Should the pill be available over the counter?

In 2012, a small Pennsylvania college made national headlines for putting packs of the emergency contraceptive pill Plan B in a vending machine in their student health center. Imagine the uproar if that vending machine had packs of the pill in it, too. Selling the pill in a vending machine wouldn’t be legal in the U.S., but more and more people have been asking why not.

Here’s what we know: By answering 15 questions, people are pretty good at figuring out whether they can safely use the pill. Still, it will be a long and expensive process to switch the pill to over-the-counter sales.

Is it dangerous to sell the pill over- or behind-the-counter?

Doctors have argued since 1968 that the pill can safely be sold over the counter (OTC). In 2012, the American Congress of Obstetricians and Gynecologists (ACOG) weighed in to officially recommend OTC pill access in the U.S. That means rather than go to a doctor or clinic for a prescription, a woman could go to a drugstore to pick up a pack of pills in the same way she can now buy aspirin. Behind-the-counter means a woman would ask a pharmacist for the pill, but she still wouldn’t need a prescription from a doctor. Over 50 drugs that were once prescription-only are now OTC in the U.S., including Sudafed, Cortaid, Advil, Nyquil, Monistat, and Claritin.

The pill doesn’t have much in common with other prescription-only drugs:

• It’s not addictive (unlike cigarettes that are sold in vending machines).
• Taking too many pills might make you throw up, but it doesn’t cause a deadly overdose (unlike the acetaminophen that is on the shelves of every drug store).
• All brands of the pill work without needing a health care provider to help fine-tune the dose.
• Taking the pill for a year results in long-term health benefits, including protection from cancer of the uterus or ovaries.
• The pill is for people who’ve decided they want to avoid pregnancy—no need for a diagnosis from a health care provider.

There’s a lot of misinformation about the safety of the pill. In fact, people in over 80 countries can already buy it without a prescription—including people just across the border in Mexico.* As medications go, the pill is very safe—safer than having a baby, driving, smoking, or taking daily aspirin. That said, the pill does have risks for those with certain medical conditions; if it were sold OTC, could people correctly decide whether it would be a good option for them? One study in El Paso showed that women who answered 15 questions were pretty accurate in deciding whether the pill was safe for them. The study asked a nurse to decide if the same women could safely use the pill, and compared the answers of the women and the nurse. For all but two of the questions, women and the nurse agreed nearly all of the time (98%).

The questions they didn’t agree on were about blood pressure and migraine headaches, the two most common health conditions that make the pill less safe.

1. High blood pressure. Some of the women in the study didn’t know they had high blood pressure. It becomes more common as people get older, so older women were more likely than young women to have undiagnosed high blood pressure. These women thought they could use the pill, but the nurse said they shouldn’t.

2. Migraine headaches with changes in vision, hearing and motion. Young women tend to experience more migraine headaches than women in their 30s. Only one very specific type of migraine makes the pill less safe, called migraine with aura. “Aura” means changes in vision, hearing or motion. Women who had migraines without aura sometimes thought they could not use the pill, but the nurse said they’d be able to.

In cases of disagreement like these, selling the pill from behind the counter would mean a pharmacist could provide guidance. Pharmacists help people take medications safely, and they could check a woman’s blood pressure and help identify the different types of migraines. A study in Seattle showed that women liked getting the pill directly from a pharmacist, and pharmacists liked being able to offer it. But there was a catch: zero insurance companies agreed to pay the pharmacists for their time, so women had to pay for the pharmacy consultation themselves.

The 15 Questions

If you answer “yes” to any of these questions, talk with a health care provider before using the pill:
1. Are you a smoker age 35 or older?
2. Do you think you might be pregnant?
3. Have you had a baby in the past 3 weeks?
4. Are you currently breastfeeding and is your baby less than 6 months old?
5. Do you have high blood pressure?
6. Have you had a heart attack or stroke?
7. Do you have heart disease?
8. Have you had a blood clot (thrombosis) in your lung or in your leg (NOT just varicose veins)?
9. Do you have diabetes?
10. Do you have migraine headaches?
11. Do you have liver disease or have you had liver cancer?
12. Do you have gall bladder disease?
13. Have you had breast cancer?
14. Do you take medicine for high cholesterol?
15. Do you take medicine for seizures or tuberculosis (TB)?

Would people buy the pill OTC?

A nationwide survey of reproductive-age women in the U.S. found that over two-thirds (68%) would buy contraceptives from a pharmacist and skip the doctor’s appointment. Women with lower incomes and women without health insurance were particularly interested in this option. Clearly, clinic visits can make getting prescription-only pills too much of a hassle for some people. The majority of women surveyed agreed that the pill should be available without a prescription if a pharmacist can help decide whether it’s safe.

People in other countries have been buying the pill OTC from pharmacies or community distribution centers for decades. So, are they more likely to use the pill when it’s not safe for them compared to people who get the pill by prescription? One study compared women in Mexico who got the pill from a clinic versus those who got it from a pharmacy and found no difference between the two groups—a small number of women in both groups (2%) shouldn’t have been using the pill. That suggests that going to a clinic doesn’t guarantee that people are screened for health conditions before getting the pill.

Screening is sometimes skipped in the U.S., too. A national study showed that 6% of U.S. women who use the pill probably shouldn’t. In this study, the majority of women who shouldn’t have been using the pill were over 35 and smoked, or had a history of breast, cervical, or uterine cancer. It could be that selling the pill behind-the-counter with pharmacists screening people for safe pill use would ensure that fewer people slip through the screening cracks.

If this is such a great idea, why hasn’t it happened yet?

There is an important potential downside to selling the pill OTC: the cost. Many people now have access to prescription pills without out-of pocket payments via their health insurance, as required by the Affordable Care Act. Health insurance doesn’t typically cover OTC drugs like ibuprofen and cough syrup. If the pill were sold OTC, people with health coverage could be faced with higher prices. But some health insurance has already decided to cover other OTC birth control:

• In some states, public health insurance covers existing OTC methods like condoms or emergency contraceptive pills. This coverage could be expanded to OTC pills.

• In 2013, two national health insurance providers, the military and Indian Health Services, said that they would cover OTC emergency contraception without a prescription.

We do know that if health insurance covered OTC pills, more people would be able to use them. Researchers looked at how women might be affected by the cost of an OTC pill. They estimate that if an OTC pill cost:

• $50, almost no one would buy it;

• $20, half of women who said they’d be interested would indeed buy it;

• $0, all women who said they’d be interested would grab a pack.

Even if health insurance didn’t cover OTC pills, it wouldn’t necessarily affect people who were happy getting their prescription-only pills. Not all brands of the pill would make the switch to being sold OTC at once, so some prescription-only brands would still be covered by insurance.

The Bottom Line

Ultimately, the U.S. Food and Drug Administration (FDA) will decide whether the pill can be sold OTC. The FDA makes this type of change for one brand of pill at a time, and there are over 100 brands of the pill sold in the U.S. Dr. Dan Grossman—a leader of a group of health researchers, advocates, nurses and doctors who argue for switching the pill to OTC—says that to switch, a drug company that makes a pill would have to do two studies: one showing that women understand the instructions for taking an OTC pill and one showing “women can appropriately self-select themselves as candidates for the pill and that they can use it safely and effectively for some period of time.” The process will be expensive: the two studies would cost about $10,000,000. So far, nobody has stepped forward to pay.

Switching a method of birth control from prescription-only to OTC has happened once before: the FDA decided that certain emergency contraceptive pills could be sold OTC—although it took years and a court case to make that decision final. The only active ingredient of OTC emergency contraceptive pills like Plan B One-Step is a progestin called Levonorgestrel. The exact same ingredient is in some brands of progestin-only or mini-pills. The mini-pill is safe for almost all women, including those with high blood pressure and migraines with aura. It could be that a mini-pill will be available without a prescription in the U.S. before a combined hormonal contraceptive pill… Don’t worry, there’s no way you could miss news of any kind of birth control pill going OTC—a hullabaloo is guaranteed, whether a vending machine is involved or not—and we’ll be sure to cover it all right here, on Bedsider.

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*If the pill’s so safe, why’s it prescription-only now?

(Or, a quick history of birth control in the U.S., from “lewd and lascivious” to “therapeutic”) The pill was not available in the U.S. until 1960. By that time, birth control was already firmly the domain of doctors. Nearly a century earlier, in 1873, the Comstock Act made birth control—and even information about birth control—illegal in the U.S., declaring it obscene and making it a federal offense to distribute birth control in the mail or between states.

Over the next century, this national law and 30 similar state laws were gradually challenged and overturned in courts. One major legal victory over the Comstock Act came with the 1936 U.S. Circuit Court of Appeals decision on United States v. One Package. That decision made it legal for doctors to distribute birth control across state lines. The same year, the American Medical Association recognized that providing birth control was part of a physician’s role. Doctors slowly started offering information and methods of birth control over the next few decades, and some were key players in the legal fight against state Comstock laws.

In 1957, the U.S. Food and Drug Administration (FDA) approved the first pill for therapeutic purposes only—to treat severe menstrual disorders—and not for birth control. Doctors began prescribing it and learned that there was a huge demand for the pill. When the FDA finally approved the pill for birth control in 1960, it was also prescription-only. At the time, that made good sense. It was a new kind of medication, and one that would be taken by healthy women. Following in the footsteps of the pill, all but a few modern methods of birth control are prescription-only.