Health care providers ‘excited’ about convenient, safe OTC birth control pill
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Key takeaways:
- Opill is available without a prescription for purchase in-person and online in 1-, 3- and 6-month packs.
- This OTC option alleviates some barriers for women struggling to access effective contraception.
In March, the first nonprescription, over-the-counter contraceptive pill became available to buy in stores and online. The progestin-only pill is an important step in boosting access to birth control, according to women’s health providers.
As Healio previously reported in July, the FDA approved norgestrel 0.075 mg (Opill, HRA Pharma) as the first daily OTC oral contraceptive in the U.S. The approval set the stage to provide adolescents and adults with the option to purchase an oral contraceptive without a prescription at drug stores, convenience stores, grocery stores and online. Prior to this, Opill had been FDA approved only for prescription use.
On March 4, Opill was officially released nationwide in packs of 1-, 3- or 6-month doses with prices ranging from $20 to $90 depending on the number of months purchased. Opill is effective within 48 hours after the first dose for women who are not currently on any contraception.
“This is something that advocates for women’s reproductive health have been fighting for years for in the U.S. Birth control pills outside of the U.S. had been available without prescription for a long time now,” Frank B. Williams, MD, MPH, a maternal and fetal medicine specialist and research medical director of the Women’s Health Center of Excellence at Ochsner Health, New Orleans, told Healio. “Opill is not a new medication. It’s got a great safety profile and is effective when taken with optimal use. Now, there’s one fewer barrier for somebody who wants birth control.”
Alleviating obstacles
Opill offers the option for women to obtain a safe and effective contraceptive pill without a prescription, which may help alleviate some reproductive health care barriers, according to Williams.
“We know, trying to make our own doctor’s appointments, that making an appointment in a timely fashion is not always the simplest or most straightforward thing to do,” LeeAnn Tanaka, DO, family medicine specialist and assistant professor of family medicine at the Philadelphia College of Osteopathic Medicine, told Healio. “Having the ability to do something over the counter is revolutionary from the perspective of contraception. Hopefully, Opill helps people take their reproductive goals into their own hands.”
Women who may benefit the most from Opill are those encountering barriers to receiving regular care such as those who may not have time or be able to attend annual exams or those without access to women’s health care providers. For women living in more rural areas with huge gaps in reproductive health care providers, Williams said, Opill may “open the door” for them to receive proper birth control.
Opill might also benefit those without insurance because the cost of Opill might be similar to that of out-of-pocket doctor’s appointments and prescribed birth control methods, according to Tanaka.
“Opill actually has a cost assistance program if you meet certain criteria,” Tanaka said. “You have to not have active insurance or be able to be covered by insurance, your income level has to be at a certain threshold, and you have to be in the U.S.”
In addition, Opill may benefit adolescents who might not want to talk about birth control with their parents. Adolescents now have the option to obtain safe and effective birth control without a bill being sent back to their home, Tanaka said.
Another patient population that may benefit are those skeptical of the medical system and reluctant to visit providers, Williams said. Opill gives this group the option to obtain safe and effective contraception without needing to speak to a health care provider.
Opill can also benefit women with current contraceptive prescriptions. For example, women using prescription birth control can substitute Opill when prescriptions run out or are forgotten to avoid pregnancy in the interim.
“I think Opill’s simplicity is going to be appealing to women, and I hope that this can be a backup for women who find themselves out of packs of pills,” Anita Nelson, MD, professor of obstetrics and gynecology at Western University Health Sciences, Pomona, California, told Healio. “Opill can either be their primary method or it can be a bridge method.”
In addition, Opill might help to reinforce that the progestin-only pill is safe, which might carry over into other contraceptives, according to Nelson.
“People may have more faith in the safety of progestin-only pills and, perhaps somewhere along the line, realize that there is no method of birth control that is as hazardous to women’s health as pregnancy,” Nelson said.
Possible downsides, contraindications
As with any medication, users should read Opill’s instructions to see whether they are a good candidate for this method based on medical history or contraindications. In addition, the progestin-only pill may come with effects that are not harmful but may be surprising for users.
Current or recent breast cancer history, severe liver disease, liver cancer, specific lupus subsets and use of certain antiseizure medications are all factors that may indicate that a woman should not use Opill, according to Tanaka.
“Those patients should talk to their doctor about birth control or contraceptive measures that are safe for them,” Tanaka said.
The big issue around Opill is interactions with other medications that might diminish its efficacy, according to Nelson
“That’s one of the things that you have to ask your pharmacist and ask your doctor about,” Nelson said. “If you’re using anticonvulsant medications, as it is one of the medications listed on the package, Opill may not work as well.”
One possible downside to Opill is the requirement of taking it at the same time every day, Williams said.
“If somebody struggles to take something in a regimented fashion, then the effectiveness is not going to be as high as if you’re taking it perfectly scheduled each and every day,” Williams said. “When patients want to take oral contraceptives, my preference is for a combined oral contraceptive because it’s not so time contingent, but there’s certainly a group of patients for which Opill is a great choice.”
Physicians should speak with their patients about ways to ensure they take their medications at the same time daily, Tanaka said.
“I always talk to people about tying it to something that you always do every day without thinking about it,” Tanaka said. “Put the medication by your morning cup of coffee or rubber band it to your toothbrush so that every morning, you open the bottle and take it. We should try to troubleshoot those kinds of difficulties.”
There are other progestin-only pills that suppress ovulation without needing to be taken at the same time daily, Nelson said, but those are prescription-only contraceptives.
Another possible downside is unscheduled spotting or bleeding that can occur with use of progestin without estrogen, Tanaka and Nelson noted.
“We have to let patients know that it doesn’t mean that the pill isn’t working or that there’s something wrong with them and [that] it should get better over time. But this could happen,” Nelson said. “That’s something with any of the progestin-only pills, injections or IUDs, that we just don’t have tight control over when patients will bleed.”
Things to keep in mind
Since Opill is available without a prescription, physicians should remember to always ask about OTC medications when going over patient medical history and spread awareness of Opill with all patients regardless of their contraceptive status.
Opill provides an opportunity for providers to miss medications patients use when going through histories and considering drug interactions because patients might not consider OTC medications as something to divulge to their provider, according to Williams.
“Physicians should maintain vigilance for both prescribed and nonprescribed oral contraceptives in the Opill era,” Williams said.
Opill does not have “a ton” of drug interactions, Tanaka said, but physicians should continue encouraging patients to inform them of any OTC medication they are using.
“It is important to make sure that people know that they should communicate to the doctors that they are taking Opill, so we can make a fully educated plan for them that incorporates what’s already happening,” Tanaka said.
It is important to continue talking about Opill, even if a patient is happy with her current contraceptive method, Nelson said.
“My concern here is that because it’s OTC, it’s not going to be talked about,” Nelson said. “We need to educate about the things that patients have available, whether we’re writing the prescription or not.”
When the emergency contraceptive Plan B was first launched, according to Nelson, it was prescription only and physicians were constantly discussing it with patients.
“We got involved, we promoted and we educated,” Nelson said. “Then it went OTC, and we stopped talking to patients about it and we stopped writing prescriptions.”
Patients should start talking about Opill on social media to spread the word and advertisers should promote Opill as an OTC contraceptive option, according to Nelson.
“It’s great that we’re able to have a medication that’s been proven to be safe and has a low risk of complications available for patients, especially in an era where reproductive access for women has become limited,” Williams said. “Being able to have one more avenue to get daily planning methods to the general population is something I’m certainly excited about.”
For more information:
Anita Nelson, MD, can be reached at anitalnelson1@gmail.com.
Frank B. Williams, MD, MPH, can be reached at frank.williams2@ochsner.org.