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University of California, San Francisco | Bixby Center for Global Reproductive Health
Telehealth
The next frontier in abortion care
Ushma Upadhyay, PhD, MPH
January 9, 2019
University of California, Los Angeles
Los Angeles, CA
Disclosures
Slide 2January 2019
 I have no conflicts of interest.
 I will be sharing information on off-label use of
Mifepristone.
Telehealth
Slide 3January 2019
tel·e·health
/ˈteləˌhelTH/
noun
◼ The provision of healthcare remotely by means of
telecommunications technology.
◼ Telehealth is different from telemedicine because it
refers to a broader scope of remote healthcare
services than telemedicine. While telemedicine refers
specifically to remote clinical services, telehealth can
refer to remote non-clinical services.
Medication abortion
◼ Two types of pills
◼ Mifepristone
◼ 1 pill taken orally/swallowed
◼ Misoprostol
◼ 4 pills put between gums and cheek until they
are dissolved
◼ Taken 24-48 hours after mifepristone
◼ Cramping and bleeding then usually
starts 1-4 hours after taking
misoprostol and can last for several
hours
Slide 4January 2019
Medication Abortion is highly effective
95%
Intervention needed for
completion: 5%
Slide 5January 2019
Data from ~11,000 medication
abortions covered by Medi-Cal,
(Upadhyay et al. 2015)
95%
Effectiveness
Medication Abortion is extremely safe
99.7%
Serious adverse event: 0.3%
Slide 6January 2019
Data from ~11,000 medication
abortions covered by Medi-Cal,
(Upadhyay et al. 2015)
Medication Abortion is extremely safe
Slide 7Month YEAR
3 Million
Women Have
Used Mifeprex
Between 2000-2017
19 deaths have
been reported
Mortality rate of
0.00063%
This is much lower than the mortality rate for childbirth
in the U.S. (0.009%)
Medication abortion is safer than many common drugs
in the U.S., including Tylenol or Viagra
=
Medication Abortion in California
◼ In 2014, estimated 157,350 abortions in California
◼ 2014 Medi-Cal data indicates 46% were
medication abortions
46.0%
8.2%
45.6%
0.2%
FFS Medi-Cal funded abortions, 2014
First trimester aspiration
2nd trimester or later
Medication Abortion
Other
Source: DHCS
~78,000/year
Slide 8January 2019
Self-Managed Abortion
Slide 9Month YEAR
How do women obtain pills?
◼ Websites such as Plan C, SASS (Self-Managed Abortion; Safe
and Supported), Women on Web, and safe2choose provide
information to women on how to get pills and how to use them.
◼ plancpills.org
◼ abortionpillinfo.org
◼ womenonweb.org
◼ safe2choose.org
◼ An online search will bring up numerous results of places to buy
the pills via the Internet.
◼ There is evidence that most, if not all, pills purchased online from
these websites are real medications, with active ingredients.
Substantial demand for getting abortion pills online
◼ 2015: 700,000+ Google searches using terms related to
self-induced abortion in the U.S.
◼ Online sites report many U.S. consultation requests for
pills initiated each year:
◼ Safe2choose: 120,000;
◼ Women on Web: 36,000
◼ AID ACCESS reports substantial traffic:
 600 requests in 6 months from the U.S.
◼ Over 4000/year are denied an abortion and carry to term
because they can’t access abortion
Slide 10January 2019
State Laws
REMS
Hurdles to telehealth abortion
Slide 11
◼ State laws regulating use of medication abortion
◼ Physical presence laws (telemedicine bans)
◼ Criminalization of self-managed abortion
◼ U.S. FDA REMS
◼ Makes it illegal to send abortion pills by mail
January 2019
Slide 13January 2019
US FDA REMS
Risk Evaluation and Mitigation Strategies (REMS)
◼“To mitigate a specific, serious risk listed in the labeling of the drug”
◼atypical infection
◼prolonged heavy vaginal bleeding
◼REMS not applied to other conditions/procedures with similar risks
◼In February 2017, Mifeprex REMS Study Group called for withdrawal
of REMS in the NEJM
Slide 14January 2019
Elements to Assure Safe Use
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
Slide 15January 2019
Impact of the REMS
Slide 16
Keeping the REMS in place limits its use.
◼ Prevents primary care providers from providing
occasionally
◼ Requires burdensome requirements for registration,
storage, and reporting
◼ Limits the ability for generics to be developed
Largest limitation:
◼ Prohibits the mailing of abortion pills
January 2019
3 Telemedicine models: Clinic Model
◼ Iowa (Grossman et al., 2011)
◼ PPFA – Expanding throughout the United States (Alaska, etc)
◼ Maine Family Planning
Ultrasound and any tests
completed onsite
Telemedicine consult
with off-site physician
who can “dispense”
mifepristone.
Patient presents to facility
Slide 17January 2019
3 Telemedicine models: Tests Model
◼ Tabbot Foundation in Australia
◼ Gynuity Health Projects in the U.S.
Initial consultation at home
Patient obtains
ultrasound and
other tests from
a local health
care provider
Results sent to
telemedicine
provider
If eligible,
medications and
instructions
mailed to patient
Slide 18January 2019
3 Telemedicine models: No-Tests Model
Person completes
screening form online
Medical history
is reviewed by a
telemedicine
provider
If eligible,
medications and
instructions
mailed to patient
◼ Ireland: Similar safety rates to in-clinic models
(Aiken et al. 2017)
Slide 19January 2019
Slide 20
Many Unanswered Questions
about Telehealth Abortion
January 2019
1. Do we really need ultrasounds for gestational
dating?
Slide 21January 2019
◼Small risk of underestimation of pregnancy
◼Pills may not work delayed abortion, emergency room or
unwanted baby
◼However a study of 3041 U.S. women over 99%
correctly estimated their gestational age was
within the eligibility window of 10 weeks
(Bracken et al.2010)
2. What are the efficacy rates of telehealth abortion
in the United States?
Slide 22
◼ Study of 400 women provided medication
abortion without ultrasound, 99% had complete
abortions without major adverse events
(Raymond et al. 2018)
◼ In Ireland, Women on Web found 95% (CI:93%-
96%) reported successfully ending their
pregnancy without aspiration. (Aiken et al. 2017)
3. Does telehealth abortion enable people to have
their abortions at earlier gestations?
Slide 23
◼ What is the average time to abortion care and how
does time differ for those who choose referrals?
◼ In Iowa after clinic-based telemedicine was
introduced, women were less likely to have a second-
trimester abortion (Grossman et al 2013)
4. Do we really need ultrasounds to diagnose
ectopic pregnancy?
Slide 24January 2019
◼ Small risk of missed ectopic pregnancy (~1%)
◼ Delayed diagnosis  call the on-call clinician  emergency room
◼ However, abortion pills do not increase risk of ectopic
pregnancy
◼ Patients would be at the same risk of ectopic pregnancy had
they not sought an abortion at all.
5. Is Rhogam needed for Rh negative people?
Slide 25
◼ An Rh-positive baby born to an Rh-negative woman who did not
receive immune globulin is at risk of developing hemolytic disease
◼ In abortion care: Routine test to assess negative blood type
◼ About 15% of people are Rh-negative
◼ In abortion and early miscarriage Rh immune globulin is used to
protect a future pregnancy, but is only theoretical.
◼ No studies demonstrate subsequent maternal sensitization or
development of hemolytic disease in the fetus after an early
medication abortion
◼ What are people’s preferences for Rhogam after having this
information?
6. What is our appetite/tolerance for risk?
Slide 26
◼ Small risk of underestimation of pregnancy
◼ Pills may not work delayed abortion, emergency room or unwanted baby
◼ Small risk of missed ectopic pregnancy
◼ Delayed diagnosis  still same as wanted pregnancy  emergency room
◼ Unknown risk of not getting Rhogam
◼ Many people know their rh status/blood type from previous pregnancies, some may not want
future children
◼ Large legal risk if seeking treatment at a rural or restrictive ED
◼ Who should decide what level of risk is acceptable?
◼ Legislatures?
◼ U.S. FDA?
◼ Physicians?
◼ People who get pregnant?
7. What information do individuals need to make an
informed choice between in-clinic and telehealth
abortion?
Slide 27
◼ How can we support individuals who are choosing
between having an in-clinic abortion and having a
telehealth abortion?
◼ How much do they want to know on these issues?
◼ Costs/Insurance/Medicaid coverage
◼ Legal risks
◼ Pain control
◼ Ectopic pregnancy
◼ Rh status
University of California, San Francisco | Bixby Center for Global Reproductive Health
Thank you!
Ushma Upadhyay
Ushma.Upadhyay@ucsf.edu

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Telehealth: The next frontier in abortion care

  • 1. University of California, San Francisco | Bixby Center for Global Reproductive Health Telehealth The next frontier in abortion care Ushma Upadhyay, PhD, MPH January 9, 2019 University of California, Los Angeles Los Angeles, CA
  • 2. Disclosures Slide 2January 2019  I have no conflicts of interest.  I will be sharing information on off-label use of Mifepristone.
  • 3. Telehealth Slide 3January 2019 tel·e·health /ˈteləˌhelTH/ noun ◼ The provision of healthcare remotely by means of telecommunications technology. ◼ Telehealth is different from telemedicine because it refers to a broader scope of remote healthcare services than telemedicine. While telemedicine refers specifically to remote clinical services, telehealth can refer to remote non-clinical services.
  • 4. Medication abortion ◼ Two types of pills ◼ Mifepristone ◼ 1 pill taken orally/swallowed ◼ Misoprostol ◼ 4 pills put between gums and cheek until they are dissolved ◼ Taken 24-48 hours after mifepristone ◼ Cramping and bleeding then usually starts 1-4 hours after taking misoprostol and can last for several hours Slide 4January 2019
  • 5. Medication Abortion is highly effective 95% Intervention needed for completion: 5% Slide 5January 2019 Data from ~11,000 medication abortions covered by Medi-Cal, (Upadhyay et al. 2015) 95% Effectiveness
  • 6. Medication Abortion is extremely safe 99.7% Serious adverse event: 0.3% Slide 6January 2019 Data from ~11,000 medication abortions covered by Medi-Cal, (Upadhyay et al. 2015)
  • 7. Medication Abortion is extremely safe Slide 7Month YEAR 3 Million Women Have Used Mifeprex Between 2000-2017 19 deaths have been reported Mortality rate of 0.00063% This is much lower than the mortality rate for childbirth in the U.S. (0.009%) Medication abortion is safer than many common drugs in the U.S., including Tylenol or Viagra =
  • 8. Medication Abortion in California ◼ In 2014, estimated 157,350 abortions in California ◼ 2014 Medi-Cal data indicates 46% were medication abortions 46.0% 8.2% 45.6% 0.2% FFS Medi-Cal funded abortions, 2014 First trimester aspiration 2nd trimester or later Medication Abortion Other Source: DHCS ~78,000/year Slide 8January 2019
  • 9. Self-Managed Abortion Slide 9Month YEAR How do women obtain pills? ◼ Websites such as Plan C, SASS (Self-Managed Abortion; Safe and Supported), Women on Web, and safe2choose provide information to women on how to get pills and how to use them. ◼ plancpills.org ◼ abortionpillinfo.org ◼ womenonweb.org ◼ safe2choose.org ◼ An online search will bring up numerous results of places to buy the pills via the Internet. ◼ There is evidence that most, if not all, pills purchased online from these websites are real medications, with active ingredients.
  • 10. Substantial demand for getting abortion pills online ◼ 2015: 700,000+ Google searches using terms related to self-induced abortion in the U.S. ◼ Online sites report many U.S. consultation requests for pills initiated each year: ◼ Safe2choose: 120,000; ◼ Women on Web: 36,000 ◼ AID ACCESS reports substantial traffic:  600 requests in 6 months from the U.S. ◼ Over 4000/year are denied an abortion and carry to term because they can’t access abortion Slide 10January 2019
  • 11. State Laws REMS Hurdles to telehealth abortion Slide 11 ◼ State laws regulating use of medication abortion ◼ Physical presence laws (telemedicine bans) ◼ Criminalization of self-managed abortion ◼ U.S. FDA REMS ◼ Makes it illegal to send abortion pills by mail January 2019
  • 12.
  • 14. Risk Evaluation and Mitigation Strategies (REMS) ◼“To mitigate a specific, serious risk listed in the labeling of the drug” ◼atypical infection ◼prolonged heavy vaginal bleeding ◼REMS not applied to other conditions/procedures with similar risks ◼In February 2017, Mifeprex REMS Study Group called for withdrawal of REMS in the NEJM Slide 14January 2019
  • 15. Elements to Assure Safe Use 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 Slide 15January 2019
  • 16. Impact of the REMS Slide 16 Keeping the REMS in place limits its use. ◼ Prevents primary care providers from providing occasionally ◼ Requires burdensome requirements for registration, storage, and reporting ◼ Limits the ability for generics to be developed Largest limitation: ◼ Prohibits the mailing of abortion pills January 2019
  • 17. 3 Telemedicine models: Clinic Model ◼ Iowa (Grossman et al., 2011) ◼ PPFA – Expanding throughout the United States (Alaska, etc) ◼ Maine Family Planning Ultrasound and any tests completed onsite Telemedicine consult with off-site physician who can “dispense” mifepristone. Patient presents to facility Slide 17January 2019
  • 18. 3 Telemedicine models: Tests Model ◼ Tabbot Foundation in Australia ◼ Gynuity Health Projects in the U.S. Initial consultation at home Patient obtains ultrasound and other tests from a local health care provider Results sent to telemedicine provider If eligible, medications and instructions mailed to patient Slide 18January 2019
  • 19. 3 Telemedicine models: No-Tests Model Person completes screening form online Medical history is reviewed by a telemedicine provider If eligible, medications and instructions mailed to patient ◼ Ireland: Similar safety rates to in-clinic models (Aiken et al. 2017) Slide 19January 2019
  • 20. Slide 20 Many Unanswered Questions about Telehealth Abortion January 2019
  • 21. 1. Do we really need ultrasounds for gestational dating? Slide 21January 2019 ◼Small risk of underestimation of pregnancy ◼Pills may not work delayed abortion, emergency room or unwanted baby ◼However a study of 3041 U.S. women over 99% correctly estimated their gestational age was within the eligibility window of 10 weeks (Bracken et al.2010)
  • 22. 2. What are the efficacy rates of telehealth abortion in the United States? Slide 22 ◼ Study of 400 women provided medication abortion without ultrasound, 99% had complete abortions without major adverse events (Raymond et al. 2018) ◼ In Ireland, Women on Web found 95% (CI:93%- 96%) reported successfully ending their pregnancy without aspiration. (Aiken et al. 2017)
  • 23. 3. Does telehealth abortion enable people to have their abortions at earlier gestations? Slide 23 ◼ What is the average time to abortion care and how does time differ for those who choose referrals? ◼ In Iowa after clinic-based telemedicine was introduced, women were less likely to have a second- trimester abortion (Grossman et al 2013)
  • 24. 4. Do we really need ultrasounds to diagnose ectopic pregnancy? Slide 24January 2019 ◼ Small risk of missed ectopic pregnancy (~1%) ◼ Delayed diagnosis  call the on-call clinician  emergency room ◼ However, abortion pills do not increase risk of ectopic pregnancy ◼ Patients would be at the same risk of ectopic pregnancy had they not sought an abortion at all.
  • 25. 5. Is Rhogam needed for Rh negative people? Slide 25 ◼ An Rh-positive baby born to an Rh-negative woman who did not receive immune globulin is at risk of developing hemolytic disease ◼ In abortion care: Routine test to assess negative blood type ◼ About 15% of people are Rh-negative ◼ In abortion and early miscarriage Rh immune globulin is used to protect a future pregnancy, but is only theoretical. ◼ No studies demonstrate subsequent maternal sensitization or development of hemolytic disease in the fetus after an early medication abortion ◼ What are people’s preferences for Rhogam after having this information?
  • 26. 6. What is our appetite/tolerance for risk? Slide 26 ◼ Small risk of underestimation of pregnancy ◼ Pills may not work delayed abortion, emergency room or unwanted baby ◼ Small risk of missed ectopic pregnancy ◼ Delayed diagnosis  still same as wanted pregnancy  emergency room ◼ Unknown risk of not getting Rhogam ◼ Many people know their rh status/blood type from previous pregnancies, some may not want future children ◼ Large legal risk if seeking treatment at a rural or restrictive ED ◼ Who should decide what level of risk is acceptable? ◼ Legislatures? ◼ U.S. FDA? ◼ Physicians? ◼ People who get pregnant?
  • 27. 7. What information do individuals need to make an informed choice between in-clinic and telehealth abortion? Slide 27 ◼ How can we support individuals who are choosing between having an in-clinic abortion and having a telehealth abortion? ◼ How much do they want to know on these issues? ◼ Costs/Insurance/Medicaid coverage ◼ Legal risks ◼ Pain control ◼ Ectopic pregnancy ◼ Rh status
  • 28. University of California, San Francisco | Bixby Center for Global Reproductive Health Thank you! Ushma Upadhyay Ushma.Upadhyay@ucsf.edu