Medication Abortion Via Pharmacy Dispensing

Daniel Grossman

Status and phase: Completed; Phase 4

Conditions: Abortion Early; Pregnancy Related

Treatments: Other: Training on mifepristone dispensing; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT03320057

A128753

Details and patient eligibility

About

This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.

Full description

Improving access to and efficiency of abortion provision is important for patients and providers. The Risk Evaluation and Mitigation Strategy (REMS) requires that Mifeprex ® ( mifepristone) be dispensed only from a doctor's office, clinic or hospital (not from a pharmacy by prescription) by a certified health care provider and the health care provider must obtained a signed Patient Agreement Form before dispensing mifepristone. Data are needed to investigate the feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. In order to address the study question, a mixed methods study design is appropriate. To assess feasibility, the study will collect data on pharmacists' satisfaction with dispensing mifepristone. To assess acceptability, qualitative data will be collected from pharmacists about their perspectives on dispensing Mifeprex before and after the study, as well as measure patient satisfaction through open-ended and close-ended survey questions. To assess effectiveness of the pharmacy dispensing model, the study will evaluate clinical outcomes from electronic health records. The proposed feasibility study would take place at sites in California and Washington states.

Enrollment: 326 patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

• Women seeking medication abortion through 70 days gestation
• Eligible for Mifeprex® at a study clinical site
• English or Spanish speaking
• Willing and able to participate in the study, including willing to go to the study pharmacy to obtain mifepristone

Patient Exclusion Criteria:

• Not pregnant

• Not seeking medication abortion

• Under the age of 15

• Contraindications for medication abortion

  • All pharmacists providing services at one of the study pharmacies during the study are eligible for the pharmacist survey and interview.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Medication abortion patients

Experimental group

Description:

Oral mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)

Treatment:

Drug: Mifepristone

Pharmacists

Other group

Description:

Pharmacists providing services at one of the study pharmacies during the study

Treatment:

Other: Training on mifepristone dispensing