Practical Updates in Acne Management

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Hi everyone.
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Welcome to the Game Changers Clinical Update Podcast.
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I'm your host, Rachel Maynard.
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On today's episode, we'll be talking about the management of acne, one of the most common dermatologic conditions we face in pharmacy practice.
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There are some key changes happening around tubits for acne, and we've recently seen the RX to OTC switch of adapoline benzoic peroxide.
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And we'll also soon be seeing some big upcoming changes to the iPledge Risk Evaluation and Mitigation Strategy, or REMS, for isotretinoin products.
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So to help us tackle some of these key updates related to acne management, I'm so pleased to welcome our expert guest, Dr.
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Jenna Mills.
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Welcome, Jenna.
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Great to have you.
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Thank you, Rachel.
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I'm excited to be here.
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Excellent.
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Well, to help our listeners learn a little bit more about you and your background, your current role, and maybe why you're interested in this topic, would you mind just sharing a little intro about yourself?
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Sure, I'm happy to.
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Thank you again.
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My name is Jenna, and I am an associate professor and the vice chair of our pharmacy practice department at the University of Finlay College of Pharmacy.
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We're located in Finlay, Ohio.
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But I am a pharmacist.
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I do work one day a week in Dayton.
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I work at the Rehabilitation Institute of Ohio, which is an inpatient rehab facility.
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But I'm excited to be here today and to talk more about some updates to acne because I teach it twice in our pharmacy curriculum at two different levels.
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I teach both the self-treatment side of acne and looking at over-the-counter options.
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But then I also teach in our disease state modules, prescription sides, and guideline recommended therapies.
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So excited to be here and to talk more about some updates.
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Excellent.
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Yeah.
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And very thankful for your time and taking time out of your busy schedule to meet with us.
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But um, it sounds like you really do have that great sort of both sides of the coin with the OTC angle and then also speaking to some of the prescription options and just the guideline and the guideline managed sort of considerations with acne more broadly.
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Um and I just want to mention to our listeners, I have a bit of a throg in my throat.
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So I apologize for any of my voice sounding a little off today.
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But yeah, super excited to get into this.
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And we we talked about, I alluded to some of those updates with the RX to OTC switch, but let's just at a high level start with considerations with acne management in general.
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So what what are some of those factors that you're thinking about when it comes to treatment selection?
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Because I don't I don't think we think of this as a maybe one size fits all sort of approach.
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And there's some considerations that we need to think about.
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So can you talk through that a little bit, Jenna?
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Definitely.
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So I guess to make a short story long, acne is it's very common.
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It is a common, but it's a chronic inflammatory dermatologic condition.
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But just because it's it's common doesn't mean that it's inconsequential.
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So for patients that suffer from acne, I think we as pharmacists we have a big opportunity to work directly with patients to kind of classify what they are experiencing because it can present a number of different ways.
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Some patients may have non-inflammatory acne, white heads and blackheads.
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Some patients may have more inflammatory lesions, and that could be capules and pustules, but it can range all the way to nodules and cysts.
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And if it's left untreated or if it's not adequately treated, it can lead to complications.
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Big ones that come to my mind are the potential for scarring, um, there can be hyperpigmentation, and then there is the psychological burden that can come with acne.
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Patients may experience some associated anxiety, depression, or low self-esteem.
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So again, just because it's very common doesn't mean that it doesn't come without consequence.
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That said, when I guess I'm thinking about some treatment selections, the big thing that comes to mind is working directly with the patient to better understand what they are suffering from, what types of lesions and how many, and trying to get a pulse on how can you at least roughly classify mild versus a moderate versus a more severe?
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Because that will largely guide, you know, our treatment recommendation.
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What I would add to that though is to also just think about some practical considerations as a pharmacist.
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So feeling the patient out, what have they tried previously?
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How did they use it?
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How long did they use it for?
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And what was their response to it?
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And I'm thinking both efficacy and tolerability.
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But I may also think about what is available to them and cost, and all of those different factors can influence treatment selection.
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Absolutely.
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So you called out a number of great questions, and again, one of the reasons we're chatting about this is because of that RX to OTC switch of adaplene, benzoy peroxide and uh its place in therapy and what that's going to add to the over-the-counter options.
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And so you mentioned sort of the consideration of mild versus moderate to severe.
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And if you are working with a patient and helping to try to distinguish where they fall, what what are sort of those categories?
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How are you what distinct what what are you what are your cutoffs?
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Definitely.
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So I would think pretty big picture here using our most recent guideline by the American Academy of Dermatology.
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Topical therapy is still going to be the mainstay of treating acne.
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Um, so it's very possible that a patient is suffering from mild acne.
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I'm tending to think mostly non-inflammatory lesions, blackheads and whiteheads, it's very possible that they may just be able to get away with topical therapy alone.
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And I will say that with the newer guideline, there has been more of a push and best practice type recommendation to consider a multimodal therapeutic approach.
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And I as a pharmacist, I think it's mostly like where that comes from is acne itself is not driven by one pathway.
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I tend to think about four big factors at play.
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So for me, if I'm thinking about the pathophysiology, it makes sense to have a multimodal approach to target some of the different areas.
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And maybe then if a patient's using, say, two different drugs from two different classes, maybe then you don't have to have such a high concentration of one of those products.
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And you may be able to minimize some of the side effects associated with it.
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Gotcha.
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Okay, that makes sense.
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So, so that's potentially a role for a dappling benzo peroxide, thinking about these two different classes with two different mechanisms treating different parts of the pathophysiology of acne.
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So that's interesting.
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And and so even thinking about mild acne, that could be an option for them, is what you're saying.
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A combo product that has two different classes that are treating different different causes, I guess.
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I think so.
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I definitely think that could be an option for patients that have mild acne.
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I tend to think about again, topical therapy is going to be the foundation.
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It's a great starting point.
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It's very likely that a patient, if it's very mild, they may be able to get away with one product alone.
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And there may not be the need then for that combination of adaplene with benzoyl peroxide, as long as their acne is being managed.
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For a patient, though, that maybe is not getting a response to adaplene as a topical retinoid alone or benzyl peroxide alone, or if they're not able to tolerate a higher concentration, that's where I'm thinking now that the combination may be a great option for that patient.
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I tend to think systemic therapy, whether that could be, for example, an oral antibiotic, um, doxycycline specifically is given a strong recommendation by our guideline.
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I'm thinking systemic therapy is coming more into play when acne is getting more severe and more inflammatory.
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And that's likely owing to the bacterial proliferation that happens at that stage, and as a consequence, more inflammation that can result.
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And then for your patients that have severe acne, or patients that have failed conventional topical or systemic therapies, or patients that have suffered either physical or psychological complications, whether they have evidence of scarring, hyperpigmentation, or the guideline even advocates for patients that have significant psychosocial burden as a result of acne, those can all be candidates for isotretinoin.
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You've raised a lot of questions for me.
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So isotretinoin.
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No, no, it's great.
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And and thinking about sort of that spectrum of acne, I think is really important.
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So if we're if we're going back to again, thinking about that OTC angle and self-management.
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And, you know, we we talked about multimodal, but also how patients could start with potentially adaplene or benzyl peroxide, for example, on their own as well.
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What what goes into that decision-making process?
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Say a patient hasn't tried anything starting out fresh.
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Where would you go first?
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Single ingredient, both?
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What's the decision thought process there?
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Yeah, that's a great question.
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And I know myself as a pharmacist, what I'm going to think about first is going to be our guideline recommendations by the American Academy of Dermatology.
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Here's the caveat.
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They give multiple options, and there's multiple recommendations that all are given a strong endorsement.
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And the immediate over-the-counter examples that come to mind are topical retinoids.
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So in this case, adapolene 0.1% as a standalone ingredient is available, as well as benzoyl peroxide, has been available over-the-counter for many years.
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And both are given a strong recommendation by the guideline.
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Myself personally, as a pharmacist, if a patient has mild apnea, so long as it's not perfuse or diffuse, if it's pretty limited in its location, I may feel comfortable with a single ingredient product and see how the patient responds to that efficacy and tolerability, and then reassess a few weeks later.
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That was going to be my next question is how do you reassess?
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Because one of your questions initially, which is a great one, is what have you tried?
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How long have you tried it?
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How have you used it?
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Making sure that they, if they have tried something in the past, that they've been adherent, that they are using it properly, making sure they're they're getting that effect.
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But would you say a couple of weeks is sort of your time frame to check back in and see how it's going and then reassess whether if that's not working, switching or combining therapies?
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Yes.
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Yes.
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So I think that is a key point for pharmacists to keep in mind is most acne therapies are designed to be preventative therapies, um, not necessarily a spot treatment that's going to work fast to resolve the acne, which understand the rationale for that, but I'm thinking from a patient's perspective, how disheartening that might be if that expectation is not communicated up front.
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Um, so I think from a pharmacist perspective, a great counseling point for patients that are starting acne therapy is to be very realistic in those expectations, not to disappoint the patient, but to hopefully avoid any sort of premature discontinuation of what could be an effective therapy for them.
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Acne, again, most therapies are designed to be preventative.
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We are largely trying to prevent the development of new lesions.
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So realistically, decreasing lesion number and the lesion severity.
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So if I'm thinking about monitoring, for me, two quick things that come to mind are rough number of acne lesions and severity, your non-inflammatories versus your inflammatory lesions.
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I would say an adequate trial at minimum would be two weeks, but I might even go all the way up to four weeks with consistent use to see if there has been a decrease in the development.
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And then I know it does go back to your earlier point about patient-specific considerations, which could include cost and tolerability and even things like pregnancy considerations, that the, you know, all of those need to come into that discussion.
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But I guess depending on response, say lack of response or inadequate restaurants, and you are confirming that they've applied it properly, that they aren't using it as spot treatment, that they are using it daily, all of those questions.
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And if it's not seeing adequate response, again, depending on severity, you may then go to a combo product, and or you may think about referral at that point.
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I guess it's hard, right?
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Without a specific case, a patient case, to sort of generalize there.
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But would you say that's fair or other considerations you're thinking about?
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I definitely think that's fair.
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If there had I would say if there's been some response, if the patient is tolerating it, then generally speaking, you might consider, okay, can we add a second agent and thinking to from a pharmacist perspective, one that's going to target a different mechanism behind Affy's formation?
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Um, and then see, you know, maybe the patient's going to respond to that.
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If a patient, though, I would say if their severity is leaning more toward like a moderate to severe, if you have quite a few inflammatory lesions, or if you are working directly with a patient and you're suspecting that it's negatively impacting their quality of life and their mood, um, I think that is an additional case where a referral could be justified.
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And you're thinking, you know, the severity, it might be outside of the scope of what an over-the-counter option can provide, and at minimum have the provider evaluate their acne and determine what's going to be the most appropriate in that case.
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Yeah, great call out.
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And I I appreciate you bringing up the impact of the condition on mental health, and that can have a huge role and and can itself be a reason for referral to ensure that they're getting adequate management and assessment.
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Yeah, great call out.
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So let's sort of I I think we've got a good, I have a good understanding now based on our discussion around this potential role of that RX to OT sweet OTC switch with the dappling benzolaproxide.
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I think that is offering something different.
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And in like with any combination product, it requires then not having to apply to different products.
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So there's a potential benefit with that.
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But it seems like this is actually something that it could positively impact patients and acne management more broadly.
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Any other like sort of additional thoughts about that RX to OT suite switch that we haven't chatted about that you want to mention?
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Sure.
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So this is, I think, gonna be like the big headline update, really, is that we are now about to have for the first time a multimodal option available over the counter.
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So your big update is going to be the adapolene 0.1%.
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So your topical retinoid with benzoyl peroxide 2.5% in a fixed dose combination product.
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What I think, in terms of patient acceptability or adherence, is great about this product is it's one pump and it's once a day.
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So for a patient that truly would benefit from two different ingredients targeting multiple pathways in acne's formation.
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You're purchasing now one product instead of two, you're only having to apply it once per day.
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I think that that can really help to improve adherence for a patient instead of juggling multiple products and multiple dosing regimens.
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Yeah.
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Yeah.
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Yeah.
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The big news is really, I think it's it's great that the ingredients themselves are not new to pharmacists.
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Right.
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But the the access has expanded.
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So something that was available as a prescription only, now patients can access this just over the counter.
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Right.
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And to your point, not not even the ingredients new to us as pharmacists and technicians, but also uh over-the-counter ingredients as single ingredients too.
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We had adablene and benzyl peroxide as single ingredients.
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So now this is a combination product that patients may have tried either or both of those on their own, too, and and now have this new option that they might have questions about.
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So really good for us to chat about that.
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And I I do think the over-the-counter product is for ages 12 and up, and the prescription version is still available for nine to 11, I think was the age range I saw.
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So yeah, still available by prescription for some ages.
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So that's another consideration too when you're having those discussions, right?
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Is what is the age of the patient and how is that going to guide therapy too.
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Yes.
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And to your point earlier, too, considering that it does have the topical retinoid as part of it, considering if a patient is of reproductive potential, that topical retinoid is not going to be a safe option or the safest option that we have for patients who are actively pregnant or trying to conceive.
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So for any patients that are interested in that scanning for that.
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Yeah, absolutely.
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And and I think the labeling is pretty clear on the OTC products around pregnancy.
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There's different risk considerations with different topical retinoids.
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But if we're thinking about an OTC product specifically and self-management, yeah, that's a great question to be asking and ensuring patients are aware of, you know, looking at the label, being aware of that as a potential concern.
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Sure.
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So that's great.
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And and I I think it's just again, uh, what often seems to come up on the podcast is, you know, having more options is always a good thing.
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It's always a good thing to have more options, have a menu of options for people to be able to choose from.
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So that's good.
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And then going back to sort of that spectrum of acne management, and we we started with a mild to sort of moderate discussion, and you alluded to the role of oral antibiotics as well.
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Topical antibiotics are also not available over the counter only by prescription.
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So maybe we can talk a little bit more about the role of antibiotics or other therapies for more moderate to severe acne and where those fit in.
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Definitely.
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Um, so if we're thinking topical antibiotics are also given a strong recommendation by the guideline, but to your point, with prescription only.
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So then when we start to get into more of inflammatory acne lesions, that's where I think that oral antibiotics have more of a role.
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And that's where they specifically are recommended by the American Academy of Dermatology guideline.
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And doxycycline specifically is given the strong recommendation.
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Others are given conditional recommendations.
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And then a few other systemic therapies, too, um, that are given conditional recommendations.
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I'm thinking about hormonal options that are available that, you know, technically you're thinking about your menu of options, those can also be there.
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Mm-hmm.
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And and the hormonal options, which types of patients might benefit most from those?
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When, when does that what what options are we talking about?
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And when would you be thinking about those for a patient?
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Yes.
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So I'm tending, if I'm thinking about hormonal options, we do have a few different combined oral contraceptives that specifically are indicated for acne management.
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I tend to think about female patients that maybe you're trying to like, you know, quote unquote kill two birds with one stone.
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Yep.
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Maybe they're already wanting to be on a combined oral contraceptive, anyways, to prevent pregnancy and they're suffering from acne.
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You know, that could be a good case for that.
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Sporanolactone is another option that I'm tending to think about.
00:20:28.880 --> 00:20:42.400
Um, so I guess I'm thinking about patients that as long as their blood pressure can tolerate it, electrolytes are within normal limits, kidney function is good, you might be able to make a case for sporanolactone as an alternative.
00:20:42.640 --> 00:20:43.039
Mm-hmm.
00:20:43.119 --> 00:20:43.519
Mm-hmm.
00:20:44.079 --> 00:20:53.440
And you know, I think the other one I saw in the hormonal sort of category is this topical clusterotone, closeterone.
00:20:54.960 --> 00:20:56.160
It's a newer one, yes.
00:20:56.400 --> 00:20:57.599
Yeah, fairly newer too.
00:20:57.680 --> 00:21:02.240
But I think also, yeah, conditional recommendation, but yes, falls into that hormonal category.
00:21:02.319 --> 00:21:05.279
I don't know if you have anything to share about that or any other insight there.
00:21:05.839 --> 00:21:14.240
So what I think is unique about closcerone is the mechanism of action is unique in that it is going to help to reduce androgen production.
00:21:14.319 --> 00:21:16.319
Um, so that's kind of how it's going to help.
00:21:16.400 --> 00:21:19.119
That's where the hormonal part's being derived from.
00:21:19.279 --> 00:21:23.279
And that can help to reduce the amount of sebum that your body is producing.
00:21:23.839 --> 00:21:30.000
What I, as a pharmacist, find to be appealing about that medication is that it is a topical.
00:21:30.160 --> 00:21:44.880
So I guess if I'm thinking about a topical application versus a systemic in terms of side effects profiles, and then of course the opportunity too with it being topical is being able to apply it to your acne prone area to hopefully prevent development of new lesions.
00:21:45.119 --> 00:21:52.799
Um, but your topical option is a little bit unique compared to oral in that it can be used in both men and women.
00:21:54.559 --> 00:21:54.880
Okay.
00:21:55.279 --> 00:21:59.680
So rather than having thinking about the combined oral contraceptives and the hormonal benefits.
00:22:00.079 --> 00:22:06.799
And yeah, that it's it's that's a great call out, actually, the applicability of that for a broader range of patients.
00:22:07.119 --> 00:22:07.279
Right.
00:22:07.519 --> 00:22:09.200
Because or at least the potential for it.
00:22:09.359 --> 00:22:09.680
Yep.
00:22:09.920 --> 00:22:10.240
Okay.
00:22:10.640 --> 00:22:19.839
And then with the antibiotic considerations, you know, we're all aware of the need to have antimicrobial stewardship and appropriate use of antibiotics.
00:22:19.920 --> 00:22:28.079
And so I think that is a question that often comes up when we're talking about, okay, even if a patient does have more moderate to severe, but they do have more inflammatory lesions.
00:22:29.039 --> 00:22:34.799
How do you balance that concern and ensure appropriate use of antibiotics in the management of acne?
00:22:34.960 --> 00:22:39.279
And maybe, you know, even talking a little bit about the role of antibiotics in acne.
00:22:39.359 --> 00:22:42.160
Is it is it really as an antibiotic or an anti-inflammatory?
00:22:42.240 --> 00:22:43.599
Maybe you can speak to that a little bit.
00:22:44.000 --> 00:22:44.240
Sure.
00:22:44.400 --> 00:22:45.359
Yes, I'm happy to.
00:22:45.440 --> 00:22:46.480
And that's a great call out.
00:22:46.720 --> 00:23:00.160
Um, so kind of like the high-level thought on this is that one of the pathological features of acne is proliferation of cootibacterium acne or C acne.
00:23:00.559 --> 00:23:02.960
For many years was known as P acnes.
00:23:03.200 --> 00:23:05.440
Um, so you may see either C or P acne.
00:23:06.720 --> 00:23:07.119
Yeah.
00:23:07.920 --> 00:23:13.200
Um, so now we have the more recent C acne getting reported in literature.
00:23:13.519 --> 00:23:22.960
But effectively, when if you're thinking about where acne affects the body, you have skin cell follicular hypercarotinization that's going on.
00:23:23.119 --> 00:23:36.960
There's increase in sebums, so kind of like that oil production provides effectively just a great environment for C acne to grow and to proliferate, which can then lead to an inflammatory response.
00:23:37.279 --> 00:23:52.240
So that is, I think, the rationale when you start to lend more to moderate to severe lesions, oral antibiotics can have a role where you're now targeting the bacterial and inflammatory sides of acne pathogenesis.
00:23:52.559 --> 00:24:00.960
To your point, though, antibiotics for acne, I think a great role of a pharmacist is being aware of the stewardship opportunities.
00:24:01.119 --> 00:24:05.359
And that is something that I think ran through the guideline quite a bit.
00:24:05.599 --> 00:24:15.200
Both the multimodal therapeutic approach and stewardship efforts run through the most recent guideline by the American Academy of Dermatology.
00:24:15.599 --> 00:24:25.440
My immediate thoughts when I'm thinking about systemic antibiotic therapy one is that an acne antibiotic really should have an exit strategy.
00:24:25.599 --> 00:24:31.839
It's not intended to be like a long-term, indefinite type of therapeutic approach.
00:24:32.160 --> 00:24:43.680
Best practice and guideline recommendations are to not use either a topical or a systemic antibiotic as monotherapy because of the risk of developing resistance.
00:24:44.319 --> 00:24:57.519
So great lookouts to be aware of as a pharmacist is making sure a patient's not applying a topical antibiotic alone, or that they're not just, say, taking doxycycline or minocycline on their own.
00:24:57.680 --> 00:25:08.400
Um, great concomitant therapies can be benzoyl peroxide, which does also have some antibacterial activity, and even a topical retinoid as well.
00:25:08.720 --> 00:25:15.759
Those should be applied concomitantly with a topical or an oral antibiotic.
00:25:16.880 --> 00:25:28.240
Topical or oral antibiotic typical duration, I would expect to see is three to four months, and then that to be taken away, and then your topical therapies to be continued.
00:25:28.880 --> 00:25:30.240
Okay, great.
00:25:30.480 --> 00:25:34.559
Okay, so a few key takeaways I got from that is the exit strategy.
00:25:34.720 --> 00:25:35.119
I love that.
00:25:35.279 --> 00:25:45.839
The idea of if you have a patient starting an oral or topical antibiotic, having that exit plan, and uh you mentioned earlier too about setting realistic expectations.
00:25:46.000 --> 00:26:00.480
That's part of this, too, setting realistic realistic expectations, ensuring they know this is not something to be used indefinitely, three to four months is what we're shooting for, and sort of even, you know, keeping an eye on those refills and not making sure it's not years on years that patients are using this.
00:26:00.720 --> 00:26:04.480
And then the other great call-out is the combination therapy.
00:26:04.640 --> 00:26:08.880
So not having a patient just be using an oral or topical antibiotic alone.
00:26:08.960 --> 00:26:21.920
It should always be combined with bentyl peroxide or potentially a topical retinoid and and helping to limit that antibiotic resistance concern by having that combination therapy.
00:26:22.079 --> 00:26:24.480
So really two key critical points, I think.
00:26:24.799 --> 00:26:33.920
Yeah, I I think that that is where, again, like the two large threads that ran through the guideline are the multimodal approach and stewardship efforts.
00:26:34.079 --> 00:26:40.960
And especially when we're thinking about systemic antibiotic therapy, being on the lookout for when to peel away if we can.
00:26:41.119 --> 00:26:57.119
And I tend to use three to four months as an adequate trial and ensuring that the patient then is going to remain on either their topical therapy or possibly topical therapies, you know, maybe benzoyl peroxide, but likely benzoyl peroxide and a topical retinoid.
00:26:57.279 --> 00:27:01.920
And then that is what is being continued to manage their acne lesions.
00:27:02.240 --> 00:27:02.640
Right.
00:27:02.799 --> 00:27:06.559
And I guess I'm thinking about it as sort of an initial management consideration.
00:27:06.720 --> 00:27:10.640
You can you were referring to preventive therapies before in our discussion.
00:27:10.720 --> 00:27:16.960
And so I can see patients being potentially concerned about coming off of an antibiotic if it's working well for them.
00:27:17.119 --> 00:27:21.200
So providing some of that reassurance around, okay, it's now managed.
00:27:21.279 --> 00:27:27.519
Now we're in the prevention mode, and you're going to continue to use these other topical products to help maintain where you're at.
00:27:27.920 --> 00:27:28.240
Yes.
00:27:28.400 --> 00:27:36.880
I think again, that is as a pharmacist, some great counseling and great expectations of therapy to provide up front out of transparency.
00:27:37.200 --> 00:27:41.359
A big one that I think often gets missed is appropriate application.
00:27:41.759 --> 00:27:47.440
So we talked at the start about thinking about different treatment selection principles.
00:27:47.759 --> 00:28:09.119
And you can come up with a quote unquote perfect guideline recommended therapy or regimen for a patient based on how severe their acne is and even taking into account their history, but it's not going to land or actually help the patient if they're not using it appropriately.
00:28:09.440 --> 00:28:09.599
Right.
00:28:10.240 --> 00:28:18.559
So I think as a pharmacist, we we can have a big impact with just providing counseling, such as most appropriate application principles.
00:28:18.880 --> 00:28:22.160
The face is such a common site for acne formation.
00:28:22.400 --> 00:28:27.200
A P-sized amount is often sufficient for facial application.
00:28:27.440 --> 00:28:32.319
You can apply a P-sized amount using what I refer to as a five-dot method.
00:28:32.480 --> 00:28:46.559
So your forehead, chin, each cheek, and nose, and spread it over the entire area to prevent the development of new lesions, not just a spot treatment for your active acne.
00:28:47.920 --> 00:29:01.200
Um, and I think too, like another great counseling point is if we're talking about counseling, is advising patients that using more does not equal better results or more efficacious.
00:29:01.440 --> 00:29:01.680
Right.
00:29:01.839 --> 00:29:16.880
But what it can mean is more side effects and more irritation, which then can lead to a premature treatment discontinuation or a treatment failure when it could have been a viable option had it been used appropriately.
00:29:17.279 --> 00:29:26.480
And then I think like the third big counseling is setting the realistic expectation of not to expect to see your acne to improve immediately.
00:29:26.640 --> 00:29:32.319
And in fact, it may even get worse when therapy gets started due to the purging effect.
00:29:32.640 --> 00:29:35.680
But rather, meaningful improvement can take weeks.
00:29:36.000 --> 00:29:44.880
So not to feel discouraged if it's yeah, I think that's a really important point too, the fact that it can get worse before it gets better.
00:29:45.039 --> 00:30:08.240
So again, as you said, setting realistic expectations in a number of different ways in terms of duration of use, appropriate use, but also having that expectation that it might get worse, it will get better, and stick with it because again, we don't want a patient to give up an option because they either can't tolerate it or they're not thinking it's working.
00:30:08.480 --> 00:30:11.119
Um, sometimes it takes a little persistence.
00:30:11.279 --> 00:30:15.039
So you had three great counseling points, and I want to make sure I recap those properly.
00:30:15.119 --> 00:30:23.839
So the setting realistic expectations, it could get worse before it gets better, proper application in terms of the P-sized amount on the five areas of the face, which I thought was great.
00:30:24.000 --> 00:30:24.799
Little call out there.
00:30:24.960 --> 00:30:27.759
What was the first point that you had recently you called out?
00:30:27.920 --> 00:30:35.599
It was after, you know, we were talking about the idea of prevention and maintenance, and I guess maybe duration of therapy giving it an adequate shot.
00:30:35.839 --> 00:30:36.160
Yeah.
00:30:36.400 --> 00:30:42.720
The big the first one was mostly just not treating today's pimples, but trying to prevent the development.
00:30:43.200 --> 00:30:44.160
Yes, exactly.
00:30:44.319 --> 00:30:45.519
Yep, yep, exactly.
00:30:45.680 --> 00:30:49.599
Okay, yeah, really, really key points to be thinking about for patients.
00:30:49.759 --> 00:31:02.319
And in terms of since we're talking about counseling points, in terms of the tolerability angle and knowing that some of these therapies can be drying or cause irritation or redness, which again, thinking about that worse before it gets better concept.
00:31:02.400 --> 00:31:09.759
How do we help patients work through those, manage that tolerability potential issue, and help a patient stick with it?
00:31:10.079 --> 00:31:11.759
Yeah, that's it's a great question.
00:31:11.920 --> 00:31:12.960
Um, and I think it's key.
00:31:13.119 --> 00:31:16.960
Like this is as a pharmacist, great counseling that you can provide up front.
00:31:17.119 --> 00:31:19.119
I think part of it is reassurance.
00:31:19.359 --> 00:31:31.440
So advising the patient if they are going to walk away, say with a topical retinoid or benzoyl peroxide, that the common side effects are going to be dryness or skin redness.
00:31:31.599 --> 00:31:37.279
Um, there may be some peeling associated with that dryness, burning, irritation.
00:31:37.519 --> 00:31:47.440
These are all common and oftentimes they improve with continued use, so long as it's not severe or really, you know, affecting the patient.
00:31:48.079 --> 00:31:53.440
Some um, so I think being transparent, advising the patient not to be alarmed if they experience that.
00:31:53.599 --> 00:31:54.640
It should be mild.
00:31:54.799 --> 00:32:05.519
I think that that can help because I'm thinking if I'm a patient, I go home and I start using this product, is it normal that my face is drying out and peeling as a result of this?
00:32:05.920 --> 00:32:10.000
Or do I just need to try and see this through and see if it will get better?
00:32:10.480 --> 00:32:17.359
To help it get better or to help the patient stay on that regimen, there's a few different strategies as a pharmacist that you can recommend.
00:32:17.599 --> 00:32:22.160
One can be to reduce the application frequency of the product.
00:32:22.400 --> 00:32:27.759
So, for example, if they're using it twice a day, can you cut back to once a day?
00:32:28.000 --> 00:32:32.559
If it already is once a day, can you cut down to once every other day?
00:32:32.960 --> 00:32:35.440
Just to give a few very vague examples.
00:32:35.759 --> 00:32:45.519
The other big one that comes to mind is using, especially topical retinoids and benzyl peroxide with a moisturizer afterwards.
00:32:46.000 --> 00:32:51.359
Um, and we need to be careful too, because we know that not all moisturizers are built the same.
00:32:51.599 --> 00:32:54.160
And some are going to contain some oil.
00:32:54.640 --> 00:33:02.799
Oil is great in the sense that it's very hydrating, but oil is you know not the best for a patient who's going to be acne prone.
00:33:03.200 --> 00:33:15.279
So as a pharmacist, you can, if a patient's suffering from some dryness or facial irritation, try to look for a non-kinogenic moisturizer if you can.
00:33:16.000 --> 00:33:35.920
Um and I'll also put a plug in, it's not so much related to the irritation, but just thinking about skincare, not stopping at the moisturizer, but after that's been applied and is dried down a bit, applying a sunscreen because of the risk of photosensitivity with these products, namely your topical retinoids and even bentyl peroxide.
00:33:36.240 --> 00:33:37.119
Right, right.
00:33:37.359 --> 00:33:40.559
Super important call out there, the photosensitivity risk.
00:33:40.799 --> 00:33:47.119
And there are combination sunscreen and moisturizer products that are, you know, for sensitive skin.
00:33:47.200 --> 00:33:54.319
And so there, there are options out there that might be available for patients to get that sort of two-in-one approach.
00:33:54.400 --> 00:33:55.839
Um they may be able to get both.
00:33:55.920 --> 00:34:06.400
Um, but reinforcing the I and again, I think that's something that patients may have hesitancy around because they don't want to apply things that could make their acne worse when they're trying to actively manage it.
00:34:06.559 --> 00:34:27.360
And so reassurance around choosing the right moisturizer and sunscreen, both, so that they're getting the the benefits of lessening tolerability concerns, but also that sun protection was just going to be critical, not only for acne and and with those products that can cause photosensitivity, but also more broadly in terms of skin cancer prevention and that too.
00:34:27.599 --> 00:34:29.840
So yeah, definitely long-term.
00:34:30.559 --> 00:34:31.199
Yeah, yeah.
00:34:31.360 --> 00:34:42.079
Key, key if we're thinking about over-the-counter management and patients getting these products on their own, providing that additional support with those other products they may need over the counter too.
00:34:42.320 --> 00:34:42.960
Yeah, yeah.
00:34:43.039 --> 00:34:56.000
For me, the big ones that immediately come to mind will be the moisturizer and ideally a broad spectrum sunscreen that has an FPF of at least 15 to 30 to offer that protection.
00:34:56.320 --> 00:34:57.280
Yep, absolutely.
00:34:57.519 --> 00:35:14.320
I'll just put in a plug for technicians also who are often the first people that farm that patients may have interactions with at the pharmacy if they're coming up with a particular product, helping patients look at that label and identify for the the medication side, looking at the active ingredients to see what's actually in that.
00:35:14.480 --> 00:35:20.880
Because with a lot of acne products in particular, there's there's so many, there's so many out there.
00:35:21.039 --> 00:35:22.400
There's so many products out there.
00:35:22.480 --> 00:35:22.719
Yes.
00:35:22.880 --> 00:35:25.360
And they're marketed very heavily in different ways.
00:35:25.440 --> 00:35:36.800
And so helping patients get to the root of what it is, what it actually contains by looking at the drug ingredients and the active ingredients label, I think it's just a a good reminder too for patient awareness and definitely, definitely.
00:35:36.960 --> 00:35:50.960
That reminds me of thinking about even brand name extensions that not all brand names, you know, are built one in the same, absolutely, but really needing to be on the lookout for your active ingredients and what exactly does that product contain.
00:35:51.440 --> 00:35:52.239
Absolutely.
00:35:52.400 --> 00:35:53.519
Yeah, yep.
00:35:54.000 --> 00:35:56.320
Well, that I we covered a lot of great concept.
00:35:58.239 --> 00:35:59.679
Acne's a big topic, yes.
00:36:00.079 --> 00:36:02.480
There's a lot, it is there's a lot you can unpack.
00:36:02.800 --> 00:36:10.800
There is, and and it is one of those things where I think the these are patients we're going to be potentially seeing at regular intervals.
00:36:10.880 --> 00:36:19.760
And so continuing to have those conversations and remind patients about appropriate use adherence, all of those are going to be important, I think, as we as we continue to interact with those patients.
00:36:20.000 --> 00:36:24.559
Let's go on to the that last part of the spectrum, which is the more severe side.
00:36:24.639 --> 00:36:27.920
And I did allude to the i Pledge REMS changes.
00:36:28.079 --> 00:36:34.480
And so um, you talked about the role of isotretinoin in particular for severe acne or for patients with scarring.
00:36:34.639 --> 00:36:42.960
It it is a it is a very good option, strong recommendation for this for isotretinoin for that severe inflammatory acne.
00:36:43.119 --> 00:36:50.719
So let's talk about that and the role of that a little bit more, and then also what are some of these changes that's coming with the IPLEDS REMS program that we need to be aware of?
00:36:51.039 --> 00:36:51.840
Yeah, yeah.
00:36:51.920 --> 00:36:52.480
So you're right.
00:36:52.639 --> 00:37:14.639
Isotretinoin, if I'm thinking about it in terms of guideline recommendations, it's really gonna be at the end of the spectrum with patients that have severe, I'm tending to think nodular or cystic acne, evidence of scarring, or that are carrying that the mental health of psychosocial burden, all candidates that a prescriber is going to consider.
00:37:14.800 --> 00:37:16.800
Could you benefit from isotretinoin?
00:37:16.960 --> 00:37:18.239
It's highly effective.
00:37:18.400 --> 00:37:19.519
It's very important.
00:37:19.760 --> 00:37:25.039
You know, it has an important role for treating severe, treatment-resistant acne as well.
00:37:25.519 --> 00:37:36.079
But in terms of safety, that efficacy comes with the potential for a profound, pretty embryo fetal toxicity risk.
00:37:36.400 --> 00:37:40.480
So that is why we have our iPledge REMS.
00:37:40.719 --> 00:37:47.760
So a bit of background here for our listeners, um, just a reminder that iPledge is a shared system, REMS.
00:37:48.079 --> 00:38:01.760
It includes all of the FDA approved isotretinoin products, and it brings in the prescribers, the pharmacies, and the patients into one centralized risk mitigation system.
00:38:02.320 --> 00:38:14.079
Um so while we're beginning to allude to some changes that are going to be happening with iFledge, um processes are going to change, but the potential teratogenic risk does not.
00:38:14.719 --> 00:38:21.119
The fundamental safety concern and what we're trying to prevent, that that is going to remain.
00:38:21.519 --> 00:38:22.239
Right, right.
00:38:22.400 --> 00:38:22.559
Yeah.
00:38:22.719 --> 00:38:52.639
And I think the the reason for the change is to maintain the safety considerations, ensure that patients who may be at risk of getting pregnant and having those potential birth defect considerations, maintaining that aspect while still allowing for access and potentially helping to streamline access a little bit to sort of have that balance of access to this very effective medication for patients who need it while still preserving the safety considerations.
00:38:53.199 --> 00:39:06.960
Yeah, that was exactly my takeaway, is it seems like it's a bit of a more streamlined process and tried to take away some of the burden in terms of processing without compromising on the overall safety standards to mitigate the risk.
00:39:07.280 --> 00:39:08.000
Right, right.
00:39:08.159 --> 00:39:24.079
And so, you know, pregnancy tests are still required, but still may be allowed outside of an office setting at home instead of just as one example to say like this is how they're trying to help increase access to this important medication.
00:39:24.239 --> 00:39:26.480
But I'd love to hear your thoughts on this a little bit more.
00:39:26.880 --> 00:39:32.239
Implementation is slated to take effect on November 15th of 2026.
00:39:32.639 --> 00:39:42.000
So a key point here for our listeners is that these changes have been approved, but approved doesn't mean or equal implemented.
00:39:42.239 --> 00:39:47.679
We're anticipating that November 15th will be implementation go live.
00:39:48.079 --> 00:39:56.159
But right now we we're kind of like in this transition period where we know changes are approved, but they are not yet implemented.
00:39:56.719 --> 00:40:04.239
So we can prepare just to add to that, you know, they they were planning to do this in August, these changes and it was pushed back until mid-November.
00:40:04.320 --> 00:40:05.519
So we may still see that again.
00:40:05.599 --> 00:40:06.480
So we'll see.
00:40:06.800 --> 00:40:07.840
Yes, that's very true.
00:40:08.000 --> 00:40:08.400
You're right.
00:40:08.480 --> 00:40:24.400
It was originally slated early August, but to allow for some additional testing, trying to make sure that they're trying to minimize any sort of technical difficulties and prevent any disruptions to access did justify the delay.
00:40:24.559 --> 00:40:30.400
But you're right, that doesn't that doesn't guarantee you know that November 15th will sure you know is it's definitely gonna be it.
00:40:30.639 --> 00:40:38.800
Um the big one of the big changes you've already alluded to is going to be for patients of reproductive potential, they can become pregnant.
00:40:38.960 --> 00:40:45.519
Um, yes, pregnancy testing is still going to be required, um, but it could be done outside of a medical facility.
00:40:45.679 --> 00:40:48.880
Um, prescribers can allow that, including at home.
00:40:49.039 --> 00:40:51.840
And that is both during and after treatment.
00:40:52.079 --> 00:41:00.000
For a patient that's getting started on treatment, though, confirming that negative pregnancy test does still need to be done in office.
00:41:00.480 --> 00:41:06.320
Another key change that I noticed is that the 19-day lockout is being eliminated.
00:41:06.559 --> 00:41:19.840
So if a patient, say, were to miss their seven-day prescription window, then that patient is now going to be able to repeat their pregnancy test immediately without that additional waiting period.
00:41:20.480 --> 00:41:32.239
Another key change that I'll note is for patients who cannot become pregnant, monthly documentation of that counseling is no longer going to be required.
00:41:32.480 --> 00:41:35.440
It is still upon initiating treatment.
00:41:35.519 --> 00:41:37.280
Um, so they're at enrollment.
00:41:37.360 --> 00:41:45.920
And of course, best practice is to continue to provide that counseling, but the documentation piece is no longer going to be the requirement.
00:41:47.679 --> 00:41:48.000
Okay.
00:41:48.400 --> 00:41:48.719
Yeah.
00:41:48.800 --> 00:41:57.840
And again, that that goes back to the point about trying to streamline some of these considerations for patients, prescribers, um, and uh, you know, e even for pharmacies.
00:41:59.760 --> 00:42:02.880
What what is the impact for pharmacies?
00:42:03.039 --> 00:42:05.039
What are some of those considerations specifically there?
00:42:05.199 --> 00:42:13.840
Because I there it wasn't as significant, I think, um, as on the prescriber side, but let's make sure we understand what is what is being what's changing there.
00:42:14.239 --> 00:42:14.880
Definitely.
00:42:15.039 --> 00:42:22.960
Um, so for our viewers, I a big takeaway that I would have is to circle November 15th on your calendar and at least prepare for it.
00:42:23.039 --> 00:42:30.400
Um, because you know, really the goal and in a perfect world, there is going to be the patients won't even know any difference, right?
00:42:30.639 --> 00:42:38.960
If everything is streamlined and rolled out well, the goal is that the patient's not going to see any of these effects from the pharmacist's side.
00:42:39.119 --> 00:42:44.159
Um, in terms of what's specifically changing for pharmacies, three things come to mind.
00:42:44.480 --> 00:42:51.599
And the first is that the 30-day prescription window for patients who cannot become pregnant is going to be removed.
00:42:52.000 --> 00:43:01.199
Second is that pharmacies might have to at least evaluate and potentially change their workflow if a patient doesn't pick up their prescription.
00:43:01.440 --> 00:43:08.559
So the authorization is going to need to be reversed in iPledge and the medication returned to stock.
00:43:08.880 --> 00:43:23.519
The third kind of key takeaway for pharmacists to be aware of is that the revised REMS explicitly states the need for annual education and documentation of that education and training with the staff.
00:43:23.679 --> 00:43:29.840
And that documentation does need to be maintained by the pharmacy's authorized representative.
00:43:30.079 --> 00:43:49.119
So at bare minimum for right now, I would say pharmacy should at least identify who their authorized representative is and be preparing to conduct that training and document that training and keep, you know, kind of um a history of that training since that is going to be required every year.
00:43:50.960 --> 00:43:51.280
Yeah.
00:43:51.360 --> 00:43:54.719
So I think you highlighted some of those key considerations too.
00:43:54.800 --> 00:44:06.159
And and the most important part to your point is circle that date November 15th, because There might be other changes that are going to affect your specific practice depending on how you currently operationalize iPledge.
00:44:06.400 --> 00:44:12.159
So just being aware of these changes, because again, not only changes for pharmacies, but also for prescribers.
00:44:12.320 --> 00:44:15.119
So just knowing what patients are going to need to do and not do.
00:44:15.280 --> 00:44:19.599
There's more details than we can get into here on the podcast, but definitely something to be aware of.
00:44:19.760 --> 00:44:29.199
And hopefully it will have a positive impact overall in increasing access, but it's still something that we need to be aware of and ensuring safe use.
00:44:29.519 --> 00:44:29.840
Right.
00:44:30.000 --> 00:44:43.599
Especially if patients, you know, they may call a pharmacy or come to the front counter and say, like, I've heard, you know, do I not have to go into my medical office anymore to conduct a pregnancy test, just being aware of some of these updates that are coming down the pipeline.
00:44:43.920 --> 00:44:44.639
Right, right.
00:44:44.800 --> 00:44:52.079
And I think to that point about doing the pregnancy test at home as an option, prescriber offices may have different practices or rules around that too.
00:44:52.239 --> 00:44:57.119
And how they're going to actually enforce that, ensure that the the results are valid, all of that.
00:44:57.360 --> 00:45:00.000
So it could vary by by practice setting too.
00:45:00.159 --> 00:45:00.480
Absolutely.
00:45:00.800 --> 00:45:01.199
Definitely.
00:45:01.360 --> 00:45:01.679
Definitely.
00:45:02.000 --> 00:45:07.519
Calling out that annual staff training for pharmacists specifically is an important one for us.
00:45:07.679 --> 00:45:22.159
And the other thing that I had seen was about pharmacists who interact with that IPledge system may need their own personal account rather than if they are if they're going to be using the system, they can't necessarily rely on a pharmacy level authorized representative.
00:45:22.239 --> 00:45:24.000
They may need their own individual account too.
00:45:24.159 --> 00:45:29.280
So again, looking into that for your pharmacy is going to be important so that you're you're compliant.
00:45:29.840 --> 00:45:31.199
Yeah, definitely.
00:45:32.320 --> 00:45:32.800
All right.
00:45:32.960 --> 00:45:36.480
Well, there's plenty to think about there.
00:45:36.880 --> 00:45:54.159
But just to circle back, we talked through the spectrum of mild, moderate, severe acne, the RX to OTC switch with the adopylene benzoyl peroxide, which is an interesting sort of option now, and that meets with the multimodal approach with the guidelines that we talked about, the other end of the spectrum with these eye pledge changes.
00:45:54.400 --> 00:45:55.280
We talked about a lot.
00:45:55.360 --> 00:46:00.559
So is there anything else that we didn't really get to that that we want to be sure we address before we wrap up?
00:46:01.440 --> 00:46:02.480
I think you're right.
00:46:02.639 --> 00:46:18.400
It's this was a bit of a unique podcast in that we we kind of hit both sides of the spectrum here with expanded access for likely more mild cases of acne, but then some changes to just ensuring safe and compliant dispensing of isotretinoid on the severe side.
00:46:18.559 --> 00:46:21.679
So a lot of good information, hopefully, for listeners here.
00:46:21.920 --> 00:46:22.320
Absolutely.
00:46:22.480 --> 00:46:33.199
Yeah, Jenna, I really appreciate your review of the guidelines too, sort of within the moderate side of the spectrum, too, because it can be a little bit confusing and it does need to be very individualized.
00:46:33.280 --> 00:46:41.039
So I think it's it's yes good for us to refresh our memories on where things stand with the guidelines and then how how these changes are going to impact practice as well.
00:46:41.199 --> 00:46:42.400
So thank you so much for that.
00:46:42.559 --> 00:46:45.440
And to wrap up our discussion, it is the game changers podcast.
00:46:45.519 --> 00:46:50.079
So we always end with a game changer and what you think our our listeners should walk away with as that key point.
00:46:50.239 --> 00:46:52.800
So, what would you say is the game changer for this discussion?
00:46:53.199 --> 00:46:53.440
Sure.
00:46:53.519 --> 00:46:53.920
Is it all right?
00:46:54.000 --> 00:46:57.280
If I have two game changers since we had two big points to this one.
00:46:57.599 --> 00:46:58.000
All right.
00:46:58.159 --> 00:46:58.639
Sure.
00:46:58.960 --> 00:46:59.440
Excellent.
00:46:59.599 --> 00:47:13.280
So two big uh game changers that come to mind is going to be the expanded access of an evidence-based multimodal therapeutic approach with your adaplene 0.1%, topical retinoid with benzoyl peroxide 2.5%.
00:47:14.239 --> 00:47:20.880
Expanded access, though, I would say doesn't mean that it's the right fit for every single patient.
00:47:21.039 --> 00:47:32.079
So to your point, yes, it is going to be available over the counter for patients that are 12 years and older, but that doesn't mean that it is the go-to for every single patient.
00:47:32.320 --> 00:47:45.920
So at minimum, assessing the patient's acne, severity, their number of lesions, themselves as a person, like you had mentioned age or pregnancy status, just to name two considerations and making it individualized from there.
00:47:46.400 --> 00:47:56.800
On the other side, on the prescription side of the spectrum, pharmacists again should have November 15th circled on their calendars because the eye pledge processes are changing.
00:47:57.039 --> 00:48:06.639
Um, but our responsibility for preventing pregnancy in patients that are taking isotretinoin, that is not changing.
00:48:06.960 --> 00:48:07.199
Yep.
00:48:07.360 --> 00:48:09.360
I think that's a great takeaway and bottom line.
00:48:09.440 --> 00:48:16.719
So good, good two game changers, and they're both totally valid because we did talk about a lot and there were two ties to the whole spectrum that we looked at.
00:48:16.880 --> 00:48:19.199
So thank you, Jenna, so much for this excellent discussion.
00:48:19.360 --> 00:48:21.679
Really appreciate all the practical points you've brought in here.
00:48:21.840 --> 00:48:27.199
And yeah, thank you for highlighting those changes and where we are now and what we're going to be seeing in practice.
00:48:27.360 --> 00:48:28.159
Appreciate your time.
00:48:28.239 --> 00:48:30.400
Really thank you for having me, Rachel.
00:48:30.480 --> 00:48:34.719
And thanks for letting me talk for quite a bit here about all things acne.
00:48:35.199 --> 00:48:35.760
Yeah, that's right.
00:48:35.840 --> 00:48:36.800
I know it was a great review.
00:48:36.880 --> 00:48:42.159
I feel like we covered a lot of ground and I have a very good understanding going forward of acne management in general.
00:48:42.239 --> 00:48:43.039
So thank you so much.
00:48:43.280 --> 00:48:44.480
I hope our listeners do too.
00:48:44.639 --> 00:48:45.440
Thank you.
00:48:46.639 --> 00:48:49.599
Well, we talked a lot about a lot of great practical tips today.
00:48:49.679 --> 00:48:52.880
These will all be summarized in the practice resource that goes along with the podcast.
00:48:53.039 --> 00:48:56.239
And we hope that this conversation gave you something useful to bring back to your practice.
00:48:56.320 --> 00:48:57.360
That's always our goal.
00:48:57.519 --> 00:49:02.800
Before you go, be sure to claim your continue education credit, your time and engagement count, and we want to make sure you get credit for it.
00:49:02.880 --> 00:49:05.280
But thank you so much for being part of the Game Changers community.
00:49:05.440 --> 00:49:07.760
We look forward to the conversation with you all next week.