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Hopkins-led study finds 'the pill' would be safe without prescription

Hopkins may help boost the chances of "the pill" being sold over the counter.

A new Johns Hopkins study could fuel ongoing efforts to allow women to get birth control pills without seeing a doctor.

Bills pending in each house of the Maryland General Assembly would allow pharmacists to prescribe contraceptives.

The study led by researchers at Johns Hopkins' School of Medicine found that oral contraceptives can be sold safely over the counter to all women, including teens.

"Oral contraceptives are popular, safe and effective methods of pregnancy prevention for women and teens," said Dr. Krishna Upadhya, a Johns Hopkins assistant professor of pediatrics who led a group of pediatric, adolescent and women's health experts in the study. "Our review emphasizes that any future over-the-counter pill has the potential to benefit teens, and there is no scientific rationale to restrict access based on age."

For years some health and women's rights advocates have pushed to make "the pill" more readily available, as it is throughout much of the world. The American College of Obstetricians and Gynecologists endorsed the idea in 2012, arguing over-the-counter access would further drive down abortion and teen pregnancy.

Opponents of over-the-counter access, including some doctors, argue the pill does not protect women from sexually transmitted disease and can cause long-term harm such as blood clots. The doctors believe use of the pill should be done under medical supervision. Religious groups also have opposed measures to expand access to contraception.

There have been efforts in Congress in recent years to change the law to allow over-the-counter access to contraception, but they failed to garner enough support. With federal legislative efforts stalled, the issue has been taken up in some states, including Maryland. Bills allowing patients to see pharmacists instead of doctors for contraceptives have passed in Oregon and California.

Meanwhile, HRA Pharma, a French pharmaceutical company, plans to seek approval from the U.S. Food and Drug Administration to offer birth control pills to women who don't consult any health provider. The firm has partnered with Ibis Reproductive Health, a nonprofit research and advocacy group, to research the possible effects of such a move.

"Too many people in the United States face barriers to accessing the contraceptive methods they want," HRA and Ibis said in a statement in December, "a safe and effective hormonal birth control pill available over the counter would improve access and help people overcome some of those barriers."

The Johns Hopkins-led research was done independently of Ibis, though Upadhya has attended meetings of an Ibis-formed working group. She has no formal role and said she has not been compensated, though another researcher on the study is listed on the group's steering committee.

For the study published this week in the Journal of Adolescent Health, the researchers made an expansive review of existing studies. They looked at data on women and teenagers related to safety and effectiveness or oral contraceptives, pregnancy risk associated with various contraceptive methods, teen's ability to use the pill correctly, the impact on sexual behaviors and concerns that easy access might reduce clinician's ability to counsel young people about contraception.

The state legislation being considered this year in both chambers would allow pharmacists to prescribe and dispense contraceptive medications and devices if they are trained and agree to provide patients with a risk assessment tool and referral for further care if needed. The bill requires all insurance carriers to cover the cost of the contraceptives.

The Johns Hopkins-led research "confirms my belief that broadening access to contraception is safe for women of all ages," said Del. Shelley L. Hettleman, a Baltimore County Democrat who sponsored the House bill. "Until the federal government makes oral contraception available over the counter, if enacted, my legislation will allow women to get contraception safely through trained pharmacists much easier than they can today."

But MedChi, the state medical society, and the Maryland chapter of the American Academy of Pediatrics both oppose the legislation. In a February letter to lawmakers, the groups cited "concerns about patient safety and health implications."

The statement said pharmacists aren't trained to evaluate a patient's health risks and drug store access to contraceptives could deter women and teens from seeing a doctor for other preventive health services. Further, they said, the bill poses questions about how pharmacists would be reimbursed for reviewing patients' risk assessment or how they would charge those with no insurance.

"While access to contraceptives is supported by, and a priority of both MedChi and MDAAP, authorizing pharmacists to prescribe and dispense contraceptives will not meaningfully increase access and may have significant unintended consequences that negatively impact those who need access of contraception," the groups said in the letter . "These unintended consequences are particularly compelling given the lack of evidence showing that there are barriers to accessing contraceptives in Maryland."

The pill already is the most commonly used hormonal method of birth control, according to the National Survey of Family Growth that found more than half of females age 15-19 used it. It's widely available without a prescription in many other countries and full coverage for it in the United States was included in the Affordable Care Act, though GOP members of Congress are working to replace the law.

The Johns Hopkins-led research team said a review of the outcome of allowing the emergency contraceptive, called "Plan B," or the so-called "morning-after pill", to be sold without a prescription indicates that access remains a problem for teens. The researchers found use of the pill by teens tripled after it was approved for use without a prescription in 2012.

meredith.cohn@baltsun.com

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