In Washington state, pharmacists are poised to start prescribing abortion drugs

Over the past several months, a handful of community pharmacies in states where abortion remains legal have begun to take advantage of a new rule that allows them to fill prescriptions for the abortion pill mifepristone. Prior to the rule change, which was finalized last January by the Food and Drug Administration, pregnant people had to get the drug directly from their doctor or by mail if using telemedicine, depending on the laws in their state.

Reproductive health experts have said relaxing that requirement could help ease the growing burden on abortion clinics in states where abortion is legal. And perhaps nowhere is the potential for that greater than in Washington state, where efforts are underway to open up access to medication abortion in a radical new way: by training pharmacists not only to dispense abortion pills but also to prescribe them to their walk-in patients.

"We think this could have a huge impact in our state," says Don Downing, a professor emeritus of clinical pharmacy at the University of Washington in Seattle. Medication abortion now accounts for more than half of abortions in the U.S.

Last spring, Downing and colleagues launched the Pharmacy Abortion Access Project to provide community pharmacists in Washington with training on screening for medication abortion eligibility, prescribing abortion pills, and dispensing them from their brick-and-mortar stores — a streamlined model of care that currently exists nowhere else in the United States.

"This is about meeting women where they are," says Downing, adding that close to 90% of Americans live within 5 miles of a community pharmacy and that patients visit their pharmacist almost twice as frequently as they visit their primary care physician. "We do believe this can serve as a model for other states."

And it may be more than a matter of physical access. Pharmacists are consistently rated among the most trusted health care providers, he says. "So we think there may be people — possibly many people — for whom it's too frightening, too stigmatizing to go to a doctor but who, as we've seen over the years, are very comfortable coming to us."

There are 10 pharmacists in the first cohort, and Downing expects them to start prescribing in the next few weeks. But word is spreading, he says. More and more calls are coming in. And Downing frequently finds himself explaining how a law passed more than forty years ago first opened the way for this model, by making it possible for pharmacists in Washington to prescribe any FDA-approved drug.

Redefining the pharmacy

In 1979, Washington became the first state in the nation to enact legislation allowing for the formation of collaborative practice agreements, or CPAs. Under the agreements, a licensed prescriber, such as a physician or a nurse practitioner, can delegate to a pharmacist the authority to prescribe a given drug and administer it to patients.

This step opened the way for pharmacists to expand their scope of practice in Washington — and Downing has spent his career working to expand it further.

As a doctoral student in the mid-1970s, Downing was part of a growing push led by the Indian Health Service to use pharmacists to reach underserved communities. Concerned about the low immunization rates among Native Americans long neglected by the federal government, he helped Native activists in Seattle build the country's first urban tribal clinic. After graduating, he went to work with other tribes, serving as a pharmacist medical provider on reservations throughout the region.

Those experiences opened Downing's eyes to the vast inequities in access to basic health services—and the untapped potential for pharmacists to help close that gap. In the early 1990s, he and a colleague, Jackie Gardner, a professor of epidemiology at UW, began training community pharmacists to administer flu shots and other vaccines, leading to the launch of the first formalized training program in 1994. Today, pharmacists in all 50 states routinely administer vaccines.

Following that success, Downing, Gardner and other colleagues at UW partnered with the nonprofit PATH to develop the nation's first pharmacist-provided emergency contraception program. At the time, women who needed emergency contraception had to schedule a doctor's appointment, which often meant taking time off from work or school, finding transportation, and arranging for childcare. "We knew there was unmet demand," says Downing. "But we had no idea how much."

When the pilot project started in 1998, they had hoped to reach around 1,500 women, he says, "and we thought we were being optimistic." By the end of the following year, they'd enrolled close to 12,000, with pharmacists in Washington writing more prescriptions for emergency contraception in a single month than the state's doctors had written in the previous year.

Emergency contraception is now over-the-counter, but having pharmacists prescribe it was an important step, says Elisa Wells, a co-founder of the abortion rights group Plan C, who helped start the project while working at PATH. "And for something like emergency contraception, where there's a clock ticking — and this is true for abortion as well — that convenience is crucial."

Downing also worked for years to get pharmacists reimbursed for these clinical services by insurers. Finally, in 2015, Washington's governor Jay Inslee signed a law making Washington the first state in the nation to formally recognize pharmacists as medical providers and require that they not be excluded from health insurance provider networks.

"That allowed pharmacists in Washington to function at the full extent of their licensure and training," said Jenny Arnold, chief executive officer of the Washington State Pharmacy Association, noting that pharmacists today typically complete a doctorate degree and many go on to do residencies. "There's a lot more they can do than just make sure the patient gets the right meds in the bottle."

And yet in many states, she says, pharmacists are still greatly underutilized. While all states now allow pharmacists to enter into a CPA, most limit pharmacists' prescriptive authority to certain patients, circumstances or types of drugs. Washington's law governing CPAs is one of the broadest and most flexible, allowing the clinicians themselves to decide what to prescribe and to whom.

In Washington nearly every pharmacist is signed onto a CPA, says Arnold. In addition to prescribing contraceptives and giving flu shots, many pharmacists have long played a lead role in managing chronic conditions—everything from heart disease and hypertension to diabetes, depression and pain. "Pharmacists are very integrated into their communities," she says. "They're open on evenings, weekends, and holidays, and oftentimes you don't need an appointment to see one."

Obstacles to providing medication abortion

That doesn't mean every pharmacist in Washington is going to start prescribing abortion pills, Arnold says.

For one, many say they lack sufficient knowledge of medication abortion, which is not covered by pharmacy school curricula. That's where Downing's training program fills a gap, guiding pharmacists through a "no-test" protocol designed for evaluating patients remotely, without the need for ultrasound, pelvic exam, or blood work. The protocol includes guidelines for appropriate patient selection, treatment regimen and follow-up care, and excludes patients with symptoms of, or risk factors for, ectopic pregnancy.

The largest U.S. study of no-test screening for medication abortion to date found it to be safe and effective, with outcomes similar to those for patients who received in-person care.

There are several administrative hurdles, too — both for the pharmacist and the pharmacy that employs them.

While the F.D.A. now allows retail pharmacies to dispense mifepristone, it also requires those pharmacies to undergo a new certification process. Currently, just one pharmacy in Washington is known to have been certified. But major pharmacy chains CVS and Walgreens say they continue to work through the required steps. A spokesperson for Walgreens told NPR that the company is "finalizing the certification process to dispense mifepristone" and "expects to begin dispensing soon, consistent with federal and state laws."

To become certified, a pharmacy must meet a number of regulations related to record-keeping, adverse-event reporting, and more. Pharmacies must also appoint a representative to ensure mifepristone is distributed in compliance with the F.D.A's Risk Evaluation and Mitigation Strategies program, or REMS, the stringent set of rules by which the agency regulates certain drugs.

Among them is the requirement that doctors and other health care providers —including pharmacists—who wish to prescribe mifepristone first register with one of the two licensed manufacturers.

That requirement has long been a significant barrier for primary care physicians, particularly those who work for religiously-affiliated health systems. Indeed, though they've been capable of prescribing mifepristone since its approval in 2000, just a small fraction of family physicians and other clinicians currently offer medication abortion.

In Washington state, most primary care is provided by Catholic-owned or federally funded clinics — and for both of these, "the REMS makes it very difficult for a provider to 'register' to prescribe," says Emily Godfrey, a professor of family medicine and of obstetrics and gynecology at UW and the principal investigator for Access, Delivered, a project that helps primary care providers integrate telehealth medication abortion into their clinical practice. "And of course, pharmacists at these institutions would face the same hurdles."

Viability in other states

Nevertheless, interest in pharmacist-led provision of medication abortion appears to be growing, and not only in Washington. A bill pending in the New York State Assembly would grant pharmacists the authority to provide abortion medications under a "standing order" or non-patient specific prescription—the same way pharmacists administer vaccines and dispense naloxone, the opioid overdose reversal drug.

And in California, researchers at the University of California, San Diego recently reported the results of a proof-of-concept pilot study in which a pair of pharmacists safely and effectively provided medication abortions under the study protocol.

"We want pharmacists to be able to practice in the current environment, but we also want to train them to be ready for what's coming five years from now," in terms of expanded scope of practice, says Sally Rafie, the founder of Birth Control Pharmacist and a co-author of the study. Last spring, Rafie and colleagues published the results of a survey study of more than 900 pharmacists and pharmacy students in California that found that 75% "would be willing to prescribe abortion medications to their pharmacy clients if allowed by law."

A limited number of pharmacists in California may already be legally allowed to prescribe mifepristone if they've gotten an advanced practice certification. Rafie says she's hopeful that in the future the state may establish a pathway for all pharmacists to prescribe the drug.

Legal challenges to mifepristone

Meanwhile, a serious legal challenge to the FDA's nearly 25-year-old approval of mifepristone continues to threaten access to the drug across the country.

The Supreme Court is considering whether the FDA may be required to roll back changes it had made in recent years to make the drug more accessible, including allowing it to be sent through the mail and prescribed by health care providers who are not physicians.

Until the Supreme Court issues a decision later this year, mifepristone remains available under the current rules.

"Medication abortion is extremely safe and extremely effective," said Ushma Upadhyay, a professor at the University of California, San Francisco School of Medicine and a chair of the Society of Family Planning's #WeCount project, an ongoing tally of abortions in the U.S.

In October, Upadhyay and colleagues reported that despite abortion bans in 14 states and new limits imposed in 7 others, the past year saw a slight uptick in abortions across the country, with major increases in states where abortion remains legal.

"All of the moves made to shore up access in the legal states—things like expanding insurance coverage of abortion, more protections for providers, and building up the telehealth infrastructure—are having a real impact," she says. Pharmacist prescribing of mifepristone puts the drug a step closer to over-the-counter, she adds. "It's one stop. And to be able to get your medication the same day, to not have to wait for it to come in the mail — that is huge."

Patrick Adams is a freelance journalist based in Atlanta.

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