For the first time, retail pharmacies can dispense abortion medication pills directly to consumers in states where the procedure is legal, after the Food and Drug Administration made a long-sought rule change in early January.
The subsequent decisions by CVS and Walgreens, the two largest drugstore chains in the United States, to seek certification to offer the pills, as required under the rule change, are expected to expand access to the procedure.
Subscribe to The Post Most newsletter for the most important and interesting stories from The Washington Post.
Still, the two-drug regimen is unlikely to be available at neighborhood pharmacies anytime soon. Analysts say that implementing the requirements to dispense mifepristone, including being able to maintain provider confidentiality and track shipments, are time-consuming and may dissuade smaller stores from participating.
Here's what we know so far:
- How does medication abortion work?
Medication abortion involves taking two drugs that have been shown to be a safe way to terminate pregnancies in the first 10 weeks of gestation, which begins on the first day of a person's last menstrual cycle. (The World Health Organization says medication abortion is safe in the first 12 weeks.)
The first drug, mifepristone, also known as RU-486 and sold under the brand name Mifeprex, blocks the hormone progesterone, preventing a pregnancy from progressing. It is used in conjunction with a second drug, misoprostol, which causes contractions that empty the uterus.
Mifepristone was approved in 2000 to end pregnancies through seven weeks, and that was extended to 10 weeks in 2016. By 2020, the drugs were used in more than half the abortions in the United States, according to the Guttmacher Institute, a think tank that supports abortion rights.
- Can I buy the abortion pill without a prescription?
No. Patients will still need to obtain a prescription from a certified health-care provider.
- When will I be able to get abortion pills from my local pharmacy?
That is not yet clear.
The online telemedicine platform GoodRx is already listing prices for mifepristone, suggesting to some experts that pharmacies in states where abortion is legal have begun preparing to dispense the drug. Prices start at just over $30, with an average retail price of close to $75.
But others caution the process could take a while as pharmacies apply for certification and set up systems to monitor prescribers and shipments.
"It's going to take time to build out compliance programs and to ensure a compliance officer is following them," said Greer Donley, an expert on abortion and the law at the University of Pittsburgh School of Law.
- Where can I get the abortion pills?
The pills can be offered only in states where abortion is legal because the Supreme Court in June overturned Roe v. Wade, which had made abortion a constitutional right. More than a dozen states, mostly in the South and Southwest, subsequently outlawed the procedure.
Pharmacists who mail the drug to a state where abortion is illegal could risk losing their licenses in that state.
"It's very early to know which pharmacy is going to become certified," said Ilisa Bernstein, interim CEO of the American Pharmacists Association. She said the process will probably play out in the first few months of 2023.
Even though CVS and Walgreens are applying for certification, it's not clear whether they will dispense the medication from all or only some stores in states where abortion is legal, or only through mail order.
A Walgreens spokesman said in an email that the company is "evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements."
Other major chains like Rite Aid and Walmart have not stated their intentions.
While the certification process does not appear to be cumbersome, experts believe the administrative requirements and potential for controversy could dissuade small corner drugstores from signing on.
"The administrative burden will probably disincentivize smaller pharmacies that can't readily absorb the cost," said Rachel Rebouché, dean of Temple University's Beasley School of Law.
Some experts also suggested that pharmacies close to states where abortion is banned may choose not to dispense the pills to avoid potential legal challenges.
"It may be they want to be well insulated," said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School.
- Is medication abortion safe?
Multiple studies have shown the procedure to be safe, and top medical groups, including the American Medical Association and American College of Obstetricians and Gynecologists, consider mifepristone both safe and effective.
Side effects often include cramping and bleeding, with occasional reports of heavy bleeding that needs to be stopped through surgery.
Adverse events are rare. As of June 30, 28 deaths had been reported in the 20 years since the product was approved, including two linked to ectopic pregnancies, according to data collected by the FDA. The agency determined that those deaths could not be attributed to mifepristone because of the patients' use of other drugs, other medical or surgical treatments, or information gaps about their health status.
During the pandemic, medication abortion prescriptions obtained through telehealth consultations, with the pills delivered by mail gained prominence because the process did not require patients to risk infection by going to clinics or doctors' offices. A small observational study published in JAMA Network found the practice "feasible, safe, and efficacious."
"It is a method of abortion that people can rely on," said Elizabeth Nash, who specializes in public policy for the Guttmacher Institute.
- Who is allowed to sell the abortion pill?
When the FDA approved mifepristone in 2000, it imposed several restrictions to ensure safety, including devising a risk evaluation and mitigation strategy that was just updated as part of its rule change. The requirements include ensuring the medication is made available only via certified prescribers and pharmacies.
Mifepristone is one of only 60 drugs the FDA lists that require a REMS, as the restrictions are called.
Many experts believe those requirements are excessive and a reflection of political, more than health-care, concerns.
"I am of the opinion that those safeguards are not needed considering the safety profile of the drug," said Sarpatwari.
You can find out more about those requirements on the FDA website.
- How old do you have to be to get abortion pills?
There is no age requirement to obtain a prescription under the new rules. But many states require those under 18 to get permission from or notify a parent or older family member before an abortion, unless a judge issues a "judicial bypass."
Planned Parenthood keeps a list of states and their parental notification laws.
- How much will abortion pills cost?
GoodRx is listing mifepristone prices at numerous major chains, with an average retail price of almost $75.
But that could change. Drug prices are determined by manufacturers, distributors and retailers in the United States. The FDA has no say about whether an insurance company chooses to cover a drug. Also, costs for a patient will include the consultation with a certified provider to get a prescription, which can be done online.
The pharmacies' need to meet the regulatory requirements, from training staff to tracking shipping, could increase costs, some experts say. On the other hand, an increase in demand could help push prices down.
"It's really hard to say in a straightforward way what the overall effect on cost would be," said Susan Lee, a partner at the global law firm Goodwin, who advises biologics and drug companies on regulatory and compliance matters.
- Is it legal to buy the abortion pill on the internet?
Women in states that ban abortion have been ending unwanted pregnancies with abortion pills ordered online from overseas, though importing drugs for personal use is generally illegal. While U.S. providers could lose their licenses or face other consequences for shipping pills to states where abortion is illegal, it is difficult to punish providers outside the United States who send pills to women in states with abortion bans.
But the FDA added warnings about selling "unapproved and misbranded" mifepristone and misoprostol over the internet, specifically naming the suppliers AidAccess and Rablon and saying drugs sourced outside of the official U.S. drug supply chain can pose "serious risks" to patients.
"This could have a chilling effect," said Sarpatwari.
- What role does medication abortion play in the battle over reproductive rights?
Medication abortions are the latest battleground over abortion rights, in part because they have become increasingly common over the two decades.
A federal lawsuit filed by antiabortion groups in Texas in November seeks to halt the use of medication abortion nationwide by overturning the FDA's approval of mifepristone. The groups argued that the agency lacked the authority to approve the drug and didn't adequately study it and that the medication is unsafe.
Should the judge in that case, appointed by President Donald Trump, rule in favor of the groups, access to the pills could be halted, unless the ruling is put on hold or overruled by a higher court.
Last year was a huge year in space. Here's what to look for in 2023.
The world's torrid future is etched in the crippled kidneys of Nepali workers
Penn State vowed to open a racial justice center. Now the plan is dead.
8 mmol and diphenylphosphoryl azide 17 accutane over the counterREPLY
Clenbutrol crazy bulk is a popular steroid alternative that bodybuilders use to retain their lean muscle, encourage fat loss, and improve endurance and energy clomid cycle They weren t very important charactersREPLY
Doxilin Uses lasix for dogs fluid in lungsREPLY
lasix in usa Menopause 2017; 24 728 53REPLY