In a recent regulatory change, the FDA made it possible for retail pharmacies like CVS (CVS) and Walgreens (WBA) to begin supplying mifepristone, which may be used in a pharmaceutical abortion.
This decision follows a similar one made by the Biden administration last year in response to the Supreme Court's Roe v. Wade ruling, which eliminated the need for patients to personally pick up their prescriptions. The packaging is revised to reflect the expanded availability of medicines through telemedicine and mail orders.
Upper East Side Obstetrics & Gynecology OBGYN Dr. Jennifer Butt told Yahoo Finance that the FDA's decision to allow pharmacies to administer mifepristone with a prescription from a qualified prescriber was a "significant step" in ensuring that women had access to the drug they needed. Keep in mind that mifepristone is used for more than just abortions; it is also effective in preventing and treating miscarriages.
Combining mifepristone with misoprostol, another prescription medicine but one that is more widely available, may greatly improve the success rate of treating a miscarriage. "There will be more people who can get mifepristone as a result of the judgment, but that doesn't imply it will be readily available at pharmacies right away.
Just what is mifepristone, and how does it help women?
When combined with misoprostol, mifepristone may terminate a pregnancy up to 10 weeks along. The medicine is effective because it prevents the body from producing the hormone progesterone, which is required for a pregnancy to progress.
To terminate a pregnancy, the Mayo Clinic recommends taking mifepristone first, followed by misoprostol between 24 and 48 hours later. Patients are instructed to schedule a follow-up appointment 7–14 days after taking mifepristone.
Before this, Mifepristone was only available through a limited number of medical professionals and facilities, including certain hospitals and clinics and a few mail-order pharmacies. The second medicine in the course, misoprostol, is widely accessible at retail pharmacies with a prescription and is used to treat a variety of diseases, including stomach ulcers.
Dr. Butt disagrees with those who worry about the safety of the FDA's decision to allow pharmacies to dispense Mifepristone, and she explains why patients will still need a prescription from their doctor, who "would determine if they were a good candidate for medical treatment and counsel them on any risks beforehand."
So, what happens after this?
There will be a certification procedure that retail pharmacies must complete before they may begin providing mifepristone to patients.
The certification process is simple, says Dr. Ushma Upadhyay, director of research at the University of California Global Health Institute's Center of Expertise in Women's Health, Gender, and Empowerment; however, specific infrastructure must be in place and pharmacists must be trained before the drug can be dispensed.
According to Upadhyay of Yahoo Finance, "the FDA is placing a lot of constraints on pharmacies that seek to administer mifepristone since there are so many residual regulations in place on mifepristone." "Stores dispensing mifepristone must institute measures to monitor their prescribers."
If the pharmacy doesn't already have a certification form on file, the physician will need to fax or email one to them before they fill the prescription. These are the types of processes that need to be established to guarantee that only qualified doctors are writing prescriptions.
Mifepristone certification for pharmacies is a way to guarantee that they understand and follow the REMS (Risk Evaluation and Mitigation Strategies) program's guidelines for handling the drug.
Prescriber agreement paperwork must be sent through email or fax, a tracking shipment service must be used, an authorized person must be appointed to handle certification, and the Mifepristone REMS Program must be followed to meet REMS criteria. This procedure guarantees that only prescriptions for mifepristone issued by licensed physicians will be filled.
"Enable any pharmacy that desires to distribute mifepristone to become certified, ensuring a fair playing field for all pharmacies," the American Pharmacists Association urged the FDA in a statement.
When can we anticipate the completion of the certification process?
Upadhyay said that pharmacists should take the decision seriously and start the certification procedure as soon as possible, even if there is no set deadline. She said that the delay in beginning operations was contingent on the level of preparation the government desired.
"Smaller, independent pharmacies will probably build their procedures once they get their first request." "I don't believe pharmacists know how many prescriptions they'll be filling right now."
To supply mifepristone, Walgreens has already indicated its intention to undergo the necessary certification processes.
Walgreens spokesperson Fraser Engerman recently said, "We plan to become a certified pharmacy under the program and are in the process of registering and training our pharmacists, as well as evaluating our pharmacy network to determine the best locations for dispensing mifepristone in compliance with federal and state laws and any additional FDA requirements."
Additionally, CVS claimed that it "intends to pursue certification to administer mifepristone whenever legally permitted."
What percentage of pharmacies plan to stock it?
Upadhyay said the medication won't be offered in all states, especially those with strict abortion laws.
Upadhyay argued that those living in states with restrictive abortion laws would not benefit from the reform. "Most Mississippi CVS pharmacies probably won't stock your drug." "There are loopholes in every state's abortion law, but it's implausible that anyone CVS would have mifepristone on hand only for those states."
Upadhyay maintains a positive outlook on the shift, saying she believes it will mainstream discussions about abortion care.
Upadhyay hopes that the new law will make abortion more commonplace in America. "In the same way that people may access birth control and STI treatment at local pharmacies, they should be able to acquire these prescriptions as well."
Mifepristone is safe and should be readily available at pharmacies throughout the country as a result of this ruling. "Although I do not anticipate its availability in places that prohibit abortion, I do want a shift in cultural norms."
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