Pharmacist Provision of Medication Abortion Pilot
Phase: NA
Conditions: Abortion in First Trimester
Sponsor: University of California, San Diego

 
 
 
 
 
 
 
Pharmacist Provision of Medication Abortion Pilot Study 
Protocol Number: 210175 
National Clinical Trial (ClinicalTrials.gov) Identifier Number: NCT04956731 
Principal Investigator: Dr. Sarah Averbach, MD, MAS 
Funded by: Society of Family Planning 
Version: 12.01.2021 
 

Pharmacist Provision of Medication Abortion Pilot Study 
 
Protocol 210175 
 
 
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1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title:  
Pharmacist Provision of Medication Abortion Pilot 
 
Study Description: 
A pilot study will be conducted among 2 pharmacists providing start to 
finish medication abortions to 10 patients utilizing a previously created 
toolkit. Following completion of the pilot, in-depth semi-structured 
interviews will be performed with the participating patients and 
pharmacists to understand their experiences with pharmacist provision of 
medication abortion.  In addition, feedback will be elicited about ways to 
refine the toolkit to support the scale-up of pharmacist provision of 
medication abortion in the future.  
 
 
 
Aims: 
1. To pilot a toolkit for pharmacist provision of medication abortion.  
2. To understand patient and provider satisfaction with pharmacist 
provision of medication abortion.  
 
  
Study Population: 
Patients desiring a medication abortion 
 
 
Description of Sites 
Enrolling Participants: 
University of California, San Diego (UCSD)  
  
Study Duration: 
1 year 
 
Participant Duration: 
6 weeks 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
We will conduct a pilot study among 2 pharmacists providing start to finish medication abortions to 10 
patients utilizing a previously created toolkit. Following completion of the pilot, we will perform in-
depth semi-structured interviews with the participating patients and pharmacists to understand their 
experiences with pharmacist provision of medication abortion.  In addition, we will elicit feedback about 

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ways to refine the toolkit to support the scale-up of pharmacist provision of medication abortion in the 
future.  
 
2.2 
BACKGROUND  
Approximately 90% of counties in the United States do not have a single clinic offering abortion care, 
and 39% of women ages 15-44 living within those counties.1 Travel required for patients to access 
abortion leads to increases of out-of-pocket costs for the patient, including child care, lodging, food and 
lost wages in addition to delays in care.2  In contrast, more than 90% of Americans live within 2 miles of 
a community pharmacy.3 Pharmacies commonly have expanded evening hours and are open to patients 
on the weekends. Although the overall abortion rate in the United States has decreased, the proportion 
of abortions that are medication abortion has increased from 5% of all abortions in 2001 to 39% of all 
abortions in 2017.1   
 
With the goal of increasing access to medication abortions, a sample protocol for “no touch” medication 
abortion was recently published, which includes recommendations for appropriate patient selection, Rh 
evaluation, treatment regimen and follow up care.4 A prospective case-series conducted from 2015-
2016 in the United States, Mexico and Moldova demonstrated the safety of medication abortion 
without pretreatment ultrasound or pelvic exam among 365 women.5   
 
A previous study among 11,487 patients demonstrated the safety of abortion care provided by 
advanced practice clinicians. The study showed abortion complications were clinically equivalent 
between the newly trained advanced practice clinicians and physicians, demonstrating that expanding 
the pool of clinicians who can provide abortion is feasible and may increase access without 
compromising safety.6  
 
Pharmacists have safely provided care in other aspects of reproductive health in the U.S. including 
provision of hormonal contraception.7  Pharmacy dispensing of medication abortion drugs from 
pharmacies  in Australia has led to improved access to medication abortion, specifically in rural areas.8 
Pharmacists regularly review prescriptions to ensure safety and efficacy in addition to providing patient 
counseling.  
Recently a study in California and Washington states, including UCSD as a site, investigated the 
feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone. This study used 
qualitative surveys to explore pharmacists’ perspectives on dispensing mifepristone.9 The researchers 
also evaluated the clinical outcomes of participants and satisfaction with pharmacist provision of 
medication abortion. The data demonstrates that pharmacists can safely dispense mifepristone safely 
and effectively and patients are satisfied with this care.10 Additionally, a systematic review published in 
2018 evaluated medication abortion provision in pharmacies and drug shops in low and middle-income 
countries by pharmacy workers and drug sellers. The review found the knowledge and counseling 
provided by the pharmacy workers was poor when unregulated and there was a wide variation in the 
advice given regarding complications. In the three studies included in the review that included a training 
intervention however, the results were all positive with increases in knowledge and information 
provision demonstrating the need for structured support for pharmacists when implementing 
medication abortion care.11 
 

Pharmacist Provision of Medication Abortion Pilot Study 
 
Protocol 210175 
 
 
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Provision of medication abortion in pharmacies could lead to increased access to medication abortion in 
the United States especially in rural areas without physician or other abortion providers.12  
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
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. However, this study will 
determine eligibility of gestational age by the patient’s last menstrual period without confirmation by 
pelvic exam or ultrasound. This is sometimes done in clinical practice and supported by society guidelines.  
However, there is a risk that any patient who does not complete an ultrasound could undergo medication 
abortion beyond 70 days gestational age. However previous studies have discovered that less than 1% of 
patients who are certain of their last menstrual period present at gestational ages beyond their reported 
dating by last menstrual period.16 Additionally, the mifepristone and misoprostol regimen included in this 
protocol has been shown to be safe and effective to 77 days gestational age, allowing for the possibility of 
a small underestimate in dating.17  In addition, there is potential risk of loss of confidentiality. 
Other risks to consider include:  
1. Pain experienced during medication abortion 
2. Heavy vaginal bleeding 
3. Known side effects of mifepristone/misoprostol including nausea, vomiting, diarrhea and 
headache 
4. Unknown risks 
 
These risks are related to the medication abortion and not unique to provision by pharmacists or expected 
to be affected by pharmacist provision 
 
During the post abortion interviews, there is a risk of emotional discomfort. Interviews will be performed 
in a private room. Patients and pharmacists will have the option to decline to answer any questions or to 
stop the interview at any point. Additionally, patients will be offered additional mental health and 
wellbeing resources such as social work referral or connection to the All-Options support line.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
Participants may not experience direct benefit from participation in this study. However, we are hopeful 
this research will begin to provide preliminary data about a novel model of medication abortion 
provision that has potential to greatly increase access nation-wide. We hope the findings of our 
proposed project will lead our audience to continue investigating additional models for abortion care. 
Our goal in the piloting of a created toolkit for pharmacist provision of medication abortion is to provide 
the support tools necessary for a larger pilot of this model. The current political climate in the United 
States requires that we continue to explore and investigate alternative methods to provide care to our 
patients. Now, more than ever, these new models can make large impacts. With further research and 
investigation into this model of abortion care, pharmacist provision of medication abortion has the 
potential to increase abortion access, especially for patients in counties without current abortion 
providers. 
 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  

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The benefit of the proposed research potentially increasing abortion access nation-wide outweighs the 
minimal increase in risk of medication abortion within our pilot compared to the risk incurred by 
undergoing a medication abortion outside of the study. 
 
 
3 
OBJECTIVES AND ENDPOINTS 
 
1. To pilot a toolkit for pharmacist provision of medication abortion.  
2. To understand patient and provider satisfaction with pharmacist provision of medication 
abortion.  
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
We will conduct a ‘proof of concept’ pilot study among two pharmacists providing start to finish 
medication abortions utilizing a previously created toolkit4, followed by in-depth interviews with the 
patients and the pharmacists providing their care to understand their experiences. We will be adapting 
an existing toolkit, created by the University of Washington, to assist primary care providers in their 
provision of medication abortion13. The toolkit will be finalized following analysis of pharmacist 
interviews assessing the acceptability and feasibility of pharmacist provision of medication abortion. 
These interviews and subsequent toolkit adaptations will take place under a separate IRB application. 
The final toolkit is expected to contain the no test protocol to be followed; medication abortion basics, 
such as information on mifepristone restrictions and appropriate patient criteria and selection; tools to 
assist in setting up abortion care clinics; implementation guidance, such as guidance on dispensing and 
distributing medications; protocols for follow up of patients receiving abortion care; and additional 
considerations, such as local abortion laws and restrictions. We will recruit patients calling to schedule 
medication abortion at the University of California, San Diego (UCSD) Family Planning Clinics. We have 
one central scheduler for the Division of Family Planning at UCSD, who has been trained in and is 
responsible for phone recruitment for studies.  This scheduler has experience discussing patients’ 
preferred method of abortion. Patients will be offered participation in the pilot study with provision of 
medication abortion with a pharmacist. The visits with the pharmacist will take place in a private room 
within the hospital-affiliated outpatient clinical pharmacy at the UCSD outpatient clinic in the same 
building as the family planning physicians provide medication abortion in the Women’s Health clinic.  
The goal for recruitment is 10 participants.  Inclusion criteria include last menstrual period less than 70 
days prior to planned mifepristone administration, regular menses and no symptoms or risk factors of 
ectopic pregnancy.  
 
Patients who meet the inclusion criteria will provide written informed consent with a research assistant 
experienced in consenting patients for abortion care prior to the start of their visit with the pharmacist. 
Patients who provide consent to participate will be further counseled about pregnancy options by a 
pharmacist. If a patient decides they do not want a medication abortion or would like to proceed with a 
visit with a physician first, they will be scheduled within 3 days to see a physician. 
 
If a patient decides to proceed with a medication abortion and the participating pharmacist assesses 
that they are an appropriate candidate, the patient will be provided Mifepristone 200 mg. Two doses of 
800 mcg of Misoprostol will also be dispensed at the visit. Patients will be instructed to take the 

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mifepristone within 24-48 hours and the 800 mcg of misoprostol buccally 24-48 hours after their 
Mifepristone. Patients whose estimated gestational age is between 64 and 70 days will be instructed to 
take the additional dose of 800 mcg of misoprostol 4 hours after the first dose. Patients who estimated 
gestational age is 63 days or less will be instructed to take the additional dose of 800 mcg of misoprostol 
if they do not experience at least moderate bleeding within the first 24 hours following their first 
misoprostol dose. For pain control, 20 tablets of 600 mg Ibuprofen will be dispensed and 20 tablets of 
650mg Acetaminophen will be provided.  Patient’s will be instructed to alternate the Ibuprofen and 
Tylenol, with each medication take each medication 6 hours apart from itself.  
 
In congruency with a “no test” protocol published by the Society of Family Planning, Rh typing and 
administration of anti-D immunoglobulin will not be performed if the patient reports a positive Rh type, 
if the patient does not desire future childbearing or if the patient declines. For all other patients, they 
will be offered Rh typing and administered anti-D immunoglobulin as indicated. The blood typing and 
Rhogam administration will be ordered and administered by the participating pharmacists. Patient 
participants will be provided with two high sensitivity urine pregnancy tests to be used four weeks after 
the abortion as well as a patient instruction sheet that will include symptoms for which to call their 
abortion provider. These symptoms will include severe pain, pain not responsive to provided analgesics, 
bleeding soaking 2 maxi pads an hour for two consecutive hours, multiple clots the size of an egg or 
greater, dizziness or vomiting lasting more than 2 hours, an increase in bleeding or pain 24 hours after 
taking the misoprostol, fever of 100.4°F or higher 24 hours or more after taking the misoprostol and 
vomiting within 30 minutes of taking the misoprostol. The patients will be provided with written 
instructions about when to call and the emergency phone numbers to reach a UCSD provider. The 
participating pharmacist will provide a pager number and will be the initial provider available for 
questions and concerns with immediately available support from the UCSD family planning physicians as 
indicated. The family planning fellow will also be available to the pharmacists and patients at all times 
via the paging system for concerns or questions. Post-abortion contraception will be available to the 
patient by prescription from the pharmacist for oral contraceptive pills, contraceptive rings, the 
contraceptive patch or Depo Provera. Patient electing for intrauterine devices, contraceptive implants or 
sterilization will be scheduled for an appointment with a physician. Participants will be reimbursed a $40 
electronic gift card for their time and participation. 
 
Following completed visits with the participating pharmacist, but prior to administration of 
Mifepristone, the patients will complete a brief 5-10 minute telehealth visit with a registered physician 
Mifepristone prescriber. This will allow the prescriber to confirm dating and will also offer an additional 
opportunity for the patient to ask questions and to review signs and symptoms for which to be 
concerned and how to reach a provider should they have concerns. The standard Mifepristone consent 
form will be signed at this time and the patient will then be instructed to take the Mifepristone orally. 
This will allow the pilot to meet the FDA REMs requirement on mifepristone.  
 
Participants will be contacted one week after receiving treatment by the providing pharmacist to 
evaluate symptoms and bleeding. If the participant history suggests any concern for a continuing 
pregnancy, ectopic pregnancy or worrisome bleeding they will be referred to the UCSD Family Planning 
Division where they will be scheduled for an ultrasound in clinic with a physician and further evaluation 
as indicted in a timely fashion. If the participant does not indicate any concern for a continuing 
pregnancy or ectopic pregnancy and is having appropriate bleeding, they will be instructed to use the 
high sensitivity urine pregnancy test four weeks after taking their misoprostol. This is a standard method 
for follow up supported by the American College of Obstetricians and Gynecologists.14  If the 
participant’s first high sensitivity urine pregnancy test is positive but they have no symptoms concerning 

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for ongoing pregnancy, they will be instructed to perform a second, high sensitivity urine pregnancy test 
in one week. If the second, high sensitivity urine pregnancy test is also positive, the patient will be 
evaluated by a physician and ultrasound or serial serum HCGs will be utilized if indicated.   
  
The study participants will have the option to exit the pilot and proceed with a medication abortion or 
procedural abortion or consultation visit with a physician at any time. Should any questions, concerns, 
or abnormal symptoms arise, the UCSD family planning fellow will be responsible for facilitating a timely 
evaluation and treatment of patients if needed, either on the phone or in the clinic. The fellow and the 
overseeing Family Planning attending will decide if further treatment or evaluation is warranted 
according to standard of care.  
 
Pharmacists’ involvement in this pilot project will be conducted under a collaborative practice 
agreement (CPA). UCSD has an established history of CPAs across a variety of clinical services including 
HIV care, anticoagulation and transplant medicine. Under the agreement with a supervising physician, 
pharmacists can prescribe provide care for specified conditions.  CPAs are utilized in some form in all 
states except for Delaware, and 36 states are currently allowing pharmacists to initiate patient 
medications in outpatient setting via CPAs.15 The pharmacists providing the medication abortions are 
not investigators nor research team members on this study. 
 
Following completion of study recruitment and patient visits, we will continue our study by performing 
in-depth semi-structured interviews with the participating patients and pharmacists to understand their 
experiences.  In addition, we will elicit feedback about ways to refine the toolkit to support the scale up 
of pharmacist provision of medication abortion in the future. We will follow a prepared interview guide 
(See Appendix A and Appendix B) The interviews will be analyzed using directed content analysis.  
4.2 
END OF STUDY DEFINITION 
A participant is considered to have completed the study after she has completed all phases of the study 
including verifying completion of the medication abortion and completion of the post pilot survey and 
interview.  
 
5 
STUDY POPULATION 
We plan to recruit 10 patients who are calling to schedule a medication abortion.  
 
There will be no limitations of gender identity or ethnic background for the patients recruited.  Only 
people assigned female at birth who have a uterus, regardless of current gender identity, can become 
pregnant and, therefore, will be included. 
 
5.1 
INCLUSION CRITERIA 
In order to participate in the pilot study, the patients must meet the following inclusion criteria:  
1. Age 18 or older 
2. Pregnancy must be confirmed by either patient report of a positive urine pregnancy test, serum 
pregnancy test or ultrasound 
3. Patient’s last menstrual period (LMP) must be less than 70 days before the anticipated date of 
mifepristone administration 
4. Patient must be certain of their LMP within 7 days and have regular menses 
5. Patient has no symptoms or risk factors for ectopic pregnancy including bleeding or spotting in 
the week before their visit, prior ectopic pregnancy, significant pelvic pain the last week, prior 

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permanent contraception or tubal surgery, current intrauterine device (IUD) in place or IUD in 
place at time of conception.  
 
5.2 
EXCLUSION CRITERIA 
Patients may not participate in the proposed pilot if they meet any other following exclusion criteria: 
1. Any contraindications to medication abortion, as reported on their medical history. These 
contraindicated include:  
a) Hemorrhagic bleeding disorder 
b) Current anticoagulation therapy 
c) Chronic adrenal failure 
d) Long-term systemic corticosteroid therapy 
e) Inherited porphyria 
d) Allergy to misoprostol or mifepristone 
2. Any patient with complex medical conditions will also be excluded from this initial pilot. These 
medical conditions include:  
a) Poorly controlled hypertension as defined a history of systolic blood pressure >160 or 
diastolic blood pressure >110 or patients requiring two or more antihypertensive 
medication to control their blood pressure. This will be exclusion criteria for the study but it 
not a standard exclusion criteria for medication abortion   
b) Poorly controlled diabetes as defined by a known history of Type 1 or Type 2 diabetes with 
history of finger stick blood sugar >200 or HbA1c>10 in the last 6 months. This will be 
exclusion criteria for the study but it not a standard exclusion criteria for medication 
abortion   
c) Hepatic or renal failure 
d) History of solid organ transplant 
e) 4 or more cesarean sections 
f) Allergy to NSAIDs. 
 
 
5.3 
SCREEN FAILURES 
For individuals who do not meet the criteria for participation in this trial (screen failure) due to not 
meeting eligibility requirements, they will be schedule within one week in a UCSD Family Planning 
physician clinic for pregnancy evaluation and options counseling. No identifying information will be 
collected from screen failures.   
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION 
Pharmacist provision of medication abortion.  
 
6.2 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
This pilot study will not be randomized or blinded.  
 

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7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
If a participant chooses not to move forward with pharmacist provision of medication abortion, she will 
be offered scheduling in either a UCSD Family Planning clinic for abortion care or in an obstetric clinic for 
ongoing obstetric care.  
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants may withdraw voluntarily from the study at any time. The PI or study team will not 
withdraw anyone from the study without specific request from the participant. Medical care will be 
provided by the patient’s clinician as standard of care in the case of study withdrawal.  
 
 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if she fails to return for any scheduled visits or fails to 
complete her post pilot survey and interview and is unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to respond to surveys or return for the required 
study visit: 
• 
The research coordinator will attempt to contact the participant, re-send surveys and 
reschedule the missed visit within one week and counsel the participant on the importance of 
maintaining the assigned visit schedule and ascertain if the participant wishes to and/or should 
continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant, including 3 telephone calls or texts. These contact 
attempts should be documented in the participant’s study file.  
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
Participants will be contacted one week after receiving treatment by the providing pharmacist to 
evaluate symptoms and bleeding. If the participant history suggests any concern for a continuing 
pregnancy, ectopic pregnancy or worrisome bleeding they will be referred to the UCSD Family Planning 
Division where they will be scheduled for an ultrasound in clinic with a physician and further evaluation 
as indicted in a timely fashion. If the participant does not indicate any concern for a continuing 
pregnancy or ectopic pregnancy and is having appropriate bleeding, they will be instructed to use the 
high sensitivity urine pregnancy test four weeks after taking their misoprostol. This is a standard method 
for follow up supported by the American College of Obstetricians and Gynecologists.14  If the 
participant’s first high sensitivity urine pregnancy test is positive but they have no symptoms concerning 
for ongoing pregnancy, they will be instructed to perform a second, high sensitivity urine pregnancy test 
in one week. If the second, high sensitivity urine pregnancy test is also positive, the patient will be 
evaluated by a physician and ultrasound or serial serum HCGs will be utilized if indicated.   
 
 

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8.2 
SAFETY AND OTHER ASSESSMENTS 
A Data Safety and Monitoring Board (DSMB) is not planned for this small pilot study. 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
The FDA definition of an Adverse event is any untoward medical occurrence associated with the use of 
an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)).  
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization, a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered serious 
when, based upon appropriate medical judgment, they may jeopardize the participant and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition.  
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment. 
The degree of certainty about causality will be graded using the categories below. In a clinical trial, the 
study product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 

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• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
OR 
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study intervention administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study intervention (DE challenge) should be clinically plausible. The event must be 
pharmacologically or phenomenologically definitive, with use of a satisfactory rechallenge 
procedure if necessary. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within 
a reasonable time after administration of the study intervention, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration of the 
study intervention) and in which other drugs or chemicals or underlying disease provides 
plausible explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
 
 
8.3.3.3 EXPECTEDNESS  
 
The PI will be responsible for determining whether an adverse event (AE) is expected or unexpected.  An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, by 
communication from the participant to the study team, or upon review by a study monitor. 
 

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All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured. 
Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study product (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study must be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE. Changes in the severity of an AE will be documented 
to allow an assessment of the duration of the event at each level of severity to be performed. AEs 
characterized as intermittent require documentation of onset and duration of each episode. 
 
At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  
Events will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
All adverse events will be reported to th UCSD IRB. The management of information that is relevant to 
the protection of participants including adverse events, UPRs, protocol violations/deviations, interim 
results and protocol modifications will be the responsibility of the PI. 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
All serious adverse events will be reported to th UCSD IRB. The management of information that is 
relevant to the protection of participants including adverse events, UPRs, protocol violations/deviations, 
interim results and protocol modifications will be the responsibility of the PI. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
The UCSD IRB provide guidance to the PI on informing participants regarding AEs and SAEs as needed.  
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
Unanticipated problems involving risks to participants or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 

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• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
 
The investigators will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the lead principal investigator (PI). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported to the IRB within reasonable 
timing of the investigator becoming aware of the problem.    
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
The IRB at each site will provide guidance to PIs on informing participants regarding UPs as needed.  
 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
Not applicable 
 
9.2 
SAMPLE SIZE DETERMINATION 
The sample size (N=10) was chose as a sample of convenience as this was a proof concept pilot 
 
9.3 
POPULATIONS FOR ANALYSES 
All patients (N=10) will be included in the single sample 
 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
Participants will be contacted one week after receiving treatment by the providing pharmacist to 
evaluate symptoms and bleeding. If the participant history suggests any concern for a continuing 
pregnancy, ectopic pregnancy or worrisome bleeding they will be referred to the UCSD Family Planning 

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Division where they will be scheduled for an ultrasound in clinic with a physician and further evaluation 
as indicted in a timely fashion. If the participant does not indicate any concern for a continuing 
pregnancy or ectopic pregnancy and is having appropriate bleeding, they will be instructed to use the 
high sensitivity urine pregnancy test four weeks after taking their misoprostol. This is a standard method 
for follow up supported by the American College of Obstetricians and Gynecologists.14  If the 
participant’s first high sensitivity urine pregnancy test is positive but they have no symptoms concerning 
for ongoing pregnancy, they will be instructed to perform a second, high sensitivity urine pregnancy test 
in one week. If the second, high sensitivity urine pregnancy test is also positive, the patient will be 
evaluated by a physician and ultrasound or serial serum HCGs will be utilized if indicated.   
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Following completion of study recruitment and patient visits, we will continue our study by performing 
in-depth semi-structured interviews with the participating patients and pharmacists to understand their 
experiences. The interviews will be analyzed using directed content analysis. 
9.4.4 SAFETY ANALYSES 
 
AEs and SAEs will be recorded by the study team when they become aware. Adverse events leading to 
premature discontinuation from the study intervention and serious treatment-emergent AEs will be 
presented in a table. 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Not applicable  
 
9.4.6 PLANNED INTERIM ANALYSES  
Interim analyses are not planned during this short pilot study.  
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator and funding agency. 
If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform 
study participants, the Institutional Review Board (IRB), and sponsor and will provide the reason(s) for 
the termination or suspension.  Study participants will be contacted, as applicable, and be informed of 
changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 

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Protocol 210175 
 
 
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• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor and/or IRB. 
 
 
10.1.2 STUDY GOVERNANCE 
The name and contact information of the Principal Investigator: 
Sarah Averbach, MD, MAS, Associate Professor 
University of California, San Diego  
9500 Gilman Drive, La Jolla, CA, 92093 
858-329-4464 
saverbach@health.ucsd.edu 
 
10.1.3 SAFETY OVERSIGHT 
Safety oversight will be monitored by the study PI.  
 
10.1.4 CLINICAL MONITORING 
Data verification will take place periodically. This will ensure data completeness and monitor safety of 
participants.  
 
10.1.5 DATA HANDLING AND RECORD KEEPING  
 
10.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
10.1.5.2 STUDY RECORDS RETENTION  
Study documents will be retained for 2 years after the formal completion of the study.  
 
10.1.6 PROTOCOL DEVIATIONS  
It is the responsibility of the PI to use continuous vigilance to identify and report deviations. Protocol 
deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The site 
investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
 
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