Mifepristone Abortion

in Your Office:What you need to know

Dr. Lianne Yoshida MD, CCFP, FCFP

Medical Co-Director Nova Scotia Women’s Choice Clinic

Dalhousie Refresher March 7, 2019

Conflict of Interest none

Off Label Use I will mention evidence based off label use of a

medication

Learning Objectives• Review recent changes to abortion access in Nova

Scotia

• Discuss medical abortion with Mifegymiso

Brief history

Mechanism of action

Prescribing protocols

Barriers to provision of medical abortion

• Discuss resources and support

Abortion Access in NS As of February 5, 2018 patients can call our clinic

directly to book an appointment or get information

about abortion services in all of Nova Scotia

New Name

TPU

NSWCC

(Nova Scotia Women’s

Choice Clinic)

WCC Toll Free Number

1-833-352-0719

Monday – Friday 8am – 3pm

Can leave confidential message and be called back with 24 hours

Toll Free Number Patients will talk to a clerk or RN to discuss options:

• Options counseling

• Social work support

• Information about surgical or medical abortion

• Surgical abortion appointment

• Medical abortion referral

Surgical Abortion No change from previous service

• up to 16 weeks gestational age

• procedure under conscious sedation

Medical Abortion• Available at the NS Women’s Choice Clinic since June

2018

• Process explained to patient, more information on NS

Women’s Choice website

• http://www.nshealth.ca/abortion

• Patients are given name of a doctor who is currently

performing medical abortions

Nova Scotia - Mifegymiso Providers Network

Medical Abortion with

Mifegymiso

Overview and

history

MIFEGYMISO Canadian Trade Name

Use up to 63 days gestation age (9 weeks)

One package with two boxes

Mifepristone 200mg (Green Box)

Misoprostol 800μg - 4 x 200μg (Orange Box)

Authorized in July 2015

Cost - $270.00 / package

Brief History of Mifepristone (RU486)

• 1970s – investigation of drugs to block the action of cortisol

• Some compounds found to block progesterone

• 1980s – RU-38486, the 38,486th compound synthesized by Roussel-Uclaf, developed and tested for abortion

• Approved in France 1988

Brief History of Mifepristone (RU486)

1991 – approved in Great Britain and Sweden

1999 – approved in China

2000 – approved in US (Mifeprex)

In 2013, 45% of induced abortions at ≤ 9 weeks

gestation were medical abortions1

2015 – approved in Canada, available Jan.

2017

Approved in over 60 countries world wide

1. Jatlaoui TC et al. 2016.. CDC Abortion Surveillance. 2013.

Uptake of mifepristone abortion

Berard V, Fiala C, et al. PloS ONE DOI: 10.1371/journal.pone.0112401

Medical Abortion with

Mifegymiso

Mechanism of Action

Mifepristone Blocks progesterone, causing:

Breakdown of endometrium through decidual necrosis

Softening of cervix

Induces contractions of the uterus

Increases sensitivity of uterine and cervical muscles to the

action of Misoprostol

http://www.chemspider.com/Chemical-Structure.49889.html

Misoprostol

Synthetic Prostaglandin

Used to induce strong uterine contractions

Health Canada has approved its use along with

mifepristone in Mifegymiso

http://www.chemspider.com/Chemical-Structure.4445541.html

Efficacy of Mifepristone + Miso

Very strong evidence for this protocol 1

A systematic review of 20 studies involving 33, 846

patients up to 70 days

When looking at 63 days only (~33,000)

96.7% for completed abortion

0.8% continued pregnancy

2.9 – 3.7% ER visits

1. Chen MJ and Creinin M.” Mifepristone with Buccal Misoprostol for Medical Abortion: a Systematic Review” ObstetGynecology 2015 126(1):12

Medical Abortion ProtocolContraindications

Ectopic pregnancy

Chronic adrenal failure

Inherited porphyria

Known hypersensitivity to these medications

Ambivalence

Medical Abortion ProtocolRelative Contraindications

Unconfirmed gestational age

needs ultrasound

IUD in place

remove first

Concurrent long-term systemic corticosteroid therapy

effectiveness suppressed for 3-4 days after mifepristone

Clotting disorder or anticoagulation

caution if anemic (hemoglobin <95mg/l)

Medical Abortion with

Mifegymiso

Complications

Retained Products 3.3% of women having a medical abortion need a

subsequent aspiration 1

Symptoms include prolonged bleeding and cramping or

failure of any bleeding 2

Can be managed by repeat misoprostol or aspiration

1. Chen MJ and Creinin M.” Mifepristone with Buccal Misoprostol for Medical Abortion: a Systematic Review” Obstet

Gynecology 2015 126(1):12

2. Costescu D et al. Medical Abortion CPG. JOGC 2016; 332: 366-389.

Ongoing Pregnancy

Ongoing viable pregnancy found in < 1 % of MA less

than 63 days 1

1. Medical Abortion: Clinical Practice Guidelines: SOGC No. 332, April 2016

2. Chen MJ and Creinin M.” Mifepristone with Buccal Misoprostol for Medical Abortion: a Systematic Review” Obstet

Gynecology 2015 126(1):12

Infection

Serious infection is very rare; <0.1 %

Serious infection = IV abx, hospitalization, sepsis, death

Most commonly endometritis or undefined genital tract

infection

Signs and symptoms – fever more than 24 hours after

miso, foul-smelling discharge, increasing pelvic pain,

Treatment – amoxicillin 500mg tid, metronidozole 500mg tid

for 14 days

1. Shannon C et al. “Infection after medical abortion: a review of literature” Contraception. 2004; 70(3):183

2. UpToDate – “Post Partum Endometritis” – accessed Feb. 2019.

Infection – Bottom Line

Inform patients of to seek medical attention if showing

signs of infection or feeling unwell for 14 days following

mifepristone

Use buccal route for misoprostol

Screen for chlamydia and gonorrhea and treat

NO need for prophylactic antibiotics in Medical

Abortion

recommendation of SOGC, WHO, ACOG

Hemorrhage

Rate of hemorrhage requiring IV fluid or transfusion

less than .1% 1

Patients should be counseled re: when to present to

ED – soaking more than 2 maxi pads an hour for more

than 2 hours in a row or orthostatic symptoms

1. Grimes DA. Medical abortion in early pregnancy: a review of the evidence. Obstet Gynecol 1997; 89: 790–796

Providing a Medical Abortion

Patient Selection Must be able to follow through with entire process:

appointments, calls, lab tests, access ER in case of

emergency

Able to have a surgical abortion if medical abortion fails

The process is irreversible once mifepristone is taken

due to high rate of teratogenicity

Counseling Points Pain and Bleeding

o lower abdominal cramping will be severe for several

hours, then be moderate for a few days

o Bleeding – starts ~4 hours after taking misoprostol,

will pass blood, clots and whitish – grey tissue, may

last for 1-2 weeks

o Most women will pass the tissue within the first 24

hours

MEDICAL SURGICAL

PROS• Can be done earlier in pregnancy• Seems more natural for some• More privacy at home• Less invasive• Can be with someone with you

PROS• Can be done later in pregnancy• Over in a few minutes• Higher success rate• Less bleeding• In a clinic/hospital setting

CONS• Takes longer• Bleeding can be heavy with tissue• It is a multi-step process• Must follow through with entire process

AVAILABILITY COST (in some areas)

CONS• Surgical procedure involving instruments

in vagina and uterus• Risk of procedure• Less control for woman, limits who can

be with her

AVAILABILITY TRAVEL TO CLINICS

Medical Abortion Protocol

Preliminary Visit

• Options counseling

• Discuss medical vs. surgical abortion

• Determine gestational age – order ultrasound

• Blood type, beta HCG level, hemoglobin

Medical Abortion Protocol

First Visit

Review results, give prescription for Mifegymiso

Counsel her about what to expect

Give requisition for follow up beta HCG

Confirm emergency contact

Confirm date she will take mifepristone, then the

timing of misoprostol, follow up beta HCG and

follow up appointment.

Medical Abortion ProtocolFollow up Visit

Confirmation of completion

History alone is not adequate

beta HCG measurement:

A drop of 80% from pre-treatment levels on day 8 -16

confirms expulsion

Ultrasound, not superior to other methods

Contraception plan

OCP can be started on same day as misoprostol (use

condoms for 7 days)

IUD insertion

Access to Medical Abortion:

Barriers

Announced on Friday September 22, 2017.

Cost

Access to Medical Abortion:

Barriers

Province Universal Coverage Pharmacist

Dispensing

PEI ✗ ✗

NB ✔ ✗

NS ✔ ✔

Coverage and dispensing

Access to Medical Abortion:

Barriers

03.03 V, 47.5 Units – since May 2018.

Inconsistent across the country, but most are

developing them

Billing Codes

Training Resources and Support

Training and Support SOGC website – on line learning

https://sogc.org/online-courses/welcome.html

Celopharma- manufacturer of Mifegymiso

http://celopharma.com/

CAPS – Canadian Abortion Provider Support

Online community hosted by UBC

SOGC Medical abortion training program

Health Canada approved

Hosted by SOGC with support from CFPC and CPhA

Cost: $50 – 6 Mainpro credits

Modules:

1. Overview of medical abortion in Canada

2. Pre abortion care

3. Assessment of Unintended Pregnancy

4. Evidence Based Medical Abortion Regimen

5. Provision of Medical Abortion with the prior approved regimen

6. Post abortion Care

SOGC Clinical Practice Guideline

Celopharma Drug manufacturer website

Educational presentation

Handouts, consent form, FAQ

CAPSCanadian Abortion Provider Support

Online community of support for medical abortion

providers and pharmacists

Confidential – providers only

Resource – FAQ, handouts, consent forms etc

“Ask the Expert”

“Find a Pharmacy”

Regional information and updates

Run and moderated out of UBC

Over

700

physicians and

pharmacists have

completed a survey on

their mifepristone practice.

239 physicians

215 pharmacists

48 facility staff

33 nurse practitioners

3 midwives

have joined the CAPS community.

7% of physicians

worked in communities

with no prior abortion

service.

37% of physicians had never

provided abortions before.

The majority of

mifepristone providers are currently in

British Columbia, and Ontario.

MIFEPRISTONE IN CANADA

Who is providing abortions and where?

The Canadian Abortion Providers Support (CAPS-CPCA) website is an online community of practice for

practitioners and pharmacists that provide mifepristone.

Since January 2017 the Contraception and Abortion Research Team has been tracking the growth of this

community.

January 2018

Acknowledgements Thank you to Dr. Wendy Norman and Dr. Sheila Dunn –

founders of CAPS for sharing slides

Questions?

53