Over-the-counter pill has improved access to birth control, OHSU study says

The Food and Drug Administration approved the sale of over-the-counter birth control pills two years ago. The decision has dramatically increased access to contraception, according to a new study from Oregon Health & Science University.

Researchers found that more than a quarter of participants who were using the over-the-counter pill had switched from using no birth control at all. They also found that members of the over-the-counter group were more likely to be uninsured and live in rural areas than participants who used prescription birth control.

Maria Rodriguez is the director of both the Center for Reproductive Health Equity and the Center for Women’s Health at OHSU. She joins us with more on the importance of removing barriers to reproductive health care.

Note: The following transcript was transcribed digitally and validated for accuracy, readability and formatting by an OPB volunteer.

Dave Miller: This is Think Out Loud on OPB. I’m Dave Miller. For decades in this country, the only way to get birth control pills was through a prescription. That changed two years ago, when the Food and Drug Administration approved the sale of the pill over the counter.

Now, a new study from Oregon Health and Science University [OHSU] found that this has dramatically increased access to contraception. Researchers found that more than a quarter of participants who were using the over-the-counter pill had previously been using no birth control at all.

Maria Rodriguez is an OBGYN and the director of the Center for Women’s Health at OHSU. She is the lead author of this new paper, and she joins us now. It’s great to have you on the show.

Maria Rodriguez: Thanks so much for having me. I’m excited to be here and talk about this with you.

Miller: What went through your mind when the FDA approved the over-the-counter birth control pill just two years ago?

Rodriguez: Honestly, it can be summed up with one word and that was “finally.”

Miller: Why? Why that word?

Rodriguez: We’ve been waiting such a long time for this to happen. It is a huge endeavor and the result of basically two decades of work by advocates, public health officials and people kind of coming together from industry to make this a reality for people in the United States to have access to. The pill has been available over the counter in countries around the world – more than 100 – for decades in some cases. And that’s how long it took us to get this initiative through and approved by the FDA.

Miller: Why? I mean, if this was the norm in so many countries, why did it take so long in the U.S.?

Rodriguez: I always tend to be a little bit cynical about bureaucracy, and I think it’s hard to distill it down to just one thing, but there was multiple factors. The first is that the FDA has a very rigorous process to move a medicine from prescription to over the counter. It costs millions of dollars for companies to initiate that application, because you have to do all kinds of different studies to show that the drug would be safe, that people can read the label and use it correctly. It’s a considerable amount of work. So, even though we had all this existing evidence, we needed a manufacturer, a partner in industry to kind of come forward and say, “we’re willing to do this,” to make a method available over the counter.

Then, secondly, I would also just say that reproductive health continues to be overly legislated and controlled in the United States. And even though we’ve got great testimonials from public health organizations like the American Congress of OBGYNs, American Medical Association, and we know that this is safer than, say, Tylenol – which you can buy in gigantic jugs at your grocery store – people still have the sense that contraception is not safe, that it might be harmful to women, that we have to regulate it, that we can’t trust women or people capable of pregnancy to make this decision themselves, despite all the evidence we have to the contrary.

Miller: So I want to turn to why so many people did work so hard to make this a reality. And it has to do with the challenges people could face when trying to get a birth control prescription. What were those challenges, or what are those challenges still?

Rodriguez: I think, first of all, it’s important to acknowledge that everybody deserves to have reproductive autonomy – kind of control over their own body, over their own choices. And the decision of if or when you want to become pregnant has huge impacts for not just that person, but their family and even the broader community. So it’s critically important that we give as much control to people themselves over this aspect of their life. And I think some of the desire and effort to do so comes from what we’re seeing nowadays with a real rolling back of those rights and the rolling back of people’s ability to decide for themselves, their reproductive health care.

And what people that kind of came together to work on this did so because they knew the drug was safe. They knew it was working well globally, and they knew this was critically important to the millions of Americans who need contraception to prevent an unintended pregnancy and help them achieve all of their goals.

Miller: And what might have made it hard for them in the past, if it wasn’t over the counter, and they had to get a prescription?

Rodriguez: Yeah. So I think it’s just the reality, in a lot of cases, it can be just the barriers of getting in to see somebody in a clinic. So first, a lot of Americans still are uninsured and that’s likely to continue to get worse with all the cuts that are being proposed to Medicaid now. We made great gains with the Affordable Care Act, but as more and more people are uninsured, it’s cost prohibitive to get into a clinic, to see a clinician and have them prescribe the method for you.

We know that you don’t need any exams or tests before starting the oral contraceptive pill. The CDC has issued guidance on that. But we do have clinics and providers that will still kind of hold back contraception as a way to insist people come in for their annual exam, and that’s just not appropriate. People work busy jobs, they have kids, there’s hard to get childcare, clinic hours aren’t always compatible with work hours – trying to find an evening clinic when you can go to after work if you don’t have paid time off. All of those different things, or if you have to take a bus, two buses to get across town, it’s hard for people to get in to get the care they need.

Miller: It seems clear how the Supreme Court’s overturning of Roe v. Wade, which struck down the constitutional right to abortion in this country, could lead to more demand for contraception. But did it also have an effect on contraception availability?

Rodriguez: Yeah, there’s a lot of emerging data on this. And some of the best information comes from Guttmacher, which did a prospective study of people in four different states. And what they saw was that the demand for contraception was going up, but that access was decreasing, and that, in particular, people felt like the quality of care they were getting was less and they weren’t able to access their preferred method.

That’s really important, because not only is abortion less available in the United States than ever before in my lifetime, but maternal care is in crisis as well. There’s been a very well-publicized crisis in maternal mortality and morbidity in the United States, and that’s just continuing to grow.

So I say that, because when pregnancy is dangerous, you don’t have access to safe abortion and our contraceptive workforce is currently inadequate to meet demand, people who can get pregnant are in a real, real difficult situation, right? So that’s why having this new option become available, where it’s over the counter, it’s safe for almost everyone, it’s private – you can go in and pick it up without talking to a pharmacist, without talking to a clinician – it is so important.

Miller: What were the big questions you wanted to answer in this study?

Rodriguez: I was really curious to see who was using it and why. I’ve also done a lot of research on pharmacists’ prescription of contraception. And while people frequently confuse the two, they’re very different. This is no prescription needed. It’s on the shelf next to your other medications. You can just pick it up, pay for it and walk out.

And what I was hoping to find was that this would be reaching the people who have the greatest barriers to getting care in clinics. That this wouldn’t sort of just be … It’s really important we have a range of methods that are available for anybody, and people need different methods. But I was hoping that it would reach people that weren’t able to get care elsewhere, that weren’t currently using a method, but didn’t want to become pregnant, and maybe not just a matter of convenience for somebody like me who’s, “Oh jeez, I ran out of pills, let me just pick up some packs at the store rather than getting in to see my primary care doctor.”

Miller: That’s what you were hoping to find. What do you see as the most important findings from this survey? And I should say that you did surveys of … was it close to 2,000 people in the end?

Rodriguez: Just under 1,000.

Miller: One thousand. And then about two-thirds of them had prescriptions for the pill and about a third of them had over-the-counter pills. Then you were able to learn more about them. What most stood out to you in those findings?

Rodriguez: Well, I think when I was starting this study, I did hypothesize that maybe at baseline, people that were using the pill over the counter would somehow be different from people getting it filled by prescription. Maybe they would be not in long-term relationships, less sexually active, more ambivalent about whether or not they wanted to become pregnant in the next year. But what I found was, across the board, these were all people that were sexually active, with male partners, that they did not want to become pregnant in the next year. They rated it as “extremely” to “very important” to not become pregnant.

But in the over-the-counter group, nearly three-quarters of them were not using any contraceptive method at baseline. So that’s kind of staggering, right? And the reason they weren’t using it is because a big chunk of them were uninsured or underinsured on Medicaid, didn’t have a regular provider, or couldn’t afford to go to clinic. If you add on to that, the fact that a lot of them were younger and also living in rural areas, you can kind of get a better sense for how some of the sort of social determinants like the conditions in which people kind of live and work affect their contraceptive access.

Miller: I may have read the study wrong, but as I said in my intro, when I read it, I thought that it was 26% of people who had over-the-counter pills who had not been previously using any birth control. You said it was three-quarters. So, did I misread that?

Rodriguez: Oh, I’m talking about the model findings, which showed that people – we had a large 31-percentage-point increase in people moving from no method to the pill. And then another group of people were using a method, so I did misspeak a little bit. I apologize. Another 40% of people moved from using condoms, which are considerably less effective than the oral contraceptive pill, or emergency contraception, which isn’t meant to be an ongoing method, to using the pill. So amongst that whole population, we saw a really large shift in people being able to access a more effective form of contraception that they wanted.

Miller: What did you learn about the demographics of the people who got oral contraceptives over the counter as opposed to by prescription?

Rodriguez: What we learned was really interesting and it did kind of validate what I suspected. When we think about the maternal health care crisis, and we think about abortion bans and challenges in accessing contraception, it’s unfortunately the same populations that keep on being impacted by the same things – sort of ratcheting up the disparities we’re going to see in reproductive health. So that’s young people, teens. It’s people living in rural areas. It’s people who are uninsured, communities of color, and that includes our Medicaid population as well. So we found that the over-the-counter pill was being used by a lot of these groups at a higher rate than getting prescription methods. Younger people and people living in rural areas were much more likely to be using the over-the-counter pill.

Miller: If I understand one of the charts in the paper correctly, the percentage of people who used prescription birth control as opposed to over-the-counter was higher in the West than in most of the rest of the country. How do you explain that?

Rodriguez: Yeah, I think what it comes down to is reproductive health care varies a lot by where you live. That’s one of my areas of work, is kind of looking at how your zip code determines your reproductive health. So we know in certain environments, like in Oregon, you have Medicaid expansion, you have pharmacist prescription of contraception, there’s legislation mandating a 12-month supply of oral contraception be covered by all insurance companies at no cost. We have all these great protective resources, meaning people living here have less of a need for … We have safe abortion, we’ve done a lot of work to improve maternal health.

All of those factors probably make it more likely that people don’t need to get their pill over the counter. There’s more resources available in our state to support reproductive health broadly than a lot of the places in the Southeast, which is where a lot of our over-the-counter population came from. This is just me surmising, we didn’t study this directly, but a lot of places in the Southeast, or where states didn’t expand Medicaid, where they don’t have publicly funded family planning networks that are as strong as in the West, don’t have access to safe abortion, have real challenges with their maternal health as well.

Miller: As you were saying earlier, one of the big policy hopes behind this change was that easier access to the pill would lead more people who want it to get it. And that is what your study found to have happened. I’m wondering if anything surprised you in the data.

Rodriguez: I was a little bit surprised in the sense that I thought that maybe people using the over-the-counter pill wouldn’t be as likely to be partnered or would be more infrequently sexually active, maybe more dating casually. But I didn’t find that at all. These were people that were partnered, were more likely to have already had kids, in ongoing relationships, that definitely did not want to become pregnant. So just seeing what the need was really shocked me, that we found such a big difference, to be honest.

Miller: There is a lot of social media content now saying that birth control is unhealthy or it leads to hormonal imbalances. This is social media content that’s not based on science, but do you think it’s finding an audience?

Rodriguez: Yes, unfortunately. I think, in some ways, one of the biggest threats to our time is some of the restrictions we’re seeing on the press and actual accurate reporting. And also just, we know that the algorithms are serving stuff up that doesn’t necessarily make sense. But people believe it, and people are really likely to get their information from the internet or from a friend.

It’s hard for me as both a scientist and as a practicing OBGYN to kind of understand this focus on hormones aren’t healthy, because it’s something people say to me all the time. And as a physician, I can’t help but say, like, hormones are what keep us alive, like your thyroid hormone, your adrenal hormone, all your pituitary hormones. And the hormones that we have that are in contraceptive pills – estrogen and progestin – are both present at much higher levels in reproductive-age people than they are in the pill. And the condition that they’re really elevated in, which the pill helps protect against, is pregnancy. So there I think is like a little bit of the disconnect where hormones are sort of demonized a little bit, when the reality is they help us all live our lives, and protect our bodies, and do many wonderful things.

I think we need to really listen to women, hear what their concerns are about hormone use and to be able to speak to them honestly and accurately about what are the side effects, what are the potential risks. But I do like to emphasize – this is mainly for other clinicians who frequently are afraid of prescribing contraception because they worry it’ll be dangerous or unsafe – I like to remind people that for reproductive-aged people who are sexually active, the majority of people, 85%, are going to become pregnant in one year. And that’s at a much higher hormone level than anything you’re going to get in the pill. So we have to kind of weigh those competing risks of pregnancy, particularly if the person doesn’t want to become pregnant, with the use of any form of contraception.

Miller: One of the ultimately unsuccessful arguments against over-the-counter birth control pills is that without a doctor’s guidance, people might not take the pill correctly, or consistently, or, say, within the right time window every day. Were you able to look at that in your study?

Rodriguez: Yeah. I mean, first of all, that’s just ridiculous. People are plenty smart, can read a label and make adult grown-up decisions for themselves about how to take a medication. We trust them with Tylenol, with ibuprofen, both of which can have serious side effects if not taken correctly. And we’ve got great evidence showing that people can accurately self-screen for pregnancy and take the pill just fine.

But we have some information that’ll be coming out in about a year, when we finished recruiting for this entire cohort, because what we presented just now is the data from the baseline study. We’re following them up through this next year, which we’ll have all the data next March and we’ll be able to answer more of those types of questions then.

Miller: Maria Rodriguez, thanks very much.

Rodriguez: Thank you.

Miller: Maria Rodriguez is an OBGYN and the director of the Center for Women’s Health at OHSU. She is the lead author of a new study that found that the over-the-counter availability of birth control pills has greatly increased access and use of contraception.

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