Narrator - Dr. Abel  00:00
Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast is

Narrator - ?  00:12
provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy.

Narrator - Dr. Abel  00:17
This podcast contains general information for educational purposes only. This is not professional advice, and should not be used in lieu of obtaining advice from a qualified health care provider.

Narrator - ?  00:27
And now on to the show.

Dr. Sean Kane  00:31
Welcome to HelixTalk episode 168 I'm your co host, Dr. Kane,

Dr. Khyati Patel  00:36
and I'm Dr. Patel, and the title of today's episode is beyond the controversy exploring efficacy and safety of medication abortion and so Doctor Kane, you know, there has been a lot in the news about abortion medications, especially since the overturn of Roe v Wade in 2022 which you know, the one year mark just passed us. The individual states are now passing their own laws and bans and restrictions access to the abortion and this includes access to abortion medications. The rems criteria for some of these medications have relaxed where dispensing is allowed by certified pharmacy. So I feel like these things have reached our front and so this impacts how pharmacists practice. And so the summary, or the goal of this episode, is to bring everything together the science behind the two main abortive medications, mifepristone and misoprostol, and provide a picture of you know, where does access medication in the United States lie as of now?

Dr. Sean Kane  01:45
And Dr. Patel, I'm sure the audience appreciates that we understand how controversial this topic is. And so for the audience, I want the audience to understand that we've really approached today's episode with the intent of focusing on the science in terms of the effectiveness, the safety, and to some extent, the legal implications of medication induced abortion. It's not our goal to be controversial. It's not our goal to get into the politics or ethics or anything like that. So we're really trying very hard to stay in the non controversial area as much as we can. And I hope the audience can appreciate that.

Dr. Khyati Patel  02:19
Yeah, and what we are talking or summarizing here is based on the facts and what's out there in terms of the legal landscape. But to start us off, Dr. Kane, just to kind of put a you know, land of the layout here is that the termination of pregnancy under Medicaid medical care is done using either procedures, medical procedures or medications, depending on the time and gestation. There are two medications approved by FDA in the United States, mifepristone and misoprostol, that are indicated for medication abortion up to 70 days of gestation, 10 weeks. And the use in this manner is also supported by major national as well as international organizations,

Dr. Sean Kane  03:02
and just to give some statistics to the current landscape in the United States, 60% of abortions occur at or before 10 weeks of gestation. This is 2017 data, and almost 40% of those were medication induced abortions, as opposed to surgical procedures. So at least back in 2017 the majority were surgical procedures. Fast forward a couple years now, in 2020, 53% of abortions are now performed using medication. So it's becoming more common to use medications as opposed to a surgical procedure, and that shift is in part due to the availability of these medications that we're talking about today. We've seen this shift over several decades. Actually, it wasn't just 2017 to today. From a cost standpoint, a medication abortion is cheaper than a procedural abortion in the first and second trimester. The cost, roughly, for the medications is cash price of about $500 in the United States, but in foreign clinics and other pharmacies outside of the US, it's probably half the cost. So that gives you a rough sense of cost, and that this is a common way that abortions are done in the United States,

Dr. Khyati Patel  04:14
and then there is more legality behind you know how the insurance coverage comes about too. So this cost really is just out of pocket cost. If patient is paying out of pocket, they don't have insurance, or they have they live in a state where, you know, Medicaid, for example, is not bound to pay for these services, right? So it's going to be different depending on where you live. But Dr. Kane, you know these two drugs, we've obviously heard about them more so in the news now than before, and we were talking earlier, as well as that, we didn't get to dive into these drugs as in detail when graduating from school. Obviously we don't practice in these areas either. So to inform our audience, let's go into some of the. The nitty gritty, the pharmacology and availability of these medication before we dive into the efficacy and safety and Common uses.

Dr. Sean Kane  05:10
So Dr. Patel, why don't we start with that first drug, mifepristone. This was approved back in 2000 Can you tell us how it was approved, or what was unique about its approval?

Dr. Khyati Patel  05:20
Yeah, there's been a trailing history here with mifepristone approval. Initially, it was approved by FDA in 2000 under sub part H provision. Basically the sub part H provision requires restricted use. And now fast forward in 2007 these restrictions were formally introduced as REMS (Risk Evaluation and Mitigation Strategies), and so the subpart H introduction now has changed to REMS criteria, and we're going to talk about those aspects in just a little bit. But mifepristone, brand name, Mifeprex, is the one that's used for medical abortion. That's a 200 milligram tablet. In 2019 a generic product was also approved for its use. There is another brand, Korlym, that's used for hyperglycemia that's related to Cushing syndrome. This particular product is a 300 milligram tablet, and no generic is

Dr. Sean Kane  06:19
available now. From a mechanistic standpoint, mifepristone is a selective progesterone receptor modulator. What that means is that when you have higher levels of progesterone, it acts essentially as a competitive progestin antagonist. So when you have lots of progesterone, which is something that happens during pregnancy to maintain the uterine wall, and you take this medication, it's going to block some of that progesterone from working, and therefore you'll have an anti progesterone, or anti progestin like effect. It's going to induce endometrial necrosis, cervical softening, uterine contractions, prostaglandin sensitivity, and we'll talk about prostaglandins in a second. And for that reason, this is usually used in combination with a prostaglandin analog like misoprostol, which is the prostaglandin e1 analog. Now in other patient populations that are not pregnant, so where you don't have high levels of progesterone, the higher doses of this medication, of mifepristone, is used as a partial progesterone agonist, so it will actually promote progesterone as opposed to blocking it in the presence of a low progesterone level. And this is helpful, as we mentioned, in hyperglycemia because of Cushing syndrome. And we won't get into that necessarily in this episode, but just note that it can have this modulatory effect on progestin, either blocking it if the levels are really high, or augmenting it if the serum levels are really low.

Dr. Khyati Patel  07:46
And these two were FDA approved uses. There are some off label uses for this drug too, which is, you know, patients who've had miscarriage, the early pregnancy loss for, you know, and obviously those patients who are uncomplicated, so they don't have heavy blood loss or sepsis and things like that, who do not want to undergo like surgical evacuation of the tissues, and then the other uses termination of the ectopic pregnancy. So, you know, there are some, there are some dire situations where these medications could be used. As far as the dosing is concerned. We kind of laid it out that this is always used along with that prostaglandin, even analog, the misoprostol. However, on day one is where this dosing of mifepristone lies, which is given as a 200 milligram tablet, and then the misoprostol is followed 24 to 48 hours after we're going to talk about the regimens later on. And then, if

Dr. Sean Kane  08:42
you were to use this for cushion syndrome, the dose is completely different. So instead of 200 milligrams once, you're going to take it every single day, and the doses can be up to 1200 milligrams a day, so absolutely different than how you would take it for termination of pregnancy. And from a pharmacokinetic, pharmacodynamic standpoint, the main thing to know is that is absorbed fairly quickly. Its onset of action is fairly fast. The half life is depending on how many doses you need, but roughly 18 hours, and it goes through the CYP3A4 system for metabolism,

Dr. Khyati Patel  09:16
and then one dose situations. You know, it might not be a big deal, but just just so the audience knows this is metabolized by CYP3A4. So you're looking for some drug interactions here. But again, with the one dose situation, we don't think that this interaction gonna be substantial.

Dr. Sean Kane  09:32
And then for our second medication. And we said, again, the typical scenario is that a patient is going to take both of these medications. The second medication is misoprostol. The brand name is cytotec. It's available as 102 100 microgram strengths. And as we mentioned, this is in a prostaglandin e1, analog

Dr. Khyati Patel  09:51
again, when it's, you know, used in medical abortion and pregnant patient, it leads to cervical softening, induces those uterine. Contractions. Again, it's, you know, kind of used as a follow up to that mifepristone dosing. However, there is off label use of using multiple doses of misoprostol in the event that mifepristone is not available. Again, this is an off label use. You know, in my in my research for this episode, I found that in non US countries or foreign countries, this is a commonly used method when mifepristone, again, is not available. Interestingly enough, Dr. Kane, though, outside of you know this particular use, we've heard misoprostol before. I learned about this one in pharmacy school, for sure. It's a prevention of gastric ulcers. Yeah.

Dr. Sean Kane  10:45
So when patients take NSAIDs, NSAIDs block the production of a variety of different prostaglandins through blocking Cox one and Cox two enzymes. And one reason that patients can get gi ulcers is that they don't have enough prostaglandin e1 and you can essentially give the patient the prostaglandin e1 that they would normally produce to help protect their gastrointestinal lining in their stomach, so misoprostol can replace what they aren't producing from a prostaglandin standpoint. And there's actually a combination product on the market where they've combined misoprostol with diclofenac. And the brand name of that is arthrotech, kind of like arthritis and technology as a combination brand name there. But you can also just get it on its own, where you would take it, you know, two to four times a day to help prevent gi ulcers in patients that really want to take an NSAID but have a history typically, of Gi ulcers or bleeding, yeah.

Dr. Khyati Patel  11:37
And just like mifepristone here, Dr. Kane, there are some off label uses of misoprostol, again, in early pregnancy loss, to induce labor, also to prevent and treat postpartum hemorrhage and to kind of complete the incomplete abortion. So give additional doses to complete that medical abortion. Dosing here, you know, as part of that combination regimen with mifepristone, you know the misoprostol is going to be given 24 to 48 hours after. We're going to talk about the regimen in just a little bit, if you are using it as an off label use for monotherapy. Again, that's going to be dependent on patients gestational age. But in general, know that this is, you know, administered frequently, every few hours until the fetus and the placenta are expelled. Dosing is a little bit different, obviously, for when we use it for gastric ulcer prevention. This is 200 microgram four times a day that's used, as you mentioned, Dr. Kane Arthrotec, or there is a combination of diclofenac and misoprostol added in there. This could be dose two to four times per day, depending on the indication.

Dr. Sean Kane  12:50
Then, from a kinetic standpoint, this is absorbed very quickly, and it has a fairly short half life. We're talking 20 to 40 minutes. And that's one of the reasons why, depending on the indication, you would take it either multiple times a day or every few hours until the abortion is complete. So short half life, really quick onset of action, right?

Dr. Khyati Patel  13:10
And something that is more interesting Dr. Kane is the handling and the access of these medication. And I'm not talking about legal access. I'm talking about just what's FDA mandated in terms of that restricted distribution in the REMS criteria? I do remember working back at my pharmacy when I was in pharmacy school. Is very few times that we had to fill this prescription or handle the prescription. We were asked to put on gloves, and so there is a requirement in the label when you're handling the drug, such as receiving, unpacking, placing it in the storage. Single gloved hands are recommended again. Single globing is also recommended if we are in the clinic and administering this medication oral doses to the patient

Dr. Sean Kane  13:56
and from an access standpoint, Dr. Patel, earlier on, when we talked about mifepristone, you had mentioned that it was originally approved, kind of under this restricted use criteria, and then that 2007 can was converted into a rems program. Can you tell us a little bit more about where things went after the REMS program in 2007

Dr. Khyati Patel  14:15
Yeah, so the REMS is FDA, way of regulating high risk medications, the onus is on the manufacturer of the drug to collect safety information, make sure the use of the medication is done safely, both by the providers and the patient, and then track this data, provide the data to the FDA, and then FDA independently reviews this data to decide whether they want to further restrict the access to the drug or loosen up the access to the drug in the not just related to mifepristone, just overall, this REM structure came to FDA in 2007 slowly down the road in 2011 the first rems for. Was added, and this was the clinicians needed to be certified and complete a prescriber agreement form before they could prescribe, and the clinician had to make sure that the patient they were giving this medication also was completing patient agreement form, and the counseling was done so two part REM system that was done, and with this rems, again, the pharmacies could not stock and dispense mifepristone. It was still clinicians getting it directly from the manufacturer. Once they had these forms in place, the manufacturer will release the dose given specifically to the patient who has filled out that agreement form. So again, this was very close distribution, restricted access,

Dr. Sean Kane  15:49
and I'm guessing, given the fairly favorable safety data that we'll talk about, this high restriction was probably not well received by certain organizations that wanted to relax the restriction of abortion medications in the US. Is that correct?

Dr. Khyati Patel  16:04
That's absolutely right. Then one of the organization is the, you know, ACOG, the American College of opposition and gynecology, who were kind of opposing this strict rems criteria that were in place. So that made FDA to kind of reevaluate this. Things kind of boiled down to a quicker roll ball down the hill when the public emergency was put in place during the pandemic. So in July, 2020 FDA, basically, was, you know, quote, unquote, enjoined from enforcing this in person dispensing requirement. So again, the clinician still needed to be certified, the patients still needed to be filling out the form, but they basically said they're not really enforcing this in person dispensing requirement. So lo and behold, from January 2021 to December 2021 there were still more debates. FDA kind of reviewed the REMS criteria and finally decided to come out and say we are removing this in person dispensing requirement. And what this meant is that the provider wasn't the only entity that could dispense the medication. If a pharmacy was to certify they could also dispense the medication, or the provider could mail, so provider will still get the medication from the manufacturer, but they could mail the medication to the patient rather than that. You know, you have to do this in clinic. You have to do this in my presence, kind of a thing. At that time, FDA announced plans for pharmacy to get the certification. However, it took them until this year, in January, to really implement that certification process for the pharmacy. So big news, big legislatory update came out January 2023 that pharmacies who wishes to dispense this drug needed to complete the certification process and they could dispense mifepristone to the patients for this purpose.

Dr. Sean Kane  18:06
And Dr. Patel, I just want to highlight that, you know, we can argue about whether this process is necessary for mifepristone or not, but I did want to highlight that there are other medications on the market, and Clozapine comes to my mind at the moment where dispensing pharmacies do have to do certain tasks, whether it's certification or submitting lab values or checking lab values before a medication can be dispensed. So it's not like this certification thing is only for mifepristone. There are other medications out there that belong to rems programs that pharmacies have to do certain tasks or check certain things before they are allowed to dispense the medication. Again, the argument here is whether this degree of checking is necessary for mifepristone, but there are other programs out there for other medications that have a similar format, right?

Dr. Khyati Patel  18:57
And you know, if you're working in a retail pharmacy, this decision is going to be made at your, you know, national office or chain level. You're not going to have to individually fill out the certification form. You're going to be, you know, they're going to be certified at a national level. This really boils down, if you are independent pharmacy, whether you decide to do it to really, like, look into the certification process and do it as an individual pharmacy owner.

Dr. Sean Kane  19:21
Well, that was mifepristone in terms of misoprostol. This does not have an FDA rems. So this can be dispensed like any other medication by any other prescriber at any other pharmacy. Remember, this is medication that is somewhat commonly used to prevent NSAID-induced GI ulceration. So this is more widely used for other things, aside from a medication induced abortion, so there are no restrictions for misoprostol.

Dr. Khyati Patel  19:48
And there is also that argument about in office versus home use. We did talk about that the in person requirement was lifted, but again, none of the package insert. Or labeling of this drug require that dosing have to happen in the provider office. So again, this was just an additional rems criteria that was put in place for the previous one. And so now patients are okay to use these drugs once dispensed either from the pharmacy or clinicians that are certified, they could take it that at home, and so the services for telemedicine to offer medication abortion also have increased. There's some data out there, when compared to standard of care practice that there is equal efficacy to in person visit with no additional safety issues. When you know this, drugs are given using telemedicine modality, this further reduces the rate of delays or care that's provided in remote areas. However, just because there is that overall ban in some state, this practice is banned in the 14 states that ban abortions in general.

Dr. Sean Kane  20:57
So in terms of the regimens that could tell so we went through the medications, we kind of alluded to that there's a couple different regimens here. There is a kind of preferred regimen. The preferred regimen, which is the FDA approved approach, is that for women who have a gestational age of 70 days or less or 10 weeks, the regimen is mifepristone, 200 milligrams orally, and then one to two days later, 24 to 48 hours later, misoprostol, 800 micrograms taken buccally, so in the cheek and let dissolved. And that's the preferred regimen. There's also a World Health Organization recommendation for gestational age, up to 12 weeks, as opposed to 10 weeks. And the regimen is fairly similar. So it's mifepristone, 200 milligrams orally. So same regimen, and then you wait one or two days, same thing, and then misoprostol, 800 micrograms, same dose. But the only difference here is that the misoprostol can be given buccally, sublingually or even vaginally. So three different regimen routes that are available from the World Health Organization that are not necessarily FDA approved, but are still a preferred route of administration, right?

Dr. Khyati Patel  22:06
And again, we're going to emphasize that this combination regimens are more preferred. There is an alternative regimen, which is misoprostol only, as we discussed. This is not FDA approved, so if you were to use it, that would be considered off label, as I also mentioned, though, you know, this is a commonly used regimen internationally. How is it done? Basically, patients going to take 800 microgram of misoprostol either of those three routes, buccally, sublingually or vaginally, but they're going to do it every three hours up to three doses. Now, the studies that we are looking at use no more than three doses. But then if you look at the WHO guidance, they're not saying that there is a max dose. The package insert however does list that that you need may need to use less strength doses as your gestational age increases, and then it also recommends against vaginal use and those who have obviously vaginal bleeding or signs of infections.

Dr. Sean Kane  23:13
So Dr. Patel, if the monotherapy with misoprostol is not preferred, I'm assuming that we have some efficacy or safety reason why we prefer the dual regimen as opposed to the monotherapy regimen.

Dr. Khyati Patel  23:25
Yeah, and you know, we're going to talk about the efficacy for dual regimen in just a little bit. But just comparing this mono therapy to combination regimen. You know, the termination of pregnancy success is 80 200% of the time. Major complications were rated less than 1% obviously, it's misoprostol only regimen, so the frequency of side effects were higher, particularly diarrhea, fever and chills.

Dr. Sean Kane  23:53
Now there are other regimens out there for other patient populations. So for example, in the second trimester of gestational age, a similar combination regimen is used sometimes, but sometimes you also do other things, so additional interventions like oxytocin, but in those in the second trimester, it's more common that you'll see a surgical approach, so surgical procedure, as opposed to a medication only regimen To induce abortion in that second trimester?

Dr. Khyati Patel  24:22
Yes, absolutely right. And I want to remind our audience at this point that we have linked the ACOG bulletin for medication abortion use with, you know, 70 day or less of gestational age. However, there is another bulletin for second trimester abortion, and that's where you know they're recommending the D&E, which is the procedural type of abortion that is preferred. And you can find that link as well. In general, you know supportive care should be followed for a lot of these patients, to manage the side effect, to manage the. The the abortion in general, and this, this includes pain management, and generally, NSAIDs are preferred in this scenario over other remedies such as opioids. There is debate about prophylactic use of antibiotics in general. You know, we can go into it in very detail, but in general, the routine use of prophylactic antibiotics is not recommended, so

Dr. Sean Kane  25:24
from an efficacy standpoint, in terms of how effective is it when someone takes these medications or this regimen for abortion, for those that are under the FDA indication, so that means gestational age of 70 days or less, combination therapy is more effective than misoprostol monotherapy and with combination therapy, we're looking at a success rate of a complete abortion of 91.6 to 99.7% so it depends that range is due to different misoprostol route, dose and the duration of time between the mifepristone and the misoprostol. So you'll see some variability there, but generally, we're easily looking at more than 90% and in some cases, almost 100% effectiveness, depending on the route and timing and things like that.

Dr. Khyati Patel  26:12
And you know what could go wrong, which is basically failure of abortion, or, you know, even after administering the doses patient has ongoing pregnancy. Again, range here due to different studies measuring the interval between the two drugs, but that was ranging between zero to 5%. Again, the risk of failure of abortion with this regimen could be higher if patient is in the advanced gestational age, and therefore, you know, recommended method is D&E over this medication abortion at that point.

Dr. Sean Kane  26:52
So from a safety standpoint, and again, one of the reasons for a rems program, honestly, the primary reason for a rems program is because of safety concerns, whether it's a side effect of a medication, usually it's a rare but serious side effect or additional monitoring that's needed. So from an adverse drug reaction standpoint, what are some of the common side effects that we're going to think about? So we're looking at more than 10% often more than 50% of women who take these medications are going to have gi intolerances like nausea, vomiting, diarrhea, they may have weakness, dizziness, headache, chills, fever, hot flushes, warmth. These are very common expected side effects of the dual regimen that we're referring to today.

Dr. Khyati Patel  27:36
Yeah, and it's it's important to note that most of these side effects come after misoprostol administration. So again, do a regimen, mifepristone first, and then misoprostol follows. And a lot of the side effects are related to that misoprostol administration.

Dr. Sean Kane  27:54
And Dr. Patel, as you mentioned earlier, the route matters, right?

Dr. Khyati Patel  27:58
Oh, 100% and so again, these side effects are dependent on the route of misoprostol administration as well as gestational age. One example of how the route matters, evidence says that the vaginal route has less gi ADRs than buccal and sublingual route, and that makes sense.

Dr. Sean Kane  28:17
And then there are other risks and patient counseling, things that we should talk about. So the risk of serious complications are less than 0.4% and the risk of death during the time of the medication induced abortion is less than 0.001% so we're looking at a very low risk of serious complications and death.

Dr. Khyati Patel  28:39
And what are the serious complications? Right? Heavy bleeding. You are aborting the entire uterine wall tissue, fetus, all of that. So heavy bleeding is there? Obviously, patients are counseled very well on what to expect, and they're told if they're having like more bleeding, which is like two Maxi Pads per hour for two consecutive hours, or they need to seek medical care, because they may need more surgical or procedural interventions to lead to complete abortion in that case. And so another risk is, as we talked about, failure of this regimen, right? Meaning the pregnancy doesn't terminate, it keeps on going. But then we know the reason why we have to glove up, you know, handling this medication is because of the potential teratogenicity. So again, we talked about the efficacy of this regimen. The efficacy is very high, but in very rare cases where pregnancy is not terminated, there are increased risk of birth defects. We're talking about limb defects as well as accompanied with facial paralysis in the fetus as well.

Dr. Sean Kane  29:50
So Dr. Patel in terms of monitoring. So once the decision is made to prescribe the medication, the medication is given. We talked about bleeding as the main complication. What are. There monitoring parameters to look for efficacy and safety that we need to be aware of.

Dr. Khyati Patel  30:04
Great question. Dr. Kane, you know, we talk about the overall comprehensive care for these patients. Now there's some mixed data, and you look at the patient you have in front of you, meaning you individualize these monitoring. It's not a standard of care. However, things such as RH testing and patients who have anemia at baseline, you know, testing for hemoglobin, hematocrit and ultrasound, clinical exam and ultrasounds are done in some patients, I would say some of these tests are also repeated again in your high risk patient, individualized this care. Generally, no follow up. Care is needed. However, if you look at individual rules and restrictions per state, there are requirements to complete the evaluation before you know, maybe it's a clinical exam, public exam, and then it's an ultrasound before and after. So again, depends on the state and the ruling. But in general, what ACOG recommends is that individualizes monitoring for the patient you have in front of you, and

Dr. Sean Kane  31:16
then, of course, you know after the abortion contraception is something that should be considered if someone's going to be sexually active and does not want to get pregnant in the future. And all of those contraceptives can be resumed, except for IUDs or permanent contraception within day one of the medication abortion. So those can be resumed down the road, but all other forms of contraception can be started immediately. And then, of course, talking about fertility in the future, having a medication induced abortion does not impact the ability to get pregnant or pregnancy outcomes in the future. So someone can still become pregnant in the future, even though they had a medication abortion, right?

Dr. Khyati Patel  31:56
And this is important for a patient to understand, in case they need to plan out, you know, contraception thereafter. And as you said, Dr. Kane, really, you know, IUD is not to be used on day one, but really, after a successful medication abortion, all contraceptives are considered to be safe and initiated, so patients should be counseled about that as well.

Dr. Sean Kane  32:18
So, Dr. Patel, we've really covered the pharmacotherapy of medication induced abortion. Not surprisingly, there's a bunch of legal stuff that we have to cover to help providers understand what is the current landscape of the legal implications of medication induced abortion in the United States. And I'm sure everyone is going to originally think of Roe versus Wade in 1973 this was a Supreme Court ruling. The Supreme Court said that it is constitutional for pregnant women to have the ability to have an abortion in the United States, right?

Dr. Khyati Patel  32:53
This was overturned with the decision that was made for Dobbs versus Jackson's woman Health Organization case where the Supreme Court overruled or overturned Roe v Wade and stated that the Constitution does not confer a right to abortion. And what this essentially did, Dr. Kane, is that, you know, at federal levels, you know, we're not saying this is doable, and so the states kind of had the free rights and fee for grabs kind of rules and regulations. So states started deciding and drafting some of the laws. Mind you, since the passing of Roe v Wade, there were some states with trigger laws that were put in place. And what trigger laws really mean is, if at one point in time roe is overturned, these laws will go in effect immediately. So they were just kind of waiting to be there. We are one year past the ruling now. And so it's important for us to understand what the axis of abortion in general, especially medication abortion lines in the United States. And you know, sorry to say, but it's a complete chaos and essentially a political game. What we know is that there are 14 states out there currently banning abortion, and when they say they're banning abortion, the penalty lies on any healthcare provider who offers the service most states legal language does not include penalizing patients who use abortive options to terminate pregnancy.

Dr. Sean Kane  34:33
And you know, in those 14 states, 13 of the 14 do have exceptions. So rape, incest, fetal abnormalities, endangerment to the pregnant patient, things like that. There are exceptions, but one of the states does not allow for those, those exceptions. So again, it does vary by the state. Dr. PHIL I think that we have a link in the show notes for a resource in terms of what states do, what and how is that correct?

Dr. Khyati Patel  34:59
That's right. You know this, things are changing. As we speak, there are a lot of cases in the court at this time, you know, someone passes it, and then there is a ban that's put in place. So there are a few trackers out there. Kaiser Family Foundation is doing a great job keeping all this information straight. And there is another tracker, which is gut natural Institute, at both of these trackers, you can look up specific information for your state. And so if you are out practicing pharmacy in certain state and you want to know what the laws are, you can go to either of these trackers. And you know,

Dr. Sean Kane  35:34
Dr. Patel, obviously we're not going to cover all 14 states, but maybe it would be helpful for the audience to understand a couple examples of what the laws are like in a given state, and what are some restrictions or lack of restrictions, or or things like that, different laws that have been passed in those states.

Dr. Khyati Patel  35:51
Yeah, you know, in 2022 and 23 more proactive legislations have passed. So we talked about the 14 states completely banning but then there are states like Vermont, Washington, New York, they're kind of passing bills to safeguard their providers from using or providing these services. You know, to the extreme Colorado had to put out and create a ban for abortion medication reversal. And just to, you know, enlighten the audience here is, there is a belief that if mifepristone is an anti progesterone, if you give progesterone, you can overcome the effect of abortive medications. Again, this practice is not evidence based. Acot recommend against this. And so Colorado had to come out and kind of say, you you can't do these unfounded medical practices. On the other hand, Wyoming just passed a specific law that states, you know, any medication that could be used for medic medication abortion are banned again. This is, you know, tied up in legality at the moment, but they are trying to pass these type of laws and telemedicine, right? We're talking about access to these drugs, so not just at a clinician's office or not just at a pharmacy, but what is its fate in terms of telemedicine? So again, 25 states are allowing it freely, I love and allow it with some restrictions. And the restrictions are, example, you have to have a you know, provider visit in two days. And so if a patient lives in a different state, and they have to come see the provider in two days, that probably is not possible. And 14 other states ban it completely. And this kind of then has implications on whether pharmacies can mail these medications

Dr. Sean Kane  37:44
or not. I personally have seen this in the news, and I'm sure many of our listeners have as well, that different attorney generals from different states are warning retail chains to not send these medications to the residents of their states, and then opposite political parties are now writing letters to those same chains, or urging them to continue mailing those medications. So it's really turning into a very political fight, which is really not surprising, to be honest with you, but that's what it's turning into. And US Post Service, the people who would actually do the mailing have clarified that they will mail these two meds because it is supported by the law to mail them. So this really is a state by state fight, as opposed to something that has been regulated or restricted on the federal level, right?

Dr. Khyati Patel  38:29
And I think that other important litigations that are that everybody is watching, because, you know, there's going to be, it's going to be have an influential implications on the use of these medications, as well as just overall authority of FDA approval for future medication. So we're on for some slippery slope over here. But most people also know about this. You know, filing by Alliance for Hippocratic medicine in Texas against FDA, that FDA has violated certain acts, including the Administrative Procedures Act as well as the ffdc Act in its initial approval of mifepristone, but it's subsequent loosening of The rems criteria and also, by allowing mailing of the anti abortion medication, you're violating this camp STOCK Act. So there's multiple different claims here. Again, in my opinion, this is a slippery slope, because if you overrule this particular drugs approval by FDA, there is a chance that you know it can happen to other medications that FDA may have jurisdiction over for approval.

Dr. Sean Kane  39:45
Then, of course, the there are opposing filings that are favorable to allowing access to these abortion medications. So West Virginia and North Carolina, they recognize that the federal law supersedes the state law. Therefore the FDA approved. People in the regulation of mifepristone should not and cannot be opposed by states that are making their own laws, and Washington and Oregon have attorney generals that are questioning the need for rems at all for mifepristone. So we are seeing, again, a state by state fight with very different perspectives of the role of the federal government, with the approval and ongoing review of these medications.

Dr. Khyati Patel  40:24
And obviously, Dr. Kane, you know, this is when these two meds are used for abortion reasons. We talked about a non abortion indication that uses and even the states who have banned medication abortion, they allow pharmacists to dispense these drugs if they are used for non abortion indication. So if you're in one of those states and you're practicing as a pharmacist, you have the right to reach out to the prescriber and ask for the indication if it's not already provided on the script.

Dr. Sean Kane  40:55
Now, Dr. Patel, the obvious question here is, from a federal level, this is legal to have a medication induced abortion, but if you would like a medication induced abortion and you live in one of the 14 states that completely prohibits it, what are your options in terms of aside from traveling to a different state, are there options, or are patients doing certain things that maybe aren't preferred options because of their lack of access.

Dr. Khyati Patel  41:22
This is a great question. Doctor Kane, you know, we kind of talked about how the medication abortion, method of abortion has picked up from 2017 to 2020 we've seen a huge jump. More than half the abortions are done this way. Interestingly enough, since the overturning of the bro there's been a lot of confusion as to where states stand. And there was a poll done by Kaiser Family Foundation, published in February of 2023 that shows, you know, 50% of the adults don't know what their state laws are. So not just the people who live in states who have total ban, but people who live in states who don't have any ban, or maybe have losing restrictions, don't know how to access this medication, and a lot of them, unfortunately, are turning to foreign services, and I'm talking foreign clinicians as well as foreign pharmacies, to obtain these medications, as you can imagine, this is a slippery slope. Again. Here there was a rems criteria for a reason. This process is still supposed to be done under supervision of a physician, and so FDA, in their rems declaration had to kind of put a statement out and advise patients against this practices. Again, some would, you know, the abortion right activists would come out and say, Well, how are we supposed to or how are patients supposed to get the access? And it's just, it's confusing, for sure,

Dr. Sean Kane  42:59
and you know, from the perspective of how this impacts a practicing pharmacist, the confusion is probably the worst part, right? So the chaos and confusion of different states having different laws, the laws are passed, but then the court system puts a hold on those laws and just kind of understanding what is the current state of the current state that you live in when it comes to medication induced abortion. And you know one area is that Boards of Pharmacy or state pharmacist associations are going to provide guidance, in many cases, to pharmacists and other health care providers to understand what the current state in their state is when it comes to these medications.

Dr. Khyati Patel  43:39
And so it's important to be involved in your local state pharmacy organizations, or be in touch with your board of pharmacies and not but the least you know, obviously, if you work for a chain pharmacy, you know, contacting your legal counseling team, I'm sure there are a lot of directives coming up, so staying up to date on the communications and the literatures and the training that is given would be the answer at this point.

Dr. Sean Kane  44:06
So Dr. Patel, I think that rounds out today's episode quite nicely, and I hope the audience would agree. I feel that we try to avoid the controversy as much as possible and stick to the science and the drug therapy of medication induced abortion in terms of some key concepts. There are multiple modalities to terminate a pregnancy, but medication induced abortion, safe, effective, growingly more common option in the first trimester compared to a surgical procedure, especially post Dobbs versus Jackson, who decision

Dr. Khyati Patel  44:37
and the FDA approved use of the combination of mifepristone and mesoprostol regimen to terminate pregnancy up to 70 days again, this is 10 weeks of gestation. Is based on strong evidence for its efficacy and safety.

Dr. Sean Kane  44:53
And then again, since the overturning of Roe versus Wade in 2022 that really left it up to the states to. Decide how they wanted to regulate abortion, and as we mentioned, it is complete chaos, and things are changing seemingly day by day, so relying on pharmacy organizations can be helpful for that. So for the listener, if you want to see show notes, we have a variety of references for today's podcast episode. We're also on Twitter at HelixTalk, and we love getting those five star reviews in iTunes, so keep those coming. So with that, I'm Dr. Kane

Dr. Khyati Patel  45:26
and I'm Dr. Patel, and as always, study hard and advocate hard.

Narrator - Dr. Abel  45:32
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Narrator - ?  45:43
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