Medication Abortion Via Pharmacy Dispensing
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 15 - Any |
Updated: | 3/17/2019 |
Start Date: | June 1, 2018 |
End Date: | July 2019 |
Contact: | Shelly Kaller, MPH |
Email: | shelly.kaller@ucsf.edu |
Phone: | 510-986-8945 |
Alternative Provision of Medication Abortion Via Pharmacy Dispensing
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.
(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.
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.
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.
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.
We found this trial at
6
sites
200 West Arbor Drive
San Diego, California 92103
San Diego, California 92103
Phone: 619-543-7878
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Sacramento, California 95817
Phone: 916-734-6670
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2356 Sutter Street
San Francisco, California 94115
San Francisco, California 94115
Phone: 415-353-2566
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Tacoma, Washington 98405
Phone: 800-769-0045
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