Calif. Testing Morning-After Pill Access

California has become the second state in which a woman can buy the morning-after contraceptive pill, a prescription drug, at a neighborhood pharmacy without first being seen by a doctor.

A handful of drugstores began offering the pills late last month to potentially thousands of women in a low-key experiment made possible by a 2-year-old law. The program in Los Angeles and seven other counties is part of a nationwide push to make the morning-after pill available without a prescription.

The effort, funded by a $2.2-million grant from the David and Lucile Packard Foundation, is spearheaded by a coalition of public health activists and academics, operating as Pharmacy Access Partnership.

The pilot puts California on the leading edge of a revolution in public health in which pharmacists are assuming a greater role in patient care, sometimes over the objections of doctors. And it moves the abortion debate to a new front: Public health activists say the pills will prevent unwanted pregnancies, but abortion foes see the pills as another way to terminate them.

The partnership, which draws support from abortion rights advocates, aims to increase sales of morning-after pills by matching neighborhood pharmacies with clinics that have agreed to refer women to them. These patients may purchase the morning-after pill from the drugstores whenever they need it, without a prescription. Valley Community Clinic in North Hollywood, which is sending women to three nearby drugstores, has 3,000 to 4,000 patients in its women’s health-care program.

Sales Volume Limited

Many physicians believe the contraceptive is safe enough for women to buy on their own. But even if the Food and Drug Administration gave its approval, prescription sales are too low to support a switch to over-the-counter status, according to New Jersey-based Gynetics, which markets a morning-after pill, Preven.

Drug and supermarket chains assign shelf space to products based on sales volume, said Roderick MacKensie, Gynetics chairman. “Preven would have to compete for space with Tylenol, et cetera,” MacKensie said. “We will go over the counter eventually. . . . Our volume now doesn’t justify it.”

If taken within 72 hours after intercourse, the morning-after pill prevents a fertilized egg from implanting itself in the uterus.

Public health activists and many doctors say the morning-after pill does not end a pregnancy as does RU-486, the French abortion pill.

But abortion foes disagree. The National Right to Life Committee, when asked for comment, said that once fertilization has occurred, a life has begun and it opposes “destroying new human life.”

Some lawmakers are sensitive about providing the pills to minors. The San Bernardino County Board of Supervisors is seeking a federal waiver so it may ban morning-after pills from county-run clinics, where teens would have access to them. The pilot doesn’t operate in San Bernardino, said Jane Boggess, director of the Pharmacy Access Partnership.

Pharmacists, eager to expand their role as health-care providers, strongly support the project. The California Pharmacists Assn. is holding workshops for druggists who want to distribute the pill--including sensitivity training on how to discuss contraception with women.

Pharmacists already adjust asthma medication in cooperation with physicians and offer adult immunizations, said Elizabeth Johnson, association vice president. “Emergency contraception is one more step into patient care,” Johnson said.

Covered by State Law

Advocates have based the project on a little-noticed 1999 state law--even though a literal reading of the law allows druggists to adjust only prescription medication for specific patients based on advance instructions from that patient’s physician. The doctor can require pharmacists to perform tests or offer counseling. So far, nobody has raised legal objections.

The activists recruited neighborhood pharmacies and community clinics. The clinics give women who might want the drug a referral card to present at a participating pharmacy.

About 30 states have such laws that permit “collaborative agreements” under which physicians can delegate their authority to prescribe medication to a pharmacist. The FDA regulates drugs, but states decide whether doctors or pharmacists may prescribe them.

The project in California is modeled on one in Washington state, where pharmacies have filled nearly 12,000 orders in its first 16 months. Public health activists in Washington credit the program with preventing 677 pregnancies. Typically, eight of 100 women who do not use birth control will become pregnant if they have intercourse during the second or third week of their menstrual cycle. The morning-after pill reduces the odds to 2 in 100.

Pharmacies in California must set aside a private area where druggists counsel women. Before receiving the drug, women are asked to complete “encounter forms” that pose questions about their sexual activity (the number of partners in the last six months) and birth control methods (how frequently they use condoms). Pharmacists, in turn, must notify a woman’s clinic when she receives the pills.

Some druggists are taking extraordinary steps to make the pilot work. Ira Freeman of Key Pharmacy in North Hollywood is providing an after-hours number so he can arrange to meet women who need the pills at his drugstore on weekends, when it typically is closed. Ken Ross of Medical Arts Pharmacy, also in North Hollywood, also has agreed to be on call.

“When you think of all the abortion clinics just cranking out,” Ross said. “It is nice to think that with this pill, women can avoid that agonizing decision.”

The project isn’t fully endorsed by the medical community, however. Though the state medical society supports use of the pills, it believes pharmacists “are pushing the envelope,” said Steven Thompson of the California Medical Assn.

He said the law allows doctors to delegate their authority to pharmacists for specific patients--not entire groups, such as the thousands of women who use the clinics involved in the pilot program. And he said the law applies to adjustments of medications, not new prescriptions.

The CMA believes the pills are safe enough to be sold without a prescription; last month it urged the FDA to approve them for nationwide nonprescription use.

Jack Lewin, CMA chief executive, explained: “We support an over-the-counter approach, but we do not support pharmacies initiating prescriptions. . . . It is a very clever idea, but it seems there is a loophole.”

The pharmacists are distributing primarily Plan B, a more expensive competitor to Preven that boasts fewer side effects. It was launched in 1999 by Women’s Capital Corp., whose backers include Planned Parenthood and the Packard Foundation, which helped bring RU-486 to the United States.

The brands are intensely competitive. On its Web site, Women’s Capital says women using its Plan B, made from synthetic progestin, experience 50% less nausea and 70% less vomiting than women who use pills made from estrogen and progestin. Preven, launched in 1998, is a combination pill.

Preven, meanwhile, claims broader retail distribution than Plan B, which is hard to find in drugstores outside Washington state. MacKensie said Preven is carried by every large drugstore chain, including Walgreen’s and Rite Aid. The companies wouldn’t provide sales figures.

Pills Get Slow Start

Neither company can claim great marketing success. Fewer than 20% of women are aware of the pills, according to a Gynetics survey. Ads placed in Glamour, Ebony and Soap Opera Digest in 1998 and 1999 didn’t budge Preven sales. Wal-Mart has said it doesn’t carry either brand because demand is too low.

Gynetics and Women’s Capital say they lack the money to court physicians, the primary target for prescription drug pitches. Drugstores offer an alternative route to the consumer, said Women’s Capital Chief Executive Sharon Camp. “We need to get pharmacies more proactively involved. . . . Over time, they will increase market share for Plan B,” Camp said.

Pilots are being planned in Oregon and Alaska. But last month, Virginia lawmakers handed activists a setback when they failed to pass legislation that would have made the pills available without a prescription. A House of Delegates version required parental consent for minors, though the state Senate version did not.

Public health experts contend it’s important for women to get the pills as quickly as possible, and a doctor’s visit delays the process. Treatment consists of two pills taken exactly 12 hours apart.

“You don’t want people counting down to the 71st hour before getting treatment,” said Diane Chamberlain, chief operating officer of Valley Community Clinic, which, besides participating in the pilot program, provides the pills directly to patients.

Still, the pills have been a difficult sell, MacKensie said. A woman must make an important decision quickly. Beyond that, he said, women are bombarded with messages to avoid drugs and alcohol if there is a chance they are pregnant. Neither brand of morning-after pill will harm a fertilized egg that is implanted in the womb. But some women are hesitant about using the medication.

The experience of Washington state points to another possible disincentive: cost.

Health plans won’t cover Plan B when a doctor doesn’t prescribe it, said Dan Connelly, chief pharmacist for the regional Bartell Drug chain. And insurers won’t pay pharmacists to counsel women.

In Washington state, where any woman may buy the drug without a prescription, out-of-pocket costs range from $35 to $70--about $20 for the drug and the rest in counseling fees. At those prices, it is a difficult purchase for teenagers and--because Plan B isn’t covered by state Medicaid programs--poor women. (Women’s Capital hasn’t agreed on a price with the state-federal Medicaid program.)

Pharmacies in young, affluent neighborhoods do well. The top-seller--a 24-hour Bartell Drug near downtown Seattle--fills more than 100 a month. Sales at a Bartell Drug near the University of Washington are almost as strong. But pharmacies statewide average 10 orders a month.

In all but a few cases, the volume is too small to help any single store’s bottom line, said Don Downing, a University of Washington pharmacist involved in the state’s emergency-contraception project. Only 15% of the state’s pharmacies participate in the pharmacy access program, which started in 1997.

Advocates in California recognize insurance is a problem. “It is something we’re working on,” said Johnson, the state pharmacy association official.

FamilyPACT, a state health plan for low-income people who don’t qualify for Medi-Cal, will help some women buy Plan B, said Pharmacy Access Partnership director Boggess. Women enrolled in Medi-Cal may use Preven or a large dose of birth control pills, which Medi-Cal covers. High dosages of birth control pills prevent pregnancy but often cause queasiness.

As for counseling fees, the Pharmacy Access Partnership is paying druggists $15 per woman, enough to cover the cost of a 15-minute session. North Hollywood pharmacist Freeman said the program may strengthen his community ties, but probably not his business. “It’s not going to be a gold mine.”