Commentary

The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.

kali9/Getty Images

While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.¹ Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.

While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.

Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”² Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.³ Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”³ This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.^4,5

As health care workers, we can help promote resilience in children and families during this universally difficult time by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:

Help children and adolescents identify and reach out to positive supports

Research has shown the importance of a stable adult figure in the development of resilience in children.^4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.⁴ To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”

Screen for substance use and mental health challenges

Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.⁶ Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.⁷ Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.

Provide parents with resources on how to cope with ongoing stressors

These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).

Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”³ Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.²
 

Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

Resources: Coping with COVID-19

1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.

2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.

3. American Psychiatric Association COVID-19 Resources for Families.

4. American Psychological Association COVID-19 Information and Resources.

Resources: Racism and discrimination

1. American Academy of Pediatrics Talking to Children About Racial Bias.

2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.

3. American Psychological Association Bias, Discrimination, and Equity Resources.

References

1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).

2. “Building your resilience.” American Psychological Association.

3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.

4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).

5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.

6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.

7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.

The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.

kali9/Getty Images

While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.¹ Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.

While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.

Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”² Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.³ Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”³ This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.^4,5

As health care workers, we can help promote resilience in children and families during this universally difficult time by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:

Help children and adolescents identify and reach out to positive supports

Research has shown the importance of a stable adult figure in the development of resilience in children.^4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.⁴ To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”

Screen for substance use and mental health challenges

Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.⁶ Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.⁷ Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.

Provide parents with resources on how to cope with ongoing stressors

These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).

Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”³ Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.²
 

Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

Resources: Coping with COVID-19

1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.

2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.

3. American Psychiatric Association COVID-19 Resources for Families.

4. American Psychological Association COVID-19 Information and Resources.

Resources: Racism and discrimination

1. American Academy of Pediatrics Talking to Children About Racial Bias.

2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.

3. American Psychological Association Bias, Discrimination, and Equity Resources.

References

1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).

2. “Building your resilience.” American Psychological Association.

3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.

4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).

5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.

6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.

7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.

The start of a new school year is usually a time of excitement and return to routine, structure, and consistency for children, teenagers, and families. With the current COVID-19 pandemic, this year is anything but typical. Face masks, hand washing, physical distancing, remote learning, and restrictions on extracurricular activities are just a few of the changes experienced by children in schools. At home, the disruptions and uncertainty for families are equally dramatic with loss of employment, limited child care, risk of eviction and foreclosure, food insecurity, and growing numbers of families directly impacted by loss of health and life due to the coronavirus.

kali9/Getty Images

While every family is impacted by the current global pandemic, the realities of the pandemic have thrown increasing light on the racial, social, and structural injustices in our system. People of color are much more likely to be infected, have more severe disease, and die from COVID-19; they are more likely to experience the socioeconomic impacts.¹ Centuries of racial injustice and inequity have been highlighted not just by this pandemic but by ongoing differential treatment of people of color in our education, health, justice, economic, and housing systems. The murders of George Floyd, Breonna Taylor, Ahmaud Arbery, and too many others are just one source of the constant stress facing children and families of color.

While each family and individual currently faces a distinct combination of stressors and adversity, no one has been spared from these disruptions. International, national, and local communities all need to continue efforts to overcome the current pandemic and systemic racism. As providers, we have a profound opportunity and responsibility to engage both in advocacy for our communities and the individual care of children and families. We are aware of the negative impacts of acute and chronic stress on long-term health outcomes but are equally familiar with the power of resilience.

Resilience has broadly been defined as the “process of adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress.”² Some have argued that resilience should be further defined to include an individual making a “conscious effort to move forward” after or during adversity.³ Another definition with particular utility in considering how to develop and promote resilience describes it as “a process to harness resources to sustain well-being.”³ This definition not only discusses the end result, but the need to reach beyond the current capacity of an individual by harnessing both internal and external resources. These resources may be as tangible as money, food, infrastructure, or treatment, but also can include relationships, social capital, and the lived experience of others. Social supports, mature mentors, and solid bonds with parents/caregivers are critical resources for the development of child and adolescent resilience.^4,5

As health care workers, we can help promote resilience in children and families during this universally difficult time by both being a resource and helping them harness other resources that can lead to physical, emotional, and relationship well-being. To do this, consider incorporating the following into your practice:

Help children and adolescents identify and reach out to positive supports

Research has shown the importance of a stable adult figure in the development of resilience in children.^4,5 Ideally, parents will be a major positive support to their children in times of crisis. When parents are not appropriate supports, teachers, coaches, mentors, grandparents, or other extended family members can provide the needed support for children to be resilient across educational, emotional, and relationship domains.⁴ To find out who your patients have as a stable adult figure, ask the following or a related question: “Who do you have in your life who you can talk to or get support from on a regular basis?”

Screen for substance use and mental health challenges

Do this for children, adolescents, AND adults. Then treat and refer to appropriate treatment as indicated. Rates of depression, anxiety, suicide, substance use, and overdose all have increased with recent events.⁶ Treating parents with mental health and substance use disorders will not only facilitate their ability to be a positive support and role model for their children and promote resilience, but it has been shown to decrease child psychopathology.⁷ Providing parents with referrals for substance use and mental health services as well as educating them on the importance of self-care is vital for helping the development of children.

Provide parents with resources on how to cope with ongoing stressors

These stressors may be related to the COVID-19 pandemic, racism, or both. By providing resources to parents, they can better help their children overcome stressors. Multiple organizations have free online collections to support parents and families including the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and many others (See below for a list of resources).

Encourage families to find and develop purpose and meaning during this time. Children and families have devoted their time to many activities, some more adaptive and health promoting than others. If we think of resilience as the process of “moving forward” then developing goals and plans to be productive can be helpful and “meaning-making.”³ Spending time together as families, developing skills, accomplishing goals, becoming involved in important social movements, or volunteering all can be ways that individuals and families can develop feelings of self-worth, purpose, and accomplishment.²
 

Dr. Heward is a child and adolescent psychiatrist at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

Resources: Coping with COVID-19

1. American Academy of Pediatrics HealthyChildren.org page on COVID-19.

2. American Academy of Child and Adolescent Psychiatry COVID-19 Resources for Families.

3. American Psychiatric Association COVID-19 Resources for Families.

4. American Psychological Association COVID-19 Information and Resources.

Resources: Racism and discrimination

1. American Academy of Pediatrics Talking to Children About Racial Bias.

2. American Academy of Child and Adolescent Psychiatry Racism Resource Library.

3. American Psychological Association Bias, Discrimination, and Equity Resources.

References

1. “Double jeopardy: COVID-19 and behavioral health disparities for Black and Latino communities in the U.S.” Substance Abuse and Mental Health Services Administration. (Submitted by Office of Behavioral Health Equity).

2. “Building your resilience.” American Psychological Association.

3. Eur J Psychotraumatol. 2014 Oct 1. doi: 10.3402/ejpt.v5.25338.

4. Psychological and biological factors associated with resilience to stress and trauma, in “The Unbroken Soul: Tragedy, Trauma, and Human Resilience” (Lanham, Md.: Jason Aronson, 2008, pp.129-51).

5. Biol Psychiatry. 2019 Sep 15. doi: 10.1016/j.biopsych.2019.07.012.

6. MMWR Morb Mortal Wkly Rep. 2020;69:1049-57.

7. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):379-89.

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

Uterine leiomyomata (fibroids) are the most common pelvic tumor diagnosed in women.¹ Women with symptomatic fibroids often report abnormal uterine bleeding (AUB) and pelvic cramping, fullness, or pain. Fibroids also may cause frequency of urination and contribute to fertility and pregnancy problems. Treatment options for the AUB caused by fibroids include, but are not limited to, hysterectomy, myomectomy, uterine artery embolization, endometrial ablation, insertion of a levonorgestrel intrauterine device, focused ultrasound surgery, radiofrequency ablation, leuprolide acetate, and elagolix plus low-dose hormone add-back (Oriahnn; AbbVie, North Chicago, Illinois).¹ Oriahnn is the most recent addition to our treatment armamentarium for fibroids and represents the first US Food and Drug Administration (FDA)-approved long-term hormonal option for AUB caused by fibroids.

Gene dysregulation contributes to fibroid development

Most uterine fibroids are clonal tumors, which develop following a somatic mutation in a precursor uterine myocyte. The somatic mutation causes gene dysregulation that stimulates cell growth resulting in a benign tumor mass. The majority of fibroids contain a mutation in one of the following 6 genes: mediator complex subunit 12 (MED12), high mobility group AT-hook (HMGA2 or HMGA1), RAD51B, fumarate hydratase (FH), collagen type IV, alpha 5 chain (COL4A5), or collagen type IV alpha 6 chain (COL4A6).²

Gene dysregulation in fibroids may arise following chromothripsis of the uterine myocyte genome

Chromothripsis is a catastrophic intracellular genetic event in which one or more chromosomes are broken and reassemble in a new nucleic acid sequence, producing a derivative chromosome that contains complex genetic rearrangements.³ Chromothripsis is believed to occur frequently in uterine myocytes. It is unknown why uterine myocytes are susceptible to chromothripsis,³ or why a catastrophic intracellular event such as chromothripsis results in preferential mutations in the 6 genes that are associated with myoma formation.

Estrogen and progesterone influence fibroid size and cell activity

Although uterine fibroids are clonal tumors containing broken genes, they are also exquisitely responsive to estradiol and progesterone. Estradiol and progesterone play an important role in regulating fibroid size and function.⁴ Estrogen stimulates uterine fibroids to increase in size. In a hypoestrogenic state, uterine fibroids decrease in size. In addition, a hypoestrogenic state results in an atrophic endometrium and thereby reduces AUB. For women with uterine fibroids and AUB, a reversible hypoestrogenic state can be induced either with a parenteral GnRH-agonist analogue (leuprolide) or an oral GnRH-antagonist (elagolix). Both leuprolide and elagolix are approved for the treatment of uterine fibroids (see below).

Surprisingly, progesterone stimulates cell division in normal uterine myocytes and fibroid cells.⁵ In the luteal phase of the menstrual cycle, uterine myocyte mitoses are more frequent than in the follicular phase. In addition, synthetic progestins appear to maintain fibroid size in a hypoestrogenic environment. In one randomized trial, women with uterine fibroids treated with leuprolide acetate plus a placebo pill for 24 weeks had a 51% reduction in uterine volume as measured by ultrasound.⁶ Women with uterine fibroids treated with leuprolide acetate plus the synthetic progestin, oral medroxyprogesterone acetate 20 mg daily, had only a 15% reduction in uterine volume.⁶ This finding suggests that synthetic progestins partially block the decrease in uterine volume that occurs in a hypoestrogenic state.

Further evidence that progesterone plays a role in fibroid biology is the observation that treatment of women with uterine fibroids with the antiprogestin ulipristal decreases fibroid size and reduces AUB.^7-9 Ulipristal was approved for the treatment of fibroids in many countries but not the United States. Reports of severe, life-threatening liver injury—some necessitating liver transplantation—among women using ulipristal prompted the European Medicines Agency (EMA) in 2020 to recommend that women stop taking ulipristal. In addition, the EMA recommended that no woman should initiate ulipristal treatment at this time.¹⁰

Continue to: Leuprolide acetate...

Leuprolide acetate

Leuprolide acetate is a peptide GnRH-agonist analogue. Initiation of leuprolide treatment stimulates gonadotropin release, but with chronic administration pituitary secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) decreases, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Leuprolide treatment concomitant with iron therapy is approved by the FDA for improving red blood cell volume prior to surgery in women with fibroids, AUB, and anemia.¹¹ Among women with fibroids, AUB, and anemia, after 12 weeks of treatment, the hemoglobin concentration was ≥12 g/dL in 79% treated with leuprolide plus iron and 56% treated with iron alone.¹¹ The FDA recommends limiting preoperative leuprolide treatment to no more than 3 months. The approved leuprolide regimens are a maximum of 3 monthly injections of leuprolide 3.75 mg or a single injection of leuprolide 11.25 mg. Leuprolide treatment prior to hysterectomy surgery for uterine fibroids usually will result in a decrease in uterine size and may facilitate vaginal hysterectomy.

Elagolix plus estradiol plus norethindrone acetate (Oriahnn)

GnRH analogues cause a hypoestrogenic state resulting in adverse effects, including moderate to severe hot flashes and a reduction in bone mineral density. One approach to reducing the unwanted effects of hot flashes and decreased bone density is to combine a GnRH analogue with low-dose steroid hormone add-back therapy. Combining a GnRH analogue with low-dose steroid hormone add-back permits long-term treatment of AUB caused by fibroids, with few hot flashes and a minimal decrease in bone mineral density. The FDA recently has approved the combination of elagolix plus low-dose estradiol and norethindrone acetate (Oriahnn) for the long-term treatment of AUB caused by fibroids.

Elagolix is a nonpeptide oral GnRH antagonist that reduces pituitary secretion of LH and FSH, resulting in a decrease in ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. Unlike leuprolide, which causes an initial increase in LH and FSH secretion, the initiation of elagolix treatment causes an immediate and sustained reduction in LH and FSH secretion. Combining elagolix with a low dose of estradiol and norethindrone acetate reduces the side effects of hot flashes and decreased bone density. Clinical trials have reported that the combination of elagolix (300 mg) twice daily plus estradiol (1 mg) and norethindrone acetate (0.5 mg) once daily is an effective long-term treatment of AUB caused by uterine fibroids.

To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) for the treatment of AUB caused by uterine fibroids, two identical trials were performed,¹² in which 790 women participated. The participants had a mean age of 42 years and were documented to have heavy menstrual bleeding (>80 mL blood loss per cycle) and ultrasound-diagnosed uterine fibroids. The participants were randomized to one of 3 groups:

• elagolix (300 mg twice daily) plus low-dose steroid add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily),
• elagolix 300 mg twice daily with no steroid add-back (elagolix alone), or
• placebo for 6 months.¹²

Menstrual blood loss was quantified using the alkaline hematin method on collected sanitary products. The primary endpoint was menstrual blood loss <80 mL per cycle as well as a ≥50% reduction in quantified blood loss from baseline during the final month of treatment. At 6 months, the percentage of women achieving the primary endpoint in the first trial was 84% (elagolix alone), 69% (elagolix plus add-back), and 9% (placebo). Mean changes from baseline in lumbar spine bone density were −2.95% (elagolix alone), −0.76% (elagolix plus add-back), and −0.21% (placebo). The percentage of women reporting hot flashes was 64% in the elagolix group, 20% in the elagolix plus low-dose steroid add-back group, and 9% in the placebo group. Results were similar in the second trial.¹²

The initial trials were extended to 12 months with two groups: elagolix 300 mg twice daily plus low-dose hormone add-back with 1 mg estradiol and 0.5 mg norethindrone acetate once daily (n = 218) or elagolix 300 mg twice daily (elagolix alone) (n = 98).¹³ Following 12 months of treatment, heavy menstrual bleeding was controlled in 88% and 89% of women treated with elagolix plus add-back and elagolix alone, respectively. Amenorrhea was reported by 65% of the women in the elagolix plus add-back group. Compared with baseline bone density, at the end of 12 months of treatment, bone mineral density in the lumbar spine was reduced by -1.5% and -4.8% in the women treated with elagolix plus add-back and elagolix alone, respectively. Compared with baseline bone density, at 1 year following completion of treatment, bone mineral density in the lumbar spine was reduced by -0.6% and -2.0% in the women treated with elagolix plus add-back and elagolix alone, respectively. Similar trends were observed in total hip and femoral neck bone density. During treatment with elagolix plus add-back, adverse effects were modest, including hot flushes (6%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Two women developed liver transaminase levels >3 times the upper limit of normal, resulting in one woman discontinuing treatment.¹³

Continue to: Contraindications to Oriahnn include known allergies...

Contraindications to Oriahnn include known allergies to the components of the medication (including the yellow dye tartrazine); high risk of arterial, venous thrombotic or thromboembolic disorders; pregnancy; known osteoporosis; current breast cancer or other hormonally-sensitive malignancies; known liver disease; and concurrent use of organic anion transporting polypeptide 1B1 inhibitors, which includes many HIV antiviral medications.¹⁴ Undiagnosed AUB is a contraindication, and all women prescribed Oriahnn should have endometrial sampling before initiating treatment. Oriahnn should not be used for more than 24 months due to the risk of irreversible bone loss.¹⁴ Systemic estrogen and progestin combinations, a component of Oriahnn, increases the risk for pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction, especially in women at increased risk for these events (such as women >35 years who smoke cigarettes and women with uncontrolled hypertension).¹⁴ In two studies there was a higher incidence of depression, depressed mood, and/or tearfulness in women taking Oriahnn (3%) compared with those taking a placebo (1%).¹⁴ The FDA recommends promptly evaluating women with depressive symptoms to determine the risks of initiating and continuing Oriahnn therapy. In two studies there was a higher risk of reported alopecia among women taking Oriahnn (3.5%) compared with placebo (1%).¹⁴

It should be noted that elagolix is approved for the treatment of pelvic pain caused by endometriosis at a dose of 150 mg daily for 24 months or 200 mg twice daily for 6 months. The elagolix dose for the treatment of AUB caused by fibroids is 300 mg twice daily for up to 24 months, necessitating the addition of low-dose estradiol-norethindrone add-back to reduce the frequency and severity of hot flashes and minimize the loss of bone density. Norethindrone acetate also protects the endometrium from the stimulatory effect of estradiol, reducing the risk of developing endometrial hyperplasia and cancer. Oriahnn is formulated as two different capsules. A yellow and white capsule contains elagolix 300 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg to be taken in the morning, and a blue and white capsule contains elagolix 300 mg to be taken in the evening.

AUB caused by fibroids is a common problem in gyn practice

There are many procedural interventions that are effective in reducing AUB caused by fibroids. However, prior to the approval of Oriahnn there were no hormonal medications that were FDA approved for the long-term treatment of AUB caused by fibroids. Hence, Oriahnn represents an important advance in the hormonal treatment of AUB caused by fibroids and expands the treatment options available to our patients. ●

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

A patient hugged me yesterday, the second one in a week. I am not a hugging doctor. And if I were, sure, I wouldn’t be hugging now while we pass through the eye of the COVID-19 storm. But in both cases, my patients opened their arms wide and leaned in before I had a chance to defend myself.

The first, a carrot-coiffed 80-year-old who stood only as tall as my shoulders, asked if she could hug me just as she put her arms around me, closing any window of opportunity for me to foil her attempt. The second was more of a modified hug. She also was an elderly woman and she too walked in close, then started to put her arm around my back. I dodged, awkwardly so it was more shoulder-to-shoulder than a full on embrace. Best buds. She too acknowledged we shouldn’t be hugging in the time of COVID-19, but felt she just had to. She couldn’t resist the urge.

Hugs may be dangerous, but they’re special. They are how we thank family and close friends, how we say I love you, I missed you, or I got you. Hugging transfers a feeling of gratitude in a richer manner than just words. Both of these hugs given to me were done to thank me and show appreciation. They were also likely part of what they wanted from me in their visit.

We’re taught in medicine about the power of touch. Abraham Verghese, MD, the Stanford University professor of medicine and TED speaker, says indeed, the most important innovation in medicine is the human hand. Yet, because of the risks of infectious diseases and risk of harm caused by inappropriate or unwanted touch, we avert it more often than not these days. Or we use it with surgical precision to mitigate risks or chances of any misadventure.

Still, touch is powerful. It releases oxytocin, lowers blood pressure and cortisol, and boosts immune responses. To be held is a basic human need. And in this time of COVID-19, many of our patients are being deprived of it.

Psychologists have a name for this condition: “skin hunger.” Skin hunger describes our universal need to be touched and, like true hunger, the health consequences of being starved of it. The first thing we do to a newborn is plop her or him, skin to skin, right on mom’s chest. From the start, touch is life giving and is hardwired into our brains as a requirement for survival.

As the pandemic rolls on, it feels we’re losing the power of this most important innovation. Through our masks and face shields, sitting 6 feet away are some patients who might more than anything else need us to touch them. With safety superseding the desire to sate physical contact craving, touch has now become one of the more difficult tasks for us as physicians. We must iterate on this innovation of the human hand. Perhaps through deeper eye contact, by spending an extra minute or two to inquire about a patient’s family or favorite TV shows. It might be a few elbow bumps, perhaps lingering for just a second to transfer your energy and comfort to them. Or using the gloved auscultation exam as an opportunity to rest your hand gently on a patient’s back.

The dangers of COVID-19 won’t be with us forever, but perhaps we can use this extraordinary time to improve upon one of our most valuable tools, the touch that comforts and heals.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

A patient hugged me yesterday, the second one in a week. I am not a hugging doctor. And if I were, sure, I wouldn’t be hugging now while we pass through the eye of the COVID-19 storm. But in both cases, my patients opened their arms wide and leaned in before I had a chance to defend myself.

The first, a carrot-coiffed 80-year-old who stood only as tall as my shoulders, asked if she could hug me just as she put her arms around me, closing any window of opportunity for me to foil her attempt. The second was more of a modified hug. She also was an elderly woman and she too walked in close, then started to put her arm around my back. I dodged, awkwardly so it was more shoulder-to-shoulder than a full on embrace. Best buds. She too acknowledged we shouldn’t be hugging in the time of COVID-19, but felt she just had to. She couldn’t resist the urge.

Hugs may be dangerous, but they’re special. They are how we thank family and close friends, how we say I love you, I missed you, or I got you. Hugging transfers a feeling of gratitude in a richer manner than just words. Both of these hugs given to me were done to thank me and show appreciation. They were also likely part of what they wanted from me in their visit.

We’re taught in medicine about the power of touch. Abraham Verghese, MD, the Stanford University professor of medicine and TED speaker, says indeed, the most important innovation in medicine is the human hand. Yet, because of the risks of infectious diseases and risk of harm caused by inappropriate or unwanted touch, we avert it more often than not these days. Or we use it with surgical precision to mitigate risks or chances of any misadventure.

Still, touch is powerful. It releases oxytocin, lowers blood pressure and cortisol, and boosts immune responses. To be held is a basic human need. And in this time of COVID-19, many of our patients are being deprived of it.

Psychologists have a name for this condition: “skin hunger.” Skin hunger describes our universal need to be touched and, like true hunger, the health consequences of being starved of it. The first thing we do to a newborn is plop her or him, skin to skin, right on mom’s chest. From the start, touch is life giving and is hardwired into our brains as a requirement for survival.

As the pandemic rolls on, it feels we’re losing the power of this most important innovation. Through our masks and face shields, sitting 6 feet away are some patients who might more than anything else need us to touch them. With safety superseding the desire to sate physical contact craving, touch has now become one of the more difficult tasks for us as physicians. We must iterate on this innovation of the human hand. Perhaps through deeper eye contact, by spending an extra minute or two to inquire about a patient’s family or favorite TV shows. It might be a few elbow bumps, perhaps lingering for just a second to transfer your energy and comfort to them. Or using the gloved auscultation exam as an opportunity to rest your hand gently on a patient’s back.

The dangers of COVID-19 won’t be with us forever, but perhaps we can use this extraordinary time to improve upon one of our most valuable tools, the touch that comforts and heals.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

A patient hugged me yesterday, the second one in a week. I am not a hugging doctor. And if I were, sure, I wouldn’t be hugging now while we pass through the eye of the COVID-19 storm. But in both cases, my patients opened their arms wide and leaned in before I had a chance to defend myself.

The first, a carrot-coiffed 80-year-old who stood only as tall as my shoulders, asked if she could hug me just as she put her arms around me, closing any window of opportunity for me to foil her attempt. The second was more of a modified hug. She also was an elderly woman and she too walked in close, then started to put her arm around my back. I dodged, awkwardly so it was more shoulder-to-shoulder than a full on embrace. Best buds. She too acknowledged we shouldn’t be hugging in the time of COVID-19, but felt she just had to. She couldn’t resist the urge.

Hugs may be dangerous, but they’re special. They are how we thank family and close friends, how we say I love you, I missed you, or I got you. Hugging transfers a feeling of gratitude in a richer manner than just words. Both of these hugs given to me were done to thank me and show appreciation. They were also likely part of what they wanted from me in their visit.

We’re taught in medicine about the power of touch. Abraham Verghese, MD, the Stanford University professor of medicine and TED speaker, says indeed, the most important innovation in medicine is the human hand. Yet, because of the risks of infectious diseases and risk of harm caused by inappropriate or unwanted touch, we avert it more often than not these days. Or we use it with surgical precision to mitigate risks or chances of any misadventure.

Still, touch is powerful. It releases oxytocin, lowers blood pressure and cortisol, and boosts immune responses. To be held is a basic human need. And in this time of COVID-19, many of our patients are being deprived of it.

Psychologists have a name for this condition: “skin hunger.” Skin hunger describes our universal need to be touched and, like true hunger, the health consequences of being starved of it. The first thing we do to a newborn is plop her or him, skin to skin, right on mom’s chest. From the start, touch is life giving and is hardwired into our brains as a requirement for survival.

As the pandemic rolls on, it feels we’re losing the power of this most important innovation. Through our masks and face shields, sitting 6 feet away are some patients who might more than anything else need us to touch them. With safety superseding the desire to sate physical contact craving, touch has now become one of the more difficult tasks for us as physicians. We must iterate on this innovation of the human hand. Perhaps through deeper eye contact, by spending an extra minute or two to inquire about a patient’s family or favorite TV shows. It might be a few elbow bumps, perhaps lingering for just a second to transfer your energy and comfort to them. Or using the gloved auscultation exam as an opportunity to rest your hand gently on a patient’s back.

The dangers of COVID-19 won’t be with us forever, but perhaps we can use this extraordinary time to improve upon one of our most valuable tools, the touch that comforts and heals.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

How do you feel about expectantly managing a well-dated pregnancy past 41 weeks’ gestation?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019) 

Is it reasonable to choose the age of 40 for proposing an anticipation of labor induction?

In physiologic ongoing pregnancies (whether they are spontaneous or autologous in vitro fertilization [IVF] or heterologous IVF), the evidence for anticipating labor induction based upon the only factor of age (after 40 years) is missing. Nonetheless, the number of women becoming pregnant at an older age is expected to increase, and from my perspective, to induce all physiologic pregnancies at term by 41 weeks and 5 days’ gestation does not appear to be best practice. I favor the idea of all women aged 40 and older to start labor induction earlier (for instance, to offer labor induction, with proper informed consent, by 41+ 0 and not 41+ 5 through 42+ 0 weeks of pregnancy).

Luca Bernardini, MD

La Spezia, Italy 

Dr. Barbieri responds

At Brigham and Women’s Hospital in Boston, Massachusetts, our approach is to offer women ≥40 years of age induction of labor (IOL) at 39 weeks’ gestation, unless there is an obstetric contraindication to IOL. We believe that IOL at 39 weeks’ gestation is associated with a reduced risk of both cesarean delivery and a new diagnosis of hypertension.¹

Reference

1. Grobman WA, Rice MM, Reddy, UM, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

What is the optimal hormonal treatment for women with polycystic ovary syndrome?

ROBERT L. BARBIERI, MD

(EDITORIAL; JANUARY 2020)

OCs and spironolactone study

I often recommend oral contraceptives (OCs) containing drospirenone for patients with polycyctic ovary syndrome (PCOS)-associated mild acne and hirsutism—since OCs are already approved by the US Food and Drug Administration for acne, with similar effects as spironolactone. My patients seem to do well on an OC, and require only one medication. Of course, I would add spironolactone to the treatment regimen and switch OCs if she was not responding well.

Michael T. Cane, MD

Arlington, Texas

Dr. Barbieri responds

The Endocrine Society agrees with Dr. Cane’s approach, recommending the initiation of monotherapy with an estrogen-progestin followed by the addition of spironolactone if 6 months of monotherapy produces insufficient improvement in dermatologic symptoms of PCOS, including hirsutism and acne. Most contraceptives contain 3 mg or 4 mg of drospirenone, which is thought to have antiandrogenic effects similar to spironolactone 25 mg. I believe that spironolactone 100 mg provides more complete and rapid resolution of the dermatologic symptoms caused by PCOS. Hence, I initiate both an estrogen-progestin contraceptive with spironolactone.

As most of you know, Medicare publishes its proposed rule, which determines the physician fee schedule, around July 1 each year, accepts comments for 60 days, and then publishes a final rule on or around Nov. 1, which becomes final on Jan. 1 of the following year. The proposed rule is watched closely and has great impact, because not only are Medicare fees based on the rule, but most private insurances are based on Medicare.

This year’s proposed rule, announced in early August, is extraordinary by any past standard. It can be found here.

It cuts the conversion factor (which is what the work, practice expense, and malpractice values are multiplied by to get a payment) by 10.6%, from $36.09 to $32.26. This is necessary to maintain “budget neutrality” since there is a fixed pool of money, and payments for cognitive services are increasing. The overall effect on dermatology is a 2% cut, which is mild, compared with other specialties, such as nurse anesthetists and radiologists, both with an 11% decrease; chiropractors, with a 10% decrease; and interventional radiology, pathology, physical and occupational therapy, and cardiac surgery, all with a 9% decrease. General surgery will see a 7% decrease. Those with major increases are endocrinology, with a 17% increase; rheumatology, with a 16% increase; and hematology/oncology, with a 14% increase.

The overall push by CMS (and the relative value update committee) is to improve the pay for cognitive services, that is evaluation and management (E/M) services. Since dermatology also provides such services, the effect of the proposed rule will vary dramatically depending on your case mix. I must also point out that, since existing overhead is relatively fixed, say at 50%, a 10% decrease in revenue may translate into a 20% loss in physician income.


 

The good

Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. For dermatology, any visit where a decision to do a minor procedure or prescribe a medication takes place will become a level 4 visit. Most of the useless documentation requirements and need to examine multiple organ systems will be eliminated. The most common E/M code currently used by dermatologists is a level 3, and this will on average move up to a level 4. Thus, general dermatology will benefit from the new rule. For example, if a dermatologist sees a patient and does a tangential biopsy of the skin, the payment will be $214.52, compared with $178.65 in 2020.

The bad

As mentioned above, the impact will vary by case mix. Those doing a lot of surgery will see a much larger cut. Mohs surgeons, for example will see about a 6.5% decrease.¹

Aggravating the cuts to surgery is the fact that, while CMS has bolstered the pay for E/M stand-alone codes, they did not increase the reimbursement level of the built-in follow-up visits inside the 10- and 90-day global periods.

The ugly

Procedure codes with a lot of practice expense built into them, such as Mohs and reconstruction, are not hit as hard by the conversion factor cut because the practice expense is generally spared. There is much less practice expense in a pathology code so dermatopathology faces the most severe cuts. Pathology and other specialties that do not generally bill office/outpatient E/M codes are estimated to see the greatest decrease in payment in 2021.

Code 88305, the most common dermatopathology code, will decrease overall from $71.46 to $66.78 (–6.5%). Digging a little deeper, we find that the technical charge (the payment to process and make the slide) actually increases from $32.12 to $32.26, but the professional component (the interpretation of the slide and report generation) decreases from $39.34 to $34.52 (–12.3%).

I must also point out that this proposed rule allows for nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs), and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians. I wonder if we will see an increase in billing of dermatopathology by the untrained.

Adding more confusion – and an additional hit to hospital-based practices – is the federal appeals court decision affirming the ability of the Centers for Medicare & Medicaid Services to mandate site-neutral payments for E/M codes. This means that hospital-affiliated practices, which used to enjoy payment of up to 114% more than offices, will be paid the same as offices. This will save CMS $300 million, but these savings will not be flowing back into the physician fee schedule.

Fixing this will require congressional action since CMS is bound by law to maintain budget neutrality. The specialty societies saw this coming and have already been lobbying furiously to waive budget neutrality requirements, especially in this time of a pandemic that has had an adverse impact on physicians. This is noted in detail on the AADA website, accessible to AAD members.

Since this will take a legislative fix, you should contact your congressional representative or senator and ask them to enact legislation to waive Medicare’s budget neutrality requirements to apply the increased E/M adjustment to all 10- and 90-day global code values. You might also inquire where the $300 million saved by site neutral payment reform will go, and suggest applying it towards restoring the conversion factor to a more normal number.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Reference

1. Calculations and tables courtesy of Brent Moody, M.D., AAD AMA relative value update committee practice expense representative and specialist.

As most of you know, Medicare publishes its proposed rule, which determines the physician fee schedule, around July 1 each year, accepts comments for 60 days, and then publishes a final rule on or around Nov. 1, which becomes final on Jan. 1 of the following year. The proposed rule is watched closely and has great impact, because not only are Medicare fees based on the rule, but most private insurances are based on Medicare.

This year’s proposed rule, announced in early August, is extraordinary by any past standard. It can be found here.

It cuts the conversion factor (which is what the work, practice expense, and malpractice values are multiplied by to get a payment) by 10.6%, from $36.09 to $32.26. This is necessary to maintain “budget neutrality” since there is a fixed pool of money, and payments for cognitive services are increasing. The overall effect on dermatology is a 2% cut, which is mild, compared with other specialties, such as nurse anesthetists and radiologists, both with an 11% decrease; chiropractors, with a 10% decrease; and interventional radiology, pathology, physical and occupational therapy, and cardiac surgery, all with a 9% decrease. General surgery will see a 7% decrease. Those with major increases are endocrinology, with a 17% increase; rheumatology, with a 16% increase; and hematology/oncology, with a 14% increase.

The overall push by CMS (and the relative value update committee) is to improve the pay for cognitive services, that is evaluation and management (E/M) services. Since dermatology also provides such services, the effect of the proposed rule will vary dramatically depending on your case mix. I must also point out that, since existing overhead is relatively fixed, say at 50%, a 10% decrease in revenue may translate into a 20% loss in physician income.


 

The good

Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. For dermatology, any visit where a decision to do a minor procedure or prescribe a medication takes place will become a level 4 visit. Most of the useless documentation requirements and need to examine multiple organ systems will be eliminated. The most common E/M code currently used by dermatologists is a level 3, and this will on average move up to a level 4. Thus, general dermatology will benefit from the new rule. For example, if a dermatologist sees a patient and does a tangential biopsy of the skin, the payment will be $214.52, compared with $178.65 in 2020.

The bad

As mentioned above, the impact will vary by case mix. Those doing a lot of surgery will see a much larger cut. Mohs surgeons, for example will see about a 6.5% decrease.¹

Aggravating the cuts to surgery is the fact that, while CMS has bolstered the pay for E/M stand-alone codes, they did not increase the reimbursement level of the built-in follow-up visits inside the 10- and 90-day global periods.

The ugly

Procedure codes with a lot of practice expense built into them, such as Mohs and reconstruction, are not hit as hard by the conversion factor cut because the practice expense is generally spared. There is much less practice expense in a pathology code so dermatopathology faces the most severe cuts. Pathology and other specialties that do not generally bill office/outpatient E/M codes are estimated to see the greatest decrease in payment in 2021.

Code 88305, the most common dermatopathology code, will decrease overall from $71.46 to $66.78 (–6.5%). Digging a little deeper, we find that the technical charge (the payment to process and make the slide) actually increases from $32.12 to $32.26, but the professional component (the interpretation of the slide and report generation) decreases from $39.34 to $34.52 (–12.3%).

I must also point out that this proposed rule allows for nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs), and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians. I wonder if we will see an increase in billing of dermatopathology by the untrained.

Adding more confusion – and an additional hit to hospital-based practices – is the federal appeals court decision affirming the ability of the Centers for Medicare & Medicaid Services to mandate site-neutral payments for E/M codes. This means that hospital-affiliated practices, which used to enjoy payment of up to 114% more than offices, will be paid the same as offices. This will save CMS $300 million, but these savings will not be flowing back into the physician fee schedule.

Fixing this will require congressional action since CMS is bound by law to maintain budget neutrality. The specialty societies saw this coming and have already been lobbying furiously to waive budget neutrality requirements, especially in this time of a pandemic that has had an adverse impact on physicians. This is noted in detail on the AADA website, accessible to AAD members.

Since this will take a legislative fix, you should contact your congressional representative or senator and ask them to enact legislation to waive Medicare’s budget neutrality requirements to apply the increased E/M adjustment to all 10- and 90-day global code values. You might also inquire where the $300 million saved by site neutral payment reform will go, and suggest applying it towards restoring the conversion factor to a more normal number.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Reference

1. Calculations and tables courtesy of Brent Moody, M.D., AAD AMA relative value update committee practice expense representative and specialist.

As most of you know, Medicare publishes its proposed rule, which determines the physician fee schedule, around July 1 each year, accepts comments for 60 days, and then publishes a final rule on or around Nov. 1, which becomes final on Jan. 1 of the following year. The proposed rule is watched closely and has great impact, because not only are Medicare fees based on the rule, but most private insurances are based on Medicare.

This year’s proposed rule, announced in early August, is extraordinary by any past standard. It can be found here.

It cuts the conversion factor (which is what the work, practice expense, and malpractice values are multiplied by to get a payment) by 10.6%, from $36.09 to $32.26. This is necessary to maintain “budget neutrality” since there is a fixed pool of money, and payments for cognitive services are increasing. The overall effect on dermatology is a 2% cut, which is mild, compared with other specialties, such as nurse anesthetists and radiologists, both with an 11% decrease; chiropractors, with a 10% decrease; and interventional radiology, pathology, physical and occupational therapy, and cardiac surgery, all with a 9% decrease. General surgery will see a 7% decrease. Those with major increases are endocrinology, with a 17% increase; rheumatology, with a 16% increase; and hematology/oncology, with a 14% increase.

The overall push by CMS (and the relative value update committee) is to improve the pay for cognitive services, that is evaluation and management (E/M) services. Since dermatology also provides such services, the effect of the proposed rule will vary dramatically depending on your case mix. I must also point out that, since existing overhead is relatively fixed, say at 50%, a 10% decrease in revenue may translate into a 20% loss in physician income.


 

The good

Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. For dermatology, any visit where a decision to do a minor procedure or prescribe a medication takes place will become a level 4 visit. Most of the useless documentation requirements and need to examine multiple organ systems will be eliminated. The most common E/M code currently used by dermatologists is a level 3, and this will on average move up to a level 4. Thus, general dermatology will benefit from the new rule. For example, if a dermatologist sees a patient and does a tangential biopsy of the skin, the payment will be $214.52, compared with $178.65 in 2020.

The bad

As mentioned above, the impact will vary by case mix. Those doing a lot of surgery will see a much larger cut. Mohs surgeons, for example will see about a 6.5% decrease.¹

Aggravating the cuts to surgery is the fact that, while CMS has bolstered the pay for E/M stand-alone codes, they did not increase the reimbursement level of the built-in follow-up visits inside the 10- and 90-day global periods.

The ugly

Procedure codes with a lot of practice expense built into them, such as Mohs and reconstruction, are not hit as hard by the conversion factor cut because the practice expense is generally spared. There is much less practice expense in a pathology code so dermatopathology faces the most severe cuts. Pathology and other specialties that do not generally bill office/outpatient E/M codes are estimated to see the greatest decrease in payment in 2021.

Code 88305, the most common dermatopathology code, will decrease overall from $71.46 to $66.78 (–6.5%). Digging a little deeper, we find that the technical charge (the payment to process and make the slide) actually increases from $32.12 to $32.26, but the professional component (the interpretation of the slide and report generation) decreases from $39.34 to $34.52 (–12.3%).

I must also point out that this proposed rule allows for nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs), and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians. I wonder if we will see an increase in billing of dermatopathology by the untrained.

Adding more confusion – and an additional hit to hospital-based practices – is the federal appeals court decision affirming the ability of the Centers for Medicare & Medicaid Services to mandate site-neutral payments for E/M codes. This means that hospital-affiliated practices, which used to enjoy payment of up to 114% more than offices, will be paid the same as offices. This will save CMS $300 million, but these savings will not be flowing back into the physician fee schedule.

Fixing this will require congressional action since CMS is bound by law to maintain budget neutrality. The specialty societies saw this coming and have already been lobbying furiously to waive budget neutrality requirements, especially in this time of a pandemic that has had an adverse impact on physicians. This is noted in detail on the AADA website, accessible to AAD members.

Since this will take a legislative fix, you should contact your congressional representative or senator and ask them to enact legislation to waive Medicare’s budget neutrality requirements to apply the increased E/M adjustment to all 10- and 90-day global code values. You might also inquire where the $300 million saved by site neutral payment reform will go, and suggest applying it towards restoring the conversion factor to a more normal number.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Reference

1. Calculations and tables courtesy of Brent Moody, M.D., AAD AMA relative value update committee practice expense representative and specialist.

Let us begin with a thought exercise. Close your eyes and picture the word, “hero.” What comes to mind? A relative, a teacher, a fictional character wielding a hammer or flying gracefully through the air?

© Maridav / iStockphoto.com

Several months ago, our country was introduced to a foe that brought us to our knees. Before that time, the idea of a hero had fluctuated with circumstance and had been guided by aging and maturity; however, since the moment COVID-19 struck, a new image has emerged. Not all heroes wear capes, but some wield stethoscopes.

Over these past months the phrase, “Health Care Heroes” has spread throughout our collective consciousness, highlighted everywhere from talk shows and news media to billboards and journals. Doctors, nurses, and other health care professionals are lauded for their strength, dedication, resilience, and compassion. Citizens line up to clap, honk horns, and shower praise in recognition of those who have risked their health, sacrificed their personal lives, and committed themselves to the greater good. Yet, what does it mean to be a hero, and what is the cost of hero worship?

The focus of medical training has gradually shifted to include the physical as well as mental well-being of future physicians, but the remnants of traditional doctrine linger. Hours of focused training through study and direct clinical interaction reinforce dedication to patient care. Rewards are given for time spent and compassion lent, and research is lauded, but family time is rarely applauded. We are encouraged to do our greatest, work our hardest, be the best, rise and defeat every test. Failure (or the perception thereof) is not an option.

According to Rikinkumar S. Patel, MD, MPH, and associates, physicians have nearly twice the burnout rate of other professionals (Behav Sci. [Basel]. 2018 Nov;8[11]:98). The dedication to our craft propels excellence as well as sacrifice. When COVID-19 entered our lives, many of my colleagues did not hesitate to heed to the call for action. They immersed themselves in the ICU, led triage units, and extended work hours in the service of the sick and dying. Several were years removed from emergency/intensive care, while others were allocated from their chosen residency programs and voluntarily thrust into an environment they had never before traversed.

These individuals are praised as “brave,” “dedicated,” “selfless.” A few even provided insight into their experiences through various publications highlighting their appreciation and gratitude toward such a treacherous, albeit, tremendous experience. Even though their words are an honest perspective of life through one of the worst health care crises in 100 years, in effect, they perpetuate the noble hero; the myth of the super doctor.

In a profession that has borne witness to multiple suicides over the past few months, why do we not encourage open dialogue of our victories as well as our defeats? Our wins as much as our losses? Why does an esteemed veteran physician feel guilt over declining to provide emergency services to patients whom they have long forgotten how to manage? What drives the guilt and the self-doubt? Are we ashamed of what others will think? Is it that the fear of not living up to our cherished medical oath outweighs our own boundaries and acknowledgment of our limitations?

A hero is an entity, a person encompassing a state of being, yet health care professionals are bestowed this title and this burden on a near-daily basis. Physicians are people. We love, we fear, we hesitate, we fight, we deem to overcome. We are perfectly imperfect. The more in tune we are to vulnerability, the more honest we can become with ourselves and one another.
 

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

Let us begin with a thought exercise. Close your eyes and picture the word, “hero.” What comes to mind? A relative, a teacher, a fictional character wielding a hammer or flying gracefully through the air?

© Maridav / iStockphoto.com

Several months ago, our country was introduced to a foe that brought us to our knees. Before that time, the idea of a hero had fluctuated with circumstance and had been guided by aging and maturity; however, since the moment COVID-19 struck, a new image has emerged. Not all heroes wear capes, but some wield stethoscopes.

Over these past months the phrase, “Health Care Heroes” has spread throughout our collective consciousness, highlighted everywhere from talk shows and news media to billboards and journals. Doctors, nurses, and other health care professionals are lauded for their strength, dedication, resilience, and compassion. Citizens line up to clap, honk horns, and shower praise in recognition of those who have risked their health, sacrificed their personal lives, and committed themselves to the greater good. Yet, what does it mean to be a hero, and what is the cost of hero worship?

The focus of medical training has gradually shifted to include the physical as well as mental well-being of future physicians, but the remnants of traditional doctrine linger. Hours of focused training through study and direct clinical interaction reinforce dedication to patient care. Rewards are given for time spent and compassion lent, and research is lauded, but family time is rarely applauded. We are encouraged to do our greatest, work our hardest, be the best, rise and defeat every test. Failure (or the perception thereof) is not an option.

According to Rikinkumar S. Patel, MD, MPH, and associates, physicians have nearly twice the burnout rate of other professionals (Behav Sci. [Basel]. 2018 Nov;8[11]:98). The dedication to our craft propels excellence as well as sacrifice. When COVID-19 entered our lives, many of my colleagues did not hesitate to heed to the call for action. They immersed themselves in the ICU, led triage units, and extended work hours in the service of the sick and dying. Several were years removed from emergency/intensive care, while others were allocated from their chosen residency programs and voluntarily thrust into an environment they had never before traversed.

These individuals are praised as “brave,” “dedicated,” “selfless.” A few even provided insight into their experiences through various publications highlighting their appreciation and gratitude toward such a treacherous, albeit, tremendous experience. Even though their words are an honest perspective of life through one of the worst health care crises in 100 years, in effect, they perpetuate the noble hero; the myth of the super doctor.

In a profession that has borne witness to multiple suicides over the past few months, why do we not encourage open dialogue of our victories as well as our defeats? Our wins as much as our losses? Why does an esteemed veteran physician feel guilt over declining to provide emergency services to patients whom they have long forgotten how to manage? What drives the guilt and the self-doubt? Are we ashamed of what others will think? Is it that the fear of not living up to our cherished medical oath outweighs our own boundaries and acknowledgment of our limitations?

A hero is an entity, a person encompassing a state of being, yet health care professionals are bestowed this title and this burden on a near-daily basis. Physicians are people. We love, we fear, we hesitate, we fight, we deem to overcome. We are perfectly imperfect. The more in tune we are to vulnerability, the more honest we can become with ourselves and one another.
 

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

Let us begin with a thought exercise. Close your eyes and picture the word, “hero.” What comes to mind? A relative, a teacher, a fictional character wielding a hammer or flying gracefully through the air?

© Maridav / iStockphoto.com

Several months ago, our country was introduced to a foe that brought us to our knees. Before that time, the idea of a hero had fluctuated with circumstance and had been guided by aging and maturity; however, since the moment COVID-19 struck, a new image has emerged. Not all heroes wear capes, but some wield stethoscopes.

Over these past months the phrase, “Health Care Heroes” has spread throughout our collective consciousness, highlighted everywhere from talk shows and news media to billboards and journals. Doctors, nurses, and other health care professionals are lauded for their strength, dedication, resilience, and compassion. Citizens line up to clap, honk horns, and shower praise in recognition of those who have risked their health, sacrificed their personal lives, and committed themselves to the greater good. Yet, what does it mean to be a hero, and what is the cost of hero worship?

The focus of medical training has gradually shifted to include the physical as well as mental well-being of future physicians, but the remnants of traditional doctrine linger. Hours of focused training through study and direct clinical interaction reinforce dedication to patient care. Rewards are given for time spent and compassion lent, and research is lauded, but family time is rarely applauded. We are encouraged to do our greatest, work our hardest, be the best, rise and defeat every test. Failure (or the perception thereof) is not an option.

According to Rikinkumar S. Patel, MD, MPH, and associates, physicians have nearly twice the burnout rate of other professionals (Behav Sci. [Basel]. 2018 Nov;8[11]:98). The dedication to our craft propels excellence as well as sacrifice. When COVID-19 entered our lives, many of my colleagues did not hesitate to heed to the call for action. They immersed themselves in the ICU, led triage units, and extended work hours in the service of the sick and dying. Several were years removed from emergency/intensive care, while others were allocated from their chosen residency programs and voluntarily thrust into an environment they had never before traversed.

These individuals are praised as “brave,” “dedicated,” “selfless.” A few even provided insight into their experiences through various publications highlighting their appreciation and gratitude toward such a treacherous, albeit, tremendous experience. Even though their words are an honest perspective of life through one of the worst health care crises in 100 years, in effect, they perpetuate the noble hero; the myth of the super doctor.

In a profession that has borne witness to multiple suicides over the past few months, why do we not encourage open dialogue of our victories as well as our defeats? Our wins as much as our losses? Why does an esteemed veteran physician feel guilt over declining to provide emergency services to patients whom they have long forgotten how to manage? What drives the guilt and the self-doubt? Are we ashamed of what others will think? Is it that the fear of not living up to our cherished medical oath outweighs our own boundaries and acknowledgment of our limitations?

A hero is an entity, a person encompassing a state of being, yet health care professionals are bestowed this title and this burden on a near-daily basis. Physicians are people. We love, we fear, we hesitate, we fight, we deem to overcome. We are perfectly imperfect. The more in tune we are to vulnerability, the more honest we can become with ourselves and one another.
 

Dr. Thomas is a board-certified adult psychiatrist with an interest in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. She has no conflicts of interest.

Every antepartum record, whether it is on paper or EMR, has a space asking whether the patient feels fetal movement at the visit. Every provider inherently knows that fetal movement is important and worth asking about at each visit. Yet the education for patients about fetal movement and when to alert a provider to changes is not currently standardized in the United States. There is no practice bulletin or guideline from the American College of Obstetricians and Gynecologists and, therefore, there is a wide variation in clinical practice. An Australian study found that 97% of women were asked about fetal movement, but only 62% reported formal education regarding fetal movement. More concerning, only 40% were advised to call immediately if concerned about fetal movement change. A quarter were told to call only if baby moved fewer than 10 times in an hour.¹

We have a standardized approach to most aspects of prenatal care. We know what to do if the patient has contractions, or protein in their urine, or an increased blood pressure. Our management and education regarding fetal movement must be standardized as well. In this article I will go through the incorrect education that often is given and the data that do not support this. Evidence in other countries indicates that appropriate, thoughtful education can reduce the stillbirth rate. We need a similar care plan or model for fetal movement education in the United States.
 

Myth one: Kick counts

When education is done, kick counts are far and away what providers and nurses advise in the clinic and hospital triage when women present with complaint of decreased fetal movement. The standard approach to this is advising the patient to perform a kick count several times per day to check in on the baby and call if less than 10 kicks per hour. This is not bad advice as it may help create awareness for the mom about what is “normal” for her baby and may help her to “check in” on the baby when she is occupied at work or with older children. However, advising that a kick count should be done to reassure a patient about a concerning change in fetal movement is not supported in the literature. A meta-analysis in the February 2020 issue of the Green Journal found that advised kick count monitoring did not significantly reduce stillbirth risk.² Research shows that most moms will get 10 kicks normally within an hour, but there are no data showing what percentage of moms with perceived decreased fetal movement also will get a “passing” result despite their concern. For example, take a patient who normally feels 50 movements in an hour and is not reassured by 10 movements in an hour, but because she is told that 10 movements is okay, she tries not to worry about the concerning change. Many mothers in the stillbirth community report “passing kick counts” in the days leading up to the diagnosis. We need to move away from kick count education to a much simpler plan. We must tell patients if they are worried about a concerning change in fetal movement, they should call their provider.

Myth 2: Fetuses slow down at the end of pregnancy

There is a very common myth that fetuses slow down at the end of pregnancy, especially once labor has started. A study in the Journal of Physiology continuously monitored term fetuses when mom was both awake and asleep. The study also looked at the effect on fetal heart rate and fetal activity based on different maternal positions. The study found the fetuses spent around 90% of the day with active movements and with reactive nonstress tests (NSTs).³ A 2019 study looking at fetal movement at term and preterm in third-trimester patients illustrated that fetal movement does not decrease in frequency or strength at term. It found that only 6% of patients noted decreased strength and 14% decreased frequency of movements at term. Furthermore, 59% reported an increase in strength, and nearly 39% reported an increase in frequency of fetal movements at term.⁴ We must educate patients that a change in frequency or strength of movements is not normal or expected, and they must call if concerned about a change.

Myth 3: Try juice, ice water, or food before coming in for evaluation

A common set of advice when a patient calls with a complaint of decreased fetal movement is to suggest a meal or something sugary, although there is little or no evidence to support this. A randomized controlled trial found maternal perception of increased fetal movement was similar among the two groups. Giving something sugary at NST also was not shown in this study to improve reactivity.⁵ Another randomized, double placebo blind study was done to answer the question of whether glucose via IV helped improve fetal movements and decreased the need for admission for induction or further monitoring. In this study, no difference in outcome is found.⁶

When a patient calls with decreased fetal movement, advice should be to come and be evaluated, not recommendation of measures like ice water, orange juice, or sugary meal because it is not supported by the literature. This incorrect message also may further the false impression that a baby who is not moving is most likely sleeping or is simply in need of sugar, not that the baby may be at risk for impending stillbirth. The Perinatal Society of Australia and New Zealand and Royal College of Obstetricians and Gynecologists have fetal movement protocol that both discourage this advice and encourage immediate evaluation of patients with complaint of concerning fetal movement change.^7,8

Myth 4: An increase in fetal movement is not of concern

I used to believe that increased fetal movement is never of concern. However, the STARS study illustrated that a concerning increase in fetal movement often is noted just before the diagnosis of stillbirth. A single episode of excessively vigorous activity which often is described as frantic or crazy is associated with an odds ratio for stillbirth of 4.3. In the study, 30% of cases reported this, compared with 7% of controls.⁹ In our practice, we manage mothers who call with this concern the same way as a decreased fetal movement complaint, and bring the mother in immediately for evaluation.

Myth 5: Patients all know that a concerning change in fetal movement is a risk factor for stillbirth

Decreased fetal movement has been associated with an increased OR for stillbirth of 4.51.¹⁰ However, patients often do not know of this association. A study in the United States of providers and stillbirth families showed fear of anxiety kept providers from talking about stillbirth and that it still happens. Because of this patients were completely surprised by the diagnosis.¹¹ We tell patients that stillbirth still happens because research by Dr Suzanne Pullen found that 77% of families said they never worried their baby could die outside of the first trimester. Our patients have received this information without increased anxiety and are very appreciative and reassured about the education and protocol (based on the U.K. Saving Babies Lives Care Bundle Version 2) that we have implemented in our practice.

Fact: Fetal movement education guidelines exist and are easy to implement

The practice I am a partner at has been using a formalized method for educating patients about fetal movement over the past year. As mentioned earlier the U.K. and Australia have formal fetal movement education and management guidelines.7,⁸ Both protocols encourage formal education around 20-24 weeks and education for the patient to call immediately with concerns; the patient should be evaluated within 2 hours of the complaint. The formal education we provide is quite simple. The Star Legacy Foundation (United States) and Still Aware (Australia) have created a simple card to educate patients.

Conclusions

When I think about the patients I have cared for who have presented with a stillborn baby, I think often that they usually presented for a complaint other than decreased fetal movement such as labor check or routine prenatal visit. When asked when they last felt fetal movement they will often say days before. This does not need to happen. Protocols in Norway for fetal movement education have shown that patients call sooner with decreased fetal movement when they have received a formal education.¹⁴

Not all stillbirth can be prevented but proper education about fetal movement and not perpetuating dangerous myths about fetal movement, may keep presentations like this from happening. I hope we may soon have a formal protocol for fetal movement education, but until then, I hope some will take these educational tips to heart.
 

Dr. Heather Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, NY. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.

References

1. Aust N Z J Obstet Gynaecol. 2012 Oct;52(5):445-9.

2. Obstet Gynecol. 2020 Feb;135(2):453-62.

3. J Physiol. 2017 Feb 15;595(4):1213-21.

4. PLOS One. 2019 Jun 12. doi: 10.1371/journal.pone.0217583.

5. J Matern Fetal Neonatal Med. 2013 Jun;26(9):915-9.

6. J Perinatol. 2016 Aug;36(8):598-600.

7. Aust N Z J Obstet Gynaecol. 2018 Aug;58(4):463-8.

8. Reduced fetal movements: Green top #57, Royal College of Obstetricians and Gynaecologists.

9. BMC Pregnancy Childb. 2017. doi: 10.1186/s12884-017-1555-6.

10. BMJ Open. 2018. doi: 10.1136/bmjopen-2017-020031.

11. BMC Pregnancy Childb. 2012. doi: 10.1186/1471-2393-12-137.

12. BMC Pregnancy Childb. 2015. doi: 10.1186/s12884-015-0602-4.

13. EClinicalMedicine. 2019 Apr. doi: 10.1016/j.eclinm.2019.03.014.

14. BMC Pregnancy Childb. 2009. doi: 10.1186/1471-2393-9-32.

Every antepartum record, whether it is on paper or EMR, has a space asking whether the patient feels fetal movement at the visit. Every provider inherently knows that fetal movement is important and worth asking about at each visit. Yet the education for patients about fetal movement and when to alert a provider to changes is not currently standardized in the United States. There is no practice bulletin or guideline from the American College of Obstetricians and Gynecologists and, therefore, there is a wide variation in clinical practice. An Australian study found that 97% of women were asked about fetal movement, but only 62% reported formal education regarding fetal movement. More concerning, only 40% were advised to call immediately if concerned about fetal movement change. A quarter were told to call only if baby moved fewer than 10 times in an hour.¹

We have a standardized approach to most aspects of prenatal care. We know what to do if the patient has contractions, or protein in their urine, or an increased blood pressure. Our management and education regarding fetal movement must be standardized as well. In this article I will go through the incorrect education that often is given and the data that do not support this. Evidence in other countries indicates that appropriate, thoughtful education can reduce the stillbirth rate. We need a similar care plan or model for fetal movement education in the United States.
 

Myth one: Kick counts

When education is done, kick counts are far and away what providers and nurses advise in the clinic and hospital triage when women present with complaint of decreased fetal movement. The standard approach to this is advising the patient to perform a kick count several times per day to check in on the baby and call if less than 10 kicks per hour. This is not bad advice as it may help create awareness for the mom about what is “normal” for her baby and may help her to “check in” on the baby when she is occupied at work or with older children. However, advising that a kick count should be done to reassure a patient about a concerning change in fetal movement is not supported in the literature. A meta-analysis in the February 2020 issue of the Green Journal found that advised kick count monitoring did not significantly reduce stillbirth risk.² Research shows that most moms will get 10 kicks normally within an hour, but there are no data showing what percentage of moms with perceived decreased fetal movement also will get a “passing” result despite their concern. For example, take a patient who normally feels 50 movements in an hour and is not reassured by 10 movements in an hour, but because she is told that 10 movements is okay, she tries not to worry about the concerning change. Many mothers in the stillbirth community report “passing kick counts” in the days leading up to the diagnosis. We need to move away from kick count education to a much simpler plan. We must tell patients if they are worried about a concerning change in fetal movement, they should call their provider.

Myth 2: Fetuses slow down at the end of pregnancy

There is a very common myth that fetuses slow down at the end of pregnancy, especially once labor has started. A study in the Journal of Physiology continuously monitored term fetuses when mom was both awake and asleep. The study also looked at the effect on fetal heart rate and fetal activity based on different maternal positions. The study found the fetuses spent around 90% of the day with active movements and with reactive nonstress tests (NSTs).³ A 2019 study looking at fetal movement at term and preterm in third-trimester patients illustrated that fetal movement does not decrease in frequency or strength at term. It found that only 6% of patients noted decreased strength and 14% decreased frequency of movements at term. Furthermore, 59% reported an increase in strength, and nearly 39% reported an increase in frequency of fetal movements at term.⁴ We must educate patients that a change in frequency or strength of movements is not normal or expected, and they must call if concerned about a change.

Myth 3: Try juice, ice water, or food before coming in for evaluation

A common set of advice when a patient calls with a complaint of decreased fetal movement is to suggest a meal or something sugary, although there is little or no evidence to support this. A randomized controlled trial found maternal perception of increased fetal movement was similar among the two groups. Giving something sugary at NST also was not shown in this study to improve reactivity.⁵ Another randomized, double placebo blind study was done to answer the question of whether glucose via IV helped improve fetal movements and decreased the need for admission for induction or further monitoring. In this study, no difference in outcome is found.⁶

When a patient calls with decreased fetal movement, advice should be to come and be evaluated, not recommendation of measures like ice water, orange juice, or sugary meal because it is not supported by the literature. This incorrect message also may further the false impression that a baby who is not moving is most likely sleeping or is simply in need of sugar, not that the baby may be at risk for impending stillbirth. The Perinatal Society of Australia and New Zealand and Royal College of Obstetricians and Gynecologists have fetal movement protocol that both discourage this advice and encourage immediate evaluation of patients with complaint of concerning fetal movement change.^7,8

Myth 4: An increase in fetal movement is not of concern

I used to believe that increased fetal movement is never of concern. However, the STARS study illustrated that a concerning increase in fetal movement often is noted just before the diagnosis of stillbirth. A single episode of excessively vigorous activity which often is described as frantic or crazy is associated with an odds ratio for stillbirth of 4.3. In the study, 30% of cases reported this, compared with 7% of controls.⁹ In our practice, we manage mothers who call with this concern the same way as a decreased fetal movement complaint, and bring the mother in immediately for evaluation.

Myth 5: Patients all know that a concerning change in fetal movement is a risk factor for stillbirth

Decreased fetal movement has been associated with an increased OR for stillbirth of 4.51.¹⁰ However, patients often do not know of this association. A study in the United States of providers and stillbirth families showed fear of anxiety kept providers from talking about stillbirth and that it still happens. Because of this patients were completely surprised by the diagnosis.¹¹ We tell patients that stillbirth still happens because research by Dr Suzanne Pullen found that 77% of families said they never worried their baby could die outside of the first trimester. Our patients have received this information without increased anxiety and are very appreciative and reassured about the education and protocol (based on the U.K. Saving Babies Lives Care Bundle Version 2) that we have implemented in our practice.

Fact: Fetal movement education guidelines exist and are easy to implement

The practice I am a partner at has been using a formalized method for educating patients about fetal movement over the past year. As mentioned earlier the U.K. and Australia have formal fetal movement education and management guidelines.7,⁸ Both protocols encourage formal education around 20-24 weeks and education for the patient to call immediately with concerns; the patient should be evaluated within 2 hours of the complaint. The formal education we provide is quite simple. The Star Legacy Foundation (United States) and Still Aware (Australia) have created a simple card to educate patients.

Conclusions

When I think about the patients I have cared for who have presented with a stillborn baby, I think often that they usually presented for a complaint other than decreased fetal movement such as labor check or routine prenatal visit. When asked when they last felt fetal movement they will often say days before. This does not need to happen. Protocols in Norway for fetal movement education have shown that patients call sooner with decreased fetal movement when they have received a formal education.¹⁴

Not all stillbirth can be prevented but proper education about fetal movement and not perpetuating dangerous myths about fetal movement, may keep presentations like this from happening. I hope we may soon have a formal protocol for fetal movement education, but until then, I hope some will take these educational tips to heart.
 

Dr. Heather Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, NY. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.

References

1. Aust N Z J Obstet Gynaecol. 2012 Oct;52(5):445-9.

2. Obstet Gynecol. 2020 Feb;135(2):453-62.

3. J Physiol. 2017 Feb 15;595(4):1213-21.

4. PLOS One. 2019 Jun 12. doi: 10.1371/journal.pone.0217583.

5. J Matern Fetal Neonatal Med. 2013 Jun;26(9):915-9.

6. J Perinatol. 2016 Aug;36(8):598-600.

7. Aust N Z J Obstet Gynaecol. 2018 Aug;58(4):463-8.

8. Reduced fetal movements: Green top #57, Royal College of Obstetricians and Gynaecologists.

9. BMC Pregnancy Childb. 2017. doi: 10.1186/s12884-017-1555-6.

10. BMJ Open. 2018. doi: 10.1136/bmjopen-2017-020031.

11. BMC Pregnancy Childb. 2012. doi: 10.1186/1471-2393-12-137.

12. BMC Pregnancy Childb. 2015. doi: 10.1186/s12884-015-0602-4.

13. EClinicalMedicine. 2019 Apr. doi: 10.1016/j.eclinm.2019.03.014.

14. BMC Pregnancy Childb. 2009. doi: 10.1186/1471-2393-9-32.

Every antepartum record, whether it is on paper or EMR, has a space asking whether the patient feels fetal movement at the visit. Every provider inherently knows that fetal movement is important and worth asking about at each visit. Yet the education for patients about fetal movement and when to alert a provider to changes is not currently standardized in the United States. There is no practice bulletin or guideline from the American College of Obstetricians and Gynecologists and, therefore, there is a wide variation in clinical practice. An Australian study found that 97% of women were asked about fetal movement, but only 62% reported formal education regarding fetal movement. More concerning, only 40% were advised to call immediately if concerned about fetal movement change. A quarter were told to call only if baby moved fewer than 10 times in an hour.¹

We have a standardized approach to most aspects of prenatal care. We know what to do if the patient has contractions, or protein in their urine, or an increased blood pressure. Our management and education regarding fetal movement must be standardized as well. In this article I will go through the incorrect education that often is given and the data that do not support this. Evidence in other countries indicates that appropriate, thoughtful education can reduce the stillbirth rate. We need a similar care plan or model for fetal movement education in the United States.
 

Myth one: Kick counts

When education is done, kick counts are far and away what providers and nurses advise in the clinic and hospital triage when women present with complaint of decreased fetal movement. The standard approach to this is advising the patient to perform a kick count several times per day to check in on the baby and call if less than 10 kicks per hour. This is not bad advice as it may help create awareness for the mom about what is “normal” for her baby and may help her to “check in” on the baby when she is occupied at work or with older children. However, advising that a kick count should be done to reassure a patient about a concerning change in fetal movement is not supported in the literature. A meta-analysis in the February 2020 issue of the Green Journal found that advised kick count monitoring did not significantly reduce stillbirth risk.² Research shows that most moms will get 10 kicks normally within an hour, but there are no data showing what percentage of moms with perceived decreased fetal movement also will get a “passing” result despite their concern. For example, take a patient who normally feels 50 movements in an hour and is not reassured by 10 movements in an hour, but because she is told that 10 movements is okay, she tries not to worry about the concerning change. Many mothers in the stillbirth community report “passing kick counts” in the days leading up to the diagnosis. We need to move away from kick count education to a much simpler plan. We must tell patients if they are worried about a concerning change in fetal movement, they should call their provider.

Myth 2: Fetuses slow down at the end of pregnancy

There is a very common myth that fetuses slow down at the end of pregnancy, especially once labor has started. A study in the Journal of Physiology continuously monitored term fetuses when mom was both awake and asleep. The study also looked at the effect on fetal heart rate and fetal activity based on different maternal positions. The study found the fetuses spent around 90% of the day with active movements and with reactive nonstress tests (NSTs).³ A 2019 study looking at fetal movement at term and preterm in third-trimester patients illustrated that fetal movement does not decrease in frequency or strength at term. It found that only 6% of patients noted decreased strength and 14% decreased frequency of movements at term. Furthermore, 59% reported an increase in strength, and nearly 39% reported an increase in frequency of fetal movements at term.⁴ We must educate patients that a change in frequency or strength of movements is not normal or expected, and they must call if concerned about a change.

Myth 3: Try juice, ice water, or food before coming in for evaluation

A common set of advice when a patient calls with a complaint of decreased fetal movement is to suggest a meal or something sugary, although there is little or no evidence to support this. A randomized controlled trial found maternal perception of increased fetal movement was similar among the two groups. Giving something sugary at NST also was not shown in this study to improve reactivity.⁵ Another randomized, double placebo blind study was done to answer the question of whether glucose via IV helped improve fetal movements and decreased the need for admission for induction or further monitoring. In this study, no difference in outcome is found.⁶

When a patient calls with decreased fetal movement, advice should be to come and be evaluated, not recommendation of measures like ice water, orange juice, or sugary meal because it is not supported by the literature. This incorrect message also may further the false impression that a baby who is not moving is most likely sleeping or is simply in need of sugar, not that the baby may be at risk for impending stillbirth. The Perinatal Society of Australia and New Zealand and Royal College of Obstetricians and Gynecologists have fetal movement protocol that both discourage this advice and encourage immediate evaluation of patients with complaint of concerning fetal movement change.^7,8

Myth 4: An increase in fetal movement is not of concern

I used to believe that increased fetal movement is never of concern. However, the STARS study illustrated that a concerning increase in fetal movement often is noted just before the diagnosis of stillbirth. A single episode of excessively vigorous activity which often is described as frantic or crazy is associated with an odds ratio for stillbirth of 4.3. In the study, 30% of cases reported this, compared with 7% of controls.⁹ In our practice, we manage mothers who call with this concern the same way as a decreased fetal movement complaint, and bring the mother in immediately for evaluation.

Myth 5: Patients all know that a concerning change in fetal movement is a risk factor for stillbirth

Decreased fetal movement has been associated with an increased OR for stillbirth of 4.51.¹⁰ However, patients often do not know of this association. A study in the United States of providers and stillbirth families showed fear of anxiety kept providers from talking about stillbirth and that it still happens. Because of this patients were completely surprised by the diagnosis.¹¹ We tell patients that stillbirth still happens because research by Dr Suzanne Pullen found that 77% of families said they never worried their baby could die outside of the first trimester. Our patients have received this information without increased anxiety and are very appreciative and reassured about the education and protocol (based on the U.K. Saving Babies Lives Care Bundle Version 2) that we have implemented in our practice.

Fact: Fetal movement education guidelines exist and are easy to implement

The practice I am a partner at has been using a formalized method for educating patients about fetal movement over the past year. As mentioned earlier the U.K. and Australia have formal fetal movement education and management guidelines.7,⁸ Both protocols encourage formal education around 20-24 weeks and education for the patient to call immediately with concerns; the patient should be evaluated within 2 hours of the complaint. The formal education we provide is quite simple. The Star Legacy Foundation (United States) and Still Aware (Australia) have created a simple card to educate patients.

Conclusions

When I think about the patients I have cared for who have presented with a stillborn baby, I think often that they usually presented for a complaint other than decreased fetal movement such as labor check or routine prenatal visit. When asked when they last felt fetal movement they will often say days before. This does not need to happen. Protocols in Norway for fetal movement education have shown that patients call sooner with decreased fetal movement when they have received a formal education.¹⁴

Not all stillbirth can be prevented but proper education about fetal movement and not perpetuating dangerous myths about fetal movement, may keep presentations like this from happening. I hope we may soon have a formal protocol for fetal movement education, but until then, I hope some will take these educational tips to heart.
 

Dr. Heather Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, NY. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures.

References

1. Aust N Z J Obstet Gynaecol. 2012 Oct;52(5):445-9.

2. Obstet Gynecol. 2020 Feb;135(2):453-62.

3. J Physiol. 2017 Feb 15;595(4):1213-21.

4. PLOS One. 2019 Jun 12. doi: 10.1371/journal.pone.0217583.

5. J Matern Fetal Neonatal Med. 2013 Jun;26(9):915-9.

6. J Perinatol. 2016 Aug;36(8):598-600.

7. Aust N Z J Obstet Gynaecol. 2018 Aug;58(4):463-8.

8. Reduced fetal movements: Green top #57, Royal College of Obstetricians and Gynaecologists.

9. BMC Pregnancy Childb. 2017. doi: 10.1186/s12884-017-1555-6.

10. BMJ Open. 2018. doi: 10.1136/bmjopen-2017-020031.

11. BMC Pregnancy Childb. 2012. doi: 10.1186/1471-2393-12-137.

12. BMC Pregnancy Childb. 2015. doi: 10.1186/s12884-015-0602-4.

13. EClinicalMedicine. 2019 Apr. doi: 10.1016/j.eclinm.2019.03.014.

14. BMC Pregnancy Childb. 2009. doi: 10.1186/1471-2393-9-32.

The Centers for Disease Control and Prevention reported recently that opioid overdose deaths will increase to a new U.S. record, and more are expected as pandemic-related overdose deaths are yet to be counted.¹

Specifically, according to the CDC, 70,980 people died from fatal overdoses in 2019,² which is record high. Experts such as Bruce A. Goldberger, PhD, fear that the 2020 numbers could rise even higher, exacerbated by the coronavirus pandemic.

Deaths from drug overdoses remain higher than the peak yearly death totals ever recorded for car accidents, guns, or AIDS. Overdose deaths have accelerated further – pushing down overall life expectancy in the United States.³ Headlines purporting to identify good news in drug death figures don’t always get below top-level data. Deaths and despair tied to drug dependence are indeed accelerating. I am concerned about these alarmingly dangerous trends.

Synthetic opioids such as fentanyl accounted for about 3,000 deaths in 2013. By 2019, they accounted for more than 37,137.⁴ In addition, 16,539 deaths involved stimulants such as methamphetamine, and 16,196 deaths involved cocaine, the most recent CDC reporting shows. Opioids continue to play a role in U.S. “deaths of despair,” or rising fatalities from drugs, suicides, and alcohol among Americans without employment, hope of job opportunities, or college degrees.⁵ As the American Medical Association has warned,⁶ more people are dying from overdoses amid the COVID-19 pandemic. Clinicians need to be aware of trends so that we can help our patients navigate these challenges.
 

Fentanyl presents dangers

Experts had predicted that the pandemic, by limiting access to treatment, rescue, or overdose services, and increasing time at home and in the neighborhood, would result in more tragedy. In addition, the shift from prescription opioids to heroin and now to fentanyl has made deaths more common.

Fentanyls – synthetic opioids – are involved in more than half of overdose deaths, and in many of the cocaine and methamphetamine-related deaths, which also are on the rise. Fentanyl is about 100 times more potent than morphine and 50 times more potent than heroin. Breathing can stop after use of just 2 mg of fentanyl, which is about as much as trace amounts of table salt. Fentanyl has replaced heroin in many cities as the pandemic changed the relative ease of importing raw drugs such as heroin.

Another important trend is that fentanyl production and distribution throughout the United States have expanded. The ease of manufacture in unregulated sectors of the Chinese and Mexican economies is difficult for U.S. authorities to curb or eliminate. The Internet promotes novel strategies for synthesizing the substance, spreading its production across many labs; suppliers use the U.S. Postal Service for distribution, and e-commerce helps to get the drug from manufacturers to U.S. consumers for fentanyl transactions.

A recent RAND report observes that, for only $10 through the postal service, suppliers can ship a 1-kg parcel from China to the United States, and private shipments cost about $100.⁷ And with large volumes of legal trade between the two countries making rigorous scrutiny of products difficult, especially given the light weight of fentanyl, suppliers find it relatively easy to hide illicit substances in licit shipments. Opioid users have made the switch to fentanyl, and have seen fentanyl added to cocaine and methamphetamine they buy on the streets.
 

OUD and buprenorphine

Fentanyl is one part of the overdose crisis. Opioid use disorder (OUD) is the other. Both need to be addressed if we are to make any progress in this epidemic of death and dependency.

The OUD crisis continues amid the pandemic – and isn’t going away.⁸ Slips, relapses, and overdoses are all too common. Medication-assisted treatment (MAT) and OUD treatment programs are essential parts of our response to overdose initiatives. After naloxone rescue, the best anti-overdose response is to get the OUD patient into treatment with MATs. Patients with OUD have continuously high risks of overdose. The best outcomes appear to be related to treatment duration of greater than 2 years. But it is common to see patients with OUDs who have been in treatment multiple times, taking MATs, dropping out, overdosing, and dying. Some have been described as treatment resistant.⁹ It is clear that treatment can work, but also that even evidence-based treatments often fail.¹⁰

A recent study compared OUD patients who continued treatment for 6-9 months to those patients who had continued MAT treatment for 15-18 months. The longer the treatment, the fewer emergencies, prescriptions, or hospitalizations.¹¹

But this study reminds us that all OUD patients, whether they are currently buprenorphine treated or not, experience overdoses and emergency department interventions. Short and longer treatment groups have a similar nonfatal overdose rate, about 6%, and went to the emergency department at a high rate, above 40%. Discontinuation of buprenorphine treatment is a major risk factor in opioid relapse, emergency department visits, and overdose. Cures are not common. Whether an OUD patient is being treated or has been treated in the past, carrying naloxone (brand name Narcan), makes sense and can save lives.
 

Methadone still considered most effective

Methadone is a synthetic opioid first studied as a treatment for OUD at Rockefeller University in New York City in the 1960s. Methadone may be the most effective treatment for OUD in promoting treatment retention for years, decreasing intravenous drug use, and decreasing deaths.¹² It has been studied and safely used in treatment programs for decades. Methadone is typically administered in a clinic, daily, and with observation. In addition, methadone patients periodically take urine drug tests, which can distinguish methadone from substances of abuse. They also receive counseling. But methadone can be prescribed and administered only in methadone clinics in the United States. It is available for prescription in primary care clinics in Great Britain, Canada, and Australia.¹³ Numerous experts have suggested passing new legislation aimed at changing how methadone can be prescribed. Allowing primary care to administer methadone, just like buprenorphine, can improve access and benefit OUD patients.¹²

Availability of Narcan is critical

A comprehensive treatment model for OUDs includes prescribing naloxone, encouraging those patients with an OUD and their loved ones to have naloxone with them, and providing MATs and appropriate therapies, such as counseling.

As described by Allison L. Pitt and colleagues at Stanford (Calif.) University,¹⁴ the United States might be on track to have up to 500,000 deaths tied to opioid overdoses that might occur over the next 5 years. They modeled the effect on overdose of a long list of interventions, but only a few had an impact. At the top of the list was naloxone availability. We need to focus on saving lives by increasing naloxone availability, improving initiation, and expanding access to MAT, and increasing psychosocial treatment to improve outcomes, increase life-years and quality-adjusted life-years, and reduce opioid-related deaths. When Ms. Pitt and colleagues looked at what would make the most impact in reducing OUD deaths, it was naloxone. Pain patients on higher doses of opioids, nonprescription opioid users, OUD patients should be given naloxone prescriptions. While many can give a Heimlich to a choking person or CPR, few have naloxone to rescue a person who has overdosed on opioids. If an overdose is suspected, it should be administered by anyone who has it, as soon as possible. Then, the person who is intervening should call 911.
 

What we can do today

At this moment, clinicians can follow the Surgeon General’s advice,¹⁵ and prescribe naloxone.

We should give naloxone to OUD patients and their families, to pain patients at dosages of greater than or equal to 50 MME. Our top priorities should be patients with comorbid pain syndromes, those being treated with benzodiazepines and sleeping medications, and patients with alcohol use disorders. This is also an important intervention for those who binge drink, and have sleep apnea, and heart and respiratory diseases.

Naloxone is available without a prescription in at least 43 states. Naloxone is available in harm reduction programs and in hospitals, and is carried by emergency medical staff, law enforcement, and EMTs. It also is available on the streets, though it does not appear to have a dollar value like opioids or even buprenorphine. Also, the availability of naloxone in pharmacies has made it easier for family members and caregivers of pain patients or those with OUD to have it to administer in an emergency.

An excellent place for MDs to start is to do more to encourage all patients with OUD to carry naloxone, for their loved ones to carry naloxone, and for their homes to have naloxone nearby in the bedroom or bathroom. It is not logical to expect a person with an OUD to rescue themselves. Current and past OUD patients, as well as their loved ones, are at high risk – and should have naloxone nearby at all times.

Naloxone reverses an opioid overdose, but it should be thought about like cardioversion or CPR rather than a treatment for an underlying disease. Increasing access to buprenorphine, buprenorphine + naloxone, and naltrexone treatment for OUDs is an important organizing principle. Initiation of MAT treatment in the emergency setting or most anywhere and any place a patient with an OUD can begin treatment is necessary. Treatment with buprenorphine or methadone reduces opioid overdose and opioid-related acute care use.¹⁶

Reducing racial disparities in OUD treatment is necessary, because buprenorphine treatment is concentrated among White patients who either use private insurance or are self-pay.¹⁷ Reducing barriers to methadone program licenses, expanding sites for distribution,¹⁸ prescribing methadone in an office setting might help. Clinicians can do a better job of explaining the risks associated with opioid prescriptions, including diversion and overdose, and the benefits of OUD treatment. So, while naloxone saves lives and is a wonder drug, it does not replace an intervention such as MAT, a counselor, a good treatment program, and a treatment plan. To reduce opioid overdoses, we must increase physician competencies in addiction medicine.
 

Dr. Gold is professor of psychiatry (adjunct) at Washington University, St. Louis. He is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. For more than 40 years, Dr. Gold has worked on developing models for understanding the effects of opioid, tobacco, cocaine, and other drugs, as well as food, on the brain and behavior. He disclosed financial ties with ADAPT Pharma and Magstim Ltd.

References

1. Kamp J. Overdose deaths rise, may reach record level, federal data show. Wall Street Journal. 2020 Jul 15.

2. 12 month–ending provisional number of drug overdose drugs. Centers for Disease Control and Prevention. 2020 Jul 5.

3. Katz J et al. In shadow of pandemic, U.S. drug overdose deaths resurge to record. New York Times. 2020 Jul 15.

4. Gold MS. The fentanyl crisis is only getting worse. Addiction Policy Forum. Updated 2020 Mar 12.

5. Gold MS. Mo Med. 2020-Mar-Apr;117(2):99-101.

6. Reports of increases in opioid-related overdoses and other concerns during the COVID-19 pandemic. American Medical Association. Issue brief. Updated 2020 Jul 20.

7. Pardo B et al. The future of fentanyl and other synthetic opioids. RAND report.

8. Gold MS. New challenges in the opioid epidemic. Addiction Policy Forum. 2020 Jun 4.

9. Patterson Silver Wolf DA and Gold MS. J Neurol Sci. 2020;411:116718.

10. Oesterle TS et al. Mayo Clin Proc. 2019;94(10):2072-86.

11. Connery HS and Weiss RD. Am J Psychiatry. 2020;177(2):104-6.

12. Kleber HD. JAMA. 2008;300(19):2303-5.

13. Samet JH et al. N Engl J Med. 2018;379(1):7-8.

14. Pitt AL et al. Am J Public Health. 2018;108(10):1394-1400.

15. U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. hhs.gov.

16. Wakeman SE et al. JAMA Netw Open. 2020;3(2):e1920622.

17. Lagisetty PA et al. JAMA Psychiatry. 2019;76(9):979-81.

18. Kleinman RA. JAMA Psychiatry. 2020 Jul 15. doi: 10.1001/jamapsychiatry.2020.1624.

The Centers for Disease Control and Prevention reported recently that opioid overdose deaths will increase to a new U.S. record, and more are expected as pandemic-related overdose deaths are yet to be counted.¹

Specifically, according to the CDC, 70,980 people died from fatal overdoses in 2019,² which is record high. Experts such as Bruce A. Goldberger, PhD, fear that the 2020 numbers could rise even higher, exacerbated by the coronavirus pandemic.

Deaths from drug overdoses remain higher than the peak yearly death totals ever recorded for car accidents, guns, or AIDS. Overdose deaths have accelerated further – pushing down overall life expectancy in the United States.³ Headlines purporting to identify good news in drug death figures don’t always get below top-level data. Deaths and despair tied to drug dependence are indeed accelerating. I am concerned about these alarmingly dangerous trends.

Synthetic opioids such as fentanyl accounted for about 3,000 deaths in 2013. By 2019, they accounted for more than 37,137.⁴ In addition, 16,539 deaths involved stimulants such as methamphetamine, and 16,196 deaths involved cocaine, the most recent CDC reporting shows. Opioids continue to play a role in U.S. “deaths of despair,” or rising fatalities from drugs, suicides, and alcohol among Americans without employment, hope of job opportunities, or college degrees.⁵ As the American Medical Association has warned,⁶ more people are dying from overdoses amid the COVID-19 pandemic. Clinicians need to be aware of trends so that we can help our patients navigate these challenges.
 

Fentanyl presents dangers

Experts had predicted that the pandemic, by limiting access to treatment, rescue, or overdose services, and increasing time at home and in the neighborhood, would result in more tragedy. In addition, the shift from prescription opioids to heroin and now to fentanyl has made deaths more common.

Fentanyls – synthetic opioids – are involved in more than half of overdose deaths, and in many of the cocaine and methamphetamine-related deaths, which also are on the rise. Fentanyl is about 100 times more potent than morphine and 50 times more potent than heroin. Breathing can stop after use of just 2 mg of fentanyl, which is about as much as trace amounts of table salt. Fentanyl has replaced heroin in many cities as the pandemic changed the relative ease of importing raw drugs such as heroin.

Another important trend is that fentanyl production and distribution throughout the United States have expanded. The ease of manufacture in unregulated sectors of the Chinese and Mexican economies is difficult for U.S. authorities to curb or eliminate. The Internet promotes novel strategies for synthesizing the substance, spreading its production across many labs; suppliers use the U.S. Postal Service for distribution, and e-commerce helps to get the drug from manufacturers to U.S. consumers for fentanyl transactions.

A recent RAND report observes that, for only $10 through the postal service, suppliers can ship a 1-kg parcel from China to the United States, and private shipments cost about $100.⁷ And with large volumes of legal trade between the two countries making rigorous scrutiny of products difficult, especially given the light weight of fentanyl, suppliers find it relatively easy to hide illicit substances in licit shipments. Opioid users have made the switch to fentanyl, and have seen fentanyl added to cocaine and methamphetamine they buy on the streets.
 

OUD and buprenorphine

Fentanyl is one part of the overdose crisis. Opioid use disorder (OUD) is the other. Both need to be addressed if we are to make any progress in this epidemic of death and dependency.

The OUD crisis continues amid the pandemic – and isn’t going away.⁸ Slips, relapses, and overdoses are all too common. Medication-assisted treatment (MAT) and OUD treatment programs are essential parts of our response to overdose initiatives. After naloxone rescue, the best anti-overdose response is to get the OUD patient into treatment with MATs. Patients with OUD have continuously high risks of overdose. The best outcomes appear to be related to treatment duration of greater than 2 years. But it is common to see patients with OUDs who have been in treatment multiple times, taking MATs, dropping out, overdosing, and dying. Some have been described as treatment resistant.⁹ It is clear that treatment can work, but also that even evidence-based treatments often fail.¹⁰

A recent study compared OUD patients who continued treatment for 6-9 months to those patients who had continued MAT treatment for 15-18 months. The longer the treatment, the fewer emergencies, prescriptions, or hospitalizations.¹¹

But this study reminds us that all OUD patients, whether they are currently buprenorphine treated or not, experience overdoses and emergency department interventions. Short and longer treatment groups have a similar nonfatal overdose rate, about 6%, and went to the emergency department at a high rate, above 40%. Discontinuation of buprenorphine treatment is a major risk factor in opioid relapse, emergency department visits, and overdose. Cures are not common. Whether an OUD patient is being treated or has been treated in the past, carrying naloxone (brand name Narcan), makes sense and can save lives.
 

Methadone still considered most effective

Methadone is a synthetic opioid first studied as a treatment for OUD at Rockefeller University in New York City in the 1960s. Methadone may be the most effective treatment for OUD in promoting treatment retention for years, decreasing intravenous drug use, and decreasing deaths.¹² It has been studied and safely used in treatment programs for decades. Methadone is typically administered in a clinic, daily, and with observation. In addition, methadone patients periodically take urine drug tests, which can distinguish methadone from substances of abuse. They also receive counseling. But methadone can be prescribed and administered only in methadone clinics in the United States. It is available for prescription in primary care clinics in Great Britain, Canada, and Australia.¹³ Numerous experts have suggested passing new legislation aimed at changing how methadone can be prescribed. Allowing primary care to administer methadone, just like buprenorphine, can improve access and benefit OUD patients.¹²

Availability of Narcan is critical

A comprehensive treatment model for OUDs includes prescribing naloxone, encouraging those patients with an OUD and their loved ones to have naloxone with them, and providing MATs and appropriate therapies, such as counseling.

As described by Allison L. Pitt and colleagues at Stanford (Calif.) University,¹⁴ the United States might be on track to have up to 500,000 deaths tied to opioid overdoses that might occur over the next 5 years. They modeled the effect on overdose of a long list of interventions, but only a few had an impact. At the top of the list was naloxone availability. We need to focus on saving lives by increasing naloxone availability, improving initiation, and expanding access to MAT, and increasing psychosocial treatment to improve outcomes, increase life-years and quality-adjusted life-years, and reduce opioid-related deaths. When Ms. Pitt and colleagues looked at what would make the most impact in reducing OUD deaths, it was naloxone. Pain patients on higher doses of opioids, nonprescription opioid users, OUD patients should be given naloxone prescriptions. While many can give a Heimlich to a choking person or CPR, few have naloxone to rescue a person who has overdosed on opioids. If an overdose is suspected, it should be administered by anyone who has it, as soon as possible. Then, the person who is intervening should call 911.
 

What we can do today

At this moment, clinicians can follow the Surgeon General’s advice,¹⁵ and prescribe naloxone.

We should give naloxone to OUD patients and their families, to pain patients at dosages of greater than or equal to 50 MME. Our top priorities should be patients with comorbid pain syndromes, those being treated with benzodiazepines and sleeping medications, and patients with alcohol use disorders. This is also an important intervention for those who binge drink, and have sleep apnea, and heart and respiratory diseases.

Naloxone is available without a prescription in at least 43 states. Naloxone is available in harm reduction programs and in hospitals, and is carried by emergency medical staff, law enforcement, and EMTs. It also is available on the streets, though it does not appear to have a dollar value like opioids or even buprenorphine. Also, the availability of naloxone in pharmacies has made it easier for family members and caregivers of pain patients or those with OUD to have it to administer in an emergency.

An excellent place for MDs to start is to do more to encourage all patients with OUD to carry naloxone, for their loved ones to carry naloxone, and for their homes to have naloxone nearby in the bedroom or bathroom. It is not logical to expect a person with an OUD to rescue themselves. Current and past OUD patients, as well as their loved ones, are at high risk – and should have naloxone nearby at all times.

Naloxone reverses an opioid overdose, but it should be thought about like cardioversion or CPR rather than a treatment for an underlying disease. Increasing access to buprenorphine, buprenorphine + naloxone, and naltrexone treatment for OUDs is an important organizing principle. Initiation of MAT treatment in the emergency setting or most anywhere and any place a patient with an OUD can begin treatment is necessary. Treatment with buprenorphine or methadone reduces opioid overdose and opioid-related acute care use.¹⁶

Reducing racial disparities in OUD treatment is necessary, because buprenorphine treatment is concentrated among White patients who either use private insurance or are self-pay.¹⁷ Reducing barriers to methadone program licenses, expanding sites for distribution,¹⁸ prescribing methadone in an office setting might help. Clinicians can do a better job of explaining the risks associated with opioid prescriptions, including diversion and overdose, and the benefits of OUD treatment. So, while naloxone saves lives and is a wonder drug, it does not replace an intervention such as MAT, a counselor, a good treatment program, and a treatment plan. To reduce opioid overdoses, we must increase physician competencies in addiction medicine.
 

Dr. Gold is professor of psychiatry (adjunct) at Washington University, St. Louis. He is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. For more than 40 years, Dr. Gold has worked on developing models for understanding the effects of opioid, tobacco, cocaine, and other drugs, as well as food, on the brain and behavior. He disclosed financial ties with ADAPT Pharma and Magstim Ltd.

References

1. Kamp J. Overdose deaths rise, may reach record level, federal data show. Wall Street Journal. 2020 Jul 15.

2. 12 month–ending provisional number of drug overdose drugs. Centers for Disease Control and Prevention. 2020 Jul 5.

3. Katz J et al. In shadow of pandemic, U.S. drug overdose deaths resurge to record. New York Times. 2020 Jul 15.

4. Gold MS. The fentanyl crisis is only getting worse. Addiction Policy Forum. Updated 2020 Mar 12.

5. Gold MS. Mo Med. 2020-Mar-Apr;117(2):99-101.

6. Reports of increases in opioid-related overdoses and other concerns during the COVID-19 pandemic. American Medical Association. Issue brief. Updated 2020 Jul 20.

7. Pardo B et al. The future of fentanyl and other synthetic opioids. RAND report.

8. Gold MS. New challenges in the opioid epidemic. Addiction Policy Forum. 2020 Jun 4.

9. Patterson Silver Wolf DA and Gold MS. J Neurol Sci. 2020;411:116718.

10. Oesterle TS et al. Mayo Clin Proc. 2019;94(10):2072-86.

11. Connery HS and Weiss RD. Am J Psychiatry. 2020;177(2):104-6.

12. Kleber HD. JAMA. 2008;300(19):2303-5.

13. Samet JH et al. N Engl J Med. 2018;379(1):7-8.

14. Pitt AL et al. Am J Public Health. 2018;108(10):1394-1400.

15. U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. hhs.gov.

16. Wakeman SE et al. JAMA Netw Open. 2020;3(2):e1920622.

17. Lagisetty PA et al. JAMA Psychiatry. 2019;76(9):979-81.

18. Kleinman RA. JAMA Psychiatry. 2020 Jul 15. doi: 10.1001/jamapsychiatry.2020.1624.

The Centers for Disease Control and Prevention reported recently that opioid overdose deaths will increase to a new U.S. record, and more are expected as pandemic-related overdose deaths are yet to be counted.¹

Specifically, according to the CDC, 70,980 people died from fatal overdoses in 2019,² which is record high. Experts such as Bruce A. Goldberger, PhD, fear that the 2020 numbers could rise even higher, exacerbated by the coronavirus pandemic.

Deaths from drug overdoses remain higher than the peak yearly death totals ever recorded for car accidents, guns, or AIDS. Overdose deaths have accelerated further – pushing down overall life expectancy in the United States.³ Headlines purporting to identify good news in drug death figures don’t always get below top-level data. Deaths and despair tied to drug dependence are indeed accelerating. I am concerned about these alarmingly dangerous trends.

Synthetic opioids such as fentanyl accounted for about 3,000 deaths in 2013. By 2019, they accounted for more than 37,137.⁴ In addition, 16,539 deaths involved stimulants such as methamphetamine, and 16,196 deaths involved cocaine, the most recent CDC reporting shows. Opioids continue to play a role in U.S. “deaths of despair,” or rising fatalities from drugs, suicides, and alcohol among Americans without employment, hope of job opportunities, or college degrees.⁵ As the American Medical Association has warned,⁶ more people are dying from overdoses amid the COVID-19 pandemic. Clinicians need to be aware of trends so that we can help our patients navigate these challenges.
 

Fentanyl presents dangers

Experts had predicted that the pandemic, by limiting access to treatment, rescue, or overdose services, and increasing time at home and in the neighborhood, would result in more tragedy. In addition, the shift from prescription opioids to heroin and now to fentanyl has made deaths more common.

Fentanyls – synthetic opioids – are involved in more than half of overdose deaths, and in many of the cocaine and methamphetamine-related deaths, which also are on the rise. Fentanyl is about 100 times more potent than morphine and 50 times more potent than heroin. Breathing can stop after use of just 2 mg of fentanyl, which is about as much as trace amounts of table salt. Fentanyl has replaced heroin in many cities as the pandemic changed the relative ease of importing raw drugs such as heroin.

Another important trend is that fentanyl production and distribution throughout the United States have expanded. The ease of manufacture in unregulated sectors of the Chinese and Mexican economies is difficult for U.S. authorities to curb or eliminate. The Internet promotes novel strategies for synthesizing the substance, spreading its production across many labs; suppliers use the U.S. Postal Service for distribution, and e-commerce helps to get the drug from manufacturers to U.S. consumers for fentanyl transactions.

A recent RAND report observes that, for only $10 through the postal service, suppliers can ship a 1-kg parcel from China to the United States, and private shipments cost about $100.⁷ And with large volumes of legal trade between the two countries making rigorous scrutiny of products difficult, especially given the light weight of fentanyl, suppliers find it relatively easy to hide illicit substances in licit shipments. Opioid users have made the switch to fentanyl, and have seen fentanyl added to cocaine and methamphetamine they buy on the streets.
 

OUD and buprenorphine

Fentanyl is one part of the overdose crisis. Opioid use disorder (OUD) is the other. Both need to be addressed if we are to make any progress in this epidemic of death and dependency.

The OUD crisis continues amid the pandemic – and isn’t going away.⁸ Slips, relapses, and overdoses are all too common. Medication-assisted treatment (MAT) and OUD treatment programs are essential parts of our response to overdose initiatives. After naloxone rescue, the best anti-overdose response is to get the OUD patient into treatment with MATs. Patients with OUD have continuously high risks of overdose. The best outcomes appear to be related to treatment duration of greater than 2 years. But it is common to see patients with OUDs who have been in treatment multiple times, taking MATs, dropping out, overdosing, and dying. Some have been described as treatment resistant.⁹ It is clear that treatment can work, but also that even evidence-based treatments often fail.¹⁰

A recent study compared OUD patients who continued treatment for 6-9 months to those patients who had continued MAT treatment for 15-18 months. The longer the treatment, the fewer emergencies, prescriptions, or hospitalizations.¹¹

But this study reminds us that all OUD patients, whether they are currently buprenorphine treated or not, experience overdoses and emergency department interventions. Short and longer treatment groups have a similar nonfatal overdose rate, about 6%, and went to the emergency department at a high rate, above 40%. Discontinuation of buprenorphine treatment is a major risk factor in opioid relapse, emergency department visits, and overdose. Cures are not common. Whether an OUD patient is being treated or has been treated in the past, carrying naloxone (brand name Narcan), makes sense and can save lives.
 

Methadone still considered most effective

Methadone is a synthetic opioid first studied as a treatment for OUD at Rockefeller University in New York City in the 1960s. Methadone may be the most effective treatment for OUD in promoting treatment retention for years, decreasing intravenous drug use, and decreasing deaths.¹² It has been studied and safely used in treatment programs for decades. Methadone is typically administered in a clinic, daily, and with observation. In addition, methadone patients periodically take urine drug tests, which can distinguish methadone from substances of abuse. They also receive counseling. But methadone can be prescribed and administered only in methadone clinics in the United States. It is available for prescription in primary care clinics in Great Britain, Canada, and Australia.¹³ Numerous experts have suggested passing new legislation aimed at changing how methadone can be prescribed. Allowing primary care to administer methadone, just like buprenorphine, can improve access and benefit OUD patients.¹²

Availability of Narcan is critical

A comprehensive treatment model for OUDs includes prescribing naloxone, encouraging those patients with an OUD and their loved ones to have naloxone with them, and providing MATs and appropriate therapies, such as counseling.

As described by Allison L. Pitt and colleagues at Stanford (Calif.) University,¹⁴ the United States might be on track to have up to 500,000 deaths tied to opioid overdoses that might occur over the next 5 years. They modeled the effect on overdose of a long list of interventions, but only a few had an impact. At the top of the list was naloxone availability. We need to focus on saving lives by increasing naloxone availability, improving initiation, and expanding access to MAT, and increasing psychosocial treatment to improve outcomes, increase life-years and quality-adjusted life-years, and reduce opioid-related deaths. When Ms. Pitt and colleagues looked at what would make the most impact in reducing OUD deaths, it was naloxone. Pain patients on higher doses of opioids, nonprescription opioid users, OUD patients should be given naloxone prescriptions. While many can give a Heimlich to a choking person or CPR, few have naloxone to rescue a person who has overdosed on opioids. If an overdose is suspected, it should be administered by anyone who has it, as soon as possible. Then, the person who is intervening should call 911.
 

What we can do today

At this moment, clinicians can follow the Surgeon General’s advice,¹⁵ and prescribe naloxone.

We should give naloxone to OUD patients and their families, to pain patients at dosages of greater than or equal to 50 MME. Our top priorities should be patients with comorbid pain syndromes, those being treated with benzodiazepines and sleeping medications, and patients with alcohol use disorders. This is also an important intervention for those who binge drink, and have sleep apnea, and heart and respiratory diseases.

Naloxone is available without a prescription in at least 43 states. Naloxone is available in harm reduction programs and in hospitals, and is carried by emergency medical staff, law enforcement, and EMTs. It also is available on the streets, though it does not appear to have a dollar value like opioids or even buprenorphine. Also, the availability of naloxone in pharmacies has made it easier for family members and caregivers of pain patients or those with OUD to have it to administer in an emergency.

An excellent place for MDs to start is to do more to encourage all patients with OUD to carry naloxone, for their loved ones to carry naloxone, and for their homes to have naloxone nearby in the bedroom or bathroom. It is not logical to expect a person with an OUD to rescue themselves. Current and past OUD patients, as well as their loved ones, are at high risk – and should have naloxone nearby at all times.

Naloxone reverses an opioid overdose, but it should be thought about like cardioversion or CPR rather than a treatment for an underlying disease. Increasing access to buprenorphine, buprenorphine + naloxone, and naltrexone treatment for OUDs is an important organizing principle. Initiation of MAT treatment in the emergency setting or most anywhere and any place a patient with an OUD can begin treatment is necessary. Treatment with buprenorphine or methadone reduces opioid overdose and opioid-related acute care use.¹⁶

Reducing racial disparities in OUD treatment is necessary, because buprenorphine treatment is concentrated among White patients who either use private insurance or are self-pay.¹⁷ Reducing barriers to methadone program licenses, expanding sites for distribution,¹⁸ prescribing methadone in an office setting might help. Clinicians can do a better job of explaining the risks associated with opioid prescriptions, including diversion and overdose, and the benefits of OUD treatment. So, while naloxone saves lives and is a wonder drug, it does not replace an intervention such as MAT, a counselor, a good treatment program, and a treatment plan. To reduce opioid overdoses, we must increase physician competencies in addiction medicine.
 

Dr. Gold is professor of psychiatry (adjunct) at Washington University, St. Louis. He is the 17th Distinguished Alumni Professor at the University of Florida, Gainesville. For more than 40 years, Dr. Gold has worked on developing models for understanding the effects of opioid, tobacco, cocaine, and other drugs, as well as food, on the brain and behavior. He disclosed financial ties with ADAPT Pharma and Magstim Ltd.

References

1. Kamp J. Overdose deaths rise, may reach record level, federal data show. Wall Street Journal. 2020 Jul 15.

2. 12 month–ending provisional number of drug overdose drugs. Centers for Disease Control and Prevention. 2020 Jul 5.

3. Katz J et al. In shadow of pandemic, U.S. drug overdose deaths resurge to record. New York Times. 2020 Jul 15.

4. Gold MS. The fentanyl crisis is only getting worse. Addiction Policy Forum. Updated 2020 Mar 12.

5. Gold MS. Mo Med. 2020-Mar-Apr;117(2):99-101.

6. Reports of increases in opioid-related overdoses and other concerns during the COVID-19 pandemic. American Medical Association. Issue brief. Updated 2020 Jul 20.

7. Pardo B et al. The future of fentanyl and other synthetic opioids. RAND report.

8. Gold MS. New challenges in the opioid epidemic. Addiction Policy Forum. 2020 Jun 4.

9. Patterson Silver Wolf DA and Gold MS. J Neurol Sci. 2020;411:116718.

10. Oesterle TS et al. Mayo Clin Proc. 2019;94(10):2072-86.

11. Connery HS and Weiss RD. Am J Psychiatry. 2020;177(2):104-6.

12. Kleber HD. JAMA. 2008;300(19):2303-5.

13. Samet JH et al. N Engl J Med. 2018;379(1):7-8.

14. Pitt AL et al. Am J Public Health. 2018;108(10):1394-1400.

15. U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. hhs.gov.

16. Wakeman SE et al. JAMA Netw Open. 2020;3(2):e1920622.

17. Lagisetty PA et al. JAMA Psychiatry. 2019;76(9):979-81.

18. Kleinman RA. JAMA Psychiatry. 2020 Jul 15. doi: 10.1001/jamapsychiatry.2020.1624.

August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.

FatCamera/Getty Images

In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.

We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order to avert another public health crisis, we need action as well as awareness to catch up with childhood immunizations, and that is going to take more than a single month.
 

Identify patients who’ve missed vaccinations

Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.

Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
 

Get some inspiration to talk about vaccination

Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.

The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
 

Educate young children about vaccines

Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
 

Consider vaccination advocacy in your communities

Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
 

How are we doing?

Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.

Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.

FatCamera/Getty Images

In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.

We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order to avert another public health crisis, we need action as well as awareness to catch up with childhood immunizations, and that is going to take more than a single month.
 

Identify patients who’ve missed vaccinations

Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.

Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
 

Get some inspiration to talk about vaccination

Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.

The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
 

Educate young children about vaccines

Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
 

Consider vaccination advocacy in your communities

Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
 

How are we doing?

Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.

Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.

FatCamera/Getty Images

In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.

We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order to avert another public health crisis, we need action as well as awareness to catch up with childhood immunizations, and that is going to take more than a single month.
 

Identify patients who’ve missed vaccinations

Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.

Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
 

Get some inspiration to talk about vaccination

Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.

The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
 

Educate young children about vaccines

Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
 

Consider vaccination advocacy in your communities

Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
 

How are we doing?

Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.

Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.