Healthcare is in a state of flux. As extraordinary measures are taken to stem the spread of the coronavirus, regular medical care—from routine checkups and screenings to in-office treatments and procedures—has been subject to significant disruptions and challenges. Social distancing requirements of the 

 pandemic have created new limitations on in-person physician visits. 

Office closures and safety concerns have resulted in the delay or cancelation of medical appointments for some patients. Compounding matters is the dynamic and uncertain nature of the pandemic. The issues that patients and physicians are confronting today have evolved since the COVID-19 shutdowns began in March—and further change is undoubtedly on the horizon.

 patients and their eye care professionals, the pandemic has led to an array of stressors, given the progressive but indolent nature of a disease that can lead to blindness and requires close ongoing monitoring and treatment. The current health environment is particularly worrisome for elderly patients because they are most at risk for vision loss from glaucoma and are also among the highest risk groups for COVID-19 mortality.

To better understand the concerns and experiences of glaucoma patients during the pandemic, the Glaucoma Research Foundation (GRF) commissioned an online survey in May 2020. The aim was to gain valuable, real-time patient input that can help eye care professionals better address patients’ emotional needs as they adapt to the new, and continually changing, care requirements of COVID-19. 

The GRF survey, which was supported by Aerie Pharmaceuticals, assessed patients’ confidence in their disease management during the pandemic; specific disease management concerns; patients’ experience with telemedicine; and patients’ comfort in returning to eye professionals’ offices. The survey drew a national response, with 1051 adult glaucoma patients from 49 states participating in the questionnaire.

The survey findings bring to light several key considerations for ophthalmology practices evolving glaucoma care in the COVID-19 environment.

Notably, the survey found that more than half of respondents (53%) had to delay and/or cancel an eye care appointment during the first months of the pandemic. These disruptions seem to have significantly impacted patients’ confidence in their disease management, with approximately one-third (36%) of glaucoma patients surveyed saying they were not confident that their disease was well-managed. Those who had the lowest confidence levels in their glaucoma management were 30% more likely to have had an eye care appointment delayed or canceled.

This feedback highlights the central role of communication in enhancing glaucoma care and the importance of nurturing the physician-patient relationship during the pandemic. With physician offices open again, personal and direct doctor-patient communication is paramount to helping patients understand their unique level of risk and rebuild confidence in their disease management. 

Without scaring patients, it’s important that they understand the consequences of delaying an office visit and the real risk it may have for further, even permanent, vision loss.

At my practice in San Francisco, we went through every patient record that had an appointment during the early phase of the pandemic and conducted a risk assessment. We then communicated with each patient to make them aware of their particular situation and the risk of not coming in to be evaluated when our office reopened.

The first step was to speak with our staff about our responsibility to be safe, not just in the office, but also outside of work, with specifics about how to minimize risk. I sought their input and we developed together an action plan with new office protocols.

We also invested in an expansion of our office team. With this increased staff, we are able to directly answer more patient calls and engage in longer, in-depth conversations. In addition, we have placed a greeter at our main entrance who screens patients, which includes basic health questions, a temperature check, and a check for an appropriate mask. 

After completing these safety protocols, the greeter asks patients to use hand sanitizer prior to entering the clinic. These new measures have played a valuable role in boosting our patients’ confidence in their disease management during the pandemic.

The “COVID-19 Office” and Telemedicine

The survey also reveals that glaucoma patients place high value on being able to see their physician in person. Six in 10 (63%) respondents said they are comfortable returning to their eye doctors’ offices as long as social distancing measures, such as face masks and less crowded waiting rooms, are implemented. This preference for in-person physician visits, coupled with technology challenges, make patients largely uninterested in telemedicine. A vast majority (87%) of glaucoma patients surveyed said they would rather wait six weeks for an in-person office visit than have a telemedicine visit in two weeks.

While telemedicine has been a valuable tool in other medical specialties during the pandemic, it has significant limitations for standard diagnostic procedures in glaucoma care. Since intraocular pressure (IOP) checks, visual field evaluation, and other tests cannot be easily conducted virtually, practitioners may lose considerable clinical information by trying to manage glaucoma via telemedicine.

During these unprecedented times, the safety and well-being of patients is the principal concern of all eye care professionals. It is also important to consider the needs of your staff as well. At my center, we have modified several standard procedures that not only have enhanced patient safety during COVID-19 but have also made us operate more efficiently and safely as an eye care practice. 

I have found that when members of my office team feel safe at work, their calmness and confidence extend to the patient-provider relationship, helping patients feel more comfortable about the visit. By fostering a caring and professional approach to glaucoma care in the midst of uncertainty, we can all navigate the COVID-19 pandemic while continuing to protect the vision of our patients.

Andrew Iwach, MD, is Executive Director of the Glaucoma Center of San Francisco, Associate Clinical Professor of Ophthalmology at the University of California, San Francisco, and a faculty instructor at the California Pacific Medical Center Department of Ophthalmology. 

The article reflects the views of the author, not necessarily those of the publication.

A new survey assessed patients’ confidence in their disease management during the pandemic, specific disease management concerns, and experiences with telemedicine.

Managing Glaucoma During COVID-19: Patients Point the Way to Improved Care

Andrew Iwach, MD

On February 10, 2022, the US Centers for Disease Control and Prevention (CDC) 

 of their revised guideline for prescribing opioids for chronic pain. While the 

 is more than 200 pages, the most important part is the actual guideline itself, which is 12 statements that take the place of the 12 statements that comprised the 2016 version that this draft is intended to replace.

Because it is likely that the primary intended audience of clinicians will not read the full document but will focus on the 12 statements, it’s key to examine what has changed, what has not, and the potential impact of this new guideline on the lives of millions of patients with chronic pain whose lives have been 

The biggest change is the removal of specific dosage cautions and limits in statement 4 and 5 and specific days duration of opioid therapy for acute pain in statement 6.These dosage and duration limits were arbitrary and unsupported by clinical evidence yet widely implemented across the country and even codified in law in at least 33 states. Prescribers, insurers, and even pharmacies, implemented them as strict limits. They have caused the most egregious harms over the past six years including forced tapering, hundreds of documented suicides, sudden loss of access to medication triggering withdrawal, dismissal from physician practices, inability to find medical care, and loss of function and quality of life.

In an acknowledgement of these harms to patients with chronic pain from abrupt discontinuation of opioid therapy, statement 5 now includes repeated cautions to “exercise care”, “gradually taper” and “not discontinue abruptly or rapidly” when reducing dosage.

The other less significant changes in the guideline itself are slightly easing the directives on patient surveillance and softening the absolute restriction on concurrent prescribing of benzodiazepines. Statement 9 changed checking the prescription drug monitoring program (PDMP) “ranging from every prescription to every 3 months” to when starting opioid therapy and periodically thereafter.Statement 10 changed the recommendation to use urine drug testing when starting opioid therapy and annually to “consider toxicology testing”.Statement 11 changed “avoid” concurrent prescribing of benzodiazepines and opioids to “use extreme caution” if doing so.

What has not changed in the revised guideline is the lack of balance in the discussion of whether to initiate, continue or discontinue opioid therapy.As in the 2016 version there is a focus on the risks and harms of opioids without any mention of the benefits of opioids for pain control when medically supervised or the risks and harms of inadequately managed pain, especially when other therapies have proven inadequate or contraindicated.

With their focus on patient surveillance through regularly checking the PDMP and using toxicology, the risk the guideline is most concerned about is the risk of addiction.Yet, repeated research has shown the risk of addiction in medically supervised pain patients on opioid therapy to be very small – between less than 1% to 8%. Stated another way, between 99% and 92% of chronic pain patients on opioid therapy do not become addicted to their medication.

However, millions of patients on stable doses of their medication have been forced to taper off their medication since 2016 due in large part to the widespread adoption of the CDC Guideline and the consequent fear of scrutiny and loss of licensure they have created in the minds of U.S. physicians. In 2015, the National Institutes of Health (NIH) reported that there were between 5 and 8 million Americans on opioid therapy for chronic pain.

Further, what has also not changed is the weak body of evidence most of the 12 statements are based on, as in the 2016 version.Using the Group Reading Assessment and Diagnostic Evaluation (GRADE) system which rates the strength of the evidence underlying each guideline statement, 7 out of 12 statements have a rating of 4 on a 1 – 4 scale, where 4 is the weakest level of evidence considered “very weak”. Three additional statements have an evidence rating of 3 or “weak”. Yet, 4 out of the 7 statements with very weak evidence were given the strongest “A” level recommendation rating by the CDC Guideline authors. That is, simply put, intellectual dishonesty.

This revised guideline again excludes certain pain conditions (cancer, sickle cell disease, palliative care, and end-of-life care) as more worthy of pain control where the stated risks and harms don’t apply. Pain is pain, and chronic pain is fundamentally a disease of the nervous system and brain regardless of the etiology. Due to great variation in individual differences regarding disease progression, severity of condition, sensitivity to pain, metabolic variables and more, benefits and risks must be considered on an individual basis. A person with any given pain condition could be in much worse pain for longer duration than a person with one of the excluded conditions.

Will the Revised Guideline Change Practice?

I think it’s unlikely that there will be a renewed willingness on the part of physicians to prescribe opioids again to chronic pain patients who were removed from opioid treatment against their will. According to a report from the US Department of Health and Human Services (HSS) to Congress in April 2020, at least 33 states have adopted statutory limits on opioid analgesic prescriptions. It’s doubtful that any of these codified restrictions will be repealed anytime soon. Once laws are on the books it’s very hard to change them. And, as long as the intense scrutiny of opioid prescribing continues as a result of these laws, regulations and US Drug Enforcement Administration (DEA) investigations of prescribers, I don’t anticipate that access will improve for chronic pain sufferers.

Of course, nothing will bring back all the pain sufferers who committed suicide as a result of being forced off their medication. And nothing can give back all the years lost to relentless pain and suffering of the innocent people living with debilitating chronic pain who were forced off their medication since 2016.

What is more likely to improve in the short term is payer coverage of non-opioid restorative, behavioral and complementary treatments, and medical devices for those with chronic pain, and perhaps with increased recognition of the harms caused by the guideline, a lessening of the punishing stigma associated with being a person in pain in the US. In the long term, I remain hopeful that the current trend of significant increases in public and private investments in neuroscience pain research will lead to novel therapeutics to more effectively treat chronic pain.

Listen to Cindy Steinberg discuss the implications of these changes in an 

interview featured on our DocTalk podcast.

Cindy Steinberg is the Director of Policy and Advocacy for the 

and Policy Council Chair for the Massachusetts Pain Initiative. She is a nationally prominent and articulate spokesperson for the needs of people living with pain and has won numerous awards for her pain policy accomplishments. In 2018, she was appointed by HHS Secretary Alex Azar to serve on the 

HHS Pain Management Best Practices Task Force 

and in 2019 she was invited to testify before the US Senate HELP Committee.

The Director of Policy and Advocacy for the US Pain Foundation addresses the important changes made to the updated draft of the CDC Clinical Practical Guideline for Prescribing Opioids 2022.

Assessing the Draft Revised CDC Clinical Practice Guideline for Prescribing Opioids 2022

Cindy Steinberg

 What’s really important—and we’re not here to give advice to the manufacturer of inclisiran—is the reputation a drug develops when it’s brought to the marketplace. It sticks. To Dean’s point, if you look at data published by Seth Baum and others, they found that the utilization of PCSK9 was somewhere about 0.3% of those who were eligible.

What happened was you had the insurance payers creating these incredible speed bumps. It didn’t really matter. The manufacturers of PCSK9 inhibitors cut their price in half. As Dean, Manesh, and Linda have said, the access to the PCSK9 inhibitors has certainly become easier. But the doctors just aren’t interested in prescribing. As far as they’re concerned, it’s a drug that’s very difficult for patients to access. It’s an “expensive” drug. I urge the manufacturer of inclisiran to think the process through, so that when this drug finally comes to market, it is accessible. 

Otherwise, you’re going to have the same issues that we face with PCSK9 inhibitors. Perhaps we need to inject some artificial intelligence into value-based care instead of what seems to be artificial insanity. We need to be able to count on really good algorithms to determine appropriate use for these compounds.

I still have heterozygotes being turned down for PCSK9 inhibitors. It’s insanity out there. What we really need is really good artificial intelligence, not artificial insanity, in terms of making sure these drugs are being used in the appropriate patient at the appropriate time.

 Norman, that was a wonderful take-home message. In fact, I’m going to start with Dean, Manesh, and Linda; you’ll be last. Give me a similar take-home message, something you think our audience needs to hear from you. Dean?

 In secondary prevention, the LDL [low-density lipoprotein] goal is less than 70 mg/dL and probably lower for all our patients. That’s going to require combination therapy, the best statin dose you can get them on, and then other drugs.

If the cost of the medicine is too expensive, then use ezetimibe. For primary prevention, family history, pay attention to risk-enhancing factors in the guidelines and calcium scoring. That’s how we can get these patients treated earlier, so we’re not in the situation where they’ve already had events and you’ve got to be that much more intensive with regard to their treatment.

 We’re at the age where we have an explosion of possible therapies for our patients, which is great. The take-home message for me is this isn’t about cardiology or specialty care; it’s about primary care. This is about getting the message and the care pattern and the access to the primary care. That’s how we’re going to affect the population health, by getting these therapies—statin, inclisiran if it comes on the market, PCSK9 as we’ve just heard—into the hands of our primary care doctors and getting them comfortable with having the conversation with patients to get the therapies to them.

 That’s a great comment. Linda, you have the last take-home.

I just want to reemphasize lifestyle. Diet is absolutely critical. You can have somebody who is not at goal and they’re eating a terrible diet, and they can have really good results from changing that diet. Using our licensed nutrition folks and getting these people to improve their diet is very much a part of the picture.

 Thank you very much. I’m Dr Keith Ferdinand for HCPLive®. We’ve had a rich and informative discussion. Linda, Dean, Norm, and Manesh have given us a wealth of ideas and information, reviewed data, and given some opinions on where we are now with the intent of lowering risk in patients who are high risk, including the FH [familial hypercholesterolemia] patients, patients with ASCVD [atherosclerotic cardiovascular disease].

If you enjoyed watching this HCPLive® Peer Exchange, if you enjoyed the content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your in-box. Thank you very much for listening to this program.

Final thoughts from expert KOLs regarding treatment decisions and how they relate to patient accessibility when manage dyslipidemia. 

Treatment Decisions and its Relation to Patient Accessibility  

Dean Karalis, MD

Some practical tips to share with community physicians. IPF [idiopathic pulmonary fibrosis] can be a difficult diagnosis. Sometimes it’s black and white, clearly IPF or clearly not. But most of the patients fall in that gray zone of uncertainty. What I would say is if you’re uncertain, and this might be self-serving, contact your local ILD [interstitial lung disease] center. Get a second opinion and see what they have to say. I look to my colleagues all the time in our clinic, and I say, what do you think of this CT, or what do you make of this or that?

Talking among ourselves and putting these patients before multidisciplinary discussion, which typically happens at ILD centers, can be very important for validation of the diagnosis. Because probably the most difficult aspect of IPF is to make an accurate diagnosis first. The value of sending folks to ILD centers is that they can be looked at for clinical trials. Many ILD centers, such as ours, are transplant centers as well.

It becomes 1-stop shopping. You can get validation of the diagnosis concurrently. If you don’t want to start the therapy yourselves and leave it to the ILD docs, you can do it. They get looked at for clinical trials, and they get evaluated even in a cursory fashion as a potential lung transplant candidate.

To the community docs out there, don’t feel like you’re flying alone. I think I speak for all the ILD centers out there. We’re only too happy to partner with you in taking care of your patients and making sure they have the best possible outcomes.

I believe strongly that the primary care clinician should be the principal player in guiding patients and their caregivers through any disease process. I’ve had strong bias all along. I trained as a primary care physician years ago. My sense is that the primary care clinician needs to understand these disorders because of their severity and the implication for patient and their family members. That includes having a high index of suspicion of when this disease may be present.
So there have been a series of studies that are lovely and demonstrate that an older person presenting with a chronic cough is a tip-off to the primary care clinician that they should consider these disorders, and IPF in particular, as a potential diagnosis. Because it’s our suspicion that earlier diagnosis, particularly with these effective drugs, is likely going to be better in the long term. It makes sense, and the data would support that. Trying to work with our primary care clinicians to have a higher index of suspicion of when these disorders are present is crucial. The same thing for our radiologists, because we have a sense that early changes on a CT scan can be very instructive with regard to the early diagnostic process. 

That interaction has improved. If you think about how we consider optimizing the patient’s quality of life and survival, the importance of being able to address the potential tolerability issues of the drugs and how to manage them. The comorbid conditions and their interaction. In the middle of all that is a primary care clinician.

When we develop therapeutic plans with our patients and their caregivers, when we have a disease-management plan, it’s immediately transmitted to their primary care clinician, ideally by a phone call or a video chat, so the primary care clinician is fully aware of where we are at each stage and can aid the patient in making decisions at each stage.

The primary care clinician is a crucial player from the early diagnosis to the management at the end stage of disease. They are the quarterback in most of what happens with these patients.

Steven D. Nathan, MD, FCCP, and Fernando J. Martinez, MD, MS, share clinical pearls and advice for the management of IPF.

Clinical Pearls for the Management of IPF

Fernando J. Martinez, MD, MS

 In the little time that we have left, I want to go around and get some final thoughts from each one of you. I would like you to address the whole issue of using naloxone. How do you address this with patients? How do you address this with clinicians, and what is your view about going forward? How is this going to change the landscape of opioid use in the United States? Why don’t we start with Jeremy, and we will keep going from there? Take 30 seconds, and we will just keep going.

 I think we have covered a lot of ground today. We know, and have known for a long time, that opioids have certain risks. They pose risks to patients, and they pose risks in the community when they are taken unsupervised or misused. From a safety measure perspective, there are things we can do. We can do a better job identifying the patients at risk or when identifying those patients who should or should not receive opioids. At the same time, I think we need more community awareness, and we can do this by using the naloxone program or some of the other programs discussed today. Rhode Island sounds amazing, and I am interested to learn more about what is happening out there. The tools we have today can enhance the safety of what we are doing on the medical side and help out there in the community with the substance misuse and illicit side. That is outside of the reach for some of us who do not work in settings where one can reach out to the community, but I think that these types of tools are underutilized. If these tools are utilized on a more frequent basis, and in a more normalized way, we have the potential to reverse what we have seen here with opioids and the subsequent harm caused by them.

 While acknowledging that opioids are still commonly used as part of a multidisciplinary approach to pain management and that opiates are still being misused illicitly, we need to have strategies that emphasize the availability of naloxone so that people can be as safe as possible. As Dr Adler said, this must be normalized, and we need to realize, when we think about this, it is going to take more years than we would like before it will become normalized, but we need to step it up and work toward that.

 I cannot agree more with my colleagues. I think that, when it comes to normalizing naloxone, we need to take the lessons we have learned from what successfully normalizes this method of treatment. Whether it is enacting policy interventions, having naloxone everywhere, putting up billboards, or getting that access. What we are doing is studying people, saying what makes you dispense naloxone, to pharmacists? Saying what makes you dispense it, to primary care physicians? What makes you want to give it, to a caregiver? What are those barriers? How do we break them down? I look forward to the day of over-the-counter naloxone that is still covered by insurance so we do not have financial barriers. There is a lot that we know, areas where we have been successful, and I think that yes, it is going to be around a long time. We have seen how COVID-19 has created these divisions. I think, by solving those divisions during COVID-19, we will solve some of the divisions in access to care for people with opioid use disorder or people who use opioids.

I see naloxone as one part of the puzzle here, one part of the comprehensive approach that we try to take in the emergency department [ED], and that is decreasing the barriers that patients need to overcome to get naloxone. This is improving their access to naloxone not only in the ED but also in other areas of life where they have access to health care, and in their daily lives. Having it available works, whether it is having a naloxone box sitting next to an AED [automated external defibrillator] box somewhere or offering it to patients proactively and not requiring them to have to ask for it.

Additionally, I think that, as science for medication-assisted treatment continues to be redefined every day—how effective that is for treatment—it is our responsibility to not only make sure that our patients are safe as they go out and use this, or that their community is safer because naloxone is out there. But we also need to provide multiple opportunities for patients to get linked to treatment, to be linked to peers, and to have access to medication-assisted treatment. I think this is equally important and should be offered as routinely as possible.

Theresa, some people hate to be the last one to speak when all the good stuff is taken.

Theresa Mallick-Searle, MS, RN-BC, ANP-BC:

heresa Mallick-Searle, MS, RN-BC, ANP-BC: 

As the token nurse on the platform here, I am really big into listening to my patients. It is not that my colleagues are not, but I want to hear what is important to the patient. I want to be able to have them partner with me in their health care. I want to be able to encourage my peers to look at the bigger community and be in it for the long term, to decrease the amount of fear out there. As a health care provider, for anything that we do, we are trying to do the best we can to take care of our patients.

Thank you all very much. I want to thank you at home as well for watching this HCPLive® Peer Exchange. If you enjoyed this content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your inbox.

I am Dr Peter Salgo, and I will see you again next time.

The multidisciplinary panel of experts share final thoughts on strategies to normalize naloxone and decrease barriers to its obtainment and utilization. 

Final Thoughts on the Opioid Crisis and Normalizing Naloxone

Jeremy Adler, DMSc, PA-C, DFAAPA, Pacific Pain Medicine Consultants 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: 

What do we do? How can we assist our colleagues in helping them look at one, how do we choose therapies, and when do we collaborate and refer these patients, and what kind of patient education can we provide for these patients?

Well, I think just to kind of bring this all the way back around, first off an accurate diagnosis always leads to successful treatments. So, make the diagnosis. Familiarize yourself with the different presentations of atopic dermatitis and the neonate versus the toddler versus the teen versus the elderly. And I think have a high clinical index of suspicion. If it is coming back, if it is very pruritic, if it’s life-altering, even if it doesn’t look like classic atopic dermatitis, it likely is a phenotypic presentation of that even if it’s not what’s inside your dermatology textbook. So, get the right diagnosis because the right diagnosis will then lead you to begin to move into the more, what I call the empathic side of treating this How is this impacting your life? How would your life change, how are the treatments that you’ve been using working? And so, begin that dialogue with patients and just kind of let them open up a little bit. It doesn’t have to be two-hour long visits for them to really feel like why this is different than other people have seen. Just asking a few questions lets them know that you're into the diagnosis, that you're not just going to run for a cream and send them out the door, and that you can make a difference. And if you don’t have that time to really tell them everything; you're not going to unload everything on the first visit. Tell them about comorbidities, tell them about every single systemic option, you're going to get their acute flare under control with topicals. And then you're going to bring them back in, you're going to earn their trust, you're going to continue to talk to them about it, and then you're going to begin – I’m always introducing non-steroidal options to patients right up front. If I feel like I have to use a topical steroid to calm it down – I may not need to once we get this new topical JAK out but I’m always introducing the idea of us moving off the topical steroids. I don’t use them much but systemics onto these new treatments. So it’s kind of a progressive revelation of talking to them about the disease, what you believe it is, how you want to open up the box and let them know that you know how this impacts you and the family, that we’ve got good treatments out there, we’re going to start off with this, but it’s important for me to see you back because we want to look into other treatments that are on the horizon that can control this for long periods of time without having to lead the anxiety about when am I going to break out next time. 

You know I think you summarized it very well Doug. I think it’s exciting where we’ve been and where we’re going. We don’t have to use systemic agents with these high toxicities that are really rescue agents, like the cyclosporine. We have choices now. And letting the patients know that and one of the interesting things is I’ve heard people say well that’s an injection. But guess what, let’s let our patients make that choice. Let’s give a fair representation of all the treatment options that we have and the ones that are coming because the truth is that an injection may be nothing compared to the quality of life that atopic dermatitis is having on these patients. A lot more to come for us especially our adult, some of the newer agents will be anticipated FDA-approved for adults. Some of the resources you like to give your patients Doug, what are they? 

Well certainly the National Eczema Association, the NEA, I think is an excellent resource with information about clinical trials that we may have mentioned in this presentation, great patient support, practical data that’s there, practical recommendations on bathing and moisturizing. I really, really like the NEA as a great resource. Do you have others? 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP:

 The National Eczema Foundation is my choice. But I think as far as resources for you as clinicians, I think one of the best ammunitions I would have for you is if you're in primary care or if you're in derm and you're not comfortable with prescribing some of these agents that are here now or the newer ones that we anticipate that will be FDA-approved in the near future, if you're not comfortable, reach out to a local dermatologist or dermatology NPPA and let us help you. One, we’ll help you with that patient and supporting them and getting them the best treatment and optimal outcomes, but also to help you learn about it. We really, really want to support you as colleagues and that’s my suggestion. Any last words Doug? 

 I just want to echo that. You know the study is a few years old, but it showed that only 19 percent of patients with severe atopic dermatitis got referred from primary care to dermatology. I think that’s improved, especially with some of the commercials that have been out about eczema and dupilumab’s campaigns. But we just want to say that this is – our medicine is a collaborative effort. We’re not living in silos here. We want to – we in dermatology want to partner with our primary care providers, we want to partner with our allergy specialists, we want to partner with the folks that are going to help us out too. I want to tell Margaret, you're helping your patients and you're helping yourself because these folks are living with infections, they’re living with scratching, they’re living with anxiety and depression. And we now have treatments out there that can radically change and improve that. So that’s the biggest message of today’s time together is that there is help out there, that we can get these medicines covered by most insurances, and that they can really change patients’ lives. 

 Thank you so much Professor Doug. This is why we call him Professor Doug. And thank you so much. Thank you for watching 

. If you’ve enjoyed this content, please subscribe to our newsletters to receive the upcoming programs and great content right in your inbox. So thank you everyone. Be safe and live well.

Experts in dermatology discuss patient education and clinical pearls to assist colleagues in the management of atopic dermatitis.  

Care Collaboration in Atopic Dermatitis 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP

 In this section, we’re going to focus on S1P [sphingosine-1-phosphate] receptor modulators and other emerging treatments for ulcerative colitis [UC]. Ellen, we’re going to focus on ozanimod now, can you review some of the data from the phase 3 True North study with ozanimod? Give us the overview and any other information you want to add about ozanimod, and then Dave I’ll move to you, and then Marla as well. Ellen, why don’t you kick us off?

 This is a phase 3 study that achieved clinically meaningful improvement in endoscopic mucosal healing as well as steroid-free remission. At week 52, 37% of patients on ozanimod were in clinical remission as opposed to only 18.5% on the placebo. Adverse events were similar and not significant: low incidence of anemia, headaches, and nasopharyngitis, which we tend to see. This is an important study that showed regardless of whether the patient was TNF [tumor necrosis factor agent] experienced or naive, these were the remission rates. They were also comparable in terms of who went into the trial, again, equal for disease severity and gender. I want to come back to ECCO [the European Crohn’s and Colitis Organization meeting] 2022, which recently, with Britta Siegmund, MD, et al,showed the rapidity of onset, with a 2-week response in patients who had a response, and a 5-week response with those who were in clinical remission. There was a slight improvement in those who were anti-TNF naïve, but overall, no difference in the TNF experience versus naive. We’ve made this point so many times, but you want to get this in as a first-line treatment before the patient has experienced a TNF. Whether you try a non-TNF biologic or small molecule first is a topic I will cover later.

 Nice overview on ozanimod, this new mechanism of action, first in its class showing that there is benefit in the moderate to severe UC study. Nice job outlining the overall data related to True North and some of the more recent data on rapidity of onset with ozanimod, and now long-term extension. I’m going to ask all 3 of you this, but I’ll start with Dave and then Marla, can you tell me your experience with ozanimod? And Dave, if you want to add anything to what Ellen said about the trials, but I want to get into your experience in your clinics with ozanimod.

 Sure, I’ll start with my experience and then touch on the safety or the screenings; that’s a concern both for providers and patients. When you look at the data, and Ellen outlined it nicely, about 70% of the patients included in the True North were TNF-naive or biologic-naive. This medication is going to play in those moderate patients, biologic-naive. Of the patients I’ve used it for so far in that group, I’ve had good results, response rates, remission, and I’ve had them on long enough now where I’ve seen mucosal healing. Anytime a new therapy comes on, we all have patients who have failed multiple therapies, and you’re giving them another shot. In those situations, I haven’t seen as good of results, just like I didn’t see as good of results with our other therapies when vedolizumab and ustekinumab came out. But as a first-line agent, it plays well. It’s how do you select that.

There were a couple of things that came up from the trial when this therapy came out. First is this idea of getting an EKG [electrocardiogram] and realizing this is a screening EKG. There are 5 S1P receptors, and ozanimod touches on 2 of them, type 1 and 5, whereas fingolimod, which is approved for multiple sclerosis [MS], covers all of them. That’s where you saw this AV [atrioventricular] conduction delay and bradycardia. For ozanimod, they’re looking for a baseline screening EKG, and if there’s no significant bradycardia/AV conduction delays, it’s OK to use. If you look at the True North data, the average drop was less than 2 beats per minute, nothing significant. Another concern is the lymphocyte count and that dropping, is that going to increase risk of infections? We’re going to need more real-world data on that, but in the clinical trials, at least to date, we haven’t seen that, and lymphopenia might be a biomarker of efficacy, almost like when we’re using thiopurines. It looks like the lymphocyte count might drop by about 50%, and that plateaus during induction around week 8 to week 10, and then it stays there. We’re going to have to see analysis, but for patients in that True North data who had low lymphocytes counts, less than 200 per mm3, there were no associated opportunistic infections.

Just one last comment on the safety, there was something else that got brought up about using it with certain types of foods or overlapping SSRIs [selective serotonin reuptake inhibitors] or SNRIs [serotonin-norepinephrine reuptake inhibitors]. The breakdown, the metabolites of ozanimod interact with monoamine oxidase. The concern is, if a patient is on an SSRI or an SNRI with ozanimod, are they more likely to have serotonin syndrome? There was a nice abstract that was just released looking at all of the patients with ulcerative colitis, all of the patients with MS, there were close to 300 patients who were on an SSRI or SNRI with ozanimod, and there were no cases of serotonin syndrome. So I don’t think it’s something we need to be concerned with.

 To add on to that, we’re seeing good safety with ozanimod. To your point, the expected lymphocyte drop doesn’t seem to be clinically significant in an adverse events form. The other thing that I tell my patients who read about ozanimod and may be worried about the cardiac part, is that ozanimod doesn’t cause cardiac abnormalities. It’s just that if they have an underlying preexisting block that they’re not aware of, because of the first dose heart rate reduction, we must be careful, but it doesn’t cause these. The final thing, before I move to Marla, is that I agree David, and I’m wondering as I say this, Marla, what are your thoughts? Could ozanimod possibly be used in that moderately severe patient who’s failed a 5-ASA [5-aminosalicylic acid], for whom we’re looking for that next therapy, and maybe even not steroids? Is this something that we can use in that biologic-naive patient? It’s just an interesting thought as I look at my own practice. We don’t get those patients as often because they’ve usually been on 3 or 4 things. Marla, your experience with or any other comments related to ozanimod?

 Sure. Remember that at week 52, the average heartbeat change per minute was 1 from baseline to week 52. When you included the patients with MS, it was 1.2 beats per minute at 2 years. We must keep everything in context, which you just said, because the idea of us ordering EKGs sets people into a different mindset about, “Oh my God, something bad is going to happen with this drug in my heart.” Thank you for clarifying the screening and what the reason for the screening EKG is. I’ve used it in several different ways. I presented at ACG [American College of Gastroenterology] the matched indirect adjusted comparison, and it looks very similar to vedolizumab. I think about ozanimod as an oral alternative for a patient you would use VEDO [vedolizumab] on, so I want you to think in that concept. It also looks similar to ustekinumab, and superior to adalimumab. This isn’t a head-to-head, so take everything within these network meta-analyses and these matched indirect adjusted comparisons for what they are. They try to match study to study, but Brian Fagan, MD, is in the bubble in my head saying, “never compare across trials.” So I say that with Brian as an asterisk footnote.

What’s interesting is, I think about it as an oral alternative. I don’t have to fail a TNF. Maybe it’s a similar patient population, I think of it like a traffic cop, just like I think about vedolizumab. Instead of it going and binding to the lymphocyte once it’s exited the lymph node, these drugs go to the lymph node, which is why you have lower circulating lymphocytes, because it’s going after those that are carrying this S1P hat. I think of it in that vein, so it made sense to me to think of it in that category. I have definitively used it as an add-on with someone who is partially responding, or I scope them, and they have just a bit of proctitis left. I don’t want to abandon my biologic—I’ve added it by the way to every biologic that we have—it works differently. It’s not increasing the rates of infection; it’s not like me adding a JAK inhibitor to a TNF, that’s not what I’m doing here so. I’m thinking about the mechanism of action, are they complementary to another cytokine-based interaction? That’s where I am using it. I am looking at it in the naïve instead of vedolizumab if they so choose.

The other question that patients want to know is, “Am I going to have a problem eating cheese?” The reason I say that is the tyramine. The amount of tyramine toxicity means they could eat cheese for 24 hours straight; I believe it’s 150 g before you get an effect from it. I tell them that unless there’s some sort of mouse that is eating cheese for 24 hours, I think we’re OK. That’s the biggest question I get asked, “Can I eat cheese and deli meat?” That must be written somewhere about the cheese and deli meat. I like to talk about that because it is important for patients.

 Sometimes beer and wine too, patients ask. And I agree, to put that to rest, the amount of tyramine you would need to have is nearly impossible. I guess nothing’s impossible in eating. To Dave’s point about SSRIs, SNRIs, and showing safety, it’s the same thing with tyramine, it’s essentially a nonissue. Ellen, I’m going to ask you the same question, how are you using ozanimod in your practice?

 First, I’m starting to use it more in the biologic-naive patient, but we did participate in the trial. We enrolled all the anti-TNF, multiple failures, with a tremendous response, so we use it in the refractory patients as well. The ophthalmologic exam, we get it as routine, having to do with the vasculature trapping of lymphocytes. But these are not problems. When we think about steroids, all of our patients should have ophthalmologic exams, and that’s exactly what I say. There’s no stigma to this. I’m using it in both of those patient populations. It’s relatively easy to get approved, and the results are quite good. Also, the washout period; to Marla’s point, in the real world, if you have a patient who’s on an anti-TNF, we go right onto ozanimod, no washout, whereas with a JAK inhibitor, maybe we want a bit of washout.

 What I’m hearing from all 3 of you is that you’re comfortable with the safety profile of ozanimod. It may be good to use early, prior to biologics, or off-label, just to make that clear to the audience, like Marla said, as an add-on to another biologic. And because of the lymphocyte trafficking, it works differently than most, except vedolizumab. I also want to say, I’m glad Ellen that you brought up the eye because we talked about the heart and the lymphocytes. But the ophthalmologic exam, and I think you alluded to this, is only necessary for those patients who have concerns of macular edema. If they have a diagnosis of macular edema, end-stage diabetes, or uveitis, but that’s a small percentage. Ellen and I agree, if they have 1 of those 3 conditions, they’re probably getting yearly exams by an ophthalmologist already. If our patients ask about the eyes, I’d say over 98% of my patients don’t need the screening exam; it’s really that rare group.

Ellen J. Scherl, MD, reviews data from the phase 3 True North study evaluating the use of ozanimod as induction and maintenance therapy for moderate to severe ulcerative colitis, and the panel shares their experience with ozanimod in clinical practice.

Ozanimod in Ulcerative Colitis

Miguel Regueiro, MD

This article was originally published by 

 in the US, accounting for significant patient mortalities and hospital burdens. Recurrent 

 infection (rCDI) is recognized as an urgent public health threat because it's associated with even higher patient deaths.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic for the treatment of 

. The therapy has been evaluated in 5 prospective clinical trials. 

One study, presented at Making a Difference in Infectious Diseases (

) 2022 Annual Meeting, examined the safety and efficacy of RBX2660 as administered under US Food and Drug Administration (FDA) enforcement discretion.

Studying the Live Microbiota-Based Biotherapeutic

Data was collected from electronic health records of adult patients with rCDI for this retrospective analysis. The primary safety set included patients who had no treatment history with RBX2660, and who had continuous treatment follow-up for 6 months after receiving the therapy. 

Study outcomes of interest included safety, absence of rCDI within 8 weeks after RBX2660, and clinical response duration. A total of 94 patients were included in the study. They were enrolled from 5 sites between November 2015-September 2019. 

The most common comorbidities included gastroesophageal reflux disease (47.9%), irritable bowel syndrome (17%), gastritis (11.7%), constipation (8.5%), microscopic colitis (7.4%), diverticulitis (6.4%), Crohn’s disease (5.3%), and ulcerative colitis (4.3%). Additionally, 16% of patients were using concomitant immunosuppressants, including glucocorticoids (7%) and monoclonal antibodies (6%).

Outcomes of Clostridioides Difficile Infection (CDI) 

Of the 94 participants, 64 were in the primary safety set and were treated with RBX2660. The treatment success rate was 82.8% (

 = 53), and there was no significant difference between the patients who received 1 dose of RBX2660 (83.3%; n = 20) and the patients who received 2 doses (82.5%; n = 33).

Among those who initially responded to treatment, 88.7% (n = 47) had a sustained clinical response after 6 months. The safety outcomes were comparable to other RBX2660 studies, with 92.2% of adverse events qualified as mild-to-moderate severity. This safety profile extended to the participants with autoimmune disorders and other inflammatory conditions.

The investigators concluded that RBX2660, administered under FDA enforcement discretion, demonstrated high clinical efficacy in reducing rCDI for 6 months. These results were corroborated by other studies, and by real-world observances of the safety and efficacy of RBX2660 in patients with common rCDI comorbidities.

This study, “RBX2660, a Live Microbiota-based Biotherapeutic, Improves Outcomes of Clostridioides difficile Infection in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion,” was accepted as an abstract for the 

Making a Difference in Infectious Diseases (MAD-ID) 2022 Annual Meeting

RBX2660, an investigational microbiota-based live biotherapeutic for the treatment of C difficile, safely and effectively reduced recurrent C diff for 6 months.

Real-World Study Shows RBX2660 Improves Recurrent C Difficile Infection

Nina Cosdon

COVID-19 has obviously presented significant challenges in our clinical work, particularly in the evaluation, diagnosis, and treatment of patients with ADHD [attention-deficit/hyperactivity disorder] of all ages. What we’ve all done, of course, is acclimate to this, largely through the use of telemedicine, telepsychiatry for a lot of our patients. Although more recently, I’ve gone back to more of a hybrid model where I am seeing some patients live and some via telepsychiatry. 

There are significant challenges. Some of those challenges include the fact that it’s a little more difficult to do an evaluation and to collect all the nonverbal information that you might get from being in the room with a person. Part of the problem is you may be seeing only a portion of the patient’s body. You may not be seeing the lower half of the body if you’re on a virtual call. You might not see some of the fidgeting or hyperactivity, for instance.

Also, what I find is patients either do really well with virtual telepsychiatry or don’t. They have trouble focusing. They get distracted. It’s really important to try to individualize care for our patients. Some people try to do in-person meetings. Ideally, this may be helpful for the initial evaluation so we can collect as much information as possible. When you’re dealing with children, you’d like to have collateral information, so you’d like to have parents and caregivers involved. That can be a little harder too, although it can be done virtually.

As far as prescribing medications, that can present a challenge. Although now, states are going to e-prescribing. In Florida, we now have to e-prescribe all controlled substances. That makes it easier, not having to handwrite a prescription and somehow get it to the patient in a COVID-19 environment.

The other thing I find is that sometimes children do a little better in this virtual environment, but many with ADHD struggle more. There’s a lot more stress and difficulty in school. Obviously, there’s more isolation, so fewer social relationships, fewer extracurricular activities, and maybe less access to exercise, which has been shown to be very beneficial for ADHD. These are some of the challenges that we’re trying to negotiate in the era of COVID-19.

Tele-prescribing of stimulants presents some unique challenges in the era of COVID-19. Part of the challenge is making sure you can e-prescribe appropriately. Most of us have figured out how to do that. Also, you want to make sure the pharmacy is available and shows up on your e-prescribing software. It is required, when we prescribe stimulants, that we monitor certain things. This can be more challenging in this environment, particularly when assessing vital signs, height, and weight. Blood pressure, heart rate, height, and weight can be a challenge in the virtual environment. This is when I may sometimes have the patient come to the office, just for the vital signs and height and weight checks. Or the patient can get 1 of the home monitoring devices, which you can get at many pharmacies. These devices can monitor blood pressure and heart rate. Your patients can check those periodically and report the results to you. Or you can certainly have them email that to you or communicate electronically.

As far as monitoring for abuse and possibility of diversion, this is something we also need to keep our eyes on. We can do this in various ways, including by checking prescribing databases, which can certainly be done online.

As far as monitoring for other issues and problems, such as the emergence of psychotic or manic symptoms or the possibility of vasoconstriction or cardiovascular issues, this is where taking a very careful history and evaluation and trying to look at the patient and evaluate them as best you can on camera really seems to help.

It’s important to understand that when evaluating and treating ADHD, comorbidity is the rule. Three-quarters of patients with ADHD will have a least 1 other comorbid condition. This is important because sometimes our core treatments for ADHD can help alleviate these other conditions. For instance, secondary anxiety or secondary depression. Sometimes, however, we do have to institute specific treatment in addition to the ADHD treatment to address a comorbid condition.

Rakesh Jain, MD, MPH: When parents and their children first come to see me for an evaluation for ADHD, there’s often a lot of confusion. We have a lot of myths in our heads. “Is this bad parenting?” “Was this just because one of us got divorced?” Is it because I had too many Diet Cokes when I was pregnant?” 

My first job is to offer parents and children a combination of sympathy and encouragement. I offer sympathy for the suffering they have gone through and encouragement that, if we do the right thing, we can make a pretty significant difference in all the challenges your child is having and you’re having as parents and caregivers. I have found that injection of enthusiasm, support, and knowledge to be as useful as anything I do.

The second step is really a pretty quick but accurate increase in knowledge base about the disease. Most people are quite surprised to know that it is a neurobiologically active condition. It is an inherited condition. It is a brain-based condition. Even though behavior is what they might see, the child is not being a “bad” child. 

Finally, we need to give an explanation of why interventions work or why a combination of nonpharmacological and pharmacological interventions is best explained in the context of neurobiology. 

When I offer that whole package of information, from sympathy to increasing their enthusiasm and encouragement to disease-state knowledge and then finally medication and nonmedication knowledge, you can see the parents and the child breathe a sigh of relief. “I’ve got a direction. There’s something I can do. I feel empowered.” That is precious. As a clinician, once I see that, I know I have established a solid therapeutic relationship that will lead to good outcomes.

Optimizing care and managing challenges for patients with ADHD during the COVID-19 pandemic and advice for clinicians educating patients and families on disease management. 

Optimizing Care for ADHD During COVID-19 

Rakesh Jain, MD, MPH, Texas Tech University School of Medicine

 I’d love for you to share with the viewers what strategies you have implemented based on your experiences to educate patients about their journey. Because that’s so important, as John has said, about making this a patient-centered diagnosis. What’s a day in the life of Dr Maron and Dr Ommen in how you approach these issues?

 I’ll go first. Like I’m sure Steve does, we spend a lot of time with patients when they come and do our own education with them, along with our health care team and nurse practitioners to educate patients about the disease. We spend a lot of time on education, reassurance, putting these issues that we’ve talked about in perspective, and doing a lot of shared decision-making, going through treatment options. At the end of the day, we try to deliver the message that hypertrophic cardiomyopathy [HCM] is a highly treatable disease. It’s going to probably be more so in the future, but even today it’s very treatable and a disease that’s compatible with normal life expectancy and good quality of life for the vast majority of patients. That’s the messaging that we give to patients the best that we can.

 I’d echo the same thing. Patients come to us after having done their own education attempts on the internet, freaked out with wide eyes because they’ve read all the dramatic stories that are available, and we have to remind them that people who have normal lives don’t usually blog about it.

I’d like to reiterate the same words about HCM in the modern era. We’ve gone from an era where it was 100% fatal in 1958 when Donald Teare described it to a 6% annual mortality in the 1980s to an annual mortality that’s the same as the general population. It’s a highly treatable disease for most patients. There are patients in whom there are issues. This discussion wasn’t about sudden cardiac arrest, which would be another 2 hours. Then there are quality-of-life issues that some patients have. But it’s a highly treatable disease and we’re getting more tools in our toolbox for the future, which is exciting.

 That’s super. Javed, any final thoughts you want to share?

 My final thought is that we have these therapies and we want to do anything and everything that we can for the patients to not unnecessarily suffer. The question is how do we educate the clinical community at large to refer the patients to the appropriate centers and to diagnose and screen these patients? While the specialists are very interested in and have a lot of these tools, more mass education about this disease would also be needed.

 From an administrator’s point of view, let me ask you to put that hat on for a second. When you’re looking at making recommendations for clinicians who are interested in getting involved in this, what things would you say are needed in terms of understanding things like catheter-based approaches, surgical approaches, and volume, which you talked a bit about? What do you think about setting certain expectations?

 You can modify behavior quite a lot by creating appropriate incentive structures in terms of education, screening, and quality metrics. You can also set up tools. We live in this digital age and everybody is on an electronic health record. A lot of the education and best practice advisories can be had for our patients in this era. Education and reminder systems are easier in the current day and age.

 Super. John, I’m going to turn to you last. You always keep the patient in the center. I’m curious to hear your final thoughts.

 First, I’m humbled by the expertise at this panel and not being an HCM expert. I feel a tremendous need to think about the infrastructure for elevating the quality of care throughout the nation. What does that entail? Does it entail thinking about algorithms, building shared decision-making tools, integrating routine assessments of health status with the KCCQ [Kansas City Cardiomyopathy Questionnaire], and coming up with very practical management strategies so that you don’t have to be in Boston or Rochester, Minnesota, to get high-quality care?

 Or Kansas City. That’s what I’m left with. It’s a complicated disease, but it’s an exciting disease. As more treatment options become available, there’s a greater call for thinking about the infrastructure of delivering high-quality patient-centered care. That’s what I’d like to see us move toward so that we can all benefit from the advances being made.

 Super. That’s a great way to conclude. I want to thank all of you for this rich and informative discussion. I want to thank you, our viewers, for watching this 

. If you enjoyed the content, please subscribe for our e-newsletters to receive upcoming 

 and other great content right in your inbox. I’m Jim Januzzi from the Massachusetts General Hospital. Thanks very much for joining.

Expert cardiologists share strategies for educating patients on the treatment and management of hypertrophic cardiomyopathy. 

Authors