Defending access to reproductive health care

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The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
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Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

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The authors are Editorial Board members of OBG Management and Ob.Gyn. News.

Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

Author and Disclosure Information

The authors are Editorial Board members of OBG Management and Ob.Gyn. News.

Dr. Kaunitz reports that his institution receives financial support from Merck and Bayer for ongoing clinical trials. Dr. Simon reports receiving grant/research support from: AbbVie Inc, Bayer Healthcare LLC, Dare´ Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, Viveve Medical; being consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services LLC, Covance Inc, Dare´ Bioscience, DEKA M.E.L.A S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals Inc, Sprout Pharmaceuticals Inc, Vella Bioscience Inc; and having served on the speakers’ bureaus of: Mayne Pharma Inc, Myovant Sciences Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals. The other authors report no financial relationships relevant to this article. 

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The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

 

 

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,1 establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey2 rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization3 overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.4 It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.5,6

How do we best prepare for these challenges?

  • We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
  • To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
  • When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
  • We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
  • Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.7 This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.8 Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
References
  1. Roe v Wade, 410 U.S. 113 (1973).
  2. Planned Parenthood v Casey, 505 U.S. 833 (1992).
  3. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.supremecourt.gov/search .aspx?filename=/docket/docketfiles/html /public/19-1392.html. Accessed May 18, 2022.
  4. Gerstein J, Ward A. Supreme Court has voted to overturn abortion rights, draft opinion shows. Politico. May 5, 2022. Updated May 3, 2022.
  5. Gold RB. Lessons from before Roe: will past be prologue? Guttmacher Institute. March 1, 2003. https://www.guttmacher.org/gpr/2003/03 /lessons-roe-will-past-be-prologue. Accessed May 18, 2022.
  6. Edelin KC. Broken Justice: A True Story of Race, Sex and Revenge in a Boston Courtroom. Pond View Press; 2007.
  7. The American College of Obstetricians and Gynecologists. Get involved in your state. ACOG web site. https://www.acog.org/advocacy /get-involved/get-involved-in-your-state. Accessed May 18, 2022.
  8. Institute of Medicine (US) Committee on Improving Birth Outcomes. Bale JR, Stoll BJ, Lucas AO, eds. Reducing maternal mortality and morbidity. In: Improving Birth Outcomes: Meeting the Challenge in the Developing World. Washington, DC: National Academies Press (US); 2003. 
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An appeal for equitable access to care for early pregnancy loss

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Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.

Dr. Eve Espey

However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2

Dr. Anwar Jackson

The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:

  • MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
  • Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
  • Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.

Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
 

Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.

References

1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.

2. Food and Drug Administration. Mifeprex (mifepristone) information.

3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.

4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.

5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.

6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.

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Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.

Dr. Eve Espey

However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2

Dr. Anwar Jackson

The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:

  • MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
  • Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
  • Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.

Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
 

Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.

References

1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.

2. Food and Drug Administration. Mifeprex (mifepristone) information.

3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.

4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.

5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.

6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.

Remarkable advances in care for early pregnancy loss (EPL) have occurred over the past several years. Misoprostol with mifepristone pretreatment is now the gold standard for medical management after recent research showed that this regimen improves both the efficacy and cost-effectiveness of medical management.1 Manual vacuum aspiration (MVA)’s portability, effectiveness, and safety ensure that providers can offer procedural EPL management in almost any clinical setting. Medication management and in-office uterine aspiration are two evidence-based options for EPL management that may increase access for the 25% of pregnant women who experience EPL. Unfortunately, many women do not have access to either option. Equitable access to early pregnancy loss management can be achieved by expanding access to mifepristone and office-based MVA.

Dr. Eve Espey

However, access to mifepristone and initiating office-based MVA is challenging. Mifepristone is one of several medications regulated under the Food and Drug Administration’s Risk Evaluation and Management Strategies (REMS) program.2

Dr. Anwar Jackson

The REMS guidelines restrict clinicians in prescribing and dispensing mifepristone, including the key provision that mifepristone may be dispensed only in clinics, medical offices, and hospitals. Clinicians cannot write a prescription for mifepristone for a patient to pick up at the pharmacy. Efforts are underway to roll back the REMS. Barriers to office-based MVA include time, culture shift among staff, gathering equipment, and creating protocols. Clinicians can improve access to EPL management in a variety of ways:

  • MVA training: Ob.gyns. who lack training in MVA use can take advantage of several programs designed to teach the skill to clinicians, including programs such as Training, Education, and Advocacy in Miscarriage Management (TEAMM).3,4 MVA is easy to learn for ob.gyns. and procedural complications are uncommon. In the office setting, complications requiring transfer to a higher level of care are rare.5 With adequate training, whether during residency or afterward, ob.gyns. can learn to safely and effectively use MVA for procedural EPL management in the office and in the emergency department.
  • Partnerships with pharmacists to reduce barriers to mifepristone: Ob.gyns. working in a variety of clinical settings, including independent clinics, critical access hospitals, community hospitals, and academic medical centers, have worked closely with on-site pharmacists to place mifepristone on their practice sites’ formularies.6 These ob.gyn.–pharmacist collaborations often require explanations to institutional Pharmacy and Therapeutics (P&T) committees of the benefits of mifepristone to patients, detailed indications for mifepristone’s use, and methods to secure mifepristone on site.
  • Partnerships with emergency department and outpatient nursing and administration to promote MVA: Provision of MVA is ideal for safe, effective, and cost-efficient procedural EPL management in both the emergency department and outpatient setting. However, access to MVA in emergency rooms and outpatient clinical settings is suboptimal. Some clinicians push back against MVA use in the emergency department, citing fears that performing the procedure in the emergency department unnecessarily uses staff and resources reserved for patients with more critical illnesses. Ob.gyns. should also work with emergency medicine physicians and emergency department nursing staff and hospital administrators in explaining that MVA in the emergency room is patient centered and cost effective.

Interdisciplinary collaboration and training are two strategies that can increase access to mifepristone and MVA for EPL management. Use of mifepristone/misoprostol and office/emergency department MVA for treatment of EPL is patient centered, evidence based, feasible, highly effective, and timely. These two health care interventions are practical in almost any setting, including rural and other low-resource settings. By using these strategies to overcome the logistical and institutional challenges, ob.gyns. can help countless women with EPL gain access to the best EPL care.
 

Dr. Espey is chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Jackson is an obstetrician/gynecologist at Michigan State University in Flint. They have no disclosures to report.

References

1. Schreiber CA et al. N Engl J Med. 2018 Jun 7;378(23):2161-70.

2. Food and Drug Administration. Mifeprex (mifepristone) information.

3. The TEAMM (Training, Education, and Advocacy in Miscarriage Management) Project. Training interprofessional teams to manage miscarriage. Accessed March 15, 2021.

4. Quinley KE et al. Ann Emerg Med. 2019 Jul;72(1):86-92.

5. Milingos DS et al. BJOG. 2009 Aug;116(9):1268-71.

6. Calloway D et al. Contraception. 2021 Jul;104(1):24-8.

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Mifepristone freed of restrictions for the pandemic

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Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

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Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

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Empowering women through self-managed abortion

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Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.

In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.

Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3

As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.

Two models of telemedicine could improve access for Ashley.

In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4

In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6

Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.

Dr. Eve Espey


Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:

 

 

  • Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
  • Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
  • Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.

Dr. Anwar Jackson

This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.

Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at obnews@mdedge.com.

References

1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .

2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.

3. Obstet Gynecol. 2017 Oct;130(4):778-82.

4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.

5. Guttmacher Rep Public Policy. 2018;21:41-7.

6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.

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Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.

In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.

Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3

As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.

Two models of telemedicine could improve access for Ashley.

In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4

In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6

Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.

Dr. Eve Espey


Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:

 

 

  • Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
  • Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
  • Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.

Dr. Anwar Jackson

This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.

Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at obnews@mdedge.com.

References

1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .

2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.

3. Obstet Gynecol. 2017 Oct;130(4):778-82.

4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.

5. Guttmacher Rep Public Policy. 2018;21:41-7.

6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.

 

Consider Ashley, a 22-year-old G3P2, 8 weeks pregnant, on Medicaid and living in rural Arkansas. The victim of intimate partner violence, she just broke up with her boyfriend and feels she does not have the financial or emotional resources to raise another child; she has no family in town to turn to and wants to be the best parent she can be to her 10-month-old and 3-year old.

In Arkansas, as in many other states and the District of Columbia, Medicaid covers abortion only for rape, incest, or danger to the woman’s life. Arkansas, as well as many other states, requires women to wait 48 hours following counseling before they can proceed with abortion. Waiting periods exacerbate Ashley’s tenuous situation. Will her boss give her time off from work? How will she get to the clinic? Who will watch her children? And lost wages and greater expenses are not the only problems she faces. Arkansas requires a legal contract between the abortion provider and a physician with hospital admitting privileges to provide medical abortion. The result: Only one clinic in Arkansas can legally provide medical abortion for its entire female population. For our impoverished young mother of two, the best choice is the most difficult. And she is far from alone.

Since 2010, many states have passed numerous laws restricting access to safe abortion. As geography plays a growing role in determining access, women and health care providers actively seek ways to circumvent barriers. Telemedicine, initially designed to expedite primary care for patients whose access was hampered by Boston traffic, now brings quality health care to areas lacking providers.1 Telemedicine works for a variety of medical services, from prescribing antibiotics to performing neurosurgery; reproductive health care is part of this digital revolution.2 In 2008, Iowa’s Planned Parenthood of the Heartland began using telemedicine to offer medical abortion.3

As approved by the Food and Drug Administration, medical abortion is the termination of a pregnancy of up to 10 weeks’ gestation using a combination of mifepristone and misoprostol, the former taken to block progesterone receptors, the latter to cause expulsion of the pregnancy. Today, about a third of all abortions in the United States are medical abortions. Because current FDA regulations require that mifepristone be dispensed by a physician, patients usually receive the medications after an in-person evaluation by a health care provider in a clinic.

Two models of telemedicine could improve access for Ashley.

In the first, like the Iowa Planned Parenthood model, remote clinic staff evaluate patients with history and physical examination, ultrasonography, and hemoglobin measurement; the information is forwarded to an off-site physician who has a video discussion with the patient and remotely dispenses the medication for eligible candidates. Between 2008 and 2015, Iowa Planned Parenthood provided 8,765 medical abortions using this model.3 Clinically adverse events, such as hospital admission, surgery, blood transfusion, and death occurred in 16 (0.18%) with no ectopic pregnancies or death.3 For comparison, the rate of severe maternal morbidity in the United States is 1.4%, approximately 10 times the rate with this model of medical abortion.4

In the second model of fully self-managed telemedicine abortion, patients complete a checklist that is reviewed by a provider who sends the medications through the mail. For safety, women must be able to determine their eligibility through the checklist, manage the medications, and self-assess for abortion completion. The World Health Organization endorses self-managed abortion as an option when there is “a source of accurate information and access to a health care provider should they need or want it at any stage of the process.”5 Women on Web, an organization that has provided telemedicine abortion to women globally, has recently begun providing services to the United States after sweeping restrictions vastly increased the number of requests from U.S. women. The U.S. service, Aid Access, operates similarly and for $95 provides online consultation, shipping of the medications, and Skype or phone calls for questions.6

Self-managed abortion has a bad reputation, in part from anti-abortion activists who seek to punish women who attempt to end their pregnancies themselves, but also because of its association with pre–Roe v. Wade “back alley” unsafe abortions. Neither perspective recognizes the benefits of safe self-managed abortion. Some states have criminalized self-induced abortion; both the American College of Obstetricians and Gynecologists and the American Medical Association have voiced opposition to such laws to ensure that women do not fear prosecution for seeking medical care for complications.

Dr. Eve Espey


Given the landscape of abortion access in the United States, where legal constraints, lack of insurance, and a dearth of providers may create insurmountable barriers, we support self-managed abortion for the following reasons:

 

 

  • Access barriers: The complexity and number of legal restrictions to abortion care have made it unavailable/unaffordable through traditional clinic visits in many parts of the United States. With the addition of Justice Brett M. Kavanaugh to the Supreme Court, restrictions are likely to increase.
  • Safety: The evidence-based assessment of the World Health Organization is that in-person clinical evaluation is unnecessary if the appropriate checklists, educational information, and access to a provider are available.
  • Autonomy and equity: Even without the barriers mentioned above, self-managed telemedicine abortion remains a patient-centered option. Often more accessible and less expensive, inherently more private, it is bound to appeal to many women.

Dr. Anwar Jackson

This decade has seen unprecedented challenges to comprehensive safe reproductive health care, with no relief in sight. In the decades prior to Roe v. Wade, illegal abortions were responsible for 20% of all maternal mortality in the United States. As government, national medical organizations, and the public become more aware of our intolerably high maternal mortality rate, these actors are increasingly driven to bring our maternal health to parity with our industrialized peers. Restricting access to safe abortion runs counter to that goal. Two hundred forty years of American history teach us that legal restrictions do not prevent abortions, because they do not eliminate the reasons for which women seek abortion. Legal restrictions do, however, prevent women from ending pregnancies in the safest manner possible. The inability to obtain safe abortions invariably leads to dead women – our mothers, daughters, sisters, and wives. In this country’s harsh political climate, we must protect a woman’s right to choose. By advocating for innovative approaches to protect women’s reproductive choices, we empower women and save lives.

Dr. Anwar is an obstetrician/gynecologist at Michigan State University in Flint and Dr. Espey is professor and chair of obstetrics and gynecology at the University of New Mexico, Albuquerque. Neither of them have conflicts of interest. Email them at obnews@mdedge.com.

References

1. “How a ‘Stupid Idea’ Gave Birth to Telemedicine,” MedPageToday. Dec 15, .

2. J Neurosurg Pediatr. 2016 Dec;25(6):753-7.

3. Obstet Gynecol. 2017 Oct;130(4):778-82.

4. Centers for Disease Control and Prevention. Severe Maternal Morbidity in the United States.

5. Guttmacher Rep Public Policy. 2018;21:41-7.

6. “International ‘safe abortions by mail’ service can now ship to women in US,” The Hill, Nov 7, 2018.

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Contraception coverage rollback is discriminatory

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On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.

Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.

In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.

Dr. Sarah Prager


Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.

By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health.
Dr. Eve Espey


Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
 

Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.

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On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.

Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.

In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.

Dr. Sarah Prager


Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.

By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health.
Dr. Eve Espey


Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
 

Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.

On Oct. 6, the Trump administration rolled back a crucial piece of the Affordable Care Act so that any employer can now claim a moral or religious objection to providing contraception coverage, thus denying their employees access to critical health care – contraception.

Nearly all women – 99% – who have had sex have used some form of contraception at some point during their reproductive lives, regardless of faith or religion (National health statistics reports. 2013 Feb 14[62]). Most women spend the majority of their fertile life span, approximately 35-40 years, avoiding pregnancy, and only a few years actively trying to become pregnant. A desired pregnancy is a gift, but unplanned pregnancies may have a negative impact on women, families, and society.

In the United States, our rising maternal mortality ratio is currently at 26.4 per 100,000 live births (Lancet. 2016 Oct 8;388[10053]:1775-812). Given the risks of pregnancy, especially to those with medical conditions that make pregnancy more dangerous, women need access to methods to avoid pregnancy until they actively seek it. If employers of for-profit businesses now choose to claim a moral or religious objection to providing coverage for contraception, millions of women could become unable to access affordable, effective contraception.

Dr. Sarah Prager


Since the Affordable Care Act mandate that provided coverage for contraceptive methods with no cost-sharing, thousands of women have had improved access to contraception, including IUDs and contraceptive implants, the most effective and longest-lasting reversible methods available. Since President Trump took office, many women have presented to clinics across the country to get long-acting contraception, like an IUD or implant, before the Trump administration could pull the plug on the contraceptive mandate. That scenario has now occurred, leaving millions of women up in the air about the future of their contraceptive coverage.

By allowing employers to deny coverage of contraception, the Trump administration is demonstrating its lack of concern for women’s health and its denial of the most fundamental principles of public health.
Dr. Eve Espey


Rolling back the contraceptive mandate is rolling back on vital women’s preventive health services. It is counter to society’s interest in public health and is discriminatory against women.
 

Dr. Prager is associate professor of obstetrics and gynecology at the University of Washington, Seattle. She is also the director of the family planning division and family planning fellowship. Dr. Prager is an unpaid trainer for Nexplanon (Merck). Dr. Espey is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. Dr. Espey reported having no relevant disclosures.

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