Thursday, August 03, 2006

FDA plan eases access to Plan B pill

Posted on: Thursday, August 3, 2006

FDA plan eases access to Plan B pill

By Mary Vorsino Honolulu Advertiser Staff Writer

A U.S. Food and Drug Administration proposal to allow over-the-counter sales of the so-called "morning-after" contraceptive pill would make it more readily accessible to Hawai'i women 18 and older.

One of eight states that do not require a doctor's prescription to get the emergency contraceptive called Plan B, Hawai'i mandates a consultation with a pharmacist before obtaining the pill.

The proposed federal guidelines would lift that condition for women 18 and older. The requirement would remain for girls 14 to 17, who legally can obtain the pill from pharmacies.
Family planning advocates in the Islands support the FDA's move, noting that it would eliminate some barriers — including the cost of a consultation with a pharmacist — that now hinder the efforts of some girls and women to get the pill. Opponents of easier access to Plan B counter that, among other things, emergency contraceptive poses thorny moral questions and could encourage unprotected sex.


Hawai'i Right to Life and other anti-abortion groups came out against Plan B in 2003, when state lawmakers took up the bill that permits pharmacists to prescribe Plan B and does not require parental permission for minors. The measure passed with a wide majority and went into effect in 2004.

John Long, executive director of Hawai'i Right to Life, said selling the emergency contraceptive over the counter would send the wrong message to girls. Instead, he said, lawmakers and educators should be promoting abstinence. In cases of unwanted pregnancies, he said, "the safest alternative is to have the child."

But family planning advocates say the pill provides an option for females who had unprotected sex and are not ready for a child.

Rep. Hermina Morita, D-14th (Kapa'a, Hanalei), a strong proponent of the 2004 law, said she believes the FDA should provide Plan B over the counter with no age restrictions.

"I think it should be available to any female that had unprotected sex," Morita said. "Ultimately, for a minor, you want the support system to be there. But we also have to be very realistic that a minor may not go directly to a parent for help."

Plan B works best if taken about 12 hours to 24 hours after unprotected sex, but can still be effective up to five days afterward. About 95 percent of women who take the pill avoid pregnancy, according to the Healthy Mothers, Healthy Babies Coalition of Hawai'i. It is not effective in ending pregnancies, like the controversial RU-486, known as the "abortion pill," which is available only through a doctor's prescription.

The FDA's decision on the matter is still weeks off, but the issue is spurring a political firestorm in Washington.

Acting FDA Commissioner Andrew von Eschenbach sent out a letter earlier this week to Barr Pharmaceuticals, the maker of Plan B, outlining the federal agency's proposal for selling it without a prescription to women.

In his request for a meeting with Barr representatives, von Eschenbach expressed concern about how to ensure the drug would not be available to minors without a prescription.
The offer comes as von Eschenbach is seeking confirmation to the top FDA post, and two senators — Patty Murray, of Washington, and Hillary Clinton, of New York — have threatened to block his nomination until the drug is approved for over-the-counter sale.


In Hawai'i, pharmacists who administer Plan B must be state-certified. The state Department of Health said yesterday that 167 pharmacists at 60 pharmacies in the Islands have completed the required training.

State statistics also show 38 clinics in the Islands tallied a total of 4,327 visits for emergency contraceptives last year.

Kit Uyeda, of the state Health Department family planning branch, said Plan B is the preferred emergency contraceptive among healthcare providers because it requires fewer doses and is less likely to cause nausea and other side effects.

In 2005, Planned Parenthood of Hawai'i handed out about 2,500 doses of emergency contraceptives, a large portion of which were Plan B doses. Sonia Blackiston, health educator at the nonprofit organization, said the price tag for a pharmacy prescription prompts many women and girls to go to clinics for Plan B.

Pharmacies can charge a consultant fee of upwards of $25, Blackiston said, adding that a single dose of the drug costs between $50 and $75, but some doctors and clinics offer it at a reduced rate.

Blackiston also said that access to the drug is still difficult in places, especially the Neighbor Islands. She said no emergency contraceptives are sold at pharmacies in certain areas of the Big Island, forcing women to travel to Hilo and Kona.

Longs Drugs Stores, one of the biggest private providers of Plan B in the state, has had about 1,000 requests for the drug since 2004, clinical pharmacist Cindy Minakami said.
"It is pretty popular," she said. She also says she has never heard of a situation in which a girl under 14 attempted to get the drug.


The Associated Press contributed to this report.

Reach Mary Vorsino at mvorsino@honoluluadvertiser.com.

FACTS ON PLAN B PILL, HAWAI'I'S REGULATIONS


Q: What is Plan B?
A: Plan B is an emergency contraceptive best taken at least 24 hours after unprotected sex. It is one of the most popular brands on the market among the so-called "morning-after pills," and is reported to have the fewest side effects.


Q: What is the law in Hawai'i regarding the drug?
A: In Hawai'i, a doctor's prescription is not needed for Plan B. Instead, women and girls at least 14 years old may get the contraceptive from a pharmacist. Pharmacists must undergo certification training before conducting screenings for a Plan B prescription. The screening consists of verifying age eligibility and providing information about the pill.


Q: What other states allow someone to get Plan B without a doctor's prescription?
A: Besides Hawai'i, those states are Alaska, California, Maine, Massachusetts, New Hampshire, New Mexico and Washington.


Q: Is the FDA recommending a plan to sell Plan B over the counter?
A: The FDA is proposing to allow Plan B to be sold over the counter to people who are at least 18 years old. Minors would still be required to get a prescription for the drug, according to the proposal. In Hawai'i, girls 14 and older would still be able to get the drug from a pharmacist with a prescription.

No comments: