Medication Talk - Expert Insights on Drug Therapy & Patient Care

Rx and OTC Oral Contraceptives

TRC Healthcare Season 2 Episode 13

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Special guest Sarah E. Stumbar, MD, MPH, Assistant Dean for Clinical Education, Office of Medical Education and Associate Professor of Family Medicine, Department of Medical Education from the Herbert Wertheim College of Medicine, Florida International University joins us to talk about oral contraceptives.

Listen in as our expert panel discusses safety and efficacy of combined oral contraceptives and progestin-only pills.  They’ll also prepare you to help patients navigate norgestrel tablets, the first over the counter daily oral contraceptive.

You’ll also hear practical advice from panelists on TRC’s Editorial Advisory Board:

  • Stephen Carek, MD, CAQSM, DipABLM, Clinical Assistant Professor of Family Medicine, Prisma Health/USC-SOMG Family Medicine Residency Program at the USC School of Medicine Greenville
  • Craig D. Williams, PharmD, FNLA, BCPS, Clinical Professor of Pharmacy Practice at the Oregon Health and Science University

None of the speakers have anything to disclose. 

TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist’s Letter or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.

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Narrator

Welcome to Medication Talk, the official podcast of TRC Healthcare, Homopharmacist Letter, Prescriber Insights, RX Advanced, and the most trusted clinical resources. On today's episode, we'll listen in as our expert panel discusses safety and efficacy of combined oral contraceptives and progestin-only pills. They'll also prepare you to help patients navigate norgestrel tablets, the first over-the-counter daily oral contraceptive. Our guest today is Dr. Sarah Stunbar from Florida International University. You'll also hear practical advice from panelists on TRC's Editorial Advisory Board, Dr. Stephen Carrick from the USC School of Medicine Greenville, and Dr. Craig Williams from the Oregon Health and Science University. This podcast is an extract from TRC's Emerging Recommendations panel webinar. Each month, experts and frontline providers discuss current medication therapy topics and practical recommendations to include in TRC's letter articles. The full webinar originally aired on December 14, 2023.

CE Narrator

And now, the CE information.

Narrator

This podcast offers continuing education credit for pharmacists, physicians, and nurses. Please log into your pharmacist letter or prescriber insights account and look for the title of this podcast in the list of available CE courses. None of the speakers have anything to disclose. Now, let's join TRC editor Dr. Sarah Clockers and start our discussion.

Sara Klockars

We're talking about this now because Norgestrel 0.075 milligram tablets or OPIL will be the first daily oral contraceptive to make the RX to OTC switch. And for some perspective here, the first oral contraceptive was approved by the FDA in 1960. Overett was approved in 1973, and then discontinued by the manufacturer in 2005. Then in 2015, a new manufacturer started working on the RX to OTC switch. And the proposed OTC labeling was tested in 14 different consumer studies over the course of seven years. Then Nordestral OTC was approved in July of 2023, and it's slated to be available in the first quarter of 2024. I also want to point out that another company is working toward FDA approval of an OTC version of a combination oral contraceptive pill. So stay tuned for that. And before we talk more about OPIL, I wanted to spend some time reviewing the oral contraceptive options and focus on considerations such as safety and efficacy when recommending or choosing an oral contraceptive. So, Sarah, to start us off, I was hoping you could comment on how often you prescribe oral contraceptives over other contraceptive options. And are the oral contraceptives still the most utilized contraception today?

Sarah E. Stumbar

Sure. I think that contraceptives are an interesting medication that we prescribe because I treat them a little bit differently, because so much of what makes the best option for a patient has to do with what their preferences are about their own body, their ability to remember to take a medication. And I really look at it as my job to figure out what the medically acceptable options are, and then to present all of the options to the patient. And so you kind of have to, as a physician, really take a thorough history, figure out what the patient priorities are for the right type of birth control for the patient. And in all honesty, most patients, or at least most of my patients, want something that they don't really have to think about. And then for my patients, who are a lot of them are uninsured and underinsured, having something that they don't have to pay for every month or every three months is really important. And so I think about two-thirds of women of reproductive age use contraception, and female sterilization is the most common, and then oral contraceptive pills and then long-acting reversible contraceptives. That is a great introduction.

Sara Klockars

So I'd like to start and just kind of give a brief overview of the types of the oral contraceptives. Can you kind of go over just some of the higher level differences between the two? And then we'll dig in to some of the nuances a little later.

Sarah E. Stumbar

For the oral contraceptive pills, we have the two major types, the combined OCPs that contain estrogen, so ethanol estradiol, and then one of many different types of a progestin. And then within those, within that kind of bucket of oral contraceptive pills, you have the monophasic or multiphasic, extended or continuous use, varying doses and durations of medication. I think that the kind of biggest defining feature of a person's experience with those medications is that they generally cause much more regular and predictable periods for people. And that really contrasts them to the progestin-only pills, which have fewer contraindications but can cause irregular bleeding and spotting, which is a major kind of barrier or concern that a lot of people taking the progestin-only pills have, in addition to the fact that they, on the whole, have a much more regulated dosing schedule that's not very forgiving, which makes it even more difficult to appropriately take the medication and can raise concerns about typical use efficacy.

Sara Klockars

Excellent. Thank you for that. And then I also wanted to kind of showcase the three different types of progestin-only pills, with the new norgesterol being more closely related to the norethendrone. Would you just take a few seconds to orient us to the three different types?

Sarah E. Stumbar

Sure. So you have drospirinone, which is known as SLIND, is newer availability. It has a much larger missed dose window, which is the big advantage of the drospirinone, so that patients don't have to necessarily take it within that three-hour window. It also has four days of placebo pills or the hormone-free pills, which is when the patient generally will get their period, although patients continue to have kind of that irregular bleeding and spotting with the drospirinone. I know that for some patients, cost for drospirinone can be more of a barrier than with the norothindrone. And I'm not sure what the norgester will look like, but that that has been an issue for some patients. And then with the norothindrone, it's a continuous use medication. So all 28 tablets have the progestin in it, and then it has that very narrow missed dose window of three hours. And that closely, as you already mentioned, mimics the norgesterol or what the Opil will be like.

Sara Klockars

Yes, thank you so much. We know that the pharmaceutic shelves are stocked with so many different oral contraceptives. And for prescribers, the list seems endless in the order entry pick list. So, Steven, I would be interested in your thoughts. Once you decide that your patient does want to try an oral contraceptive, what are some general considerations that help you choose one for the patient?

Stephen Carek

Really, I think the two big decisions to make are one, what is the indication for this? What are the patient's preferences? And then second, are there any medical contraindications to utilizing a combined oral contraceptive versus a progestin-only contraception? And sort of individualizing the patient's goals. Is this truly for birth control only? Is it for menstrual psycho control? Are there certain other sort of secondary either side effects or benefits to using combined oral contraceptive versus progestine only versus those contraindications? And I think there's a research available that can outline those, but sort of the big things being cardiovascular disease, high blood pressure, history, your personal or family history of breast uterine cancers, history of clot, stroke. Those are all kind of the big questions I think to ask. And I think we're interested asking the patient too. You know, is this how reliable may you be? What do you think some of the challenges you might have of taking a pill every day reliably? What medications are you on? Are any other medications that may interfere with your metabolism of these medications? Yeah, I think those are kind of a few big things, at least I think of when trying to counsel a patient and discuss what oral contraceptive we may want to use.

Sara Klockars

Excellent. In our article, we also say to continue to screen patients for contraindications to all oral contraceptives, and as we mentioned earlier, the history of breast cancer, severe liver problems, and also undiagnosed abnormal uterine bleeding. So we know that there are some contraindications to all of the oral contraceptives where we would go with a different option. Sarah, do you agree with that statement?

Sarah E. Stumbar

These are the main the main ones that we ask patients about in addition to uncontrolled hypertension and the history of clotting disorders or risk factors for thrombolembolism that would be the contraindication for the combined method and and would lean us toward the progesterone only method.

Sara Klockars

Okay, that leads us into the next question. If you have a patient that has hypertension or high cholesterol or diabetes, how do you have that discussion about which option to use if they're wanting to use an oral contraceptive?

Craig Williams

Yeah, the progesterone only is certainly much safer from that standpoint. But really, for the combinations or this, if you can avoid oral, that's even better. So the a number of those effects come from kind of downstream effects. What happens in the liver when this relatively large oral dose of these agents hits the liver, and so the the long-acting reversibles don't have that to the same degree, and progestions only are safer from that standpoint. So but that's not I wouldn't consider hypertension or dyslipnemia or diabetes, that's certainly not a contraindication to use. Patients should know that there are options with those conditions, but it kind of goes more the underlying overall cardiac concern and thrombotic risk, and that is greater with oral agents than with a long-actine depot formulation. And but most all that comes from estrogen, as you've heard people saying. So I as far as counseling someone who's maybe purchasing the mini-pill at a pharmacy, that's something for them to be aware of, but would not be a reason necessarily to not use this agent. So fortunately, it's one of the benefits of a progestine-only option.

Sara Klockars

Yes, definitely. Another big question we get, Sarah, I'd be interested in your thoughts here. Is can patients who are overweight or obese use progestine-only pills?

Sarah E. Stumbar

Yes. So I believe that we're gonna mention the CDC MEC criteria later, if we haven't already, but I always refer to the CDC MEC criteria when I have a question, they rate the progestin-only pills as a one, which means that they are safe and efficacious and able to be used. Also, not a lot of evidence showing that they cause weight gain, which is often a concern for all people, but particularly people who are already overweight and obese. So they can be used by people who are overweight and obese.

Sara Klockars

And can you speak to the efficacy? Is the efficacy decreased?

Sarah E. Stumbar

No, they they're efficacious, or there hasn't been any high-quality studies showing that they're have reduced efficacy.

Sara Klockars

What are the differences and side effects between the progestin only and combined contraceptives?

Stephen Carek

For progestin only, the the biggest one is that just inability to really predict sort of bleeding or cycling, and that can oftentimes just be the biggest, most limiting side effect, I think, for each of these medications from regular compliance. We'll talk about some of the cardiovascular and clothed risk that we're worried about, from progestin-only to maybe some more acne or some more uh skin changes that may be associated as well.

Sara Klockars

I wanted to touch briefly on drug interactions. Are there any differences between the progestin-only pills and the combo oral contraceptives when it comes to drug interactions? Or can we lump them all, you know, pretty much together? So if patients are on certain drugs, they really should not be on an oral contraceptive. Craig, can you comment on that?

Craig Williams

Yeah, a little bit. So I'd say they're reduced in number and severity, but still present. So without the estrogen components, it's a little bit more forgiving. So I kind of use the analogy of warfarin versus a doac. You can never not think about drug interactions, but it's not quite as severe. So I know for the, I mean, these are steroidal hormonal compounds, and so the cytochrome P450 system is probably kind of literally evolved with some of these compounds in mind for the human body. So we're kind of back to the cytochromes and 3A4 being a big one. So you're used to talking about 3A4 inhibitors and inducers, and those are the ones to think about. And I know in the labeling for OPIL, it's gonna mention talk to your doctor or pharmacist if you were on medications for seizures, tuberculosis, or HIV are the big three they're going to call out. And so which are things we're used to thinking about are antiepileptics, things like carbozipine and phenytoin, your inducers are gonna potentially lower the concentration. So, in terms of pregnancy risk, again, some of the history of seizures on seizure medicine for tuberculosis is really rifampin as far as an inducer. And then anyone HIV medicines that would need some some screening. So those three seizures, tuberculosis, and HIV are the ones to be aware of.

Sara Klockars

Excellent. Thank you for that. So to summarize the safety of progestin-only pills, we say in our article to point out that progestin-only pills have a long safety track record with fewer risks than combo OCs with estrogen. Now I want to try to move us along. In our article, we say caution that progestin-only pills are less forgiving than combo oral contraceptives if a dose is missed or taken late. We go on to say, you know, explain that taking OPIL at the same time daily is more effective than other OTC contraceptive options. So first wanted to take kind of a step back to review where oral contraceptives fit in the bigger picture. So, Sarah would you mind just reviewing the efficacy of the different contraceptive options?

Sarah E. Stumbar

Sure. So I always think of all of our birth control options in kind of three buckets: the most effective, the medium effective, and the least effective. Those are notably the ones that don't rely on people remembering to take them at all. And then we move to the moderately effective options, which, if they are taken perfectly, are actually pretty close to 99% effective. But the way that people take them, so forgetting to come in or being late to come in for an injection, or forgetting to take a pill or being late, forgetting to switch off a patch or put a new patch on, or forgetting to switch out of the ring, the way that people actually take them, they are effective somewhere around 93, 95% of the time, which means in one year for 100 women that are taking them, about five would get pregnant. And then we have the least effective methods that are very dependent on use. And so diaphragm, condoms, cervical caps, sponges, spermics, the things that people really have to remember before each intercourse act. And those are the most difficult for people to use reliably, somewhere around 87, 88% effective. And I really like that the article points out that the pill, that the oat-hill is more effective than our other over-the-counter options. I think it's really important to put efficacy into perspective that way. I really like that in the article. And I think it's a useful counseling point for patients as well.

Sara Klockars

Great. I think a common question that we get every time we write about any contraceptive is what's the difference in efficacy between the progestine-only and combined oral contraceptives? So every chart, every study lists the efficacy as the same. But in our article, we say, you know, that the progestine-only pills are less forgiving. So can you just comment on why the progestin-only pills might not be as effective as combo oral contraceptives?

Sarah E. Stumbar

So I think that perception goes back to the three-hour window that we were talking about earlier. So if a patient is more than three hours late in taking the pill in taking one of the progestin-only pills, they should take it when they remember. Um, but then they need to use backup contraceptives, namely condoms or a barrier method for 48 hours. So having to take the pill at the same time every day is just very challenging and there's very little give there. And so typical use therein becomes more challenging for um for patients.

Sara Klockars

Great. Thank you. Now I'd like to circle back to our article draft and discuss the new Nordestral oral contraceptive in more detail. Starting with the benefits of having an OTC oral contraceptive. So in our article, we say the hope is to improve access to contraception and limit the number of unintended pregnancies. And as we kind of alluded to, we still don't know what cost or coverage will be. So there's a potential for that to be a barrier. But can we just talk a little bit more, Sarah, just about the the benefits of having an OTC contraceptive and why this is a big deal?

Sarah E. Stumbar

Yeah. So as I think was mentioned earlier, I see patients in just north of Miami on a mobile health center, many people who are undocumented, everyone who's uninsured, and having access to a doctor or someone who's able to prescribe contraceptives requires the time, the knowledge of how our healthcare system works, and a lot of resources that patients don't always have. And a lot of my patients actually are coming from Latin America where you can get a lot of medications without a doctor's prescription, and they're very used to that. And so I think that this is really important for people who have limited access to our healthcare system, to not have to go into an office, get a prescription, go to the pharmacy, and kind of navigate all of those barriers to access. And I also think like on a deeper level, it really gives control back to women over their own bodies and to make decisions without the physician or the provider standing there as the gateway. It lets people kind of take back that control over when and if they want to get pregnant. Mm-hmm. Great.

Sara Klockars

Thank you. I wanted to take a few minutes to put kind of the role of OTC norgester into perspective. And we say to think of norgester as similar to other prescription progestin-only pills that we spoke about, the drosperinone and norethidrone. And then we say, you know, we're used to saving these for patients who can't take a combo OC, such as those needing to avoid estrogen. So we talked about these patients earlier as well with, you know, breastfeeding or patients who have migraine with aura or high risk of blood clots, those sorts of things. We might consider a progestin-only pill for those. But the question that I have for the panelists is now that we have these progestin-only pills OTC, do we think that its role will change?

Sarah E. Stumbar

I still don't look at the progestin-only pills as my first line choice for most patients. If there are other options available, other medications are other options that patients are willing to try or to accept. Of family planning or of birth control is the method that the patient wants and will take and finds acceptable for her body. And so this just increases those options for patients, but still, because of that window, because of needing to remember to take a pill every day, if the patients have access to other options, those would still probably be my first choice for most people.

Sara Klockars

And I think we can we see this situation coming up a lot in the pharmacies where you have a patient asking about OTC progestine-only pills, but the pharmacist might think there are other options that might be better for the patient. Do you have any advice for the pharmacist that's trying to answer questions for the patient about these progestine-only pills and kind of encouraging them to see a prescriber? What kind of advice can you give, you know, frontline pharmacists on counseling about this?

Sarah E. Stumbar

Yeah, so I will fully admit that I have limited knowledge about the way counseling happens in the pharmacy. But I think that if a patient comes in asking about the OTC progestin-only pills or any form of birth control that they're able to get at the counter, that in no way should we not be providing that prescription unless there's a medical contraindication to doing that, because you're looking at a very motivated patient, a patient who's seeking out a prescription for medication that she presumably wants because she's asking you for it. This method is definitely better than no method for a patient who's looking not to get pregnant.

Craig Williams

If it is a patient who does have other options, it's just this is the way they kind of enter the healthcare system and they have insurance that allows other options. As you said, there's a lot of states now that do allow the pharmacist to explore those options with the patient. And so yeah, we we wouldn't want this to just become the default option for patients who for whom a better option might be available that they are just not aware of. But but I do think this is going to be really a useful tool for patients who who right now don't have those other options available to them.

Sara Klockars

We do say that if a patient opts for OTC nor gestral to ensure it's added to patient profiles and help reinforce proper use. And I think that's where all of us come into play to ensure that if patients are getting it, that they're using it so it can be the most effective that it possibly can. And so, you know, when we start patients on OTC nor gestrol, we have an article to tell patients to take a pill at the same time every day and to reinforce to take it continuously with no breaks between packs. And Sarah, would you comment on you know how to start this pill or how to switch to this pill from a different contraceptive?

Sarah E. Stumbar

Sure. So patients can start on any day of the menstrual cycle. So essentially what we call the quick start method, patients should use backup contraceptives for two days after starting the first pack. So presumably condoms for those two days. And then again, if the dose is more than three hours late, or if they vomit or have severe diarrhea within four hours of taking a dose, they should also use that backup contraceptive method or condoms.

Sara Klockars

That's great. And I think the other big point is the emphasizing the strict adherence. And so we say that in our article and we give some suggestions to use tools, alarms, apps to ensure it's taken at the same time every day. Some other tips include, you know, taking at the same time you already do something, such as brush your teeth, or if you have coffee every day, that sort of thing, and alarms in your smartphone, and then put a reminder in your mirror, all sorts of different things. Craig, do you have any other, you know, general med adherence tips that you tell patients that we could add to this list?

Craig Williams

Yeah, I mean, the big thing is really you do need to link it to uh habit as a prompt. So I think the easiest thing from uh you know decades of research on how do we help patients to be compliant and how do you improve adherence, the big part here, which Sarah alluded to earlier, these should be motivated patients. Then it's really a matter of you know, what can you link it to every day? And the easiest thing in the literature is when you get up in the morning and when you go to bed at night. So if there's something else you always do first thing in the morning or last thing at night, and you can link this to that, then do that. But it has to become just part of a daily habit.

Sara Klockars

Excellent. The other point I wanted to touch on a little bit is we often get questions about the breakthrough bleeding. So we discussed earlier that progestinal pills, you're more likely to have, you know, menstrual irregularities. And so we've had the question come up is norgester or other progestinal pills still effective if the patient's having breakthrough bleeding while taking the pill at the same time every day? And if, you know, should they continue taking it? Stephen, would you like to comment on that?

Stephen Carek

Yeah, it's a common challenge that presents itself with the progressin only pills, and unfortunately, it's just very, very hard to predict. I've sort of had the uh uh I was taught that with protestin-on only pills, that in a given month you'll have the same number of days of bleeding, but it may be unpredictable with when those days are, which can be for some patients who are willing to just try that and see and see how things go for a period of time, whether it be uh a month, three months, a year. Some patients go through the month and just say, This is not for me. So, really just kind of counseling those patients with that expectation and trying to help guide them through that and just seeing how their sort of individual situation or their body may respond to these medications is is at least what I do in practice.

Sara Klockars

Sarah, how do you prepare your patients for the breakthrough bleeding piece?

Sarah E. Stumbar

I think pretty similarly to what Stephen was saying. And you know, I also tell people in relation to all side effects with the pills in particular, that if one doesn't work for you, if you don't like the breakthrough bleeding with one pill, we have other pills that are options for you. And instead of just stopping taking it and waiting for your next appointment, give us a call, come back in, we can work with you. And there are other options, and it's unpredictable how people respond to one pill versus another pill, and so that we have other options for you that are available. So just try to kind of set the stage for sometimes this happens, but if this happens to you and you don't like it, we can work with you to figure out something that works better for your body.

Sara Klockars

I also wanted to just clarify real quick, too, there could be a misperception here because the progestin only pills are taken continuously. People might think that these will lead to amenorrhea, um, which it can they can in some, but it's more likely that the patient will have breakthrough bleeding. Would you agree with that? Yes. Yeah, I think that's common. We also get a lot of different questions because of the irregular medzies, and often we like to tell our pharmacists when to direct patients to a prescriber. So how how often would you recommend that you see a patient if they are using a birth control pill?

Sarah E. Stumbar

So I generally give patients for obviously this is for prescription birth control pills, but give them a year's worth of medication, which is essentially the most that we're we can give a patient without seeing them. If patients are happy and satisfied with the method, don't necessarily need to see them back regularly. You don't need to do a pelvic exam to begin birth control pills or any form of birth control except for the IUV, obviously. And so really try to reduce the barriers to access. And one of those is not requiring things like PAF smears, except by standard guidelines. If someone is really bleeding a lot, soaking through pads, noticing some other change in their bleeding pattern, having discharge, having severe pelvic pain or uterine pain, those would all be things that would be concerning to me that something else is going on besides just side effect and breakthrough bleeding, and would be the reasons that I would want to see a patient for possibly STI testing and for a physical exam at that point.

Sara Klockars

Excellent.

Craig Williams

Uh add briefly that you know, warning patients to expect spotting or intermittent bleeding. So continuous bleeding would be a red flag. So we've always kind of said seven days. I think the labeling for OPIL is going to say if there's bleeding for eight or more days, but persistent bleeding would certainly be a concern.

Stephen Carek

Yeah, I agree with that. Those comments like for most refills on prescriptions, I mean, don't you have to see the patient most of the times when we start getting these abnormal situations or for preventative screenings, namely like a PAPS mirror, we want to get the patient in the office, do our, you know, do our due diligence exam, testing, whatever else is needed to help work that up thoroughly.

Sara Klockars

Great. Super helpful information. Thank you all. I also wanted to kind of get your thoughts from each of you real quick before the end, as to who would be an ideal candidate for OTC, Norgesterol. Could you describe the perfect patient?

Sarah E. Stumbar

It's probably not a patient who I would see in my office as someone who's walking more into where all of you are working in the parts who's looking for an efficacious birth control method, but maybe doesn't have an access to a prescriber. And obviously someone who's a medical candidate as well, based off of everything that we spoke about before. But I think that that really highlights that the major benefit of this is the fact that it should hopefully expand access to birth control methods for our patients. Excellent.

Stephen Carek

I agree. I think the ide the ideal patient with this is probably someone who's relatively young, healthy, but it definitely just has immense barriers to coming and seeing a healthcare provider in any setting, whether that's rural, inner city, whether their family or whoever they live with, guardianship may not allow them to get access to birth control. It just I think reduces so many barriers for patients that may be at high risk socially, economically from getting pregnant, or just have that desire or the ability to choose when and if they want to get pregnant. Those are probably the patients that would benefit the most from this.

Craig Williams

Yeah, no, those are spot on turnists. I'll add that I think that's exactly right, that this is for patients who didn't previously have access to the healthcare system or a provider.

Narrator

We hope you enjoyed and gained practical insights from listening into this discussion. Now that you've listened, pharmacists, physicians, and nurses can receive CE credit. Just log in to your pharmacist letter or prescriber insights account and look for the title of this podcast in the list of available CE courses. You'll also be able to access and print out additional materials on this topic, like charts and other quick reference tools from the Pharmacist Letter and Prescriber Insights websites. If you're not yet a pharmacist letter or prescriber insights subscriber, find out more about our product offerings at TRCHealthcare.com. Be sure to follow or subscribe, rate, and review this show in your favorite podcast app. It helps spread the word about our show and is a great way for you to let us know how we're doing. You can also reach out to provide feedback or make suggestions by emailing us at contact us at trchealthcare dot com. Thanks for listening to medication talk.

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