cats to backyard poultry, and from pet rabbits and pigs to large livestock farms, the same restrictions are going to apply. All of these medically important antibiotics will require a prescription from a veterinarian in order to be used. Now the process that was outlined in GFI 263 is part of the FDA is broader effort to combat antimicrobial resistance which is a serious threat to animal and public health. The increasing threat of antimicrobial resistance to both human and animal health compelled the FDA to take action. Now Antimicrobial Use and humans animals and the environment contributes to the development of antimicrobial resistance. GFI 263, puts the responsibility for the use of medically important antimicrobials into the hands of veterinarians, veterinarians who are trained to understand not only when these medications are needed, but also what is the appropriate drug to use the appropriate dose duration and administration method to resolve infection and protect animal health and our food supply. The veterinarians expertise is critical to ensuring the responsible use of antibiotics and ailments. So Dr. Costin, I'm just curious, what are the most commonly used products that might be affected by this and when is the hard cutoff date that we can anticipate these products not being available in retail stores? Well, let me answer your first question first. So some of the commonly common products that are sold in retailers that will be impacted by this. Are you know anything that's medically Careers clitic farm family, your ISVMA is with you. It's membership renewal time. As a veterinarian or CVT member of the ISVMA. Your association always has your best interests in mind. The ISVMA protects and promotes the veterinary profession in Illinois and your license to practice founded by members for members, your ISVMA promises to be a legislative and political advocate for the profession, engage membership for new career opportunities and to promote a career in veterinary medicine to untapped individuals, advanced careers through numerous continuing education opportunities, inform members and the public about who we are and what we do in our communities and lead in our communities as premier health care providers. renew your membership today. If you haven't yet joined look for a recently sent email from the ISVMA directly linking you to your membership profile. Join us today during our annual membership drive currently underway. Your ISVMA is with you. So really, this prescription status protects animals and people and I'm just curious, you know, how do you think this will impact veterinarians? It shouldn't be too bad. So what I think's going to happen is we're going to see, some new clients will be calling on veterinarian seeking to establish a relationship and seeking advice and assistance with their animals. I see, you know, seeing that you were a large animal dairy veterinarian, how you know, in general, do you see that creating more herd health exams are what do you feel? Is there something that we can kind of put a little, you know, spin on it as far as will this cause the veterinarian to have to maybe do one herd health check per year or a few or what are your thoughts on that? Well, on the food animal side, a lot of time the veterinarians are visiting their clients in their farms more frequently than once a year. We do anticipate as this will impact both the large and the small animal veterinarians, primarily in having clients they've not worked with before calling upon them because they're going to need to establish that relationship with the veterinarian establish the veterinary client patient relationship, in order to have access to the antimicrobials they might need to treat animals. Exactly. infections in their And as we all know, the VCPR so important and has to be established. What steps will veterinarians such as us need to take to ensure affected clients needs are met in a timely manner? First thing I think veterinarians should be reaching out to their clients proactively and letting them know this change. Just coming, when it's going to start and why it's occurring. I believe this will precipitate conversations with the clients. And in that communication, I believe that veterinarians should ask their clients to contact them if they have been using over the counter medications on their animals without the veterinarians knowledge by doing so, that will allow the veterinarian and the client to have discussion about why they're using those medications. and for what reasons, and allow that discussion to occur, which will allow the veterinarian to better assist their client going forward. Yes, I completely concur with that. I know that there's several times in my small animal practice that folks will have brought a new puppy and they'll say, Oh, we already do worming with this product, or that, or we've already given them a specific antibiotic. And I'll often say, you know why. So I think just it's going to open up more of a discussion. And also it puts the, you know, the prescription roll in the hands of the animal health professionals that we are. So do you think we'll need to be implement any new administrative procedures and keeping records? No, I believe the records requirements remain the same. And that does depend on state somewhat. So as you mentioned earlier, I'm I'm licensed in Wisconsin, are required record requirements are seven years. I'm not quite sure what Illinois are, but the records requirements haven't changed. I see. Okay. And, you know, anytime when there's something new, such as this gfi 263. I'm just wondering if you can predict any sort of confusion by the veterinarians, the client and specifically some of these large animal, you know, breed operators, because those are the ones it seems like it's going to impact the most. What are your thoughts on that doctor? Well, anytime there's changed, it can lead to some confusion. Right. That said, the AVMA has is not alone, in letting people know about the upcoming changes. I know FDA has been very active spreading the word, speaking with and answering questions from the pharmaceutical industry, distributors and retailers. And I've actually seen signs and some of the retailers in their animal health sections letting their customers know about the upcoming change. Many of the AVMA is allied veterinary associations, the national ones like bovine practitioners, swine vets, small ruminant practitioners, American Association of avian pathologists, they've been letting their members know about the upcoming changes. Additionally, producer groups and associations have been letting their members know groups like National Academies, Beef Association, National Pork Producers, Council, American sheep industry, so there's a lot of different groups letting their membership know, their client base know that this change is coming. But ultimately, it depends on people seeing one of those messages. And being aware that this is happening. Is there a chance that some people are not aware? Yes. And that's where the confusion might come? I see. And, you know, there's, like you said, like, anything, that change is always a little challenging for us. Um, does the AVMA have any literature or anything that could be shared on, you know, such as Facebook or anything like that anything that we could look at and, you know, help you, I think the easiest way to get some of your listeners to our materials, if you if you go to the ad Ma's main web page, and in the search bar, just type in OTC to RX, that'll pull up a list of various resources we have. For two or three resources, there should be links to either blog posts or social media or news items we've put out over the last year kind of letting our membership know that this change is coming. Additionally, there's a link to a webpage that we've put up which explains the reasoning behind the implementation of GFI 263, as well as some different resources that we have available. It also links to us numerous of the FDA is web pages, some other resources that your listeners might be interested in. And if you they want to go to the FDA is main webpage and in their search bar, you type in GFI 263 in the FDA search bar that will take you to several of the pages and resources they have available. They have a list of the antimicrobials which will be impacted by the implementation of this rule. Additionally, they have a FAQ page that answers a lot of people's commonly asked questions. Well, that sounds fantastic. So it sounds like you've been very busy about the this GFI 263 Doctor Well, we've had two years we've we've been doing what we can to get the message out. And hopefully we've reached enough people that the confusion that does occur is minimal. Yes and no from a public health standpoint, which is ironic. My daughter just graduated from college yesterday with a public health degree And we've talked a lot about populations, and we're really looking at keeping the population of us humans safe. And, you know, when we think about just the previous two, three years, we really do see how animals do impact our health through the whole COVID process and the where the process that emanated from so this seems like a really good way to help keep us healthy. Thank you so much for for joining us. And I really glad that we could shed some light on this and the ever evolving world of veterinary medicine. Any other comments or things you'd like to add? Dr. Costin? I think the biggest thing is, for those who may not be aware and for your veterinary listeners, you know, we anticipate the implementation of this rule impacting a couple of groups and geographies I guess, groups, we expect both small and large animal that's to notice this change primarily from clients they may not have worked with previously calling and looking to establish that relationship that is established that VCPR And these clients may have animals that veterinarians don't normally work with, we expect that this will impact the hobbyist. So people who may have backyard chickens, backyard pigs, some small ruminants, geographically, we expect this change to impact the rural areas where veterinary coverage may not be as extensive. There are some people out there who have not used to visit veterinarians in the past, they've always gone to the like the local farm store, to source some of their meds, they may not be able to do that, or they won't be able to do that now without a prescription from a veterinarian. So the rural veterinarians may see some new clients calling. Additionally, the fringes of the larger urban areas. It's where a lot of the hobbyists are located. Those people in their search for veterinarians, they may be reaching out to companion animal that's looking for help. And we see this as an opportunity for those Companion Animal Services to expand their services if they're interested in doing so. Absolutely. I love chickens. And I must say that I would love to have them but my current Association does not allow them but I would love to see some chicken folks and I you know, also sheep, you mentioned sheep, I just love sheep. So I think that that's a great possibility. My last question for you is you're from Kansas. You live in Schaumburg, you know, suburb of Chicago. Who do you root for and baseball doctor? Actually, I am originally from Chicago. Oh, I won't give you the whole story of how I ended up in Kansas. But I was raised a White Sox fan. Oh, my family's from the south side. All right. Well, you know what, obviously, I wrote for the Cubs, but you know what it says Chicago team. So that's good. But it was great chatting with you and have a great day. Thank you for the invitation. You know, for those listeners, if you do have a topic suggestions, please reach out and send them to us because we are open and we want to give the information that you would like to hear. Thank you, Dr. Costin and Carlson for all the discussion and information surrounding this important developments for veterinarians and their clients. Not only here in Illinois, but nationwide. This concludes our veterinary today podcast again. Thank you to our guests Dr. Michael Costin, Associate Director of the Division of animal and public health with the AVMA and of course thank you Dr. Carlson. of loving care animal clinic and palatine and president of the ISVMA. Your podcast host I'm Joey McLaughlin. Thanks for listening and we'll be back soon with another timely topic on veterinary today.