5-day pill moves emergency contraception back to doctor's office

When the Food and Drug Administration approved Plan B in 1999, some doctors objected on moral grounds to prescribing the emergency contraceptive.

Much of the controversy faded when Plan B went to over-the-counter status in 2006, taking the prescribing decision largely out of doctors' hands. Today, the drug is available OTC for women 17 and older, but younger patients still need a prescription.

Now that the FDA has approved ella (ulipristal acetate), a prescription-only emergency contraceptive, the debate about whether to prescribe such drugs is moving back to the doctor's office. With it comes ethical and legal questions for physicians, particularly those who object to emergency contraception for various reasons.

"There will be plenty of doctors who won't provide the drug because it probably does cause abortion," said Gene Rudd, MD, senior vice president of the Christian Medical and Dental Assns. He said approval of ella "raises the issue of right of conscience and whether ... a patient or health care system can tell a doctor he no longer has the right to exercise his moral [belief]."

Dr. Rudd said he heard that some employed physicians were pressured by their employers to offer Plan B when it was a prescription-only drug.

On Aug. 13, the FDA approved ella for use in the U.S. The drug probably will be available by the end of the year. The progesterone agonist/antagonist prevents pregnancy when taken orally within 120 hours after a contraceptive failure or unprotected sex. Emergency contraceptives now on the market, including Plan B, are indicated for use up to 72 hours after sex.

Ella works by blocking progesterone activity, and in doing so, inhibits or delays ovulation. The drug's patient information notes the possibility that the medication also might prevent implantation of a fertilized egg in the lining of the uterus.

The American College of Obstetricians and Gynecologists says the medication offers women another option to prevent unintended pregnancies. ACOG recommends that health professionals make emergency contraception available to women who had unprotected sex or inadequately protected sex and who do not desire pregnancy.

The Guttmacher Institute, a nonprofit policy research organization that supports abortion rights, said a woman is considered pregnant when implantation occurs. But some health professionals consider preventing implantation an abortion.

Jane Orient, MD, executive director of the Assn. of American Physicians and Surgeons, is among those who have raised concerns about ella's chemical similarities to mifepristone, or RU-486. Mifepristone, when used with misoprostol, ends early pregnancies by blocking progesterone, which is needed for the pregnancy to continue.

Dr. Orient said doctors may take issue with the similarities between ella and RU-486. "For that reason, many doctors will have concerns of conscience about prescribing it," she said.

Although ella blocks progesterone, animal studies have shown that the medication is significantly less potent than RU-486 in interrupting gestation, said Erin Gainer, PhD, MPH, chief executive officer of HRA Pharma, which manufacturers ella. She said drawing parallels between the two drugs is misleading.

"We are clearly in the realm of contraception. We're not in the realm of pregnancy termination," she said.

Raising legal, ethical issues

Twenty-one states have legislation that guides health professionals' actions concerning emergency contraception, according to the National Conference of State Legislatures.

Some states require hospitals to provide information about the drugs and/or administer them to women who have been sexually assaulted. In other states, a minor can, under certain conditions, get the drugs now available without having to obtain a physician's prescription.

Many states also have conscience laws that protect the rights of health professionals who objected on moral grounds to performing abortions, among other procedures. But these laws are typically broad and do not usually cover emergency contraception, said Mary Harned, staff council for the nonprofit Americans United for Life, an anti-abortion law and policy organization in Washington, D.C.

Most ethicists agree that physicians who consider contraception immoral do not need to provide emergency contraceptives. Instead, they can refer patients to physicians who will prescribe such drugs, said Anne Drapkin Lyerly, MD, faculty associate in the Trent Center for the Study of Medical Ethics and Humanities at Duke University Medical Center in North Carolina.

American Medical Association policy states that it might be ethically permissible for physicians to decline a potential patient when requested treatment is incompatible with the doctor's personal, religious or moral beliefs.

When a patient-physician relationship has been established, AMA policy says patients have the right to discuss the benefits, risks and costs of appropriate treatment alternatives with their doctors. Patients also have the right to continuity of care, and physicians are obligated to coordinate care with other health professionals to treat the patients.

Internist Beth Jordan, MD, medical director of the Assn. of Reproductive Health Professionals, said patient care should be among physicians' top priorities when deciding whether to prescribe emergency contraceptives.

"Ella is an approved drug. ... If a woman comes [to a doctor] wanting that medication, then it is important to treat her," Dr. Jordan said.

Nearly half of all pregnancies each year in the U.S. are unintended, according to the Guttmacher Institute. About 4 in 10 of those pregnancies end in an abortion.

While proponents of emergency contraceptives say the drugs have the potential to reduce the abortion rate, few women use them, according to the Centers for Disease Control and Prevention. About 10% of women who had intercourse at least once between 2006 and 2008 used emergency contraception, the CDC said. In 1995, before Plan B was approved, less than 1% of women age 15 to 44 who had intercourse at least once used emergency contraception. In 2002, that number increased to 4.1%, according to agency data.

David Weismiller, MD, a family physician in Greenville, N.C., said more needs to be done to educate patients about emergency contraceptives. When he discusses the drugs during annual checkups, most patients have never considered them as an option if traditional contraception fails.

He routinely discusses the drugs with his patients. He tells them, "About 50% of pregnancies are unintended, and half are with people using birth control."

The FDA's approval of ella gives the medical community "another opportunity as a profession to have this conversation with patients. ... We need to be pretty loud in making sure our patients know about" emergency contraceptives, Dr. Weismiller said.

The FDA recommends that doctors take a woman's medical history and counsel her on the proper use of ella before prescribing it. The drug is not intended for routine use as a contraceptive and should not be taken multiple times within the same menstrual cycle, according to the drug's prescribing information.

Ella should not be prescribed for pregnant women because its risk to a fetus is unknown. If pregnancy cannot be ruled out through a patient history or a physical exam, doctors should perform a pregnancy test.

Dr. Rudd, of the Christian Medical and Dental Assns., suggests that physicians who object to using ella alert their staffs and make patients aware of their position.

If a patient requests ella during an office visit, he said a physician should tell her, with compassion and sensitivity, "This is something I can't participate in."

"You don't want doctors to deny following their conscience," he said.