Good morning! I'm feeling a bit nerdy today and would like to explain what "REMS" is and why it's making medication abortion pills less accessible as they could be.
First, what is "REMS"?
Well, it stands for Risk Evaluation and Mitigation Strategy. It's a restriction the Food and Drug Administration (FDA) puts on medications that have high safety concerns to ensure it is used safely.
fda.gov/drugs/drug-saf….
Well, it stands for Risk Evaluation and Mitigation Strategy. It's a restriction the Food and Drug Administration (FDA) puts on medications that have high safety concerns to ensure it is used safely.
fda.gov/drugs/drug-saf….
There a few medications that have REMS, and some make sense. Take Clozapine for example; it's a medication for people with schizophrenia which can lower a patient's white blood cell count, so when a patient goes to the pharmacy, a pharmacist can check it prior to dispensing.
When your medical provider writes a prescription, you simply go to the pharmacy or fill it by mail and get the prescription. Pretty simple.
In this case, Clozapine has REMS on it, and pharmacists provide an extra check prior to dispensing the medication.
In this case, Clozapine has REMS on it, and pharmacists provide an extra check prior to dispensing the medication.
How is this different from medication abortion? Well, the REMS do not allow mifepristone* to be dispensed in a pharmacy. Only in a physician's office, clinic or hospital.
*Mifepristone, the first pill of 2 taken for a medication abortion, followed by misoprostol 24 hours later.
*Mifepristone, the first pill of 2 taken for a medication abortion, followed by misoprostol 24 hours later.
The REMS the FDA has placed on mifepristone are strict, despite it being very safe to use. In fact, we studied its safety for 16 years. It’s extremely safe to take for abortion procedures.
nejm.org/doi/full/10.10…
nejm.org/doi/full/10.10…
The reality is mifepristone is very safe and no longer meets the profile of a medication with strict REMS. If patients were able to access it in a pharmacy, they would be able to obtain abortions via telemedicine and pills via mail.
japha.org/article/S1544-…
japha.org/article/S1544-…
We've studied telemedicine provision of medication abortion and found that it's just as safe as in-clinic provision. It's very safe. The only thing keeping it out of patients hands is overregulation.
journals.lww.com/greenjournal/F…
@acog's statement: acog.org/Clinical-Guida…
journals.lww.com/greenjournal/F…
@acog's statement: acog.org/Clinical-Guida…
Removing the REMS would also increase access to medication abortion via pharmacies, which would increase access in rural areas and communities without providers.
japha.org/article/S1544-…
japha.org/article/S1544-…
All that to say, medication abortion is safe and it's past time to remove the REMS.
nejm.org/doi/full/10.10…
nejm.org/doi/full/10.10…
