CEimpact Podcast

Pharmacists Expand Access to Contraceptive Care

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With over-the-counter birth control expanding access to contraception, pharmacists have a growing role in guiding patients through their options, ensuring safe use, and providing essential counseling. This episode explores the pharmacist’s role in OTC birth control recommendations, patient education, and broader hormonal contraception services within community pharmacy practice. Tune in to learn how you can confidently support patients in making informed decisions about their reproductive health.

HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact

GUEST
Kate Riddell, PharmD, MS
Pharmacist
Consultant/CPESN IN

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Looking for more information on Over-the-Counter Contraception? Check out our course, Pharmacist Prescribing of Hormonal Contraceptives: An Advanced Training!



CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Explain the pharmacist's role in recommending and counseling patients on over-the-counter birth control and other hormonal contraception options.
2. Identify key safety considerations, eligibility criteria, and best practices for providing contraception services in a community pharmacy setting.

0.05 CEU/0.5 Hr
UAN: 0107-0000-25-191-H01-P
Initial release date: 5/26/2025
Expiration date: 5/26/2026
Additional CPE details can be found here.

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Speaker 1:

Hey, ce Impact subscribers, Welcome to the Game Changers Clinical Conversations podcast. I'm your host, josh Kinsey, and, as always, I'm excited about our conversation today. Access to birth control is evolving and pharmacists are at the forefront of expanding contraceptive care through over-the-counter options and pharmacy-based services. In this episode, we'll discuss the role of pharmacists in guiding patients on OTC birth control, counseling on hormonal contraception and ensuring safe, informed reproductive healthcare decisions. And it's so great to have Kate Rydell back as one of our guest experts in this episode. We had you on gosh, probably back in the fall, discussing OTC cough and cold recommendations. So, kate, thanks for joining us again. It's good to have you back.

Speaker 2:

Yes, thank you, I'm excited to be here.

Speaker 1:

Yeah. So if you weren't able to listen to the previous recording with Kate, I'll give her an opportunity to kind of introduce herself, talk a little bit about her practice site, her role and her passion for today's topic, and then we'll jump into content.

Speaker 2:

Absolutely. Thanks, Josh. My name is Kate Rydell and I am a practicing community pharmacist. I practice at an independent community pharmacy in Indiana and there I actually am able to prescribe hormonal contraceptives, which we'll talk a little bit about in this podcast, as that is something that pharmacists can do in Indiana. And then we do stock Ophil, the OTC birth control. So those are some of the things that I do there. I'm also on a grant funded team for expanding pharmacy access to hormonal contraceptives for Hoosiers. It's called the Patch Project. So I do a lot of work in this space and I'm excited to be here as a guest and talk a little bit about Ophil today. Yeah, and I'm excited to be here as a guest and talk a little bit about Ophel today, yeah.

Speaker 1:

So again, thanks for taking time out of your busy schedule. Sounds like you have your plates full, so we appreciate it very much. So, kate, you've been here before. You know the drill, so you know I like to jump right in and get started on content. So let's talk about, if you can just remind us of, I guess, the inception, the beginning of birth control in general, and then kind of when OTC birth control came on the market and why that's kind of revolutionized some things and why we need to talk about it.

Speaker 2:

Yeah, so we've had some hormonal birth control options since I don't want to say the exact year in here, but kind of the 1960s to 1970s year in here, but kind of the 1960s to 1970s and actually norgesterol, which is the synthetic progestin that is in OPIL, the OTC birth control, was approved for prescription use in 1973. So that's been around for quite some time Now. That shift to us having that over-the-counter birth control product which was due to HR Pharma actually applying to change the status of norgesterol from prescription only to over-the-counter use. And so when I was preparing for this podcast I looked a little bit into what does that process actually look like? And essentially, when you want to change something from a prescription-use product only to an over-the-counter-use product, you have to be able to demonstrate that the product can be used by consumers safely and effectively without huge healthcare professional intervention, so that you know the marketing for the medication, the drug fact information labels that we see on those over-the-counter products that you know.

Speaker 2:

These are easy enough things for most folks to understand without having that healthcare professional interaction that is often, often, will always, needed for prescription use products. So essentially just meaning that those drug fact labels are easy to understand. And so they got that approval in July of 2023 from the FDA, and so we, since then that is when we've had our first over-the-counter progestin only hormonal birth control option, and this is something that I know has been in the making and that ACOG has definitely recommended over-the-counter use to increase access. So this is super exciting. Even on the FDA approval letter describing this new approval for Opil nogesterol, they talked about how that increase in access and how that is super critical. They talked about how that increase in access and how that is super critical. I'm actually going to glance here on that approval. They said that almost half of the 6.1 million pregnancies in the United States each year are considered unintended.

Speaker 2:

So if we can improve access to birth control. We can bring that number down because we know that unintended pregnancies can have been linked to negative maternal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery. So access to hormonal birth control options can be really critical for reducing that unintended pregnancy rate and also improving maternal outcomes.

Speaker 1:

Yeah. So the impact of this moving over the counter is just is is even greater than just the fact of oh, now it's easy for anyone to have access to it. Like it just yeah.

Speaker 2:

So yeah, so much further than that.

Speaker 1:

Yeah, that reach is just so great. So one thing I would ask that remind all listeners in case they don't stock it is this something that has to be in a specific area? Is it just randomly on a shelf, any shelf of your choice, like just maybe kind of review those parameters there?

Speaker 2:

Yeah, absolutely so. Opil can go anywhere in your shelf. I know some pharmacies have chosen to keep it behind the counter so that folks are prompted to ask pharmacist questions before getting it, but that's, honestly, isn't always recommended. We want it to be easy access and out on the shelves in the pharmacy so.

Speaker 2:

I know where I work as a pharmacist. We have it with prenatal vitamins, pregnancy tests, fertility, just other prevention strategies. The family planning area is the section that we have it in, Although you might, you could put it in other sections too, but there's not really any restrictions or guidance.

Speaker 1:

Okay, yeah, and you know one thing to your point. I understand why some would maybe want to keep it behind the counter to make sure that questions are being asked and that they're really guiding. But, as you mentioned, that kind of defeats the whole purpose, because the whole purpose was to get it over the counter that maybe there's signage that you put near it that this is a new product. We'd love to help you answer any questions you have so that at least it directs them back to the pharmacy team to ask questions, absolutely.

Speaker 2:

Another thing you could do is our family planning section is in an area that's really easy for me to see from behind the pharmacy counter. So if I see somebody spending some time over there, it's really easy for me to go over there and just ask if they have any questions or just let them know. Hey, if something does come up that you want to ask me, like I am here, like I see you. Also, I do like the idea of the signage, especially some of our younger patients.

Speaker 2:

There's a lot of studies coming out that suggest that some younger patients don't always want to go ask questions. So if we can put the signage out that maybe addresses those questions and kind of think you know what are the most common things that my patients are going to want to know about this and have specific signage for that, we can still answer their questions without them having to have that direct conversation with us. Another thing is I know a lot of pharmacies, including mine, have like a patient messaging portal, so that might be another way that we can encourage patients to ask us questions. So a couple of different things that we can utilize to make sure that we're keeping OPIL accessible but also making sure that we are readily available in whatever format patients prefer to answer questions.

Speaker 1:

Those generational differences, those kids of today love to text. They don't like to direct conversation or face-to-face even.

Speaker 2:

And they text us on our pharmacy system.

Speaker 1:

So it can be another great avenue. Yeah, good call out. We've kind of talked about the role of hormonal contraception in general and its inception and whatnot, but let's just reiterate pharmacy's expanding role, the pharmacist's expanding role in this space. So, obviously, what should we be doing in the space of hormonal contraceptive care?

Speaker 2:

Oh, that's a loaded question, Josh. I mean, it kind of depends on what state you're in.

Speaker 1:

That's fair fair yeah.

Speaker 2:

More than 30 states right now have some kind of legislation that allows prescribing of hormonal contraception in some format.

Speaker 2:

Now it looks different state to state, so it might be through a standing order, it might be through a statewide protocol. Some states have utilized collaborative practice agreements to do this, or they have a blanket like prescriptive authority to do this, or they have a blanket like prescriptive authority, and then the methods that pharmacists can prescribe alter state to state. Most states that have this permission allow pharmacists to prescribe the pill, but some can also do the patch, the ring and the depo shot.

Speaker 1:

Injection yeah.

Speaker 2:

So if you're listening to this and you're like I have no idea what I can do, in my state there's a couple of references. So birth control pharmacist keeps an updated list, and so does the Guttmacher Institute. So those are some really good resources to look at what's permissible in your state and how. And so more and more pharmacists are getting involved in this, but whether or not you're in a state where you have prescriptive authority, or if you are but you're just not there yet, opil is still something that you can offer as a solution for your patients that is over the counter.

Speaker 2:

And then I wanted to touch on emergency contraception too, because most pharmacies will have Plan B or the generic, which is levonorgesterol, and then in some states pharmacists can also prescribe Ella or the Ulipristal, so there's also some prescribing or some stocking of that medication as well.

Speaker 1:

And I think it's a great point right here, since you brought it up. It's a good segue to talk about the fact that the OTC birth control pill is different than the emergency contraceptive care. You're correct. Let's just make sure that that is laid out on the table, that those are different.

Speaker 2:

Absolutely. O-pil is a take it every day, just like you would think of any of your prescribed progestin onlys. It's take it every day at the same time, every day. That's really important. And actually, if you look at the drug facts labels on Opil, they have that part highlighted. So it's highlighted in yellow and it says take at the same time every day. That's so important. And then, yes, as we know, with emergency contraceptive options, you want to take it as soon as possible after the unprotected sexual intercourse. But that's a one time and only after unprotected sexual intercourse, whereas with opil it's every day.

Speaker 1:

Yeah, so back to my loaded question. So back to my loaded question. I think what I was getting at was, at the very least, what pharmacists should be doing in this space is providing education, being accessible for consultations, assessing eligibility. Again, some people may have confusion on do I need the? I just had an unwanted, you know, potential scare. Do I get on the O-pill or do I need the emergency care first, you know? So I think that sort of thing, understanding the difference between those and being able to provide the right education and the right counseling. And then, yes, if you have other opportunities in your state, please check your scope of practice and expand upon that. But I think in general, at the very least, all pharmacists should be in the know about these products so that they can provide proper education, assess eligibility accurately and just support that patient's journey, whether it be needed for long-term or emergency or whatnot.

Speaker 1:

So, yeah, I'm glad I presented it as a loaded question first, because that allowed you to go down that pathway of scope of crisis. So that was good. Let's continue to talk about the opportunities that exist for pharmacists and for pharmacy teams in general, because this, being an OTC product, you know it could very well be that questions are asked of other staff members first, and so they need to know maybe certain answers that they can provide and then when to pass that referral on to the pharmacist for additional assistance. So, but let's talk about how, increasing the access to contraception, how is that going to affect the underserved population? Are we, are we going to solve all the problems or are we still going to have some problems?

Speaker 2:

I don't think we can solve all of them. So, first off, over-the-counter birth control is really accessible. It means that somebody can come in as long as a pharmacy stocks it. That's key. So as long as your pharmacy stocks it, then you're providing this accessible option. But we still have to realize that there are going to be patients who live in areas that have pharmacies that may or may not stock it or, if they choose to stock it, have it kind of behind the counter, like we talked about earlier. So those are some considerations. So kind of behind the counter, like we talked about earlier. So those are some considerations. So is it actually accessible in an area for the patient where the patient can get to a pharmacy where they can access this? What's really nice about over-the-counter is they can decide at last minute I want to try this, or I want to pick this up, or when they have that access. They don't have to wait for an appointment, which we know in certain areas, appointment wait times to establish with a new provider can be really long.

Speaker 2:

One thing that I did want to bring up, though, is that OPIL, at this time, is not routinely covered by insurance, so even for patients with insurance options, this would still be an out-of-pocket cash expense.

Speaker 2:

One month of OPIL runs around $20 and then three months is around $50. It might be a little bit different place to place, but that's like a ballpark cost, and so we do know. For some folks the access of being able to actually find it somewhere might be great, but the financial access might be a barrier. Opil does have a cost assistance program, so it is a program that patients can apply for to help cover part of the cost of OPIL. But even going through that process doesn't allow for them to immediately get OPIL. So there's some considerations there. So it's still, you know, a great resource, a great thing to know about and look into, especially if you have a lot of patients who might have that need. Even having to utilize a program like that does not necessarily provide the patient with that instantaneous access to Opal as they would have if they were able to afford it and buy it right away, right off the pharmacy.

Speaker 1:

Yeah, so again, we've certainly increased access to the product, but there are still some limitations that we have to consider, and so we can't just assume that we stock it. It's out front, anybody and everybody can grab it. There could still be some issues that we're facing. Yeah, there are probably some listeners. I would be remiss if I didn't say, if I were listening and hadn't done my research on some of this, I would be in the same boat where it's like I'm a little hesitant, I don't know if I know enough about what kind of questions are going to come at me. What do I need to be doing to fully assess and ensure that the patient is eligible? So what are the education points? What do we need to know as a pharmacist, to make sure that we're saying yes? You, if they ask yes, you should pick that up and take it Totally fine for you to do. Like, what should you be asking?

Speaker 2:

Absolutely so. If you have a patient come up to you at the counter and they're like, can I take this? Here are the things that I would ask. Perfect One I would ask if they have any thoughts that they may be pregnant or are currently pregnant. If they are currently pregnant or think that they may be pregnant, I'm going to advise them to hold off until they can be certain that they are not pregnant. Now, when you're prescribing, there's a couple extra steps you have to go through in most states to determine that a patient is reasonably not pregnant. But that's not necessarily the case with an over-the-counter, so you can use your best clinical judgment with that. But if the patient tells you, no, I don't think I'm pregnant, then you can go with that and we don't need to say show proof of that or show me your over-the-counter use, so use your clinical judgment there.

Speaker 2:

The next thing to consider is asking them if they're currently on any other form of hormonal contraception.

Speaker 2:

So you know, they might have an IUD and think that they need to take this as well, and so we want to clear up that, if they are using any other form of hormonal contraception, that they do not want to use Opil on top of that. So this is in case they're using nothing, or if they're wanting, you know, maybe they're using condoms but they want to use something else, so they can continue to use condoms, and we'd actually recommend them to continue to use condoms while they use over-the-counter birth control. The reason for that is because we know that hormonal contraceptive options do not do anything for reducing your risk of STIs, but condoms do. So that is the big counseling point with why you would even if you're using a hormonal contraceptive method, you would still want to recommend condom use. And then the other one is if the patient has ever had or has breast cancer, they cannot use O-Pill, and these are also laid out very clearly in patient-friendly language on the drug facts label on.

Speaker 2:

OPIL. So if patients don't ask you this, they should get that information from the box. But those are the three things that I want to make absolutely sure of before I recommend that somebody were to use OPIL.

Speaker 1:

Yeah, no, that's great One of the things so you mentioned and I think it's a great call out to remind patients, if you have this opportunity to have the conversations with them, if they're asking questions about the. Hormonal contraception does not protect against STIs. It is important to also utilize condoms, but if the main take-home too, isn't there a transition period where they must use condoms or else it's not effective, right?

Speaker 2:

They start using Opil. They want to use condoms for the next two days or 48 hours. I usually like to say the 48 hours, so we're clear on what that two-day window is before Opil is at its like peak efficacy, if you will. So at least for those two days, yeah.

Speaker 1:

OK, that's what I wanted to clarify for sure, obviously we would, we would recommend and encourage to utilize condoms, you know always, but making sure that they understand that in order for it to be effective, at least 48 hours, in order for it to be effective at least 48 hours, okay, perfect, yes, what are some of the side effects that we would need to know about or counsel on for the OTC pill? What are some of the things that, if someone says, what's it gonna do to me? What information would we need or want to provide?

Speaker 2:

Yeah, the most common side effects which, for our listeners, are going to be very similar to any other progestin only birth control method.

Speaker 2:

The biggest things that we would want to warn them about is irregular bleeding, so they might have some spotting in between their periods that they don't normally experience, and that's pretty common, as you get used to any form of hormonal contraceptives, but especially a progestin only as well as they could experience headaches, dizziness, nausea, increased appetites, sometimes abdominal pain, cramps and bloating, and so these are the ones that are actually also notated on that drug facts label. So something I also like to do just as a sidebar, is I like to point to where I'm getting this information from when I'm talking to patients, so that they know where to refer to if they forget one of the things that I said so those are the biggest ones, I will say.

Speaker 2:

There's also a warning on there and it does say, if your headaches are worse, to contact a doctor because they might recommend that you stop using O-pills. So that is on there as well and I know that's something that I've talked to patients about with other forms of hormonal contraceptives.

Speaker 1:

Sure. So, kate, going back to those common side effects, are any of those what I like to call rate limiting Like, are any of those where, if you get this, other than the headache that you just mentioned, or is it just a recommendation of be on the lookout for these things? You might, you might notice them, sort of things?

Speaker 2:

Mostly a lookout. But things like the irregular bleeding, like if you're bleeding continuously or it's very heavy, that's something you'd want to contact like an OBGYN or PCP for. Another thing is abdominal pain, like if this is, you know, surpassing, like the cramps that some folks experience, that's something you'd also want to contact a provider about. And then, yes, the headaches if they get really, really bad, you'll want to escalate that.

Speaker 1:

Yeah, for sure. And then remind us again of the contraindications for this.

Speaker 2:

As far as like if a patient is thinks they may be pregnant, if they've have or had breast cancer, and then as well as if they're already using a form of hormonal birth control.

Speaker 1:

Got it Okay? Yep, and I think that last one is really what I wanted to reiterate because, like you said, sometimes there's confusion, or I mean, if they're, if they like me, they forget about things. I've had to think back and if I were in that case, I'd probably have to remember if I have an IUD or you know, like so I wonder, you can have for years, yeah exactly so like it's very possible that you forget or you know, you think that you should be doing both things, or whatever.

Speaker 2:

Yes. Or there could also be this thought that like oh, there's this over-the-counter. So if I take two forms, like I will be double protected and actually that just increases your risks for a lot of this stuff.

Speaker 1:

So we don't want to do that at all. Yep, okay, perfect. So then what are? I know we talked about it's very state specific and it's on the listener to make sure that they're digging into the state requirements so that they can determine whether or not they can expand care. But you briefly mentioned that you are in that space and that you do offer expanded pharmacy services. Can you talk a little bit about what does that look like? That's different than what we just talked about, where you know, asking these certain questions, checking for contraindications, counseling on side effects, like what takes it a step further other than the fact that you're actually prescribing something.

Speaker 2:

Yeah, so with over-the-counter conversation it's really casual. You know the big things. We're checking for those contraindications first. We are going over still going over side effects and what to expect, and you know that. You know 48 hour window of still needing to utilize condoms, and so it's a lot of the same counseling. It's just a much more informal fashion but I'm doing the actual appointments. So we do accept walk-ins. We encourage folks to call ahead because it just helps us prepare a little bit. But if someone walks in and we can accommodate them, we absolutely will, and so that's a more formal process because I have them fill out a full intake form. So there's different regulations that we need to make sure that we check for a couple different things when based on our statewide protocol that we complete this you know intake form and that we also check blood pressure.

Speaker 2:

That's another important distinction, because for a lot of estrogen containing birth control products, we need to make sure that a patient's blood pressure is within a certain range, so that's a big thing. That is different with actually prescribing the method, and then you know, we're looking over their intake forms, looking at their blood pressure, looking at there's a couple different medications that can interact with estrogen containing products specifically, and so looking at some of those and using the CDC has an MEC medical eligibility criteria document. That is really helpful, and so we're bound by there's four levels, and four is like the most risky, if you will, so we're able to prescribe anything that falls into like a one or two, which are less risky areas. So like, for example, an estrogen containing product with a patient who has migraines with aura is a four. So we cannot prescribe an estrogen containing product for a patient who states that they have migraines with aura, and so there's just a lot more questionnaire things yeah.

Speaker 2:

Questionnaires parts, but then the. You know, as far as identifying the product and the counseling that part is, once we identify the best product for them and their preferences, the counseling part is pretty similar.

Speaker 1:

Yeah, and I want to go back and reiterate that, the blood pressure control, just to make sure listeners understand that's not an issue with the OTC birth control, because it doesn't have the estrogen component.

Speaker 2:

Yeah, the estrogen components are what we want to watch blood pressure with closely. However, Opil is a progestin-only product and that is not something that we need to be concerned about.

Speaker 1:

So if a patient were to ask I've heard in the past that you can't have high blood pressure or whatever. If we're talking about the OTC pill, that's not really. I mean, obviously, if they have high blood pressure, we want to get that under control. That's a different conversation.

Speaker 2:

Yeah, well, that's a whole other intervention, Whole other intervention yeah.

Speaker 1:

Concerns with a progestin-only pill. No, we don't have those. Got it Okay. All right, that's great, Okay. So in our last few minutes I want to just talk about some of those challenges. So when you've had these conversations with patients about the OTC option, have they had any concerns or misconceptions that you want to bring to light so that we're not blindsided by those two in our practice settings?

Speaker 2:

I think the biggest one is the one we already spoke to is just that difference between using levonorgestrel so emergency contraception and so the fact that this is not a new form of emergency contraception, which is what most patients are pretty familiar with being over the counter as far as a birth control option, and that it is truly a once every day preventative. So I think making sure that that's clear the cost has been a concern for a few people, and then also, yeah, that's a pill every day and that same time is going to be important.

Speaker 2:

We do know. Like our combined products, you have a little bit more leeway on what time of day you take it, but with the progestin only is you really want it to be the same time every day. So, like I said, it's highlighted on the box. It's one of the things I definitely choose to reiterate when I'm talking about it, and I think that those are probably the biggest things that, at least in my experience, I've run into.

Speaker 1:

Yeah, okay, and I loved your recommendation of actually pointing to those sections on the box I think you know again showing them, I'm not just making this up like it says right here that you know this is these are the potential side effects. It says right here you know you can't be on other birth control, you can't have had breast cancer, whatever. So I love that, that practice.

Speaker 2:

And then they can refer back to it. And I know I'm personally not an auditory learner, I'm a visual learner, so being able to see that as someone's telling the same things to me, it's super helpful. Yeah, so yeah.

Speaker 1:

And kudos to them for putting that in the packaging that way. I think that's really important, so it's very patient friendly.

Speaker 2:

If you haven't seen the box, it's cute, like it has a really like colorful design, it's like very, it's like a playful design, if you will. So I think it's really patient-friendly in just the color scheme as well as the wording on the drug facts label. So I do think that that positions it well for over-the-counter use and for us to help navigate questions.

Speaker 1:

Yeah, that's great. Well, Kate, is there anything else that we didn't cover that you want to be sure that we shared with our learners for today?

Speaker 2:

I think we covered everything. The big things about Excel and expanding scope.

Speaker 1:

So yeah, no, that's great. Well, as I always do, I like to circle back at the end. I think it's pretty obvious what the game changer is here, but just summarize again for our listeners what's the game changer here? But just summarize again for our listeners what's the game changer here? Is the game changer the fact that it exists or the fact that we have that responsibility? I want your opinion Like what do you think? The game changer is yeah, yeah.

Speaker 2:

Can it be both?

Speaker 1:

Sure Can it be let's forget it.

Speaker 2:

One it exists and honestly we need to have it. We need to make sure that it is actually accessible to the patients in our area. You know we can't access it if we don't have it in our pharmacies, right, and then with that, whereas I know I've said that the drug facts labels does a really good job of outlining everything we've talked about today, but we can be creative in the ways that we make sure our patients know that we're still here for them, for even their over-the-counter needs, and that they can ask us those questions about new over-the-counters like Opal and beyond, and we can be creative with how we make sure that they know that.

Speaker 2:

I think some people only think they can ask us questions about the medications that are prescribed to them, but we absolutely are here for those over-the-counter recommendations too.

Speaker 1:

Yeah. So I think that goes back to my somewhat of a challenge, I guess, to make sure that your signage is correct and that your marketing is accurate and that you're trying to relate to the customer that, just because it's out here for you to grab, we're still here, we can still answer your questions, we're still your trusted professional. So, yeah, well, that's great, kate, thanks again for giving us your time. It's always a pleasure and, as I always state, time flies, I guess, when you're having fun. So our time is up, but thank you so much for being here.

Speaker 2:

Yeah, thanks for having me again.

Speaker 1:

I appreciate it. So if you're a CE Plan subscriber, be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpactcom and, as always, have a great week and keep learning. I can't wait to dig into another game-changing topic with you all next week.