Health Policy

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

Here is our problem: Family medicine has allowed itself, and its patients, to be picked apart by the forces of reductionism and a system that profits from the sick and suffering. We have lost sight of our purpose and our vision to care for the whole person. We have lost our way as healers.

The result is not only a decline in the specialty of family medicine as a leader in primary care but declining value and worsening outcomes in health care overall. We need to get our mojo back. We can do this by focusing less on trying to be all things to all people at all times, and more on creating better models for preventing, managing, and reversing chronic disease. This means providing health care that is person centered, relationship based, recovery focused, and paid for comprehensively.

I call this model Advanced Primary Care, or APC ­(FIGURE). In this article, I describe exemplars of APC from across the United States. I also provide tools to help you recover its central feature, holism—care of the whole person in mind, body, community, and spirit—in your practice, thus returning us to the core purpose of family medicine.

Holism is central to family medicine

More than 40 years ago, psychiatrist George Engel, MD, published a seminal article in Science that inspired a radical vision of how health care should be practiced.¹ Called the biopsychosocial model, it stated what, in some ways, is obvious: Human beings are complex organisms embedded in complex environments made up of distinct, yet interacting, dimensions. These dimensions included physical, psychological, and social components. Engel’s radical proposition was that these dimensions are definable and measurable and that good medicine cannot afford to ignore any of them.

Engel’s assertion that good medicine requires holism was a clarion call during a time of rapidly expanding knowledge and subspecialization. That call was the inspiration for a new medical specialty called family medicine, which dared to proclaim that the best way to heal was to care for the whole person within the context of that person’s emotional and social environment. Family medicine reinvigorated primary care and grew rapidly, becoming a preeminent primary care specialty in the United States.

Continue to : Reductionism is relentless

Reductionism is relentless

But the forces of medicine were—and still are—driving relentlessly the other way. The science of the small and particular (reductionism), with dazzling technology and exploding subspecialty knowledge, and backed by powerful economic drivers, rewards health care for pulling the patient and the medical profession apart. We pay more to those who treat small parts of a person over a short period than to those who attend to the whole person over the lifetime.

Today, family medicine—for all of its common sense, scientific soundness, connectedness to patients, and demonstrated value—struggles to survive.^2-6 The holistic vision of Engel is declining. The struggle in primary care is that its holistic vision gets co-opted by specialized medical science—and then it desperately attempts to apply those small and specialized tools to the care of patients in their wholeness. Holism is largely dead in health care, and everyone pays the consequences.⁷

Health care is losing its value

The damage from this decline in holism is not just to primary care but to the value of health care in general. Most medical care being delivered today—comprising diagnosis, treatment, and payment (the innermost circle of the FIGURE)—is not producing good health.⁸ Only 15% to 20% of the healing of an individual or a population comes from health care.⁹ The rest—nearly 80%—comes from other factors rarely addressed in the health care system: behavioral and lifestyle choices that people make in their daily life, including those related to food, movement, sleep, stress, and substance use.¹⁰ Increasingly, it is the economic and social determinants of health that influence this behavior and have a greater impact on health and lifespan than physiology or genes.¹¹ The same social determinants of health also influence patients’ ability to obtain medical care and pursue a meaningful life.¹²

The result of this decline in holism and in the value of health care in general has been a relentless rise in the cost of medical care^13-15 and the need for social services; declining life expectancy^16,17 and quality of life¹⁸; growing patient dissatisfaction; and burnout in providers.^19,20 Health care has become, as investor and business leader Warren Buffet remarked, the “tapeworm” of the economy and a major contributor to growing disparities in health and well-being between the haves and have-nots.²¹ Engel’s prediction that good medicine cannot afford to ignore holism has come to pass.

Family medicine has allowed itself, and patients, to be picked apart by forces of reductionism and a system that profits from the sick and suffering.

3-step solution:Return to whole-person care

Family medicine needs to return to whole-person care, but it can do so only if it attends to, and effectively delivers on, the prevention, treatment, and reversal of chronic disease and the enhancement of health and well-­being. This can happen only if family medicine stops trying to be all things to all people at all times and, instead, focuses on what matters to the patient as a person.

Continue to: This means that the core...

This means that the core interaction in family medicine must be to assess the whole person—mind, body, social, spirit—and help that person make changes that improve his/her/their health and well-being based on his/her/their individualized needs and social context. In other words, family medicine needs to deliver a holistic model of APC that is person centered, relationship based, recovery focused, and paid for comprehensively.

How does one get from “standard” primary care of today (the innermost circle of the FIGURE) to a framework that truly delivers on the promise of healing? I propose 3 steps to return holism to family medicine.

STEP 1: Start with comprehensive, coordinated primary care. We know that this works. Starfield and others demonstrated this 2 decades ago, defining and devising what we know as quality primary care—characterized by first-contact care, comprehensive primary care (CPC), continuous care, and coordinated care.²² This type of primary care improves outcomes, lowers costs, and is satisfying to patients and providers.²³ The physician cares for the patient throughout that person’s entire life cycle and provides all evidence-based services needed to prevent and treat common conditions. Comprehensive primary care is positioned in the first circle outward from the innermost circle of the FIGURE.

As medicine has become increasingly complex and subspecialized, however, the ability to coordinate care is often frayed, adding cost and reducing quality.^24-26 Today, comprehensive primary care needs enhanced coordination. At a minimum, this means coordinating services for:

• chronic disease management (outpatient and inpatient transitions and emergency department use)
• referral (specialists and tests)
• pharmacy services (including delivery and patient education support).

An example of a primary care system that meets these requirements is the Catalyst Health Network in central Texas, which supplies coordination services to more than 1000 comprehensive primary care practices and 1.5 million patients.²⁷ The Catalyst Network makes money for those practices, saves money in the system, enhances patient and provider satisfaction, and improves population health in the community.²⁷ I call this enhanced primary care (EPC), shown in the second circle out from the innermost circle of the FIGURE.

STEP 2: Add integrative medicine and mental health. EPC improves fragmented care but does not necessarily address a patient’s underlying determinants of healing. We know that health behaviors such as smoking cessation, avoidance of alcohol and drug abuse, improved diet, physical activity, sleep, and stress management contribute 40% to 60% of a person’s and a population’s health.¹⁰ In addition, evidence shows that behavioral health services, along with lifestyle change support, can even reverse many chronic diseases seen in primary care, such as obesity, diabetes, hypertension, cardiovascular disease, depression, and substance abuse.^28,29

Continue to: Therefore, we need to add...

Therefore, we need to add routine mental health services and nonpharmacotherapeutic approaches (eg, complementary and alternative medicine) to primary care.³⁰ Doing so requires that behavioral change and self-care become a central feature of the ­doctor–patient dialogue and team skills³¹ and be added to primary care.^30,31 I call this integrative primary care (IPC), shown on the left side in the third circle out from the innermost circle of the FIGURE.
 

Only 15% to 20% of individual and population healing comes from health care; the rest, from behavioral and lifestyle choices rarely addressed in primary care.

An example of IPC is Whole Health, an initiative of the US Veteran’s Health Administration. Whole Health empowers and informs a person-centered approach and integrates it into the delivery of routine care.³² Evaluation of Whole Health implementation, which involved more than 130,000 veterans followed for 2 years, found a net overall reduction in the total cost of care of 20%—saving nearly $650 million or, on average, more than $4500 per veteran.³³

STEP 3: Address social determinants of health. Primary care will not fully be part of the solution for producing health and well-being unless it becomes instrumental in addressing the social determinants of health (SDH), defined as “… conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”³⁴ These determinants include not only basic needs, such as housing, food, safety, and transportation (ie, social needs), but also what are known as structural determinants, such as income, education, language, and racial and ethnic bias. Health care cannot solve all of these social ills,but it is increasingly being called on to be the nexus of coordination for services that address these needs when they affect health outcomes.^35,36

Examples of health systems that provide for social needs include the free “food prescription” program of Pennsylvania’s Geisinger Health System, for patients with diabetes who do not have the resources to pay for food.³⁷ This approach improves blood glucose control by patients and saves money on medications and other interventions. Similarly, Kaiser Permanente has experimented with housing vouchers for homeless patients,and most Federally Qualified Health Centers provide bus or other transportation tickets to patients for their appointments and free or discounted tests and specialty care.³⁸

Implementing whole-person care for all

I propose that we make APC the central focus of family medicine. This model would comprise CPC, plus EPC, IPC, and community coordination to address SDH. This is expressed as:

CPC + EPC + IPC + SDH = APC

Continue to: APC would mean...

APC would mean health for the whole person and for all people. Again, the FIGURE shows how this model, encompassing the entire third circle out from the center circle, could be created from current models of care.

How do we pay for this? We already do—and way too much. The problem is not lack of money in the health care system but how it is organized and distributed. The Centers for Medicare and Medicaid Services and other payers are developing value-based payment models to help cover this type of care,³⁹ but payers cannot pay for something if it is unavailable.

Can family physicians deliver APC? I believe they can, and have given a few examples here to show how this is already happening. To help primary care providers start to deliver APC in their system, my team and I have built the HOPE (Healing Oriented Practices & Environments) Note Toolkit to use in daily practice.⁴⁰ These and other tools are being used by a number of large hospital systems and health care networks around the country. (You can download the HOPE Note Toolkit, at no cost, at https://drwaynejonas.com/­resources/hope-note/.)

At a minimum, comprehensive primary care needs to coordinate services for chronic disease management, referral (to specialists and testing), and pharmacy services.

Whatever we call this new type of primary care, it needs to care for the whole person and to be available to all. It finds expression in these assertions:

• We cannot ignore an essential part of what a human being is and expect them to heal or become whole.
• We cannot ignore essential people in our communities and expect our costs to go down or our compassion to go up.
• We need to stop allowing family medicine to be co-opted by reductionism and its profits.

In sum, we need a new vision of primary care—like Engel’s holistic vision in the 1970s—to motivate us, and we need to return to fundamental concepts of how healing works in medicine.⁴¹

CORRESPONDENCE

Wayne B. Jonas, MD, Samueli Integrative Health Programs, 1800 Diagonal Road, Suite 617, Alexandria, VA 22314; wayne@drwaynejonas.com.

President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

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

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

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

The U.S. Surgeon General and Department of Health & Human Services are calling on health care professionals, hospitals, employers, insurers, women, and the nation to work together to reduce maternal morbidity and mortality – and the disparities that make the risks higher for women of color.

The maternal mortality rate in the United States is the highest among developed countries of the world and continues to rise. In 2018, for every 100,000 live births, approximately 17 women died while pregnant or within 42 days of the end of pregnancy from causes related to pregnancy or delivery – that’s a substantial increase from 7 deaths per 100,000 live births in 1987, according to the surgeon general’s new call to action.

“Our mothers had much lower rates of dying related to pregnancy, compared to women today,” Dorothy Fink, MD, HHS deputy assistant secretary for women’s health, said at a briefing held Dec. 3 to mark the call to action.

Cardiovascular conditions were the most common cause of pregnancy-related deaths between 2011 and 2015, accounting for more than one in three of the deaths. HHS’s related action plan sets a target of achieving blood pressure control in 80% of women of reproductive age with hypertension by 2025.

The plan also seeks to reduce the maternal mortality rate by 50% and decrease low-risk cesarean deliveries by 25% within 5 years.

“A woman dies every 12 hours in this country from pregnancy-related complications,” Surgeon General Jerome Adams, MD, said at the briefing. “This is not just unacceptable, it is just something that we need to understand is not inevitable,” he said, adding that the Centers for Disease Control and Prevention has determined that two thirds of the deaths are preventable.

Dr. Adams also noted that it was important to address maternal health now, especially with COVID-19 raging. “Without attention and action, maternal health could actually worsen because of this pandemic,” he said.

“We cannot discuss maternal health, much less improve it, unless we acknowledge women of color are at a much greater risk of harm related to childbirth,” Dr. Adams said. “Black women are two to three times more likely to die of pregnancy-related causes compared to many other racial and ethnic groups.” The disparity increases with age, according to the CDC.

Studies have shown that education does not eliminate those disparities. Black women with a college degree are twice as likely to die as White or Asian American women who did not finish high school, Dr. Adams said.

He held up a photo of a colleague, Shalone Irving, who he said was a PhD-educated epidemiologist who “died not long ago from pregnancy-related complications.”

Income is also not a factor, said Dr. Adams, noting that pop singer Beyonce had a near-death experience with preeclampsia. He also noted that Serena Williams, a top athlete, also struggled with pregnancy complications.
 

Recommendations not all funded

The HHS action plan is not explicitly funded, although Dr. Fink and Dr. Adams said that President Donald J. Trump’s fiscal 2021 budget includes some specific requests for improving maternal health. It will be up to Congress to grant the requests.

The budget seeks $80 million for the Health Resources and Services Administration to improve access to and quality of care. It also includes money to expand Medicaid coverage for 1 year after birth for women with substance use disorders. The American Medical Association in 2019 adopted a policy urging Medicaid coverage to be expanded to include all women for a year after childbirth. The American College of Obstetricians and Gynecologists has also encouraged this extension.

“We are encouraged that the HHS action plan includes support for policies to close coverage and care gaps for all postpartum women after pregnancy-related Medicaid coverage expires,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in an interview.

The HHS could act immediately by approving Medicaid waivers to extend such coverage, Dr. Phipps said.

The budget also requests $24 million to expand maternal mortality review programs to every state, said Dr. Fink. Currently, 43 states and the District of Columbia, have such committees, which are charged with reviewing deaths of women within a year of pregnancy or birth.

The HHS will also join with the March of Dimes to address the disparities in Black women by implementing evidence-based best practices to improve quality in hospital settings.

It is not the first time the Trump administration has taken aim at reducing maternal morbidity and mortality. In 2018, the president signed the Preventing Maternal Deaths Act, which authorized the CDC to award $50 million over 5 years so that every state could form maternal mortality review committees.

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

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

From the UT Health Long School of Medicine San Antonio, Texas.

Abstract

Objective: To educate pregnant patients with opioid use disorder (OUD) about the effects of opioids in order to improve understanding and help achieve sustained abstinence.

Methods: The Center for Health Care Services and University Hospital System (UHS) in San Antonio, TX, jointly operate a methadone clinic, the Mommies Program, for pregnant women with OUD. As part of this program, medical students discuss methadone use in pregnancy and the health effects of OUD on mother and child and review resources for sustained peripartum abstinence at prenatal visits with pregnant patients with OUD concurrently enrolled in the program. To evaluate the impact of this education intervention, students assessed patients’ knowledge of methadone effects on mother and baby, state laws concerning heroin and methadone use in pregnancy, and motivation to quit using opioids with pre- and post-intervention surveys.

Results: Of 68 women enrolled in the program, 33 completed both the pre-survey and the post-survey (48.5%). Nearly half (48%) were very motivated to quit before pregnancy, but 85% were very motivated to quit once pregnant. All participants said learning more about the effects of opiates would increase motivation for sobriety. Prior to the educational intervention, 39% of participants knew it was safe to breastfeed on methadone, which improved to 97% in the post-survey, and 76% incorrectly thought they would be reported to authorities by their health care providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so.

Conclusion: Pregnancy and education about opioids increased patients’ motivation to quit. Patients also advanced their breastfeeding knowledge and learned about patient-provider confidentiality. Our greatest challenge was participant follow-up; however, this improved with the help of a full-time Mommies Program nurse. Our future aim is to increase project awareness and extend the educational research.

Keywords: pregnancy; addiction; opioids; OUD; counseling.

In 2012 more than 259 million prescriptions for opioids were written in the United States, which was a 200% increase since 1998.¹ Since the early 2000s, admissions to opioid substance abuse programs and the death rate from opioids have quadrupled.^2-4 Specifically, the rate of heroin use increased more than 300% from 2010 to 2014.⁵ Opioid use in pregnancy has also escalated in recent years, with a 3- to 4-fold increase from 2000 to 2009 and with 4 in 1000 deliveries being complicated by opioid use disorder (OUD) in 2011.^6-8

Between 2000 and 2014, the maternal mortality rate in the United States increased 24%, making it the only industrialized nation with a maternal mortality rate that is rising rather than falling.⁹ The Texas Maternal Mortality and Morbidity Task Force found that between 2012 and 2015 drug overdose was the leading cause of maternal death in the period from delivery to 365 days postpartum, and it has increased dramatically since 2010.^10,11

In addition, maternal mortality reviews in several states have identified substance use as a major risk factor for pregnancy-associated deaths.^12,13 In Texas between 2012 and 2015, opioids were found in 58% of maternal drug overdoses.¹⁰ In 2007, 22.8% of women who were enrolled in Medicaid programs in 46 states filled an opioid prescription during pregnancy.¹⁴ Additionally, the rising prevalence of opioid use in pregnancy has led to a sharp increase in neonatal abstinence syndrome (NAS), rising from 1.5 cases per 1000 hospital births in 1999 to 6.0 per 1000 hospital births in 2013.¹⁵ Unsurprisingly, states with the highest rates of opioid prescribing also have the highest rates of NAS.¹⁶

Methadone combined with counseling and behavioral therapy has been the standard of care for the treatment of OUD in pregnancy since the 1970s. Methadone treatment prevents opioid withdrawal symptoms and increases adherence to prenatal care.¹⁷ One of the largest methadone treatment clinics in the San Antonio, TX, area is the Center for Health Care Services (CHCS). University Health System in San Antonio (UHS) has established a clinic called The Mommies Program, where mothers addicted to opioids can receive prenatal care by a dedicated physician, registered nurse, and a certified nurse midwife, who work in collaboration with the CHCS methadone clinic. Pregnant patients with OUD in pregnancy are concurrently enrolled in the Mommies Program and receive prenatal care through UHS and methadone treatment and counseling through CHCS. The continuity effort aims to increase prenatal care rates and adherence to methadone treatment.

Once mothers are off illicit opioids and on methadone, it is essential to discuss breastfeeding with them, as many mothers addicted to illicit opioids may have been told that they should not be breastfeeding. However, breastfeeding should be encouraged in women who are stable on methadone if they are not using illicit drugs and do not have other contraindications, regardless of maternal methadone dose, since the transfer of methadone into breast milk is minimal.^18-20 Breastfeeding is beneficial in women taking methadone and has been associated with decreased severity of NAS symptoms, decreased need for pharmacotherapy, and a shorter hospital stay for the baby.²¹ In addition, breastfeeding contributes to the development of an attachment between mother and infant, while also providing the infant with natural immunity. Women should be counseled about the need to stop breastfeeding in the event of a relapse.²²

Finally, the postpartum period represents a time of increased stressors, such as loss of sleep, child protective services involvement, and frustration with constant demands from new baby. For mothers with addiction, this is an especially sensitive time, as the stressors may be exacerbated by their new sobriety and a sudden end to the motivation they experienced from pregnancy.²³ Therefore, early and frequent postpartum care with methadone dose evaluation is essential in order to decrease drug relapse and screen for postpartum depression in detail, since patients with a history of drug use are at increased risk of postpartum depression.

In 2017 medical students at UT Health Long School of Medicine in San Antonio created a project to educate women about OUD in pregnancy and provide motivational incentives for sustained abstinence; this project has continued each year since. Students provide education about methadone treatment and the dangers of using illicit opioids during and after pregnancy. Students especially focus on educating patients on the key problem areas in the literature, such as overdose, NAS, breastfeeding, postpartum substance use, and postpartum depression.

Methods

From October 2018 to February 2020, a total of 15 medical students volunteered between 1 and 20 times at the Mommies Program clinic, which was held once or twice per week from 8 am to 12 pm. Prior to attending clinic, a fourth-year medical student oriented that year’s group of first-, second-, and third-year medical students who volunteered to attend the clinic. The orientation introduced students to the Mommies Program and instructed them on how and why methadone is prescribed and distributed. Students were also taught how to begin and proceed through each patient encounter, and were given a standard handout to review with patients. This handout made it possible for students of every level to attend the Mommies Program and ensured that the education was standardized at every session (Figure 1).

The only inclusion criteria for participating in the educational intervention and survey was participants had to be 18 years of age or older and enrolled in the Mommies Program. Patients who met the inclusion criteria and agreed to participate completed a pre-survey administered by the students during the patient’s initial prenatal visit (Figure 2). This survey collected baseline information about the patient’s history with opioid use and their current knowledge of methadone treatment, NAS, legal aspects of drug use disclosure, and drug testing prior to the education portion of the encounter. After the pre-survey was administered, students spent 30 minutes reviewing the correct answers of the survey with the patients by utilizing the standardized handout to help patients understand details of methadone and opioid use in pregnancy (Figure 1). The post-survey was administered by a student once patients entered the third trimester to assess whether the education session increased patients’ knowledge of these topics.

At the time patients completed the post-survey, they received a Baby Bag as well as education regarding each item in the bag. The aim of distributing Baby Bags was to relieve some possible postnatal stressors and educate the patients about infant care. Items included in the bag were diapers, wipes, bottles, clothes, and swaddles. Prenatal vitamins were added in January 2020, as many patients struggle to afford vitamins if they are not currently covered by Medicaid or have other barriers. The Baby Bag items were purchased through a Community Service Learning grant through UT Health San Antonio.

Results

Of 68 women enrolled in the Mommies Program during the intervention period, 33 completed the pre-survey and the post-survey (48.5%). Even though all patients enrolled in the program met the inclusion criteria, patients were not included in the educational program for multiple reasons, including refusal to participate, poor clinic follow-up, or lack of students to collect surveys. However, all patients who completed the pre-survey did complete the post-survey. In the pre-survey, only 39% of participants knew it was safe to breastfeed while on methadone. In the post-survey, 97% knew it safe to breastfeed. Nearly half (48%) reported being very motivated to quit opioids before pregnancy, but 85% were very motivated to quit once pregnant. In the pre-survey, 76% incorrectly thought they would be reported to authorities by their health providers if they used illegal drugs during pregnancy, while in the post-survey, 100% knew they would not be reported for doing so. Also, all participants said learning more about the effects of opiates would increase motivation for sobriety.

Discussion

Questions assessed during the educational surveys revolved around patients’ knowledge of the intricacies, legally and physiologically, of methadone treatment for OUD, as well as beneficial aspects for patients and future child health, such as breastfeeding and motivation to quit and stay sober.

It was clear that there was a lack of knowledge and education about breastfeeding, as only 39% of the participants thought that it was safe to breastfeed while on methadone in the pre-survey; in the post survey, this improved to 97%. Students spent a large portion of the educational time going over the safety of breastfeeding for patients on methadone and the many benefits to mother and baby. Students also reviewed breastfeeding with patients every time patients came in for a visit and debunked any falsehoods about the negatives of breastfeeding while on methadone. This is another testament to the benefits of reinforcement around patient education.

The area of trust between provider and patient is essential in all provider-patient relationships. However, in the area of addiction, a trusting bond is especially important, as patients must feel confident and comfortable to disclose every aspect of their lives so the provider can give the best care. It was clear from our initial data that many patients did not feel this trust or understand the legal aspects regarding the provider-patient relationship in the terms of drug use, as the pre-survey shows 76% of patients originally thought they would be reported to authorities if they told their provider they used illegal drugs during pregnancy. This was an enormous issue in the clinic and something that needed to be addressed because, based on these data, we feared many patients would not be honest about using illegal drugs to supplement their methadone if they believed they would be reported to the authorities or even jailed. The medical student education team continually assured patients that their honesty about illegal drug use during pregnancy would not be revealed to the authorities, and also made it clear to patients that it was essential they were honest about illegal drug use so the optimal care could be provided by the team. These discussions were successful, as the post-survey showed that 100% of patients knew they would not be reported to the authorities if they used illegal drugs during the pregnancy. This showed an increase in knowledge, but also suggested an increase in confidence in the provider-patient relationship by patients, which we speculate allowed for a better patient experience, better patient outcomes, and less emotional stress for the patient and provider.

Last, we wanted to study and address the motivation to quit using drugs and stay sober through learning about the effects of opiates and how this motivation was related to pregnancy. A study by Mitchell et al makes clear that pregnancy is a motivation to seek treatment for drug use and to quit,²⁴ and our survey data support these findings, with 48% of patients motivated to quit before they were pregnant and 85% motivated to quit once they knew they were pregnant. In addition, all patients attested on the pre- and post-survey that learning more about opioids would increase their motivation for sobriety. Therefore, we believe education about the use of opioids and other drugs is a strong motivation towards sobriety and should be further studied in methadone treatment and other drugs as well.

We will continue to focus on sobriety postpartum by using the education in pregnancy as a springboard to further postpartum education, as education seems to be very beneficial to future sobriety. In the future, we believe extending the educational program past pregnancy and discussing opioid use and addiction with patients at multiple follow-up visits will be beneficial to patients’ sobriety.

We faced 2 main challenges in implementing this intervention and survey: patients would often miss multiple appointments during their third trimester or would not attend their postpartum visit if they only had 1 prenatal visit; and many clinic sessions had low student attendance because students often had many other responsibilities in medical school and there were only 15 volunteers over the study time. These challenges decreased our post-survey completion rate. However, there has been improvement in follow-up as the project has continued. The Mommies Program now has a full-time registered nurse, and a larger number of medical student teachers have volunteered to attend the clinic. In the future, we aim to increase awareness of our project and the benefits of participation, expand advertising at our medical school to increase student participation, and increase follow-up education in the postpartum period.

Another future direction is to include local, free doula services, which are offered through Catholic Charities in San Antonio. Doulas provide antepartum, intrapartum, and postpartum services, which we believe will help our patients through advocacy and support for sobriety during this emotional and stressful time.

Conclusion

Counseled participants were receptive to learning about the effects of OUD and methadone on themselves and their newborn. Participants unanimously stated that learning more about OUD increased their motivation for sobriety. It was also clear that the increased motivation to be sober during pregnancy, as compared to before pregnancy, is an opportunity to help these women take steps to get sober. Patients also advanced their breastfeeding knowledge, as we helped debunk falsehoods surrounding breastfeeding while on methadone, and we anticipate this will lead to greater breastfeeding rates for our patients on methadone, although this was not specifically studied. Finally, patients learned about patient-provider confidentiality, which allowed for more open and clear communication with patients so they could be cared for to the greatest degree and trust could remain paramount.

Drug use is a common problem in the health care system, and exposure to patients with addiction is important for medical students in training. We believe that attending the Mommies Program allowed medical students to gain exposure and skills to better help patients with OUD.

Corresponding author: Nicholas Stansbury, MD, Nmstansbury85@gmail.com.

Financial disclosures: None.

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

OBG Management takes the issues of systemic and structural racism incredibly seriously--not just by talking about it but by trying to highlight areas in medicine, particularly in obstetrics and gynecology, that are barriers to progress. In this new series for OBG Management, Board Member Barbara Levy, MD, faces the issues head-on, beginning with this peer-to-peer interview with Pierre Johnson, MD, ObGyn in Chicago, Illinois. Watch for future installments in upcoming issues of OBG Management.

Finding inspiration among life’s challenges

Barbara Levy, MD: I am fortunate to have met Pierre serendipitously at a training that we were both attending and was impressed by Dr. Johnson’s life story, his passion and commitment, and his dedication—not only to his personal career but also to raising up other young men of color by trying to break down barriers that face them. His life story highlights those areas of systemic and structural problems that all of us together need to address if we are going to make any progress.

Pierre Johnson, MD: Thank you, Barbara. A little about myself: I am a board-certified ObGyn, and I specialize in minimally invasive surgery. I was born on the South side of Chicago, experiencing gang violence, drugs, and substandard, underserved schools. Long story short, I had a very rough upbringing. I had a single mom and several different issues at home. I am the oldest of 5 siblings, and life was tough.

But I knew that I wanted to do something different with my life. I saw that there was a need in my community as far as health care was concerned, in particular women’s health and childbirth. I knew early on that I wanted to be an ObGyn, and the reason had a lot to do with The Cosby Show. It was the only example of a positive, successful Black man that I saw. No one graduated from college in my family. There weren’t any models of young Black excellence around me. Saying that I wanted to be a doctor planted a seed. I was 9 when my mom became pregnant with my first sibling, and it was fascinating to me. The physiology of pregnancy, and eventually childbirth, was extremely fascinating to me; it set me off on my journey to be an ObGyn.

As I got older, things didn’t get any easier. I went to high school in one of the toughest areas on the South side of Chicago. Gang violence, and violence in and of itself, were all around me, but I was able to stay focused. I went on to Xavier University in Louisiana.

Dr. Levy: There are some important things that I learned from your book and from talking to you at our first meeting. Your mom’s ObGyn, when she was pregnant with your next youngest sibling, was also a Black ObGyn. He took some time to take you under wing?

Dr. Johnson: He did. My mom’s ObGyn was a Black man. Other than The Cosby Show, that’s the only time I saw something like that. When I spoke to him, he really took the time to answer my questions and show me that he was like me; he wasn’t just a far-off mythical person, or something that I could not obtain.

Continue to: Seeing is believing when it comes to success...

Seeing is believing when it comes to success

Dr. Levy: Do you think it was important to have a role model who wasn’t a sports star?

Dr. Johnson: If you can’t see it, you can’t achieve it. He took his time to really talk to me, and it’s the little things for kids that go a long way in their life experience. I still have a relationship with him to this day. How he handled me as a kid made me realize that this is something that I could do. That was extremely important for me.

Dr. Levy: One of the structural things I think we need to point out is that the ability to see yourself as someone successful is critical. When we see 1,000 images a day and they are all White, and they are all so different from where we are that it gets incorporated into our sense of being. I think that’s really difficult for those of us of with privilege to understand what that privilege is.

Dr. Johnson: Absolutely, and I’ll even go further. In residency, 2 White females were my classmates, and both of their parents were doctors. They had grandparents who were doctors. My mom was addicted to drugs; my father was not around. They had been talking medicine since they were 5. You have to make things equitable, but in medicine it’s really not equitable. In medicine, what we don’t realize is that there is an importance for all aspects of someone’s upbringing and environment, and it’s not just what they can regurgitate on a standardized test. If a patient can’t relate to you and tell you what is wrong with them, how can you adequately treat them?

Dr. Levy: Even if they are trying to tell me, but I can’t hear it because I don’t have the language and I don’t have the background. There are really good data to show, in fact, that Black male physicians do a better job at engaging Black men to manage their hypertension.¹ When we look at the inequities in birth outcomes for women of color, indigenous women and Black women, there’s evidence that providers who come from a similar background do a better job.

Dr. Johnson: There was the study of Black infants that just came out about them dying at a 3-time higher rate in non-Black physicians’ hands.² These things need to be recognized. They need to be discussed, and they need to be identified as issues and then, realistically, we need to start talking about solutions, not get offended by what actual statistics are saying.

Foundational inequities in education

Dr. Levy: To address some of the barriers that you faced: I know that you went to a high school that was not geared toward pushing students into professional careers. Your colleagues, however, had educations that prepared them for the standardized tests and other things that they would face academically.

Dr. Johnson: People think I am kidding when I say it, but when I went into college, I didn’t know what a periodic table was. I saw it, but I had no idea what these things meant. I didn’t have any sciences or any AP classes in high school. I did well, but grades are smoke and mirrors. The true test of medicine comes with testing. From the MCATs to the boards, every step of the way there is a standardized test.

Knowledge is something that you can obtain, but test taking is a cultivated skill that happens from a very early age. Trying to teach an adult or someone in their late teens a skill that they should have learned as a kid is difficult. For me, I did not have that, so I had to program myself. I had to learn how to fundamentally take tests as an adult, where most people understand how to do that going into college and professional school.

Dr. Levy: I was impressed with your resilience. I think all of us as human beings, if we fail a test, we take it personally and think it’s about our lack of knowledge. One of the insights that you came to was that failure on those things was not that you didn’t study hard enough. In fact, you probably studied 4 times harder than most other people. You had the knowledge. Being able to get that knowledge into a standardized structured test score was the huge challenge for you.

Dr. Johnson: That’s it. I can remember taking the MCAT, and if you looked at the step 1 book, I could regurgitate to you everything on that page. However, it’s not a test about do you know it or not. It’s an understanding of the English language and how to break things down to make things fit into particular scenarios.

Continue to: A college experience focused on growth and exposure...

Dr. Levy: I was impressed by the distinction between your experience at Xavier University where there was a lot of support and guidance and help in your premed program, and what happened to you when you hit medical school.

Dr. Johnson: Xavier University in Louisiana is the number 1 institution in the country for getting minorities into professional school. They understand that they have kids that are brilliant but underprepared, and just have not had the background to actually tackle some of these tough curriculums. I always had good grades in school. But by not being challenged, I didn’t know what I didn’t really know. So now that I was seeing biology, chemistry for the first time, and trying to tackle it; there’s a failure point. I didn’t know how to take tests, and I didn’t know how to study properly. The harder I tried, the worse things got for me.

Xavier has seen that story a multitude of times. If I went to a bigger or predominantly White university, a counselor would have told me, “Well, medicine’s maybe not for you. You can’t handle a premed curriculum.” Instead, I said, “Listen, I’m studying. I’m doing all of these things, and I’m not hacking it.” And they broke it down: “Let’s get you into study groups with kids that have had these type of AP classes before. We’ll have you watch how they study,” and everything started to click. That facilitation of how to adjust to this curriculum was a godsend. It’s the only reason I’m here. I am a prime example of being brilliant enough to be able to do it, but needing the infrastructure and a system set up.

Dr. Levy: There’s a great book by Carol Dweck called Mindset that talks about education of young kids and putting them into silos so early in life; the brilliant kids go into the AP courses and the rest are labeled as inadequate. It’s assumed in a fixed mindset based on their heredity and IQ, and not based on the fact that they have not been exposed to the right things.

Xavier was growing you into the man who could, in fact, do all of those things. I think that is one of the systemic and structural issues that we have—that fixed mindset that frames a kid who is not succeeding as therefore unable to succeed, as opposed to framing that child as not having the correct tools.

New tribulations of medical school

Dr. Johnson: Absolutely. I think what Xavier did for me is to at least let me understand what I needed to do, how to comprehend and retain information, which I never had been exposed to before. Those years were very important to establishing a foundation. When going to medical school, it was like, “There’s no more excuses. What could be the problem now?” Well, now let’s talk about taking tests—a whole different skill. Xavier focused on getting me to understand how to structure my thought process and knowledge base. In medical school I had to apply those skills (because if you can’t apply them, there’s no fit).

My second through fourth year of medical school, I was the only African-American kid in my class. I was spending 20-hour days sometimes just studying, trying to overcompensate by knowing as much as I possibly could and thinking that would propel me from the test-taking standpoint. Even though I didn’t have a lot of classmates in medical school that looked like me, I did have mentors that looked similarly, who really saw potential in me. Dr. Frederick Horvath, a nephrologist in Peoria said, “What are you doing? I want you to get out of these books, and let’s go out to lunch.”

He ended up buying me some instrumental books, really talked to me, listening to my background and understanding how driven I was as a person. He took me under his wing for the rest of medical school and said, “This is how you navigate through these spaces. Yes, you need to have a fund of knowledge to be able to take these tests, but you need to start understanding how to apply it to these questions.” I’m forever grateful to Dr. Horvath for doing that because it was a point in time where I was lost and struggling.

Continue to: Hitting a stride but facing racism head-on...

Dr. Levy: You talk about the systemic and pervasive racism that was on the wards when you hit them in fourth year. If you don’t mind sharing just a little bit of that, it would help people reading this to have a better understanding of the kinds of barriers that are out there.

Dr. Johnson: Even when I talk about it today, it bothers me.

I went to medical school in Peoria, Illinois, not far from the home of the Ku Klux Klan. At that time, once you got out of Chicago it was a very brutal place, with systemic racism throughout. I was a young Black kid going through a process that not many young Black kids from the South side of Chicago go through, and you had people who had never seen anyone like me. When I was going through my clinical rotations, I knew what I was up against. I was dressed “to the T” every day, arriving early, leaving late, trying to answer questions. I would look at the evaluations, and they would be disparaging. I would look at my counterparts, how their evaluations were, and how people would respond to them, and it would be completely different.

Surgery was the part of ObGyn that I really grew to love more than anything, even more than obstetrics. When general surgery came, I wanted to take it very seriously and learn as much as I possibly could. From the beginning, I knew there was a problem because the chief resident, an older White man, wouldn’t look me in the eye or talk to me. He would make disparaging remarks. The thing that stuck out in my mind the most was when I was in the operating room transporting patients, just like a medical student did, and he came up behind me and said, “You know, Pierre, this is where a small mind and a strong back come into play.” For me, it took me to a place where I had to corral my emotions and thoughts because I just wanted to lash out and just tell him how racist and horrible that was for him to say that to me. I explained this to the powers that be, the director of the department, and they basically blew it off to the side.

When it came down to the end of the evaluation period, I passed with flying colors. But they gave me an incomplete because of that chief resident and his remarks on my evaluations. He had 3 pages of report about me as a person and as a student. He said that he had difficulty in expressing his opinions about me because of possible cultural biases that he may have had. He put “cultural biases” in an evaluation, and they looked at that and said that was enough for me to have to remediate my time. I was required to do an extra month in Pontiac, Illinois, which is even more rural than Peoria, because of a racist person that did not give me a fair opportunity because I was Black.

Like everything else in life, it was a learning experience. It’s why I fight so hard today. It’s why I’m so passionate about equity, not only in medicine but also in all aspects of society. It shows why we have police brutality and Black men dying in the streets. It shows how this happens because there are cultural and implicit biases that play out in every part of life, and we are not honest about it. Until we are honest about it and until we say that this is happening and there is something that needs to be done to address it, it’s going to continue to happen. That is my fight.

Exposing the unspoken power struggle

Dr. Levy: I couldn’t agree more. Attributing things like that to the individual, where you talk about a White man in power and a power structure that didn’t literally physically beat you but did beat you into submission. You talk about how to succeed in medical school, and how you had to suck it up and submit to something that was incredibly unfair. You understood, you were old enough, mature enough, to understand that if you fought back, you were going to lose. The only opportunity you had was to submit to that inequity and push forward.

Dr. Johnson: When I did try to fight, the chair of the department told me that either I accept the consequences or I would not graduate from medical school and be forced to do another year. That struck a chord with me. I think that happens a lot in our society, and it needs to be exposed.

Past experiences reflected in today’s society

Dr. Levy: Can you talk about what you faced in your ObGyn residency in terms of the systemic pushback, people not taking your orders, people questioning you. I know that I have heard that a great deal, and I experienced that myself as a woman.

Dr. Johnson: We look at the things that are happening now, everything from George Floyd’s murder to Colin Kaepernick taking a knee. These things are 10 years past when I first started residency. The year before I started residency, there was a noose hanging on the capitol lawn of Springfield, Illinois’ capital city. There’s systemic racism and hatred there. When I first started on the wards of my first year of ObGyn, again, I was the very first Black resident of my program’s history. Nobody could relate to me.

I went from a year-long general surgery internship at Washington Hospital Center in Washington, DC, to ObGyn residency. In the first 2 months, there were complaints of, “He’s not answering his pages. He’s not being prompt.” I went to my program director and said, “Listen, I have never had one complaint like this. There’s a problem here. And there’s a problem when I’m on the floor: When trying to give orders to nurses, they’re not taking them. I had to tell a couple of nurses, ‘I’m Dr. Johnson. Don’t call me by my first name, especially not in front of patients.’”

My director was just not hearing me, because the entire scenario was something they had never been exposed to. Systemic racism is real, and unless you experience it, it’s very difficult to accept that it is happening. But biases happen when you are not cognizant. People are used to things a certain way. Things play out in the media that make your mind think a certain way, and you don’t even realize it. You may not even want to be that way.

Continue to: Unconscious bias is a barrier to ensuring equity...

Dr. Levy: One very important point you just made is that we as the system need to be able to recognize those unconscious things, the language that we use, the disparaging remarks, the things that put people down, as well as the things that keep people out of promotion.

There are some interesting data about both race and gender and the language that we use when we write recommendations for people, that we do things unconsciously. The big message to all of us at the end is to open our minds to where those things can occur. For myself, professionally, I keep a list of words that I use when I write recommendations. I measure myself to ensure that I am using the same language for men and women, for Black and White. I think we need to overcome the system and the structure to create real equity—not equality but equity.

It begins with being real about the issues

Dr. Johnson: It’s a bigger problem than the existence of bias and racism. I think these are systemic issues that have been cultivated over centuries that have never been addressed. The true issue is that we deny that these are problems and refuse to talk about it because it makes us uncomfortable. To truly make things more equitable, we have to push our levels of comfort to be able to talk about things in a healthy manner, be open and transparent, and to start to understand how we are thinking about certain things. When you can see it, you can start to implement changes and start to change mentalities and thought processes.

For me, people say, “You don’t look like a doctor.” I get that all the time—because I have tattoos and earrings. I wear my hair in a mohawk. The image of what success looks like has been manifested through our media and culture, and it has imprinted on our minds as to how things are supposed to be. If someone doesn’t fit those molds, we start to shun them out, or we start to exhibit biases against those things. What I am trying to do is change that thought process of what a successful or a professional person looks like. It doesn’t have a look. It is not a White or Black thing. It’s an intellect, a mindset, a way of living. You have to treat every person as an individual and take all the biases out of it and understand where they are coming from and what they have to offer to the profession.

Dr. Levy: I personally was so impressed by you when I met you. I was impressed by the tattoos and the earrings, and my initial response to them was exactly that biased, “Oh, who is this person?” I checked that at the door, listened to you, and was really impressed at your surgical skill, your knowledge, your background. I am really grateful that you have been willing to spend the time to share that with everyone.

Dr. Johnson: Thank you for this discussion.

To watch the full interview between Drs. Levy and Johnson, visit: https://www.mdedge.com/obgyn/article/228507/facing-systemic-racism-health-care-inequities-medical-education. ●

From the University of Toronto (Dr. Basuita, Corey L. Kamen, and Dr. Soong) and Sinai Health System (Corey L. Kamen, Cheryl Ethier, and Dr. Soong), Toronto, Ontario, Canada. Co-first authors are Manpreet Basuita, MD, and Corey L. Kamen, BSc.

Abstract

• Objective: Routine laboratory testing is common among medical inpatients; however, when ordered inappropriately testing can represent low-value care. We examined the impact of an evidence-based intervention bundle on utilization.
• Participants/setting: This prospective cohort study took place at a tertiary academic medical center and included 6424 patients admitted to the general internal medicine service between April 2016 and March 2018.
• Intervention: An intervention bundle, whose first components were implemented in July 2016, included computer order entry restrictions on repetitive laboratory testing, education, and audit-feedback.
• Measures: Data were extracted from the hospital electronic health record. The primary outcome was the number of routine blood tests (complete blood count, creatinine, and electrolytes) ordered per inpatient day.
• Analysis: Descriptive statistics were calculated for demographic variables. We used statistical process control charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome.
• Results: The mean number of combined routine laboratory tests ordered per inpatient day decreased from 1.19 (SD, 0.21) tests to 1.11 (SD, 0.05), a relative reduction of 6.7% (P < 0.0001). Mean cost per case related to laboratory tests decreased from $17.24 in the pre-intervention period to $16.17 in the post-intervention period (relative reduction of 6.2%). This resulted in savings of $26,851 in the intervention year.
• Conclusion: A laboratory intervention bundle was associated with small reductions in testing and costs. A routine test performed less than once per inpatient day may not be clinically appropriate or possible.

Keywords: utilization; clinical costs; quality improvement; QI intervention; internal medicine; inpatient.

Routine laboratory blood testing is a commonly used diagnostic tool that physicians rely on to provide patient care. Although routine blood testing represents less than 5% of most hospital budgets, routine use and over-reliance on testing among physicians makes it a target of cost-reduction efforts.^1-3 A variety of interventions have been proposed to reduce inappropriate laboratory tests, with varying results.^1,4-6 Successful interventions include providing physicians with fee data associated with ordered laboratory tests, unbundling panels of tests, and multicomponent interventions.⁶ We conducted a multifaceted quality improvement study to promote and develop interventions to adopt appropriate blood test ordering practices.

Methods

Setting

This prospective cohort study took place at Mount Sinai Hospital, a 443-bed academic hospital affiliated with the University of Toronto, where more than 2400 learners rotate through annually. The study was approved by the Mount Sinai Hospital Research Ethics Board.

Participants

We included all inpatient admissions to the general internal medicine service between April 2016 and March 2018. Exclusion criteria included a length of stay (LOS) longer than 365 days and admission to a critical care unit. Patients with more than 1 admission were counted as separate hospital inpatient visits.

Intervention

Based on internal data, we targeted the top 3 most frequently ordered routine blood tests: complete blood count (CBC), creatinine, and electrolytes. Trainee interviews revealed that habit, bundled order sets, and fear of “missing something” contributed to inappropriate routine blood test ordering. Based on these root causes, we used the Model for Improvement to iteratively develop a multimodal intervention that began in July 2016.^7,8 This included a change to the computerized provider order entry (CPOE) to nudge clinicians to a restrictive ordering strategy by substituting the “Daily x3” frequency of blood test ordering with a “Daily x1” option on a pick list of order options. Clinicians could still order daily routine blood tests for any specified duration, but would have to do so by manually changing the default setting within the CPOE.

From July 2017 to March 2018, the research team educated residents on appropriate laboratory test ordering and provided audit and feedback data to the clinicians. Diagnostic uncertainty was addressed in teaching sessions. Attending physicians were surveyed on appropriate indications for daily laboratory testing for each of CBC, electrolytes, and creatinine. Appropriate indications (Figure 1) were displayed in visible clinical areas and incorporated into teaching sessions.⁹

Clinician teams received real-time performance data on their routine blood test ordering patterns compared with an institutional benchmark. Bar graphs of blood work ordering rates (sum of CBCs, creatinine, and electrolytes ordered for all patients on a given team divided by the total LOS for all patients) were distributed to each internal medicine team via email every 2 weeks (Figure 2).^1,10-12

Data Collection and Analysis

Data were extracted from the hospital electronic health record (EHR). The primary outcome was the number of routine blood tests (CBC, creatinine, and electrolytes) ordered per inpatient day. Descriptive statistics were calculated for demographic variables. We used statistical process control (SPC) charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome. SPC charts display process changes over time. Data are plotted in chronological order, with the central line representing the outcome mean, an upper line representing the upper control limit, and a lower line representing the lower control limit. The upper and lower limits were set at 3δ, which correspond to 3 standard deviations above and below the mean. Six successive points above or beyond the mean suggests “special cause variation,” indicating that observed results are unlikely due to secular trends. SPC charts are commonly used quality tools for process improvement as well as research.^13-16 These charts were created using QI Macros SPC software for Excel V. 2012.07 (KnowWare International, Denver, CO).

The direct cost of each laboratory test was acquired from the hospital laboratory department. The cost of each laboratory test (CBC = $7.54/test, electrolytes = $2.04/test, creatinine = $1.28/test, in Canadian dollars) was subsequently added together and multiplied by the pre- and post-intervention difference of total blood tests saved per inpatient day and then multiplied by 365 to arrive at an estimated cost savings per year.

Results

Over the study period, there were 6424 unique patient admissions on the general internal medicine service, with a median LOS of 3.5 days (Table).

The majority of inpatient visits had at least 1 test of CBC (80%; mean, 3.6 tests/visit), creatinine (79.3%; mean, 3.5 tests/visit), or electrolytes (81.6%; mean, 3.9 tests/visit) completed. In total, 56,767 laboratory tests were ordered.

Following the intervention, there was a reduction in both rates of routine blood test orders and their associated costs, with a shift below the mean. The mean number of tests ordered (combined CBC, creatinine, and electrolytes) per inpatient day decreased from 1.19 (SD, 0.21) in the pre-intervention period to 1.11 (SD, 0.05) in the post-intervention period (P < 0.0001), representing a 6.7% relative reduction (Figure 3). We observed a 6.2% relative reduction in costs per inpatient day, translating to a total savings of $26,851 over 1 year for the intervention period.

Discussion

Our study suggests that a multimodal intervention, including CPOE restrictions, resident education with posters, and audit and feedback strategies, can reduce lab test ordering on general internal medicine wards. This finding is similar to those of previous studies using a similar intervention, although different laboratory tests were targeted.^{1,2,5,6,10,17}

Our study found lower test result reductions than those reported by a previous study, which reported a relative reduction of 17% to 30%,¹⁸ and by another investigation that was conducted recently in a similar setting.¹⁷ In the latter study, reductions in laboratory testing were mostly found in nonroutine tests, and no significant improvements were noted in CBC, electrolytes, and creatine, the 3 tests we studied over the same duration.¹⁷ This may represent a ceiling effect to reducing laboratory testing, and efforts to reduce CBC, electrolytes, and creatinine testing beyond 0.3 to 0.4 tests per inpatient day (or combined 1.16 tests per inpatient day) may not be clinically appropriate or possible. This information can guide institutions to include other areas of overuse based on rates of utilization in order to maximize the benefits from a resource intensive intervention.

There are a number of limitations that merit discussion. First, observational studies do not demonstrate causation; however, to our knowledge, there were no other co-interventions that were being conducted during the study duration. One important note is that our project’s intervention began in July, at which point there are new internal medicine residents beginning their training. As the concept of resource allocation becomes more important, medical schools are spending more time educating students about Choosing Wisely, and, therefore, newer cohorts of residents may be more cognizant of appropriate blood testing. Second, this is a single-center study, limiting generalizability; however, we note that many other centers have reported similar findings. Another limitation is that we do not know whether there were any adverse clinical events associated with blood work ordering that was too restrictive, although informal tracking of STAT laboratory testing remained stable throughout the study period. It is important to ensure that blood work is ordered in moderation and tailored to patients using one’s clinical judgment.

Future Directions

We observed modest reductions in the quantity and costs associated with a quality improvement intervention aimed at reducing routine blood testing. A baseline rate of laboratory testing of less than 1 test per inpatient day may require including other target tests to drive down absolute utilization.

Corresponding author: Christine Soong, MD, MSc, 433-600 University Avenue, Toronto, Ontario, Canada M5G 1X5; Christine.soong@utoronto.ca.

Financial disclosures: None.

From the University of Toronto (Dr. Basuita, Corey L. Kamen, and Dr. Soong) and Sinai Health System (Corey L. Kamen, Cheryl Ethier, and Dr. Soong), Toronto, Ontario, Canada. Co-first authors are Manpreet Basuita, MD, and Corey L. Kamen, BSc.

Abstract

• Objective: Routine laboratory testing is common among medical inpatients; however, when ordered inappropriately testing can represent low-value care. We examined the impact of an evidence-based intervention bundle on utilization.
• Participants/setting: This prospective cohort study took place at a tertiary academic medical center and included 6424 patients admitted to the general internal medicine service between April 2016 and March 2018.
• Intervention: An intervention bundle, whose first components were implemented in July 2016, included computer order entry restrictions on repetitive laboratory testing, education, and audit-feedback.
• Measures: Data were extracted from the hospital electronic health record. The primary outcome was the number of routine blood tests (complete blood count, creatinine, and electrolytes) ordered per inpatient day.
• Analysis: Descriptive statistics were calculated for demographic variables. We used statistical process control charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome.
• Results: The mean number of combined routine laboratory tests ordered per inpatient day decreased from 1.19 (SD, 0.21) tests to 1.11 (SD, 0.05), a relative reduction of 6.7% (P < 0.0001). Mean cost per case related to laboratory tests decreased from $17.24 in the pre-intervention period to $16.17 in the post-intervention period (relative reduction of 6.2%). This resulted in savings of $26,851 in the intervention year.
• Conclusion: A laboratory intervention bundle was associated with small reductions in testing and costs. A routine test performed less than once per inpatient day may not be clinically appropriate or possible.

Keywords: utilization; clinical costs; quality improvement; QI intervention; internal medicine; inpatient.

Routine laboratory blood testing is a commonly used diagnostic tool that physicians rely on to provide patient care. Although routine blood testing represents less than 5% of most hospital budgets, routine use and over-reliance on testing among physicians makes it a target of cost-reduction efforts.^1-3 A variety of interventions have been proposed to reduce inappropriate laboratory tests, with varying results.^1,4-6 Successful interventions include providing physicians with fee data associated with ordered laboratory tests, unbundling panels of tests, and multicomponent interventions.⁶ We conducted a multifaceted quality improvement study to promote and develop interventions to adopt appropriate blood test ordering practices.

Methods

Setting

This prospective cohort study took place at Mount Sinai Hospital, a 443-bed academic hospital affiliated with the University of Toronto, where more than 2400 learners rotate through annually. The study was approved by the Mount Sinai Hospital Research Ethics Board.

Participants

We included all inpatient admissions to the general internal medicine service between April 2016 and March 2018. Exclusion criteria included a length of stay (LOS) longer than 365 days and admission to a critical care unit. Patients with more than 1 admission were counted as separate hospital inpatient visits.

Intervention

Based on internal data, we targeted the top 3 most frequently ordered routine blood tests: complete blood count (CBC), creatinine, and electrolytes. Trainee interviews revealed that habit, bundled order sets, and fear of “missing something” contributed to inappropriate routine blood test ordering. Based on these root causes, we used the Model for Improvement to iteratively develop a multimodal intervention that began in July 2016.^7,8 This included a change to the computerized provider order entry (CPOE) to nudge clinicians to a restrictive ordering strategy by substituting the “Daily x3” frequency of blood test ordering with a “Daily x1” option on a pick list of order options. Clinicians could still order daily routine blood tests for any specified duration, but would have to do so by manually changing the default setting within the CPOE.

From July 2017 to March 2018, the research team educated residents on appropriate laboratory test ordering and provided audit and feedback data to the clinicians. Diagnostic uncertainty was addressed in teaching sessions. Attending physicians were surveyed on appropriate indications for daily laboratory testing for each of CBC, electrolytes, and creatinine. Appropriate indications (Figure 1) were displayed in visible clinical areas and incorporated into teaching sessions.⁹

Clinician teams received real-time performance data on their routine blood test ordering patterns compared with an institutional benchmark. Bar graphs of blood work ordering rates (sum of CBCs, creatinine, and electrolytes ordered for all patients on a given team divided by the total LOS for all patients) were distributed to each internal medicine team via email every 2 weeks (Figure 2).^1,10-12

Data Collection and Analysis

Data were extracted from the hospital electronic health record (EHR). The primary outcome was the number of routine blood tests (CBC, creatinine, and electrolytes) ordered per inpatient day. Descriptive statistics were calculated for demographic variables. We used statistical process control (SPC) charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome. SPC charts display process changes over time. Data are plotted in chronological order, with the central line representing the outcome mean, an upper line representing the upper control limit, and a lower line representing the lower control limit. The upper and lower limits were set at 3δ, which correspond to 3 standard deviations above and below the mean. Six successive points above or beyond the mean suggests “special cause variation,” indicating that observed results are unlikely due to secular trends. SPC charts are commonly used quality tools for process improvement as well as research.^13-16 These charts were created using QI Macros SPC software for Excel V. 2012.07 (KnowWare International, Denver, CO).

The direct cost of each laboratory test was acquired from the hospital laboratory department. The cost of each laboratory test (CBC = $7.54/test, electrolytes = $2.04/test, creatinine = $1.28/test, in Canadian dollars) was subsequently added together and multiplied by the pre- and post-intervention difference of total blood tests saved per inpatient day and then multiplied by 365 to arrive at an estimated cost savings per year.

Results

Over the study period, there were 6424 unique patient admissions on the general internal medicine service, with a median LOS of 3.5 days (Table).

The majority of inpatient visits had at least 1 test of CBC (80%; mean, 3.6 tests/visit), creatinine (79.3%; mean, 3.5 tests/visit), or electrolytes (81.6%; mean, 3.9 tests/visit) completed. In total, 56,767 laboratory tests were ordered.

Following the intervention, there was a reduction in both rates of routine blood test orders and their associated costs, with a shift below the mean. The mean number of tests ordered (combined CBC, creatinine, and electrolytes) per inpatient day decreased from 1.19 (SD, 0.21) in the pre-intervention period to 1.11 (SD, 0.05) in the post-intervention period (P < 0.0001), representing a 6.7% relative reduction (Figure 3). We observed a 6.2% relative reduction in costs per inpatient day, translating to a total savings of $26,851 over 1 year for the intervention period.

Discussion

Our study suggests that a multimodal intervention, including CPOE restrictions, resident education with posters, and audit and feedback strategies, can reduce lab test ordering on general internal medicine wards. This finding is similar to those of previous studies using a similar intervention, although different laboratory tests were targeted.^{1,2,5,6,10,17}

Our study found lower test result reductions than those reported by a previous study, which reported a relative reduction of 17% to 30%,¹⁸ and by another investigation that was conducted recently in a similar setting.¹⁷ In the latter study, reductions in laboratory testing were mostly found in nonroutine tests, and no significant improvements were noted in CBC, electrolytes, and creatine, the 3 tests we studied over the same duration.¹⁷ This may represent a ceiling effect to reducing laboratory testing, and efforts to reduce CBC, electrolytes, and creatinine testing beyond 0.3 to 0.4 tests per inpatient day (or combined 1.16 tests per inpatient day) may not be clinically appropriate or possible. This information can guide institutions to include other areas of overuse based on rates of utilization in order to maximize the benefits from a resource intensive intervention.

There are a number of limitations that merit discussion. First, observational studies do not demonstrate causation; however, to our knowledge, there were no other co-interventions that were being conducted during the study duration. One important note is that our project’s intervention began in July, at which point there are new internal medicine residents beginning their training. As the concept of resource allocation becomes more important, medical schools are spending more time educating students about Choosing Wisely, and, therefore, newer cohorts of residents may be more cognizant of appropriate blood testing. Second, this is a single-center study, limiting generalizability; however, we note that many other centers have reported similar findings. Another limitation is that we do not know whether there were any adverse clinical events associated with blood work ordering that was too restrictive, although informal tracking of STAT laboratory testing remained stable throughout the study period. It is important to ensure that blood work is ordered in moderation and tailored to patients using one’s clinical judgment.

Future Directions

We observed modest reductions in the quantity and costs associated with a quality improvement intervention aimed at reducing routine blood testing. A baseline rate of laboratory testing of less than 1 test per inpatient day may require including other target tests to drive down absolute utilization.

Corresponding author: Christine Soong, MD, MSc, 433-600 University Avenue, Toronto, Ontario, Canada M5G 1X5; Christine.soong@utoronto.ca.

Financial disclosures: None.

From the University of Toronto (Dr. Basuita, Corey L. Kamen, and Dr. Soong) and Sinai Health System (Corey L. Kamen, Cheryl Ethier, and Dr. Soong), Toronto, Ontario, Canada. Co-first authors are Manpreet Basuita, MD, and Corey L. Kamen, BSc.

Abstract

• Objective: Routine laboratory testing is common among medical inpatients; however, when ordered inappropriately testing can represent low-value care. We examined the impact of an evidence-based intervention bundle on utilization.
• Participants/setting: This prospective cohort study took place at a tertiary academic medical center and included 6424 patients admitted to the general internal medicine service between April 2016 and March 2018.
• Intervention: An intervention bundle, whose first components were implemented in July 2016, included computer order entry restrictions on repetitive laboratory testing, education, and audit-feedback.
• Measures: Data were extracted from the hospital electronic health record. The primary outcome was the number of routine blood tests (complete blood count, creatinine, and electrolytes) ordered per inpatient day.
• Analysis: Descriptive statistics were calculated for demographic variables. We used statistical process control charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome.
• Results: The mean number of combined routine laboratory tests ordered per inpatient day decreased from 1.19 (SD, 0.21) tests to 1.11 (SD, 0.05), a relative reduction of 6.7% (P < 0.0001). Mean cost per case related to laboratory tests decreased from $17.24 in the pre-intervention period to $16.17 in the post-intervention period (relative reduction of 6.2%). This resulted in savings of $26,851 in the intervention year.
• Conclusion: A laboratory intervention bundle was associated with small reductions in testing and costs. A routine test performed less than once per inpatient day may not be clinically appropriate or possible.

Keywords: utilization; clinical costs; quality improvement; QI intervention; internal medicine; inpatient.

Routine laboratory blood testing is a commonly used diagnostic tool that physicians rely on to provide patient care. Although routine blood testing represents less than 5% of most hospital budgets, routine use and over-reliance on testing among physicians makes it a target of cost-reduction efforts.^1-3 A variety of interventions have been proposed to reduce inappropriate laboratory tests, with varying results.^1,4-6 Successful interventions include providing physicians with fee data associated with ordered laboratory tests, unbundling panels of tests, and multicomponent interventions.⁶ We conducted a multifaceted quality improvement study to promote and develop interventions to adopt appropriate blood test ordering practices.

Methods

Setting

This prospective cohort study took place at Mount Sinai Hospital, a 443-bed academic hospital affiliated with the University of Toronto, where more than 2400 learners rotate through annually. The study was approved by the Mount Sinai Hospital Research Ethics Board.

Participants

We included all inpatient admissions to the general internal medicine service between April 2016 and March 2018. Exclusion criteria included a length of stay (LOS) longer than 365 days and admission to a critical care unit. Patients with more than 1 admission were counted as separate hospital inpatient visits.

Intervention

Based on internal data, we targeted the top 3 most frequently ordered routine blood tests: complete blood count (CBC), creatinine, and electrolytes. Trainee interviews revealed that habit, bundled order sets, and fear of “missing something” contributed to inappropriate routine blood test ordering. Based on these root causes, we used the Model for Improvement to iteratively develop a multimodal intervention that began in July 2016.^7,8 This included a change to the computerized provider order entry (CPOE) to nudge clinicians to a restrictive ordering strategy by substituting the “Daily x3” frequency of blood test ordering with a “Daily x1” option on a pick list of order options. Clinicians could still order daily routine blood tests for any specified duration, but would have to do so by manually changing the default setting within the CPOE.

From July 2017 to March 2018, the research team educated residents on appropriate laboratory test ordering and provided audit and feedback data to the clinicians. Diagnostic uncertainty was addressed in teaching sessions. Attending physicians were surveyed on appropriate indications for daily laboratory testing for each of CBC, electrolytes, and creatinine. Appropriate indications (Figure 1) were displayed in visible clinical areas and incorporated into teaching sessions.⁹

Clinician teams received real-time performance data on their routine blood test ordering patterns compared with an institutional benchmark. Bar graphs of blood work ordering rates (sum of CBCs, creatinine, and electrolytes ordered for all patients on a given team divided by the total LOS for all patients) were distributed to each internal medicine team via email every 2 weeks (Figure 2).^1,10-12

Data Collection and Analysis

Data were extracted from the hospital electronic health record (EHR). The primary outcome was the number of routine blood tests (CBC, creatinine, and electrolytes) ordered per inpatient day. Descriptive statistics were calculated for demographic variables. We used statistical process control (SPC) charts to compare the baseline period (April 2016-June 2017) and the intervention period (July 2017-March 2018) for the primary outcome. SPC charts display process changes over time. Data are plotted in chronological order, with the central line representing the outcome mean, an upper line representing the upper control limit, and a lower line representing the lower control limit. The upper and lower limits were set at 3δ, which correspond to 3 standard deviations above and below the mean. Six successive points above or beyond the mean suggests “special cause variation,” indicating that observed results are unlikely due to secular trends. SPC charts are commonly used quality tools for process improvement as well as research.^13-16 These charts were created using QI Macros SPC software for Excel V. 2012.07 (KnowWare International, Denver, CO).

The direct cost of each laboratory test was acquired from the hospital laboratory department. The cost of each laboratory test (CBC = $7.54/test, electrolytes = $2.04/test, creatinine = $1.28/test, in Canadian dollars) was subsequently added together and multiplied by the pre- and post-intervention difference of total blood tests saved per inpatient day and then multiplied by 365 to arrive at an estimated cost savings per year.

Results

Over the study period, there were 6424 unique patient admissions on the general internal medicine service, with a median LOS of 3.5 days (Table).

The majority of inpatient visits had at least 1 test of CBC (80%; mean, 3.6 tests/visit), creatinine (79.3%; mean, 3.5 tests/visit), or electrolytes (81.6%; mean, 3.9 tests/visit) completed. In total, 56,767 laboratory tests were ordered.

Following the intervention, there was a reduction in both rates of routine blood test orders and their associated costs, with a shift below the mean. The mean number of tests ordered (combined CBC, creatinine, and electrolytes) per inpatient day decreased from 1.19 (SD, 0.21) in the pre-intervention period to 1.11 (SD, 0.05) in the post-intervention period (P < 0.0001), representing a 6.7% relative reduction (Figure 3). We observed a 6.2% relative reduction in costs per inpatient day, translating to a total savings of $26,851 over 1 year for the intervention period.

Discussion

Our study suggests that a multimodal intervention, including CPOE restrictions, resident education with posters, and audit and feedback strategies, can reduce lab test ordering on general internal medicine wards. This finding is similar to those of previous studies using a similar intervention, although different laboratory tests were targeted.^{1,2,5,6,10,17}

Our study found lower test result reductions than those reported by a previous study, which reported a relative reduction of 17% to 30%,¹⁸ and by another investigation that was conducted recently in a similar setting.¹⁷ In the latter study, reductions in laboratory testing were mostly found in nonroutine tests, and no significant improvements were noted in CBC, electrolytes, and creatine, the 3 tests we studied over the same duration.¹⁷ This may represent a ceiling effect to reducing laboratory testing, and efforts to reduce CBC, electrolytes, and creatinine testing beyond 0.3 to 0.4 tests per inpatient day (or combined 1.16 tests per inpatient day) may not be clinically appropriate or possible. This information can guide institutions to include other areas of overuse based on rates of utilization in order to maximize the benefits from a resource intensive intervention.

There are a number of limitations that merit discussion. First, observational studies do not demonstrate causation; however, to our knowledge, there were no other co-interventions that were being conducted during the study duration. One important note is that our project’s intervention began in July, at which point there are new internal medicine residents beginning their training. As the concept of resource allocation becomes more important, medical schools are spending more time educating students about Choosing Wisely, and, therefore, newer cohorts of residents may be more cognizant of appropriate blood testing. Second, this is a single-center study, limiting generalizability; however, we note that many other centers have reported similar findings. Another limitation is that we do not know whether there were any adverse clinical events associated with blood work ordering that was too restrictive, although informal tracking of STAT laboratory testing remained stable throughout the study period. It is important to ensure that blood work is ordered in moderation and tailored to patients using one’s clinical judgment.

Future Directions

We observed modest reductions in the quantity and costs associated with a quality improvement intervention aimed at reducing routine blood testing. A baseline rate of laboratory testing of less than 1 test per inpatient day may require including other target tests to drive down absolute utilization.

Corresponding author: Christine Soong, MD, MSc, 433-600 University Avenue, Toronto, Ontario, Canada M5G 1X5; Christine.soong@utoronto.ca.

Financial disclosures: None.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

From T1D Exchange, Boston, MA (Dr. Ebekozien, Dr. Odugbesan, and Nicole Rioles); Barbara Davis Center, University of Colorado, Boulder, CO (Dr. Majidi); Cincinnati Children’s Hospital Medical Center, Cincinnati, OH (Dr. Jones); and Nationwide Children’s Hospital, Columbus, OH (Dr. Kamboj)

Health equity has been described as the opportunity for all persons to obtain their highest level of health possible.¹ Unfortunately, even with advances in technology and care practices, disparities persist in health care outcomes. Disparities in prevalence, prognosis, and outcomes still exist in diabetes management.² Non-Hispanic Black and/or Hispanic populations are more likely to have worse glycemic control,^3,4 to encounter more barriers in access to care,⁵ and to have higher levels of acute complications,⁴ and to use advanced technologies less frequently.⁴ Diabetes is one of the preexisting conditions that increase morbidity and mortality in COVID-19.^6,7 Unfortunately, adverse outcomes from COVID-19 also disproportionately impact a specific vulnerable population.^8,9 The urgent transition to managing diabetes remotely during the COVID-19 pandemic may exacerbate long-term inequities because some vulnerable patients might not have access to technology devices necessary for effective remote management.

Here, we describe how quality improvement (QI) tools and principles can be adapted into a framework for advancing health equity. Specifically, we describe a 10-step framework that may be applied in diabetes care management to achieve improvement, using a hypothetical example of increasing use of continuous glucose monitors (CGMs) among patients with type 1 diabetes mellitus.¹⁰ This framework was developed to address the literature gap on practical ways health care providers can address inequities using QI principles, and was implemented by 1 of the authors at a local public health department.¹¹ The framework’s iterative and comprehensive design makes it ideal for addressing inequities in chronic diseases like diabetes, which have multiple root causes with no easy solutions. The improvement program pilot received a national model practice award.^11,12

10-Step Framework

Step 1: Review program/project baseline data for existing disparities. Diabetes programs and routine QI processes encourage existing data review to determine how effective the current system is working and if the existing process has a predictable pattern.^13,14 Our equity-revised framework proposes a more in-depth review to stratify baseline data based on factors that might contribute to inequities, including race, age, income levels, ethnicity, language, sexual orientation, insurance type, and zip code. This process will identify patients not served or unfairly impacted due to socioeconomic factors. For example, using the hypothetical example of improving CGM use, a team completes a preliminary data review and determines that baseline CGM use is 30% in the clinic population. However, in a review to assess for disparities, they also identify that patients on public insurance have a significantly lower CGM uptake of only 15%.

Step 2: Build an equitable project team, including patients with lived experiences. Routine projects typically have clinicians, administrative staff, and analytic staff as members of their team. In a post-COVID-19 world, every team needs to learn directly from people impacted and share decision-making power. The traditional approach to receiving feedback has generally been to collect responses using surveys or focus groups. We propose that individuals/families who are disproportionately impacted be included as active members on QI teams. For example, in the hypothetical example of the CGM project, team members would include patients with type 1 diabetes who are on public insurance and their families.

Step 3: Develop equity-focused goals. The traditional program involves the development of aims that are SMART (specific, measurable, achievable, realistic, time-bound).¹⁵ The proposed framework encourages the inclusion of equity-revised goals (SMARTer) using insights from Steps 1 and 2. For example, your typical smart goal might be to increase the percentage of patients using CGM by 20% in 6 months, while a SMARTer goal would be to increase the proportion of patients using CGM by 20% and reduce the disparities among public and private insurance patients by 30% in 6 months.

Step 4: Identify inequitable processes/pathways. Traditional QI programs might use a process map or flow diagram to depict the current state of a process visually.¹⁶ For example, in Figure 1, the process map diagram depicts some differences in the process for patients with public insurance as opposed to those with private insurance. The framework also advocates for using visual tools like process maps to depict how there might be inequitable pathways in a system. Visually identifying inequitable processes/pathways can help a team see barriers, address challenges, and pilot innovative solutions.

Step 5: Identify how socioeconomic factors are contributing to the current outcome. A good understanding of factors that contribute to the problem is an essential part of finding fundamental solutions. The fishbone diagram¹⁶ is a visualization tool used to identify contributing factors. When investigating contributing factors, it is commonplace to identify factors that fit into 1 of 5 categories: people, process, place, product, and policies (5 Ps). An equity-focused process will include equity as a new major factor category, and the socioeconomic impacts that contribute to inequities will be brainstormed and visually represented. For example, in the hypothetical CGM improvement example, an equity contributing factor is extensive CGM application paperwork for patients on public insurance as compared to those on private insurance. Figure 2 shows equity integrated into a fishbone diagram.

Step 6: Brainstorm possible improvements. Potential improvement ideas for the hypothetical CGM example might include redesigning the existing workflow, piloting CGM educational classes, and using a CGM barrier assessment tool to identify and address barriers to adoption.

Step 7: Use the decision matrix with equity as a criterion to prioritize improvement ideas. Decision matrix¹⁵ is a great tool that is frequently used to help teams prioritize potential ideas. Project team members must decide what criteria are important in prioritizing ideas to implement. Common criteria include implementation cost, time, and resources, but in addition to the common criteria, the team can specify ”impact on equity” as one of their criteria, alongside other standard criteria like impact.

Step 8: Test one small change at a time. This step is consistent with other traditional improvement models using the Plan, Do, Study, Act (PDSA) model for improvement.¹⁷ During this phase, the team should make predictions on the expected impact of the intervention on outcomes. For example, in the hypothetical example, the team predicts that testing and expanding CGM classes will reduce disparities among public versus private health insurance users by 5% and increase overall CGM uptake by 10%.

Step 9: Measure and compare results with predictions to identify inequitable practices or consequences. After each test of change, the team should review the results, including implementation cost considerations, and compare them to the predictions in the earlier step. The team should also document the potential reasons why their predictions were correct or inaccurate, and whether there were any unforeseen outcomes from the intervention.

Step 10: Celebrate small wins and repeat the process. Making fundamental and equitable changes takes time. This framework aimed at undoing inequities, particularly those inequities that have been amplified by the COVID-19 pandemic, is iterative and ongoing.^18,19 Not every test of change will impact the outcome or reduce inequity, but over time, each change will impact the next, generating sustainable effects.

Conclusion

There are ongoing studies examining the adverse outcomes and potential health inequities for patients with diabetes impacted by COVID-19.²⁰ Health care providers need to plan for post-COVID-19 care, keeping in mind that the pandemic might worsen already existing health disparities in diabetes management.^3,4,21 This work will involve an intentional approach to address structural and systemic racism.²² Therefore, the work of building health equity solutions must be rooted in racial justice, economic equity, and equitable access to health care and education.

Initiatives like this are currently being funded through foundation grants as well as state and federal research or program grants. Regional and national payors, including the Centers for Medicare & Medicaid Services, are currently piloting long-term sustainable funding models through programs like accountable care organizations and the Accountable Health Communities Model.²³

Health systems can successfully address health equity and racial justice, using a framework as described above, to identify determinants of health, develop policies to expand access to care for the most vulnerable patients, distribute decision-making power, and train staff by naming structural racism as a driver of health inequities.

Acknowledgment: The authors acknowledge the contributions of patients, families, diabetes care teams, and collaborators within the T1D Exchange Quality Improvement Collaborative, who continually seek to improve care and outcomes for people living with diabetes.

Corresponding author: Osagie Ebekozien, MD, 11 Avenue De La Fayette, Boston, MA 02115; oebekozien@t1dexchange.org.

Financial disclosures: None.

Funding: T1D Exchange QI Collaborative is funded by The Leona M. and Harry B. Helmsley Charitable Trust. No specific funding was received for this manuscript or the development of this framework.

Keywords: type 1 diabetes; quality improvement; QI framework; racial justice; health disparities.

From T1D Exchange, Boston, MA (Dr. Ebekozien, Dr. Odugbesan, and Nicole Rioles); Barbara Davis Center, University of Colorado, Boulder, CO (Dr. Majidi); Cincinnati Children’s Hospital Medical Center, Cincinnati, OH (Dr. Jones); and Nationwide Children’s Hospital, Columbus, OH (Dr. Kamboj)

Health equity has been described as the opportunity for all persons to obtain their highest level of health possible.¹ Unfortunately, even with advances in technology and care practices, disparities persist in health care outcomes. Disparities in prevalence, prognosis, and outcomes still exist in diabetes management.² Non-Hispanic Black and/or Hispanic populations are more likely to have worse glycemic control,^3,4 to encounter more barriers in access to care,⁵ and to have higher levels of acute complications,⁴ and to use advanced technologies less frequently.⁴ Diabetes is one of the preexisting conditions that increase morbidity and mortality in COVID-19.^6,7 Unfortunately, adverse outcomes from COVID-19 also disproportionately impact a specific vulnerable population.^8,9 The urgent transition to managing diabetes remotely during the COVID-19 pandemic may exacerbate long-term inequities because some vulnerable patients might not have access to technology devices necessary for effective remote management.

Here, we describe how quality improvement (QI) tools and principles can be adapted into a framework for advancing health equity. Specifically, we describe a 10-step framework that may be applied in diabetes care management to achieve improvement, using a hypothetical example of increasing use of continuous glucose monitors (CGMs) among patients with type 1 diabetes mellitus.¹⁰ This framework was developed to address the literature gap on practical ways health care providers can address inequities using QI principles, and was implemented by 1 of the authors at a local public health department.¹¹ The framework’s iterative and comprehensive design makes it ideal for addressing inequities in chronic diseases like diabetes, which have multiple root causes with no easy solutions. The improvement program pilot received a national model practice award.^11,12

10-Step Framework

Step 1: Review program/project baseline data for existing disparities. Diabetes programs and routine QI processes encourage existing data review to determine how effective the current system is working and if the existing process has a predictable pattern.^13,14 Our equity-revised framework proposes a more in-depth review to stratify baseline data based on factors that might contribute to inequities, including race, age, income levels, ethnicity, language, sexual orientation, insurance type, and zip code. This process will identify patients not served or unfairly impacted due to socioeconomic factors. For example, using the hypothetical example of improving CGM use, a team completes a preliminary data review and determines that baseline CGM use is 30% in the clinic population. However, in a review to assess for disparities, they also identify that patients on public insurance have a significantly lower CGM uptake of only 15%.

Step 2: Build an equitable project team, including patients with lived experiences. Routine projects typically have clinicians, administrative staff, and analytic staff as members of their team. In a post-COVID-19 world, every team needs to learn directly from people impacted and share decision-making power. The traditional approach to receiving feedback has generally been to collect responses using surveys or focus groups. We propose that individuals/families who are disproportionately impacted be included as active members on QI teams. For example, in the hypothetical example of the CGM project, team members would include patients with type 1 diabetes who are on public insurance and their families.

Step 3: Develop equity-focused goals. The traditional program involves the development of aims that are SMART (specific, measurable, achievable, realistic, time-bound).¹⁵ The proposed framework encourages the inclusion of equity-revised goals (SMARTer) using insights from Steps 1 and 2. For example, your typical smart goal might be to increase the percentage of patients using CGM by 20% in 6 months, while a SMARTer goal would be to increase the proportion of patients using CGM by 20% and reduce the disparities among public and private insurance patients by 30% in 6 months.

Step 4: Identify inequitable processes/pathways. Traditional QI programs might use a process map or flow diagram to depict the current state of a process visually.¹⁶ For example, in Figure 1, the process map diagram depicts some differences in the process for patients with public insurance as opposed to those with private insurance. The framework also advocates for using visual tools like process maps to depict how there might be inequitable pathways in a system. Visually identifying inequitable processes/pathways can help a team see barriers, address challenges, and pilot innovative solutions.

Step 5: Identify how socioeconomic factors are contributing to the current outcome. A good understanding of factors that contribute to the problem is an essential part of finding fundamental solutions. The fishbone diagram¹⁶ is a visualization tool used to identify contributing factors. When investigating contributing factors, it is commonplace to identify factors that fit into 1 of 5 categories: people, process, place, product, and policies (5 Ps). An equity-focused process will include equity as a new major factor category, and the socioeconomic impacts that contribute to inequities will be brainstormed and visually represented. For example, in the hypothetical CGM improvement example, an equity contributing factor is extensive CGM application paperwork for patients on public insurance as compared to those on private insurance. Figure 2 shows equity integrated into a fishbone diagram.

Step 6: Brainstorm possible improvements. Potential improvement ideas for the hypothetical CGM example might include redesigning the existing workflow, piloting CGM educational classes, and using a CGM barrier assessment tool to identify and address barriers to adoption.

Step 7: Use the decision matrix with equity as a criterion to prioritize improvement ideas. Decision matrix¹⁵ is a great tool that is frequently used to help teams prioritize potential ideas. Project team members must decide what criteria are important in prioritizing ideas to implement. Common criteria include implementation cost, time, and resources, but in addition to the common criteria, the team can specify ”impact on equity” as one of their criteria, alongside other standard criteria like impact.

Step 8: Test one small change at a time. This step is consistent with other traditional improvement models using the Plan, Do, Study, Act (PDSA) model for improvement.¹⁷ During this phase, the team should make predictions on the expected impact of the intervention on outcomes. For example, in the hypothetical example, the team predicts that testing and expanding CGM classes will reduce disparities among public versus private health insurance users by 5% and increase overall CGM uptake by 10%.

Step 9: Measure and compare results with predictions to identify inequitable practices or consequences. After each test of change, the team should review the results, including implementation cost considerations, and compare them to the predictions in the earlier step. The team should also document the potential reasons why their predictions were correct or inaccurate, and whether there were any unforeseen outcomes from the intervention.

Step 10: Celebrate small wins and repeat the process. Making fundamental and equitable changes takes time. This framework aimed at undoing inequities, particularly those inequities that have been amplified by the COVID-19 pandemic, is iterative and ongoing.^18,19 Not every test of change will impact the outcome or reduce inequity, but over time, each change will impact the next, generating sustainable effects.

Conclusion

There are ongoing studies examining the adverse outcomes and potential health inequities for patients with diabetes impacted by COVID-19.²⁰ Health care providers need to plan for post-COVID-19 care, keeping in mind that the pandemic might worsen already existing health disparities in diabetes management.^3,4,21 This work will involve an intentional approach to address structural and systemic racism.²² Therefore, the work of building health equity solutions must be rooted in racial justice, economic equity, and equitable access to health care and education.

Initiatives like this are currently being funded through foundation grants as well as state and federal research or program grants. Regional and national payors, including the Centers for Medicare & Medicaid Services, are currently piloting long-term sustainable funding models through programs like accountable care organizations and the Accountable Health Communities Model.²³

Health systems can successfully address health equity and racial justice, using a framework as described above, to identify determinants of health, develop policies to expand access to care for the most vulnerable patients, distribute decision-making power, and train staff by naming structural racism as a driver of health inequities.

Acknowledgment: The authors acknowledge the contributions of patients, families, diabetes care teams, and collaborators within the T1D Exchange Quality Improvement Collaborative, who continually seek to improve care and outcomes for people living with diabetes.

Corresponding author: Osagie Ebekozien, MD, 11 Avenue De La Fayette, Boston, MA 02115; oebekozien@t1dexchange.org.

Financial disclosures: None.

Funding: T1D Exchange QI Collaborative is funded by The Leona M. and Harry B. Helmsley Charitable Trust. No specific funding was received for this manuscript or the development of this framework.

Keywords: type 1 diabetes; quality improvement; QI framework; racial justice; health disparities.

From T1D Exchange, Boston, MA (Dr. Ebekozien, Dr. Odugbesan, and Nicole Rioles); Barbara Davis Center, University of Colorado, Boulder, CO (Dr. Majidi); Cincinnati Children’s Hospital Medical Center, Cincinnati, OH (Dr. Jones); and Nationwide Children’s Hospital, Columbus, OH (Dr. Kamboj)

Health equity has been described as the opportunity for all persons to obtain their highest level of health possible.¹ Unfortunately, even with advances in technology and care practices, disparities persist in health care outcomes. Disparities in prevalence, prognosis, and outcomes still exist in diabetes management.² Non-Hispanic Black and/or Hispanic populations are more likely to have worse glycemic control,^3,4 to encounter more barriers in access to care,⁵ and to have higher levels of acute complications,⁴ and to use advanced technologies less frequently.⁴ Diabetes is one of the preexisting conditions that increase morbidity and mortality in COVID-19.^6,7 Unfortunately, adverse outcomes from COVID-19 also disproportionately impact a specific vulnerable population.^8,9 The urgent transition to managing diabetes remotely during the COVID-19 pandemic may exacerbate long-term inequities because some vulnerable patients might not have access to technology devices necessary for effective remote management.

Here, we describe how quality improvement (QI) tools and principles can be adapted into a framework for advancing health equity. Specifically, we describe a 10-step framework that may be applied in diabetes care management to achieve improvement, using a hypothetical example of increasing use of continuous glucose monitors (CGMs) among patients with type 1 diabetes mellitus.¹⁰ This framework was developed to address the literature gap on practical ways health care providers can address inequities using QI principles, and was implemented by 1 of the authors at a local public health department.¹¹ The framework’s iterative and comprehensive design makes it ideal for addressing inequities in chronic diseases like diabetes, which have multiple root causes with no easy solutions. The improvement program pilot received a national model practice award.^11,12

10-Step Framework

Step 1: Review program/project baseline data for existing disparities. Diabetes programs and routine QI processes encourage existing data review to determine how effective the current system is working and if the existing process has a predictable pattern.^13,14 Our equity-revised framework proposes a more in-depth review to stratify baseline data based on factors that might contribute to inequities, including race, age, income levels, ethnicity, language, sexual orientation, insurance type, and zip code. This process will identify patients not served or unfairly impacted due to socioeconomic factors. For example, using the hypothetical example of improving CGM use, a team completes a preliminary data review and determines that baseline CGM use is 30% in the clinic population. However, in a review to assess for disparities, they also identify that patients on public insurance have a significantly lower CGM uptake of only 15%.

Step 2: Build an equitable project team, including patients with lived experiences. Routine projects typically have clinicians, administrative staff, and analytic staff as members of their team. In a post-COVID-19 world, every team needs to learn directly from people impacted and share decision-making power. The traditional approach to receiving feedback has generally been to collect responses using surveys or focus groups. We propose that individuals/families who are disproportionately impacted be included as active members on QI teams. For example, in the hypothetical example of the CGM project, team members would include patients with type 1 diabetes who are on public insurance and their families.

Step 3: Develop equity-focused goals. The traditional program involves the development of aims that are SMART (specific, measurable, achievable, realistic, time-bound).¹⁵ The proposed framework encourages the inclusion of equity-revised goals (SMARTer) using insights from Steps 1 and 2. For example, your typical smart goal might be to increase the percentage of patients using CGM by 20% in 6 months, while a SMARTer goal would be to increase the proportion of patients using CGM by 20% and reduce the disparities among public and private insurance patients by 30% in 6 months.

Step 4: Identify inequitable processes/pathways. Traditional QI programs might use a process map or flow diagram to depict the current state of a process visually.¹⁶ For example, in Figure 1, the process map diagram depicts some differences in the process for patients with public insurance as opposed to those with private insurance. The framework also advocates for using visual tools like process maps to depict how there might be inequitable pathways in a system. Visually identifying inequitable processes/pathways can help a team see barriers, address challenges, and pilot innovative solutions.

Step 5: Identify how socioeconomic factors are contributing to the current outcome. A good understanding of factors that contribute to the problem is an essential part of finding fundamental solutions. The fishbone diagram¹⁶ is a visualization tool used to identify contributing factors. When investigating contributing factors, it is commonplace to identify factors that fit into 1 of 5 categories: people, process, place, product, and policies (5 Ps). An equity-focused process will include equity as a new major factor category, and the socioeconomic impacts that contribute to inequities will be brainstormed and visually represented. For example, in the hypothetical CGM improvement example, an equity contributing factor is extensive CGM application paperwork for patients on public insurance as compared to those on private insurance. Figure 2 shows equity integrated into a fishbone diagram.

Step 6: Brainstorm possible improvements. Potential improvement ideas for the hypothetical CGM example might include redesigning the existing workflow, piloting CGM educational classes, and using a CGM barrier assessment tool to identify and address barriers to adoption.

Step 7: Use the decision matrix with equity as a criterion to prioritize improvement ideas. Decision matrix¹⁵ is a great tool that is frequently used to help teams prioritize potential ideas. Project team members must decide what criteria are important in prioritizing ideas to implement. Common criteria include implementation cost, time, and resources, but in addition to the common criteria, the team can specify ”impact on equity” as one of their criteria, alongside other standard criteria like impact.

Step 8: Test one small change at a time. This step is consistent with other traditional improvement models using the Plan, Do, Study, Act (PDSA) model for improvement.¹⁷ During this phase, the team should make predictions on the expected impact of the intervention on outcomes. For example, in the hypothetical example, the team predicts that testing and expanding CGM classes will reduce disparities among public versus private health insurance users by 5% and increase overall CGM uptake by 10%.

Step 9: Measure and compare results with predictions to identify inequitable practices or consequences. After each test of change, the team should review the results, including implementation cost considerations, and compare them to the predictions in the earlier step. The team should also document the potential reasons why their predictions were correct or inaccurate, and whether there were any unforeseen outcomes from the intervention.

Step 10: Celebrate small wins and repeat the process. Making fundamental and equitable changes takes time. This framework aimed at undoing inequities, particularly those inequities that have been amplified by the COVID-19 pandemic, is iterative and ongoing.^18,19 Not every test of change will impact the outcome or reduce inequity, but over time, each change will impact the next, generating sustainable effects.

Conclusion

There are ongoing studies examining the adverse outcomes and potential health inequities for patients with diabetes impacted by COVID-19.²⁰ Health care providers need to plan for post-COVID-19 care, keeping in mind that the pandemic might worsen already existing health disparities in diabetes management.^3,4,21 This work will involve an intentional approach to address structural and systemic racism.²² Therefore, the work of building health equity solutions must be rooted in racial justice, economic equity, and equitable access to health care and education.

Initiatives like this are currently being funded through foundation grants as well as state and federal research or program grants. Regional and national payors, including the Centers for Medicare & Medicaid Services, are currently piloting long-term sustainable funding models through programs like accountable care organizations and the Accountable Health Communities Model.²³

Health systems can successfully address health equity and racial justice, using a framework as described above, to identify determinants of health, develop policies to expand access to care for the most vulnerable patients, distribute decision-making power, and train staff by naming structural racism as a driver of health inequities.

Acknowledgment: The authors acknowledge the contributions of patients, families, diabetes care teams, and collaborators within the T1D Exchange Quality Improvement Collaborative, who continually seek to improve care and outcomes for people living with diabetes.

Corresponding author: Osagie Ebekozien, MD, 11 Avenue De La Fayette, Boston, MA 02115; oebekozien@t1dexchange.org.

Financial disclosures: None.

Funding: T1D Exchange QI Collaborative is funded by The Leona M. and Harry B. Helmsley Charitable Trust. No specific funding was received for this manuscript or the development of this framework.

Keywords: type 1 diabetes; quality improvement; QI framework; racial justice; health disparities.