FDA Ruling Puts Pharmacists in Crossfire

By: - September 6, 2006 12:00 am

The latest fireworks over the “morning-after pill” weren’t in Congress, or at the U.S. Food and Drug Administration, but in Kent, Wash., at last week’s meeting of the normally obscure state Board of Pharmacy.

After months of controversy and a flood of 16,000 comments, the board followed Gov. Christine Gregoire’s (D) suggestions and refused to give legal protections to pharmacists who for moral reasons object to dispensing the high-dose birth control pill.

The action, though, doesn’t end the tempest in Washington state. Druggists already are raising objections to the board’s proposed rule, which still needs final adoption. And birth control advocates are calling for the board to investigate at least four drug stores that refuse to stock the emergency contraceptive pill, known as Plan B.

As Washington’s case shows, the FDA’s decision last month to let women over age 18 buy the morning-after pill without a doctor’s prescription won’t end heated disputes in state capitols over emergency contraception. Instead, the FDA action thrusts pharmacists – more than ever – into the middle of the fray and presents additional issues that may land in state policy-makers’ laps.

“What this does is shift the burden from doctors with prescribing rights and privileges to pharmacists,” said Deirdre McQuade, the U.S. Conference of Catholic Bishops’ spokeswoman on birth control matters.

“We had been putting our efforts into preventing the FDA from doing this. … Now it seems like it’s going to be a state-based matter,” McQuade said. She added, however, that the conference hadn’t yet decided what action to take at the state level.

Emergency contraception is controversial because it poses moral questions similar to those raised in the abortion debate.

The Catholic bishops and others who believe life begins at conception object to Plan B because of the possibility that it may prevent a fertilized egg from implanting on the uterine wall.

But those who want greater access to the morning-after pill argue that the drug works the same as standard oral contraceptives, primarily by preventing fertilization of a woman’s egg. Taken within 72 hours of unprotected sex, the pill can prevent 89 percent of pregnancies, according to Plan B’s manufacturer, Duramed, a subsidiary of Barr Pharmaceuticals Inc.

Plan B is distinct from the abortion pill RU-486. The abortion pill can terminate pregnancies for up to seven weeks, whereas emergency contraception will have no effect on an embryo that already has attached to the uterus. Pharmacists cannot dispense the abortion pill, because it must be taken in the presence of a doctor.

A multi-state issue

Like Washington’s pharmacy board, states have been struggling with how to balance the rights of patients to get access to Plan B and the rights of health care providers to follow their religious or moral convictions.

Pharmacists have lost their jobs in Illinois, Texas and Wisconsin for their unwillingness to dispense emergency contraception. Wal-Mart, the nation’s largest retailer, reversed policy and began stocking the morning-after pill nationwide in March after state regulators in Illinois and Massachusetts ordered pharmacies to carry the drug.

Massachusetts Gov. Mitt Romney (R), a possible presidential contender for 2008, touched off a furor when his administration suggested that Catholic hospitals would not be subject to a state law mandating that emergency rooms offer emergency contraception to rape victims. He quickly reversed that stance.

States are split over whether to give priority to health care providers who have ethical concerns or to women seeking contraception.

Four states – Arkansas, Georgia, Mississippi and South Dakota – have enacted “conscience clauses” that specifically protect pharmacists who choose not to dispense emergency contraception. Five more – Colorado, Florida, Illinois, Maine and Tennessee – have more general conscience clause policies that likely would protect pharmacists.

The Washington Board of Pharmacy at first considered enacting a conscience clause but reversed course after the governor weighed in. If Gregoire’s proposal receives final approval early next year, Washington would join the nine other states that have adopted “must-fill” policies requiring pharmacists to fill all scripts. Some of those states, though, have provisions that allow pharmacists who have objections to refer a prescription to another druggist.

California , for example, requires pharmacists to fill all prescriptions, unless they notify their employer ahead of time and the employer makes arrangements so patients can receive their medicine promptly.

In Illinois and Maine, administrative must-fill rules are in force but conflict with conscience clause statutes that don’t mention emergency contraception.

The American Medical Association passed a resolution last year calling on pharmacists to fill all prescriptions. It even suggested that, if no pharmacist within 30 miles of a patient would fill a script, the patient should be able to buy the drug from the doctor instead.

New policy questions

The FDA’s decision leaves states with even more questions to resolve: Should stores be required to stock Plan B, now that it’s a non-prescription drug for women over age 18? Will pharmacy technicians, along with druggists, be covered by conscience clauses? And should other states follow the lead of nine states that currently let girls under 18 get the drug without seeing a doctor?

These questions fall to the states because, while the FDA regulates medicines, states police the doctors who prescribe drugs and the pharmacists who dispense them.

In its long-delayed decision, the FDA on Aug. 24 agreed to allow women age 18 and over to buy Plan B without a prescription, but kept the prescription requirement for girls 17 and under. The manufacturer can sell the drug only to stores and clinics where a pharmacist works. The medicine must be kept behind the counter, and store employees must verify the age of the purchaser. Men can pick up the drug, if they are old enough, for their girlfriends, wives or other women.

When layered over existing state laws, the FDA rules create new wrinkles.

Nine states already allow specially trained pharmacists to give emergency contraception to patients who haven’t visited a doctor. Druggists are allowed to partner with doctors or to follow state regulations to essentially write prescriptions for the drug on their own.

Under those arrangements, girls under age 18 in Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington may continue to get Plan B without seeing a physician.

The absence of a prescription requirement for women over 18 also could affect the already contentious debates over whether emergency rooms, especially at Catholic hospitals, should be required to give the pill to rape victims who desire it.

Seven states, including Massachusetts, have those laws for rape victims, and eight states direct ERs to provide victims information about the morning-after pill, according to the Guttmacher Institute , an abortion rights research group.

Conscience clause issues also might be raised about other pharmacy employees behind the counter. Lawmakers in Missouri this year drafted legislation to legally shelter pharmacy workers other than druggists, but it stalled in committee.

The FDA’s unique arrangement that makes Plan B non-prescription for women 18 and over but prescription for younger females poses new policy questions in Illinois and Massachusetts, which pushed Wal-Mart and all pharmacies in their states to stock Plan B.

Hot topic in Illinois

Michael Patton, executive director of the Illinois Pharmacists Association , said the FDA action could trump an administrative rule imposed in April 2005 by Gov. Rod Blagojevich (D) that requires pharmacies that stock other contraception to carry the morning-after pill.

“It’s kind of like if I decided I didn’t want to handle Robitussin cough medicine. There is nothing in the law that would require me to handle something that is not prescription-driven,” he said.

But Sue Hofer, a spokeswoman for the Illinois Department of Financial and Professional Regulation, which issued the rule, disagreed. Plan B is still a prescription drug for girls, so the stocking requirements still will apply, she said.

While Washington is the latest state to feel the heat over emergency contraception, the issue is at its hottest in Illinois.

Since 1977, Illinois has had one of the strongest conscience clauses in the country, according to Americans United for Life, a public interest law firm that opposes abortion. But Blagojevich’s order last year imposed one of the strongest must-fill regulations in the nation, requiring store owners to stock the drug and to display signs outlining the rights of patients to have their prescriptions filled. The apparent contradiction in policies has led to numerous lawsuits and confusion for pharmacists.

Four pharmacists fired by Walgreen’s last year for saying they wouldn’t dispense emergency contraception are challenging their termination; their complaint is now with the Equal Employment Opportunity Commission. Other pharmacy owners who worry they could lose their stores are in court challenging the governor’s rule mandating that they stock the morning-after pill.

History of conscience clauses

The controversy over women’s access to Plan B has parallels in the abortion debate, not just in principles but in tactics.

The introduction of Plan B as a prescription drug in 1999 – and the manufacturer’s application to the FDA in 2003 for over-the-counter sales — sparked a renewed interest in conscience clauses, which first cropped up following the U.S. Supreme Court’s 1973 Roe. v. Wade decision legalizing abortion.

According to the Congressional Research Service , the first conscience clause to become law was passed by Congress in 1973.

The so-called Church Amendment – named for U.S. Sen. Frank Church, D-Idaho – prohibited officials from forcing federally funded health-care providers to perform abortions. Since the mid-1990s, Congress has passed numerous other restrictions to ensure that health-care professionals and insurance programs aren’t forced to participate in abortions.

Most recently, Congress began attaching a Hyde-Welden Amendment to appropriation bills in 2004. It bars government agencies from treating health-care providers differently for refusing to perform or pay for abortions.

States rapidly adopted conscience clauses – mostly for abortion – after the Church Amendment.

Today, 46 states specifically give doctors the right to refuse to perform abortions, according to the Guttmacher Institute. By comparison, 16 states similarly shield doctors who object to performing sterilization, and nine have laws allowing doctors to refuse to prescribe contraception.

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