What’s next after the FDA expanded abortion pill access to retail pharmacies
The Food and Drug Administration (FDA) recently took major steps toward increasing access to abortion pills in the U.S. with a rule change that will allow retail pharmacies, including CVS ( CVS ) and Walgreens ( WBA ), to start dispensing mifepristone, which may be used in a medical abortion.
This decision builds on the Biden administration’s move last year after the Supreme Court overturned Roe v. Wade to remove the requirement that patients take their medication in person. It also updates the drug’s labeling to allow it to be dispensed through telehealth consultations and by mail where permitted by law.
“The FDA’s decision to allow pharmacies to dispense mifepristone with a prescription from a certified prescriber is an important step in allowing women to get the medication they need,” said Dr. Jennifer Butt, an OBGYN at Upper East Side Obstetrics & Gynecology, told Yahoo Finance. “It is important to remember that mifepristone is not only used for abortions, but also to treat early miscarriage. When used in combination with misoprostol, which is also a prescription drug but more readily available, mifepristone can increase significantly the efficacy of abortion treatment”.
While the decision promises to expand access to mifepristone, it does not mean that pharmacies will immediately start dispensing the drug.
A package of Mifeprex pills, used to terminate early pregnancies, is shown in this photo illustration taken May 11, 2022. REUTERS/Caitlin Ochs/Illustration
What is mifepristone and how does it work?
Mifepristone, when taken in combination with the drug misoprostol, can be used to terminate a pregnancy up to 10 weeks. The drug works by blocking the hormone progesterone, which is necessary for pregnancy to continue.
According to the Mayo Clinic, for those terminating the pregnancy, the regimen consists of taking a dose of mifepristone followed by a dose of misoprostol 24-48 hours later. Patients are then advised to follow up with a healthcare provider 7-14 days after taking mifepristone.
Previously, patients could only get Mifepristone through selected doctors, clinics and mail order pharmacies. Misoprostol, the second drug in the regimen, is now available in many retail pharmacies with a prescription, and the drug is also used for other conditions such as stomach ulcers.
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While Dr. Butt doesn’t believe there are any safety concerns with the FDA’s announcement to allow pharmacies to dispense Mifepristone, she explained that patients will still need a prescription from their doctor who “would determine if they were a good candidate for medical treatment and they would be advised of any risks in advance.”
What happens next?
Before retail pharmacies can begin dispensing mifepristone to individuals, they must first undergo a certification process.
According to Dr. Ushma Upadhyay, director of research at the University of California Global Health Institute’s Center of Expertise on Women’s Health, Gender and Empowerment, the certification process is straightforward; however, certain systems will need to be in place and pharmacists will need to be trained to dispense the drug.
A pharmacist poses with pills of the drug Misoprostol, manufactured by Lupine Pharmaceuticals, in hand at a pharmacy in Provo, Utah, U.S., June 19, 2019. Picture taken June 19, 2019. REUTERS/George Frey
“Because there are so many restrictions remaining in place for mifepristone, there are many requirements that the FDA is placing on pharmacies that plan to dispense mifepristone,” Upadhyay told Yahoo Finance. “Pharmacies must develop a system to track who is prescribing mifepristone. With each individual prescription, the prescriber must fax or email a certification form to that specific pharmacy if the pharmacy does not already have one on file. These are the kinds of systems they need to develop to ensure that with every prescription that comes in, it’s written by a certified prescriber.”
The pharmacy certification process for mifepristone ensures that pharmacies are knowledgeable and compliant with the REMS (Risk Evaluation and Mitigation Strategies) program. REMS requirements include the ability to receive prescriber agreement forms via email and fax, use of a shipping forwarding service, designation of an authorized representative to handle the certification process, and compliance with the Mifepristone REMS Program. This process ensures that mifepristone is dispensed only for prescriptions written by certified physicians.
In a statement, the American Pharmacists Association called on the FDA to “allow any pharmacy that wishes to dispense mifepristone to be certified, creating a level playing field for all pharmacies.”
Walgreens retail chain on River Street in Mattapan. (Photo by Lane Turner/The Boston Globe via Getty Images)
How long is the certification process expected to take?
While there is no specific time frame for the certification process, Upadhyay expects pharmacies to take the decision seriously and begin the certification process as soon as possible.
“It’s just how much infrastructure they want to have before they officially start doing this,” she said. “I can imagine that the smaller, independent pharmacies will develop their processes after they get their first request. I think the pharmacies now have no information about what to expect in terms of the number of prescriptions they will receive. “
Walgreens has already announced that it intends to be certified to dispense mifepristone.
In a recent statement, Walgreens spokesman Fraser Engerman stated: “We plan to become a certified pharmacy under the program and are in the process of enrolling and training our pharmacists, as well as evaluating our pharmacy network to determine the most good for dispensing mifepristone in compliance with federal and state laws and any additional FDA requirements.”
CVS also stated that it plans to “seek certification to distribute mifepristone where legally permitted.”
Will it be available in all retail pharmacies?
Upadhyay explained that the drug will not be available in every state — especially where abortion care is prohibited.
“This change has no benefit to people living in states where abortion care is prohibited,” Upadhyay said. “Most likely CVS [pharmacies] in Mississippi will not carry this medication. States that have abortion bans all have exceptions, but CVS’ is unlikely to stock mifepristone just for those exceptions.”
Still, Upadhyay says she remains optimistic about the change and hopes it will normalize conversations about abortion care.
“What I hope this change will do is impact and normalize abortion care in the United States,” Upadhyay said. “People should expect to be able to get these medications from their local pharmacies in the same way they can get their birth control or STI treatment or any other prescription. This decision makes it clear that mifepristone is safe and should be easily accessible to you. Local pharmacy. I don’t expect it to be available in states that ban abortion, but I hope it will change cultural expectations.”
Sandra Salathe is an editor at Yahoo Finance. Follow him on Twitter at @srsalathe
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