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January 18, 2006

Save it for the morning after: Plan B survey illuminates statewide problems of access, understanding

Shelly West sits in a desk chair, talking a lot with her hands. Her straight blonde hair, covered by a military-style cap not unlike that popularized by Fidel Castro, gently dusts her shoulders when she turns her head drastically in one direction. She is tall, and her bubbly baby eyes, excitable yet calmly self-aware, are sympathetic even when she lays out an unrelenting feminist personal philosophy. It’s the sort of useful mind-body juxtaposition that has served people like Jane Fonda well.

West, a 31-year-old Spalding University graduate student, says she’s nervous, although she doesn’t stammer or speak particularly fast, which she says is typical when talking with strangers. She’s sitting near the back of an oblong room at the downtown office of the American Civil Liberties Union, talking about making phone calls to pharmacies.

“I found it much easier when I sounded kind of desperate, like I needed this,” she said of the calls, part of a survey meant to gauge the availability of emergency contraception — better known as Plan B or the morning-after pill — across Kentucky. West, an intern with ACLU’s Reproductive Freedom Project, and five volunteers conducted the survey, the first of its kind in Kentucky and one of a few nationwide.

It was easy for West to get into character for the “mystery shopper” style of the survey: both her sister and best friend are single mothers of three.

“I wanted to put myself in the place of a potential client of mine, so I thought about how they would feel if they were desperate and didn’t have any choices other than trying to get emergency contraception, and were faced with making these phone calls to pharmacists,” she said.

More than abutting the political left’s frame for reproductive freedom and choice issues, however, the survey’s results — released by RFP at a press conference in the Capital Rotunda in Frankfort last Thursday — are alarming for reasons of medical deficiency: of 309 pharmacies surveyed statewide (roughly one-fourth of the state’s 1,289 pharmacies), a mere 13 percent had Plan B in stock.
Perhaps more indicative of the core problem that has plagued Plan B, however, was this: 60 percent of the pharmacists surveyed misidentified it as RU-486, the oft-maligned “abortion pill.” Another 9 percent didn’t know what it was.

Beyond the uneasy questions the results raise about why more pharmacists aren’t aware of Plan B, the matter of whether a pharmacist has the right to refuse to dispense certain medications because of personal beliefs is paramount. Laws vary from state to state on the so-called “conscience clauses”; Kentucky has no law pertaining specifically to pharmacists in this regard, although there is one for physicians and nurses. Essentially, it’s left up to the pharmacy or the pharmacist in charge, a gray legal area that seems destined to engender conflict.

A preventative measure?
Put simply, Plan B is a loaded dose of birth control that prevents implantation of a fertilized egg onto the uterine wall, the essential point of a new pregnancy where the zygote settles into the womb to develop. According to the American Medical Association, Plan B cannot terminate an already established pregnancy. When taken up to 72 hours after unprotected sex, contraception failure or sexual assault, it has an 89 percent rate of effectiveness, according to the drug’s FDA-approved label.

Shona Murray, a reproductive endocrinologist at the University of Kentucky, deals mostly with reproductive and infertility issues.
“The more available (Plan B) is, the easier access, the more likely women are to take it,” she said. “It’s certainly medically very safe, a lot safer than being pregnant. It’s not 100-percent effective, but it’s very effective overall. And the sooner it’s taken the better it works, so anything that is an impediment to a woman getting her hands on the medication is decreasing the chances of effectiveness.”

To its supporters, Plan B is just good medicinal practice, another step toward reducing the number of abortions in America every year.
“What it does is, it prevents pregnancy,” RFP director Amanda Kreps-Long said at the Frankfort press conference last week. “If our goal is all about preventing the need for abortion, this is the perfect thing.”
In fact, in a report issued in 2004, the American Academy of Family Physicians said emergency contraception prevented 51,000 abortions in 2000, well before it became embroiled in the current controversy.
Predictably, pro-lifers and the political and religious right have rolled Plan B into the abortion debate, hanging the issue on the well-worn “when does life begin?” quandary. Plan B’s opponents equate the prevention of implantation to the controversial procedure.

“We’re opposed to emergency contraception because it keeps the fertilized ovum, which is a tiny human embryo, from implanting on the wall of the uterus,” said Margie Montgomery, director of Kentucky Right to Life, in an interview last week. “Any type of procedure that kills a tiny human being is something that we must oppose, because we respect the dignity of each and every human life.”

Beyond the typical social squabbling, Plan B is at the center of a pseudo-scientific and religious debate over whether the drug should be granted over-the-counter status, which would remove the need for a prescription.

In May 2004, a Food and Drug Administration advisory panel recommended, by a 23-4 vote, that Plan B be granted OTC status. Dr. David Hager — a Lexington OB/GYN, anti-abortion activist and evangelical Christian — wrote a minority opinion urging the FDA reject OTC status for Plan B because there wasn’t enough information about how the drug affects females under age 16.

Despite the panel’s overwhelming majority recommendation, the FDA took the unprecedented step of not granting OTC status to Plan B, citing a general lack of information. A later concession by Plan B manufacturer Barr Laboratories, to require a prescription for girls under 16, failed to persuade the FDA to overturn its decision.
Later in the summer of 2004, Congress asked the Government Accountability Office to investigate the ruling, suspecting that the decision was based more on perfunctory factors like religion than on actual science. The GAO report, released some 16 months later, called the decision “unusual.” It noted that of 67 “switch decisions” (from prescription to OTC) between 1994 and 2004, Plan B was the only drug not approved for such a change after receiving a favorable recommendation from the advisory committee.

Susan F. Wood, formerly an assistant commissioner for women’s health at the agency, resigned in protest of the decision. She told The Washington Post last November that “instead of improving and advancing women’s health, the FDA leadership is ignoring its process and not relying on science and medical evidence.”

Although agency officials denied it, many insiders assume Hager’s minority opinion figured prominently in the FDA decision. In October 2004, during a speech at Asbury College in Wilmore, Ky., Hager intoned that God aligned him with the FDA to carry out His work, and that people inside the FDA had asked him to write the minority opinion, which he told the audience influenced the agency’s decision — by way of God’s hand — not to make Plan B available without a prescription.

The AMA’s response came June 12, 2004, and it was fierce and uncompromising: “This unprecedented action refutes evidence-based medicine and creates a politically-driven barrier to safe, affordable, and effective access to emergency contraception for many women.” Later in the statement, the AMA encouraged physicians to actively promote emergency contraception and to educate patients about the drug, as well as push for advance prescriptions “until the pills are available over-the-counter.”

Three questions
The RFP survey was straightforward and simple: by phone, a woman caller reached a pharmacist on duty and asked, “If I come in with a prescription for Plan B, can you fill it today?” If the answer was yes, game over. That happened 38 times, out of 309 pharmacies surveyed.

According to the results, counties with pharmacies that do stock Plan B are somewhat well-spread across the state, with major clusters near Jefferson and Bullitt, in southern Kentucky with Allen, Barren and Warren counties, and in the southeastern portion of the state. Louisville ranked higher than the state in general; 26 percent of pharmacies surveyed stocked Plan B, double the state average.
If a pharmacist did not have the pills in stock, the woman asked if they could be ordered. That’s where the results were slightly more promising for RFP. One hundred twenty-six pharmacies surveyed that don’t carry Plan B — 53 percent — could order it. This was true for 36 percent of Louisville pharmacies. (The question included the time consideration, and five of the surveyed pharmacies in the state could only get Plan B in three days to a week, too late for a woman with an immediate need.)

But 47 percent of Kentucky pharmacies surveyed don’t stock Plan B and would not order it, many for varying reasons. Again, the figure for Louisville was 36 percent.

“I guess I just continually struggle with the issue that if we’re talking about trying to prevent the need for abortion, this is an answer,” Kreps-Long said in an interview last week. “It’s obviously not the answer, but it could really reduce the need. And for these women to have no access to it at all is pretty disturbing. Thirteen percent is just terrible.”

Similar surveys have been conducted in Pennsylvania, West Virginia and Connecticut, all with varying results. In Connecticut, for example, the survey found that more than 80 percent of pharmacies surveyed had Plan B in stock.

The last of the three questions was perhaps most indicative of how Plan B is commonly misconstrued: Is Plan B the abortion pill?
Statewide, 60 percent of pharmacists surveyed said it is. The figure in Louisville, a city many of its own residents describe as progressive, was 63 percent.

“I was very surprised (by those figures),” Kreps-Long said. “I wouldn’t be so surprised if (Plan B) was just in the newspapers, but it’s been on TV frequently.” (For a Nov. 27 show last year, the CBS news magazine “60 Minutes” — prompted by the RFP survey — sent a female reporter into Lexington pharmacies with a hidden camera in search of emergency contraception.)

West, the RFP intern, said the last question drew the ire of some pharmacists.

“I had some tell me, when I asked if it was the abortion pill, say, ‘Yeah, isn’t that what you’re taking it for?’”

A female pharmacist lectured her about personal responsibility.
“She goes, ‘If you were my daughter, I would’ve sat you down and told you your actions were wrong, you need to be on birth control’ or something. She just gave me a full-on 20-minute lecture.”

Rachel Chancy, a former pharmacist at CVS who was on hand in Frankfort last week, said it’s not uncommon for pharmacists to be undereducated about a drug their pharmacy doesn’t carry. There’s a virtually constant flow of new drugs being introduced, and drug companies are responsible for training pharmacists on new medications. But Barr Laboratories, which makes Plan B, is relatively small, and manufactures mostly generic drugs.

“They don’t really have drug reps,” she explained. “They don’t do all the bells and whistles that the other drug companies do. I think it’s sort of a systemic problem that pharmacists get their continuing education in the manner they do. There should be more unbiased continuing education put out there.”

A matter of conscience?
Nationally, there have been several recent high-profile cases involving pharmacists’ right to refuse to dispense prescribed medication, from Plan B to birth control pills to Ritalin. State laws determine whether a pharmacist is obligated to fill a prescription to which he or she may take moral objection.

Four Illinois pharmacists were suspended by Walgreens late last year for refusing to fill emergency contraception prescriptions, a violation of state law. Prompted by that action, the research firm HCD conducted a cross-country survey of 859 pharmacists and found that 69 percent of those surveyed thought they should have the right to refuse to fill Plan B prescriptions if inclined.

Michael Polzin, spokesman for Walgreens, said in an interview last week that the company’s policy allows pharmacists the right to refuse based on moral objections (see sidebar, next page). However, the pharmacist must refer the customer either to a pharmacist willing to fill the prescription or a store manager, who will refer a woman to a pharmacy that will fill her prescription. The caveat is that state law trumps store policy, Polzin said, which is the case in Illinois.

Kentucky has no law governing a pharmacist’s right to refuse. The Kentucky Board of Pharmacy is the state’s regulatory agency, and as such, the gatekeeper for potential legal issues.

“That hasn’t been addressed by the law one way or another,” said Mike Burleson, the Board’s executive director. “A pharmacist using his or her professional judgment can refuse a prescription.”

When asked, Burleson would not specifically define “professional judgment.”

A woman refused Plan B by a pharmacist can file a complaint with the Board, something RFP is urging. No complaints have been filed about Plan B, Burleson said, and there would have to be a specific complaint for the Board to weigh in on the issue.

Montgomery, of Right to Life, says the need for a so-called conscience clause is urgent, because pharmacists are dealing with “a matter of life or death.”

“I think there is a freedom of conscience, that people shouldn’t have to participate in something that goes against what their conscience is telling them,” she said.

Pharmacists for Life, a strident international organization whose Web site includes a “stupid sayings” section reserved for taking potshots at people with opposing viewpoints, is another high-end supporter of the clause.

Though ardently rejected by the state legislature in the recent past, some lawmakers are ready to move on the issue again. Jefferson County Rep. Tom Burch, D-30, a longtime legislator, introduced a bill last Friday that would create a collaborative agreement between pharmacists and physicians, and establish a protocol that would allow a pharmacist to dispense Plan B — after asking a series of questions — without a prescription. It’s an end-around on the FDA decision, but a first step.

“It always seems to me that women are in the back seat all the time, and some dude’s doing the driving,” he said last week in Frankfort. “The day-after pill and all that — just because you have sex doesn’t mean you’ve got to have kids. That’s what the ultimate design of it’s for, but it’s also meant to bond two people together. To me, (it’s) crazy to keep on having babies and having babies and having babies. If you have these types of contraceptives you don’t have to worry about that.”

Rep. Ruth Ann Palumbo, a Lexington Democrat, is a co-sponsor of Burch’s bill, along with Joni Jenkins, D-44, and Mary Lou Marzian, D-34. Louisville Sen. Tim Shaughnessy, D-19, and Lexington Sen. Ernesto Scorsone, D-13, also spoke at the press conference. There is talk that Shaughnessy will sponsor a similar Senate bill.
While no one involved expects the House bill to summit the Republican-controlled Health and Welfare committee, let alone pass the House, they say it’s important to keep it in the public eye.
“You have to keep the issue out there in order to eventually get it to pass,” Burch said.

(Disclosure: The writer’s girlfriend is an RFP volunteer who participated in this survey. She apprised the writer of the survey when it began last September, but was at no point thereafter consulted regarding this story, including in casual conversation.)