NCT03320057

Medication Abortion Via Pharmacy Dispensing

Alternative Provision of Medication Abortion Via Pharmacy Dispensing

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Daniel Grossman · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Pregnancy Related
• Abortion Early

Interventions

Type	Name	Description
DRUG	Mifepristone	Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
OTHER	Training on mifepristone dispensing	Pharmacists were offered a training on medication abortion and mifepristone dispensing

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-07-04
• Completion: 2020-07-04
• First posted: 2017-10-25
• Last updated: 2021-07-12
• Results posted: 2021-07-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study