Medication Abortion Via Pharmacy Dispensing
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Medication abortion patients 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) |
Drug: Mifepristone
Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
|
| Other: Pharmacists Pharmacists providing services at one of the study pharmacies during the study |
Other: Training on mifepristone dispensing
Pharmacists were offered a training on medication abortion and mifepristone dispensing
|
Outcome Measures
Primary Outcome Measures
- Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex [End of the study, month 24]
Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex.
- Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex [End of the study, month 24]
Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?" in endline survey
Secondary Outcome Measures
- Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy [Day 2 following initial medication abortion visit]
Number of participants who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?"
- Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion [Up to 6 weeks after initial visit]
Number of participants who report that their "abortion is now complete and they are no longer pregnant" and who did not "end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion"
- Number of Participants With an Adverse Event [Up to 6 weeks after initial visit]
Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill
- Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion [Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge]
Difference in pharmacists' mean knowledge score related to medication abortion. Knowledge scores were based on a set of 15 statements or questions related to medication abortion for which respondents selected answer(s) from multiple choice response options. Topics included medication abortion dosing regimen, biological processes during medication abortion, clinical outcomes, and federal and state policies relating to medication abortion. For pharmacists who had completed at least 50% of the items, we calculated their average number of correct responses among completed items, as a proportion of correct answers, ranging from 0-1, with 1 meaning 100% correct. All questions or statements included an "I don't know" response option, which we coded as incorrect. Higher scores mean a higher level of knowledge.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Obstetrics and Gynecology Family Planning Clinic at University of California Davis | Sacramento | California | United States | 95817 |
| 2 | Women's Health Services at University of California San Diego | San Diego | California | United States | 92103 |
| 3 | Kaiser Permanente Northern California | San Francisco | California | United States | 94115 |
| 4 | Mt. Zion Women's Options Clinic, University | San Francisco | California | United States | 94115 |
| 5 | University of Washington | Seattle | Washington | United States | 98105 |
| 6 | Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Daniel Grossman
- University of California, San Diego
- University of California, Davis
- University of Washington
- Kaiser Permanente
- Planned Parenthood of the Great Northwest and the Hawaiian Islands
Investigators
- Principal Investigator: Daniel Grossman, MD, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
None provided.- A128753
Study Results
Participant Flow
| Recruitment Details | Patient Recruitment: Study recruitment began in July 2018 and was halted before reaching our desired sample size in March 2020 owing to the coronavirus disease 2019 (COVID-19) pandemic, which limited the ability to have research staff in clinical facilities and lengthen patient visits for the purposes of research consent. Pharmacist Recruitment: We invited all pharmacists providing services at the study pharmacies to participate in the study and dispense mifepristone to study patients. |
|---|---|
| Pre-assignment Detail | Research staff assessed 499 patients for eligibility, of whom 233 were ineligible (n=163) or declined to participate (n=70). We enrolled 266 patient participants, all of whom received the study medications from the pharmacy. We invited 72 pharmacists working at six study pharmacy sites to participate in the study, including training to dispense mifepristone and completion of the baseline survey. |
| Arm/Group Title | Medication Abortion Patients | Pharmacist Providing Services at One of the Study Pharmacies During the Study |
|---|---|---|
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit | All pharmacists providing services at one of the study pharmacies during the study were invited to participate in the training on dispensing mifepristone and surveys. Only trained pharmacists were eligible to participate in the endline survey. |
| Period Title: Overall Study | ||
| STARTED | 266 | 60 |
| Patient's Clinical Outcome Information Obtained | 262 | 0 |
| Received Pharmacist Training | 0 | 56 |
| Pharmacists Completed Baseline Survey | 0 | 47 |
| COMPLETED | 260 | 43 |
| NOT COMPLETED | 6 | 17 |
Baseline Characteristics
| Arm/Group Title | Medication Abortion Patients |
|---|---|
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit |
| Overall Participants | 260 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
28
|
| Age, Customized (Count of Participants) | |
| 16-20 years |
22
8.5%
|
| 21-24 years |
45
17.3%
|
| 25-29 years |
78
30%
|
| 30-34 years |
69
26.5%
|
| 35-44 years |
46
17.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female | |
| Male | |
| Race/Ethnicity, Customized (Count of Participants) | |
| Non-Hispanic White |
99
38.1%
|
| Non-Hispanic Black |
29
11.2%
|
| Hispanic |
65
25%
|
| Asian or Pacific Islander |
45
17.3%
|
| Alaska Native or Native American |
2
0.8%
|
| Other and mixed race and ethnicity |
19
7.3%
|
| Missing |
1
0.4%
|
| Region of Enrollment (participants) [Number] | |
| United States |
260
100%
|
| Education, Categorical (Count of Participants) | |
| High school or less |
39
15%
|
| Some college or professional school |
93
35.8%
|
| College degree |
90
34.6%
|
| Advanced degree |
28
10.8%
|
| Missing |
10
3.8%
|
| Relationship status, Categorical (Count of Participants) | |
| Neither married nor in a relationship |
84
32.3%
|
| Married |
54
20.8%
|
| Committed relationship |
110
42.3%
|
| Missing |
12
4.6%
|
| Parity (Count of Participants) | |
| Nulliparous |
171
65.8%
|
| Parous |
89
34.2%
|
| History of abortion, Categorical (Count of Participants) | |
| None |
165
63.5%
|
| Previous medication abortion |
48
18.5%
|
| Previous procedural abortion only |
40
15.4%
|
| Missing |
7
2.7%
|
| Gestational age at initial visit, Continuous (days) [Median (Full Range) ] | |
| Median (Full Range) [days] |
46
|
| Gestational age at initial visit, Categorical (Count of Participants) | |
| 49 days or less |
176
67.7%
|
| 50-56 days |
43
16.5%
|
| 57-63 days |
32
12.3%
|
| 64-70 days |
9
3.5%
|
Outcome Measures
| Title | Number of Pharmacists Who Objected to Participate in Dispensing Mifeprex |
|---|---|
| Description | Number of pharmacists who objected to participate in dispensing Mifeprex at least once during the study period. This includes pharmacists who declined participation in the study training on medication abortion due to discomfort as well as pharmacists who participated in the training but declined to dispense Mifeprex. |
| Time Frame | End of the study, month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacists invited to participate in mifepristone dispensing |
| Arm/Group Title | Pharmacists |
|---|---|
| Arm/Group Description | Pharmacists providing services at one of the study pharmacies during the study |
| Measure Participants | 72 |
| Count of Participants [Participants] |
4
1.5%
|
| Title | Number of Pharmacists Who Report Being Satisfied With Pharmacy Dispensing of Mifeprex |
|---|---|
| Description | Number of pharmacists who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied are you with mifepristone dispensing at your pharmacy?" in endline survey |
| Time Frame | End of the study, month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacists at study pharmacist who were trained to dispense mifepristone and completed an endline survey |
| Arm/Group Title | Pharmacists |
|---|---|
| Arm/Group Description | Pharmacists providing services at one of the study pharmacies during the study |
| Measure Participants | 43 |
| Count of Participants [Participants] |
36
13.8%
|
| Title | Number of Participants Who Report Being Satisfied With Obtaining Mifeprex in the Pharmacy |
|---|---|
| Description | Number of participants who report being "somewhat satisfied" or "very satisfied" when asked "Overall, how satisfied were you with your experience at the pharmacy when you got the abortion pill?" |
| Time Frame | Day 2 following initial medication abortion visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patient participants who completed Day 2 survey following initial medication abortion visit |
| Arm/Group Title | Medication Abortion Patients |
|---|---|
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit |
| Measure Participants | 252 |
| Count of Participants [Participants] |
230
88.5%
|
| Title | Number of Participants With a Complete Abortion With Medication Alone and Who do Not Require a Surgical Procedure to Complete the Abortion |
|---|---|
| Description | Number of participants who report that their "abortion is now complete and they are no longer pregnant" and who did not "end up having a suction procedure (or vacuum aspiration or dilation and curettage procedure) to complete the abortion" |
| Time Frame | Up to 6 weeks after initial visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patient participants with abortion outcome information |
| Arm/Group Title | Medication Abortion Patients |
|---|---|
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit |
| Measure Participants | 260 |
| Count of Participants [Participants] |
243
93.5%
|
| Title | Number of Participants With an Adverse Event |
|---|---|
| Description | Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill |
| Time Frame | Up to 6 weeks after initial visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with follow-up data from clinical data or survey responses |
| Arm/Group Title | Medication Abortion Patients |
|---|---|
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit |
| Measure Participants | 260 |
| Count of Participants [Participants] |
4
1.5%
|
| Title | Difference in Pharmacists' Mean Knowledge Score Related to Medication Abortion |
|---|---|
| Description | Difference in pharmacists' mean knowledge score related to medication abortion. Knowledge scores were based on a set of 15 statements or questions related to medication abortion for which respondents selected answer(s) from multiple choice response options. Topics included medication abortion dosing regimen, biological processes during medication abortion, clinical outcomes, and federal and state policies relating to medication abortion. For pharmacists who had completed at least 50% of the items, we calculated their average number of correct responses among completed items, as a proportion of correct answers, ranging from 0-1, with 1 meaning 100% correct. All questions or statements included an "I don't know" response option, which we coded as incorrect. Higher scores mean a higher level of knowledge. |
| Time Frame | Before and after the intervention, approximately month 1 and month 18 of the study to assess differences in knowledge |
Outcome Measure Data
| Analysis Population Description |
|---|
| We compared knowledge scores for pharmacists at baseline and endline. We excluded from the baseline knowledge analyses four respondents who participated in the study training on medication abortion prior to taking the baseline survey and one person from the overall knowledge analyses because they only completed four items. |
| Arm/Group Title | Pharmacists |
|---|---|
| Arm/Group Description | Pharmacists providing services at one of the study pharmacies during the study |
| Measure Participants | 53 |
| Baseline knowledge score |
0.51
(0.21)
|
| Endline knowledge score |
0.64
(0.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pharmacists |
|---|---|---|
| Comments | Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score. | |
| Type of Statistical Test | Other | |
| Comments | We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta Coefficient |
| Estimated Value | 0.14 | |
| Confidence Interval |
(2-Sided) 95% 0.11 to 0.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline. | |
Adverse Events
| Time Frame | Patients: Up to 6 weeks after initial visit Pharmacists: study duration including training, mifepristone dispensing, survey data collection (approximately 24 months) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Patients: A medical problem that required patients to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving the abortion pill. Pharmacists: Any untoward/unfavorable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with participation in training, mifepristone dispensing, or survey data collection, whether or not considered related to their participation in the research. | |||
| Arm/Group Title | Medication Abortion Patients | Pharmacists | ||
| Arm/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) Mifepristone: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit | Pharmacists providing services at one of the study pharmacies during the study and consenting to training | ||
All Cause Mortality |
||||
| Medication Abortion Patients | Pharmacists | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/260 (0%) | 0/60 (0%) | ||
Serious Adverse Events |
||||
| Medication Abortion Patients | Pharmacists | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/260 (0%) | 0/60 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Medication Abortion Patients | Pharmacists | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/260 (1.5%) | 0/60 (0%) | ||
| General disorders | ||||
| Dehydration | 1/260 (0.4%) | 1 | 0/60 (0%) | 1 |
| Reproductive system and breast disorders | ||||
| Heavy uterine bleeding | 1/260 (0.4%) | 1 | 0/60 (0%) | 1 |
| Pelvic Inflammatory Disease | 1/260 (0.4%) | 1 | 0/60 (0%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Swelling in cheeks | 1/260 (0.4%) | 1 | 0/60 (0%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Shelly Kaller |
|---|---|
| Organization | University of California San Francisco |
| Phone | 510-986-8945 |
| shelly.kaller@ucsf.edu |
- A128753