Sufficient Scruples

Bioethics, healthcare policy, and related issues.

December 13, 2005

Divergent Approaches to EC in Different States

by @ 3:54 PM. Filed under Access to Healthcare, Autonomy, General, Global/Community Health, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

Stateline.org, of the Pew Research Center, has a good review of the various actions taken in different states in regard to making emergency contraception more widely available. Some states have moved decisively to make the medication easily obtainable; others have seen roadblocks thrown up by conservative governors or legislators. One state – Wisconsin – announced last week it will be suing the FDA to force approval of OTC availability of Plan B.

While the Food and Drug Administration delays a decision on whether to allow the “morning-after pill” to be sold over the counter, officials in several states are mounting efforts to make the emergency contraceptive easier to get.

In recent weeks, the stakes have increased in the contentious policy debate over the pill, which is sold under the name Plan B, with four pharmacists losing their jobs in Illinois, state attorneys preparing a lawsuit against the FDA in Wisconsin and tempers flaring in Massachusetts. . . .

In Illinois, four Walgreens pharmacists who said they wouldn’t fill prescriptions for the morning-after pill were suspended without pay because of a one-of-a-kind Illinois rule put in place by Gov. Rod Blagojevich (D) requiring pharmacies to sell the drug.

Three of the pharmacists filed a complaint Dec. 7 with the Equal Employment Opportunity Commission, arguing their employer “effectively fired” them for their moral beliefs. Blagojevich’s order requires all pharmacies that sell birth control pills also to stock the morning-after pill, a set of two pills that contain a higher dose of hormones than standard oral contraceptives. . . .

Right now, Illinois is the only state with such a requirement, but it won’t be for long. California lawmakers pushed through a similar law, effective in January, that differs in one key aspect: It also would give pharmacists with moral objections to dispensing the pill a way to opt out. The compromise won the endorsement of pharmacists, though the more ardent anti-abortion groups still objected.

Wisconsin Attorney General Peg Lautenschlager (D) last week took the first steps toward filing a lawsuit to force the FDA to let the drug be sold without a prescription. Under Wisconsin law, Lautenschlager needs the permission of Gov. Jim Doyle (D) before suing the federal government. Doyle gave his approval on Thursday, Dec. 9. . . .

As a legal matter, she said the FDA’s repeated delays – without an outright rejection of the application — are “political” and violate the federal Administrative Practice Act, which governs how federal agencies must operate.

Next week, Massachusetts will begin allowing pharmacists to dispense the morning-after pill without a doctor’s prescription. The Democratic-controlled Legislature overrode a July veto by Gov. Mitt Romney (R) to make the Bay State the eighth to let patients buy the drug without visiting a physician. The law allows specially trained pharmacists who partner with doctors to write and fill the prescriptions themselves.

It also requires hospitals to offer the drug to rape victims. Earlier this week, Romney’s administration ruled that the mandate did not apply to Catholic hospitals, touching off a furor among politicians who say the administration’s stance undermines the purpose of the law. But Romney reversed course Dec. 9 after speaking to his lawyers and said that the law will be applied to all hospitals, according to the Boston Globe.

Legislators in New York didn’t have the votes to overcome Republican Gov. George Pataki’s veto of a similar measure there, but the legislation did clear the Republican-controlled Senate before ending up on Pataki’s desk.

In reaction to the emergency contraception controversy, the American Medical Association passed a resolution this summer 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. . . .

Mississippi enacted a broad law meant to protect pharmacists and other health-care professionals who have moral objections to administering certain drugs, including the morning-after pill. It joins Arkansas, Georgia and South Dakota in giving pharmacists the right to refuse to dispense emergency contraception.

In Indiana and Texas, lawmakers passed measures designed to limit Medicaid funding for emergency contraception.

And when Arkansas legislators told health insurance companies they had to cover contraception, the lawmakers explicitly excluded emergency contraception.

[emphases added]

Good Beginning on “OTC” Emergency Contraception

by @ 2:55 PM. Filed under Access to Healthcare, Autonomy, General, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

New Hampshire has begun a program to allow dispensing of EC without prescription by pharmacists who have taken a two-day special training. This is not quite the same thing as OTC availability (and finding yet another way to make EC availability dependent on pharmacists’ cooperation, though a positive step in some ways, is not completely a step forward). However, it is a major advance in making this medication available at the time of need.

Six months after Gov. John Lynch signed a bill that would make “morning-after” pills available to women hoping to prevent unwanted pregnancies, about 200 pharmacists have received training in dispensing the drug.

The law allows pharmacists who have volunteered for the training to provide women with an elevated dose of birth-control hormones without a doctor’s prescription. The drug, if taken within 72 hours of unprotected sex, can cut a woman’s chance of pregnancy by up to 89 percent. . . .

Two training sessions for pharmacists were held this past weekend. Once trained, pharmacists need to partner with a doctor or nurse practitioner to be able to prescribe the pill.

One problem with this approach is that, by putting the responsibility on pharmacists to dispense this medication, it unavoidably puts on them the responsibility to deal with issues that are fundamentally the woman’s concern alone:

The training sessions address such issues as a pharmacist’s personal views on emergency contraception and the medical side effects or liability that comes with dispensing the drugs.

Part of the protocol is to prescribe the pill first, then ask questions afterward, said Don Downing, a pharmacist and associate professor at the University of Washington School of Pharmacy.

Any woman, regardless of her age, can have the pill if she’s had unprotected sex in the past five days and has had her period in the past four weeks, which means she’s not pregnant. She must also sign a consent form.

If a pharmacist suspects that a woman has been raped, he or she can refer the woman to a hospital or to one of the state’s 14 crisis centers.

It is not mandatory that the pharmacist report the assault unless the woman is under 18. If that is the case, Downing suggested that a pharmacist dispense the drug, then tell the girl about his or her intention to call authorities.

“You never hold them hostage,” he said. “They’ve just been held hostage.”

Though this training seems to have been designed to be as empowering of women as possible, questions about the pharmacists’ personal views, whether the medication will be dispensed, who must be notified, and whether notification will be conducted against the woman’s wishes would not arise if states could just trust women to make their own decisions about their own bodies, with a medication that has proven to be highly safe and effective for all age groups. There is no reason for pharmacists to “address” these issues at all, let alone allow them to stand as explicit – or even implicit – barriers to women’s healthcare. European practice, and the studies resulting in a near-unanimous approval for OTC sale of Plan B by the FDA’s scientific advisory panel, show that women can use this medication safely on their own initiative, without submitting their decisionmaking to someone else’s review.

New Hampshire is to be commended for taking a large step toward increasing availability of Plan B, but it would be much easier, and better for the women, if the FDA would simply let women have what they need without anyone else’s intervention.

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