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Medication abortion rule change could see pharmacies dispense pills in more states

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Medication abortion rule change could see pharmacies dispense pills in more states

Image source: The Dialog

Medication abortion is a safe and effective method of ending a pregnancy during its early stages.

It involves taking medications that cause the uterus to contract and expel the pregnancy.

There are two main medications used in medication abortion: mifepristone and misoprostol.

Mifepristone is taken first and works by blocking the hormone progesterone, which is necessary for the pregnancy to continue.

Misoprostol is taken 24-48 hours later and causes the uterus to contract and expel the pregnancy.

Medication abortion is typically offered up to 10 weeks after the last menstrual period, but it may be available up to 24 weeks in some cases.

It is generally more effective the earlier it is done.

Distribution of the pills

In the United States, the distribution of abortion pills is regulated by the Food and Drug Administration (FDA). 

The FDA has approved mifepristone and misoprostol for medication abortion, and they can only be prescribed by a licensed healthcare provider.

There are some restrictions on the distribution of abortion pills, such as the requirement that they are provided in person by a healthcare provider rather than being mailed or shipped directly to patients.

Additionally, certain states have laws that impose additional restrictions on the provision of abortion pills, such as mandatory waiting periods or required in-person counseling.

Rule change

Following a change in FDA rules, pharmacy chains CVS and Walgreens shared plans to seek certification to distribute abortion pills in legal areas.

On Tuesday, the FDA’s website said that pharmacies certified to dispense mifepristone could directly send it to people with a certified prescription.

The change allows outpatient pharmacies to dispense mifepristone, but not all pharmacies will dispense the medication.

“In terms of whether or not that is going to have any impact in states where abortion is banned, I think the answer is probably not,” said law professor Lewis Grossman.

“I don’t see any real effects there.”

University of Michigan law professor Leah Litman chimed in, saying:

“It’s not at all clear that many or all or most pharmacies, or pharmacies in more rural areas, or pharmacies in red states will do so in ways that meaningfully increases access to medication abortion.”

“Mail order pharmacies have already been dispensing pills with the FDA’s permission,” she added.

“So the possibility of getting medication abortion existed before this latest decision.”

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Pharmacies

On Wednesday, Walgreens released a statement saying it is working through the registration pharmacist training and evaluating its pharmacy network.

Meanwhile, CVS plans to seek certification to dispense mifepristone where it’s legal.

On Tuesday, online pharmacy Honeybee Healthy posted on its official Facebook page that it is officially the first pharmacy certified to dispense medication abortion.

As a result, the online pharmacy can distribute pills in states that allow it to.

“At the onset of the pandemic, Honeybee Health quickly became the first digital pharmacy to supply and ship medication abortion,” the official statement read.

“We are proud to partner with the majority of telemedicine abortion providers in the US and to work closely with our manufacturer to help set the high standards required for certification in response to the FDA’s adjustment to the REMS program.”

REMS is the Risk Evaluation and Mitigation Strategy program utilized for mifepristone.

However, as it can be complicated, many other pharmacies will take time to review and decide if they should go through the certification process.

“Mifepristone is not the kind of drug for which any kind of pharmacy certification is normally required,” said Grossman.

“And this particular pharmacy certification regime seems much more onerous than one would expect for a random drug with a similar safety profile.”

Meanwhile, the American Society of Health-System Pharmacists released a statement saying:

“FDA’s change does not mandate that pharmacies must stock or dispense mifepristone, nor does it supersede any state laws that restrict prescribing or dispensing of the medication.”

Impact on abortion

According to Leah Litman, there are still questions about how the changes affect the abortion access landscape.

She said:

“It’s still not clear that the latest FDA move means that states couldn’t enforce different abortion restrictions against doctors who prescribe medication abortion, or pharmacists who fulfill prescriptions, or people who take medication abortion to induce an abortion.”

It’s also unclear if people living in anti-abortion states can use telehealth services for mifepristone prescriptions and have it mailed.

According to the principal policy associate of state issues at the Guttmacher Institute, Elizabeth Nash, the pills remain banned in places banning abortion before the FDA rule change.

“The FDA’s change in allowing dispensing at pharmacies means that there are more options for access for people in states where abortion is not heavily regulated and abortion rights are protected,” said Nash.

“Where abortion has been banned, abortion remains banned.”

“What we are seeing now is that if a state has banned abortion, then medication abortion is unavailable,” she continued.

“And I think we’re going to see how this tension plays out between the FDA’s authority over drugs and devices and the state laws.”

“We may see some court cases around this very issue as to FDA’s authority and state law,” Nash added.

Reception

Andrea Miller of the National Institute for Reproductive Health praised the FDA’s decision, saying it was an important step forward.

However, she pointed out that there is an “unfortunate reality.”

“The unfortunate reality is that there are more than a dozen states right now where abortion is illegal or close to fully illegal, it is banned,” Miller elaborated.

“And unfortunately, just like people are forced to do now, it is likely that some people in states where abortion is banned may choose to travel to another state to seek medication abortion.”

“We don’t believe that anyone should be forced to travel in that way, and certainly, as this moves forward, there are a lot of very smart lawyers who are looking at the question of how they’ll be incorporated into drugstores and pharmacy chains, and where that can happen – and how these different federal and state provisions interplay.”

With today’s political climate, Leah Litman believes it’s not clear if the Supreme Court will say the FDA’s rule change “preempts” state laws that restrict access to medication abortion.

Reference:

Some major pharmacies are planning to dispense abortion pills, but not in every state

Scarlet Logan is a marketing professional who loves writing. She graduated with a double major in journalism and economics.

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