Pharmacist Provision of Medication Abortion

Pharmacist Provision of Medication Abortion Pilot

This will be a pilot study among two 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 ways to refine the toolkit to support the scale-up of pharmacist provision of medication abortion in the future.

Study Overview

• Status: Completed
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Other: Pharmacist Provision of Medication Abortion

Detailed Description

We will conduct a 'proof of concept' pilot study. Participating patients will be counseled by a trained pharmacist who will provide Mifepristone 200 mg and two doses of 800 mcg of Misoprostol. Patients will be instructed to take 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.

The standard Mifepristone consent form will be signed at this time and the patient will then be instructed to take the Mifepristone orally.

Participants will be contacted one week after receiving treatment by the providing pharmacist. If the participant history suggests concern for a continuing pregnancy, ectopic pregnancy or worrisome bleeding, they will be scheduled for in person evaluation. If the participant does not indicate any concern, they will be instructed to use the high sensitivity urine pregnancy test four weeks after taking their misoprostol. 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 in person.

We will continue our study by performing in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences and elicit feedback about ways to refine the toolkit. We will follow a prepared interview guide.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92103
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 or older
• Pregnancy must be confirmed by either patient report of a positive urine pregnancy test, serum pregnancy test or ultrasound
• Patient's last menstrual period (LMP) must be less than 70 days before the anticipated date of mifepristone administration
• Patient must be certain of their LMP within 7 days and have regular menses
• 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 permanent contraception or tubal surgery, current intrauterine device (IUD) in place or IUD in place at time of conception.

Exclusion Criteria:

• Any contraindications to medication abortion, as reported on their medical history. These contraindicated include:

  1. Hemorrhagic bleeding disorder
  2. Current anticoagulation therapy
  3. Chronic adrenal failure
  4. Long-term systemic corticosteroid therapy
  5. Inherited porphyria

  d) Allergy to misoprostol or mifepristone

• Any patient with complex medical conditions will also be excluded from this initial pilot. These medical conditions include:

  1. 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
  2. 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
  3. Hepatic or renal failure
  4. History of solid organ transplant
  5. 4 or more cesarean sections
  6. Allergy to NSAIDs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist provision of medication abortion; This is a single arm study with 10 participants undergoing start to finish medication abortion provided by a pharmacist.	Other: Pharmacist Provision of Medication Abortion; Pharmacists providing start to finish medication abortions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Medication Abortion	Negative Pregnancy Test	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacist Experience	qualitative analysis of post pilot in depth interviews	2 weeks following completion of all 10 medication abortion visits
Patient Satisfaction, # of Patients Reporting "Very Satisfied"	qualitative analysis of post abortion in depth interviews	2 weeks following completion of medication abortion
Toolkit Changes	per recommendation by participating pharmacists at post pilot in depth interviews	2 weeks following completion of all 10 medication abortion visits

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Sarah Averbach, MD, MAS, UC San Diego Health

Publications and helpful links

General Publications

• Sandoval S, Rafie S, Kully G, Mody S, Averbach S. Pharmacist provision of medication abortion: A pilot study. Contraception. 2024 Mar;131:110346. doi: 10.1016/j.contraception.2023.110346. Epub 2023 Dec 7.

Helpful Links

• Pharmacist provision of medication abortion: A pilot study

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: medication abortion, no-test medication abortion, pharmacist
• Other Study ID Numbers: 210175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No