Mifepristone with misoprostol is the safest, most effective way to manage abortion and early pregnancy loss (EPL) with medications. However, regulations on mifepristone make it difficult for primary care clinicians to provide this basic, evidence-based care. Currently, the US Food and Drug Administration regulates mifepristone under a Risk Evaluation and Mitigation Strategy (REMS), which means it’s classified as a “dangerous drug” – despite its history of safe and effective use. It prevents clinicians from prescribing mifepristone, but rather requires them to stock and dispense the pill directly to patients in-office.
Last fall, we surveyed primary care clinicians around the US to tell us about their experiences and stories trying to provide mifepristone, and the effects on their patients.
Here’s what we learned:
- Primary care clinicians want to provide medication abortion and/or EPL care in their primary care practices, but 63.2% did not have mifepristone available in their clinics.
- If mifepristone could be prescribed like other medications, 77.6% and 91.7% of respondents would prescribe it for medication abortion and EPL management, respectively. This could potentially increase the availability of medication abortion and EPL care providers.
- Clinicians across the country commonly shared two main REMS-related obstacles to providing mifepristone: navigating the many logistics and “bureaucratic hurdles” involved in fulfilling REMS requirements and resistance from their organizations’ administrative leaders to stock the medicine.
When mifepristone is inaccessible in primary care, patients are harmed. Their continuity of care is disrupted, they experience unnecessary and invasive procedures, they must manage multiple appointments and delays in care, and they receive less effective EPL care.
“Patients have come to me wanting medical management of miscarriage or a medical abortion, and I have had to turn them away and send them to other practices…stigmatizing their experience and sending the message that their management of their pregnancy and fertility is not part of primary care – which is outrageous.”
Today, this pandemic is exacerbating these challenges in accessing abortion and EPL care. The REMS rules require patients to come in-person to health care facilities to obtain mifepristone – sometimes multiple times over the course of several days – putting themselves and their families at increased risk of exposure. It has never been more clear that mifepristone must be available by prescription for medication abortion and EPL care. Stay tuned for a full publication on our research this year.