PACCARB 13th Public Mtg, Day 2 Pt 6: Welc, Opening Remarks & PANEL 4: Day-to-Day Provider Challenges

>> Martin Blaser: Good morning everyone My name is Martin Blaser I’m serving as the chair of PACCARB It’s my pleasure to welcome everybody to the second day of our public meeting, July 2019 Again, we have a very full agenda We thank the many terrific presenters from yesterday, and we have a great program for today I’d like to turn over the microphone to my co-chair, Dr. Lonnie King, who will make some further remarks >> Lonnie King: Marty, thank you very much and good morning everybody and welcome to day two of our public meeting We’re very happy to have you here at a different location in Tysons Corner And we welcome everybody in the room and also, especially those joining us virtually So, we’re going to gain as much time as possible As usual we have a jam-packed day, and today we’re going to hear a lot of challenges about behavior change from those of that expertise that are working in this area And hopefully, we’ll discuss and come up with some ways to address this — address this issue So, again, welcome And now, I’m going to turn it over to Dr Musmar for a roll call and for a special introduction >> Jomana Musmar: Thank you, Dr. King Welcome everyone This is our second day as everybody mentioned, so we’re just going to continue the same conflict — rules of engagement apply as yesterday We ask that all of our presenters please turn on your microphones when speaking and turn them off when others are speaking as well This meeting is being recorded and transcribed And so, we’ll go ahead and start off with our voting members for roll call Marty Blazer >> Martin Blaser: Here >> Jomana Musmar: Mike Apley >> Michael Apley: Here >> Jomana Musmar: Helen Boucher >> Helen Boucher: Here >> Jomana Musmar: Angie Caliendo >> Angela Caliendo: Here >> Jomana Musmar: Alicia Cole >> Alicia Cole: Here >> Jomana Musmar: Sara Cosgrove >> Sara Cosgrove: Here >> Jomana Musmar: Paula Cray >> Paula Fedorka-Cray: Here >> Jomana Musmar: Christine Ginocchio Locke Karriker Lonnie King >> Lonnie King: Here >> Jomana Musmar: Kent Kester >> Kent Kester: Here >> Jomana Musmar: Ramanan Laxminarayan Aileen Marty >> Aileen Marty: Here >> Jomana Musmar: Bob Weinstein >> Robert Weinstein: Here >> Jomana Musmar: David White >> David White: Here >> Jomana Musmar: On to our representatives, Elaine Larson >> Elaine Larson: Here >> Jomana Musmar: Denise Toney >> Denise Toney: Here >> Jomana Musmar: Alice Johnson Tiffany Lee Kathy Talkington >> Kathryn Talkington: Here >> Jomana Musmar: Onto our regular government employees CDC, Rima Khabbaz >> Rima Khabbaz: Here >> Jomana Musmar: Dennis Dixon, NIH >> Jane Knisely: Jane Knisely for Dennis Dixon >> Jomana Musmar: Thank you, Jane Christopher Houchen, SPRA >> Christopher Houchen: Here >> Jomana Musmar: Shari Ling Dan Sigelman, FDA >> Bill Flan: Bill Flan for Dan Sigelman >> Jomana Musmar: Thank you, Bill Larry Kerr >> Lynn Philippe: Lynn Philippe for Larry Kerr >> Jomana Musmar: Thank you Paige Waterman >> Female Speaker: Twee Simm [phonetic sp] for Paige Waterman >> Jomana Musmar: Thank you, Twee Sarah Tomlinson >> Chelsea Shivley: Chelsea Shively for Sarah Tomlinson >> Jomana Musmar: Thank you, Chelsea Jeff Silverstein >> Jeff Silverstein: Here >> Jomana Musmar: Thank you Emilio Esteban Okay, great Thank you all so much As you’ve seen yesterday, the Admiral had introduced Dr. Tammy Beckham, and we have the honor of having her today Dr. Tammy Beckham is the director of our Office of Infectious Disease and HIV AIDS Policy, and we’re happy to have her this morning Thanks for joining us >> Tammy Beckham: Thanks, Jomana And thank you all for taking time and allowing me to insert myself today on your schedule I really appreciate it I know how busy you are I’m really happy to be here with you today And I look forward to the proceedings that come from this meeting as well So, as Jomana mentioned — well, first of all, before I get out of the gate, let me say thank you to Jomana Thank you to Sarah Thank you to Aya [phonetic sp] Thank you for the entire team that have put these meetings together and the outstanding work that you guys do We have a huge portfolio in the new office, and I’m going to talk about that in a minute But because of the exceptional leadership of these individuals this is one thing that they always keep me informed and I stay on top of And I’m engaged with, but I know that things are being taken care of very well in PACCARB So, we have — you have, as you know already, some of the finest leadership at HHS And so, thanks Jomana and thanks to the team We appreciate it So, let me just start out — Adm. Giroir is a hard act to follow, but I’m going to kind of talk a little bit about some of the things he talked about yesterday He mentioned yesterday that the Office of Infectious Disease and HIV AIDS Policy has just been formed And this is true As of June 10th, the Office of HIV AIDS and Infectious Disease Policy and the National Vaccine Program Office merged to form the Office of Infectious Disease and HIV AIDS Policy So, let me tell you a little bit about what’s in that portfolio It makes total sense to merge these two offices

There’s a lot of overlap with what was happening in the Vaccines and Immunizations Office and what was happening with the Office of HIV AIDS and Infectious Disease Policy Well, that’s the new name — Okay So, they just flip the terms on me So, we have HIV, all things STIs, all things viral hepatitis We have tick borne diseases, and we also have blood and tissue safety under the OHAIDP office And that office, as you know, has merged with MVPO, which was, again, everything, vaccines, immunizations So, under the new office now we have five Federal Advisory Committees in which PACCARB is one, and we have four others that meet on a regular basis Plus, we have that entire portfolio merged into one And so, as of June 10th, we’re working very effectively across the new organization to look at synergies and to look at leveraging opportunities I mean, it’s only common when you talk about HPV vaccinations that you also talk about STIs in the context of that as well So, as we’re developing our new Federal Action Plan for STIs and we look at HPV, there’s some clear commonalities there with vaccination, et cetera As is antimicrobial resistance and STIs as well So, there’s clear synergies between what was happening in those two offices And I’m thrilled to have the great team now all under one roof and all working together under this new office And I think we’re going to see some real opportunities to cross communicate, to leverage, to synergize — some of those terms are Jomana’s favorite So, I’ll throw those out there And we’re just really excited to have everybody together And we think that with bringing the talent and the expertise and the portfolios together, we’re going to just be able to strengthen our mission, and we’re going to be able to really work across the broader spectrum of infectious diseases and microbial resistance, vaccinations, et cetera So, I think it’s also important for you to know, and I think that Ash reiterated as well, that our commitment to antimicrobial resistance, our commitment to this FACA, our commitment to vaccines and immunizations is as strong if not stronger than before We are fully committed to this mission space And see this merger of these offices as a way for us to strengthen ourselves and integrate more of what we do as we move forward So, as a veterinarian too, this particular federal advisory committee is very important to me You guys are truly working from a One Health perspective I would say that within the context of all things that are always discussed One Health, this is truly a venue where you’re actually seeing one health in action And so, it’s very near and dear and passionate to me And I’m thrilled to hear this morning that there were things that committee members have learned so much about the veterinary side and vice versa as well And so, I think you guys really do put One Health into action here And I am thrilled for that and hope that we can take this example and do that more across other topics as well So, thank you guys very much for all your work and everything that you’ve done We really do appreciate it I do think there’s some clear next steps for you all with, you know, we talked about environment, we talked about fungi, all of those types of initiatives And so, I’m encouraged that you’re thinking through those challenges that we have and look forward to your thoughts coming out of this meeting and in the future of how we might continue to engage on some of those complex challenges that we face Some of the other things I want to talk just this morning about a little bit is that, as the Admiral mentioned, now that you guys are codified into legislation, this is a very good thing We are excited about that I want to reiterate what the Admiral said about that as well as you are now in the proper legislation, this gives you more sustainability And you continue to have our support within the Office of the Assistant Secretary moving forward We are committed to continuing to support PACCARB and the committee as it moves forward in anything that the chairs need or the committee needs, please reach out to me or through Jomana personally We know that you guys are leading the effort globally in providing priority recommendations as to what goes into the next national action plan and we’re really thrilled about that as well And just all the work that’s come out of here, you guys are tackling some really tough problems and really helping guide the federal government’s response and the national and global response to AMR And it is truly a wicked challenge, another term that Jomana likes to use And we are thrilled that we have this level of expertise across the committee, and we are thrilled that you guys are on board and continuing to move forward And so, I just want to say, again, thank you I really do look forward to hearing about the findings and the areas and the priorities that you are going to recommend for the 2020 to 2025 National Action Plan

There are some clear next logical steps for this FACA, and I look forward to working with you as it moves forward And just reiterating again what the Admiral said yesterday, that you have our full support And I also want to close by saying thank yous to Dr. Blaser and Dr. King and the entire PACCARB team for hosting yet another great meeting; and, again, approaching this from a One Health perspective, which is truly an example we can take forward across a lot of different complex challenges we face in public and animal health and environmental health So, thank you guys very much I’m happy to take any questions if you have them >> Martin Blaser: Yeah Dr. Beckham, I wonder if I could ask a question? First, I just want to thank you and thank you and Adm. Giroir We feel your support, and it’s wonderful to have it You have gotten a very hardworking group of people People have worked nights and weekends in addition to their day jobs because they’re really committed to that >> Tammy Beckham: Right >> Martin Blaser: So, we appreciate the support from up high As you and I discussed, we’re, we’re finding that the field is expanding That One Health, which was humans and animals, now — yesterday we had a number of presentations about what’s happening in agriculture and plants, and how agricultural practices are impacting on human health as well It’s not just bacteria, but it’s fungi as well, as we discussed Maybe we should change the name of PACCARB because now we’re worried about fungi, and we’re worried about other anti-microbials other than antibiotics >> Tammy Beckham: Right >> Martin Blaser: Maybe it should be PACCARO, Antimicrobial Resistant Organisms >> Tammy Beckham: Right >> Martin Blaser: I’m not sure, but I think the people on the committee here are — we’re interested in serving where the problem will take us >> Tammy Beckham: Exactly So, I would agree I think there’s an opportunity for this committee to do more and broaden the scope — and absolutely should So, I think we are open to recommendations as the committee sets forward what the next steps are for the committee And so, we’d love to have that in some form that we could take forward So, I agree >> Martin Blaser: Thank you very much >> Angela Caliendo: Okay Welcome back everybody And Good Morning >> Lonnie King: So, hang on just a sec >> Angela Caliendo: Okay >> Lonnie King: So, congratulations Dr. Beckham on your new role We really appreciate that and look forward to continuing to work with you I think it’s really interesting to have offices infectious diseases and antimicrobial resistance And I’m just reminded of a report that came out a few years ago by Kate Jones, and she did a complete look at emerging infectious diseases over six decades and how they were trending And she categorized emerging — categorized resistant bacteria as about 22 percent of all emerging infections and believes that that is actually accelerating So, it’s a nice — I think it’s a nice fit and reminds us that this is an emerging infectious disease problem Is that, that’s fine >> Tammy Beckham: Exactly >> Lonnie King: Again, thanks And congratulations on your new role >> Tammy Beckham: Thank you I’m happy to be here I’ve learned a lot, and I’ve got a great team And I couldn’t think of a more challenging yet thrilling role to be in It’s incredible So, I have to tell you all to be able to engage with subject matter expertise that we have across the board here and work with levels of experts that we have has just been absolutely thrilling So, I want to thank you all again for all your hard work here There’s a lot more to be done I will agree with you And I look forward to what you guys might propose moving forward on how this committee can continue to contribute in the ways that you’ve done over the last several years So, thank you very much >> Angela Caliendo: Okay, so now it’s me Next time Good morning everybody And welcome back As Lonnie mentioned earlier, we’ve heard in the past from several associations and organizations discussing the strategies and guidelines in place to promote antibiotic stewardship practices today And so, now, we’re going to hear from a variety of providers themselves, people that are in the trenches facing the challenges on a day in and day out basis And so, we will hear from a dentist, a pharmacist, a pediatrician, and a veterinarian about their hurdles and professional perspectives

Again, we have a timer set up so please stick to your time, so that we will have a chance to hear from everyone and have plenty of time for discussion afterwards So, our first presenter is Dr. Glenn Miller He’s a dentist at Mount Vernon Dental Smiles and founder of the Dental Whale Practice Group So, Dr. Miller >> Glen Miller: Good morning and thank you I’m fortunate to have had a career as a dentist and a dental entrepreneur My current office, Mount Vernon Dental Smiles, is located in Alexandria, Virginia, and I am affiliated with a dynamic dental management service organization called Dental Whale, whose business foresight is improving the landscape and future of dentistry My career has been a mixture of clinical dentistry and business ownership The business bug took over about halfway through my career Since then, I have acquired over 15 dental locations During the due diligence phase of acquiring a dental practice I might review 10, 20, or even 30 different locations before I zero in on one This has allowed me to look into hundreds of dental practices and peel back the layers It is with this background that I share my experience with you today Since I was looking for dental practices, I could grow I reviewed metrics and dental codes, specifically periodontic and endodontic codes Practices that were not providing these services meant opportunity They also meant something else I did not understand at the time, and it had to do with unnecessary antibiotic prescriptions Under-treatment of periodontal disease lends to more infections with result and use of antibiotics in two ways To combat existing infections and as a prophylaxis taken before some dental procedures If a patient has a painful abscess tooth, and the dentist is not doing a root canal, then the protocol is to place a patient on antibiotics and pain medications It is fair to assume that these dentists wrote more prescriptions than dentists who treat periodontal disease and endodontic emergencies Now, I can add another metric to my due diligence list, antibiotic use Little background, antibiotics each year account for the vast majority of medicines prescribed by dentists Each year we write about 24.5 million prescriptions for antibiotics The estimated cost is over $500 million General dentists and dental specialists are the third highest prescribers of antibiotics in the nation Prophylactic antibiotics taken before certain dental procedures such as extractions, implant placement, and cleanings is common Prophylaxis against infective endocarditis is the main reason we pre-medicate patients with antibiotics Indications for the use of systemic antibiotics in dentistry are limited because most dental and periodontal diseases are best managed by operative intervention and oral hygiene measures >> Jomana Musmar: Dr. Miller, I’m sorry to stop you Should we advance the slides? Would you like us? >> Glen Miller: Oh, yes >> Jomana Musmar: Please let us know when to advance the slides for you so we can follow along >> Glen Miller: Okay, we’ve got that one and go to the next slide >> Jomana Musmar: Okay Thank you >> Glen Miller: Thanks, Jomana Indications for the use of systemic antibiotics in dentistry are limited because most dental and periodontal diseases are best managed by operative intervention and oral hygiene measures A recent study found that 81 percent of prophylactic antibiotics in dentistry were unnecessary As I’ve shown you in the case of periodontal or endodontic emergencies, antibiotic prescriptions are also often a symptom of the real problem The real problem being systems or professional choices that force us to write unnecessary prescriptions So, how did we get here? What systems or choices forced the medical dental profession to confront the question of prescribing when antibiotics are not called for? Number one, failure to diagnose and treat periodontal disease — I’ll spend a little bit more time on this — lack of communication between professionals, specifically dentists and physicians; failure of professionals to keep up with current literature and treatment options If a dentist is not confident about his/her sterilization and disinfection protocol, they may decide to cover the patient with antibiotics just in case Diagnostic uncertainty Patients have been taught to demand antibiotics and/or opioids by professional behaviors of community and paradigms The insurance industry teaches patients not to comply with our findings and recommendations Lack of access to care, and this covers a lot of different areas And the threat of a lawsuit I’m going to give you a little bit background about the mouth/body connection since it’s very important Next slide It’s been reported that all known micro-organisms associated with humans are at some time found in the oral cavity as either transient or resident species The mouth is a significant potential source of both infection and inflammation Poor oral hygiene or the presence of periodontitis is associated with increasing concentrations of c-reactive protein, fibrinogen, and bacteria entering the bloodstream directly Periodontal disease can only be effectively measured by the use of periodontal probe Essentially, a small ruler that you see up there and six-point measurements around each individual tooth, regardless of what the insurance company tries to tell us or our patients Periodontal infections are increasingly associated with systemic diseases including cardiovascular

disease, stroke, diabetes, preterm low birth weight babies, respiratory infections, pancreatic cancer, and rheumatoid arthritis Patients with chronic periodontal disease will experience septicemia on a daily basis from brushing, chewing, and, if they ever think about it, flossing No one I know has ever covered this with prophylactic antibiotics, nor should they And yet we throw antibiotics at patients before their dental procedures as if the bacterial load has never been systemically realized before Other oral factors to consider; broken teeth and retained roots; abscessed teeth, which can be either symptomatic or non-symptomatic The non-symptomatic ones we call sleeping giants because when they awake, they can cause monstrous pain as the bacteria begin to replicate and exert pressure on the surrounding tissue Fungal infections; tonsillar or other lymph node inflammation; the overall look of the oral soft tissues For instance, gingival enlargement without signs of periodontal disease can be indicative of blood dyscrasia such as leukemia And even though some of these examples do not lead to the overuse of antibiotics, the possible connection is always present Without a dental clearance prior to invasive surgery, the patient’s outcome may be compromised So, which surgery should have a dental clearance prior to? It should be mandatory for the following joint replacements and implants, chemo cancer therapy treatments, transplants, cardiac surgery Without a dental consultation the result is often a lifetime of unnecessary prophylactic antibiotics In the case of the prosthetic joint replacement, dentists are asked frequently by physicians to provide our patients with prophylactic antibiotics before cleanings and other treatments which many conditions that do not — excuse me Dentists are asked frequently by physicians to provide our patients with prophylactic antibiotics before cleanings and other treatment for many conditions that do not do not fall under the current American Heart Association guidelines Such is the case with the use of prophylactic antibiotics in prosthetic joint replacements Evidence fails to demonstrate an association between dental procedures and prosthetic joint infections or any effectiveness for prophylactic antibiotic coverage prior to dental procedures Next slide Oh, wait a minute We have gone too far We need to back up one to — there we go Most postoperative prosthetic joint infections come from skin bacteria, coagulates, negative staphylococcus Staph aureus, a common oral bacterium, only accounts for 13 percent of postoperative infections This would suggest that a contamination from skin rather than bloodborne spread is the most common mechanism of infection The common cycle that dentist’s see No dental parents by MDs prior to the medically invasive procedures, which leads to a higher risk of postoperative infections For those patients who get infections, there’s a high likelihood they will be labeled as high risk Therefore, the recommendation from MDs will be a lifetime of prophylactic antibiotics prior to dental procedures Medical legally we have no choice but to comply The dentist generally ends up writing the prescription even though current guidelines call for the physician to do that Next slide This is the last time I can remember being asked by a physician — and by the way, the Cleveland Clinic was very easy to deal with But this is the last time I can remember being asked for a pre-surgical clearance It was back in 2017 I show you this example for two reasons How infrequently I get asked for pre-surgery clearance, and how easy it is to miss an infection by visual oral exam Next slide If there’s — if a physician looked in this patient’s mouth, they would see broken teeth and reasonably assume there’s an abscess But what about the broken teeth that are sub-gingival and not visible? Also, there may be visible teeth without any apparent pathology that are abscessed With a thorough dental exam these can be resolved before surgery The risk of adverse reactions to prophylactic antibiotics in healthy patients is high Dentists prescribe penicillin for many prophylactic antibiotic prescriptions Of all allergens, penicillin is the most frequent medication related cause of anaphylaxis in humans, and its use is the cause of approximately 75 percent of fatal anaphylactic cases in the United States each year Data has shown that there’s more risk to the patient by providing prophylactic antibiotics than the risk of prosthetic joint infections Clindamycin, a broad-spectrum antibiotic, which is prescribed in the case of penicillin/amoxicillin analogy is strongly associated with clostridium difficile infections that require hospitalization or already effect hospitalized patients, resulting in 14,000 deaths per year Dentists are the top prescribers of clindamycin The lack of dental and patient perspective, paradigms and when dentists don’t keep up Postoperative procedures such as extractions, placement, implants, and other oral surgery procedures have routinely been covered by antibiotics after the procedure Research shows that in the absence of any systemic infections or medical compromising, the risk of infections is small The risk of antibiotic usage is much higher

Diagnostic uncertainty, this can result from the failure to keep up by the doctor or maybe just a tough case to diagnose Patient paradigms, many patients have been taught to demand antibiotics When professionals use the empirical approach to prescribe, patients who also use this rationale to make demands Along with antibiotics Patients demand opioids too The demand for these classifications seem to go hand in hand The dentists who write the most antibiotic prescriptions tend to write the most opioid scripts too When dentists and physicians do not communicate it leads to the overuse of antibiotics Patients are advised accordingly, which puts them squarely in the middle of what is truly needed versus the decision of the doctor in a vacuum Patients develop paradigms that lead them to rely on or demand antibiotics Now, the patient is part of the problem When the insurance industry does not accept our diagnosis, periodontal disease and patients believe the insurance company’s decision, the patient ends up in a slippery slope towards more disease Next slide Access to care This covers a lot of different areas Emergency calls at night and on weekends Dentists are apt to prescribe over the phone instead of coming back to the office The patients who want party drugs, and there are plenty of them, they generally call Friday or Saturday at about five o’clock, and they always have a good story The rural community, lack of proximity, dentist density, and definitive care all conspired to create more prescription writing Lack of dental insurance and costs When patients do not feel they can afford proper dental care, more times than not the problem and costs are shifted in the medical field where definitive care is lacking In the case of emergency rooms, because emergency rooms are not equipped to do dental procedures, most patients are given a regiment of antibiotics and opioids In my experience, when symptomatic patients are placed on antibiotics, it takes anywhere from 48 to 72 hours for the antibiotics to diminish the infection to the point of pain relief Pain medication must get them to this lag period Then the need for pain med drops significantly or completely If the patient does not see a dentist after the emergency room visit, he/she is ultimately going to return with the same problem This leads to a vicious cycle of emergency room visits and prescriptions If they go to the dentist, the antibiotics make the diagnosis much harder Antibiotics cover up the symptoms to the point where it makes a diagnosis either impossible or difficult My response I put the patient back in pain I take that it’s not by choice or my preferred method, but it’s necessary for me to secure a diagnosis I take them off the antibiotics, and I place them on more opioids So, I’ve got to subject the patient to more pain and more opioids in order to get my diagnosis It’s kind of a catch 20 for the — catch 22 for the physicians I understand that It’s so much easier to give them pain meds and opioids and hopefully that takes care of it but that’s a short-term solution A better approach would be to implore the patient to see a dentist ASAP, place them on pain meds only for two-to-four days with no refills Once definitive care is rendered, there’s no need for additional antibiotics or pain med scripts Cost of care, one of the reasons that patients with dental emergencies show up in the emergency room Conclusions and recommendations Next slide Prevent the infection in the first place In my experience, traditional clinical dentistry has always lagged behind the research of periodontal disease and its effects Clinicians have been slow to embrace periodontal treatment It is standard for many dentists and hygienists to just watch it Even though I’ve seen an increase in periodontal treatment or therapy over my career, I still see many patients that have never seen a periodontal probe or have no clue to their overall oral health In my mind, my profession is far from emphasizing an acting on a disease process that affects much more than the mouth Many still don’t identify the problem Others identify it but fail to act on it I’ve always asked myself what these questions are waiting for, and the answer always comes back the same When it gets worse Honestly, I don’t even know what to make of that answer cause my next question is when should you treat disease? My answer is when it’s first identified You can’t diagnose if you don’t know, and you won’t diagnose if you don’t care My recommendation, first and foremost, as dentists, we need to up our game in the identification, treatment, and appreciation of periodontal disease It is incumbent upon the individual dentists who practice to aspire to this Professional responsibility, in my mind, is not being that a periodontal disease is not pushed to the front line of our consciousness and treatment I would encourage dental schools to spend more time on the importance of periodontal disease, systemic medicine, and uses of antibiotics And I also would ask public health service agencies and organizations such as American Dental Association, the American Academy of Periodontology to bring more public awareness to periodontal disease My patients that understand periodontal disease follow treatment recommendations and allow us to them maintain health Our industry should also stop promoting PSR PSR stands for Periodontal Screening and Recording This technique relies on spot probing for a diagnosis True, thorough probing data is more tedious to gather, but it’s thorough I call the PSR the lazy dentist exam and diagnosis Dentists should consider using oral microbial rinses such as chlorhexidine instead of systemic

antibiotics And educating the public I always asked my hygienist what the most important job is Cleaning teeth? No Taking radiographs? No Staying on time? We always pause on this one — [laughter] — it’s patient education Period A patient who is better educated on oral health is more compliant and satisfied with our care This is the ultimate proactive approach Medical community If dentists cannot get their heads wrapped around periodontal disease, why should we expect the physicians to? Nonetheless, MDs have a professional responsibility to do no harm When a dentist is not consulted prior to invasive surgery, the patient’s outcome is potentially compromised with the possibility of postop infections or a lifetime of prophylactic antibiotics Physicians should be writing the scripts, not the dentist Also, I think that the system should be developed which requires dentists to notify the patient’s primary care physician whenever we write a script If the patient has a reaction to our antibiotics, they may end up in the physician’s office, which we rarely find out about Also, joint meetings between doctors and dentists will help to bridge this divide I feel that the only way to truly level the playing field is to bring dentistry in the medical curriculum and make us part of the medical industry Separation of education and a lack of emphasis on oral medicine will always lead us down different and separate paths I’m sure many dentists would not like to hear what I just said because right now dentistry enjoys professional freedom not found in many professions Responsibility preventing — insurance industry is responsible for preventing early intervention of periodontal disease Many insurance companies demand radiographic evidence of periodontal disease before they will provide benefits for treatment They will not accept our probing measurements and diagnosis Periodontal disease begins with attachment loss long before radiographic evidence is realized The only way to effectively diagnosis is with a periodontal probe This makes the patient question our diagnosis If we do not have a strong relationship with the patient, they will either seek no care or another dentist Educating the patients and gaining their trust is the only way that dentists can overcome this Thank you >> Angela Caliendo: Thank you, Dr. Miller We’ll go through all the presentations and then open it up for questions Our next speaker is Dr. Nathan Wiehl And he is the Director of Clinical Services for Auburn Pharmacies and pharmacist in charge of Anderson County Hospital Pharmacy in Garnette, Kansas Welcome, Dr. Wiehl >> Nathan Wiehl: Thank you very much It’s a privilege to be here to give you my insight on the challenges to implementing antimicrobial stewardship programs in a community pharmacy setting Next slide, please As she said, I’m a director of Clinical Services for Auburn Pharmacies We’re an independently owned chain of 25 retail pharmacies and three long-term care pharmacies in the eastern Kansas and western Missouri market I’m the pharmacist in charge of Anderson County Hospital, which is a critical access regional facility for the Saint Luke’s health system in Garnett, Kansas And as part of that role, I sit on the Antimicrobial Stewardship Committee for the Saint Luke’s health system And it’s unrelated to this discussion, but I’m board certified in advanced diabetes management Next slide, please During my short discussion today, I have a few objectives I’d like to meet First, explain the difference between antimicrobial stewardship in the inpatient and outpatient settings, review pharmacy reimbursement for antibiotics, and how the impact of DIR can fees can affect our decision making process on services to provide, evaluate how pharmacy reimbursement for antibiotics compares to the national average cost to dispense, and, lastly, explain how consumer education level impacts the appropriate use of antibiotics Next slide So, diving into the differences between inpatient and outpatient settings when it comes to antibiotic use and appropriateness In an inpatient setting, the pertinent information that’s available is readily available It’s right at your fingertips Information that allows us to evaluate renal function, so we can appropriately dose antibiotics based on kidney function We have a diagnosis readily available and often required So, we know, when that antibiotic is selected, if we’re treating a UTI a pneumonia or Sepsis We have cultures and susceptibilities on the ready in case, you know, so we can evaluate what the microbes are susceptible to, what isolates are susceptible to and make a decision based on that true evidence We have access to dedicated infectious disease experts, full teams of pharmacists and infectious disease experts to aid our decision-making process if we need additional support There’s monitoring of the patient that’s easily available Because they’re in house we can monitor symptoms, vital signs like temperature, ins and out so we can see trends and actually evaluate success of medication regiment And we can monitor regular lab work Trends in white blood cells, we can see a procalcitonin level to evaluate the risk of

infection or risk for sepsis And then lastly, we’ve got a guaranteed medication adherence where we can hang the bag or put the pill in the patient’s mouth That you don’t get in an outpatient setting Once you discharge a patient home or when you see them in a clinic and refer them to the pharmacy to get their antibiotic, once they’re gone, you have absolutely no way of monitoring their adherence You have no way of monitoring their symptoms without a lot of additional legwork That gets really difficult once you see the amount of reimbursement that pharmacies are given So, next slide, please This is a couple examples of the information that we’re given in a community pharmacy setting Couple — actually these are good prescriptions Because they are electronic, we don’t have to read any bad handwriting But this first one here is Cephalexin 500 milligram, one capsule four times a day, and the provider And that’s the extent of the information We don’t know the kidney function We don’t know what they’re treating If it’s a skin and soft tissue infection or a urinary tract infection Hopefully, not an ammonia in this case That would be an inappropriate selection We’ve got no way of evaluating that And the next example is a little bit more concerning because it’s Levaquin 500 milligrams a day for two weeks in a 94-year-old female We have no way of evaluating that renal function, but my experience tells me that a 94-year-old female probably doesn’t have the kidney function to support that dose But, again, the information is not there for us But we could obtain some of this information from the patient, but a significant number of times when somebody is ill, they’re not coming into the pharmacy to pick up their own medication They’re sending family or friends in to pick it up So, the information that we could get from that person isn’t reliable either Next slide, please Contrast that to the information that’s available in a hospital management software That top bar is a screenshot of patient information, de-identified of course It shows height, weight, and an estimated creatinine clearance They readily evaluate kidney function along with patient allergies staring you in the face The next bar is the order You see cefpodoxime 200 milligram to be taken twice a day for a urinary tract infection So, we have the diagnosis there and know that that is an appropriate selection for that diagnosis The next pane down is an advanced monitoring windows It’s kind of a fine print there, but we can track every dose that was given and the date and time it was administered to monitor for compliance We can see vital signs and track trends in temperature and ins and outs to monitor for symptom improvement We’ve got labs that are readily available In this case, a procalcitonin level that’s very high indicating sepsis and a urine culture that grew enterococcus physalis sensitive to both ampicillin and Vancomycin So, it’s a lot of information available within a few clicks of a mouse for us to decide if that selection is appropriate or not Next slide, please This diagram is not my own It came from a Dr. David Highnin from right here in D.C The senior officer at the Antibiotic Resistance Project But it’s a lot to digest, but once you do, you kind of get an idea of the challenges presented to hospital providers in an inpatient setting compared to an outpatient provider In an inpatient setting, working from left to right on that diagram, a hospital provider is supported by robust hospital policies that are written to incentivize providers to use the tools at their discretion in the inpatient setting They have an electronic health record that can be customized, and specific order sets custom tailored for aiding the provider when ordering medications and labs for specific diagnosis And then IT support that can, that can put restrictions in place that guide providers to appropriate selections For instance, when a Hurricane Maria devastated Puerto Rico and the supply of IV mini bags was just decimated, we had to really ration those bags So, within our order set we could put restrictions on certain antibiotics that had to be delivered IV push instead of IV piggyback So, we could use those bags for more serious patients in the ICU or surgery setting But that was all possible because of the IT support and that electronic health record We’ve got teams of data analysts that measure the success of the program that drive the hospital policy decision making process And then teams of experts, including MDs and pharmacists, that specialize in infectious disease and antimicrobial stewardship that can provide technical expertise down to the hospital providers And in an outpatient setting, I’m thinking of a private practice that doesn’t have the

support of a major health system You really don’t get any of that You’ve got no entity writing robust policies You don’t have a team to measure, and you don’t have the technical expertise The best you could do is refer to an infectious disease expert, which could delay treatment and worsen symptoms before — you know, before the patient gets the antibiotics that they need Next slide, please So, those are some of the logistical challenges I want to talk a little bit about the dollar and cents challenges to community pharmacies when they need to make the decision about trying to implement these programs The Pharmacy Services Administrative Organization for Auburn Pharmacies did a little data analysis for me They looked at 435,000 prescription claims, specifically for antibiotics across their network of independent pharmacies and discovered that our average profit margin per prescription is $9.12 Compare that to the average cost to dispense for an independent pharmacy of $10.79 per prescription That came from the NCPA digest in 2018 You see that we’re already underwater in dispensing antibiotics And that’s before the DIR fees levied by pharmacy benefit managers DIR fees, direct and indirect remuneration fees, is a retroactive recoupment of payment from a PBM based on non-transparent metrics that were not — that they calculate and then recoup sometimes up to six months after the point of sale That in this case totaled almost 38 percent of our profit margin Adjusting our net profit margin down to $5.68, about half of what it costs us to dispense That cost to dispense includes salaries, utilities, the cost of the vials and labels — all our overhead in dispensing a prescription And pharmacists have the skillset to be able to do this When we get out of school, we have the tools to help evaluate antibiotic appropriateness But when it comes down to how much we’re reimbursed, we can’t spend the time or invest the energy and effort into implementing those programs when the dollars just aren’t there Next slide, please If you boil that information down a little bit further, you can see by drug class across the board we’re underwater on all prescriptions The blue bar represents the reimbursement So, for your amino glycosides, antibiotics that may be used to treat more serious infections, the reimbursement is higher, but the DIR fees are also steeper, leading to a net loss in revenue But across the board DIR fees are crippling our profit margins, which, again, forces our decisions to be made not — the decisions that are made are not the ones we want to make because we want to be able to provide additional services But you can’t when you can’t afford to Next slide, please So, in addition to a reimbursement barrier to appropriate antibiotic selection, there’s also some insurance barriers just in access to appropriate antibiotics This is a case study A patient was seen in a Saint Luke’s emergency department for treatment of a urinary tract infection Upon admission to the ED, the provider collected a UA They isolated enterococcus faecium, a pretty sinister bacterium A prescription for Cephalexin was written, which on the face of it is a pretty poor choice But even within the same four walls of a hospital outpatient departments don’t have the tools at their discretion that inpatient departments have to evaluate appropriate antibiotic use So, three days go by, susceptibilities are returned And at that point when they realized it’s a multi-drug resistant organism, the Antimicrobial Stewardship Director was consulted His recommendation was a week of Linezolid twice a day or a single dose of Fosfomycin, three grams Because the provider anticipated some insurance restrictions Both meds were prescribed in the hopes that one of the two would be covered, but neither was And the patient again was unable to get the medication they needed The prior authorization — so the, the provider was forced to contact the insurance company and provide them medical reasoning for the antibiotic selection ED providers are not well accustomed to doing that, so they punted over to the primary care physician, who then wasn’t able to provide the information either cause at that point they didn’t even know the patient had been in the emergency room So — and pharmacists have the information available to provide that to do that prior authorization, but because we’re not deemed medical providers, they won’t take — they won’t allow us to do those — to make those phone calls So, another day goes by, there’s no resolution By the third of May, the patient worsened and was admitted for aggressive IV antibiotic

therapy, which ultimately costed it exponentially more dollars than either one of those antibiotics would’ve cost from a pharmacy Next slide, please So, lastly, there is an education barrier as well A community pharmacy resident from Balls Foods in the University of Kansas, Mary Beth-Seipel, did a study to assess the general knowledge of appropriate antibiotic use in the public What she found out that was over 30 percent of non-college educated participants believed antibiotics worked on most cough and colds compared to 16 percent of those with a college degree And 43 percent of non-college educated participants believed antibiotics killed viruses Compare that to 20 percent of participants with a college degree still thought antibiotics killed viruses So, there is a — there is some education improvement in the general public that needs to be made Her conclusion was that that education level influenced antibiotic appropriateness, but it still wasn’t great even in college educated participants And that community pharmacies were uniquely positioned to be able to provide that education in a community setting if the conditions were right to allow them to do that Next slide, please So, in conclusion, data available in an inpatient setting to evaluate antibiotic appropriateness is currently not available in an outpatient setting for outpatient providers and pharmacists to make those determinations Inpatient antibiotic stewardship programs are supported by robust hospital policies They’ve got teams of IT professionals and data analysts that are measuring and providing guidance to the policy decision making process And there’s infectious disease experts on the ready to assist them in the event that they need a little help Next, reimbursement for antibiotics does not allow for pharmacies to invest time, energy, and effort into evaluating antibiotic appropriateness or implementing the programs to do so And lastly, consumer education about appropriate antibiotic use needs to be improved upon And community pharmacists are in a unique position to be able to do that And again, if the situation and the environment is right So, next slide, please That’s all I have for you today Again, I appreciate the opportunity to come present to you >> Angela Caliendo: Thank you That was very informative Okay So, our next speaker is Dr. John Santos He’s the Director of Urgent Care for Children’s Hospital Colorado and an Assistant Professor of Pediatrics >> John Santos: Hello Thanks for inviting me here today to speak about antibiotic stewardship in pediatric urgent care As all of you have already heard, the challenge facing us now extends from the agricultural fields of America to hospital outbreaks in England And, based on the speaker following me, I’m assuming even to our pets Combating antibiotic resistance will take the combined efforts of many areas As chair of the American Academy of Pediatrics’ section on urgent care medicine and a pediatrician practicing in urgent care for nearly 10 years, I’m here to talk about the role urgent care can play in combating antibiotic resistance and specifically address some of the challenges and successes of pediatric focused urgent care Next slide Recognizing the expanding role of urgent care in the medical landscape, the AAP formed the subcommittee on Urgent Care in 2016 under the section of emergency medicine In only three years since the subcommittee has grown to nearly 150 urgent care pediatricians encompassing all regions of the U.S. and working in a variety of practice settings from hospital-based multi facility systems, like the one I am part of at Children’s Hospital Colorado, to private standalone sites in Boise or Little Rock Given the explosive growth of our subcommittee and urgent care in general, we petitioned the AAP to recognize urgent care medicine as its own unique field with unique challenges and opportunities And as of July 1st, we were granted status as a provisional section on urgent care medicine As a subcommittee, and now a provisional section, our mission is to work with the AAP to advocate for pediatric urgent care and pediatric readiness in general urgent care centers, to expand opportunities for pediatric urgent care education, and to promote urgent care research and collaboration Next slide By working with AAP and it’s over 67,000 members and the Urgent Care Association, who represent 3,500 providers, we can connect with a broad group of pediatricians as well as the family, emergency, and internal medicine physicians who make up the staff at most general urgent care locations Additionally, the Society for Pediatric Urgent Care, or SPUK, has about 350 members dedicated to pediatric specific urgent care And the Pediatric Urgent Care Conference hosts about 150 people each year, offering great opportunities for collaboration with a specialized group of pediatric providers Research from pediatric urgent care is also advancing

With the PAS conference, sponsored by the Academic Pediatric Association, boasting 10 abstracts in three platform presentations this year that were focused on urgent care By being able to leverage these groups in the AAP together we are in a unique position to help define what pediatric urgent care is and what it can be Next slide It comes as no surprise to people in this room that antibiotic overuse is a serious concern in all areas of medicine, not just urgent care Well, one study noted that outpatient antibiotic use had decreased by nearly a quarter in patients under 14-years-old, CDC data noted that there was still over 266 million courses of antibiotics dispense from community pharmacies in 2014 This number is even ticked up against slightly in 2015 and again in 2016 after four previous years of decline, with the 2016 data showing about 270 million antibiotic prescriptions Meanwhile, a recent study in JAMA found that at least 30 percent of outpatient antibiotics are for inappropriate indications such as viral Pharyngitis, asthma, bronchiolitis, influenza, nonsuppurative otitis media, and of course viral URI also known as the common cold If we extrapolate this rate and use the most recent prescribing data from the CDC, we are looking at around 80 million courses of antibiotics that could probably be avoided each year Next slide Now with the sense of the scope we are facing in the outpatient world, I want to take a second to highlight the importance of urgent care in this discussion Urgent care is growing at nearly 5 percent annually with 400 to 500 new sites opening every year And in 2015, the most recent acts date — the most recent year I had access to There was between 8,000 and 10,000 locations across the country Urgent care sites are most prevalent in the heavily populated states of New York, Texas, Florida, and California, but even a rural state like Idaho has 64 urgent care locations Combined, these sites had over $15 billion in charges in 2015 and in 2017 there were 90 million visits to urgent care centers across the country, representing nearly 10 percent of all outpatient visits in that year While this still means that 90 percent of outpatient visits are in an ED, office, or a specialty clinic, as a rapidly growing segment of outpatient medicine, urgent care has an ability to significantly impact antibiotic prescribing rates, both good and bad Next slide Unfortunately, I’m guessing the reason I’m here today is to discuss — to address the bad Last year, JAMA released a study that reported antibiotic use was linked to nearly 40 percent of all urgent care visits And of those, 45 percent were for antibiotic inappropriate respiratory diagnoses ED visits had the second highest rate of inappropriate antibiotic use at 25 percent while office-based visits, which continue to make up most outpatient visits, had an overall antibiotic prescription rate of 7 percent with about 14 percent inappropriate antibiotic use Interestingly, retail clinics which are also listed up there and offer limited diagnosis capabilities and equipment, were associated with antibiotic prescription rate almost as high as urgent care but have the lowest rate of inappropriate antibiotic use Next slide However, as a pediatrician and a pediatric urgent care practitioner, I want to highlight a specific challenge with caring for a pediatric population in urgent care While nearly a quarter of all urgent care visits are for pediatric patients, less than 10 percent of urgent care locations have a pediatrician on staff Most of these are actually at dedicated pediatric urgent care centers, which, while growing, continued to represent less than 5 percent of all urgent care locations Next slide The reason I bring this up is that while the healthcare world in general, and urgent care specifically, struggles with antibiotic stewardship, if we look at how pediatricians approach antibiotic use, we begin to see a different picture Most inappropriate antibiotic use is for the common pediatric illnesses listed here In this recent study from Pediatric Infectious Disease Journal, we see that while family practice and NPs or PAs prescribed antibiotics at nearly 30 percent of the time for URI in either the office or urgent care setting, pediatricians only prescribed antibiotics 8 to 9 percent of the time in those areas Research from children’s Colorado also backs us up, where we have shown that our pediatricians have an antibiotic prescribing rate of 4 percent in URI for both our urgent care and ED locations So, there’s a good amount of evidence that the pediatric community in both the outpatient, ED, and urgent care arenas have taken great strides to be good stewards of antibiotics Next slide However, we recognize that pediatrics and pediatric specific urgent care still has room for improvement One current effort comes from a collaboration between SPUK and the Antibiotic Resistance Action Center This quality improvement project kicked off earlier in 2019 and has three primary aims It seeks to build capacity for quality improvement projects and in pediatric urgent care, to

understand the prescribing patterns for antibiotics in specialized pediatric urgent care centers, and finally, to implement a trial of interventions to reduce inappropriate antibiotics prescribing Overall, this project seeks to reduce inappropriate antibiotic use in participating pediatric urgent cares by 20 percent Although, this study is still in progress, I do have some preliminary data I can share Next slide I apologize, this is going to be look a little bit small here, but the study group is comprised of 153 providers at 20 different institutions across the country As you can see in the pie chart, most antibiotic use was for appropriate indications such as ear infection, strep throat, and skin infection However, there are still a few prescriptions for non-suppurative otitis and pharyngitis is not broken down into strep versus viral However, we assume based on some of our data that the vast majority of this was for strep If we drill down into ear infections specifically, or acute otitis media, now we can see that amoxicillin was by far the most common antibiotic used, followed by amox clav, reflecting that when antibiotics were prescribed, there is good use of narrow spectrum antibiotics Next slide If we look at the interventions, there are several ways we can try to help promote antibiotic stewardship in our locations One that we’ve decided to use at Children’s Colorado is posting a signed commitment letter from our providers in patient care rooms In other settings this intervention has been shown to decrease inappropriate antibiotic use by nearly 20 percent We are also going to be rolling out a DART module, or Dialogue Around Respiratory Illness Treatment, that was developed by Seattle Children’s hospital to help educate providers about ways to discuss respiratory illnesses with patient families At Children’s Colorado, we’ve also begun to provide patient education handouts for strep throat and strep throat testing That includes information such as most sore throats are caused by viruses and do not need antibiotics and talks about how the presence of cough or runny nose makes it even more likely their sore throat is caused by a virus and does not need antibiotics We are also using language similar to the CDC regarding delayed antibiotic use, especially for ear infections This includes many options for supportive care during an illness and waiting to see how the patient does before prescribing antibiotics if that is the necessary approach Truthfully, discussing supportive care is one of the main things I talk about with patients When a concerned mother tells me her child just wants to sleep all day, I talk about how important rest is for fighting off an illness And point out that if you or I had the option of sleeping all day when we were sick, we would Kids actually have that luxury, so they do It really is good to be a kid Since the majority of illnesses we see in pediatrics are respiratory, I also bring up things like a cool mist humidifier or a nasal saline spray to help relieve congestion or giving honey to help relieve cough While many providers may think a parent wants an antibiotic, I argue that they mostly just want to be able to do something to help their child Empowering them with these simple tools for supportive care is usually all a parent really wants Next slide When I was preparing for this talk, I surveyed my colleagues about some of what they see as challenges with antibiotic stewardship in pediatric urgent care These are a few of the common quotes that came up and I think reflect some of the challenges very well “Every time she gets a cold she ends up with strep throat.” Here, I usually take a second to educate about sore throat along with cough and congestion, and how that’s very unlikely to be strep, as I already mentioned Having a handout at our disposal that specifically says this helps this conversation go a lot smoother and tends to add some weight to sort of the discussion that we have “Well my doctor gave me antibiotics, and my kid has the same symptoms.” This one’s tough because we often go out of our way to avoid disparaging someone’s PCP But also recognize that about 30 percent of antibiotics are prescribed inappropriately So, there’s a good chance that the parent might not have actually needed antibiotics anyway There’s also some differences in prescribing guidelines between pediatrics and adult medicine So, oftentimes, I’ll try to highlight some of these differences to describe and explain sort of why I would not do antibiotics for a child The next one is, “We are going out of town tomorrow and want to get her started on something before we leave.” This is a super common refrain And it’s actually sort of the danger of the easy and convenient care that urgent care offers Many of these patients in this scenario would not have been able to get in with their PCP, and in the past, would have either just gone on their trip and given a time or gone to an ED However, urgent care tends to be open at more convenient times than a PCPs office, and for those who are cost-conscious, is much less expensive than an ED visit

In these situations, I try to focus on supportive measures like I mentioned earlier, as well as the notion of giving things time If a family is flying, I talk about giving Ibuprofen before getting on a plane since a child with congestion, even without an ear infection, can have ear pain with pressure changes If any of you have flown with a congestion as well it’s the same thing with adults And I’ll often admit my bias, but I’ll suggest that the family find a pediatric specific urgent care if they think they still need to be seen again while traveling “She’s allergic to penicillin.” I included this because it’s so overused and paints us into corner with antibiotic use Getting a rash while taking Amoxicillin is common and frequently misidentified as an allergy The incidents of true allergy to penicillin is quite low One recent study in Academic Peds found that 37 or — excuse me, found that at least 67 percent of patients with reported allergy to penicillin were unlikely to have a true allergy While another article from our ENT colleagues found that nearly 90 percent of patients with a listed penicillin allergy in their chart didn’t really have a penicillin allergy on further review On a purely non-scientific note, one of our pediatric allergy specialists at Children’s Hospital recently told me his allergy tested 96 kids with reported penicillin allergy and has not had a single one with true anaphylaxis This is important because not being able to use penicillin, primarily Amoxicillin, can force us to prescribe broad spectrum antibiotics that are often more expensive and contribute to antibiotic resistance “We knew something was wrong because she wanted to come.” So, this is often my favorite ones I rarely disagree with a parent that their child is sick But just like the whiny husband with man-flu, everyone handles illnesses differently You know, cough and congestions are terrible They keep kids up at night and they keep parents up too So, everyone at the house is miserable and tired, which was — which — in any way — also when a patient’s throat hurts, they don’t want to eat or drink We all know how stubborn kids can be with eating and drinking to begin with However, none of these things necessarily mean antibiotic is going to help Most viral illnesses get better in three to four days and kids are a lot tougher than we sometimes give them credit for Often supporting them through an illness with antipyretics, nasal, saline, rest, and bribing them with a popsicle or two to keep them hydrated is generally a pretty good approach Next slide So, that’s all I have for you initially Except as a pediatrician, I’m pretty sure I’m required to have at least a few pics of Moana, Frozen, Minions, that sort of stuff So, there you go You got that And thanks for your time, and I look forward to any questions you have in the Q&A session >> Angela Caliendo: Thank you very much Okay, our final speaker in this group is Dr Mark Hitt He practices internal medicine in the Atlanta — at the Atlanta [sic] Veterinary — I’m sorry, Atlantic Veterinary Internal Medicine and Oncology Clinic >> Mark Hitt: Good morning Thank you very much to the council for having me I appreciate all the sense of organization that’s gone into this, Dr. Musamar in particular I have a background that goes back over 40 years in veterinary medicine I’ve been a veterinary technician, a kennel boy, a veterinary student, general practitioner, academic associate professor, and then in the last 25 years specialty in veterinary internal medicine and oncology Next slide So, a lot of people don’t know what veterinary new medicine actually is And — alright, breath So, I just thought I’d put a quick slide up here just to illustrate that it goes well beyond your small animal practice that you’re most familiar with Most small animal practices are not encumbered by the metric data analysis and accumulation that goes with corporate and government regulation That may be changing as we get more into a stewardship issues for antibiotics, for controlled substances We’re beginning to see more and more need to provide data But right now, there are very few metrics available to give you on antibiotic use that is not out of date or minimized The general practices can be anything from small animal and equine Then there’s food animal, poultry, and aquaculture The last three engage field services, diagnostic labs, various sizes of corporate advice in everything from the epidemiologic groups to fire engine practices I am in the second tier of veterinary medicine with specialty private practice

We function in a referral center that incorporates individual practices of surgery, neurology, imaging, radiology, cardiology, ophthalmology, all of the specialties And as such, we — they act independently very often and there is no infectious control program basically that has sway or power over their individual actions And this is pretty common except for when you get to the university level, where you start seeing stewardship issues and efforts underway It is a good day when people come to the internist and ask them to act as an infectious disease officer That is several times a week but compared to the number of times that antibiotics prescribed it’s relatively minimal Tertiary level of veterinary practice would be the university hospitals largely Next slide So, what species do we work with? Just to give you a broad spectrum here, it’s — I do canines and felines 99 percent, pet pockets, avians, amphibians, reptiles, fishes are all seen by our emergency practice and general practices that are out there Next slide So, the question was today to provide some information on what the barriers are to proper antibiotic use in private special — or, excuse me, private veterinary practices And it comes down to focusing on what are the appropriate and then the inappropriate uses of antibiotics And I think the goal today is certainly focused on the inappropriate We’re looking at the need for continuing education We need to have veterinarians go back and review pharmacokinetic issues, pharmacodynamics We need to use more culture and sensitivities We need to work on client compliance This has been an issue for the pediatricians I’m sure It’s an issue across the board We’ll talk more about these points in a few minutes We’re looking at rising costs to consumers for appropriate antibiotic use And then nosocomial risks that are rising in veterinary medicine as well and as part of the resistance package that we have to deal with There is the question of how do we identify alternatives to antibiotics We’re looking currently at UV light for sanitation We’ve just installed a hyperbaric oxygen therapy unit to be an adjunct for certain types of infections We’re looking for — I don’t think phage therapy is going to hit our world very quickly, but it’s an issue And we know the world is coming to our doorstep soon I think that one of the better resources I found online was provided by WHO, which looks at the antibiotic stewardship through access, watch or monitoring, and then reservation of antibiotics And that’s something that we see coming our way Next slide So, antibiotic choices in that veterinary medicine, there again this is a little bit of informative for you all as well because many are not aware of what we have available in veterinary medicine And it’s pretty much everything that you would use in human medicine So, the standard classes of antibiotics are there And I would say that — I’m going to highlight the fluoroquinolones because they’ve been the workhorse for the last 10 years Starting with the inappropriate use of ciprofloxacin Enrofloxacin is hitting our veterinary market, marbofloxacin, pradofloxacin Sulfonamides not used very often anymore because of the side effect risks There are way too many lawyers in the world, so we do tend to avoid issues where we can, but we still use them And then the rising tide of chloramphenicol It’s something that has never gone out of our sites but is an antibiotic that was used much more in the 80s and 90s and then kind of faded with the rise with fluoroquinolones But it is now back on our radar as we hit more resistance in our culture and sensitivity patterns and clinical cases Glycopeptide type antibiotics such as Vancomycin, clindamycin We don’t use much Vancomycin We also don’t have much of a clustered in difficile issue I’ve had one clinical case in a cat in 20 years That was — I actually have evidence-based data for Clindamycin is used all the time in veterinary medicine for predominantly dental infections Then there are certain antibiotics that we even look at as sort of on the reserve list

that most veterinarians are not educated about And they’ll see it on a culture and sensitivity occasionally and they’ll say, “Oh, I wonder if I should use that.” And the answer is no Fosfomycin I’ve used once, I think in 30 years Colistin I’ve never used Linezolid I’ve used twice in 30 years with appropriate guidance, I felt And tigecycline for staph aureus infections I can’t recall a veterinarian that’s used that And we’re trying to stay away from those But veterinarians and antibiotics is a lot like gun control Don’t try and take away our antibiotics You will get a broad spectrum of controversy coming back at you And I say that somewhat facetiously because we know that we have to be cognizant and judicious in our use Next slide So, veterinarians need to be cognizant in their selection We look to certainly that organisms are gram-negative or gram-positive We look to whether organisms are anaerobic or aerobic But I think we have to go back to the pharmacodynamics of our antibiotics And the two biggest things that are novel thoughts to a lot of veterinarians who graduated before the last 10 years is going to be whether antibiotics are concentration dependent or time dependent and the appropriate doses I think that there needs to be a return in veterinary education to basics of infectious disease, including host status, organism that we’re dealing with and it’s attributes, and then what are the effective doses that are likely to be playing a role Appropriate treatment selection with antibiotics goes to correct dosing It goes to compliance It goes to those barriers we talked about a minute ago Appropriate drug selection is also influenced then by the patient, the host What organ system are we dealing with? What data do we have about the health of the organ systems overall? Can we use amino glycoside? Do we have to adjust its dosing, would be a good example Has the animal had adverse drug reactions previously? We see few adverse drug reactions that are life-threatening in veterinary medicine to antibiotics, but we do see them We also see many less prominent side effects that are interpreted as adverse drug reactions And there, again, it’s a matter of proper education So, we also look then for guidelines to how to use antibiotics And this could be as simple as a manual of antibiotic use for infectious disease, looking at the organ system, looking at the species, looking at the comorbidity thoughts or adding those in, and picking an antibiotic as best use for the situation without a culture and sensitivity But if you give us the opportunity, we’re going to ask for that culture and sensitivity given that it’s going to take two to three days to get a result So, antibiotic use in small animal veterinary medicine is an everyday event whether it’s general practice or specialty care I think that the specialists are more judicious, but overall, it’s still a minuscule amount of antibiotics I think compared to, say, aquaculture Next slide So, we’re concerned about the pathogens You know, we’re treating bacterial infections We’re concerned about resistance That’s what’s influencing our inappropriate use sometimes We’ve all heard that resistance is coming with our pathogens That’s been the story since I graduated in 1979 I also remember my mentor in 1980 telling me it’s not something to worry about until the next millennia, which has been here now close to 20 years And it is on our doorstep We face it daily So, we see every situation you would see in human medicine I’ll show a couple of examples in a minute Treatment — I come back to review by the veterinarians We need to be concerned that we’re using the antibiotics correctly And that goes back again to education We are dealing with zoonosis and reverse zoonosis Helicobacter, for example, wants to be vastly over-treated in veterinary medicine Helicobacter pylori is a gastritis producing organism Dogs most commonly probably have it, say 70 percent of canines carry it It’s a superficial gastric mucosal infection of no real significance The vast majority of the time However, it gets treated all the time because people have it Well, the dogs usually get it from people Just as an evidence of reverse zoonosis Nosocomial infections are a rising threat, especially referral hospitals, academic university hospitals, those facilities that are obtaining or are getting cases that are much more difficult

in scope — that have had many more antibiotics before arrival So, the resistance issues are on the rise Next slide, please So, here, are the organisms we deal with are the same ones that you look at every day in human medicine The E. coli’s all the standards, the klebsiellas are facing as the extended spectrum beta lactamase resistant organisms Mycobacterium are showing up occasionally, actinomycetes more often And then the saprophytes, the Acinetobacter, pulvini [phonetic sp], enterococcus, all of these organisms we see So, next slide So, what are the barriers when we see these organisms to using the appropriate antibiotics? Approved products in veterinary medicine are few We’re supposed to use approved products for veterinary medicine when we can Cost implications to the clients are heavy People want to use less expensive options New antibiotics or routes or administration are not coming down the pipeline as we had thought or hoped 20 years ago Compounding pharmacies do provide some options, but they have their own difficulties to deal with in quality assessment Reduced fluoroquinolones sensitivity is really one of the biggest issues that we face because it’s been our work horse, and now it’s just declining in its efficacy Where people reach for the next level That’s where I fear for people reaching for those reserve drugs on occasion We’re going back to more use of chloramphenicol, trimethoprim sulfa — short term anyway And then we’re trying to avoid those reserve drugs, as I said Next slide So, we’re facing there again, kind of back hitting the same points over and over But inappropriate use of the antibiotics, you know, is there any evidence that gives us metrics on this? I guess would be my point And there — I don’t think there really is any real evidence of the metrics of it You can take individual practices, but you’re still left with uncertainty The appropriate use of antibiotics, there’s still selection pressure with resistance even when you use the proper choice of an antibiotic Bacteria resistance can be multiple forms, and there again we’re faced with these same organisms Next slide So, just a very brief, a waste of 10 seconds here But in 1984, I went to a resident seminar at the University of Missouri on client compliance, and somebody had done the phone backs to the patients, the human facility And they found that at one-week compliance for once-a-day treatment was 87 percent If you did TID treatment for two weeks, it was 27 percent Now, you take that and put it in a 17-year-old hissing mad cat, and I think that it’s compliance is going to be less So, next slide So, what is true in human veterinary medicine is true for veterinary medicine We run all the same risks of increased mortality, morbidity, grieving, loss, increased hospital costs, and then also legal litigation if we make the inappropriate choices Next slide So, principle of control, surveillance, culture monitoring We do this in our facility, but it is a rare event that many facilities would do this Next slide And so, we do go for the standards of care in preventing nosocomial infections and treating them This’ll be in the slides available for review Next slide And I’m running out of time here So, next slide And active regulatory role that’s coming down the pipe, I’ve been told be ready to be warned about it It is a concern We do look for more information that helps us make wise decisions Next slide So, in summary, continued education for veterinarians and hospital teams We want to prevent infections where we can We’re looking for appropriate cultures and sensitivities And then interpreting those sensitivities correctly — it was hammered home to me last night at dinner Proper use of antibiotics by clients Concurrent therapies, what else can we use? And then nosocomial awareness And then if we can get the labs to share data, that would be a big help And then there’s a lack of micro-clinical microbiologists Thank you Next slide Thank you >> Angela Caliendo: Thank you, gentlemen I appreciate the — these are excellent presentations and actually somewhat sobering for us of what

life is like in the trenches So, we’re going to open it up for questions Wow Okay Marty, I’ll give you the first shot >> Martin Blaser: Thank you very much And I’d like to thank everyone for coming to speak to us today These were quite enlightening And I have many questions, but — [coughs] excuse me I just want to start with Dr. Miller So, the CDC — as was mentioned, the CDC estimates that about a third of all the antibiotics used in medical practice are unnecessary, but recent estimates that for dentists it’s about 80 percent So, can you give us some insight about what’s the reason for this big difference between dentists and other doctors? >> Glen Miller: The 80 percent number, as I know it, has to do with prophylactic antibiotics The report that I read said that 81 percent were unnecessary One of the main reasons, in my mind, is we don’t prevent periodontal disease We let periodontal disease get out of control, which allows more infections to happen, which means more antibiotic usage And then the patients that have periodontal disease are also more likely to get prophylactic antibiotics And so, it’s a double-edged sword with periodontal disease That’s why I spend a fair amount of time on it So, a lot of it’s coming from the fact that we don’t control it in the first place, and the second place, when the infections come, we’ve got to throw antibiotics at it instead of doing definitive care >> Martin Blaser: So, let me just push back a little, and that is that these guidelines come from recognized authorities — experts in the field who take into account these kinds of issues So, I just — I wonder if that may be self-serving >> Glen Miller: I’m not sure I understand the question >> Martin Blaser: Well, you know, people — doctors who prescribe a lot often say, “We — oh, well my patients are sicker than everybody else’s patients.” But on average that can’t be the case It should average out So, the societies that make guidelines about use of prophylactic antibiotics are taking into account issues like periodontal disease It’s mostly about endocarditis risk and about risk in prosthetic infections, in which the true indications for prophylaxis that are evidence-based are actually quite minimal So — but dentists are prescribing a lot more than that That that’s my question >> Glen Miller: When I first started my career, we use prophylactic antibiotics for everything I mean, we never even consulted with an MD We just wrote prescriptions And also, we wrote multiple prescriptions refills because we didn’t want to be bothered by it So, we handed out a lot of antibiotics in the beginning That paradigm seems to be still manifest in my profession I still see a lot of dentists writing prescriptions for antibiotics that are totally unnecessary And I think the main reason for that is, once again, I’ll go back to periodontal disease, but the other thing is that they don’t keep up the literature I mean, even when I was reviewing the literature, and I keep — I believe that I tend to keep up on things There are some things that I was prescribing antibiotics for — it was like, “Oh, my gosh I’ve been doing this a long time.” So, I think we get into paradigms and habits But the push of the industry when I got into dentistry was antibiotics for just about everything And I see that wave still continuing It’s starting to abate a little bit, but that whole tidal wave is just such a mass that it’s been hard for dentistry to diminish it >> Martin Blaser: Yeah And that sounds closer to the case Thank you >> Glen Miller: I think it’s habit, habits and paradigms >> Martin Blaser: Yeah >> Angela Caliendo: Okay Kathy >> Kathryn Talkington: Thanks, a couple of questions First for Nathan Yeah, you talked a little bit about the sort of ins — the problems for having pharmacists get involved in what in stewardship and the incentives And you talked a little bit about payment reimbursement In lieu of the fact that that’s probably going to be hard to get changed in the near future, is there anything else? Are there other incentives that you think would be helpful on the outpatient side? You talked a little bit about information It’d be helpful to have more data and knowledge about what the conditions are Are there other things that could happen while reimbursement issues are addressed? >> Nathan Wiehl: Sure Information, if it were to flow from the provider to the pharmacist, then patients, you know, might have a better chance at a more favorable outcome In the case that I presented you, if the pharmacist dispensing the prescription, had the islet, saw that they were treating an enterococcus bacterium that probably wouldn’t have responded to Cephalexin That would have given them a fighting chance Now, I’m not going to say that every pharmacist would have caught that But if that were the usual case, if we were to get that information as standard of practice,

then we would adjust our behavior and adjust our practice to accommodate that So, we would — because when more pressure is put on pharmacies to perform, we typically do because we want to be able to be viewed as medical providers eventually But yeah, the flow of information — or if we had access to the health exchanges with information between hospitals, if we could log into a platform and see renal function or see lab work without having the provider to send it over — if we had access to that, then I think we’ve got a better opportunity to have favorable outcomes for sure >> Kathryn Talkington: Thanks And I just have one quick question for Dr Hitt as well You had talked a little bit about metrics and the lack of metrics in terms of antibiotic use in the veterinary field, in your field What — if there were metrics do you think that would be something that could be easily developed, and are there systems in place to measure use that could be helpful? >> Mark Hitt: I think that it comes back to the basics of veterinary practices and how it’s structured in the U.S., or if not, the world That only now is there sort of a consolidation of veterinary practices by industry that are providing uniform computer systems, uniform reporting back, bean counters that are looking at, you know, where money is being spent, or which distributors and how much antibiotics are purchased The software systems are disparate They’re not linked or unified in any way There are probably 25 different software electronic patient systems We have also no pressure from insurance plans or insurance providers I’m both blessed with that, that I don’t have to deal with it But on the other hand, there’s a lot of data that comes from that information So, that — right now, only 2 percent of small animal clients have pet — health insurance policies for their animals Some parts of Europe, in the United Kingdom, it may be 70 percent, 60 percent — Germany, Denmark, 70, 80 percent Whereas in the States, people don’t think about that So, pet insurance has not raised its head very strongly, but I think that’s where a lot of your data comes from in the human world It’s the requirements for reporting I think that there’s a lot of independence by history, just as with dentistry, in veterinary practices Independence of action and getting us to report just controlled substances is a whole new world for us We’ve had a lot of independence there And that may be a model for the future Hopefully, not quite as strict But in recent couple of years, veterinarians are now required to have three hours a year for Maryland, for use of controlled substances — three hours of continuing education And it almost all involves human abuse So, it’s — okay, we’re learning Our recording systems — you know, we now have at least 20 hours a month of employee time Just going back to recording how controlled substances are used, filling all the paperwork out, dotting all the t’s and i’s, and making sure the logs all match It’s just reached a new intensity, and I think that getting that layered down on top of veterinary medicine will be its own struggle in the future And it’s not that some level shouldn’t happen, it’s just that it will be a bit of a struggle to reign in veterinary medicine, so >> Angela Caliendo: Okay So, we have a lot of people with questions and not a lot of time so please limit to one question So, Mike, you’re next Choose wisely >> Michael Apley: Dr. Wiehl, I just wanted to follow up So, you talked about the cost challenges to having a stewardship role in advising How much would that need to be increased, and then when that’s increased, what is — what other barriers are there for the interaction of the pharmacist with the physician in actually having input received and having the authority or the status, if you will, to have that type of input? And does there need to be some change regulatory wise? >> Nathan Wiehl: Well, I think there’s already legislation written to recognize pharmacists as providers, but right now it’s deemed by the CBO as being too costly

But I think in reality, it’s the other way I believe in situations like this, it could be it could be cost savings when we can intervene and get a more favorable outcome from a patient that may otherwise take three or four days to jump through insurance hoops But I think that initially it starts with the information If we have the information at our fingertips A colleague of mine — Antimicrobial Stewardship Director for St Luke’s, Nick Bennett — has told me that even when you have all the information an evaluation could take anywhere between five and 15 minutes And in a retail pharmacy setting time is money It’s a volume game anymore with the reimbursement that we get So, being able to tell you, you know, an exact dollar figure I don’t know Because chain pharmacies are paid better by PBMs that they’re affiliated with or paid better or get a better net profit because they’re buying so much better And that’s one of the reasons why my company has bolstered up to 228 locations, simply so we can buy medications better to lower our cost and therefore be able to provide additional services that independent single store or two or three store groups can’t do So, I can’t really give you a dollar figure But elimination of those retroactive DIR fees, where we can appropriately budget for services down the road rather than three to six months after point of sale Getting a recoupment back to the point where we can’t evaluate our books to decide if those are services that we can provide >> Angela Caliendo: Okay Aileen >> Aileen Marty: Okay Thank you very much Thank all of you for wonderful presentations And Dr. Santos in particular, congratulations on the inroads that pediatricians are making in curbing inappropriate use of antibiotics But my question is for Dr. Miller And I’m, I’m wondering how familiar you are with the experimental porphyromonas gingivalis vaccine It’s a chimeric KS2A1 vaccine that targets the major virulence factor of the bacterium And if so, can you recommend on its potential value as it may relate to human periodontal disease and then thereby decreasing, you know, the need for antibiotics for dental procedures? And moreover, what are your thoughts on our government promoting and incentivizing the development of vaccines for oral pathogens such as this key pathogen as a mechanism for combating antibiotic resistance? >> Glen Miller: Well, that’s a big question I’m not sure I have an answer for that I’m not sure about the — I have not heard about the vaccines, so I’m not sure how to answer your question there >> Aileen Marty: Well, how about the general part of the question, which is our promoting and incentivizing the development of vaccines against oral pathogens >> Glen Miller: Anything that’s going to decrease our use of antibiotics I think is something that’s going to be beneficial, so >> Aileen Marty: Thank you >> Angela Caliendo: Okay, Paula? >> Paula Fedorka-Cray: Yes This question is for Dr. Hitt You know, you made the comment that use in small animals may be minuscule But have you considered the interaction with the human factor in all of this? I mean, there is much more intimate contact between dogs and cats than there than there is between a fish And you specifically use the aquaculture example >> Mark Hitt: I use the agriculture analogy simply because it’s a matter of tons compared to milligrams But — I’m sorry, I lost track of your question >> Paula Fedorka-Cray: So, are you — what effect — have you looked at what effect that there might be between this more intimate contact between dogs and cats and humans than other food animals or — >> Mark Hitt: There’s limited information that about the transmission of infection pathogens between the two species Certainly for, you know, more common issues such as toxocara or round worm infections and larval brand problems or rabies virus and those kinds of zoonotic issues I think the one that’s been studied the most in veterinary medicine would be staph infections And is there a role for methicillin resistant staph aureus to be harbored in pets and then transmitted back and forth with humans? And it’s been that it can happen, but it’s not a common event

It’s more of a concern when we have a dog with methicillin resistant staph aureus that’s been pursued it’s usually from the human And yet there’s very little data that shows it going the other direction Occasionally, a human will come up with methicillin resistant staph pseudo intermediates, which is a veterinary pathogen, through probably close contact and open wounds But there’s, to my knowledge, not much data published I have to say it’s a little outside of my expertise >> Paula Fedorka-Cray: Right And I think that that’s a major point >> Mark Hitt: Yeah >> Paula Fedorka-Cray: I think that there is very little information available And so, we really don’t know but, we have — we use more human related pharmaceuticals in small animal medicine than we do in food animal medicine >> Mark Hitt: Yes ma’am >> Paula Fedorka-Cray: And I think that that’s an issue that deserves study >> Mark Hitt: Agreed >> Paula Fedorka-Cray: Thank you >> Angela Caliendo: Elaine >> Elaine Larson: This is for Dr. Santos A terrific panel, thank you so much We just finished a study that’s not published yet, we’re writing up the manuscript, looking at the risk of infection and with multi-drug resistant organisms in children who are residents at pediatric long-term care facilities versus children who are admitted to acute care, who are not coming from Peds long-term care And as you — it’s about — we had about 1200 from Peds long-term care and 260,000 from not long-term care Much to our surprise, the children who are at very high risk they’re vulnerable in Peds long term care — it’s like a nursing home for kids — had much higher rates, about two and a half times the risk of any kind of an HAI, but they had a significantly lower risk of MDROs And it’s the opposite of what one would think because they’re sick They’re — they have all the risk factors of adults in long-term care And we can’t –we can’t figure out any reason Is there any thought that you might have about why this disparate finding would be there? >> John Santos: No It’s a really interesting finding, and it would be — I don’t know what the next step would be to try to look into that a little bit further Certainly, I would have thought the opposite as you say >> Elaine Larson: Right And ironically, the Peds long term care kids also had a significantly higher risk of c difficile, hospital acquired c difficile, which you would think would be consistent with, you know, more antibiotics, and they also had more antibiotics in long-term care It’s very strange So, something else is going on that is, you know, with MDROs Anyway, it’s something to think about >> John Santos: Yeah, it definitely would be interesting to look at further certainly Thank you >> Angela Caliendo: Sara >> Sara Cosgrove: Well, thanks to all the speakers My question is for Dr Wiehl I’ve been informed by several colleagues that many of the big pharmacy chains are sending automatic refill requests for antibiotics And whereas this may be appropriate for cholesterol medications and so forth, not for antibiotics And I just wondered if that’s something that your pharmacy does, or if, you know, what strategy would we even begin to take to make that stop? Because it’s just an open invitation for prolonged unnecessary courses and/or prolonged residence of pills in someone’s medicine cabinet to, you know, take at will >> Nathan Wiehl: Yeah, that’s a very good question I don’t know of any — and I have a lot of colleagues that work for major pharmacy chains I don’t think that it’s anything that is a conscious decision being made on the pharmacy staff It’s probably that a patient is phoning in a refill using an automated system that then the computer system finds doesn’t have any refills and automatically sends that So, I don’t think that there’s — I think if that same patient were to actually talk to a pharmacist, and they said, “I would like for you to request a refill.” They’d probably say, “I don’t think you were intended to have one You should probably contact your doctor.” So, it’s probably a setting in their pharmacy management software We have disabled that feature in our system, simply because of that reason We want to be able to discuss with patients whether they need a refill or not And it frustrates providers like crazy when they get unnecessary refill requests

And we’re cognizant of that My organization is largely in rural areas, where we’re the only pharmacy in the county in a lot of cases And we have very good working relationships with our providers So, we take steps not to infuriate them if we possibly can But I also think that there is a difference in community pharmacies, independent pharmacies, and chain pharmacies Nothing against my colleagues that work for major chains, but they don’t have the support of their owners or their companies to get more involved in-patient care They staff the least to make the most profit, they’re slashing hours, and under the guise of health initiatives You see Walgreens and CVS out there promoting these health initiatives, but at the same time they’re cutting their support staff, putting more and more burden on the pharmacists for the regular filling process And it’s forcing everybody in the industry to try to remain competitive with them But if they had staffing standards that were equivalent to a community pharmacy, they probably wouldn’t have the reputation of making bad decisions like that and sending requests off like that >> Angela Caliendo: Kent >> Kent Kester: So, again, great talks by all the presenters, and I was struck by a number of recurrent themes across a number of the presentations So, you know, Dr. Hitt, I just — you know, when we heard from Dr. Miller how it seems like some practices are ingrained in dentistry And, you know, maybe it just takes a long time to sort of get that out of the system as more people get trained And as Dr. Santos described, you know, oftentimes in urgent care, as well as in private practice, there’s a push by the parents You know, the kid’s sick, need some antibiotics So, in veterinary practice, you know, there’s sort of the dichotomy of, you know, sort of the routine — you know, the owner brings the dog in with diarrhea and the dog gets metronidazole and out the door — you know, but, maybe the sample’s not evaluated or, you know, routine cultures aren’t necessarily sent And the owner wants an antibiotic and so it’s provided And sometimes, you know, then there’s the cost issue of cultures Because, you know, let’s face it, people don’t necessarily want to pay big money routinely for what they view as routine sort of veterinary care How does that get addressed? Because on the one hand metrics are important, but on the other hand these are like really practiced technical operational aspects that sort of undergird a lot of this sort of stuff >> Mark Hitt: I think we come back to the same efforts that are being made at the pharmacy and the pediatric level, which is to get the information to the client in some way that antibiotics aren’t always the answer Whether it’s information brochures at the front or a poster or just — I’m not sure how you get it out to the mass media kind of scenario But it really comes back to the basics that, you know, maybe you could use the analogy of what your pediatrician’s office has told you applies to your dog That, you know, the client comes in with hemorrhagic gastroenteritis for a dog, and they can’t hospitalize And they — you don’t know as the veterinarian is it a clostridium perfringens issue or not, or is it just garbage gut, you know, eating out of the trashcan? So, the pressure is there to not wait And the client’s thinking it’s going to be 4:00 a.m. when they need that antibiotic and they didn’t get it And then they’re going to blame you the next morning We have the phone messages waiting for us in the morning for the antibiotics we didn’t dispense And I think the progress that’s been made is also maybe lost in this discussion for all of us That it is better than what it was But in essence, I think it goes back to the education of the client to try and reduce the pressure on us to make those prescriptions And then that we are able and willing to stand up And that’s what it comes down to Can you take that extra five minutes of discussion with the client and make the person reassured that you or the system will be there if they do need the antibiotic? There’ve been times I’ve written the antibiotics and said, “Do not fill this unless you end up needing it, but let’s give it till tomorrow morning and see what happens.” And a fair number of those don’t get filled

So, it is a matter of education in my mind >> Angela Caliendo: So, Dr. Hitt, I’m curious how much of the problem do you think is that the distribution of antibiotics from the veterinary practice itself is a source of their revenue? Do you think that drives any of this? >> Mark Hitt: I think your question is on revenue and how it drives the use of antibiotics I think that 15 to 20 years ago, 10 years ago even, that was a much — it would have been a much more relevant question, not that it loses relevance now But in the intervening decade we are competing with the grocery store pharmacies and Walmarts for veterinary products They will sell veterinary products now So, if I write a prescription for Clavamox as a veterinary form of augmentin, they can fill it at their — even pharmacy I can’t compete We don’t stock anything beyond occasional use for either in hospital or patients that definitely have to go home with it right at that moment We are no longer competitive price wise, so it’s less of an issue It’s not a profit center for most people any longer If your veterinary practice is depending on prescription antibiotics for a profit center, then you are probably — you might want to reconsider that function of that >> Angela Caliendo: So, you’d like me to find a new vet? [laughs] >> Mark Hitt: It shouldn’t be a profit center any long term really >> Angela Caliendo: All right, thanks Ramanan >> Ramanan Laxminarayan: Thanks So, question for Dr. Santos So, there’s some research showing that that poorer families are more likely to get antibiotics, or you, know, it’s correlated inversely with income And one thing which didn’t come up with, you know, many of the reasons that you provided why someone is asking for an antibiotic is — you know, are there people who really can’t take time off because they have no leave? I mean, this is really — people working in Walmart, for instance, they can’t afford to take the day off or even a few hours off So, that’s actually a much — I mean, is it possible that that’s a much bigger driver rather than people saying, “Well, I have to go away for the weekend I’d prefer to get them on antibiotics before I leave.” There’s a lot of people who are just — who are working two, three jobs and then getting that antibiotic for the kid is because without the antibiotic the kid can’t go to school They can’t afford to keep them at home And that probably represents a large proportion of people, perhaps not in your practices per say, but have you heard of that? >> John Santos: Yeah, I think it’s a great — it’s a great observation Certainly, you know, there’s many pressures on families and parents certainly And people working multiple jobs, non-traditional hours, all sorts of things, trying to find daycare available Especially, if a child’s sick a lot of daycares won’t take a kid if they have a fever or anything along those lines I think my challenge and my push-back on that though, is that is an antibiotic going to help? That’s always what it comes down to You know, if a kid has a viral illness — a cough, congestion, cold type thing — that antibiotic isn’t going to help that kid get back to daycare any faster at all So, I think, again, there’s — it’s relatively rare where, you know, doing something early, especially in the urgent care setting when kids come in, pretty early that getting that antibiotics started is going to make that much of a difference >> Ramanan Laxminarayan: I don’t — I’m not disagreeing with it I’m just saying how do we disabled that particular reason? >> John Santos: Yeah And, again, I think that comes back to what Mark has talked about as well as some of the others on the panel A lot of it is education You know, there was talk about education level and how that impacts patient’s perception of the use of antibiotics and whether it will help or not And so, I see my role, just like Mark had mentioned, as being an educator and talking to families about what things that they can do to try to help their child feel better as opposed to throwing antibiotics at a viral infection or it’s not going to make as much of a difference >> Angela Caliendo: Jane >> Female Speaker: Thank you And thanks for the great talks My question is for Dr. Santos, and it regards the role of diagnostics in the urgent care setting So, what rapid diagnostic tests do you use, and which do you find to be most valuable in helping to make that decision of whether or not to prescribe an antibiotic? And I guess the second part to the question is what’s your wish list for what the ideal diagnostic would be to enable you to make the best decision? >> John Santos: Thanks for the question So, in our current institution at Children’s Colorado the primary rapid test that we have

is rapid strep That being one of the more common sort of complaints for sore throat It’s well validated, has pretty good specificity and sensitivity overall So, anytime we are concerned about strep throat we will go ahead and do a rapid strep I think our group is very good about if the rapid strep is negative to not treat We see plenty of families that come in where they’re at their PCPs office, and, you know, the strep was negative but threw them on amox anyway because they figured that’s what it was And they come back a couple of days later with rash, which is a common issue with Amoxicillon if it’s not strep So, that’s one of our approaches If our strep is negative, we will send it through a culture, which takes longer to come back But that helps give us confirmatory testing about whether that truly was negative or not And if it is n-positive on our follow up culture we have a system where we can call families back and go ahead and get antibiotics started at that point in time As far as other testing, we do not have an — I know commonly a lot of places will have a rapid flu test We don’t use the rapid flu at children’s Colorado right now From talking with their discussions with our lab, we just didn’t think it was quite as accurate as we’d like it to be So, if we have concerns, true high concern for flu, we will send a PCR from our system Flu is one of those ones where, you know, I think we were focusing on bacteria, but, as someone mentioned, potentially we should look at other things too Flu is one of those ones I think where we’re always challenged with, you know, “Hey, he’s got flu Flu is all over the place Let’s get him on Tamiflu or an antiviral.” And we, again, I take that opportunity to educate that the recommendation is that for otherwise healthy pediatric patients with no other sort of comorbidities, that really Tamiflu is not indicated generally And so, I actually don’t mind not having rapid flu truthfully, because that would put me in that more difficult position sometimes of getting asked to do a test, doing a test, and saying, “Yes, it is flu, but I’m still not going to treat you.” I’d rather be able to say truthfully that, “Yeah, it probably is flu, but it’s not necessarily going to make much of a difference in the child’s outcome.” >> Angela Caliendo: Okay And our last question goes to Lonnie >> Lonnie King: Thanks to all of you for a really nice presentation So, Dr. Hitt, just a — and Angie kind of brought this up, but probably the trend for companion animals the fastest growth in practices are by corporations And certainly, looking at Banfield now in a position where they’re talking about a thousand different — or not Banfield, but Walmart is thinking about, you know, opening a thousand practices over a period of time and dropping the cost of the visit in care by 30 to 40 percent So, probably what’s made up on that is right next door to them are food, toys, and a pharmacy And whether that’s, you know, heartworm and flea and tick prevention and also antibiotics So, I just wondered in your mind, how difficult would that be to start a really effective stewardship program when you have maybe a corporate profit or mission or business model that’s like that, and is that going to be a further barrier for us to move in to be more effective? >> Mark Hitt: I think the question is the veterinary equivalent of the, the minute outpatient facility They’re already in test marketing in Targets in Walmarts in the south for veterinary medicine And you get what you pay for largely They can take your temperature and they can do a quick check over and physical, but — >> Lonnie King: — antibiotics And are they really going to do stewardship programs, or are they going to incorporate antibiotics as part of the algorithm for treatment because it’s part of the profit motive? >> Mark Hitt: They’re going to face the same pressures that the human minute clinics do, outpatient clinics That the client wants an answer They want an answer quickly, and they have — they’re — the clinic’s profit is in the volume They can’t do that more effectively than your general practitioner can, unless they cut the time and make things less available So, the pressure to dispense that antibiotic is going to be higher just as you see in human medicine So, consolidation and, you know, downplaying the value Essentially, the general practices no longer have routine small incidences of normal veterinary care to deflate the cost of the overall system, so that when you would go in with a patient who is really sick, your costs may not be as high because they could buffer those costs

out over the entire population of their clientele or their patients Now, if you take the high profit margin quick visits and set them aside and take them away from general practices, they’re going to have to up their game on quality and time spent with the client and take the opposite track Whereas the minute clinics, if it’s in the volume, they have to turn things over and that’s going to take — they’re not going to have the communications time And the pressure is going to be to dispense that antibiotic >> Angela Caliendo: Okay Thank you This session is over >> Martin Blaser: Thank you very much panelists, Dr. Caliando, PACCARB members, and we’ll take a five-minute biological break And come back by 11:05 a.m Thank you, very much >> Female Speaker: Produced by the U.S. Department of Health and Human Services at taxpayer expense