Conditions: Pregnancy Related Abortion Early
Keywords: medication abortion mifepristone
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: yes

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.

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.

Arms:
arm 1: 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) arm 2: Pharmacists providing services at one of the study pharmacies during the study

Interventions: intervention 1: Mifepristone intervention 2: Training on mifepristone dispensing
Intervention descriptions: intervention 1: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit intervention 2: Pharmacists were offered a training on medication abortion and mifepristone dispensing

Protocol document:
SAP_007.pdf: 
 
 
DANIEL GROSSMAN, MD  
Statistical Analysis Plan 
ALTERNATIVE PROVISION OF MEDICATION ABORTION 
VIA PHARMACY DISPENSING 
 
Protocol Number: 
17 - 22014 
Version Date: 
May 1, 2021 
Investigational Product: 
Mifeprex® ® 
IND Number: 
137073 
Development Phase: 
Phase 4 (post-marketing) 
Sponsor: 
Daniel Grossman, MD 
1330 Broadway Suite 1100 
Oakland, CA 94612 
Funding Organization: 
Fidelity Charitable 
Principal Investigator: 
Name: Daniel Grossman, MD 
Telephone: 510-986-8941 
Fax: 510-986-8960 
E-mail: Daniel.Grossman@ucsf.edu 
Medical Monitor: 
Name: Daniel Grossman, MD 
Telephone: 510-986-8941 
Fax: 510-986-8960 
E-mail: Daniel.Grossman@ucsf.edu 
Coordinating Center: 
UCSF 
 
 


 
 
STATISTICAL ANALYSIS PLAN 
 
 
 
1. Study Design 
 
We will conduct a prospective cohort study of patients receiving Mifeprex® dispensed by 
pharmacists after undergoing standard clinical evaluation. Women participating in this study 
will obtain Mifeprex® and misoprostol from the pharmacy instead of in the clinic. All clinical 
procedures will continue to be performed as they currently are. The only difference is that the 
Mifeprex® will be dispensed by a pharmacist in the study pharmacy rather than by the 
clinician in the clinic. In particular, patients will be evaluated for all contraindications to the 
method according to the label, and they will sign the Patient Agreement Form. A clinician who 
has completed the Prescriber Agreement Form will write a prescription for Mifeprex® 200 mg 
for the eligible patient. The patient will then go to a designated pharmacy to fill the 
prescription, where it will be dispensed by a trained pharmacist. The patient will then take the 
Mifeprex® at the time indicated by the prescribing clinician. Patients will be contacted on Day 
2 and Day 14 to complete surveys about their experience, and they will undergo standard 
clinical follow-up. In addition, we will perform surveys and interviews with pharmacists 
before and after initiating the study, as well as monitor the number of pharmacists who refuse 
to dispense Mifeprex® at the study pharmacies. 
 
 
2. Aims and Objectives 
 
The proposed study aims to investigate the feasibility, acceptability, and effectiveness of 
pharmacy dispensing of Mifeprex®; safety data will also be collected.  
 
Our primary objective is to assess the feasibility of pharmacist dispensing of Mifeprex® by 
measuring pharmacist satisfaction and the proportion of pharmacists who refuse to dispense 
the medication to patients. 
 
Secondary objectives include assessing patient satisfaction with the pharmacy-dispensing 
model; describing clinical outcomes, including effectiveness and adverse events, with 
pharmacist-dispensed Mifeprex®; and comparing pharmacist knowledge about medication 
abortion before and after the intervention. 
 
3. Analyses 
 
3.1 Patient arm 
 
We will examine three outcomes related to patient participants’ clinical experience and 
satisfaction with the pharmacist dispensing model. These will include two clinical outcomes: 
1) effectiveness of medication abortion and 2) adverse events, as well as an outcome from the 
patient perspective: 3) satisfaction with the pharmacy experience at day 2. Effectiveness of 
medication abortion is defined as the proportion of participants who have a complete abortion 
with medications alone and do not undergo vacuum aspiration. Given the accuracy of patient 
self-assessment of abortion completion, we will use self-reported survey data to document 


 
 
abortion outcome if the participant does not have follow-up contact with the clinic. Adverse 
events will be captured up to 6 weeks after participants are recruited into the study, and any 
ongoing adverse events will be followed until resolution. Adverse events are defined as 
serious using the FDA criteria and include death, hospitalization, blood transfusion, and 
surgery. Information about adverse events will be collected from abstracted data from 
patients’ charts and self-reported data in patients’ surveys. The satisfaction outcome will be 
based on participants’ ratings on a Likert scale. On the day 2 survey, we ask participants 
“Overall, how satisfied were you with your experience at the pharmacy when you got the 
abortion pill?” with response options “Very satisfied,” “Somewhat satisfied, “Somewhat 
dissatisfied,” and “Very dissatisfied.” We will dichotomize responses by those who report 
being very satisfied compared with all other responses.  All demographic variables and 
pharmacy experience responses will be collected from patient surveys except gestational age 
at the clinic visit, which will come from clinical charts. Missing survey data for age, race and 
ethnicity, and parity will be obtained from patients’ clinical chart data when available. We 
will conduct all analyses using Stata 15 and report significance at P<.05. 
 
3.2 Pharmacist Arm 
We will examine two primary outcomes and one secondary outcome related to the pharmacist 
dispensing model. Primary outcomes will include: 1) pharmacists who object to dispensing 
Mifeprex® and 2) pharmacists who report satisfaction with pharmacy dispensing of Mifeprex®, 
and the secondary outcome will be: 3) pharmacists’ knowledge related to medication abortion.  
Number of pharmacists who object to participate in dispensing Mifeprex® will be based on 
information reported by pharmacy managers and site research staff as well as pharmacists’ who 
self-report objecting to dispensing Mifeprex® in their baseline survey. Pharmacy managers and 
site research staff will track pharmacists’ participation in the training and Mifeprex® dispensing 
and report the number of pharmacists who refuse to dispense Mifeprex® to the coordinating 
study team. Using these data, we will calculate the proportion of pharmacists who refuse to 
dispense Mifeprex® during the study. 
Number of pharmacists who report being satisfied with pharmacy dispensing of Mifeprex® will be 
based on survey data reported by pharmacists. At follow-up, we will assess satisfaction with 
pharmacy dispensing of Mifeprex® (ranging from very satisfied to very unsatisfied). 
Difference in pharmacists’ mean knowledge score related to medication abortion will be based 
on data collected in pharmacists’ baseline and endline surveys. Knowledge scores will be based 
on a set of 15 items related to medication abortion for which respondents will select answers 
from multiple choice response options. Topics include medication abortion dosing regimen, 
biological processes during medication abortion, clinical outcomes, and federal and state policies 
relating to medication abortion. For pharmacists who complete at least 50% of the items, we will 
calculate their average number of correct responses among completed items. All questions or 
statements include an “I don’t know” response option, which we will code as incorrect.  
We will first assess the internal consistency reliability of the 15 knowledge items and consider a 
Cronbach’s alpha coefficient above .70 to be acceptable to examine the items as a combined 
score.19  We will run descriptive summary statistics for baseline responses describing participant 
characteristics, as well as follow-up responses on satisfaction with the model. We will conduct a 


 
 
series of multivariable logistic and linear regression analyses using Generalized Estimating 
Equation (GEE) models to assess whether study implementation is associated with pharmacists’ 
overall medication abortion knowledge and on 15 individual medication abortion topics, ease 
and support of pharmacist dispensing of Mifeprex®. Coefficients in adjusted analyses examining 
overall medication abortion knowledge will represent the difference in mean knowledge scores 
between baseline and follow-up. We will conduct analyses in Stata 15.1 (StataCorp, College 
Station, TX). 
We will also assess perceived benefits and challenges of pharmacist mifepristone dispensing. For 
perceived benefits, we will ask if this model “may improve access for women”, “expands 
pharmacists’ role in providing reproductive health services”, and “may streamline delivery of 
medications”, coding as dichotomous outcomes (yes/no). We will assess perceived ease of model 
implementation at baseline (anticipated ease) and follow-up (experienced ease) and personal 
support for pharmacist dispensing of mifepristone, measured on a four-point Likert scale, but 
coded dichotomously. We will code ease of implementation as very easy vs. somewhat 
easy/somewhat difficult/very difficult, and personal support for pharmacist dispensing of 
mifepristone as very supportive vs. somewhat supportive/somewhat unsupportive/very 
unsupportive.  
For challenges, we will examine both anticipated (baseline) and experienced (follow-up) 
challenges (for example, lack of familiarity with medication or support from other pharmacists). 
At follow-up, we will assess how sufficient the medication abortion training and resources of the 
training were perceived to be (ranging from very sufficient to very insufficient), as well as 
satisfaction with pharmacy dispensing of mifepristone (ranging from very satisfied to very 
unsatisfied).  
 

Prot_006.pdf: 
Daniel Grossman, MD 
Confidential 
Version #: 1.7 
Version Date: 1/9/20 
Page 1 of 31 
Protocol Template Effective: 07 JAN 2015 
 
 
 
 
DANIEL GROSSMAN, MD 
Research Protocol 
ALTERNATIVE PROVISION OF MEDICATION ABORTION 
VIA PHARMACY DISPENSING 
 
Protocol Number: 
17 - 22014 
Version Date: 
January 9, 2020 
Investigational Product: 
Mifeprex® 
IND Number: 
137073 
Development Phase: 
Phase 4 (post-marketing) 
Sponsor: 
Daniel Grossman, MD 
1330 Broadway Suite 1100 
Oakland, CA 94612 
Funding Organization: 
Fidelity Charitable 
Principal Investigator: 
Name: Daniel Grossman, MD 
Telephone: 510-986-8941 
Fax: 510-986-8960 
E-mail: Daniel.Grossman@ucsf.edu 
Medical Monitor: 
Name: Daniel Grossman, MD 
Telephone: 510-986-8941 
Fax: 510-986-8960 
E-mail: Daniel.Grossman@ucsf.edu 
Coordinating Center: 
UCSF 
 
Approval: 
 
 
 
 
 
 
Daniel Grossman, M.D., Principal Investigator 
1/9/20
PI or Sponsor Signature (Name and Title) 
Date 
 
 
 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time. The information in this document may 
not be disclosed unless federal or state law or regulations require such disclosure. Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a need 
to know, with the obligation not to further disseminate this information. 


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Table of Contents 
1 
BACKGROUND ................................................................................................................................ 10 
2 
STUDY RATIONALE ....................................................................................................................... 12 
2.1 
Risk / Benefit Assessment ........................................................................................................... 13 
3 
STUDY OBJECTIVES ....................................................................................................................... 14 
3.1 
Primary Objective ....................................................................................................................... 14 
3.2 
Secondary Objectives .................................................................................................................. 14 
3.3 
Study Overview .......................................................................................................................... 14 
4 
CRITERIA FOR EVALUATION ...................................................................................................... 14 
4.1 
Primary Endpoint ........................................................................................................................ 14 
4.2 
Secondary Endpoints .................................................................................................................. 14 
4.3 
Safety Evaluations ...................................................................................................................... 15 
5 
STUDY SITES .................................................................................................................................... 15 
5.1 
Mt. Zion Women’s Options Clinic, University of California San Francisco .............................. 15 
5.2 
Women’s Health Services at University of California San Diego (UCSD) ................................ 15 
5.3 
Obstetrics and Gynecology Family Planning Clinic at University of California ........................ 15 
Davis (UC Davis) .................................................................................................................................... 15 
5.4 
University of Washington, Seattle .............................................................................................. 15 
5.5 
Kaiser Permanente Northern California ...................................................................................... 15 
5.6 
Planned Parenthood Tacoma ....................................................................................................... 16 
6 
SUBJECT SELECTION ..................................................................................................................... 16 
6.1 
Study Population ......................................................................................................................... 16 
6.2 
Inclusion Criteria ........................................................................................................................ 17 
6.3 
Exclusion Criteria ....................................................................................................................... 17 
7 
CONCURRENT MEDICATIONS ..................................................................................................... 17 
7.1 
Allowed Medications and Treatments ........................................................................................ 17 
7.2 
Prohibited Medications ............................................................................................................... 18 
8 
STUDY INTERVENTION ................................................................................................................. 18 
8.1 
Method of Recruitment for Patients ............................................................................................ 18 
8.2 
Method of Recruitment for Pharmacists ..................................................................................... 19 
8.3 
Formulation of Test and Control Products .................................................................................. 20 
8.3.1 
Formulation of Test Product ............................................................................................... 20 


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8.3.2 
Packaging and Labeling ...................................................................................................... 20 
8.4 
Supply of Study Drug at the Site ................................................................................................ 20 
8.4.1 
Dosage/Dosage Regimen and Administration .................................................................... 20 
8.4.2 
Storage ................................................................................................................................ 20 
8.5 
Study Drug Accountability ......................................................................................................... 20 
8.6 
Measures of Treatment Compliance ........................................................................................... 21 
9 
STUDY PROCEDURES AND GUIDELINES .................................................................................. 21 
9.1 
Clinical Assessments ................................................................................................................... 21 
9.1.1 
Concomitant Medications ................................................................................................... 21 
9.1.2 
Demographics ..................................................................................................................... 21 
9.1.3 
Medical History ................................................................................................................... 21 
9.1.4 
Physical Examination .......................................................................................................... 22 
9.1.5 
Vital Signs ........................................................................................................................... 22 
9.1.6 
Ultrasound ........................................................................................................................... 22 
9.1.7 
Other Clinical Procedures ................................................................................................... 22 
9.1.8 
Adverse Events ................................................................................................................... 22 
9.2 
Clinical Laboratory Measurements ............................................................................................. 22 
9.2.1 
Pregnancy Test .................................................................................................................... 22 
9.2.2 
Hemoglobin ......................................................................................................................... 22 
9.2.3 
Serum human chorionic gonadotropin (hCG) ..................................................................... 22 
10   ACTIVITIES BY DAY –PATIENTS ................................................................................................. 22 
10.1 D a y  1 ............................................................................................................................................. 22 
10.2 D a y  2 Survey ................................................................................................................................. 23 
10.3 C l i n i c a l  follow-up ...................................................................................................................... 23 
10.4 D a y  14 Survey ............................................................................................................................... 23 
10.5 D a t a  Abstraction ........................................................................................................................... 24 
11   EVALUATIONS – PHARMACISTS ................................................................................................. 24 
11.1 B a s e l i n e  Survey/Interview ......................................................................................................... 24 
11.2 M o n t h l y  Assessments ................................................................................................................. 24 
11.3 E n d -line Survey............................................................................................................................. 24 
12   ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION ............................................. 25 
12.1 A d v e r s e  Events ........................................................................................................................... 25 
12.1.1   AE Severity ............................................................................................................................ 26 


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12.1.2   AE Relationship to Study Drug .............................................................................................. 27 
12.2 S e r i o u s  Adverse Events (SAE) ................................................................................................... 27 
12.2.1 Serious Adverse Event Reporting ............................................................................................ 27 
12.3 M e d i c a l  Monitoring .................................................................................................................... 27 
13   DISCONTINUATION AND REPLACEMENT OF SUBJECTS ....................................................... 28 
13.1 E a r l y  Discontinuation of Study Drug .......................................................................................... 28 
13.2 W i t h d r a w a l  of Subjects from the Study ................................................................................... 28 
13.3 
Replacement of Subjects ............................................................................................................. 28 
14   PROTOCOL VIOLATIONS ............................................................................................................... 28 
15   DATA SAFETY MONITORING ....................................................................................................... 28 
16   STATISTICAL METHODS AND CONSIDERATIONS ................................................................... 29 
16.1  Data Sets Analyzed ....................................................................................................................... 29 
16.2 D e mo g r a p h i c  and Baseline Characteristics ............................................................................. 29 
16.3 A n a l y s i s  of Primary Endpoint.................................................................................................... 29 
16.4 A n a l y s i s  of Secondary Endpoints .............................................................................................. 29 
16.5 In t e r i m Analysis ......................................................................................................................... 30 
16.6 S a mp l e  Size ................................................................................................................................. 30 
17   DATA COLLECTION, RETENTION AND MONITORING ........................................................... 30 
17.1 D a t a  Collection Instruments ......................................................................................................... 30 
17.2 D a t a  Management Procedures ...................................................................................................... 30 
17.3 D a t a  Quality Control and Reporting............................................................................................. 31 
17.4 A r c h i v i n g  of Data ...................................................................................................................... 31 
17.5 A v a i l a b i l i t y  and Retention of Investigational Records ........................................................... 31 
17.6 Monitoring ...................................................................................................................................... 31 
17.7 S u b j e c t  Confidentiality ............................................................................................................... 32 
18   ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS........................................ 32 
18.1 P r o t o c o l  Amendments ............................................................................................................... 32 
18.2 In s t i t u t i o n a l  Review Boards and Independent Ethics Committees ......................................... 32 
18.3 In f o r me d  Consent Form ............................................................................................................. 33 
18.4 R e i mb u r s e me n t  or compensation to study participants .......................................................... 33 
18.5 Publications ..................................................................................................................................... 34 
19  REFERENCES ..................................................................................................................................... 35 
 


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LIST OF ABBREVIATIONS 
 
ACOG 
AE 
The American Congress of Obstetricians and Gynecologists 
Adverse Event 
CHP 
CI 
CFR 
CTCAE 
FDA 
Certified Healthcare Provider 
Confidence Interval 
Code of Federal Regulations 
Common Terminology Criteria for Adverse Events 
Food and Drug Administration 
GCP 
hCG 
HIPAA 
Good Clinical Practice 
Human Chorionic Gonadotropin 
Health Insurance Portability and Accountability Act of 1996 
IRB 
Institutional Review Board 
LLC 
Mcg 
Mg 
OCP 
PI 
Limited Liability company 
Micrograms 
Milligrams 
Ontario College of Pharmacists 
Principal Investigator 
REMS 
SAE 
Risk Evaluation and Mitigation Strategy 
Serious Adverse Event 
SAP 
UC 
UCSD 
UCSF 
Statistical Analysis Plan 
University of California 
University of California San Diego 
University of California San Francisco 
US 
United States 


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PROTOCOL SYNOPSIS 
 
TITLE 
Alternative Provision of Medication Abortion via Pharmacy Dispensing 
SPONSOR/PI 
Daniel Grossman, MD 
FUNDING 
ORGANIZATION 
Fidelity Charitable 
NUMBER OF SITES 
6 


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RATIONALE 
The proposed study aims to investigate the feasibility, acceptability, and 
effectiveness of pharmacy dispensing of Mifeprex®; safety data will also be 
collected. The results of this study eventually could lead to changes in the 
Mifeprex® REMS that would improve access to legal, safe abortion services 
in the US. 
Trained pharmacists already successfully deliver care related for stigmatized 
health conditions, including sexually transmitted infections, family planning, 
and emergency contraception. In addition, pharmacy dispensing of 
mifepristone is already a reality in other countries, such as Australia, where 
it has improved access to medication abortion, particularly in rural areas 
(Grossman, 2015); pharmacy dispensing is also being implemented in 
Canada (OCP, 2017). 
Pharmacy dispensing of Mifeprex® by trained pharmacists could improve 
access to medication abortion for women. Pharmacy dispensing could allow 
women to bypass geographical, financial, or insurance obstacles to clinic- 
based care and receive abortion care earlier in pregnancy (Drey et al., 2006; 
D. A. Grossman, Grindlay, Buchacker, Potter, & Schmertmann, 2013; 
Jerman, Frohwirth, Kavanaugh, & Blades, 2017) and help to facilitate 
provision of medication abortion through telemedicine, reducing the 
disparity in access between rural and urban settings (D. Grossman, Grindlay, 
Buchacker, Lane, & Blanchard, 2011; D. A. Grossman et al., 2013). In light 
of a declining number of abortion providers in the US (Jones & Kooistra, 
2011, Jones & Jerman, 2014), pharmacy dispensing could also help increase 
the number of clinicians willing and able to provide medication abortion by 
enabling them to avoid the associated costs and logistical challenges of 
stocking and dispensing the medication at their facilities. 
Pharmacy dispensing of mifepristone would not affect the standard of care 
or recommended clinical protocol for medication. Mifeprex® would still be 
prescribed to patients by clinicians who are certified prescribers of 
Mifeprex® following the current standard assessment of eligibility for 
medication abortion. The only difference in this study is that the patient 
would obtain the mifepristone directly from the pharmacist, rather than in a 
clinic facility.  In most settings women go to a pharmacy for pain 
medications and anti-emetics, and sometimes for misoprostol. 
Home administration of Mifeprex® is now allowed under the updated 
Mifeprex® labeling (FDA, 2016a). Study participants will be told by the 
prescribing clinician when they should take the Mifeprex®, and participants 
will be contacted the following day to determine if they took the medication 
as prescribed. 


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STUDY DESIGN 
This is a phase 4 prospective cohort study. 
PRIMARY 
OBJECTIVE 
Our primary objective is to assess the feasibility of pharmacist dispensing of 
Mifeprex® by measuring pharmacist satisfaction and the proportion of 
pharmacists who refuse to dispense the medication to patients. 
SECONDARY 
OBJECTIVES 
Secondary objectives include assessing patient satisfaction with the 
pharmacy-dispensing model; describing clinical outcomes, including 
effectiveness and adverse events, with pharmacist-dispensed Mifeprex®; and 
comparing pharmacist knowledge about medication abortion before and after 
the intervention. 
NUMBER OF 
SUBJECTS 
300 patients and 50 pharmacists 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
All pharmacists providing services at one of the study pharmacies during the 
study; and 
English- or Spanish-speaking women age 15 or older (18 or older at Kaiser 
Permanente) seeking medication abortion through 70 days’ gestation and 
eligible for Mifeprex® at a study clinical site. Participants must be willing and 
able to participate in the study, including being willing to go to the study 
pharmacy to obtain mifepristone and willing to take misoprostol dosage via the 
buccal route of administration. 
Exclusion Criteria: 
We will exclude women who are not pregnant or not seeking medication 
abortion, under the age of 15, (or under the age of 18 at Kaiser Permanente) 
who have contraindications for medication abortion, or who choose to 
administer misoprostol vaginally instead of buccally. 
TEST PRODUCT, 
DOSE, AND ROUTE 
OF 
ADMINISTRATION 
Oral Mifeprex® 200 mg followed by misoprostol 800 mcg administered 
buccally (at 24-48 hours following mifepristone).  
DURATION OF 
SUBJECT 
PARTICIPATION AND 
DURATION OF STUDY 
The duration of the study will be 24 months. Most patient subjects’ 
participation will end after completing the Day 14 Survey approximately 2 
weeks after taking Mifeprex®.  Adverse events (AEs) will be captured up to 
6 weeks after Mifeprex®, and any ongoing will be followed until resolution. 
Pharmacists’ participation in the study will continue throughout the study, 
although data will be collected from them only at specific time points before 
launching the study and at the end of the study. 
CONCOMMITANT 
MEDICATIONS 
Allowed: Any 
Prohibited: None 
EFFICACY 
EVALUATIONS 
The UCSF study team will train sites on standardized recruitment and consent 
procedures and have regular communication with study clinics and 


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pharmacies to provide technical assistance and check on progress of study. 
Data collection tools and procedures will be pilot tested before 
implementation. Data will also be monitored periodically to ensure that data 
collection, coding, and management procedures are being conducted 
according to protocol and ethical guidelines. 
PRIMARY ENDPOINT The primary outcome will be feasibility of dispensing of Mifeprex® by 
pharmacists, measured by pharmacist satisfaction and the proportion of 
pharmacists refusing to dispense. 
SECONDARY 
ENDPOINTS 
Secondary outcomes will include patient satisfaction  and clinical outcomes 
of patients who receive Mifeprex® dispensed in the pharmacy. 
OTHER 
EVALUATIONS 
N/A 
SAFETY 
EVALUATIONS 
Data abstraction of electronic health records will provide clinical data for 
analysis. We will conduct quantitative analyses of clinical data and the PI 
will track all reports of adverse events and serious adverse events to monitor 
safety. 
PLANNED INTERIM 
ANALYSES 
No formal interim analysis is planned. Serious and unexpected adverse 
events will be monitored on an ongoing basis throughout the study. 
STATISTICS 
Primary Analysis Plan 
We will use descriptive analyses using chi-square and t tests where 
appropriate to assess pharmacist satisfaction and patient satisfaction with the 
model and clinical outcomes of patient participants. 
Rationale for Number 
of Subjects 
We aim to recruit up to 350 patients for this pilot study, which is a feasible 
sample at the study sites. With a sample size of 350, if the proportion of 
patients with a complete abortion is 95%, the 95% confidence interval of that 
proportion will be +2.7%. Abortion completion is an important clinical 
outcome. 
We aim to survey all the pharmacists at the study sites, up to 50. This 
sample size will be determined by the number of pharmacists at the study 
sites. 
 
 
 
 
 


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1 
BACKGROUND 
 
Medical termination of intrauterine pregnancy, also known as medication abortion, is a safe 
and effective alternative to surgical abortion (vacuum aspiration). Mifeprex® (generic: 
mifepristone), which is a progestin antagonist that competitively interacts with progesterone 
at progesterone- receptor sites, used together with misoprostol is the gold standard regimen 
for medication abortion. In studies performed in the United States up to 70 days gestation 
using this dosing regimen, 97.4% of patients reportedly had a complete abortion (FDA, 
2016a). Another 2.6% received surgical intervention, or vacuum aspiration, for reasons such 
as ongoing pregnancy, patient request, bleeding, medical necessity and incomplete 
expulsion. 
 
 
Medication abortion up to 70 days gestation with mifepristone 200 mg orally followed by misoprostol 
800 mcg administered via the buccal or vaginal route has a favorable safety profile. Although serious 
and sometimes fatal infections have been reported with this treatment, this complication is very rare; 
only 8 deaths related to sepsis have been reported among almost 3 million uses of the medication 
(FDA, 2011). Uterine bleeding requiring medical or surgical intervention is also a known 
complication of the treatment. Heavy bleeding requiring surgical treatment occurs in approximately 
1% of patients, and blood transfusion is required in <0.1%. Adverse events that are more common 
include nausea, vomiting, weakness, fever/chills, headache, diarrhea and dizziness (FDA, 2016a). 
 
 
In March 2016, the Food and Drug Administration (FDA) approved an updated label for 
Mifeprex® to reflect recent research published since the drug’s original approval in 2000 (FDA, 
2016a). The approved dosing regimen includes oral mifepristone (200 mg) followed by a dose of 
misoprostol (800 mcg) administered buccally 24-48 hours later. The changes made to the label 
included a more effective dosing regimen containing less mifepristone (200 mg instead of 600 mg) 
and more misoprostol (800 mcg instead of 400 mcg) via the buccal route, extension of the 
gestational age limit for treatment from 49 to 70 days, removal of the recommendation for in- person 
follow-up, removal of language indicating that the prescriber must be a physician, and elimination of 
the requirement to report nonfatal adverse events to Danco Laboratories, LLC, the drug’s US 
distributor, and the FDA. 
 
 
In addition, the updated label no longer requires that Mifeprex® or misoprostol be taken in the 
facility where they are dispensed. A systematic review of nine studies with over 4,500 participants 
compared outcomes of those who took misoprostol at home to those who took it in a clinical setting 
(Ngo, Park, Shakur, & Free, 2011). Complete abortion and complication rates were not different 
between the groups, but women who used misoprostol at home were more likely to be satisfied and 
recommend the method to a friend. In one US study of 400 women at six sites, 32% chose to take 
mifepristone at home, and complete abortion rates were similar between those who took the drug in 
the clinic and at home (96%-97%) (Chong et al., 2015). Among those who took mifepristone at 
home, 82% reported taking the medication at the time they planned with their provider, and no 
participant took it after 63 days gestation which was the gestational age limit at the time of the study. 
 
 
In addition to buccal administration, misoprostol 800 mcg is commonly administered vaginally in an 
off-label regimen for medication abortion, which is also recommended by the American College of 
Obstetricians and Gynecologists (ACOG, 2014). This regimen allows for a shorter interval between 
the two medications, which some patients prefer. Up to 63 days gestation, vaginal misoprostol given 
at the same time as mifepristone results in complete abortion in approximately 


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95% of cases (Creinin et al., 2007). Another common regimen involves administering misoprostol 
800 mcg vaginally 6-8 hours after mifepristone, which has a complete abortion rate of 95.8% up to 
63 days gestation and fewer side effects compared to a 24-hour dosing interval (Creinin et al., 
2004). 
 
 
Numerous studies performed in the US and other countries have demonstrated that medication 
abortion has a high level of acceptability for a majority of women seeking pregnancy termination 
(Beckman & Harvey, 1997; Christin-Maitre, Bouchard, & Spitz, 2000). In a meta-analysis of 
approximately 4,500 patients who underwent pregnancy termination with mifepristone and 
misoprostol, over 85% of women were satisfied with the experience (Ngo et al., 2011). Medication 
abortion accounts for a growing share of US abortions, from 17% of non-hospital procedures in 
2008 to 31% in 2014 (Jones, 2017). Medication abortions accounted for 45% of all abortions up to 
nine weeks gestation in 2014, up from 26% in 2008 (Jones, 2017). 
 
 
Some evidence suggests that improved access to mifepristone is associated with a reduction in the 
proportion of abortions performed in the second trimester, which is important from a public health 
perspective because later abortion is associated with a significantly increased risk of complications 
and death compared to early abortion (Zane et al., 2015). In one study in Iowa, development of a 
program providing medication abortion using telemedicine was associated with a significant increase 
in the proportions of abortion that were performed with medication. After controlling for other 
factors, women seeking abortion in the two years after telemedicine was introduced had a 
significantly higher odds of obtaining a first-trimester abortion compared to the two years prior (D. 
A. Grossman et al., 2013). Conversely, in Texas, second-trimester abortion increased by 27% in the 
year after restrictions on access to abortion were imposed, including limitations on the use of 
medication abortion that led to a 70% decline in use of this method (D. Grossman, 2017). 
 
 
Despite the increasing use of medication abortion, there is evidence that some women face barriers 
accessing this method, and this can be particularly distressing when they have a strong preference for 
the method (Baum, White, Hopkins, Potter, & Grossman, 2016). In particular, the closure of abortion 
facilities across the country (Deprez, 2016), which has increased the distance women must travel to 
access abortion care, may make it harder to access medication abortion. The longer travel distances, 
which increase the cost and logistical difficulty of getting to a clinic, may create delays that push 
women past the gestational age limit for medication abortion (Baum et al., 2016; Fuentes et al., 
2016). 
 
 
Medication abortion in the US is primarily offered by existing abortion providers. Uptake of 
medication abortion provision among private physicians has been less than expected—especially in 
areas not served by providers of surgical abortion. In 2005, there were only four providers of 
Mifeprex® medication abortion that were located more than 50 miles from any surgical abortion 
provider (Finer & Wei, 2009). One reason for the lack of uptake among private physicians may relate 
to the Mifeprex® Risk Evaluation and Mitigation Strategy (REMS) program. 
 
 
The Mifeprex® REMS program has three components (FDA, 2016b): 
1.   Prescribers must be certified with the program by completing the Prescriber Agreement 
Form 
2.   Patients must sign a Patient Agreement Form. 
3.   Mifeprex® must be dispensed to patients only in certain healthcare settings, specifically 
clinics, medical offices and hospitals, by or under the supervision of a certified prescriber. 


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This third component requires that prescribers stock the medication in their facilities in order to 
dispense it on site. A qualified clinician who has not completed the certification process and 
arranged to stock the drug in his or her office cannot provide timely medication abortion care to a 
woman who presents unexpectedly. Consequently, treatment of such a patient would be delayed, 
which might increase her medical risks (Bartlett et al., 2004; Mifeprex REMS Study Group, 2017). 
 
 
We recently explored this issue in a survey of practicing obstetricians-gynecologists (Grossman et al., 
2017). In 2016-2017, we performed a survey with a representative sample of Fellows of the American 
College of Obstetricians and Gynecologists. The survey was sent by email with an online link, and 
non-responders were mailed paper surveys. 1,284 currently practicing Fellows responded to the 
survey (response rate 54%). 99% reported seeing patients of reproductive age; among these, 
1,155 were included in this analysis. 75% reported having a patient in the prior year who needed or 
wanted an abortion. Only 23% (95% CI 21%-25%) reported performing an abortion in the prior 
year; 10% provided surgical and medication abortion, 9% surgical only, and 4% medication only. 
 
 
Among those not providing medication abortion, 19% said they would provide the method if they 
could write a prescription for mifepristone and their patients could obtain the medication at a 
pharmacy. An additional 18% said they were unsure if they would provide medication abortion in 
this scenario. Our findings suggest that the proportion of obstetrician-gynecologists providing 
medication would at least double (from 14% to 29%) if the dispensing restriction in the REMS 
were removed and physicians could write a prescription for Mifeprex® that could be dispensed at a 
pharmacy. 
 
 
Given this evidence that the dispensing requirement represents a barrier to access, we propose to 
perform a study of the feasibility of pharmacy dispensing of Mifeprex®. For this study, all clinical 
activities will remain consistent with the current standard of care and Mifeprex® REMS program 
except for the dispensing of Mifeprex®. In particular, patients will be evaluated for all 
contraindications to the method according to the label, and they will sign the Patient Agreement Form. 
A clinician who has completed the Prescriber Agreement Form will write a prescription for Mifeprex® 
200 mg for the eligible patient. The patient will then go to a designated pharmacy to fill the 
prescription, where it will be dispensed by a trained pharmacist. The patient will then take the 
Mifeprex® at the time indicated by the prescribing clinician. Patients will be contacted on Day 2 
and Day 14 to complete surveys about their experience, and they will undergo standard clinical 
follow-up. In addition, we will perform surveys and interviews with pharmacists before and after 
initiating the study, as well as monitor the number of pharmacists who refuse to dispense 
Mifeprex® at the study pharmacies. 
 
2 
STUDY RATIONALE 
 
The proposed study aims to investigate the feasibility, acceptability, and effectiveness of pharmacy 
dispensing of Mifeprex®; safety data will also be collected. Because of the data reviewed above that 
indicate that the dispensing restrictions on Mifeprex® limit the number of providers of medication 
abortion, the results of this study eventually could lead to changes in the Mifeprex® REMS that would 
improve access to legal, safe abortion services in the US. 
 
 
Trained pharmacists already successfully deliver care related to stigmatized health conditions, 
including sexually transmitted infections, family planning, and emergency contraception. In addition, 


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pharmacy dispensing of mifepristone is already a reality in other countries, such as Australia, where it 
has improved access to medication abortion, particularly in rural areas  (D. Grossman & Goldstone, 
2015); pharmacy dispensing of mifepristone is also being implemented in Canada (OCP, 2017). 
 
 
Pharmacy dispensing of Mifeprex® by trained pharmacists could improve access to medication 
abortion for women in a number of important ways. Pharmacy dispensing in the US could allow 
women to bypass geographical, financial, or insurance obstacles to clinic-based care and receive 
abortion care earlier in pregnancy (Drey et al., 2006; D. A. Grossman et al., 2013; Jerman et al., 
2017) and help to facilitate provision of medication abortion through telemedicine, reducing the 
disparity in access between rural and urban settings (D. Grossman et al., 2011; D. A. Grossman et 
al., 2013). In light of a declining number of abortion providers in the US (Jones & Kooistra, 2011, 
Jones & Jerman, 2014), pharmacy dispensing could also help increase the number of clinicians willing 
and able to provide medication abortion by enabling them to avoid the associated costs and logistical 
challenges of stocking and dispensing the medication at their facilities. 
 
Pharmacy dispensing of mifepristone would not affect the standard of care or recommended clinical 
protocol for medication abortion in terms of the medication, dosage, timing, and follow-up care. 
Mifeprex® would also still be prescribed to patients by clinicians who are certified prescribers of 
Mifeprex® following the current standard assessment of eligibility for medication abortion. The only 
difference in the provision model to be evaluated in this study is that the patient would obtain the 
mifepristone directly from the pharmacist, rather than in a clinic facility. This model would likely not 
add an additional step for most women, since in most settings they go to a pharmacy for pain 
medications and anti-emetics, and sometimes for the misoprostol. 
 
 
As noted above, home administration of Mifeprex® is now allowed under the updated Mifeprex® 
labeling (FDA, 2016a). Study participants will be told by the prescribing clinician when they should 
take the Mifeprex®, and participants will be contacted the following day to determine if they took the 
medication as prescribed. 
 
2.1 
Risk / Benefit Assessment 
 
Potential medical risks to medication abortion patients participating in the study are the same as those 
they would incur by undergoing a medication abortion outside of the study. Because they are 
undergoing the same clinical assessment prior to obtaining medication abortion, there is no reason to 
believe that dispensing of Mifeprex® by pharmacists will increase the risks of the procedure.  In 
addition, patients will be given detailed information about warning signs, such as heavy bleeding that 
should prompt them to seek care. 
 
The main risk related to the study is that the patient may not take Mifeprex® at the time they are told 
to—and potentially that they may take it later than 70 days gestation. There is also a risk that they may 
give the medication to someone else. It should be noted that these risks exist currently since the 
Mifeprex® label allows them to take the medication at home, and there is no reason to believe that the 
risks will increase due to the study. Patients will also be surveyed on Day 2 to be certain they took the 
Mifeprex® as instructed. Women who do not return for follow-up at the clinic will be contacted by 
phone or email to obtain information about abortion completion and adverse events. Other potential 
risks include any social risks involved if information they reveal about their seeking an abortion or 
other sensitive issues were to be disclosed outside of the research. 
 
There are minimal risks to pharmacists for participating in the study. Pharmacists who refuse to 
dispense Mifeprex® will not have any consequences to their employment. The participating 


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pharmacies will not be identified in any publications. There is a potential risk that participating 
pharmacies will experience anti-abortion picketers if participation in the study becomes known, and 
this has been discussed with the management of each pharmacy. 
 
These data will be used to assess whether it is feasible for pharmacists to dispense Mifeprex®, 
which could help to improve access to early abortion. 
 
3 
STUDY OBJECTIVES 
 
3.1 
Primary Objective 
 
The primary objective of the study is to assess the feasibility of pharmacist dispensing of Mifeprex®. 
Our primary outcome will be feasibility measured by pharmacist satisfaction with dispensing 
Mifeprex® and the proportion of pharmacists who refuse to dispense the medication to patients. 
 
 
3.2 
Secondary Objectives 
 
The secondary objectives include to assess patient satisfaction with the pharmacy-dispensing model, to 
describe clinical outcomes, and to compare pharmacist knowledge about medication abortion before 
and after the intervention. Secondary outcomes include patient satisfaction with the pharmacy-
dispensing model; clinical outcomes, including effectiveness and adverse events, with pharmacist-
dispensed mifepristone; and pharmacist knowledge about medication abortion before and after the 
intervention. 
 
3.3 
Study Overview 
We will conduct a prospective cohort study of patients receiving Mifeprex® dispensed by 
pharmacists after undergoing standard clinical evaluation. Women participating in this study will 
obtain Mifeprex® and misoprostol from the pharmacy instead of in the clinic. All clinical procedures 
will continue to be performed as they currently are. The only difference is that the Mifeprex® will be 
dispensed by a pharmacist in the study pharmacy rather than by the clinician in the clinic. 
 
4 
CRITERIA FOR EVALUATION 
 
4.1 
Primary Endpoint 
 
Feasibility of the pharmacy dispensing model will be assessed in quantitative analyses of the 
pharmacist survey responses and their willingness to dispense. In addition, feasibility will be 
assessed in qualitative analyses of open-ended interviews with pharmacists about dispensing 
Mifeprex® in pharmacies. 
 
4.2 
Secondary Endpoints 
 
Acceptability and satisfaction with the pharmacy dispensing model among patients will be assessed 
primarily through surveys with patient participants using quantitative and qualitative analyses. Clinical 
outcomes, including effectiveness and adverse events, with pharmacist-dispensed Mifeprex® will be 
assessed using quantitative data abstracted from patient medical records. Pharmacist knowledge about 


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medication abortion before and after the intervention will be assessed through quantitative analyses of 
surveys completed by the pharmacists. 
 
4.3 
Safety Evaluations 
 
Data abstraction of electronic health records will provide clinical data for analysis. We will conduct 
quantitative analyses of clinical data, and the PI will track all reports of serious and unexpected adverse 
events to monitor safety. 
 
5 
STUDY SITES 
 
The study will be performed at four sites in California and two sites in Washington State. Recruiting 
will take place at the study clinic site, and Mifeprex® dispensing will take place at an associated study 
pharmacy site. None of the selected pharmacy sites are currently prescribing mifepristone already. Each 
site and site principal investigator (PI) are listed below: 
 
5.1 
Mt. Zion Women’s Options Clinic, University of California San Francisco 
(UCSF) 
 
Dr. Karen Meckstroth will serve as the site PI and will oversee all study activities at this site. The 
study pharmacy site is a community pharmacy, which is not affiliated with UCSF. 
 
 
5.2 
Women’s Health Services at University of California San Diego (UCSD) 
 
Dr. Sarah Averbach will serve as the site PI and will oversee all study activities at two clinical sites. 
The study pharmacies are UCSD outpatient pharmacies, one located in the same building as the study 
clinic site, and the other pharmacy is the discharge pharmacy that serves the clinic at the nearby 
medical center. This site will rely on UCSF’s IRB through UC Reliance. 
 
5.3 
Obstetrics and Gynecology Family Planning Clinic at University of California 
 
Davis (UC Davis) 
 
Dr. Mitchell Creinin will serve as the site PI and will oversee all study activities at this site. The 
study pharmacy site is a UC Davis outpatient pharmacy. This site will rely on UCSF’s IRB through 
UC Reliance. 
 
5.4 
University of Washington, Seattle 
 
Dr. Elizabeth Wicks will serve as the site PI and will oversee all study activities at this site. The study 
pharmacy site is a University of Washington-affiliated pharmacy located in the same building as the 
study clinic site. This site will rely on their own IRB. 
 
5.5 
Kaiser Permanente Northern California 
 
Dr. Tina Raine-Bennett will serve as the site PI and will oversee all study activities at two clinical sites. 
The study pharmacies are Kaiser-affiliated pharmacies on site. Kaiser will rely on their own IRB. 
 
 


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5.6 
Planned Parenthood Tacoma  
 
Dr. Erin Berry will serve as the site PI and will oversee all study activities. The study pharmacy will be 
an independent pharmacy in Tacoma, WA that is typically where patients from this clinic go. This site 
will rely on UW’s IRB.  
 
 
6 
SUBJECT SELECTION 
 
6.1 
Study Population 
 
Patient participants will include women age 15 or older (18 or older at Kaiser) seeking medication 
abortion through 70 days (10 weeks) gestation and eligible for Mifeprex® at a study clinical site. The 
study will include women who are eligible for medication abortion and are willing and able to consent 
to participation, including being willing to go to the study pharmacy to obtain Mifeprex®. We will 
include minors age 15-17 because their perspectives on this service are important; in addition the study 
intervention is very simple and not burdensome. In both California (Cal Family Code 6920-6929) and 
Washington State (RCW 9.02.100 (2)), adolescent minors are able to give consent to an abortion 
without parental consent. UCSF’s, Kaiser’s, and University of Washington’s Institutional Review 
Boards (IRBs) consider legal ability to consent for care as the standard for ability to consent to 
participate in research. We include only women who communicate in English or Spanish to ensure that 
our study team can communicate clearly with participants and they can understand and consent to 
study activities. Participants must also be willing and able to be contacted by email, telephone, or text 
message as those are our planned strategies for data collection. 
 
Pharmacist participants will include any pharmacist working at one of the study pharmacy sites 
during the study who is willing to participate in the study. All pharmacists employed at the 
pharmacy sites will have a choice about participating in the research in terms of dispensing 
mifepristone and receiving the training, and in terms of completing the interviews/surveys. We 
have confirmed that there is at least one pharmacist at the site who is willing to dispense 
mifepristone. The baseline survey asks pharmacists if they plan to dispense mifepristone during 
the study. This will alert the research team if any pharmacists at a site say they do not plan to 
dispense, however, the research team will keep this information confidential. All pharmacists will 
be invited to the initial study training which will take place after baseline data collection. 
Pharmacists will be told that in order to dispense mifepristone they must receive the study 
training. (Remote training can be provided for interested pharmacists who were not able to attend 
the in-person session.) By knowing the number of pharmacists who have been trained and the total 
number of pharmacists that work at each site, we will have an idea of how many pharmacists will 
not be participating in the study dispensing. All trainings for pharmacists will include schedule 
mapping among participants to ensure that trained pharmacists are available to dispense to study 
participants during business hours.  At the end of the training, pharmacists will be asked again 
whether they plan to dispense mifepristone during the study, as a check to assess whether sites 
may have any scheduling issues. We may also follow up with a lead pharmacist or pharmacy 
manager to confirm availability of trained pharmacists and work out a system for ensuring 
mifepristone is available to patients. We will conduct periodic check ins with the pharmacy 
manager/lead pharmacist since pharmacy staffing throughout the study period may fluctuate. Any 
new pharmacists will be reached with the study consent and baseline survey and the research team 
will provide training to interested pharmacists (remote training as needed).  Our periodic check-ins 
can also assess how smoothly the study is running at the pharmacy and whether any pharmacists 


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have expressed concerns about or hesitation to dispense mifepristone. 
If a patient is unable to obtain the medications from the pharmacy, for whatever reason, the patient 
will be referred back to the clinic, where the mifepristone will be dispensed. If a rare patient must 
return to the clinic to receive the mifepristone or other drugs, she will not be removed from the 
study and will be included in the analysis per the "intention-to-treat" principle. 
 
 
6.2 
Inclusion Criteria 
 
1.   Women seeking and eligible for medication abortion with Mifeprex® and misoprostol up to 
70 days’ gestation as determined by the site 
 
2.   Women age 15 or older (18 or older at Kaiser) 
 
3.   English or Spanish speaking 
 
4.   Written informed consent obtained from subject 
 
5.   Ability for subject to comply with the requirements of the study, including being willing to go 
to the study pharmacy to obtain Mifeprex® within 48 hours and before passing the 70- day 
gestational age limit 
6.   Willing to take misoprostol dosage via the buccal route of administration 
 
7.   Willing and able to be contacted by email or telephone/text message 
 
6.3 
Exclusion Criteria 
 
1.   Not pregnant 
 
2.   Not interested in medication abortion 
 
3.   Under age 15 (under age 18 at Kaiser) 
 
4.   Contraindications to medication abortion as determined by the site 
 
5.   Presence of a condition or abnormality that in the opinion of the Investigator would 
compromise the safety of the patient or the quality of the data. 
6.   Choose to administer misoprostol vaginally instead of buccally 
 
 
7 
CONCURRENT MEDICATIONS 
 
All subjects should be maintained on the same medications throughout the entire study period, as 
medically feasible. 
 
7.1 
Allowed Medications and Treatments 
 
All concurrent medications will be allowed. All patient participants will take misoprostol as part of the 
medication abortion regimen, and most will take ibuprofen and/or an oral narcotic for analgesia. Some 
patients may be prescribed prophylactic antibiotics such as doxycycline or azithromycin or an anti-
emetic such as ondansetron. All medications deemed necessary by the treating clinician will be 
allowed. 
 


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7.2 
Prohibited Medications 
 
As noted in the Mifeprex® label, although specific drug or food interactions with Mifeprex® have not 
been studied, on the basis of this drug’s metabolism by CYP 3A4, it is possible that ketoconazole, 
itraconazole, erythromycin, and grapefruit juice may inhibit its metabolism (increasing serum 
concentrations of Mifeprex®). Mifeprex® should be used with caution in patients currently or recently 
treated with CYP 3A4 inhibitors; however, these medications will not be prohibited. 
 
CYP 3A4 inducers such as rifampin, dexamethasone, St. John’s Wort, and certain anticonvulsants 
(such as phenytoin, phenobarbital, carbamazepine) may induce Mifeprex® metabolism (lowering 
serum concentrations of mifepristone). Whether this action has an impact on the efficacy of the 
regimen is unknown. As with all patients, it is important to verify that treatment was successful. 
Again, CYP 3A4 inducers will not be prohibited. 
 
Based on in vitro inhibition information, coadministration of Mifeprex® may lead to an increase in 
serum concentrations of drugs that are CYP 3A4 substrates. Due to the slow elimination of Mifeprex® 
from the body, such interaction may be observed for a prolonged period after its administration. 
Therefore, caution should be exercised when Mifeprex® is administered with drugs that are CYP 3A4 
substrates and have a narrow therapeutic range; however, drugs that are CYP 
3A4 substrates will not be prohibited. 
 
8 
STUDY INTERVENTION 
 
8.1 
Method of Recruitment for Patients 
 
When a patient presents at the clinical site requesting abortion, she will be evaluated in the standard 
manner at that site to determine if she is eligible for medication abortion.  All standard procedures for 
medication abortion at the site will be performed before recruitment, including completing the abortion 
consent and Danco Patient Agreement. 
 
If she is eligible for medication abortion, after all procedures other than dispensing medications, she 
will be given a brief description of the study by the clinician or research coordinator and asked if she is 
interested in participating.  A flyer will be posted in the clinic waiting room and/or examination room 
and may be given to patients in advance of the abortion consent to inform patients about the study (see 
Appendix A). The patient will be told that the study will involve obtaining all medications at the 
pharmacy, rather than obtaining some medications at the clinic and some at the pharmacy.  She will be 
told that only a limited number of pharmacies are able to dispense Mifeprex® and given information 
about how to get to the participating pharmacy (as well as the hours during which a participating 
pharmacist will be working, if needed). If there are any gaps in staffing at the pharmacy, the patient 
will be notified of the timing of those gaps in coverage before leaving the clinic via the pharmacy 
directions/handout. If this will be an issue for the patient, a solution will be found at the clinic before 
the patient leaves or she will not be enrolled in the study. Patients will be told that if they have any 
problems accessing the medications at the clinic, they should come back to the clinic. All except one of 
our pharmacies is located within the same building as the clinic and a 1 minute walk with a very 
similar schedule to the pharmacy.  She will be told that there will be no additional cost to her for 
participating in the study. At University of California sites, the study will cover the costs of the 
medication abortion procedure and the medications.  At Kaiser and University of Washington, the cost 
of Mifeprex® and misoprostol will be paid for by the study, but the payment for the abortion service 
will not differ from standard practice. The participant will be told that participation also involves 


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completing an online survey the following day and another survey approximately 2 weeks later (both of 
which may also be performed over the phone if she prefers). If the patient is interested and eligible to 
participate in the study, she will undergo signed informed consent (Appendix B) on paper or on an 
iPad, by the site PI or coordinator, including HIPAA Authorization (Appendix O). After consent, the 
patients will complete a secure electronic form (on either a paper form or on an iPad; Appendix C) to 
submit their contact information and contact preferences to the UCSF study team so that UCSF can send 
and follow-up on the Day 2 and Day 14 patient surveys. Women who do not return for follow-up at the 
clinic will be contacted by phone or email to obtain information about abortion completion and adverse 
events. 
 
Participation in the study ends 6 weeks after the initial visit unless there is an ongoing unexpected 
adverse event or serious adverse event requiring follow-up. Patients will be considered lost to follow-
up if they have not been contacted to complete the follow-up survey AND they did not return to the 
clinic site by 6 weeks after the medication abortion visit. 
 
8.2 
Method of Recruitment for Pharmacists 
 
All pharmacists at the study pharmacies will be eligible. Pharmacists will be invited to participate in 
the survey/interview prior to initiating the study and at the end of the study by email/flyer and through 
face-to-face visits by study staff (see draft email in Appendix D). We will obtain the email addresses 
of pharmacists when we visit the pharmacy to introduce and launch the study. Pharmacists will 
voluntarily provide their email addresses. All pharmacists employed by the pharmacy sites will have a 
choice about participating in the research in terms of dispensing mifepristone and receiving the 
training, and in terms of completing the interviews/surveys. In the baseline survey, they will be asked 
whether they plan to dispense mifepristone when the pharmacy begins offering it. All pharmacists will 
be invited to a training and study launch to take place at their pharmacy. The training/study launch will 
involve the UCSF PI and/or site PI and research team presenting an overview of medication abortion 
and the aims and procedures of the study. They will also receive a binder of resource materials for the 
study, which they can refer to for further information throughout the study period. 
A pharmacist can participate in up to two surveys (baseline and endline) and two interviews (baseline 
and endline) but may decline to participate in any. We expect that there may be staffing changes from 
the beginning of the study to the end, so some may participate only in baseline data collection or only 
endline data collection. The survey includes a question asking if pharmacists would be willing to 
participate in an interview. Only those who respond "yes" will be contacted for interviews.  The 
informed consent (Appendix E) will be used at beginning of the study to describe all of the study 
activities, including the baseline survey and interview, the endline survey and interview, and the 
training and dispensing. The consent will be used again at the end of the study before the endline 
survey and interview. The consent document for the pharmacists will not record the pharmacists' 
names or the names of the pharmacy, however we will program the surveys so that each pharmacy has 
a different link. This is how we will know which pharmacy respondents are from. It will also alert us if 
someone from a certain pharmacy does NOT consent to the training (identifying possible scheduling 
needs at this site). While not linked with survey responses, we do also collect email in the pharmacy 
survey in order to send a gift card. We have added a question asking if it is okay to contact them with 
details about the study training. 
The consent includes language asking if pharmacists consent to audio recording of the interview. Since 
the interview may not happen immediately after the consent, we will confirm and document that 
pharmacists consent to audio recording before beginning the interview. Pharmacists can still 
participate in the study even if they decline the audio recording. Interviews will be scheduled at a 
convenient time when they do not interfere with the pharmacists’ work. 
The consent will also include description of the training and ask whether the pharmacist consents to 
the training.  


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8.3 
Formulation of Test and Control Products 
 
8.3.1 Formulation of Test Product 
 
Mifeprex®, oral: 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours 
following Mifeprex®).  
 
8.3.2 Packaging and Labeling 
 
The pharmacy site will provide Mifeprex® in its standard packaging (blister pack of one 200 mg 
tablet). The medication will be labeled with the patient’s information according to standard 
procedures prior to dispensing to the patient. 
 
8.4 
Supply of Study Drug at the Site 
 
Mifeprex® will be procured from Danco Laboratories, LLC, by the site PI, who is a licensed physician 
who has signed the Danco Prescriber’s Agreement. This physician is also referred to as a Certified 
Healthcare Provider (CHP) in the Mifeprex® REMS. We will use the existing distribution system for 
Mifeprex® that Danco Laboratories has established. In the signed Prescriber Agreement, the site PI 
will designate the pharmacy site as the site to which the Mifeprex® will be shipped. This distribution 
system is considered to be secure, confidential and controlled. UCSF will buy the medication and ship 
to the site. 
 
The pharmacy site will ensure that the Mifeprex® stock is kept separate from all other drug 
inventories maintained by the pharmacy. All study Mifeprex® received and dispensed at the 
pharmacy site will be recorded on the Investigational Drug Accountability Log. The stock of 
misoprostol and pain medications should not be affected by this study, as their stocking and 
dispensing procedures will be done according to standard practice. 
 
8.4.1 Dosage/Dosage Regimen and Administration 
 
Subjects will receive 200 mg of Mifeprex® to be taken orally at the time indicated by the patient’s 
clinician. This will be followed by misoprostol 800 mcg administered buccally (at 24-48 hours 
following mifepristone). 
 
8.4.2 Storage 
 
Per the directions on the product label, Mifeprex® will be stored at room temperature (15 to 30°C 
or 59 to 86°F) in the pharmacy. 
 
8.5 
Study Drug Accountability 
 
An accurate and current accounting of the dispensing and return of study drug for each subject will be 
maintained on an ongoing basis by a member of the study site staff based on the records maintained 
by the pharmacists at the pharmacy site. The number of study drugs transferred to the pharmacy site, 
dispensed and returned by the subject will be recorded on the Investigational Drug Accountability 
Log. The study PI will verify these documents throughout the course of the study. 
 
 


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8.6 
Measures of Treatment Compliance 
 
Participant patients will be contacted on Day 2 to complete the Day 2 Survey, which is detailed below 
in section 10.2. As part of this survey, patients will be asked if and when they took the Mifeprex®. If 
they have not yet taken the Mifeprex®, they will be asked when they plan to take it, and they will be 
contacted after that date to complete the Day 2 Survey. If they obtained the Mifeprex® in the study 
pharmacy but decided not to take it, they will be asked whether they returned it to the study clinic or 
pharmacy as instructed. 
 
9 
STUDY PROCEDURES AND GUIDELINES 
 
The UCSF study team will train sites on standardized recruitment and consent procedures and have 
regular communication with study clinics and pharmacies to provide technical assistance and check on 
progress of the study. Data collection tools and procedures will be pilot tested before implementation. 
Data will also be monitored periodically to ensure that data collection, coding, and management 
procedures are being conducted according to protocol and ethical guidelines. 
 
Prior to conducting any study-related activities, written informed consent must be signed and dated by 
the subject. If appropriate, assent must also be obtained prior to conducting any study-related 
activities. 
 
9.1 
Clinical Assessments 
 
All clinical assessments will be documented in the medical record, and this information will be 
abstracted from the medical record for analysis. 
 
9.1.1 Concomitant Medications 
 
Concomitant medications such as antibiotics and analgesics will be documented at each clinical 
visit, and this information will be abstracted from the medical record. 
 
9.1.2 Demographics 
 
Demographic information (age, parity, race, and ethnicity) will be recorded as part of the initial visit 
and will be abstracted from the medical record (see list of variables to be abstracted in Appendix G). 
The site PI will supervise the data abstraction and replace the name with the Study ID prior to 
transferring the data to the UCSF research team. Demographic information will also be collected on the 
Day 2 Survey (see section 10.2). 
 
9.1.3 Medical History 
 
At the initial visit, the following will be recorded in the medical record: date of service, gestational age 
by ultrasound and date of ultrasound, past medical history, current medications, blood pressure, weight, 
height, and medications prescribed or dispensed (Mifeprex® 200 mg, misoprostol 800 mcg, antibiotics, 
analgesics, other). At any follow-up visits, unusual symptoms such as heavy bleeding, pain or fever 
will be recorded, as well as any treatment given. Women will also be asked if they sought care 
elsewhere since the prior visit, and if so, what treatment, if any, they were given. 
 
 


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9.1.4 Physical Examination 
 
Blood pressure, weight, height, and ultrasound data will be collected at the initial visit. A targeted 
physical examination will be performed at the clinic site according to their current practice. 
 
9.1.5 Vital Signs 
 
Vital signs will be recorded at each clinical encounter. 
 
9.1.6 Ultrasound 
 
Ultrasound may be performed at the initial visit to determine gestational age of the pregnancy (if it 
is not performed at the clinic site, the date and result of an outside ultrasound must be documented). 
Ultrasound may be performed at a follow-up visit to determine whether the abortion is complete or 
incomplete or if there is an ongoing pregnancy. 
 
9.1.7 Other Clinical Procedures 
 
Patients may undergo uterine aspiration in case of heavy bleeding, incomplete abortion or ongoing 
pregnancy. This procedure will be detailed in the medical record. 
 
9.1.8 Adverse Events 
 
We will track adverse events (AEs) as described in section 11. 
 
9.2 
Clinical Laboratory Measurements 
 
9.2.1 Pregnancy Test 
 
Women will be presenting for pregnancy termination, so pregnancy will be confirmed as part of the 
visit prior to recruitment, consent, and enrollment. 
 
9.2.2 Hemoglobin 
 
Most patients will have hemoglobin measured in the clinic, and this result with the date of the test 
will be abstracted from the medical record. 
 
9.2.3 Serum human chorionic gonadotropin (hCG) 
 
Some patients will have serum hCG measured on the day of Mifeprex® administration and again 
approximately 8 days later to assess for completion of the abortion. These results with the date of the 
tests will be abstracted from the medical record. 
 
10   ACTIVITIES BY DAY –PATIENTS 
 
10.1 Day 1 
 
This is the day the patient participant is enrolled in the study. Patients choosing medication abortion 
will undergo standard assessment, including an ultrasound for gestational age assessment, if it has not 
yet been performed, and counseling. Once women have signed the Danco Patient Agreement and any 


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other specific consent forms for the site, they will be assessed for eligibility to participate in this study 
and undergo the informed consent process for this study on paper or iPad (Appendix B). Contact 
information and contact preferences will also be obtained (on an iPad; Appendix C). Study participants 
will be given a prescription for Mifeprex® 200 mg, misoprostol 800 mcg, and any other necessary 
medications (or the prescriptions will be electronically transmitted), as well as information about when 
and how to take the medications. At the pharmacy, the pharmacist will review the prescription and 
dispense Mifeprex® 200 mg (1 tablet) and misoprostol 200 mcg (4 tablets) as ordered. The lot number 
of all medications will be recorded in the standard fashion, and the dispensing pharmacist will also 
record the dispensing of the study medication in the Investigational Drug Accountability. 
 
10.2 Day 2 Survey 
 
On the following day, patient participants will be sent by email or text message, depending on their 
preference, a link to an online survey about their experience obtaining the medications, as well as to 
collect sociodemographic information (see Day 2 survey, Appendix H). Participants will be asked to 
complete the survey after going to the pharmacy to obtain Mifeprex®. If a participant prefers, or if she 
does not respond to the email link, she may be contacted by telephone to complete the survey over the 
phone or sent reminders by text message.  The survey will focus on her experience in the pharmacy, 
including how she was treated and the information she received, as well as her experience taking the 
Mifeprex®.  If the participant went to a pharmacy that was not her usual pharmacy, we will ask about 
her perspective on having to go to a different pharmacy.  We will also collect information about if and 
when the Mifeprex® and misoprostol and if the Mifeprex® might have been diverted to another person.  
If they do not respond to the survey by Day 4, participants will contacted up to three times (each day for 
three subsequent days to complete the survey). If a participant has decided not to proceed with medication 
abortion (because she has decided to have a surgical abortion or continue the pregnancy or because she 
needs more time to decide), she will be encouraged to complete the Day 2 survey, where this information 
will be captured. If a woman obtained the Mifeprex® and/or misoprostol and has decided not to take the 
medication(s), she will be asked to return them to the pharmacy or the clinic. 
 
10.3 Clinical follow-up 
 
Women undergoing medication abortion generally undergo clinical follow-up to ensure that the 
abortion is complete. This may include a follow-up visit or a phone call from clinic staff 
approximately 7-14 days after the initial visit.  In some cases, serum hCG may be measured on the day 
of Mifeprex® administration and again approximately 8 days later to assess for completion of the 
abortion.  No study-related activities will be performed as part of this clinical follow-up. Management 
of incomplete abortion without hemorrhage will be done according to the standard practice at the site, 
and may include expectant management, an additional dose of misoprostol, or vacuum aspiration. 
Participants with ongoing pregnancy will be managed according to the standard practice at the site, and 
may include an additional dose of misoprostol, repeating Mifeprex® and misoprostol or vacuum 
aspiration. No study activities will take place at this visit, although clinical information recorded at this 
visit will be later abstracted from the patient’s record (see section 9.1). 
 
10.4 Day 14 Survey 
 
On Day 14 after the initial clinic visit, patient participants will be sent by email or text message, 
depending on their preference, a link to an online survey about their overall satisfaction with the 
medication abortion process and to obtain information about whether the abortion has been 
completed (see Day 14 Survey, Appendix I). If a participant prefers, or if she does not respond to the 
email link, she may be contacted by telephone to complete the survey over the phone or sent 
reminders by text message. If the participant is unsure if the abortion is complete, we will instruct 


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her to contact the clinic and ask for permission to contact her one week later. If they do not respond 
to the survey, participants will contacted up to three times. 
 
10.5 Data Abstraction 
 
As noted above in section 9, de-identified data about the clinical visits of participants consenting for 
the study will be abstracted from the electronic medical record system of the participating sites. This 
includes clinical information including demographics (age, parity, race, ethnicity), initial visit 
information (date of service, gestational age, past medical history, medications, laboratory values), and 
follow-up visit information (date of service, treatment given, symptoms, outcome of abortion, adverse 
events, and other follow-up care). The site PI will perform a chart review for each participant 6 weeks 
after enrollment.  De-identified data will be entered into a Qualtrics or REDCap electronic form (see 
Appendix G for the variables that will be abstracted). As noted above, the site PI will supervise the data 
abstraction and replace the participant name with the Study ID prior to transferring the data to the 
UCSF research team. 
 
11   EVALUATIONS – PHARMACISTS 
 
11.1 Baseline Survey/Interview 
 
Each of the pharmacists at the study sites will be invited to participate in a survey and interview prior 
to the initiation of Mifeprex® dispensing.  This survey and interview will focus on baseline 
knowledge of medication abortion, comfort with dispensing Mifeprex®, anticipated challenges of 
dispensing Mifeprex®, and whether the respondent plans to refuse to participate in Mifeprex® 
dispensing (and why). The survey may be completed on paper or online (see Appendix J), and the 
pharmacists will provide verbal or click-through consent to the survey and interview (Appendix E). 
Only pharmacists who indicate on the survey that they would be willing to participate in a follow-
up interview will be contacted for an interview. The interview, which may be performed in person or 
over the phone and will be recorded if participants agree, will allow for collection of qualitative data 
about their perceptions of implementing the new service (Appendix K). The consent which was 
administered prior to the survey will be reviewed briefly prior to the interview, and consent to record 
the interview will be confirmed and documented. 
 
11.2 Monthly Assessments 
 
Each month after initiating the study, research staff at UCSF will contact the supervising pharmacist 
at each pharmacy site to assess the number of pharmacists working at the site, whether any 
pharmacist has started to dispense Mifeprex®, and whether any pharmacist has stopped dispensing 
Mifeprex®. 
 
11.3 End-line Survey 
 
Each of the pharmacists at the study sites will be invited to participate in a survey and interview at the 
end of the study.  This survey and interview will focus on knowledge of medication abortion, comfort 
with dispensing Mifeprex®, experienced challenges of dispensing Mifeprex®, and whether the 
respondent refused to participate in Mifeprex® dispensing at any point (and why).  Respondents who 
report having refused to dispense Mifeprex® will be asked about whether patients were referred to 
another pharmacist who was able to dispense, and if so, how that process worked. The survey may be 
completed on paper or online (see Appendix L), and the pharmacists will provide verbal or click-


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through consent to the survey and interview (Appendix E). Only pharmacists who indicate on the 
survey that they would be willing to participate in a follow-up interview will be contacted for an 
interview. The interview which may be performed in person or over the phone and will be recorded if 
participants agree, will allow for collection of qualitative data about their perceptions of implementing 
the new service (Appendix M). The consent which was administered prior to the survey will be 
reviewed briefly prior to the interview, and consent to record the interview will be confirmed and 
documented.  
 
12   ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
 
12.1 Adverse Events 
 
Adverse Events (AEs) are to be reported only for untoward medical events that occur in participants 
after they have enrolled in the study.  Only new untoward events, or a worsening of an existing 
condition, are considered AEs.  Conditions that were present before enrollment into the study, and that 
remain stable or improve during the study, are not considered AEs.  Only serious or unexpected AEs 
that are possibly, probably, or definitely related to the research will be submitted to the UCSF IRB. 
Diversion of Mifeprex® obtained in the study to someone other than the participant will also be 
considered an AE. 
 
Information regarding AEs or SAEs may be first obtained by the clinical or study staff, as both will 
communicate with the participant at her visits and by phone. 
 
Details about each AE or SAE will be recorded on an AE/SAE Form (Appendix N). This form will 
require the following information to be collected:  diagnosis, onset date, resolution date, source of 
information, severity, treatment given, relationship to the study, action taken, and comments. 
 
The PI will determine the relationship of the AE to study treatment as definitely related, probably 
unrelated, possibly related, or unrelated; and the severity of the AE as mild, moderate or severe.  For 
AEs or SAEs that have not resolved at the time of learning of the event, the study team will monitor 
the event until the event is resolved or the study is completed. 
 
The PI is also responsible for reporting all AEs to all relevant Institutional Review Boards (IRBs).  All 
AEs that are related to the study and are serious or affect IRB approval will be reported by the PI to the 
relevant IRBs according to IRB requirements.  UCSF requires that an internal (on-site) AE that the PI 
determines to be related to the study and serious or unexpected shall be reported within 5 working days 
of the UCSF PI’s knowledge. External (off-site) AE’s that change the study risks/benefits or requires a 
UCSF IRB modification must be reported within 10 working days of the UCSF PI’s knowledge.  
Diversion of Mifeprex® will be reported to the FDA within 15 days of the UCSF PI’s knowledge. 
 
An AE is any untoward medical occurrence in a clinical investigation of a patient 
administered a pharmaceutical product and that does not necessarily have a causal 
relationship with the treatment.  An AE is therefore any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom or disease temporally associated with 
the administration of an investigational product, whether or not related to that 
investigational product.  An unexpected AE is one of a type not identified in nature, 
severity, or frequency in the current Mifeprex® label or of greater severity or frequency 
than expected based on the information in the label. 
 


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The following definitions apply to adverse events occurring in clinical studies involving drugs: 
 
• 
An AE is any health-related reaction, effect, toxicity or abnormal laboratory result 
that a participant experiences during the course of the study, irrespective of 
relationship to study product use. 
 
In this study, the following routine study measurements will not be considered AEs 
because they are anticipated participant outcomes: 
 
• 
 
Ab
ortion 
 
• 
Symptoms associated with medication abortion (pain, vaginal bleeding, fever, chills, 
nausea, vomiting, headache, weakness, dizziness and diarrhea), unless they are so 
severe as to meet the criteria for a SAE (see section 12.2 below) 
 
12.1.1   AE Severity 
 
The National Cancer Institute’s Common Terminology Criteria for Adverse Events 
(CTCAE) Version 3.0 should be used to assess and grade AE severity, including laboratory 
abnormalities judged to be clinically significant. Table 1 below should be used to grade 
severity.  It should be pointed out that the term “severe” is a measure of intensity and that a 
severe AE is not necessarily serious. 
 
Table 1.  AE Severity Grading 
 
Severity (Toxicity Grade) 
Description 
Mild (1) 
Transient or mild discomfort; no limitation in activity; no medical 
intervention or therapy required. The subject may be aware of the sign 
or symptom but tolerates it reasonably well. 
Moderate (2) 
Mild to moderate limitation in activity, no or minimal medical 
intervention/therapy required. 
Severe (3) 
Marked limitation in activity, medical intervention/therapy required, 
hospitalizations possible. 
Life-threatening (4) 
The subject is at risk of death due to the adverse experience as it 
occurred. This does not refer to an experience that hypothetically 
might have caused death if it were more severe. 


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12.1.2   AE Relationship to Study Drug 
 
The relationship of an AE to the study drug should be assessed using the following the guidelines in 
Table 2. 
 
Table 2.  AE Relationship to Study Drug 
 
Relationship 
to Drug 
Comment 
Definitely 
Previously known toxicity of agent; or an event that follows a reasonable temporal 
sequence from administration of the drug; that follows a known or expected response 
pattern to the suspected drug; and that is not explained by any other reasonable 
hypothesis. 
Probably 
An event that follows a reasonable temporal sequence from administration of the 
drug; that follows a known or expected response pattern to the suspected drug; and 
that is unlikely to be explained by the known characteristics of the subject’s clinical 
state or by other interventions. 
Possibly 
An event that follows a reasonable temporal sequence from administration of the 
drug; that follows a known or expected response pattern to that suspected drug; but 
that could readily have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no relationship to the study 
drug. 
 
12.2 Serious Adverse Events (SAE) 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that: 
 
• 
Is life threatening or results in death. 
 
• 
Requires in-patient hospitalization or prolongs existing hospitalization. 
 
• 
Results in persistent or significant disability/incapacity. 
 
• 
Is a congenital abnormality/birth defect (in the offspring of a participant). 
 
• 
Jeopardizes participant and required medical/surgical intervention to prevent 
serious outcome, or 
 
• 
Any other event that the investigator considers serious. 
 
12.2.1 Serious Adverse Event Reporting 
 
Study sites will document all SAEs that occur (whether or not related to study drug) per  
UCSF IRB Guidelines. The collection period for all SAEs will begin after informed consent 
is obtained and end six weeks after the visit where Mifeprex® is prescribed. 
 
In accordance with the standard operating procedures and policies of the local IRB/the site 
PI will report SAEs to the IRB. 
 
12.3 Medical Monitoring 
 


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Site PIs should contact the PI, Daniel Grossman, MD, directly at this number to report 
medical concerns or questions regarding safety: 510-986-8941. 
 
13   DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
 
13.1 Early Discontinuation of Study Drug 
 
Because participants will only take a single dose of Mifeprex®, there will be no opportunity to 
discontinue treatment.  If a patient vomits within 30 minutes after taking Mifeprex®, she will be 
instructed to return to the clinic site for further evaluation and management. 
 
13.2 Withdrawal of Subjects from the Study 
 
A subject may be withdrawn from the study at any time if the subject, the site PI, or the PI feels that it is 
not in the subject’s best interest to continue. 
 
All subjects are free to withdraw from participation at any time, for any reason, specified or 
unspecified, and without prejudice. 
 
Reasonable attempts will be made by the site PI to provide a reason for subject withdrawals.  The 
reason for the subject’s withdrawal from the study will be specified in the subject’s data collection 
documents. 
 
13.3 Replacement of Subjects 
 
If any subject withdraws or does not complete the study as planned, they will be replaced with an 
additional participant. 
 
14   PROTOCOL VIOLATIONS 
 
A protocol violation occurs when the subject, investigator, or clinic or pharmacy staff fails to adhere to 
significant protocol requirements affecting the inclusion, exclusion, subject safety and primary 
endpoint criteria.  Potential protocol violations for this study include, but are not limited to, the 
following: 
 
• 
Failure to meet inclusion/exclusion criteria 
 
• 
Failure to comply with Good Clinical Practice (GCP) guidelines. The PI will determine if a 
protocol violation will result in withdrawal of a subject. 
 
When a protocol violation occurs, it will be discussed with the site PI and a Protocol Violation Form 
detailing the violation will be generated. This form will be signed by the PI and the site PI. A copy of 
the form will be filed in the site’s regulatory binder and in the PI’s files. 
 
15   DATA SAFETY MONITORING 
 
Safety oversight will be under the direction of the PI. Because Mifeprex® is already approved, and 
there is a great deal of safety data on its use for this approved indication, we think it is reasonable for 
safety monitoring to occur through the standard review of S/AE reports (see section 12). 
 


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As part of routine instruction in the FDA’s Mifeprex® Medication Guide provided to women 
undergoing medication abortion, participants will be instructed to return to the study site or a nearby 
facility offering emergency care in the case of heavy bleeding (more than 2 full-size pads soaked 
per hour for 2 hours), abdominal pain or “feeling sick”, fever of 100.4 degrees or higher persisting 
more than 4 hours or for any signs of complications. 
 
16   STATISTICAL METHODS AND CONSIDERATIONS 
 
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will be written 
describing all analyses that will be performed.  The SAP will contain any modifications to the 
analysis plan described below. 
 
16.1  Data Sets Analyzed 
 
All eligible patients who receive the dose of the study drug will be included in the analysis. All 
eligible pharmacists who complete at least one survey or interview will be included in the 
pharmacist analysis. 
 
16.2 Demographic and Baseline Characteristics 
 
The demographic information that will be collected: Age, parity, race/ethnicity. At the initial visit, we 
will also collect: date of service, gestational age by ultrasound and date of ultrasound, past medical 
history, current medications, blood pressure, weight, height, and medications prescribed or dispensed. 
All participants will receive the same dose of Mifeprex®. 
 
16.3 Analysis of Primary Endpoint 
 
Feasibility of the pharmacy dispensing model will be assessed in quantitative descriptive analyses of 
satisfaction variables from the pharmacists’ end line survey (overall satisfaction, perceived 
benefits/challenges, and ease of implementation of pharmacy dispensing) using chi-square and t tests 
where appropriate. We will also calculate the proportion of pharmacists who refused to dispense 
Mifeprex® during the study. In addition, feasibility will be assessed in qualitative analyses of open 
ended interviews with pharmacists about dispensing Mifeprex® in pharmacies. 
 
16.4 Analysis of Secondary Endpoints 
 
Acceptability and satisfaction with the pharmacy dispensing model among patients will be assessed 
primarily through surveys with patient participants using quantitative and qualitative analyses. The 
particular Day 2 survey variables we will analyze include those on overall satisfaction with the 
pharmacy, reasons for dissatisfaction, and perceptions about the wait time, the way the patient was 
treated and the information she received. Clinical outcomes, including effectiveness and adverse 
events, with pharmacist-dispensed mifepristone will be assessed using quantitative data abstracted 
from patient medical records, as well as information on clinical outcomes captured in the Day 14 
patient survey. Pharmacist knowledge about medication abortion before and after the intervention will 
be assessed through quantitative analyses of surveys completed by the pharmacists. 
 
Adverse event rates will be coded by body system and MedDra classification term. Adverse events 
will be tabulated and will include the number of patients for whom the event occurred, the rate of 
occurrence, and the severity and relationship to study drug. 


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16.5 Interim Analysis 
 
No interim analysis is planned. Unexpected and serious adverse events will be monitored as noted 
above (see section 12). 
 
16.6 Sample Size 
 
We aim to recruit 350 patients for this pilot study, which is a feasible sample at the study sites. With 
a sample size of 350, if the proportion of patients with a complete abortion is 95%, the 95% 
confidence interval of that proportion will be +2.7%. Abortion completion is an important clinical 
outcome. 
 
We aim to survey all the pharmacists at the study sites, up to 50. This sample size will be 
determined by the number of pharmacists at the study sites. We have confirmed that there is 
at least one pharmacy at the site who is willing to dispense mifepristone, which is sufficient 
for the study. In the unlikely event that a willing and trained pharmacist is not on site to 
dispense the medication, the patient will be told when she can return to the pharmacy to 
have the prescription filled. Alternatively, the patient may return to the clinic, where the 
mifepristone will be dispense. If that happens, the study will still cover the cost of the 
medication abortion, but the patient will be discontinued from the study.  
 
 
17   DATA COLLECTION, RETENTION AND MONITORING 
 
17.1 Data Collection Instruments 
 
Survey data will be collected directly from medication abortion patients using an online survey at Day 
2 and Day 14 following the medication abortion. Clinical data will also be abstracted from the 
electronic medical record system at each study site. Pharmacists will be invited to complete a survey 
and interview prior to the initiation of mifepristone dispensing, as well as at the end of the study. All 
study instruments will be submitted for review prior to initiating data collection. 
 
 
Study Population 
Study instruments 
Consent forms 
Medication abortion 
patients 
Day 2 survey 
Day 14 survey 
Clinical data abstraction form 
Patient informed consent (written) 
HIPAA Authorization Form 
Pharmacists 
Baseline survey 
Baseline interview guide 
End-line survey 
End-line interview guide 
Pharmacist informed consent for survey and 
interview 
(click-through or verbal) 
 
 
17.2 Data Management Procedures 
 
Survey data will be collected in Qualtrics, an online survey software. The UCSF research team will 


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access it securely through a protected account. Participants’ personal identifiers (including first name 
and last initial, phone number and email address) will be collected and stored separately from clinical, 
survey, and interview data. At Kaiser, only email address will be collected by UCSF; Kaiser staff will 
manage any in-person and phone contact with participants. 
 
 
Clinical information (including date of clinic visit/s, success of the abortion, and adverse events) will 
be extracted from the electronic health record. These data will be de-identified, linked with a unique 
study ID, and entered into a Qualtrics or REDCap electronic form by the study site. 
 
 
Interview data will be audio-recorded, transcribed and imported into the analysis software. 
Identifiers will be stored separately. 
 
17.3 Data Quality Control and Reporting 
 
The UCSF study team will train sites on standardized recruitment and consent procedures and have 
regular communication with study clinics and pharmacies to provide technical assistance and check on 
the progress of the study. Data collection tools and procedures will be pilot tested before 
implementation. Data will also be monitoring periodically to ensure that data collection, coding, and 
management procedures are being conducted according to protocol and ethical guidelines. 
 
Survey data gathered through Qualtrics, an online survey software, will be secure and HIPAA 
compliant. Because of its high level of data security, it is the recommended survey software for 
UCSF research. Data are collected and stored on a secure server and scanned regularly to ensure 
vulnerabilities are quickly found and patched. UCSF will also take special precautions to collect and 
store personal identifiers separately from research data on participants on password protected secure 
accounts, using encrypted, physically secure computers and devices. Results will be presented in 
aggregate and will not share identifying information about participants. 
 
17.4 Archiving of Data 
 
The database is safeguarded against unauthorized access by established security procedures; appropriate 
backup copies of the database and related software files will be maintained.  Databases are backed up by 
the database administrator in conjunction with any updates or changes to the database. 
 
Surveys, interview recordings, transcripts, and forms will be stored in a locked cabinet at the study 
site and on computers only accessible by core members of the research team.  When these procedures 
are followed, it is highly unlikely that any of the information revealed by participants during the 
course of the interviews will be disclosed to anyone outside the research team. 
 
17.5 Availabilit y and Retention of Investigational Records 
 
The site PI must make study data accessible to authorized representatives of the PI (or designee), IRB, 
and Regulatory Agency (e.g., FDA) inspectors upon request.  A file for each subject must be 
maintained that includes the signed Informed Consent and copies of all source documentation related 
to that subject. The site PI must ensure the reliability and availability of source documents. 
 
All study documents (patient files, signed informed consent forms, etc.) will be kept secured for a 
period of two years following the completion of the study. 
 
17.6 Monitoring 
 


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Site-specific periodic monitoring visits at the sites will be undertaken for study audits as part of our 
plan to assure quality. The monitor, consisting of the PI and/or his designee from the UCSF research 
team, will also provide monitoring reports promptly following each visit and present this information 
to the site PI. 
 
17.7 Subject Confidentiality 
 
In order to maintain subject confidentiality, only a site number, subject number and subject initials 
will identify all study subjects on documentation. 
 
Potential participants will have the option of not participating in any part of the study, including any 
part of the interview (pharmacists), and they may refuse to be audio-recorded during the interview, 
without any adverse consequences for their medical treatment (patients) or employment (pharmacists). 
Attempts to contact participants will be limited and should a message be left for the woman on her 
voicemail, no information related to the details of her study participation or nature of her care will be 
recorded. If at the time the woman is reached, she wishes to reschedule contact at a more appropriate or 
convenient time, staff will be flexible and accommodating, particularly to safeguard confidentiality. 
 
All interviews with pharmacists will be conducted in a private area or private room designated for 
this purpose at the study sites or at another mutually agreed upon location.  No identifying 
information will be included on the audio recording of the interview. 
 
18   ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
 
The study will be conducted according to the Declaration of Helsinki, Protection of Human 
Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and Obligations of Clinical 
Investigators (21 CFR 312). 
 
To maintain confidentiality, all data collection forms will be identified by a coded number and initials 
only.  All study records will be kept in secured files only accessible to the UCSF or site- specific 
research team. Data with patient identifiers used for contact purposes will be stored separately from 
survey/interview responses. Any paper forms will be stored in a locked file cabinet. Clinical 
information will not be released without written permission of the subject, except as necessary for 
monitoring by the FDA.  The PI and site PIs must also comply with all applicable privacy regulations 
(e.g., Health Insurance Portability and Accountability Act of 1996, EU Data Protection Directive 
95/46/EC). 
 
18.1 Protocol Amendments 
 
Any amendment to the protocol will be written by the PI.  Protocol amendments cannot be 
implemented without prior written IRB approval except as necessary to eliminate immediate safety 
hazards to patients.  A protocol amendment intended to eliminate an apparent immediate hazard to 
patients may be implemented immediately, provided the IRBs are notified within five working days. 
 
18.2 Institutiona l Review Boards and Independent Ethics Committees 
 
The protocol and consent form will be reviewed and approved by the UCSF IRB, as well as the 
University of Washington IRB and Kaiser IRB, prior to study initiation.  Serious adverse experiences 
regardless of causality will be reported to the IRB in accordance with the standard operating 
procedures and policies of the IRB, and the Investigator will keep the IRB informed as to the progress 
of the study. The Investigator will obtain assurance of IRB compliance with regulations. 


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Any documents that the IRB may need to fulfill its responsibilities (such as protocol, protocol 
amendments, consent forms, information concerning patient recruitment, payment or compensation 
procedures, or other pertinent information) will be submitted to the IRB.  The IRB written 
unconditional approval of the study protocol and the informed consent form will be in the possession 
of the PI and site PI before the study is initiated. This approval must refer to the study by exact 
protocol title and number and should identify the documents reviewed and the date of review. 
 
Protocol and/or informed consent modifications or changes may not be initiated without prior written 
IRB approval except when necessary to eliminate immediate hazards to the patients or when the 
change(s) involves only logistical or administrative aspects of the study.  Such modifications will be 
submitted to the IRB and written verification that the modification was submitted and subsequently 
approved should be obtained. 
 
The IRB must be informed of revisions to other documents originally submitted for review; serious 
and/or unexpected adverse experiences occurring during the study in accordance with the standard 
operating procedures and policies of the IRB; new information that may affect adversely the safety of 
the patients of the conduct of the study; an annual update and/or request for re-approval; and when the 
study has been completed. 
 
18.3 Informed Consent Form 
 
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH GCP, US Code 
of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR 
Part 56, Subpart A), the Health Insurance Portability and Accountability Act (HIPAA, if applicable), 
and local regulations. 
 
The consent form must be approved by the IRB.  The written consent document will embody the 
elements of informed consent as described in the International Conference on Harmonisation and will 
also comply with local regulations. 
 
Participants will be given information about the study and their rights as part of the informed consent 
process.  On agreeing to participate, they will be asked to sign an informed consent form. For patients, 
the form will seek consent both for obtaining clinical data from medical records, as well as for 
participation in the online or telephone surveys.  Medical record data will only be abstracted from 
patients who also provide consent using the HIPAA Authorization form. Pharmacists will be 
consented for their participation in the survey and interview separately; for the survey, the consent will 
be a click-through consent on the online platform and for the interview the consent will be verbal.   As 
part of this informed consent process, potential participants will be informed of: (1) the purpose and 
methods of the study, (2) alternatives to participation in the study, (3) procedures to protect 
confidentiality, (4) the right to withdraw from the study at any time, (5) the fact that participation or 
non-participation will not affect the medical care that they receive, and (5) persons to contact for any 
questions about the study.  The participants will also be given names and phone numbers of persons to 
contact with any questions regarding the study. 
 
18.4 Reimbursement or compensation to study participants 
 
Patients obtaining medication abortion who participate in the study will be reimbursed $25 for 
completing each of the two surveys, for a maximum reimbursement of $50.  Reimbursement will be in 
the form of an online Amazon gift card. Patients’ medication abortion procedure and medications will 
also be paid for by the study. At Planned Parenthood Tacoma, participants will be offered a $25 travel 
remuneration to compensate them for time and costs associated with travel to the study pharmacy. This 
is the only study pharmacy that is not located at the same site as the study clinic.  
 


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Pharmacists will be reimbursed $25 for completing the surveys, and another $25 if the interview is 
completed. Both the survey and interview may be completed at baseline (before the study is initiated) 
and at the end of the study, for a maximum reimbursement of $100.  Reimbursement will be in the 
form of an online Amazon gift card. 
 
Each pharmacy will be reimbursed $18 for each dose of Mifeprex® and misoprostol that is dispensed.  
Since Mifeprex® is not generally a covered benefit for pharmacy dispensing, we do not anticipate that 
pharmacies will be able to bill insurances for their standard dispensing fee, so this will be provided as 
part of the study. 
 
The study will cover the cost of the medication abortion services for all participants at UCSF, UC 
Davis, and UCSD. The study will cover the costs of the Mifeprex®, misoprostol, and associated 
dispensing fees at Kaiser, University of Washington, and Planned Parenthood Tacoma.  
 
18.5 Publications 
 
The preparation and submittal for publication of manuscripts containing the study results shall be in 
accordance with a process determined by mutual written agreement among the study PI and 
participating institutions. The publication or presentation of any study results shall comply with all 
applicable privacy laws, including, but not limited to, the Health Insurance Portability and 
Accountability Act of 1996. 


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