MDedge Psychiatry

TOPLINE:

Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.

METHODOLOGY:

• This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
• The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.

TAKEAWAY:

• Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
• Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
• Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
• Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.

IN PRACTICE:

“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.

SOURCE:

The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.

LIMITATIONS:

The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.

DISCLOSURES:

The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.

Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.

METHODOLOGY:

• This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
• The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.

TAKEAWAY:

• Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
• Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
• Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
• Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.

IN PRACTICE:

“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.

SOURCE:

The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.

LIMITATIONS:

The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.

DISCLOSURES:

The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.

Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Light therapy leads to significant improvement in several sleep measures and helps alleviate depression and agitation in patients with Alzheimer’s disease (AD), a meta-analysis of 15 high-quality trials shows.

METHODOLOGY:

• This meta-analysis included 15 randomized controlled trials involving 598 patients with mild to moderate AD.
• The included trials were written in English, published between 2005 and 2022, and performed in seven countries. A fixed-effects model was used for data analysis.

TAKEAWAY:

• Light therapy significantly improved sleep efficiency (mean difference [MD], −2.42; P < .00001), increased interdaily stability (MD, −0.04; P < .00001), and reduced intradaily variability (MD, −0.04; P < .00001), indicating better sleep quality.
• Light therapy reduced agitation (MD, −3.97; P < .00001), depression (MD, −2.55; P < .00001), and caregiver burden (MD, −3.57; P < .00001).
• Light therapy also had a significant advantage over usual care in reducing the severity of psychobehavioral symptoms as assessed by the Neuropsychiatric Inventory (MD, −3.07; P < .00001).
• Light therapy had no statistically significant effect on improving cognitive function as measured by the Mini-Mental State Examination.

IN PRACTICE:

“These findings, combined with its low side-effects, suggest the role of light therapy as a promising treatment for AD. Although light therapy has fewer side effects than pharmacological treatment, adverse behavioral outcomes in patients due to bright light exposure should be considered,” the authors wrote.

SOURCE:

The study by Lili Zang and colleagues from Weifang Medical University School of Nursing, Shandong Province, China, was published online on December 6, 2023, in PLOS One.

LIMITATIONS:

The types and degrees of dementia in the included studies were inconsistent, potentially affecting the outcome indicators. Some articles did not clearly describe their randomization and allocation concealment methods, indicating possible bias in these studies.

DISCLOSURES:

The study was supported by the Natural Science Foundation of Shandong Province, China. The authors declared no competing interests.

Megan Brooks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Depression, constipation, cystitis/urinary tract infections (UTIs), and sexual dysfunction may be early warning signs of multiple sclerosis (MS) 5 years prior to diagnosis, new research shows.

However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.

“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
 

Retracing MS Origins

The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.

Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.

Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.

After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:

• Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
• Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
• Constipation (OR, 1.5; 95% CI, 1.27-1.78)
• Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
• UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)

However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.

“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.

“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.

A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.

It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
 

Preventing Disease Evolution

In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.

“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.

“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.

The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.

A version of this article appeared on Medscape.com.

Depression, constipation, cystitis/urinary tract infections (UTIs), and sexual dysfunction may be early warning signs of multiple sclerosis (MS) 5 years prior to diagnosis, new research shows.

However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.

“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
 

Retracing MS Origins

The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.

Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.

Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.

After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:

• Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
• Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
• Constipation (OR, 1.5; 95% CI, 1.27-1.78)
• Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
• UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)

However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.

“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.

“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.

A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.

It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
 

Preventing Disease Evolution

In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.

“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.

“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.

The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.

A version of this article appeared on Medscape.com.

Depression, constipation, cystitis/urinary tract infections (UTIs), and sexual dysfunction may be early warning signs of multiple sclerosis (MS) 5 years prior to diagnosis, new research shows.

However, these prodromal symptoms are also more likely to occur in people with two other autoimmune diseases — lupus and Crohn’s disease — and therefore, will not help earlier diagnosis, study investigator, Céline Louapre, professor of neurology, Sorbonne University and Paris Brain Institute, Paris, France, said in an interview.

“On the other hand, in certain patients who may be at particular risk of developing MS, such as in certain familial forms or in patients with incidental inflammatory lesions discovered on MRI, the presence of these symptoms could suggest an already active process, prior to the first typical symptoms of the disease,” she noted.
 

Retracing MS Origins

The case-control study, published online in Neurology, included 20,174 people with newly diagnosed MS who were matched to 54,790 without MS, as well as 30,477 with Crohn’s disease and 7337 with lupus.

Using International Classification of Diseases, 10th revision (ICD-10) codes in electronic health records, the researchers assessed the associations between 113 diseases and symptoms in the 5 years before and after an MS diagnosis.

Twelve ICD-10 codes were significantly positively associated with the risk for MS compared with controls without MS.

After considering ICD-10 codes suggestive of neurologic symptoms as the first diagnosis of MS, the following five ICD-10 codes remained significantly associated with MS:

• Depression (odds ratio [OR], 1.22; 95% CI, 1.11-1.34)
• Sexual dysfunction (OR, 1.47; 95% CI, 1.11-1.95)
• Constipation (OR, 1.5; 95% CI, 1.27-1.78)
• Cystitis (OR, 1.21; 95% CI, 1.05-1.39)
• UTIs of unspecified site (OR, 1.38; 95% CI, 1.18-1.61)

However, none of these conditions was selectively associated with MS in comparison with both lupus and Crohn’s disease. All five ICD-10 codes identified were still associated with MS during the 5 years after diagnosis.

“The importance of investigating prodromal signs in MS is that it allows us to retrace the origins of the disease,” said Dr. Louapre.

“The main contribution of the data on prodromes in MS is to clarify that the disease and its mechanisms are frequently underway well before the first typical neurological symptoms, and that the causes of MS are probably present many years before diagnosis,” she added.

A limitation of the study was that data were not available for other factors that could influence people’s risk of developing MS, such as education level, ethnicity, body mass index, socioeconomic status, or genetic information.

It also remains unclear whether the conditions linked to MS are risk factors for the disease or nonspecific early MS symptoms.
 

Preventing Disease Evolution

In a linked editorial, Ruth Ann Marrie, MD, PhD, with the University of Manitoba, Manitoba, Canada, and Raffaele Palladino, MD, PhD, with the University of Naples Federico II, Naples, Italy, note these findings highlight the challenges of accurately identifying the prodromal stage of a specific disease.

“Commonalities of prodromal features are recognized across neurodegenerative diseases; this is also true for immune-mediated diseases, and it is not surprising, given shared etiologic factors and pathobiological mechanisms,” they point out.

“This suggests that we should be trying to link prodromal features to specific underlying pathobiological changes rather than specific diseases. This approach would require use of different study designs, including broad, deeply phenotyped cohorts, but would allow us to develop and test interventions targeted at those mechanisms, and could ultimately achieve the goal of preventing disease evolution,” they add.

The study was supported by the French National Research Agency. Dr. Louapre has received consulting or travel fees from Biogen, Novartis, Roche, Sanofi, Teva, and Merck Serono, unrelated to this study. Dr. Marrie is a coinvestigator on studies receiving funding from Biogen Idec and Roche Canada; receives research funding from CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Foundation, Crohn’s and Colitis Canada, National Multiple Sclerosis Society, CMSC, the Arthritis Society and the US Department of Defense; and serves on the editorial board of Neurology. Dr. Palladino has taken part in advisory boards/consultancy for MSD and Sanofi and has received support from the UK MS Society.

A version of this article appeared on Medscape.com.

UnitedHealth Group, the parent company of the nation’s largest private insurer, UnitedHealthcare (UHC), is now affiliated with or employs approximately 10% of the US physician workforce, raising anti-trust and noncompete concerns as more payers and private equity firms pursue medical practice acquisitions.

The company added 20,000 physicians in the last year alone, including a previously physician-owned multispecialty group practice of 400 doctors in New York. They join the growing web of doctors — about 90,000 of the 950,000 active US physicians — working for the UnitedHealth Group subsidiary, Optum Health, providing primary, specialty, urgent, and surgical care. Amar Desai, MD, chief executive officer of Optum Health, shared the updated workforce numbers during the health care conglomerate’s annual investor conference.

Health care mergers and consolidations have become more common as physician groups struggle to stay afloat amid dwindling payer reimbursements. Although private equity and health systems often acquire practices, payers like UHC are increasingly doing so as part of their model to advance value-based care. 

Yashaswini Singh, PhD, health care economist and assistant professor of health services, policy, and practice at Brown University, says such moves mirror the broader trend in corporate consolidation of physician practices. She said in an interview that the integrated models could possibly enhance care coordination and improve outcomes, but the impact of payer-led consolidation has not been extensively studied. 

Meanwhile, evidence considering private equity ownership is just emerging. In a 2022 study published in JAMA Health Forum, with Dr. Singh as lead author, findings showed that private equity involvement increased healthcare spending through higher prices and utilization. 

Consolidation can also raise anti-trust concerns. “If payers incentivize referral patterns of their employed physicians to favor other physicians employed by the payer, it can reduce competition by restricting consumer choice,” said Dr. Singh. 

A potential merger between Cigna and Humana that could happen by the end of the year will likely face intense scrutiny as it would create a company that rivals the size of UnitedHealth Group or CVS Health. If it goes through, the duo could streamline its insurance offerings and leverage each other’s care delivery platforms, clinics, and provider workforce. 

The Biden Administration has sought to strengthen anti-trust statutes to prevent industry monopolies and consumer harm, and the US Department of Justice and Federal Trade Commission have proposed new merger guidelines that have yet to be finalized. 

According to Dr. Singh, some of Optum’s medical practice purchases may bypass anti-trust statutes since most prospective mergers and acquisitions are reviewed only if they exceed a specific value ($101 million for 2023). Limited transparency in ownership structures further complicates matters. Plus, Dr. Singh said instances where physicians are hired instead of acquired through mergers would not be subject to current anti-trust laws. 

The ‘corporatization’ of health care is not good for patients or physicians, said Robert McNamara, MD, chief medical officer of the American Academy of Emergency Medicine Physician Group and cofounder of Take Medicine Back, a physician group advocating to remove corporate interests from health care. 

“If you ask a physician what causes them the most moral conflict, they’ll tell you it’s the insurance companies denying something they want to do for their patients,” he said. “To have the doctors now working for the insurance industry conflicts with a physician’s duty to put the patient first.” 

Dr. McNamara, chair of emergency medicine at Temple University’s Katz School of Medicine, said in an interview that more than half the states in the United States have laws or court rulings that support protecting physician autonomy from corporate interests. Still, he hopes a federal prohibition on private equity’s involvement in healthcare can soon gain traction. In November, Take Medicine Back raised a resolution at the American Medical Association’s interim House of Delegates meeting, which he said was subsequently referred to a committee. 

Emergency medicine was among the first specialties to succumb to private equity firms, but Dr. McNamara said that all types of health care providers and entities — from cardiology and urology to addiction treatment centers and nursing homes — are being swallowed up by larger organizations, including payers. 

UHC was named in a class action suit recently for allegedly shirking doctors’ orders and relying on a flawed algorithm to determine the length of skilled nursing facility stays for Medicare Advantage policyholders. 

At the investor meeting, Dr. Desai reiterated Optum’s desire to continue expanding care delivery options, especially in its pharmacy and behavioral health business lines, and focus on adopting value-based care. He credited the rapid growth to developing strong relationships with providers and standardizing technology and clinical systems.

A version of this article appeared on Medscape.com.

UnitedHealth Group, the parent company of the nation’s largest private insurer, UnitedHealthcare (UHC), is now affiliated with or employs approximately 10% of the US physician workforce, raising anti-trust and noncompete concerns as more payers and private equity firms pursue medical practice acquisitions.

The company added 20,000 physicians in the last year alone, including a previously physician-owned multispecialty group practice of 400 doctors in New York. They join the growing web of doctors — about 90,000 of the 950,000 active US physicians — working for the UnitedHealth Group subsidiary, Optum Health, providing primary, specialty, urgent, and surgical care. Amar Desai, MD, chief executive officer of Optum Health, shared the updated workforce numbers during the health care conglomerate’s annual investor conference.

Health care mergers and consolidations have become more common as physician groups struggle to stay afloat amid dwindling payer reimbursements. Although private equity and health systems often acquire practices, payers like UHC are increasingly doing so as part of their model to advance value-based care. 

Yashaswini Singh, PhD, health care economist and assistant professor of health services, policy, and practice at Brown University, says such moves mirror the broader trend in corporate consolidation of physician practices. She said in an interview that the integrated models could possibly enhance care coordination and improve outcomes, but the impact of payer-led consolidation has not been extensively studied. 

Meanwhile, evidence considering private equity ownership is just emerging. In a 2022 study published in JAMA Health Forum, with Dr. Singh as lead author, findings showed that private equity involvement increased healthcare spending through higher prices and utilization. 

Consolidation can also raise anti-trust concerns. “If payers incentivize referral patterns of their employed physicians to favor other physicians employed by the payer, it can reduce competition by restricting consumer choice,” said Dr. Singh. 

A potential merger between Cigna and Humana that could happen by the end of the year will likely face intense scrutiny as it would create a company that rivals the size of UnitedHealth Group or CVS Health. If it goes through, the duo could streamline its insurance offerings and leverage each other’s care delivery platforms, clinics, and provider workforce. 

The Biden Administration has sought to strengthen anti-trust statutes to prevent industry monopolies and consumer harm, and the US Department of Justice and Federal Trade Commission have proposed new merger guidelines that have yet to be finalized. 

According to Dr. Singh, some of Optum’s medical practice purchases may bypass anti-trust statutes since most prospective mergers and acquisitions are reviewed only if they exceed a specific value ($101 million for 2023). Limited transparency in ownership structures further complicates matters. Plus, Dr. Singh said instances where physicians are hired instead of acquired through mergers would not be subject to current anti-trust laws. 

The ‘corporatization’ of health care is not good for patients or physicians, said Robert McNamara, MD, chief medical officer of the American Academy of Emergency Medicine Physician Group and cofounder of Take Medicine Back, a physician group advocating to remove corporate interests from health care. 

“If you ask a physician what causes them the most moral conflict, they’ll tell you it’s the insurance companies denying something they want to do for their patients,” he said. “To have the doctors now working for the insurance industry conflicts with a physician’s duty to put the patient first.” 

Dr. McNamara, chair of emergency medicine at Temple University’s Katz School of Medicine, said in an interview that more than half the states in the United States have laws or court rulings that support protecting physician autonomy from corporate interests. Still, he hopes a federal prohibition on private equity’s involvement in healthcare can soon gain traction. In November, Take Medicine Back raised a resolution at the American Medical Association’s interim House of Delegates meeting, which he said was subsequently referred to a committee. 

Emergency medicine was among the first specialties to succumb to private equity firms, but Dr. McNamara said that all types of health care providers and entities — from cardiology and urology to addiction treatment centers and nursing homes — are being swallowed up by larger organizations, including payers. 

UHC was named in a class action suit recently for allegedly shirking doctors’ orders and relying on a flawed algorithm to determine the length of skilled nursing facility stays for Medicare Advantage policyholders. 

At the investor meeting, Dr. Desai reiterated Optum’s desire to continue expanding care delivery options, especially in its pharmacy and behavioral health business lines, and focus on adopting value-based care. He credited the rapid growth to developing strong relationships with providers and standardizing technology and clinical systems.

A version of this article appeared on Medscape.com.

UnitedHealth Group, the parent company of the nation’s largest private insurer, UnitedHealthcare (UHC), is now affiliated with or employs approximately 10% of the US physician workforce, raising anti-trust and noncompete concerns as more payers and private equity firms pursue medical practice acquisitions.

The company added 20,000 physicians in the last year alone, including a previously physician-owned multispecialty group practice of 400 doctors in New York. They join the growing web of doctors — about 90,000 of the 950,000 active US physicians — working for the UnitedHealth Group subsidiary, Optum Health, providing primary, specialty, urgent, and surgical care. Amar Desai, MD, chief executive officer of Optum Health, shared the updated workforce numbers during the health care conglomerate’s annual investor conference.

Health care mergers and consolidations have become more common as physician groups struggle to stay afloat amid dwindling payer reimbursements. Although private equity and health systems often acquire practices, payers like UHC are increasingly doing so as part of their model to advance value-based care. 

Yashaswini Singh, PhD, health care economist and assistant professor of health services, policy, and practice at Brown University, says such moves mirror the broader trend in corporate consolidation of physician practices. She said in an interview that the integrated models could possibly enhance care coordination and improve outcomes, but the impact of payer-led consolidation has not been extensively studied. 

Meanwhile, evidence considering private equity ownership is just emerging. In a 2022 study published in JAMA Health Forum, with Dr. Singh as lead author, findings showed that private equity involvement increased healthcare spending through higher prices and utilization. 

Consolidation can also raise anti-trust concerns. “If payers incentivize referral patterns of their employed physicians to favor other physicians employed by the payer, it can reduce competition by restricting consumer choice,” said Dr. Singh. 

A potential merger between Cigna and Humana that could happen by the end of the year will likely face intense scrutiny as it would create a company that rivals the size of UnitedHealth Group or CVS Health. If it goes through, the duo could streamline its insurance offerings and leverage each other’s care delivery platforms, clinics, and provider workforce. 

The Biden Administration has sought to strengthen anti-trust statutes to prevent industry monopolies and consumer harm, and the US Department of Justice and Federal Trade Commission have proposed new merger guidelines that have yet to be finalized. 

According to Dr. Singh, some of Optum’s medical practice purchases may bypass anti-trust statutes since most prospective mergers and acquisitions are reviewed only if they exceed a specific value ($101 million for 2023). Limited transparency in ownership structures further complicates matters. Plus, Dr. Singh said instances where physicians are hired instead of acquired through mergers would not be subject to current anti-trust laws. 

The ‘corporatization’ of health care is not good for patients or physicians, said Robert McNamara, MD, chief medical officer of the American Academy of Emergency Medicine Physician Group and cofounder of Take Medicine Back, a physician group advocating to remove corporate interests from health care. 

“If you ask a physician what causes them the most moral conflict, they’ll tell you it’s the insurance companies denying something they want to do for their patients,” he said. “To have the doctors now working for the insurance industry conflicts with a physician’s duty to put the patient first.” 

Dr. McNamara, chair of emergency medicine at Temple University’s Katz School of Medicine, said in an interview that more than half the states in the United States have laws or court rulings that support protecting physician autonomy from corporate interests. Still, he hopes a federal prohibition on private equity’s involvement in healthcare can soon gain traction. In November, Take Medicine Back raised a resolution at the American Medical Association’s interim House of Delegates meeting, which he said was subsequently referred to a committee. 

Emergency medicine was among the first specialties to succumb to private equity firms, but Dr. McNamara said that all types of health care providers and entities — from cardiology and urology to addiction treatment centers and nursing homes — are being swallowed up by larger organizations, including payers. 

UHC was named in a class action suit recently for allegedly shirking doctors’ orders and relying on a flawed algorithm to determine the length of skilled nursing facility stays for Medicare Advantage policyholders. 

At the investor meeting, Dr. Desai reiterated Optum’s desire to continue expanding care delivery options, especially in its pharmacy and behavioral health business lines, and focus on adopting value-based care. He credited the rapid growth to developing strong relationships with providers and standardizing technology and clinical systems.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

Artificial intelligence (AI) has already demonstrated its potential in various areas of healthcare, from early disease detection and drug discovery to genomics and personalized care. OpenAI’s ChatGPT, a large language model, is one AI tool that has been transforming practices across the globe, including mine.

Why should you consider using ChatGPT in your practice, and more important, why should you even consider the paid version? Let me walk you through it.

ChatGPT is essentially an AI-fueled assistant, capable of interpreting and generating human-like text in response to user inputs. Imagine a well-informed and competent trainee working with you, ready to tackle tasks from handling patient inquiries to summarizing intricate medical literature.

Currently, ChatGPT works on the “freemium” pricing model; there is a free version built upon GPT-3.5 as well as a subscription “ChatGPT Plus” version based on GPT-4 which offers additional features such as the use of third-party plug-ins.

Now, you may ask, “Isn’t the free version enough?” The free version is indeed impressive, but upgrading to the paid version for $20 per month unlocks the full potential of this tool, particularly if we add plug-ins.

Here are some of the best ways to incorporate ChatGPT Plus into your practice.

Time saver and efficiency multiplier. The paid version of ChatGPT is an extraordinary time-saving tool. It can help you sort through vast amounts of medical literature in a fraction of the time it would normally take. Imagine having to sift through hundreds of articles to find the latest research relevant to a patient’s case. With the paid version of ChatGPT, you can simply ask it to provide summaries of the most recent and relevant studies, all in seconds.

Did you forget about that PowerPoint you need to make but know the potential papers you would use? No problem. ChatGPT can create slides in a few minutes. It becomes your on-demand research assistant.

Of course, you need to provide the source you find most relevant to you. Using plug-ins such as ScholarAI and Link Reader are great.

Improved patient communication. Explaining complex medical terminology and procedures to patients can sometimes be a challenge. ChatGPT can generate simplified and personalized explanations for your patients, fostering their understanding and involvement in their care process.

Epic is currently collaborating with Nuance Communications, Microsoft’s speech recognition subsidiary, to use generative AI tools for medical note-taking in the electronic health record. However, you do not need to wait for it; it just takes a prompt in ChatGPT and then copying/pasting the results into the chart.

Smoother administrative management. The premium version of ChatGPT can automate administrative tasks such as creating letters of medical necessity, clearance to other physicians for services, or even communications to staff on specific topics. This frees you to focus more on your core work: providing patient care.

Precision medicine aid. ChatGPT can be a powerful ally in the field of precision medicine. Its capabilities for analyzing large datasets and unearthing valuable insights can help deliver more personalized and potentially effective treatment plans. For example, one can prompt ChatGPT to query the reported frequency of certain genomic variants and their implications; with the upgraded version and plug-ins, the results will have fewer hallucinations — inaccurate results — and key data references.

Unlimited accessibility. Uninterrupted access is a compelling reason to upgrade. While the free version may have usage limitations, the premium version provides unrestricted, round-the-clock access. Be it a late-night research quest or an early-morning patient query, your AI assistant will always be available.

Strengthened privacy and security. The premium version of ChatGPT includes heightened privacy and security measures. Just make sure to follow HIPAA and not include identifiers when making queries.

Embracing AI tools like ChatGPT in your practice can help you stay at the cutting edge of medical care, saving you time, enhancing patient communication, and supporting you in providing personalized care.

While the free version can serve as a good starting point (there are apps for both iOS and Android), upgrading to the paid version opens up a world of possibilities that can truly supercharge your practice.

I would love to hear your comments on this column or on future topics. Contact me at [email protected].
 

Arturo Loaiza-Bonilla, MD, MSEd, is the cofounder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is Assistant Professor of Medicine, Drexel University School of Medicine, Philadelphia, Pennsylvania, and serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has financial relationships with Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, Guardant, Amgen, Eisai, Natera, Merck, and Bristol Myers Squibb.

A version of this article appeared on Medscape.com.

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.

Difficult ethical situations can arise when treating perinatal women who have serious mental illness (SMI). Clinicians must consider ethical issues related to administering antipsychotic medications, the safety of breastfeeding, and concerns for child welfare. They need to carefully weigh the risks and benefits of each decision when treating perinatal women who have SMI. Ethical guidelines can help clinicians best support families in these situations.

In this article, we describe 2 cases of women with psychotic disorders who requested to breastfeed after delivering their child during an inpatient psychiatric hospitalization. The course of their hospitalizations illustrated common ethical questions and facilitated the creation of a framework to assist with complex decision-making regarding breastfeeding on inpatient psychiatric units.

CASE 1

Ms. C, age 41, is multigravida with a psychiatric history of chronic, severe schizoaffective disorder and lives in supportive housing. When Ms. C presents to the hospital in search of a rape kit, clinicians discover she is 22 weeks pregnant but has not received any prenatal care. Psychiatry is consulted because she is found to be intermittently agitated and endorses grandiose delusions. Ms. C requires involuntary hospitalization for decompensated psychosis because she refuses prenatal and psychiatric care. Because it has reassuring reproductive safety data,¹ olanzapine 5 mg/d is started. However, Ms. C experiences minimal improvement from a maximum dose of 20 mg/d. After 13 weeks on the psychiatry unit, she is transferred to obstetrics service for preeclampsia with severe features. Ms. C requires an urgent cesarean delivery at 37 weeks. Her baby boy is transferred to the neonatal intensive care unit (NICU) for transient tachypnea. After delivery and in consultation with psychiatry, the pediatrics team calls Child Protective Services (CPS) due to concern for neglect driven by Ms. C’s psychiatric condition. Ms. C visits the child with medical unit staff supervision in the NICU without consulting with the psychiatry service or CPS. On postpartum Day 2, Ms. C is transferred back to psychiatry for persistent psychosis.

On postpartum Day 3, Ms. C starts to produce breastmilk and requests to breastfeed. At this time, the multidisciplinary team determines she is not able to visit her child in the NICU due to psychiatric instability. No plan is developed to facilitate hand expression or pumping of breastmilk while Ms. C is on the psychiatric unit. The clinical teams discuss whether the benefits of breastfeeding and/or pumping breastmilk would outweigh the risks. CPS determines that Ms. C is unable to retain custody and places the child in kinship foster care while awaiting clinical improvement from her.

CASE 2

Ms. S, age 32, has a history of schizophrenia. She lives with her husband and parents. She is pregnant for the first time and has been receiving consistent prenatal care. Ms. S is brought to the hospital by her husband for bizarre behavior and paranoia after self-discontinuing risperidone 2 mg twice daily due to concern about the medication’s influence on her pregnancy. An ultrasound confirms she is 37 weeks pregnant. Psychiatry is consulted because Ms. S is internally preoccupied, delusional, and endorses auditory hallucinations. She requires involuntary hospitalization for decompensated psychosis. During admission, Ms. S experiences improvement of her psychiatric symptoms while receiving risperidone 2 mg twice daily, which she takes consistently after receiving extensive psychoeducation regarding its safety profile during pregnancy and lactation.

After 2 weeks on the psychiatry unit, Ms. S’s care team transfers her to the obstetrics service with one-to-one supervision. At 39 weeks gestation, she has a vaginal delivery without complications. Because there are no concerns about infant harm, obstetrics, pediatrics, and psychiatry coordinate care so the baby can room in with Ms. S, her husband, and a staff supervisor to facilitate bonding. Ms. S starts to lactate, wishes to breastfeed, and meets with lactation, pediatric, obstetric, and psychiatric specialists to discuss the risks and benefits of breastfeeding and pumping breastmilk. She pursues direct breastfeeding until the baby is discharged home with the husband at postpartum Day 2. CPS is not called because there are no concerns for parental abuse or neglect at the infant’s discharge.

On postpartum Day 2, the obstetrics service transfers Ms. S back to the psychiatric unit for further treatment of her paranoia. She wishes to pump breastmilk while hospitalized, so the treatment team supplies a breast pump, facilitates the storage of breastmilk, and coordinates supervision during pumping to reduce the ligature risk. Ms. S’s husband visits daily to transport the milk and feed the infant breastmilk and formula to meet its nutritional needs. Ms. S maintains psychiatric stability while breast pumping, and the team helps transition her to breastfeeding during visitation with her husband and infant until she is discharged home at 2 weeks postpartum.

Continue to: Approaching care with a relational ethics framework

A relational ethics framework was constructed to evaluate whether to support breastfeeding for both patients during their psychiatric hospitalizations. A relational ethics perspective is defined as “a moral responsibility within a context of human relations” [that] “recognizes the human interdependency and reciprocity within which personal autonomy is embedded.”² This framework values connectedness and commonality between various and even conflicting parties. In the setting of a clinician-patient relationship, health care decisions are made with consideration of the patient’s traditional beliefs, values, and principles rather than the application of impartial moral principles. For these complex cases, this framework was chosen to determine the safest possible outcome for both mother and child.

Risks/benefits of breastfeeding by patients who have SMI

There are several methods of breastfeeding, including direct breastfeeding and other ways of expressing breastmilk such as pumping or hand expression.³ Unlike other forms of feeding using breastmilk, direct breastfeeding has been extensively studied, has well-established medical and psychological benefits for newborns and mothers, and enhances long-term bonding.⁴ Compared with their counterparts who do not breastfeed, mothers who breastfeed have lower rates of unintended pregnancy, cardiovascular disease, postpartum bleeding, osteoporosis, and breast and ovarian cancer.⁵ Among its key psychological benefits, breastfeeding is associated with an increase in maternal self-efficacy and, in some research, has been shown to be associated with a decreased risk of postpartum depression and stress.Additionally, breastfed infants experience lower rates of childhood infection and obesity, and improved nutrition, cognitive development, and immune function.⁶ The American Academy of Pediatrics recognizes these benefits and recommends that women exclusively breastfeed for 6 months postpartum and continue to breastfeed for 2 years or beyond if mutually desired by the mother and child.⁷ Absolute contraindications to breastfeeding must be ruled out (eg, infant classic galactosemia; maternal use of illicit substances such as cocaine, opioids, or phencyclidine; maternal HIV infection, etc).

The risks of breastfeeding by patients who have SMI must also be considered. In severe situations, the infant can be exposed to a mother’s agitation secondary to psychosis.^8,9 The transmission of antipsychotic medication through breastmilk and associated adverse effects (eg, sedation, poor feeding, and extrapyramidal symptoms) are also potential risks and varies among different antipsychotic medications.^1,10 Therefore, when prescribing an antipsychotic for a patient with SMI who breastfeeds, it is crucial to consider the medication’s safety profile as well as other factors, such as the relative infant dose (the weight-adjusted [ie, mg/kg] percentage of the maternal dosage ingested by a fully breastfed infant) and the molecular characteristics of the medication.^10-12 Neonates should be routinely monitored for adverse effects, medication toxicity, and withdrawal symptoms, and care should be coordinated with the infant’s pediatrician. Certain antipsychotic medications, such as aripiprazole, may impact breastmilk production through the dopamine agonist’s interference of the prolactin reflex and anticholinergic properties.^11,13 For a patient with SMI, perhaps the most significant risk involves the time and resources needed for breastfeeding, which can interfere with sleep and psychiatric treatment and possibly further exacerbate psychiatric symptoms.^14-16 Additionally, breastfeeding difficulties or disruption can increase the risk of psychiatric symptoms and psychological distress.¹⁷ In Ms. C’s case, there was a delay in the baby latching as well as multiple medical and psychiatric factors that hindered the milk-ejection reflex to properly initiate; both of these factors rendered breastfeeding particularly difficult while Ms. C was on the inpatient psychiatry unit.¹⁷ In comparison, Ms. S was able to bond with her infant shortly after delivery, which facilitated the milk-ejection reflex and lactation.

Patients who wish to directly breastfeed but struggle to do so while tending to their acute psychiatric condition can benefit from expression of breastmilk that can be provided to the infant or discarded to facilitate breastfeeding in the future.¹⁸ While expression of breastmilk may not be as advantageous for infant health as direct breastfeeding due to the potential changes in breastmilk composition from collecting, storing, and heating, this option can be more protective than formula feeding and facilitate future breastfeeding.¹⁹ In these clinical scenarios, it is standard care to provide a hospital-grade breast pump to the patient, much like a continuous positive airway pressure machine is provided to patients with obstructive sleep apnea.²⁰ However, there is often considerable difficulty obtaining proper breastfeeding equipment and a lack of services devoted to perinatal care in general inpatient settings. Barriers to direct breastfeeding and pumping of breastmilk are highlighted in the Table.²¹

Limitations on breastfeeding on an inpatient unit

The limitations in care and restrictions placed on breastfeeding are more optimally addressed in a mother and baby unit (MBU). MBUs are specialized inpatient psychiatric units designed for mothers experiencing severe perinatal psychiatric difficulties. Unlike general psychiatric units, MBUs allow for joint, full-time admission of mothers and their infants. These units also include multidisciplinary staff who specialize in treating perinatal mental health issues as well as infant care and child development.²² Admission into an MBU is considered best practice for new mothers requiring treatment, particularly in the United Kingdom, Australia, and France, as it is well-recognized that the separation of mother and baby can be psychologically harmful.²³ In the UK, most patients admitted to an MBU showed significant improvement of their psychiatric symptoms and reported overall high satisfaction with care.^24,25 Patients who experience postpartum psychosis prefer MBUs over general psychiatric units because the latter often lack specialized perinatal support, appropriate visitor arrangements, and adequate time with their infant.^26-28

Continue to: The resistance to adopting MBUs in the United States...

The resistance to adopting MBUs in the United States has posed significant barriers in care for perinatal patients and has been attributed to financial barriers, medicolegal risk, staffing, and safety concerns.²⁹ Though currently there are no MBUs in the US, other specialized units have been created. A partial day hospitalization program created in 2000 in Rhode Island for mothers and infants revolutionized the psychiatric care experience for new mothers.³⁰ Since then, other institutions have significantly expanded their services to include perinatal psychiatry inpatient units, yet unlike MBUs, these units typically do not provide overnight rooming-in with infants.³¹ They have the necessary resources and facilities to accommodate the mother’s needs and maximize positive mother-infant interaction, while actively integrating the infant into the mother’s treatment. Breast pumping is treated as a necessary medical procedure and patients can easily access hospital-grade breast pumps with staff supervision. At one such perinatal psychiatric inpatient unit, high rates of treatment satisfaction and significant improvements in symptoms of depression, anxiety, active suicidal ideation, and overall functioning were observed at discharge.³² Therefore, it is crucial to incorporate strategies in general psychiatry units to improve perinatal care, acknowledging that most patients will not have access to these specialized units.²¹

A framework to approaching the relational ethics decisions

An interdisciplinary team used a relational ethics perspective to carefully analyze the risks and benefits of these complex cases. In Figure 1, we propose a framework for the relational ethics decisions of breastfeeding on general inpatient psychiatric units. In creating this framework, we considered principles of autonomy, beneficence, and nonmaleficence, along with the medical and logistical barriers to breastfeeding.

In Ms. C’s case, the team determined that the risks—which included disrupting the mother’s psychiatric treatment, exposing her to psychological harm due to increasing attachment before remanding the child to CPS custody, and risks to the child due to potential unpredictable agitation driven by the treatment-refractory psychosis of the mother as well as that of other psychiatric patients—outweighed the benefits of breastfeeding. We instead recommended breast pumping as an alternative once Ms. C’s psychiatric stability improved. We presented Ms. C with the option of breast pumping on postpartum Day 5. During a 1-day period in which she showed improved behavioral control, she was counseled on the risks and benefits of breastfeeding and exclusive pumping and was notified that the team would help her with the necessary resources, including consultation with a lactation specialist and breast pump. Despite lactation consultant support, Ms. C had low milk production and difficulty with hand expression, which was very discouraging to her. She produced 1 ounce of milk that was shared with the newborn while in the NICU. Because Ms. C’s psychiatric symptoms continued to be severe, with lability and aggression, and because pumping was triggering distress, the multidisciplinary team determined the best course of care would be to focus on her psychiatric recovery rather than on pumping breastmilk. To reduce milk production and minimize discomfort secondary to breast engorgement, the lactation consultant recommended cold compresses, pain management, and compression of breasts. Ultimately, the mother-infant dyad was unable to reap the benefits of breastfeeding (via pumping or direct breastfeeding) due to the mother’s underlying psychiatric illness, although the staffing, psychosocial support, and logistical limitations contributed to this outcome.³³

In Ms. S’s case, the treatment team determined that there were no medical or psychiatric contraindications to breastfeeding, and she was counseled on the risks and benefits of direct breastfeeding and pumping. The treatment team determined it was safe for Ms. S to directly breastfeed as there were no concerns for infant harm post­delivery with constant supervision while on the obstetrics floor. The patient opted to directly breastfeed, which was successful with the guidance of a lactation specialist. When she was transferred to the psychiatric unit on postpartum Day 2, her child was discharged home with the husband. The patient was then encouraged to pump while the psychiatrists monitored her symptoms closely and facilitated increased staff and resources. Transportation of breastmilk was made possible by the family, and on postpartum Day 5, as the patient maintained psychiatric stability, the team discussed with Ms. S and her husband the prospect of direct breastfeeding. The treatment team arranged for separate visitation hours to minimize the possibility of exposing the infant to aggression from other patients on the unit and advocated with hospital leadership to approve of infant visitation on the unit.

Impact of involvement of Child Protective Services

The involvement of CPS also added complexity to Ms. C’s case. Without proper legal guidance, mothers with psychosis who lose custody can find it difficult to navigate the legal system and maintain contact with their children.³⁴ As the prevalence of custody loss in mothers with psychosis is high (approximately 50% according to research published in the last 10 years), effective interventions to reunite the mother and child must be promoted (Figure 2).^35-39 Ultimately, the goal of psychiatric hospitalization for perinatal women who have SMI is psychiatric stabilization. The preemptive involvement of psychiatry is crucial because it can allow for early postpartum planning and can provide an opportunity to address feeding options and custody concerns with the patient, social supports and services, and various medical teams. In Ms. C’s case, she visited her baby in the NICU on postpartum Day 2 without consultation with psychiatry or CPS, which posed risks to the patient, infant, and staff. It is vital that various clinicians collaborate with each other and the patient, working towards the goal of optimizing the patient’s mental health to allow for parenting rights in the future and maximizing a sustainable attachment between the parent and child. In Ms. S’s case, the husband was able to facilitate caring for the baby while the mother was hospitalized and played an integral role in the feeding process via pumped breastmilk and transport of the infant for direct breastfeeding.

Continue to: The differences in these 2 cases...

The differences in these 2 cases show the extreme importance of social support to benefit both the mother and child, and the need for more comprehensive social services for women who do not have a social safety net.

Bottom Line

These complex cases highlight an ethical decision-making approach to breastfeeding in perinatal women who have serious mental illness. Collaborative care and shared decision-making, which highlight the interests of the mother and baby, are crucial when assessing the risks and benefits of breastfeeding and pumping breastmilk. Our relational ethics framework can be used to better evaluate and implement breastfeeding options on general psychiatric units.

Related Resources

• Tillman B, Sloan N, Westmoreland P. How COVID-19 affects peripartum women’s mental health. Current Psychiatry. 2021;20(6):18-22. doi:10.12788/cp.0129
• Koch J, Preinitz J. Antidepressants for patients who are breastfeeding: what to consider. Current Psychiatry. 2023;22(5):20-23,48. doi:10.12788/cp.0355

Drug Brand Names

Aripiprazole • Abilify
Olanzapine • Zyprexa
Risperidone • Risperdal

Difficult ethical situations can arise when treating perinatal women who have serious mental illness (SMI). Clinicians must consider ethical issues related to administering antipsychotic medications, the safety of breastfeeding, and concerns for child welfare. They need to carefully weigh the risks and benefits of each decision when treating perinatal women who have SMI. Ethical guidelines can help clinicians best support families in these situations.

In this article, we describe 2 cases of women with psychotic disorders who requested to breastfeed after delivering their child during an inpatient psychiatric hospitalization. The course of their hospitalizations illustrated common ethical questions and facilitated the creation of a framework to assist with complex decision-making regarding breastfeeding on inpatient psychiatric units.

CASE 1

Ms. C, age 41, is multigravida with a psychiatric history of chronic, severe schizoaffective disorder and lives in supportive housing. When Ms. C presents to the hospital in search of a rape kit, clinicians discover she is 22 weeks pregnant but has not received any prenatal care. Psychiatry is consulted because she is found to be intermittently agitated and endorses grandiose delusions. Ms. C requires involuntary hospitalization for decompensated psychosis because she refuses prenatal and psychiatric care. Because it has reassuring reproductive safety data,¹ olanzapine 5 mg/d is started. However, Ms. C experiences minimal improvement from a maximum dose of 20 mg/d. After 13 weeks on the psychiatry unit, she is transferred to obstetrics service for preeclampsia with severe features. Ms. C requires an urgent cesarean delivery at 37 weeks. Her baby boy is transferred to the neonatal intensive care unit (NICU) for transient tachypnea. After delivery and in consultation with psychiatry, the pediatrics team calls Child Protective Services (CPS) due to concern for neglect driven by Ms. C’s psychiatric condition. Ms. C visits the child with medical unit staff supervision in the NICU without consulting with the psychiatry service or CPS. On postpartum Day 2, Ms. C is transferred back to psychiatry for persistent psychosis.

On postpartum Day 3, Ms. C starts to produce breastmilk and requests to breastfeed. At this time, the multidisciplinary team determines she is not able to visit her child in the NICU due to psychiatric instability. No plan is developed to facilitate hand expression or pumping of breastmilk while Ms. C is on the psychiatric unit. The clinical teams discuss whether the benefits of breastfeeding and/or pumping breastmilk would outweigh the risks. CPS determines that Ms. C is unable to retain custody and places the child in kinship foster care while awaiting clinical improvement from her.

CASE 2

Ms. S, age 32, has a history of schizophrenia. She lives with her husband and parents. She is pregnant for the first time and has been receiving consistent prenatal care. Ms. S is brought to the hospital by her husband for bizarre behavior and paranoia after self-discontinuing risperidone 2 mg twice daily due to concern about the medication’s influence on her pregnancy. An ultrasound confirms she is 37 weeks pregnant. Psychiatry is consulted because Ms. S is internally preoccupied, delusional, and endorses auditory hallucinations. She requires involuntary hospitalization for decompensated psychosis. During admission, Ms. S experiences improvement of her psychiatric symptoms while receiving risperidone 2 mg twice daily, which she takes consistently after receiving extensive psychoeducation regarding its safety profile during pregnancy and lactation.

After 2 weeks on the psychiatry unit, Ms. S’s care team transfers her to the obstetrics service with one-to-one supervision. At 39 weeks gestation, she has a vaginal delivery without complications. Because there are no concerns about infant harm, obstetrics, pediatrics, and psychiatry coordinate care so the baby can room in with Ms. S, her husband, and a staff supervisor to facilitate bonding. Ms. S starts to lactate, wishes to breastfeed, and meets with lactation, pediatric, obstetric, and psychiatric specialists to discuss the risks and benefits of breastfeeding and pumping breastmilk. She pursues direct breastfeeding until the baby is discharged home with the husband at postpartum Day 2. CPS is not called because there are no concerns for parental abuse or neglect at the infant’s discharge.

On postpartum Day 2, the obstetrics service transfers Ms. S back to the psychiatric unit for further treatment of her paranoia. She wishes to pump breastmilk while hospitalized, so the treatment team supplies a breast pump, facilitates the storage of breastmilk, and coordinates supervision during pumping to reduce the ligature risk. Ms. S’s husband visits daily to transport the milk and feed the infant breastmilk and formula to meet its nutritional needs. Ms. S maintains psychiatric stability while breast pumping, and the team helps transition her to breastfeeding during visitation with her husband and infant until she is discharged home at 2 weeks postpartum.

Continue to: Approaching care with a relational ethics framework

A relational ethics framework was constructed to evaluate whether to support breastfeeding for both patients during their psychiatric hospitalizations. A relational ethics perspective is defined as “a moral responsibility within a context of human relations” [that] “recognizes the human interdependency and reciprocity within which personal autonomy is embedded.”² This framework values connectedness and commonality between various and even conflicting parties. In the setting of a clinician-patient relationship, health care decisions are made with consideration of the patient’s traditional beliefs, values, and principles rather than the application of impartial moral principles. For these complex cases, this framework was chosen to determine the safest possible outcome for both mother and child.

Risks/benefits of breastfeeding by patients who have SMI

There are several methods of breastfeeding, including direct breastfeeding and other ways of expressing breastmilk such as pumping or hand expression.³ Unlike other forms of feeding using breastmilk, direct breastfeeding has been extensively studied, has well-established medical and psychological benefits for newborns and mothers, and enhances long-term bonding.⁴ Compared with their counterparts who do not breastfeed, mothers who breastfeed have lower rates of unintended pregnancy, cardiovascular disease, postpartum bleeding, osteoporosis, and breast and ovarian cancer.⁵ Among its key psychological benefits, breastfeeding is associated with an increase in maternal self-efficacy and, in some research, has been shown to be associated with a decreased risk of postpartum depression and stress.Additionally, breastfed infants experience lower rates of childhood infection and obesity, and improved nutrition, cognitive development, and immune function.⁶ The American Academy of Pediatrics recognizes these benefits and recommends that women exclusively breastfeed for 6 months postpartum and continue to breastfeed for 2 years or beyond if mutually desired by the mother and child.⁷ Absolute contraindications to breastfeeding must be ruled out (eg, infant classic galactosemia; maternal use of illicit substances such as cocaine, opioids, or phencyclidine; maternal HIV infection, etc).

The risks of breastfeeding by patients who have SMI must also be considered. In severe situations, the infant can be exposed to a mother’s agitation secondary to psychosis.^8,9 The transmission of antipsychotic medication through breastmilk and associated adverse effects (eg, sedation, poor feeding, and extrapyramidal symptoms) are also potential risks and varies among different antipsychotic medications.^1,10 Therefore, when prescribing an antipsychotic for a patient with SMI who breastfeeds, it is crucial to consider the medication’s safety profile as well as other factors, such as the relative infant dose (the weight-adjusted [ie, mg/kg] percentage of the maternal dosage ingested by a fully breastfed infant) and the molecular characteristics of the medication.^10-12 Neonates should be routinely monitored for adverse effects, medication toxicity, and withdrawal symptoms, and care should be coordinated with the infant’s pediatrician. Certain antipsychotic medications, such as aripiprazole, may impact breastmilk production through the dopamine agonist’s interference of the prolactin reflex and anticholinergic properties.^11,13 For a patient with SMI, perhaps the most significant risk involves the time and resources needed for breastfeeding, which can interfere with sleep and psychiatric treatment and possibly further exacerbate psychiatric symptoms.^14-16 Additionally, breastfeeding difficulties or disruption can increase the risk of psychiatric symptoms and psychological distress.¹⁷ In Ms. C’s case, there was a delay in the baby latching as well as multiple medical and psychiatric factors that hindered the milk-ejection reflex to properly initiate; both of these factors rendered breastfeeding particularly difficult while Ms. C was on the inpatient psychiatry unit.¹⁷ In comparison, Ms. S was able to bond with her infant shortly after delivery, which facilitated the milk-ejection reflex and lactation.

Patients who wish to directly breastfeed but struggle to do so while tending to their acute psychiatric condition can benefit from expression of breastmilk that can be provided to the infant or discarded to facilitate breastfeeding in the future.¹⁸ While expression of breastmilk may not be as advantageous for infant health as direct breastfeeding due to the potential changes in breastmilk composition from collecting, storing, and heating, this option can be more protective than formula feeding and facilitate future breastfeeding.¹⁹ In these clinical scenarios, it is standard care to provide a hospital-grade breast pump to the patient, much like a continuous positive airway pressure machine is provided to patients with obstructive sleep apnea.²⁰ However, there is often considerable difficulty obtaining proper breastfeeding equipment and a lack of services devoted to perinatal care in general inpatient settings. Barriers to direct breastfeeding and pumping of breastmilk are highlighted in the Table.²¹

Limitations on breastfeeding on an inpatient unit

The limitations in care and restrictions placed on breastfeeding are more optimally addressed in a mother and baby unit (MBU). MBUs are specialized inpatient psychiatric units designed for mothers experiencing severe perinatal psychiatric difficulties. Unlike general psychiatric units, MBUs allow for joint, full-time admission of mothers and their infants. These units also include multidisciplinary staff who specialize in treating perinatal mental health issues as well as infant care and child development.²² Admission into an MBU is considered best practice for new mothers requiring treatment, particularly in the United Kingdom, Australia, and France, as it is well-recognized that the separation of mother and baby can be psychologically harmful.²³ In the UK, most patients admitted to an MBU showed significant improvement of their psychiatric symptoms and reported overall high satisfaction with care.^24,25 Patients who experience postpartum psychosis prefer MBUs over general psychiatric units because the latter often lack specialized perinatal support, appropriate visitor arrangements, and adequate time with their infant.^26-28

Continue to: The resistance to adopting MBUs in the United States...

The resistance to adopting MBUs in the United States has posed significant barriers in care for perinatal patients and has been attributed to financial barriers, medicolegal risk, staffing, and safety concerns.²⁹ Though currently there are no MBUs in the US, other specialized units have been created. A partial day hospitalization program created in 2000 in Rhode Island for mothers and infants revolutionized the psychiatric care experience for new mothers.³⁰ Since then, other institutions have significantly expanded their services to include perinatal psychiatry inpatient units, yet unlike MBUs, these units typically do not provide overnight rooming-in with infants.³¹ They have the necessary resources and facilities to accommodate the mother’s needs and maximize positive mother-infant interaction, while actively integrating the infant into the mother’s treatment. Breast pumping is treated as a necessary medical procedure and patients can easily access hospital-grade breast pumps with staff supervision. At one such perinatal psychiatric inpatient unit, high rates of treatment satisfaction and significant improvements in symptoms of depression, anxiety, active suicidal ideation, and overall functioning were observed at discharge.³² Therefore, it is crucial to incorporate strategies in general psychiatry units to improve perinatal care, acknowledging that most patients will not have access to these specialized units.²¹

A framework to approaching the relational ethics decisions

An interdisciplinary team used a relational ethics perspective to carefully analyze the risks and benefits of these complex cases. In Figure 1, we propose a framework for the relational ethics decisions of breastfeeding on general inpatient psychiatric units. In creating this framework, we considered principles of autonomy, beneficence, and nonmaleficence, along with the medical and logistical barriers to breastfeeding.

In Ms. C’s case, the team determined that the risks—which included disrupting the mother’s psychiatric treatment, exposing her to psychological harm due to increasing attachment before remanding the child to CPS custody, and risks to the child due to potential unpredictable agitation driven by the treatment-refractory psychosis of the mother as well as that of other psychiatric patients—outweighed the benefits of breastfeeding. We instead recommended breast pumping as an alternative once Ms. C’s psychiatric stability improved. We presented Ms. C with the option of breast pumping on postpartum Day 5. During a 1-day period in which she showed improved behavioral control, she was counseled on the risks and benefits of breastfeeding and exclusive pumping and was notified that the team would help her with the necessary resources, including consultation with a lactation specialist and breast pump. Despite lactation consultant support, Ms. C had low milk production and difficulty with hand expression, which was very discouraging to her. She produced 1 ounce of milk that was shared with the newborn while in the NICU. Because Ms. C’s psychiatric symptoms continued to be severe, with lability and aggression, and because pumping was triggering distress, the multidisciplinary team determined the best course of care would be to focus on her psychiatric recovery rather than on pumping breastmilk. To reduce milk production and minimize discomfort secondary to breast engorgement, the lactation consultant recommended cold compresses, pain management, and compression of breasts. Ultimately, the mother-infant dyad was unable to reap the benefits of breastfeeding (via pumping or direct breastfeeding) due to the mother’s underlying psychiatric illness, although the staffing, psychosocial support, and logistical limitations contributed to this outcome.³³

In Ms. S’s case, the treatment team determined that there were no medical or psychiatric contraindications to breastfeeding, and she was counseled on the risks and benefits of direct breastfeeding and pumping. The treatment team determined it was safe for Ms. S to directly breastfeed as there were no concerns for infant harm post­delivery with constant supervision while on the obstetrics floor. The patient opted to directly breastfeed, which was successful with the guidance of a lactation specialist. When she was transferred to the psychiatric unit on postpartum Day 2, her child was discharged home with the husband. The patient was then encouraged to pump while the psychiatrists monitored her symptoms closely and facilitated increased staff and resources. Transportation of breastmilk was made possible by the family, and on postpartum Day 5, as the patient maintained psychiatric stability, the team discussed with Ms. S and her husband the prospect of direct breastfeeding. The treatment team arranged for separate visitation hours to minimize the possibility of exposing the infant to aggression from other patients on the unit and advocated with hospital leadership to approve of infant visitation on the unit.

Impact of involvement of Child Protective Services

The involvement of CPS also added complexity to Ms. C’s case. Without proper legal guidance, mothers with psychosis who lose custody can find it difficult to navigate the legal system and maintain contact with their children.³⁴ As the prevalence of custody loss in mothers with psychosis is high (approximately 50% according to research published in the last 10 years), effective interventions to reunite the mother and child must be promoted (Figure 2).^35-39 Ultimately, the goal of psychiatric hospitalization for perinatal women who have SMI is psychiatric stabilization. The preemptive involvement of psychiatry is crucial because it can allow for early postpartum planning and can provide an opportunity to address feeding options and custody concerns with the patient, social supports and services, and various medical teams. In Ms. C’s case, she visited her baby in the NICU on postpartum Day 2 without consultation with psychiatry or CPS, which posed risks to the patient, infant, and staff. It is vital that various clinicians collaborate with each other and the patient, working towards the goal of optimizing the patient’s mental health to allow for parenting rights in the future and maximizing a sustainable attachment between the parent and child. In Ms. S’s case, the husband was able to facilitate caring for the baby while the mother was hospitalized and played an integral role in the feeding process via pumped breastmilk and transport of the infant for direct breastfeeding.

Continue to: The differences in these 2 cases...

The differences in these 2 cases show the extreme importance of social support to benefit both the mother and child, and the need for more comprehensive social services for women who do not have a social safety net.

Bottom Line

These complex cases highlight an ethical decision-making approach to breastfeeding in perinatal women who have serious mental illness. Collaborative care and shared decision-making, which highlight the interests of the mother and baby, are crucial when assessing the risks and benefits of breastfeeding and pumping breastmilk. Our relational ethics framework can be used to better evaluate and implement breastfeeding options on general psychiatric units.

Related Resources

• Tillman B, Sloan N, Westmoreland P. How COVID-19 affects peripartum women’s mental health. Current Psychiatry. 2021;20(6):18-22. doi:10.12788/cp.0129
• Koch J, Preinitz J. Antidepressants for patients who are breastfeeding: what to consider. Current Psychiatry. 2023;22(5):20-23,48. doi:10.12788/cp.0355

Drug Brand Names

Aripiprazole • Abilify
Olanzapine • Zyprexa
Risperidone • Risperdal

Difficult ethical situations can arise when treating perinatal women who have serious mental illness (SMI). Clinicians must consider ethical issues related to administering antipsychotic medications, the safety of breastfeeding, and concerns for child welfare. They need to carefully weigh the risks and benefits of each decision when treating perinatal women who have SMI. Ethical guidelines can help clinicians best support families in these situations.

In this article, we describe 2 cases of women with psychotic disorders who requested to breastfeed after delivering their child during an inpatient psychiatric hospitalization. The course of their hospitalizations illustrated common ethical questions and facilitated the creation of a framework to assist with complex decision-making regarding breastfeeding on inpatient psychiatric units.

CASE 1

Ms. C, age 41, is multigravida with a psychiatric history of chronic, severe schizoaffective disorder and lives in supportive housing. When Ms. C presents to the hospital in search of a rape kit, clinicians discover she is 22 weeks pregnant but has not received any prenatal care. Psychiatry is consulted because she is found to be intermittently agitated and endorses grandiose delusions. Ms. C requires involuntary hospitalization for decompensated psychosis because she refuses prenatal and psychiatric care. Because it has reassuring reproductive safety data,¹ olanzapine 5 mg/d is started. However, Ms. C experiences minimal improvement from a maximum dose of 20 mg/d. After 13 weeks on the psychiatry unit, she is transferred to obstetrics service for preeclampsia with severe features. Ms. C requires an urgent cesarean delivery at 37 weeks. Her baby boy is transferred to the neonatal intensive care unit (NICU) for transient tachypnea. After delivery and in consultation with psychiatry, the pediatrics team calls Child Protective Services (CPS) due to concern for neglect driven by Ms. C’s psychiatric condition. Ms. C visits the child with medical unit staff supervision in the NICU without consulting with the psychiatry service or CPS. On postpartum Day 2, Ms. C is transferred back to psychiatry for persistent psychosis.

On postpartum Day 3, Ms. C starts to produce breastmilk and requests to breastfeed. At this time, the multidisciplinary team determines she is not able to visit her child in the NICU due to psychiatric instability. No plan is developed to facilitate hand expression or pumping of breastmilk while Ms. C is on the psychiatric unit. The clinical teams discuss whether the benefits of breastfeeding and/or pumping breastmilk would outweigh the risks. CPS determines that Ms. C is unable to retain custody and places the child in kinship foster care while awaiting clinical improvement from her.

CASE 2

Ms. S, age 32, has a history of schizophrenia. She lives with her husband and parents. She is pregnant for the first time and has been receiving consistent prenatal care. Ms. S is brought to the hospital by her husband for bizarre behavior and paranoia after self-discontinuing risperidone 2 mg twice daily due to concern about the medication’s influence on her pregnancy. An ultrasound confirms she is 37 weeks pregnant. Psychiatry is consulted because Ms. S is internally preoccupied, delusional, and endorses auditory hallucinations. She requires involuntary hospitalization for decompensated psychosis. During admission, Ms. S experiences improvement of her psychiatric symptoms while receiving risperidone 2 mg twice daily, which she takes consistently after receiving extensive psychoeducation regarding its safety profile during pregnancy and lactation.

After 2 weeks on the psychiatry unit, Ms. S’s care team transfers her to the obstetrics service with one-to-one supervision. At 39 weeks gestation, she has a vaginal delivery without complications. Because there are no concerns about infant harm, obstetrics, pediatrics, and psychiatry coordinate care so the baby can room in with Ms. S, her husband, and a staff supervisor to facilitate bonding. Ms. S starts to lactate, wishes to breastfeed, and meets with lactation, pediatric, obstetric, and psychiatric specialists to discuss the risks and benefits of breastfeeding and pumping breastmilk. She pursues direct breastfeeding until the baby is discharged home with the husband at postpartum Day 2. CPS is not called because there are no concerns for parental abuse or neglect at the infant’s discharge.

On postpartum Day 2, the obstetrics service transfers Ms. S back to the psychiatric unit for further treatment of her paranoia. She wishes to pump breastmilk while hospitalized, so the treatment team supplies a breast pump, facilitates the storage of breastmilk, and coordinates supervision during pumping to reduce the ligature risk. Ms. S’s husband visits daily to transport the milk and feed the infant breastmilk and formula to meet its nutritional needs. Ms. S maintains psychiatric stability while breast pumping, and the team helps transition her to breastfeeding during visitation with her husband and infant until she is discharged home at 2 weeks postpartum.

Continue to: Approaching care with a relational ethics framework

A relational ethics framework was constructed to evaluate whether to support breastfeeding for both patients during their psychiatric hospitalizations. A relational ethics perspective is defined as “a moral responsibility within a context of human relations” [that] “recognizes the human interdependency and reciprocity within which personal autonomy is embedded.”² This framework values connectedness and commonality between various and even conflicting parties. In the setting of a clinician-patient relationship, health care decisions are made with consideration of the patient’s traditional beliefs, values, and principles rather than the application of impartial moral principles. For these complex cases, this framework was chosen to determine the safest possible outcome for both mother and child.

Risks/benefits of breastfeeding by patients who have SMI

There are several methods of breastfeeding, including direct breastfeeding and other ways of expressing breastmilk such as pumping or hand expression.³ Unlike other forms of feeding using breastmilk, direct breastfeeding has been extensively studied, has well-established medical and psychological benefits for newborns and mothers, and enhances long-term bonding.⁴ Compared with their counterparts who do not breastfeed, mothers who breastfeed have lower rates of unintended pregnancy, cardiovascular disease, postpartum bleeding, osteoporosis, and breast and ovarian cancer.⁵ Among its key psychological benefits, breastfeeding is associated with an increase in maternal self-efficacy and, in some research, has been shown to be associated with a decreased risk of postpartum depression and stress.Additionally, breastfed infants experience lower rates of childhood infection and obesity, and improved nutrition, cognitive development, and immune function.⁶ The American Academy of Pediatrics recognizes these benefits and recommends that women exclusively breastfeed for 6 months postpartum and continue to breastfeed for 2 years or beyond if mutually desired by the mother and child.⁷ Absolute contraindications to breastfeeding must be ruled out (eg, infant classic galactosemia; maternal use of illicit substances such as cocaine, opioids, or phencyclidine; maternal HIV infection, etc).

The risks of breastfeeding by patients who have SMI must also be considered. In severe situations, the infant can be exposed to a mother’s agitation secondary to psychosis.^8,9 The transmission of antipsychotic medication through breastmilk and associated adverse effects (eg, sedation, poor feeding, and extrapyramidal symptoms) are also potential risks and varies among different antipsychotic medications.^1,10 Therefore, when prescribing an antipsychotic for a patient with SMI who breastfeeds, it is crucial to consider the medication’s safety profile as well as other factors, such as the relative infant dose (the weight-adjusted [ie, mg/kg] percentage of the maternal dosage ingested by a fully breastfed infant) and the molecular characteristics of the medication.^10-12 Neonates should be routinely monitored for adverse effects, medication toxicity, and withdrawal symptoms, and care should be coordinated with the infant’s pediatrician. Certain antipsychotic medications, such as aripiprazole, may impact breastmilk production through the dopamine agonist’s interference of the prolactin reflex and anticholinergic properties.^11,13 For a patient with SMI, perhaps the most significant risk involves the time and resources needed for breastfeeding, which can interfere with sleep and psychiatric treatment and possibly further exacerbate psychiatric symptoms.^14-16 Additionally, breastfeeding difficulties or disruption can increase the risk of psychiatric symptoms and psychological distress.¹⁷ In Ms. C’s case, there was a delay in the baby latching as well as multiple medical and psychiatric factors that hindered the milk-ejection reflex to properly initiate; both of these factors rendered breastfeeding particularly difficult while Ms. C was on the inpatient psychiatry unit.¹⁷ In comparison, Ms. S was able to bond with her infant shortly after delivery, which facilitated the milk-ejection reflex and lactation.

Patients who wish to directly breastfeed but struggle to do so while tending to their acute psychiatric condition can benefit from expression of breastmilk that can be provided to the infant or discarded to facilitate breastfeeding in the future.¹⁸ While expression of breastmilk may not be as advantageous for infant health as direct breastfeeding due to the potential changes in breastmilk composition from collecting, storing, and heating, this option can be more protective than formula feeding and facilitate future breastfeeding.¹⁹ In these clinical scenarios, it is standard care to provide a hospital-grade breast pump to the patient, much like a continuous positive airway pressure machine is provided to patients with obstructive sleep apnea.²⁰ However, there is often considerable difficulty obtaining proper breastfeeding equipment and a lack of services devoted to perinatal care in general inpatient settings. Barriers to direct breastfeeding and pumping of breastmilk are highlighted in the Table.²¹

Limitations on breastfeeding on an inpatient unit

The limitations in care and restrictions placed on breastfeeding are more optimally addressed in a mother and baby unit (MBU). MBUs are specialized inpatient psychiatric units designed for mothers experiencing severe perinatal psychiatric difficulties. Unlike general psychiatric units, MBUs allow for joint, full-time admission of mothers and their infants. These units also include multidisciplinary staff who specialize in treating perinatal mental health issues as well as infant care and child development.²² Admission into an MBU is considered best practice for new mothers requiring treatment, particularly in the United Kingdom, Australia, and France, as it is well-recognized that the separation of mother and baby can be psychologically harmful.²³ In the UK, most patients admitted to an MBU showed significant improvement of their psychiatric symptoms and reported overall high satisfaction with care.^24,25 Patients who experience postpartum psychosis prefer MBUs over general psychiatric units because the latter often lack specialized perinatal support, appropriate visitor arrangements, and adequate time with their infant.^26-28

Continue to: The resistance to adopting MBUs in the United States...

The resistance to adopting MBUs in the United States has posed significant barriers in care for perinatal patients and has been attributed to financial barriers, medicolegal risk, staffing, and safety concerns.²⁹ Though currently there are no MBUs in the US, other specialized units have been created. A partial day hospitalization program created in 2000 in Rhode Island for mothers and infants revolutionized the psychiatric care experience for new mothers.³⁰ Since then, other institutions have significantly expanded their services to include perinatal psychiatry inpatient units, yet unlike MBUs, these units typically do not provide overnight rooming-in with infants.³¹ They have the necessary resources and facilities to accommodate the mother’s needs and maximize positive mother-infant interaction, while actively integrating the infant into the mother’s treatment. Breast pumping is treated as a necessary medical procedure and patients can easily access hospital-grade breast pumps with staff supervision. At one such perinatal psychiatric inpatient unit, high rates of treatment satisfaction and significant improvements in symptoms of depression, anxiety, active suicidal ideation, and overall functioning were observed at discharge.³² Therefore, it is crucial to incorporate strategies in general psychiatry units to improve perinatal care, acknowledging that most patients will not have access to these specialized units.²¹

A framework to approaching the relational ethics decisions

An interdisciplinary team used a relational ethics perspective to carefully analyze the risks and benefits of these complex cases. In Figure 1, we propose a framework for the relational ethics decisions of breastfeeding on general inpatient psychiatric units. In creating this framework, we considered principles of autonomy, beneficence, and nonmaleficence, along with the medical and logistical barriers to breastfeeding.

In Ms. C’s case, the team determined that the risks—which included disrupting the mother’s psychiatric treatment, exposing her to psychological harm due to increasing attachment before remanding the child to CPS custody, and risks to the child due to potential unpredictable agitation driven by the treatment-refractory psychosis of the mother as well as that of other psychiatric patients—outweighed the benefits of breastfeeding. We instead recommended breast pumping as an alternative once Ms. C’s psychiatric stability improved. We presented Ms. C with the option of breast pumping on postpartum Day 5. During a 1-day period in which she showed improved behavioral control, she was counseled on the risks and benefits of breastfeeding and exclusive pumping and was notified that the team would help her with the necessary resources, including consultation with a lactation specialist and breast pump. Despite lactation consultant support, Ms. C had low milk production and difficulty with hand expression, which was very discouraging to her. She produced 1 ounce of milk that was shared with the newborn while in the NICU. Because Ms. C’s psychiatric symptoms continued to be severe, with lability and aggression, and because pumping was triggering distress, the multidisciplinary team determined the best course of care would be to focus on her psychiatric recovery rather than on pumping breastmilk. To reduce milk production and minimize discomfort secondary to breast engorgement, the lactation consultant recommended cold compresses, pain management, and compression of breasts. Ultimately, the mother-infant dyad was unable to reap the benefits of breastfeeding (via pumping or direct breastfeeding) due to the mother’s underlying psychiatric illness, although the staffing, psychosocial support, and logistical limitations contributed to this outcome.³³

In Ms. S’s case, the treatment team determined that there were no medical or psychiatric contraindications to breastfeeding, and she was counseled on the risks and benefits of direct breastfeeding and pumping. The treatment team determined it was safe for Ms. S to directly breastfeed as there were no concerns for infant harm post­delivery with constant supervision while on the obstetrics floor. The patient opted to directly breastfeed, which was successful with the guidance of a lactation specialist. When she was transferred to the psychiatric unit on postpartum Day 2, her child was discharged home with the husband. The patient was then encouraged to pump while the psychiatrists monitored her symptoms closely and facilitated increased staff and resources. Transportation of breastmilk was made possible by the family, and on postpartum Day 5, as the patient maintained psychiatric stability, the team discussed with Ms. S and her husband the prospect of direct breastfeeding. The treatment team arranged for separate visitation hours to minimize the possibility of exposing the infant to aggression from other patients on the unit and advocated with hospital leadership to approve of infant visitation on the unit.

Impact of involvement of Child Protective Services

The involvement of CPS also added complexity to Ms. C’s case. Without proper legal guidance, mothers with psychosis who lose custody can find it difficult to navigate the legal system and maintain contact with their children.³⁴ As the prevalence of custody loss in mothers with psychosis is high (approximately 50% according to research published in the last 10 years), effective interventions to reunite the mother and child must be promoted (Figure 2).^35-39 Ultimately, the goal of psychiatric hospitalization for perinatal women who have SMI is psychiatric stabilization. The preemptive involvement of psychiatry is crucial because it can allow for early postpartum planning and can provide an opportunity to address feeding options and custody concerns with the patient, social supports and services, and various medical teams. In Ms. C’s case, she visited her baby in the NICU on postpartum Day 2 without consultation with psychiatry or CPS, which posed risks to the patient, infant, and staff. It is vital that various clinicians collaborate with each other and the patient, working towards the goal of optimizing the patient’s mental health to allow for parenting rights in the future and maximizing a sustainable attachment between the parent and child. In Ms. S’s case, the husband was able to facilitate caring for the baby while the mother was hospitalized and played an integral role in the feeding process via pumped breastmilk and transport of the infant for direct breastfeeding.

Continue to: The differences in these 2 cases...

The differences in these 2 cases show the extreme importance of social support to benefit both the mother and child, and the need for more comprehensive social services for women who do not have a social safety net.

Bottom Line

These complex cases highlight an ethical decision-making approach to breastfeeding in perinatal women who have serious mental illness. Collaborative care and shared decision-making, which highlight the interests of the mother and baby, are crucial when assessing the risks and benefits of breastfeeding and pumping breastmilk. Our relational ethics framework can be used to better evaluate and implement breastfeeding options on general psychiatric units.

Related Resources

• Tillman B, Sloan N, Westmoreland P. How COVID-19 affects peripartum women’s mental health. Current Psychiatry. 2021;20(6):18-22. doi:10.12788/cp.0129
• Koch J, Preinitz J. Antidepressants for patients who are breastfeeding: what to consider. Current Psychiatry. 2023;22(5):20-23,48. doi:10.12788/cp.0355

Drug Brand Names

Aripiprazole • Abilify
Olanzapine • Zyprexa
Risperidone • Risperdal

In the United States, opioid use by patients who are pregnant more than quadrupled from 1999 to 2014.¹ Opioid use disorder (OUD) in the perinatal period is associated with a higher risk for depression, suicide, malnutrition, domestic violence, and obstetric complications such as spontaneous abortion, preeclampsia, and premature delivery.² Buprenorphine and methadone are the standard of care for treating OUD in pregnancy.^3,4 While a literature review found that maternal treatment with buprenorphine has comparable efficacy to treatment with methadone,⁵ a small randomized, double-blind study found that compared to buprenorphine, methadone was associated with significantly lower use of additional opioids (P = .047).⁶ This suggests methadone has therapeutic value for patients who are pregnant.

Despite the benefits of methadone for treating perinatal OUD, the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Patients typically take methadone once a day, and the dose is titrated every 3 to 5 days to allow serum levels to reach steady state.⁷ During pregnancy, there are increases in both the volume of distribution and medication metabolism secondary to increased expression of the cytochrome P450 3A4 enzyme by the liver, intestine, and placenta.⁸ Additionally, as the pregnancy progresses, the rate of methadone metabolism increases.⁹ Methadone’s half-life (20 to 35 hours) leads to its accumulation in tissue and slow release into the blood.¹⁰ As a result, patients with OUD who are pregnant often require higher doses of methadone or divided dosing, particularly in the second and third trimesters.¹¹

In this article, we provide a strategy for divided dosing of methadone for managing opioid withdrawal symptoms in the acute care setting. We present 2 cases of women with OUD who are pregnant and describe the collaboration of addiction medicine, consultation-liaison psychiatry, and obstetrics services.

CASE 1

Ms. H, age 29, is G3P2 and presents to the emergency department (ED) during her fourth pregnancy at 31 weeks, 1 day gestation. She has a history of opioid, cocaine, and benzodiazepine use disorders and chronic hepatitis C. Ms. H is enrolled in an opioid treatment program and takes methadone 190 mg/d in addition to nonprescribed opioids. In the ED, Ms. H requests medically supervised withdrawal management. Her urine toxicology is positive for cocaine, benzodiazepines, methadone, and opiates. Her laboratory results and electrocardiogram (ECG) are unremarkable. On admission, Ms. H’s Clinical Opiate Withdrawal Scale (COWS) score is 3, indicating minimal symptoms (5 to 12: mild; 13 to 24: moderate; 25 to 36: moderately severe; >36: severe). Fetal monitoring is reassuring.

Ms. H’s withdrawal is monitored with COWS every 4 hours. The treatment team initiates methadone 170 mg/d, with an additional 10 mg/d as needed to keep her COWS score <8, and daily QTc monitoring. Ms. H also receives lorazepam 2 to 4 mg/d as needed for benzodiazepine withdrawal. Despite the increase in her daily methadone dose, Ms. H continues to experience opioid withdrawal in the early evening and overnight. As a result, the treatment team increases Ms. H’s morning methadone dose to 190 mg and schedules an afternoon dose of 30 mg. Despite this adjustment, her COWS scores remain elevated in the afternoon and evening, and she requires additional as-needed doses of methadone. Methadone peak and trough levels are ordered to assess for rapid metabolism. The serum trough level is 190 ng/mL, which is low, and a serum peak level is not reported. Despite titration, Ms. H has a self-directed premature discharge.

Five days later at 32 weeks, 2 days gestation, Ms. H is readmitted after she had resumed use of opioids, benzodiazepines, and cocaine. Her vital signs are stable, and her laboratory results and ECG are unremarkable. Fetal monitoring is reassuring. Given Ms. H’s low methadone serum trough level and overall concern for rapid methadone metabolism, the treatment team decides to divide dosing of methadone. Over 9 days, the team titrates methadone to 170 mg twice daily on the day of discharge, which resolves Ms. H’s withdrawal symptoms.

At 38 weeks, 5 days gestation, Ms. H returns to the ED after experiencing labor contractions and opiate withdrawal symptoms after she resumed use of heroin, cocaine, and benzodiazepines. During this admission, Ms. H’s methadone is increased to 180 mg twice daily with additional as-needed doses for ongoing withdrawal symptoms. At 39 weeks, 2 days gestation, Ms. H has a scheduled cesarean delivery.

Her infant has a normal weight but is transferred to the neonatal intensive care unit (NICU) for management of neonatal opioid withdrawal syndrome (NOWS) and receives morphine. The baby remains in the NICU for 35 days and is discharged home without further treatment. When Ms. H is discharged, her methadone dose is 170 mg twice daily, which resolves her opioid withdrawal symptoms. The treatment team directs her to continue care in her methadone outpatient program and receive treatment for her cocaine and benzodiazepine use disorders. She declines residential or inpatient substance use treatment.

Continue to: CASE 2

Ms. M, age 39, is G4P2 and presents to the hospital during her fifth pregnancy at 27 weeks gestation. She has not received prenatal care for this pregnancy. She has a history of OUD and major depressive disorder (MDD). Ms. M’s urine toxicology is positive for opiates, fentanyl, and oxycodone. Her laboratory results are notable for mildly elevated alanine aminotransferase, positive hepatitis C antibody, and a hepatitis C viral load of 91,000, consistent with chronic hepatitis C infection. On admission, her COWS score is 14, indicating moderate withdrawal symptoms. Her ECG is unremarkable, and fetal monitoring is reassuring.

Ms. M had received methadone during a prior pregnancy and opts to reinitiate treatment with methadone during her current admission. The team initiates methadone 20 mg/d with additional as-needed doses for ongoing withdrawal symptoms. Due to a persistently elevated COWS score, Ms. M’s methadone is increased to 90 mg/d, which resolves her withdrawal symptoms. However, on Day 4, Ms. M reports having anxiety, refuses bloodwork to obtain methadone peak and trough levels, and prematurely discharges from the hospital.

One day later at 27 weeks, 5 days gestation, Ms. M is readmitted for continued management of opioid withdrawal. She presents with stable vital signs, an unremarkable ECG, and reassuring fetal monitoring. Her COWS score is 5. The treatment team reinitiates methadone at 80 mg/d and titrates it to 100 mg/d on Day 7. Given Ms. M’s ongoing evening cravings and concern for rapid methadone metabolism, on Day 10 the team switches the methadone dosing to 50 mg twice daily to maintain steady-state levels and promote patient comfort. Fluoxetine 20 mg/d is started for comorbid MDD and eventually increased to 80 mg/d. Ms. M is discharged on Day 15 with a regimen of methadone 60 mg/d in the morning and 70 mg/d at night. She plans to resume care in an opioid treatment program and follow up with psychiatry and hepatology for her anxiety and hepatitis C.

A need for aggressive treatment

Given the rising rates of opioid use by patients who are pregnant, harmful behavior related to opioid use, and a wealth of evidence supporting opioid agonist treatment for OUD in pregnancy, there is a growing need for guidance in managing perinatal OUD. A systematic approach to using methadone to treat OUD in patients who are pregnant is essential; the lack of data surrounding use of this medication in such patients may cause overall harm.¹² Limited guidelines and a lack of familiarity with prescribing methadone to patients who are pregnant may lead clinicians to underdose patients, which can result in ongoing withdrawal, premature patient-directed discharges, and poor engagement in care.¹³ Both patients in the 2 cases described in this article experienced ongoing withdrawal symptoms despite daily titration of methadone. This suggests rapid metabolism, which was successfully managed by dividing the dosing of methadone, particularly in the latter trimesters.

These cases illustrate the need for aggressive perinatal opioid withdrawal management through rapid escalation of divided doses of methadone in a monitored acute care setting. Because methadone elimination is more rapid and clearance rates increase during the perinatal period, divided methadone dosing allows for sustained plasma methadone concentrations and improved outpatient treatment adherence.^9,14,15

Continue to: Decreasing the rate of premature discharges

Decreasing the rate of premature discharges

In both cases, the patients discharged from the hospital prematurely, likely related to incomplete management of their opioid withdrawal or other withdrawal syndromes (both patients had multiple substance use disorders [SUDs]). Compared to patients without an SUD, patients with SUDs are 3 times more likely to have a self-directed discharge.¹⁶ Patients report leaving the hospital prematurely due to undertreated withdrawal, uncontrolled pain, discrimination by staff, and hospital restrictions.¹⁶ Recommendations to decrease the rates of premature patient-directed discharges in this population include providing patient-centered and harm reduction–oriented care in addition to adequate management of pain and withdrawal.¹⁷

Impact of methadone on fetal outcomes

Approximately 55% to 94% of infants born to patients who are opioid-dependent will develop NOWS. However, there is no relationship between this syndrome and therapeutic doses of methadone.¹⁸ Moreover, long-term research has found that after adjusting for socioeconomic factors, methadone treatment during pregnancy does not have an adverse effect on postnatal development. Divided dosing in maternal methadone administration is also shown to have less of an impact on fetal neurobehavior and NOWS.¹⁹

Our recommendations for methadone treatment for perinatal patients are outlined in the Table. Aggressive treatment of opioid withdrawal in the hospital can promote treatment engagement and prevent premature discharges. Clinicians should assess for other withdrawal syndromes when a patient has multiple SUDs and collaborate with an interdisciplinary team to improve patient outcomes.

Bottom Line

The prevalence of opioid use disorder (OUD) in patients who are pregnant is increasing. Methadone is an option for treating perinatal OUD, but the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Using divided doses of methadone can ensure the comfort and safety of the patient and their baby and improve adherence and outcomes.

Related Resources

• Chaney L, Mathia C, Cole T. Transitioning patients with opioid use disorder from methadone to buprenorphine. Current Psychiatry. 2022;21(12):23-24,28. doi:10.12788/cp.0305
• Townsel C, Irani S, Buis C, et al. Partnering for the future clinic: a multidisciplinary perinatal substance use program. Gen Hosp Psychiatry. 2023;85:220-228. doi:10.1016/j. genhosppsych.2023.10.009

Drug Brand Names

Buprenorphine • Buprenex, Suboxone, Zubsolv, Sublocade
Fentanyl • Abstral, Actiq
Fluoxetine • Prozac
Lorazepam • Ativan
Methadone • Methadose, Dolophine
Oxycodone • Oxycontin

In the United States, opioid use by patients who are pregnant more than quadrupled from 1999 to 2014.¹ Opioid use disorder (OUD) in the perinatal period is associated with a higher risk for depression, suicide, malnutrition, domestic violence, and obstetric complications such as spontaneous abortion, preeclampsia, and premature delivery.² Buprenorphine and methadone are the standard of care for treating OUD in pregnancy.^3,4 While a literature review found that maternal treatment with buprenorphine has comparable efficacy to treatment with methadone,⁵ a small randomized, double-blind study found that compared to buprenorphine, methadone was associated with significantly lower use of additional opioids (P = .047).⁶ This suggests methadone has therapeutic value for patients who are pregnant.

Despite the benefits of methadone for treating perinatal OUD, the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Patients typically take methadone once a day, and the dose is titrated every 3 to 5 days to allow serum levels to reach steady state.⁷ During pregnancy, there are increases in both the volume of distribution and medication metabolism secondary to increased expression of the cytochrome P450 3A4 enzyme by the liver, intestine, and placenta.⁸ Additionally, as the pregnancy progresses, the rate of methadone metabolism increases.⁹ Methadone’s half-life (20 to 35 hours) leads to its accumulation in tissue and slow release into the blood.¹⁰ As a result, patients with OUD who are pregnant often require higher doses of methadone or divided dosing, particularly in the second and third trimesters.¹¹

In this article, we provide a strategy for divided dosing of methadone for managing opioid withdrawal symptoms in the acute care setting. We present 2 cases of women with OUD who are pregnant and describe the collaboration of addiction medicine, consultation-liaison psychiatry, and obstetrics services.

CASE 1

Ms. H, age 29, is G3P2 and presents to the emergency department (ED) during her fourth pregnancy at 31 weeks, 1 day gestation. She has a history of opioid, cocaine, and benzodiazepine use disorders and chronic hepatitis C. Ms. H is enrolled in an opioid treatment program and takes methadone 190 mg/d in addition to nonprescribed opioids. In the ED, Ms. H requests medically supervised withdrawal management. Her urine toxicology is positive for cocaine, benzodiazepines, methadone, and opiates. Her laboratory results and electrocardiogram (ECG) are unremarkable. On admission, Ms. H’s Clinical Opiate Withdrawal Scale (COWS) score is 3, indicating minimal symptoms (5 to 12: mild; 13 to 24: moderate; 25 to 36: moderately severe; >36: severe). Fetal monitoring is reassuring.

Ms. H’s withdrawal is monitored with COWS every 4 hours. The treatment team initiates methadone 170 mg/d, with an additional 10 mg/d as needed to keep her COWS score <8, and daily QTc monitoring. Ms. H also receives lorazepam 2 to 4 mg/d as needed for benzodiazepine withdrawal. Despite the increase in her daily methadone dose, Ms. H continues to experience opioid withdrawal in the early evening and overnight. As a result, the treatment team increases Ms. H’s morning methadone dose to 190 mg and schedules an afternoon dose of 30 mg. Despite this adjustment, her COWS scores remain elevated in the afternoon and evening, and she requires additional as-needed doses of methadone. Methadone peak and trough levels are ordered to assess for rapid metabolism. The serum trough level is 190 ng/mL, which is low, and a serum peak level is not reported. Despite titration, Ms. H has a self-directed premature discharge.

Five days later at 32 weeks, 2 days gestation, Ms. H is readmitted after she had resumed use of opioids, benzodiazepines, and cocaine. Her vital signs are stable, and her laboratory results and ECG are unremarkable. Fetal monitoring is reassuring. Given Ms. H’s low methadone serum trough level and overall concern for rapid methadone metabolism, the treatment team decides to divide dosing of methadone. Over 9 days, the team titrates methadone to 170 mg twice daily on the day of discharge, which resolves Ms. H’s withdrawal symptoms.

At 38 weeks, 5 days gestation, Ms. H returns to the ED after experiencing labor contractions and opiate withdrawal symptoms after she resumed use of heroin, cocaine, and benzodiazepines. During this admission, Ms. H’s methadone is increased to 180 mg twice daily with additional as-needed doses for ongoing withdrawal symptoms. At 39 weeks, 2 days gestation, Ms. H has a scheduled cesarean delivery.

Her infant has a normal weight but is transferred to the neonatal intensive care unit (NICU) for management of neonatal opioid withdrawal syndrome (NOWS) and receives morphine. The baby remains in the NICU for 35 days and is discharged home without further treatment. When Ms. H is discharged, her methadone dose is 170 mg twice daily, which resolves her opioid withdrawal symptoms. The treatment team directs her to continue care in her methadone outpatient program and receive treatment for her cocaine and benzodiazepine use disorders. She declines residential or inpatient substance use treatment.

Continue to: CASE 2

Ms. M, age 39, is G4P2 and presents to the hospital during her fifth pregnancy at 27 weeks gestation. She has not received prenatal care for this pregnancy. She has a history of OUD and major depressive disorder (MDD). Ms. M’s urine toxicology is positive for opiates, fentanyl, and oxycodone. Her laboratory results are notable for mildly elevated alanine aminotransferase, positive hepatitis C antibody, and a hepatitis C viral load of 91,000, consistent with chronic hepatitis C infection. On admission, her COWS score is 14, indicating moderate withdrawal symptoms. Her ECG is unremarkable, and fetal monitoring is reassuring.

Ms. M had received methadone during a prior pregnancy and opts to reinitiate treatment with methadone during her current admission. The team initiates methadone 20 mg/d with additional as-needed doses for ongoing withdrawal symptoms. Due to a persistently elevated COWS score, Ms. M’s methadone is increased to 90 mg/d, which resolves her withdrawal symptoms. However, on Day 4, Ms. M reports having anxiety, refuses bloodwork to obtain methadone peak and trough levels, and prematurely discharges from the hospital.

One day later at 27 weeks, 5 days gestation, Ms. M is readmitted for continued management of opioid withdrawal. She presents with stable vital signs, an unremarkable ECG, and reassuring fetal monitoring. Her COWS score is 5. The treatment team reinitiates methadone at 80 mg/d and titrates it to 100 mg/d on Day 7. Given Ms. M’s ongoing evening cravings and concern for rapid methadone metabolism, on Day 10 the team switches the methadone dosing to 50 mg twice daily to maintain steady-state levels and promote patient comfort. Fluoxetine 20 mg/d is started for comorbid MDD and eventually increased to 80 mg/d. Ms. M is discharged on Day 15 with a regimen of methadone 60 mg/d in the morning and 70 mg/d at night. She plans to resume care in an opioid treatment program and follow up with psychiatry and hepatology for her anxiety and hepatitis C.

A need for aggressive treatment

Given the rising rates of opioid use by patients who are pregnant, harmful behavior related to opioid use, and a wealth of evidence supporting opioid agonist treatment for OUD in pregnancy, there is a growing need for guidance in managing perinatal OUD. A systematic approach to using methadone to treat OUD in patients who are pregnant is essential; the lack of data surrounding use of this medication in such patients may cause overall harm.¹² Limited guidelines and a lack of familiarity with prescribing methadone to patients who are pregnant may lead clinicians to underdose patients, which can result in ongoing withdrawal, premature patient-directed discharges, and poor engagement in care.¹³ Both patients in the 2 cases described in this article experienced ongoing withdrawal symptoms despite daily titration of methadone. This suggests rapid metabolism, which was successfully managed by dividing the dosing of methadone, particularly in the latter trimesters.

These cases illustrate the need for aggressive perinatal opioid withdrawal management through rapid escalation of divided doses of methadone in a monitored acute care setting. Because methadone elimination is more rapid and clearance rates increase during the perinatal period, divided methadone dosing allows for sustained plasma methadone concentrations and improved outpatient treatment adherence.^9,14,15

Continue to: Decreasing the rate of premature discharges

Decreasing the rate of premature discharges

In both cases, the patients discharged from the hospital prematurely, likely related to incomplete management of their opioid withdrawal or other withdrawal syndromes (both patients had multiple substance use disorders [SUDs]). Compared to patients without an SUD, patients with SUDs are 3 times more likely to have a self-directed discharge.¹⁶ Patients report leaving the hospital prematurely due to undertreated withdrawal, uncontrolled pain, discrimination by staff, and hospital restrictions.¹⁶ Recommendations to decrease the rates of premature patient-directed discharges in this population include providing patient-centered and harm reduction–oriented care in addition to adequate management of pain and withdrawal.¹⁷

Impact of methadone on fetal outcomes

Approximately 55% to 94% of infants born to patients who are opioid-dependent will develop NOWS. However, there is no relationship between this syndrome and therapeutic doses of methadone.¹⁸ Moreover, long-term research has found that after adjusting for socioeconomic factors, methadone treatment during pregnancy does not have an adverse effect on postnatal development. Divided dosing in maternal methadone administration is also shown to have less of an impact on fetal neurobehavior and NOWS.¹⁹

Our recommendations for methadone treatment for perinatal patients are outlined in the Table. Aggressive treatment of opioid withdrawal in the hospital can promote treatment engagement and prevent premature discharges. Clinicians should assess for other withdrawal syndromes when a patient has multiple SUDs and collaborate with an interdisciplinary team to improve patient outcomes.

Bottom Line

The prevalence of opioid use disorder (OUD) in patients who are pregnant is increasing. Methadone is an option for treating perinatal OUD, but the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Using divided doses of methadone can ensure the comfort and safety of the patient and their baby and improve adherence and outcomes.

Related Resources

• Chaney L, Mathia C, Cole T. Transitioning patients with opioid use disorder from methadone to buprenorphine. Current Psychiatry. 2022;21(12):23-24,28. doi:10.12788/cp.0305
• Townsel C, Irani S, Buis C, et al. Partnering for the future clinic: a multidisciplinary perinatal substance use program. Gen Hosp Psychiatry. 2023;85:220-228. doi:10.1016/j. genhosppsych.2023.10.009

Drug Brand Names

Buprenorphine • Buprenex, Suboxone, Zubsolv, Sublocade
Fentanyl • Abstral, Actiq
Fluoxetine • Prozac
Lorazepam • Ativan
Methadone • Methadose, Dolophine
Oxycodone • Oxycontin

In the United States, opioid use by patients who are pregnant more than quadrupled from 1999 to 2014.¹ Opioid use disorder (OUD) in the perinatal period is associated with a higher risk for depression, suicide, malnutrition, domestic violence, and obstetric complications such as spontaneous abortion, preeclampsia, and premature delivery.² Buprenorphine and methadone are the standard of care for treating OUD in pregnancy.^3,4 While a literature review found that maternal treatment with buprenorphine has comparable efficacy to treatment with methadone,⁵ a small randomized, double-blind study found that compared to buprenorphine, methadone was associated with significantly lower use of additional opioids (P = .047).⁶ This suggests methadone has therapeutic value for patients who are pregnant.

Despite the benefits of methadone for treating perinatal OUD, the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Patients typically take methadone once a day, and the dose is titrated every 3 to 5 days to allow serum levels to reach steady state.⁷ During pregnancy, there are increases in both the volume of distribution and medication metabolism secondary to increased expression of the cytochrome P450 3A4 enzyme by the liver, intestine, and placenta.⁸ Additionally, as the pregnancy progresses, the rate of methadone metabolism increases.⁹ Methadone’s half-life (20 to 35 hours) leads to its accumulation in tissue and slow release into the blood.¹⁰ As a result, patients with OUD who are pregnant often require higher doses of methadone or divided dosing, particularly in the second and third trimesters.¹¹

In this article, we provide a strategy for divided dosing of methadone for managing opioid withdrawal symptoms in the acute care setting. We present 2 cases of women with OUD who are pregnant and describe the collaboration of addiction medicine, consultation-liaison psychiatry, and obstetrics services.

CASE 1

Ms. H, age 29, is G3P2 and presents to the emergency department (ED) during her fourth pregnancy at 31 weeks, 1 day gestation. She has a history of opioid, cocaine, and benzodiazepine use disorders and chronic hepatitis C. Ms. H is enrolled in an opioid treatment program and takes methadone 190 mg/d in addition to nonprescribed opioids. In the ED, Ms. H requests medically supervised withdrawal management. Her urine toxicology is positive for cocaine, benzodiazepines, methadone, and opiates. Her laboratory results and electrocardiogram (ECG) are unremarkable. On admission, Ms. H’s Clinical Opiate Withdrawal Scale (COWS) score is 3, indicating minimal symptoms (5 to 12: mild; 13 to 24: moderate; 25 to 36: moderately severe; >36: severe). Fetal monitoring is reassuring.

Ms. H’s withdrawal is monitored with COWS every 4 hours. The treatment team initiates methadone 170 mg/d, with an additional 10 mg/d as needed to keep her COWS score <8, and daily QTc monitoring. Ms. H also receives lorazepam 2 to 4 mg/d as needed for benzodiazepine withdrawal. Despite the increase in her daily methadone dose, Ms. H continues to experience opioid withdrawal in the early evening and overnight. As a result, the treatment team increases Ms. H’s morning methadone dose to 190 mg and schedules an afternoon dose of 30 mg. Despite this adjustment, her COWS scores remain elevated in the afternoon and evening, and she requires additional as-needed doses of methadone. Methadone peak and trough levels are ordered to assess for rapid metabolism. The serum trough level is 190 ng/mL, which is low, and a serum peak level is not reported. Despite titration, Ms. H has a self-directed premature discharge.

Five days later at 32 weeks, 2 days gestation, Ms. H is readmitted after she had resumed use of opioids, benzodiazepines, and cocaine. Her vital signs are stable, and her laboratory results and ECG are unremarkable. Fetal monitoring is reassuring. Given Ms. H’s low methadone serum trough level and overall concern for rapid methadone metabolism, the treatment team decides to divide dosing of methadone. Over 9 days, the team titrates methadone to 170 mg twice daily on the day of discharge, which resolves Ms. H’s withdrawal symptoms.

At 38 weeks, 5 days gestation, Ms. H returns to the ED after experiencing labor contractions and opiate withdrawal symptoms after she resumed use of heroin, cocaine, and benzodiazepines. During this admission, Ms. H’s methadone is increased to 180 mg twice daily with additional as-needed doses for ongoing withdrawal symptoms. At 39 weeks, 2 days gestation, Ms. H has a scheduled cesarean delivery.

Her infant has a normal weight but is transferred to the neonatal intensive care unit (NICU) for management of neonatal opioid withdrawal syndrome (NOWS) and receives morphine. The baby remains in the NICU for 35 days and is discharged home without further treatment. When Ms. H is discharged, her methadone dose is 170 mg twice daily, which resolves her opioid withdrawal symptoms. The treatment team directs her to continue care in her methadone outpatient program and receive treatment for her cocaine and benzodiazepine use disorders. She declines residential or inpatient substance use treatment.

Continue to: CASE 2

Ms. M, age 39, is G4P2 and presents to the hospital during her fifth pregnancy at 27 weeks gestation. She has not received prenatal care for this pregnancy. She has a history of OUD and major depressive disorder (MDD). Ms. M’s urine toxicology is positive for opiates, fentanyl, and oxycodone. Her laboratory results are notable for mildly elevated alanine aminotransferase, positive hepatitis C antibody, and a hepatitis C viral load of 91,000, consistent with chronic hepatitis C infection. On admission, her COWS score is 14, indicating moderate withdrawal symptoms. Her ECG is unremarkable, and fetal monitoring is reassuring.

Ms. M had received methadone during a prior pregnancy and opts to reinitiate treatment with methadone during her current admission. The team initiates methadone 20 mg/d with additional as-needed doses for ongoing withdrawal symptoms. Due to a persistently elevated COWS score, Ms. M’s methadone is increased to 90 mg/d, which resolves her withdrawal symptoms. However, on Day 4, Ms. M reports having anxiety, refuses bloodwork to obtain methadone peak and trough levels, and prematurely discharges from the hospital.

One day later at 27 weeks, 5 days gestation, Ms. M is readmitted for continued management of opioid withdrawal. She presents with stable vital signs, an unremarkable ECG, and reassuring fetal monitoring. Her COWS score is 5. The treatment team reinitiates methadone at 80 mg/d and titrates it to 100 mg/d on Day 7. Given Ms. M’s ongoing evening cravings and concern for rapid methadone metabolism, on Day 10 the team switches the methadone dosing to 50 mg twice daily to maintain steady-state levels and promote patient comfort. Fluoxetine 20 mg/d is started for comorbid MDD and eventually increased to 80 mg/d. Ms. M is discharged on Day 15 with a regimen of methadone 60 mg/d in the morning and 70 mg/d at night. She plans to resume care in an opioid treatment program and follow up with psychiatry and hepatology for her anxiety and hepatitis C.

A need for aggressive treatment

Given the rising rates of opioid use by patients who are pregnant, harmful behavior related to opioid use, and a wealth of evidence supporting opioid agonist treatment for OUD in pregnancy, there is a growing need for guidance in managing perinatal OUD. A systematic approach to using methadone to treat OUD in patients who are pregnant is essential; the lack of data surrounding use of this medication in such patients may cause overall harm.¹² Limited guidelines and a lack of familiarity with prescribing methadone to patients who are pregnant may lead clinicians to underdose patients, which can result in ongoing withdrawal, premature patient-directed discharges, and poor engagement in care.¹³ Both patients in the 2 cases described in this article experienced ongoing withdrawal symptoms despite daily titration of methadone. This suggests rapid metabolism, which was successfully managed by dividing the dosing of methadone, particularly in the latter trimesters.

These cases illustrate the need for aggressive perinatal opioid withdrawal management through rapid escalation of divided doses of methadone in a monitored acute care setting. Because methadone elimination is more rapid and clearance rates increase during the perinatal period, divided methadone dosing allows for sustained plasma methadone concentrations and improved outpatient treatment adherence.^9,14,15

Continue to: Decreasing the rate of premature discharges

Decreasing the rate of premature discharges

In both cases, the patients discharged from the hospital prematurely, likely related to incomplete management of their opioid withdrawal or other withdrawal syndromes (both patients had multiple substance use disorders [SUDs]). Compared to patients without an SUD, patients with SUDs are 3 times more likely to have a self-directed discharge.¹⁶ Patients report leaving the hospital prematurely due to undertreated withdrawal, uncontrolled pain, discrimination by staff, and hospital restrictions.¹⁶ Recommendations to decrease the rates of premature patient-directed discharges in this population include providing patient-centered and harm reduction–oriented care in addition to adequate management of pain and withdrawal.¹⁷

Impact of methadone on fetal outcomes

Approximately 55% to 94% of infants born to patients who are opioid-dependent will develop NOWS. However, there is no relationship between this syndrome and therapeutic doses of methadone.¹⁸ Moreover, long-term research has found that after adjusting for socioeconomic factors, methadone treatment during pregnancy does not have an adverse effect on postnatal development. Divided dosing in maternal methadone administration is also shown to have less of an impact on fetal neurobehavior and NOWS.¹⁹

Our recommendations for methadone treatment for perinatal patients are outlined in the Table. Aggressive treatment of opioid withdrawal in the hospital can promote treatment engagement and prevent premature discharges. Clinicians should assess for other withdrawal syndromes when a patient has multiple SUDs and collaborate with an interdisciplinary team to improve patient outcomes.

Bottom Line

The prevalence of opioid use disorder (OUD) in patients who are pregnant is increasing. Methadone is an option for treating perinatal OUD, but the physiological changes that occur in patients who are pregnant—coupled with methadone’s unique pharmacologic properties—may complicate its use. Using divided doses of methadone can ensure the comfort and safety of the patient and their baby and improve adherence and outcomes.

Related Resources

• Chaney L, Mathia C, Cole T. Transitioning patients with opioid use disorder from methadone to buprenorphine. Current Psychiatry. 2022;21(12):23-24,28. doi:10.12788/cp.0305
• Townsel C, Irani S, Buis C, et al. Partnering for the future clinic: a multidisciplinary perinatal substance use program. Gen Hosp Psychiatry. 2023;85:220-228. doi:10.1016/j. genhosppsych.2023.10.009

Drug Brand Names

Buprenorphine • Buprenex, Suboxone, Zubsolv, Sublocade
Fentanyl • Abstral, Actiq
Fluoxetine • Prozac
Lorazepam • Ativan
Methadone • Methadose, Dolophine
Oxycodone • Oxycontin

TOPLINE:

People who are extroverted and conscientious and have a positive outlook may be at lower dementia risk, whereas those who score highly for neuroticism and have a negative outlook may be at increased risk, new research suggests. 

METHODOLOGY: 

• Researchers examined the link between the “big five” personality traits (conscientiousness, extraversion, openness to experience, neuroticism, and agreeableness) and subjective well-being (positive and negative affect and life satisfaction) and clinical symptoms of dementia (cognitive test performance) and neuropathology at autopsy. 
• Data for the meta-analysis came from eight longitudinal studies with 44,531 adults (aged 49-81 years at baseline; 26%-61% women) followed for up to 21 years, during which 1703 incident cases of dementia occurred. 
• Bayesian multilevel models tested whether personality traits and subjective well-being differentially predicted neuropsychological and neuropathologic characteristics of dementia. 

TAKEAWAY:

• High neuroticism, negative affect, and low conscientiousness were risk factors for dementia, whereas conscientiousness, extraversion, and positive affect were protective.
• Across all analyses, there was directional consistency in estimates across samples, which is noteworthy given between-study differences in sociodemographic and design characteristics. 
• No consistent associations were found between psychological factors and neuropathology. 
• However, individuals higher in conscientiousness who did not receive a clinical diagnosis tended to have a lower Braak stage at autopsy, suggesting the possibility that conscientiousness is related to cognitive resilience. 

IN PRACTICE:

“These results replicate and extend evidence that personality traits may assist in early identification and dementia-care planning strategies, as well as risk stratification for dementia diagnosis. Moreover, our findings provide further support for recommendations to incorporate psychological trait measures into clinical screening or diagnosis criteria,” the authors write. SOURCE:

The study, with first author Emorie Beck, PhD, Department of Psychology, University of California, Davis, was published online on November 29, 2023, in Alzheimer’s & Dementia.

 LIMITATIONS:

Access to autopsy data was limited. The findings may not generalize across racial groups. The analysis did not examine dynamic associations between changing personality and cognition and neuropathology over time.

DISCLOSURES:

The study was supported by grants from the National Institute on Aging. The authors have declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

People who are extroverted and conscientious and have a positive outlook may be at lower dementia risk, whereas those who score highly for neuroticism and have a negative outlook may be at increased risk, new research suggests. 

METHODOLOGY: 

• Researchers examined the link between the “big five” personality traits (conscientiousness, extraversion, openness to experience, neuroticism, and agreeableness) and subjective well-being (positive and negative affect and life satisfaction) and clinical symptoms of dementia (cognitive test performance) and neuropathology at autopsy. 
• Data for the meta-analysis came from eight longitudinal studies with 44,531 adults (aged 49-81 years at baseline; 26%-61% women) followed for up to 21 years, during which 1703 incident cases of dementia occurred. 
• Bayesian multilevel models tested whether personality traits and subjective well-being differentially predicted neuropsychological and neuropathologic characteristics of dementia. 

TAKEAWAY:

• High neuroticism, negative affect, and low conscientiousness were risk factors for dementia, whereas conscientiousness, extraversion, and positive affect were protective.
• Across all analyses, there was directional consistency in estimates across samples, which is noteworthy given between-study differences in sociodemographic and design characteristics. 
• No consistent associations were found between psychological factors and neuropathology. 
• However, individuals higher in conscientiousness who did not receive a clinical diagnosis tended to have a lower Braak stage at autopsy, suggesting the possibility that conscientiousness is related to cognitive resilience. 

IN PRACTICE:

“These results replicate and extend evidence that personality traits may assist in early identification and dementia-care planning strategies, as well as risk stratification for dementia diagnosis. Moreover, our findings provide further support for recommendations to incorporate psychological trait measures into clinical screening or diagnosis criteria,” the authors write. SOURCE:

The study, with first author Emorie Beck, PhD, Department of Psychology, University of California, Davis, was published online on November 29, 2023, in Alzheimer’s & Dementia.

 LIMITATIONS:

Access to autopsy data was limited. The findings may not generalize across racial groups. The analysis did not examine dynamic associations between changing personality and cognition and neuropathology over time.

DISCLOSURES:

The study was supported by grants from the National Institute on Aging. The authors have declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

People who are extroverted and conscientious and have a positive outlook may be at lower dementia risk, whereas those who score highly for neuroticism and have a negative outlook may be at increased risk, new research suggests. 

METHODOLOGY: 

• Researchers examined the link between the “big five” personality traits (conscientiousness, extraversion, openness to experience, neuroticism, and agreeableness) and subjective well-being (positive and negative affect and life satisfaction) and clinical symptoms of dementia (cognitive test performance) and neuropathology at autopsy. 
• Data for the meta-analysis came from eight longitudinal studies with 44,531 adults (aged 49-81 years at baseline; 26%-61% women) followed for up to 21 years, during which 1703 incident cases of dementia occurred. 
• Bayesian multilevel models tested whether personality traits and subjective well-being differentially predicted neuropsychological and neuropathologic characteristics of dementia. 

TAKEAWAY:

• High neuroticism, negative affect, and low conscientiousness were risk factors for dementia, whereas conscientiousness, extraversion, and positive affect were protective.
• Across all analyses, there was directional consistency in estimates across samples, which is noteworthy given between-study differences in sociodemographic and design characteristics. 
• No consistent associations were found between psychological factors and neuropathology. 
• However, individuals higher in conscientiousness who did not receive a clinical diagnosis tended to have a lower Braak stage at autopsy, suggesting the possibility that conscientiousness is related to cognitive resilience. 

IN PRACTICE:

“These results replicate and extend evidence that personality traits may assist in early identification and dementia-care planning strategies, as well as risk stratification for dementia diagnosis. Moreover, our findings provide further support for recommendations to incorporate psychological trait measures into clinical screening or diagnosis criteria,” the authors write. SOURCE:

The study, with first author Emorie Beck, PhD, Department of Psychology, University of California, Davis, was published online on November 29, 2023, in Alzheimer’s & Dementia.

 LIMITATIONS:

Access to autopsy data was limited. The findings may not generalize across racial groups. The analysis did not examine dynamic associations between changing personality and cognition and neuropathology over time.

DISCLOSURES:

The study was supported by grants from the National Institute on Aging. The authors have declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adults diagnosed with coronary heart disease (CHD) are at an increased risk for dementia, including all-cause dementia, Alzheimer›s disease (AD), and vascular dementia (VD), with the risk highest — at 36% — if onset is before age 45, results of a large observational study show.

METHODOLOGY:

• The study included 432,667 of the more than 500,000 participants in the UK Biobank, with a mean age of 56.9 years, 50,685 (11.7%) of whom had CHD and 50,445 had data on age at CHD onset.
• Researchers divided participants into three groups according to age at CHD onset (below 45 years, 45-59 years, and 60 years and older), and carried out a propensity score matching analysis.
• Outcomes included all-cause dementia, AD, and VD.
• Covariates included age, sex, race, educational level, body mass index, low-density lipoprotein cholesterol, smoking status, alcohol intake, exercise, depressed mood, hypertension, diabetes, statin use, and apolipoprotein E4 status.

TAKEAWAY:

• During a median follow-up of 12.8 years, researchers identified 5876 cases of all-cause dementia, 2540 cases of AD, and 1220 cases of VD.
• Fully adjusted models showed participants with CHD had significantly higher risks than those without CHD of developing all-cause dementia (hazard ratio [HR], 1.36; 95% CI, 1.28-1.45; P < .001), AD (HR, 1.13; 95% CI, 1.02-1.24; P = .019), and VD (HR, 1.78; 95% CI, 1.56-2.02; P < .001). The higher risk for VD suggests CHD has a more profound influence on neuropathologic changes involved in this dementia type, said the authors.
• Those with CHD diagnosed at a younger age had higher risks of developing dementia (HR per 10-year decrease in age, 1.25; 95% CI, 1.20-1.30 for all-cause dementia, 1.29; 95% CI, 1.20-1.38 for AD, and 1.22; 95% CI, 1.13-1.31 for VD; P for all < .001).
• Propensity score matching analysis showed patients with CHD had significantly higher risks for dementia compared with matched controls, with the highest risk seen in patients diagnosed before age 45 (HR, 2.40; 95% CI, 1.79-3.20; P < .001), followed by those diagnosed between 45 and 59 years (HR, 1.46; 95% CI, 1.32-1.62; P < .001) and at or above 60 years (HR, 1.11; 95% CI, 1.03-1.19; P = .005), with similar results for AD and VD.

IN PRACTICE:

The findings suggest “additional attention should be paid to the cognitive status of patients with CHD, especially the ones diagnosed with CHD at a young age,” the authors conclude, noting that “timely intervention, such as cognitive training, could be implemented once signs of cognitive deteriorations are detected.”

SOURCE:

The study was conducted by Jie Liang, BS, School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, and colleagues. It was published online on November 29, 2023, in the Journal of the American Heart Association.

LIMITATIONS:

As this is an observational study, it can’t conclude a causal relationship. Although the authors adjusted for many potential confounders, unknown risk factors that also contribute to CHD can’t be ruled out. As the study excluded 69,744 participants, selection bias is possible. The study included a mostly White population.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China, the Non-Profit Central Research Institute Fund of the Chinese Academy of Medical Sciences, and the China Medical Board. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adults diagnosed with coronary heart disease (CHD) are at an increased risk for dementia, including all-cause dementia, Alzheimer›s disease (AD), and vascular dementia (VD), with the risk highest — at 36% — if onset is before age 45, results of a large observational study show.

METHODOLOGY:

• The study included 432,667 of the more than 500,000 participants in the UK Biobank, with a mean age of 56.9 years, 50,685 (11.7%) of whom had CHD and 50,445 had data on age at CHD onset.
• Researchers divided participants into three groups according to age at CHD onset (below 45 years, 45-59 years, and 60 years and older), and carried out a propensity score matching analysis.
• Outcomes included all-cause dementia, AD, and VD.
• Covariates included age, sex, race, educational level, body mass index, low-density lipoprotein cholesterol, smoking status, alcohol intake, exercise, depressed mood, hypertension, diabetes, statin use, and apolipoprotein E4 status.

TAKEAWAY:

• During a median follow-up of 12.8 years, researchers identified 5876 cases of all-cause dementia, 2540 cases of AD, and 1220 cases of VD.
• Fully adjusted models showed participants with CHD had significantly higher risks than those without CHD of developing all-cause dementia (hazard ratio [HR], 1.36; 95% CI, 1.28-1.45; P < .001), AD (HR, 1.13; 95% CI, 1.02-1.24; P = .019), and VD (HR, 1.78; 95% CI, 1.56-2.02; P < .001). The higher risk for VD suggests CHD has a more profound influence on neuropathologic changes involved in this dementia type, said the authors.
• Those with CHD diagnosed at a younger age had higher risks of developing dementia (HR per 10-year decrease in age, 1.25; 95% CI, 1.20-1.30 for all-cause dementia, 1.29; 95% CI, 1.20-1.38 for AD, and 1.22; 95% CI, 1.13-1.31 for VD; P for all < .001).
• Propensity score matching analysis showed patients with CHD had significantly higher risks for dementia compared with matched controls, with the highest risk seen in patients diagnosed before age 45 (HR, 2.40; 95% CI, 1.79-3.20; P < .001), followed by those diagnosed between 45 and 59 years (HR, 1.46; 95% CI, 1.32-1.62; P < .001) and at or above 60 years (HR, 1.11; 95% CI, 1.03-1.19; P = .005), with similar results for AD and VD.

IN PRACTICE:

The findings suggest “additional attention should be paid to the cognitive status of patients with CHD, especially the ones diagnosed with CHD at a young age,” the authors conclude, noting that “timely intervention, such as cognitive training, could be implemented once signs of cognitive deteriorations are detected.”

SOURCE:

The study was conducted by Jie Liang, BS, School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, and colleagues. It was published online on November 29, 2023, in the Journal of the American Heart Association.

LIMITATIONS:

As this is an observational study, it can’t conclude a causal relationship. Although the authors adjusted for many potential confounders, unknown risk factors that also contribute to CHD can’t be ruled out. As the study excluded 69,744 participants, selection bias is possible. The study included a mostly White population.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China, the Non-Profit Central Research Institute Fund of the Chinese Academy of Medical Sciences, and the China Medical Board. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Adults diagnosed with coronary heart disease (CHD) are at an increased risk for dementia, including all-cause dementia, Alzheimer›s disease (AD), and vascular dementia (VD), with the risk highest — at 36% — if onset is before age 45, results of a large observational study show.

METHODOLOGY:

• The study included 432,667 of the more than 500,000 participants in the UK Biobank, with a mean age of 56.9 years, 50,685 (11.7%) of whom had CHD and 50,445 had data on age at CHD onset.
• Researchers divided participants into three groups according to age at CHD onset (below 45 years, 45-59 years, and 60 years and older), and carried out a propensity score matching analysis.
• Outcomes included all-cause dementia, AD, and VD.
• Covariates included age, sex, race, educational level, body mass index, low-density lipoprotein cholesterol, smoking status, alcohol intake, exercise, depressed mood, hypertension, diabetes, statin use, and apolipoprotein E4 status.

TAKEAWAY:

• During a median follow-up of 12.8 years, researchers identified 5876 cases of all-cause dementia, 2540 cases of AD, and 1220 cases of VD.
• Fully adjusted models showed participants with CHD had significantly higher risks than those without CHD of developing all-cause dementia (hazard ratio [HR], 1.36; 95% CI, 1.28-1.45; P < .001), AD (HR, 1.13; 95% CI, 1.02-1.24; P = .019), and VD (HR, 1.78; 95% CI, 1.56-2.02; P < .001). The higher risk for VD suggests CHD has a more profound influence on neuropathologic changes involved in this dementia type, said the authors.
• Those with CHD diagnosed at a younger age had higher risks of developing dementia (HR per 10-year decrease in age, 1.25; 95% CI, 1.20-1.30 for all-cause dementia, 1.29; 95% CI, 1.20-1.38 for AD, and 1.22; 95% CI, 1.13-1.31 for VD; P for all < .001).
• Propensity score matching analysis showed patients with CHD had significantly higher risks for dementia compared with matched controls, with the highest risk seen in patients diagnosed before age 45 (HR, 2.40; 95% CI, 1.79-3.20; P < .001), followed by those diagnosed between 45 and 59 years (HR, 1.46; 95% CI, 1.32-1.62; P < .001) and at or above 60 years (HR, 1.11; 95% CI, 1.03-1.19; P = .005), with similar results for AD and VD.

IN PRACTICE:

The findings suggest “additional attention should be paid to the cognitive status of patients with CHD, especially the ones diagnosed with CHD at a young age,” the authors conclude, noting that “timely intervention, such as cognitive training, could be implemented once signs of cognitive deteriorations are detected.”

SOURCE:

The study was conducted by Jie Liang, BS, School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, and colleagues. It was published online on November 29, 2023, in the Journal of the American Heart Association.

LIMITATIONS:

As this is an observational study, it can’t conclude a causal relationship. Although the authors adjusted for many potential confounders, unknown risk factors that also contribute to CHD can’t be ruled out. As the study excluded 69,744 participants, selection bias is possible. The study included a mostly White population.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China, the Non-Profit Central Research Institute Fund of the Chinese Academy of Medical Sciences, and the China Medical Board. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.