Opinion

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

Background and growth

Hospitalist nurse practitioner (NP) and physician assistant (PA) providers have been a growing and evolving part of the inpatient medical workforce, seemingly since the inception of hospital medicine. Given the growth of these disciplines within hospital medicine, at this juncture it is helpful to look at this journey, to see what roles these providers have been serving, and to consider newer and novel trends in how NPs and PAs are being weaved into hospital medicine programs.

The drivers for growth in this provider population are not unlike those of physician hospitalists. The same milieu that provided inroads for physicians in hospital-based care have led the way for increased use of NP/PA providers. An aging physician workforce, residency work hour reforms, increasing complexity of patients and systems on the inpatient side, and the recognition that caring for inpatients is a specialty vastly different from the role of internist in primary care have all impacted the numbers of NPs and PAs in this arena.

A quick review of older articles and publications gives a very interesting and wry snapshot of the utilization of NP/PA providers in hospital medicine in past years. The titles alone provide for a chuckle or two:

• 2007 Today’s Hospitalist article: “Midlevels make a rocky entrance into hospital medicine”¹

• 2009 ACP Hospitalist article: “When hiring midlevels, proceed with caution”²

These titles reflect the uncertainty at the time in how best to utilize NP/PA providers in hospital medicine (as well as an unfashionable vocabulary). The numbers at the time tell a similar story. In the Society of Hospital Medicine survey in 2007-2008, about 29% and 21% of hospital medicine practices utilized NPs and PAs, respectively. However, by 2014 about 50% of Veterans Affairs inpatient medical services deployed NP/PA providers, and most recent data from the Society of Hospital Medicine reveal that about 63% of groups use these advanced practice providers (APPs), with higher numbers in pediatric programs. Clearly there is evolving growth and enthusiasm for NP/PAs in hospital medicine.

Program models

Determining how best to use NP/PAs in hospital medicine programs has had a similar evolution. Reviewing past articles addressing these issues, one can see that there has been clear migration; initially NP/PAs were primarily hired to assist with late-afternoon admission surges, with about 60% of the APP workload being utilized to admit in 2007. Their role has continued to grow and change, much as hospitalist practices have; current program models consist of a few major types, with some novel models coming to the fore.

The first model is the classic paired rounding or “dyad” model. This is where a physician and an APP split a panel of patients. The APP then cares for his/her panel of patients, including daily visits, progress notes, calling consults, discharges, discharge summaries, procedures, billing, etc. The physician does the same for his/her panel of patients. The physician and the APP may then “run the list together” and the physician may then see most or all of the APP’s patients and bill for them when medical complexity demands. This allows for a higher volume of patients to be seen and billed, at a lower overall cost; it also provides for backup/support/redundancy for both team members when the patient acuity gets high.

Another model is use of an NP/PA in an observation unit or with lower acuity observation patients. The majority of the management of the patients is completed and billed by the APP, with the physician available for backup. This hits the “sweet spot,” utilizing the right provider with the right skill set for the right patient. The program has to account for some reimbursement or compensation for the physician oversight time, but it is a very efficient use of APPs.

The third major deployment of APPs is with admissions. Many groups use APPs to admit into the late afternoon and evening, getting patients “tucked in,” including starting diagnostic work-ups and treatment plans. The physician hospitalist then evaluates the patient the next day and often bills for the admission. This model works in situations where the patient work-up is dependent on lab testing, imaging, or other diagnostic testing to understand and plan for the “arc” of the hospitalization; or in situations where the diagnosis is clear, but the patient needs time with treatment to determine response. The downside of this model is long-term job satisfaction for the APP (although some programs have them rotate through such a model at intervals).

Another area where APPs have made strong inroads is that of comanagement services. The NP or PA develops a long-term relationship with a surgical comanagement team, and is often highly engaged and extremely appreciated for managing chronic conditions such as hypertension and diabetes. This can be a very satisfying model for both teams. The NP/PA usually bills independently for these encounters.

APPS are also used in cross coverage and triage roles, allowing the day teams to focus on their primary patients. In a triage role, they can interface with the emergency department, providing a semi-neutral “mediator” for patient disposition.

On the more novel end of the spectrum, there is growth in more independent roles for APP hospitalists. Some groups are having success at using the paired rounding or dyad model, but having the physician see the patient every third day. This is most successful where there is strong onboarding and deep clarity for when to contact the backup physician. There are some data to support the effectiveness of this model, most recently in the Journal of Clinical Outcomes Management.³

Critical access hospitals are also having success in deploying APPs in a very independent role, staffing these hospitals at night. Smaller, rural hospitals with aging medical staff have learned to maximize the scope of practice of their APPs to remain viable and provide care for inpatients. This can be a very successful model for APPs working at the maximum scope of their practice. In addition, the use of telemedicine has been implemented to allow for remote physician backup. This may be a rapidly growing arm to hospital medicine practices in the future.

 

Ongoing barriers

There are many barriers to maximizing the scope of practice and efficiency of APPs in hospital medicine. They range from the “macro” to the “micro.”

On the larger stage, Medicare requires that home care orders be signed by an attending physician, which can be inefficient and difficult to accomplish. Other payers may have somewhat arcane statutes that limit billing practices, and state practice limitations vary widely. Although 22 states now allow for independent practice for NPs, other states may have a very restrictive practice environment that can impede creative care delivery models. But regardless of how liberal a practice the state allows, a hospital’s medical bylaws can still restrict the day-to-day practice of APPs. And those restrictive bylaws are emblematic of a more constant and corporeal barrier to APP practice, that of medical staff culture.

If there are physicians on the staff who fear that utilization of NP/PA providers will lead to a decay in the quality of care, or who feel threatened by the use of APPs, that can create a local stopgap to maximizing utilization of APPs. In addition, hospitalist physicians and leaders may lack knowledge or experience in APP practice. APPs take more time to successfully onboard than physicians; without clear expectations or road maps to accomplish this onboarding, leaders may feel that APP integration doesn’t work. And one bad experience can create long-term barriers for future practices.

Other barriers are the lack of standardized rigor and vigor in graduate education programs (in both educational and clinical experiences). This results in variation in the quality of NP/PA providers at graduation. Knowledge gaps may be perceived as incompetence, rather than just a lack of experience. There is a certificate for added qualification in hospital medicine for PA providers (which includes a specialty exam), and there is an acute care focus for NPs in training; however, there is no standardized licensure to ensure hospital medicine competency, creating a quagmire for hospitalist leaders who desire demonstrable competence of these providers.

Another barrier for some programs is financial; physicians may not want to give up their RVUs to an NP/PA provider. This can really inhibit a more independent role for the APP. It is important that financial incentives align with all members of the practice working at maximum scope.

Summary and future

In summary, the role of PA/NP in hospital medicine has continued to grow and evolve, to meet the needs of the industry. This includes an increase in the scope and independence of APPs, including the use of telehealth for required oversight. As a specialty, it is imperative that we continue to research APP model effectiveness, embrace innovative delivery models, and support effective onboarding and career development opportunities for our NP/PA providers.

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Ms. Cardin is vice president, Advanced Practice Providers, at Sound Physicians, and is a member of SHM’s Board of Directors.

References

1. “Midlevels make a rocky entrance into hospital medicine,” by Bonnie Darves, Today’s Hospitalist, January 2007.

2. “When hiring midlevels, proceed with caution,” by Jessica Berthold, ACP Hospitalist, April 2009.

3. “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” J Clin Outcomes Manag. 2016 Oct 1;23[10]:455-61.

 

Background and growth

Hospitalist nurse practitioner (NP) and physician assistant (PA) providers have been a growing and evolving part of the inpatient medical workforce, seemingly since the inception of hospital medicine. Given the growth of these disciplines within hospital medicine, at this juncture it is helpful to look at this journey, to see what roles these providers have been serving, and to consider newer and novel trends in how NPs and PAs are being weaved into hospital medicine programs.

The drivers for growth in this provider population are not unlike those of physician hospitalists. The same milieu that provided inroads for physicians in hospital-based care have led the way for increased use of NP/PA providers. An aging physician workforce, residency work hour reforms, increasing complexity of patients and systems on the inpatient side, and the recognition that caring for inpatients is a specialty vastly different from the role of internist in primary care have all impacted the numbers of NPs and PAs in this arena.

A quick review of older articles and publications gives a very interesting and wry snapshot of the utilization of NP/PA providers in hospital medicine in past years. The titles alone provide for a chuckle or two:

• 2007 Today’s Hospitalist article: “Midlevels make a rocky entrance into hospital medicine”¹

• 2009 ACP Hospitalist article: “When hiring midlevels, proceed with caution”²

These titles reflect the uncertainty at the time in how best to utilize NP/PA providers in hospital medicine (as well as an unfashionable vocabulary). The numbers at the time tell a similar story. In the Society of Hospital Medicine survey in 2007-2008, about 29% and 21% of hospital medicine practices utilized NPs and PAs, respectively. However, by 2014 about 50% of Veterans Affairs inpatient medical services deployed NP/PA providers, and most recent data from the Society of Hospital Medicine reveal that about 63% of groups use these advanced practice providers (APPs), with higher numbers in pediatric programs. Clearly there is evolving growth and enthusiasm for NP/PAs in hospital medicine.

Program models

Determining how best to use NP/PAs in hospital medicine programs has had a similar evolution. Reviewing past articles addressing these issues, one can see that there has been clear migration; initially NP/PAs were primarily hired to assist with late-afternoon admission surges, with about 60% of the APP workload being utilized to admit in 2007. Their role has continued to grow and change, much as hospitalist practices have; current program models consist of a few major types, with some novel models coming to the fore.

The first model is the classic paired rounding or “dyad” model. This is where a physician and an APP split a panel of patients. The APP then cares for his/her panel of patients, including daily visits, progress notes, calling consults, discharges, discharge summaries, procedures, billing, etc. The physician does the same for his/her panel of patients. The physician and the APP may then “run the list together” and the physician may then see most or all of the APP’s patients and bill for them when medical complexity demands. This allows for a higher volume of patients to be seen and billed, at a lower overall cost; it also provides for backup/support/redundancy for both team members when the patient acuity gets high.

Another model is use of an NP/PA in an observation unit or with lower acuity observation patients. The majority of the management of the patients is completed and billed by the APP, with the physician available for backup. This hits the “sweet spot,” utilizing the right provider with the right skill set for the right patient. The program has to account for some reimbursement or compensation for the physician oversight time, but it is a very efficient use of APPs.

The third major deployment of APPs is with admissions. Many groups use APPs to admit into the late afternoon and evening, getting patients “tucked in,” including starting diagnostic work-ups and treatment plans. The physician hospitalist then evaluates the patient the next day and often bills for the admission. This model works in situations where the patient work-up is dependent on lab testing, imaging, or other diagnostic testing to understand and plan for the “arc” of the hospitalization; or in situations where the diagnosis is clear, but the patient needs time with treatment to determine response. The downside of this model is long-term job satisfaction for the APP (although some programs have them rotate through such a model at intervals).

Another area where APPs have made strong inroads is that of comanagement services. The NP or PA develops a long-term relationship with a surgical comanagement team, and is often highly engaged and extremely appreciated for managing chronic conditions such as hypertension and diabetes. This can be a very satisfying model for both teams. The NP/PA usually bills independently for these encounters.

APPS are also used in cross coverage and triage roles, allowing the day teams to focus on their primary patients. In a triage role, they can interface with the emergency department, providing a semi-neutral “mediator” for patient disposition.

On the more novel end of the spectrum, there is growth in more independent roles for APP hospitalists. Some groups are having success at using the paired rounding or dyad model, but having the physician see the patient every third day. This is most successful where there is strong onboarding and deep clarity for when to contact the backup physician. There are some data to support the effectiveness of this model, most recently in the Journal of Clinical Outcomes Management.³

Critical access hospitals are also having success in deploying APPs in a very independent role, staffing these hospitals at night. Smaller, rural hospitals with aging medical staff have learned to maximize the scope of practice of their APPs to remain viable and provide care for inpatients. This can be a very successful model for APPs working at the maximum scope of their practice. In addition, the use of telemedicine has been implemented to allow for remote physician backup. This may be a rapidly growing arm to hospital medicine practices in the future.

 

Ongoing barriers

There are many barriers to maximizing the scope of practice and efficiency of APPs in hospital medicine. They range from the “macro” to the “micro.”

On the larger stage, Medicare requires that home care orders be signed by an attending physician, which can be inefficient and difficult to accomplish. Other payers may have somewhat arcane statutes that limit billing practices, and state practice limitations vary widely. Although 22 states now allow for independent practice for NPs, other states may have a very restrictive practice environment that can impede creative care delivery models. But regardless of how liberal a practice the state allows, a hospital’s medical bylaws can still restrict the day-to-day practice of APPs. And those restrictive bylaws are emblematic of a more constant and corporeal barrier to APP practice, that of medical staff culture.

If there are physicians on the staff who fear that utilization of NP/PA providers will lead to a decay in the quality of care, or who feel threatened by the use of APPs, that can create a local stopgap to maximizing utilization of APPs. In addition, hospitalist physicians and leaders may lack knowledge or experience in APP practice. APPs take more time to successfully onboard than physicians; without clear expectations or road maps to accomplish this onboarding, leaders may feel that APP integration doesn’t work. And one bad experience can create long-term barriers for future practices.

Other barriers are the lack of standardized rigor and vigor in graduate education programs (in both educational and clinical experiences). This results in variation in the quality of NP/PA providers at graduation. Knowledge gaps may be perceived as incompetence, rather than just a lack of experience. There is a certificate for added qualification in hospital medicine for PA providers (which includes a specialty exam), and there is an acute care focus for NPs in training; however, there is no standardized licensure to ensure hospital medicine competency, creating a quagmire for hospitalist leaders who desire demonstrable competence of these providers.

Another barrier for some programs is financial; physicians may not want to give up their RVUs to an NP/PA provider. This can really inhibit a more independent role for the APP. It is important that financial incentives align with all members of the practice working at maximum scope.

Summary and future

In summary, the role of PA/NP in hospital medicine has continued to grow and evolve, to meet the needs of the industry. This includes an increase in the scope and independence of APPs, including the use of telehealth for required oversight. As a specialty, it is imperative that we continue to research APP model effectiveness, embrace innovative delivery models, and support effective onboarding and career development opportunities for our NP/PA providers.

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Ms. Cardin is vice president, Advanced Practice Providers, at Sound Physicians, and is a member of SHM’s Board of Directors.

References

1. “Midlevels make a rocky entrance into hospital medicine,” by Bonnie Darves, Today’s Hospitalist, January 2007.

2. “When hiring midlevels, proceed with caution,” by Jessica Berthold, ACP Hospitalist, April 2009.

3. “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” J Clin Outcomes Manag. 2016 Oct 1;23[10]:455-61.

 

Background and growth

Hospitalist nurse practitioner (NP) and physician assistant (PA) providers have been a growing and evolving part of the inpatient medical workforce, seemingly since the inception of hospital medicine. Given the growth of these disciplines within hospital medicine, at this juncture it is helpful to look at this journey, to see what roles these providers have been serving, and to consider newer and novel trends in how NPs and PAs are being weaved into hospital medicine programs.

The drivers for growth in this provider population are not unlike those of physician hospitalists. The same milieu that provided inroads for physicians in hospital-based care have led the way for increased use of NP/PA providers. An aging physician workforce, residency work hour reforms, increasing complexity of patients and systems on the inpatient side, and the recognition that caring for inpatients is a specialty vastly different from the role of internist in primary care have all impacted the numbers of NPs and PAs in this arena.

A quick review of older articles and publications gives a very interesting and wry snapshot of the utilization of NP/PA providers in hospital medicine in past years. The titles alone provide for a chuckle or two:

• 2007 Today’s Hospitalist article: “Midlevels make a rocky entrance into hospital medicine”¹

• 2009 ACP Hospitalist article: “When hiring midlevels, proceed with caution”²

These titles reflect the uncertainty at the time in how best to utilize NP/PA providers in hospital medicine (as well as an unfashionable vocabulary). The numbers at the time tell a similar story. In the Society of Hospital Medicine survey in 2007-2008, about 29% and 21% of hospital medicine practices utilized NPs and PAs, respectively. However, by 2014 about 50% of Veterans Affairs inpatient medical services deployed NP/PA providers, and most recent data from the Society of Hospital Medicine reveal that about 63% of groups use these advanced practice providers (APPs), with higher numbers in pediatric programs. Clearly there is evolving growth and enthusiasm for NP/PAs in hospital medicine.

Program models

Determining how best to use NP/PAs in hospital medicine programs has had a similar evolution. Reviewing past articles addressing these issues, one can see that there has been clear migration; initially NP/PAs were primarily hired to assist with late-afternoon admission surges, with about 60% of the APP workload being utilized to admit in 2007. Their role has continued to grow and change, much as hospitalist practices have; current program models consist of a few major types, with some novel models coming to the fore.

The first model is the classic paired rounding or “dyad” model. This is where a physician and an APP split a panel of patients. The APP then cares for his/her panel of patients, including daily visits, progress notes, calling consults, discharges, discharge summaries, procedures, billing, etc. The physician does the same for his/her panel of patients. The physician and the APP may then “run the list together” and the physician may then see most or all of the APP’s patients and bill for them when medical complexity demands. This allows for a higher volume of patients to be seen and billed, at a lower overall cost; it also provides for backup/support/redundancy for both team members when the patient acuity gets high.

Another model is use of an NP/PA in an observation unit or with lower acuity observation patients. The majority of the management of the patients is completed and billed by the APP, with the physician available for backup. This hits the “sweet spot,” utilizing the right provider with the right skill set for the right patient. The program has to account for some reimbursement or compensation for the physician oversight time, but it is a very efficient use of APPs.

The third major deployment of APPs is with admissions. Many groups use APPs to admit into the late afternoon and evening, getting patients “tucked in,” including starting diagnostic work-ups and treatment plans. The physician hospitalist then evaluates the patient the next day and often bills for the admission. This model works in situations where the patient work-up is dependent on lab testing, imaging, or other diagnostic testing to understand and plan for the “arc” of the hospitalization; or in situations where the diagnosis is clear, but the patient needs time with treatment to determine response. The downside of this model is long-term job satisfaction for the APP (although some programs have them rotate through such a model at intervals).

Another area where APPs have made strong inroads is that of comanagement services. The NP or PA develops a long-term relationship with a surgical comanagement team, and is often highly engaged and extremely appreciated for managing chronic conditions such as hypertension and diabetes. This can be a very satisfying model for both teams. The NP/PA usually bills independently for these encounters.

APPS are also used in cross coverage and triage roles, allowing the day teams to focus on their primary patients. In a triage role, they can interface with the emergency department, providing a semi-neutral “mediator” for patient disposition.

On the more novel end of the spectrum, there is growth in more independent roles for APP hospitalists. Some groups are having success at using the paired rounding or dyad model, but having the physician see the patient every third day. This is most successful where there is strong onboarding and deep clarity for when to contact the backup physician. There are some data to support the effectiveness of this model, most recently in the Journal of Clinical Outcomes Management.³

Critical access hospitals are also having success in deploying APPs in a very independent role, staffing these hospitals at night. Smaller, rural hospitals with aging medical staff have learned to maximize the scope of practice of their APPs to remain viable and provide care for inpatients. This can be a very successful model for APPs working at the maximum scope of their practice. In addition, the use of telemedicine has been implemented to allow for remote physician backup. This may be a rapidly growing arm to hospital medicine practices in the future.

 

Ongoing barriers

There are many barriers to maximizing the scope of practice and efficiency of APPs in hospital medicine. They range from the “macro” to the “micro.”

On the larger stage, Medicare requires that home care orders be signed by an attending physician, which can be inefficient and difficult to accomplish. Other payers may have somewhat arcane statutes that limit billing practices, and state practice limitations vary widely. Although 22 states now allow for independent practice for NPs, other states may have a very restrictive practice environment that can impede creative care delivery models. But regardless of how liberal a practice the state allows, a hospital’s medical bylaws can still restrict the day-to-day practice of APPs. And those restrictive bylaws are emblematic of a more constant and corporeal barrier to APP practice, that of medical staff culture.

If there are physicians on the staff who fear that utilization of NP/PA providers will lead to a decay in the quality of care, or who feel threatened by the use of APPs, that can create a local stopgap to maximizing utilization of APPs. In addition, hospitalist physicians and leaders may lack knowledge or experience in APP practice. APPs take more time to successfully onboard than physicians; without clear expectations or road maps to accomplish this onboarding, leaders may feel that APP integration doesn’t work. And one bad experience can create long-term barriers for future practices.

Other barriers are the lack of standardized rigor and vigor in graduate education programs (in both educational and clinical experiences). This results in variation in the quality of NP/PA providers at graduation. Knowledge gaps may be perceived as incompetence, rather than just a lack of experience. There is a certificate for added qualification in hospital medicine for PA providers (which includes a specialty exam), and there is an acute care focus for NPs in training; however, there is no standardized licensure to ensure hospital medicine competency, creating a quagmire for hospitalist leaders who desire demonstrable competence of these providers.

Another barrier for some programs is financial; physicians may not want to give up their RVUs to an NP/PA provider. This can really inhibit a more independent role for the APP. It is important that financial incentives align with all members of the practice working at maximum scope.

Summary and future

In summary, the role of PA/NP in hospital medicine has continued to grow and evolve, to meet the needs of the industry. This includes an increase in the scope and independence of APPs, including the use of telehealth for required oversight. As a specialty, it is imperative that we continue to research APP model effectiveness, embrace innovative delivery models, and support effective onboarding and career development opportunities for our NP/PA providers.

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Ms. Cardin is vice president, Advanced Practice Providers, at Sound Physicians, and is a member of SHM’s Board of Directors.

References

1. “Midlevels make a rocky entrance into hospital medicine,” by Bonnie Darves, Today’s Hospitalist, January 2007.

2. “When hiring midlevels, proceed with caution,” by Jessica Berthold, ACP Hospitalist, April 2009.

3. “A Comparison of Conventional and Expanded Physician Assistant Hospitalist Staffing Models at a Community Hospital,” J Clin Outcomes Manag. 2016 Oct 1;23[10]:455-61.

 

Ten years ago, I was flying back from my last job interview – I did nearly 20 – and my wife and I were stuck: Should I take a lucrative private practice gig, an academic position, or join a group? We listed the pros and cons on several condensation-soaked Southwest Air napkins and agreed to make a decision before landing. (Fortunately, it was a cross country, BWI to SAN, flight).

I don’t know if I made the right decision. I’m sure I’d have enjoyed either a cosmetic practice or walking the halls with medical students in tow. I chose to join a medical group at Kaiser Permanente, and I’ve loved it. Working here has helped me become a better dermatologist, teammate, friend, and husband. It has also allowed me to embrace digital medicine a bit earlier and with less difficulty than most. You wouldn’t be reading my “Digital Doctor” column if I hadn’t.

When I started practicing, digital medicine referred only to EMRs and rare patient portals. I had a hunch that digital health might be a big deal. I didn’t realize, though, that the impact could be as big as the introduction of stethoscopes, perhaps more so. Digital has changed how patients receive care. It has changed how doctors deliver care. It has changed what it means to care. Touch is no longer a requirement to practice medicine, and, as a result, there are good and bad consequences.

Digital made medicine more accessible than ever. It also made medicine more of a commodity than ever. It turned us into the highest paid data entry clerks in the world. It changed the sacrosanct doctor-patient relationship. It has also presented us with the greatest opportunity in a thousand years. An opportunity to create a new medicine, one that is patient-centric, smart, affordable, efficient, and human. I started this column to explore the digital devices we doctors have and to find ways they might improve the care we give.

I’ve been in practice for 10 years, and I’m now the chief of service for a large dermatology group, as well as physician director for Healthcare Transformation for Kaiser Permanente, San Diego. My job is to help our physicians perform at their best both at work and in life. Through research, interviews, and my own practice, I’ve learned a lot and would like to share it with you.

Starting in September, I’ll broaden the scope of this column. No longer will it be just digital. Rather, it will be about you and how you can be the best you can be. We’ll explore tools, techniques, diet, exercise, and Jedi mind tricks to make you the fastest, smartest, happiest, healthiest, funniest (results may vary) doctor you can be. It’s time to take this column, and you, to the next level – the Optimized Doctor. I can hardly wait.
 

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

 

Ten years ago, I was flying back from my last job interview – I did nearly 20 – and my wife and I were stuck: Should I take a lucrative private practice gig, an academic position, or join a group? We listed the pros and cons on several condensation-soaked Southwest Air napkins and agreed to make a decision before landing. (Fortunately, it was a cross country, BWI to SAN, flight).

I don’t know if I made the right decision. I’m sure I’d have enjoyed either a cosmetic practice or walking the halls with medical students in tow. I chose to join a medical group at Kaiser Permanente, and I’ve loved it. Working here has helped me become a better dermatologist, teammate, friend, and husband. It has also allowed me to embrace digital medicine a bit earlier and with less difficulty than most. You wouldn’t be reading my “Digital Doctor” column if I hadn’t.

When I started practicing, digital medicine referred only to EMRs and rare patient portals. I had a hunch that digital health might be a big deal. I didn’t realize, though, that the impact could be as big as the introduction of stethoscopes, perhaps more so. Digital has changed how patients receive care. It has changed how doctors deliver care. It has changed what it means to care. Touch is no longer a requirement to practice medicine, and, as a result, there are good and bad consequences.

Digital made medicine more accessible than ever. It also made medicine more of a commodity than ever. It turned us into the highest paid data entry clerks in the world. It changed the sacrosanct doctor-patient relationship. It has also presented us with the greatest opportunity in a thousand years. An opportunity to create a new medicine, one that is patient-centric, smart, affordable, efficient, and human. I started this column to explore the digital devices we doctors have and to find ways they might improve the care we give.

I’ve been in practice for 10 years, and I’m now the chief of service for a large dermatology group, as well as physician director for Healthcare Transformation for Kaiser Permanente, San Diego. My job is to help our physicians perform at their best both at work and in life. Through research, interviews, and my own practice, I’ve learned a lot and would like to share it with you.

Starting in September, I’ll broaden the scope of this column. No longer will it be just digital. Rather, it will be about you and how you can be the best you can be. We’ll explore tools, techniques, diet, exercise, and Jedi mind tricks to make you the fastest, smartest, happiest, healthiest, funniest (results may vary) doctor you can be. It’s time to take this column, and you, to the next level – the Optimized Doctor. I can hardly wait.
 

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

 

Ten years ago, I was flying back from my last job interview – I did nearly 20 – and my wife and I were stuck: Should I take a lucrative private practice gig, an academic position, or join a group? We listed the pros and cons on several condensation-soaked Southwest Air napkins and agreed to make a decision before landing. (Fortunately, it was a cross country, BWI to SAN, flight).

I don’t know if I made the right decision. I’m sure I’d have enjoyed either a cosmetic practice or walking the halls with medical students in tow. I chose to join a medical group at Kaiser Permanente, and I’ve loved it. Working here has helped me become a better dermatologist, teammate, friend, and husband. It has also allowed me to embrace digital medicine a bit earlier and with less difficulty than most. You wouldn’t be reading my “Digital Doctor” column if I hadn’t.

When I started practicing, digital medicine referred only to EMRs and rare patient portals. I had a hunch that digital health might be a big deal. I didn’t realize, though, that the impact could be as big as the introduction of stethoscopes, perhaps more so. Digital has changed how patients receive care. It has changed how doctors deliver care. It has changed what it means to care. Touch is no longer a requirement to practice medicine, and, as a result, there are good and bad consequences.

Digital made medicine more accessible than ever. It also made medicine more of a commodity than ever. It turned us into the highest paid data entry clerks in the world. It changed the sacrosanct doctor-patient relationship. It has also presented us with the greatest opportunity in a thousand years. An opportunity to create a new medicine, one that is patient-centric, smart, affordable, efficient, and human. I started this column to explore the digital devices we doctors have and to find ways they might improve the care we give.

I’ve been in practice for 10 years, and I’m now the chief of service for a large dermatology group, as well as physician director for Healthcare Transformation for Kaiser Permanente, San Diego. My job is to help our physicians perform at their best both at work and in life. Through research, interviews, and my own practice, I’ve learned a lot and would like to share it with you.

Starting in September, I’ll broaden the scope of this column. No longer will it be just digital. Rather, it will be about you and how you can be the best you can be. We’ll explore tools, techniques, diet, exercise, and Jedi mind tricks to make you the fastest, smartest, happiest, healthiest, funniest (results may vary) doctor you can be. It’s time to take this column, and you, to the next level – the Optimized Doctor. I can hardly wait.
 

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

 

Question: Regarding opioid deaths, which of the following is incorrect?

A. The term refers to accidental or intentional deaths caused mostly by heroin.

B. They are reaching epidemic proportions.

C. May form the basis for a wrongful death lawsuit.

D. May lead to loss of medical license.

E. The physician may face prosecution for homicide.

Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.

Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.

Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.

Recently, an Oklahoma doctor was charged with second-degree murder in the overdose deaths of at least five patients from prescription painkillers and other drugs.¹ The doctor had prescribed more than 3 million doses over a 5-year-period. In 2010, she had prescribed for a 47-year-old patient a total of 450 painkillers, muscle relaxants, and antianxiety drugs – the so-called addict’s holy trinity. The patient died 6 days later.

This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.

For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.

According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.² The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.² It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.

The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.

States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”³

The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.⁴
 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.

2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.

3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.

4. https://www.end-opioid-epidemic.org.  Accessed July 5, 2017.

 

Question: Regarding opioid deaths, which of the following is incorrect?

A. The term refers to accidental or intentional deaths caused mostly by heroin.

B. They are reaching epidemic proportions.

C. May form the basis for a wrongful death lawsuit.

D. May lead to loss of medical license.

E. The physician may face prosecution for homicide.

Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.

Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.

Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.

Recently, an Oklahoma doctor was charged with second-degree murder in the overdose deaths of at least five patients from prescription painkillers and other drugs.¹ The doctor had prescribed more than 3 million doses over a 5-year-period. In 2010, she had prescribed for a 47-year-old patient a total of 450 painkillers, muscle relaxants, and antianxiety drugs – the so-called addict’s holy trinity. The patient died 6 days later.

This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.

For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.

According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.² The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.² It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.

The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.

States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”³

The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.⁴
 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.

2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.

3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.

4. https://www.end-opioid-epidemic.org.  Accessed July 5, 2017.

 

Question: Regarding opioid deaths, which of the following is incorrect?

A. The term refers to accidental or intentional deaths caused mostly by heroin.

B. They are reaching epidemic proportions.

C. May form the basis for a wrongful death lawsuit.

D. May lead to loss of medical license.

E. The physician may face prosecution for homicide.

Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.

Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.

Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.

Recently, an Oklahoma doctor was charged with second-degree murder in the overdose deaths of at least five patients from prescription painkillers and other drugs.¹ The doctor had prescribed more than 3 million doses over a 5-year-period. In 2010, she had prescribed for a 47-year-old patient a total of 450 painkillers, muscle relaxants, and antianxiety drugs – the so-called addict’s holy trinity. The patient died 6 days later.

This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.

For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.

According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.² The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.² It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.

The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.

States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”³

The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.⁴
 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.

2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.

3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.

4. https://www.end-opioid-epidemic.org.  Accessed July 5, 2017.

 

Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).

While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.

The before and after intervention study was performed across the nine hospitals of a regional and rural health district in southern New South Wales, Australia. The intervention consisted of an ASP supported by a computerized clinical decision support system, with subsequent introduction of targeted CDI case feedback to admitting medical officers. The main initiatives comprising the ASP were regular antimicrobial stewardship ward rounds at the three largest hospitals, restriction of broad-spectrum antimicrobials, a comprehensive education campaign, and an intranet website to improve access to guidelines.

The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.

The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.

Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.

Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.

Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.

Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.

 

Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).

While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.

The before and after intervention study was performed across the nine hospitals of a regional and rural health district in southern New South Wales, Australia. The intervention consisted of an ASP supported by a computerized clinical decision support system, with subsequent introduction of targeted CDI case feedback to admitting medical officers. The main initiatives comprising the ASP were regular antimicrobial stewardship ward rounds at the three largest hospitals, restriction of broad-spectrum antimicrobials, a comprehensive education campaign, and an intranet website to improve access to guidelines.

The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.

The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.

Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.

Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.

Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.

Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.

 

Clostridium difficile infection (CDI) remains a major cause of health care–associated diarrhea in industrialized countries and is a common target of antimicrobial stewardship programs (ASPs).

While the burden of CDI has been well described in tertiary metropolitan hospitals, there is a lack of published evidence from regional and rural hospitals. Our recent study published in the Journal of Hospital Infection explores the effect of an ASP on health care–associated CDI rates and the impact of CDI on length of stay and hospital costs.

The before and after intervention study was performed across the nine hospitals of a regional and rural health district in southern New South Wales, Australia. The intervention consisted of an ASP supported by a computerized clinical decision support system, with subsequent introduction of targeted CDI case feedback to admitting medical officers. The main initiatives comprising the ASP were regular antimicrobial stewardship ward rounds at the three largest hospitals, restriction of broad-spectrum antimicrobials, a comprehensive education campaign, and an intranet website to improve access to guidelines.

The ASP functioned alongside infection control practices, including isolation of patients with antimicrobial-resistant organisms (including C. difficile), hand hygiene, personal protective equipment, and terminal cleaning. Timely feedback emails to medical officers contained information on patient-specific risk factors for CDI, current and prior antimicrobials, and suggestions for CDI treatment. The effect of health care–associated CDI on length of stay and hospital costs was investigated using a group of matched controls, identified retrospectively using hospital performance data. Prior antimicrobial and proton pump inhibitor use were also measured and compared with background use.

The results of our study demonstrated a stable health care–associated CDI rate of around four cases per 10,000 occupied bed days over a 5-year period, similar to the average Australian rate. The length of time over which CDI rates could be effectively examined prior to the intervention was limited by changes to C. difficile stool testing methods. Median length of stay was 11 days greater, and median hospital costs were AU$11,361 higher for patients with health care–associated CDI (n = 91) than for their matched controls (n = 172). It is likely that the increase in costs was associated with additional length of stay but also with increased investigation and treatment costs. Among the group of patients with severe disease (n = 8), only four received oral vancomycin according to Australian guidelines, possibly because of under-recognition of severity criteria. The response rate to emails was low at 19%, showing that other methods are additionally necessary to communicate CDI case feedback.

Third generation cephalosporins and beta-lactamase inhibitor combinations were over-represented in the health care–associated CDI group, where narrower spectrum antimicrobials such as beta-lactamase sensitive penicillins were under represented. Rates of prior antimicrobial use and proton pump inhibitor use were broadly in agreement with the literature.

Our study demonstrated that, in the Australian nonmetropolitan setting, there was a high burden of health care–associated CDI in terms of hospital costs and length of stay, even though our health district experienced CDI rates that were similar to the Australian average. Challenges associated with the study included maintenance of consistent data collection across multiple hospital sites without comprehensive electronic medical records, provision of timely email feedback, and dissemination of study results.

Analysis of prior antimicrobial use has allowed us to identify targets for ongoing antimicrobial stewardship activities, and we also intend to provide further education on recognition of severity criteria. These activities can be supported through daily antimicrobial stewardship ward rounds. Future research could involve application of appropriateness criteria to prior and current antimicrobial use in CDI patients in order to identify avoidable cases and use of more advanced statistical techniques such as multistate modeling to determine differences in outcomes between cases and controls.

Stuart Bond, BPharm, DipPharmPrac, is an antimicrobial stewardship pharmacist based at Wollongong Hospital in New South Wales, Australia.

 

Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.

Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.

Over the last couple of years, the medical community has learned a great deal about the Zika virus. However, we still have a lot to learn. The frightening reality is that there are still more questions than answers. That is why collaboration, transparency, and support are more important than ever.

The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.

Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.

The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.

As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.

Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.

 

Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.

Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.

Over the last couple of years, the medical community has learned a great deal about the Zika virus. However, we still have a lot to learn. The frightening reality is that there are still more questions than answers. That is why collaboration, transparency, and support are more important than ever.

The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.

Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.

The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.

As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.

Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.

 

Although the Zika virus isn’t making as many news headlines as it was last summer, ob.gyns. must not forget that it could still be in our waiting rooms.

Last year, new information on Zika emerged on a weekly, sometimes daily, basis. Today, ob.gyns. remain on the front lines of counseling and treating women whose pregnancies are at risk of being affected by the Zika virus and devastating birth defects associated with it.

Over the last couple of years, the medical community has learned a great deal about the Zika virus. However, we still have a lot to learn. The frightening reality is that there are still more questions than answers. That is why collaboration, transparency, and support are more important than ever.

The American College of Obstetricians and Gynecologists prioritizes preparing ob.gyns. to comprehensively address the Zika virus with patients. To support clinicians, ACOG regularly develops, updates, and issues guidance on the risk, prevention, assessment, treatment, and outcomes of the Zika virus. This includes a regularly updated Practice Advisory, as well as information to direct ob.gyns. to critical resources from the Centers for Disease Control and Prevention, such as the U.S. Zika Pregnancy Registry.

Last month, I participated in an ad hoc meeting of international experts and professional society representatives sponsored by the Gottesfeld-Hohler Memorial Foundation. The goal of this Zika think tank was to share ongoing studies and unpublished findings and to identify ways for the groups to collaborate to fight the virus. Zika experts from endemic and risk areas, such as Brazil, Colombia, Puerto Rico, Texas, and Florida, started the meeting with on-the-ground updates. The latest epidemiologic evidence is that there appear to be waves of Zika virus infections that occur across regions/countries, spreading to virus-naive areas. Although immunity may develop eventually, Zika appears to occur in epidemics and is likely to spread further in North and South America to naive regions. Much of the United States is at risk during mosquito seasons. This collaboration with the Gottesfeld-Hohler Memorial Foundation was just the beginning, and I look forward to working more with Zika experts from all over the world.

The health reform debate in Washington also will affect our ability to respond to the ongoing Zika crisis. Current proposals allow states to opt out of essential coverage requirements, such as contraception and maternity coverage. It also would limit the federal investment in Medicaid, resulting in cuts to benefits and provider reimbursement and hamstringing our ability to treat our low-income pregnant patients with Zika exposure.

As ob.gyns., we continue to be the most important source of information for patients, and our goals of providing the most up-to-date knowledge and aiding in informed decision making are more important than ever.

Dr. Harris is a gynecologist in Gainesville, Fla., and chair of ACOG District VII. She reported having no relevant financial disclosures.

Listening is hard. We hear what we expect to hear.

“What did the patient say about the golf ball?” I asked my student.

The student looked blank. “Golf ball?” he asked.

“The patient said a golf ball hit him.”

“He did?”

“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”

“Yes,” said the student. “Now I remember.”

“Good. Now tell me why he said it.”

The student looked lost. “Because he really was hit by a golf ball?”

“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.

“Because there was trauma?”

“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.

“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.

“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”

The student did not.

“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”

“Yes, he did say that,” said the student.

“So again: Why did he think I needed to know?”

“Because picking is a form of trauma, which might cause the spot to turn into something?”

“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.

“How many patients have we seen together who asked me to take something off ‘because I keep picking at it’? Or because ‘it catches on my necklace,’ or ‘it rubs on my bra’? It’s not just annoyance. The hanging bumps often are not even close to what is supposed to be irritating them, or else they’re too small to get in the way.”

Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.

Looking at his belly, he said, “I know where I got those.”

“Which ones?” I asked.

He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.

Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.

“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”

Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.

But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@frontlinemedcom.com

Listening is hard. We hear what we expect to hear.

“What did the patient say about the golf ball?” I asked my student.

The student looked blank. “Golf ball?” he asked.

“The patient said a golf ball hit him.”

“He did?”

“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”

“Yes,” said the student. “Now I remember.”

“Good. Now tell me why he said it.”

The student looked lost. “Because he really was hit by a golf ball?”

“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.

“Because there was trauma?”

“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.

“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.

“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”

The student did not.

“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”

“Yes, he did say that,” said the student.

“So again: Why did he think I needed to know?”

“Because picking is a form of trauma, which might cause the spot to turn into something?”

“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.

“How many patients have we seen together who asked me to take something off ‘because I keep picking at it’? Or because ‘it catches on my necklace,’ or ‘it rubs on my bra’? It’s not just annoyance. The hanging bumps often are not even close to what is supposed to be irritating them, or else they’re too small to get in the way.”

Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.

Looking at his belly, he said, “I know where I got those.”

“Which ones?” I asked.

He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.

Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.

“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”

Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.

But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@frontlinemedcom.com

Listening is hard. We hear what we expect to hear.

“What did the patient say about the golf ball?” I asked my student.

The student looked blank. “Golf ball?” he asked.

“The patient said a golf ball hit him.”

“He did?”

“I showed him a precancerous red spot on his forehead, and said I could freeze it off.”

“Yes,” said the student. “Now I remember.”

“Good. Now tell me why he said it.”

The student looked lost. “Because he really was hit by a golf ball?”

“Maybe he was,” I said. “But in his 60 years, he’s been hit by a lot of things. How can he be sure the golf ball hit just that spot? And anyhow, why tell me about it? He must have thought it was important for me to know. We discussed this the other day,” I reminded him.

“Because there was trauma?”

“That’s it,” I said. “One way patients understand why things happen to them is by saying that what got sick was hit by something. They assume trauma weakens and damages the body, and disposes it to being unhealthy.

“After all,” I went on, “I had told him his spot was caused by sun exposure. But he’s had sun exposure all over his face, so why would he get a sun spot only right there? His answer: Sun damages all skin, but the part the golf ball whacked is especially susceptible.

“Is he right? I have no idea, but it’s important – to him – to think so. Not so much for this spot – we’re going to treat it anyway – but because of what he said 2 minutes later about his left shin. Remember?”

The student did not.

“He had a raised brown spot on his leg,” I reminded him. “It was just a seborrheic keratosis, not even precancerous. But he said he was always picking it.”

“Yes, he did say that,” said the student.

“So again: Why did he think I needed to know?”

“Because picking is a form of trauma, which might cause the spot to turn into something?”

“Yes, indeed,” I said. “You should train yourself to listen to these offhand remarks that seem irrelevant to you. They are relevant to the patient, or he wouldn’t say them.

“How many patients have we seen together who asked me to take something off ‘because I keep picking at it’? Or because ‘it catches on my necklace,’ or ‘it rubs on my bra’? It’s not just annoyance. The hanging bumps often are not even close to what is supposed to be irritating them, or else they’re too small to get in the way.”

Sure enough, a little later the student and I met another patient coming for a skin check. A computer scientist from a local university, he displayed a big collection of cherry angiomas on his torso, front, and back.

Looking at his belly, he said, “I know where I got those.”

“Which ones?” I asked.

He pointed to a dense collection of red spots near his navel. “A soccer ball hit me there when I was a teenager in Colombia,” he said.

Later, the student and I discussed this man’s recollection. “What makes his observation striking,” I suggested, “is not just as another example of a patient blaming body changes on trauma. It’s that he did it in a way that even a smidgen of critical thinking – the kind he applies to his professional work all the time – would show that his hypothesis makes no sense. After all, he has dozens of red spots nowhere near where the soccer ball supposedly hit him.

“You would think a computer scientist would notice this, but when it comes to looking at our own health, even sophisticated scientific training may not help. Instead, the thinking is: “I’ve got these red spots. Something caused them. A soccer ball hit me down there. That must be it.”

Sometimes hearing what patients say doesn’t matter; we’re not going to remove the cherry angiomas. But sometimes it does, by telling us the real reason they want something removed, which may include some guilt about their own picking, guilt they can do without.

But you would have to listen for that nuance, and listening is hard. Mostly, in medicine and in life, we hear only what we expect to hear.

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at dermnews@frontlinemedcom.com

 

Yes, placing drains is essential.

It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.

Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.

However, the clinically relevant question with drains during pancreatic resection is, Do drains increase the rates of fistula or infection?

A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).

A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).

Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.

Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).

Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.

I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.

Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.

No, drain placement is not always necessary.

Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.

There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.

Researchers at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City conducted the first prospective trial addressing this issue (Ann. Surg. 2001;234:487-94). They evaluated 179 patients, randomizing 88 patients to receive intraoperative drains. Patients in the cohort with drains were more likely to develop a significant intra-abdominal abscess, collection, or fistula.

Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.

We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.

When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.

A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.

If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.

I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.

There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.

 

Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.

 

Yes, placing drains is essential.

It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.

Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.

However, the clinically relevant question with drains during pancreatic resection is, Do drains increase the rates of fistula or infection?

A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).

A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).

Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.

Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).

Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.

I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.

Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.

No, drain placement is not always necessary.

Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.

There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.

Researchers at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City conducted the first prospective trial addressing this issue (Ann. Surg. 2001;234:487-94). They evaluated 179 patients, randomizing 88 patients to receive intraoperative drains. Patients in the cohort with drains were more likely to develop a significant intra-abdominal abscess, collection, or fistula.

Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.

We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.

When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.

A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.

If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.

I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.

There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.

 

Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.

 

Yes, placing drains is essential.

It’s important to look at the evidence in the literature, starting with a randomized controlled trial of 179 patients from 2001 that showed no reduction in death or complication rate associated with use of surgical intraperitoneal closed suction drainage (Ann. Surg. 2001;234:487-94). Interestingly, even though this study showed there was no benefit to using drains, they address the use of closed suction drainage. The investigators were not claiming all drains are unnecessary.

Why drain placement? The argument for drains includes evacuation of blood, pancreatic juice, bile, and chyle. In addition, assessing drainage can act as a warning sign for anastomotic leak or hemorrhage, so patients can potentially avoid additional interventions.

However, the clinically relevant question with drains during pancreatic resection is, Do drains increase the rates of fistula or infection?

A study from University of Tokyo researchers found three drains were more effective than one. In addition, the investigators argued against early removal, pointing out that the risk for infection associated with drains only increased after day 10. The researchers were not only in favor of drains but in favor of multiple drains (World J Surg. 2016;40:1226-35).

A multicenter, randomized prospective trial conducted in the United States compared 68 patients with drains to 69 others without during pancreaticoduodenectomy. They reported an increase in the frequency and severity of complications when drains were omitted, including the number of grade 2 or greater complications. Furthermore, the safety monitoring board stopped the study early because mortality among patients in the drain group was 3%, compared with 12% in the no-drain group. (Ann. Surg. 2014:259:605-12).

Another set of researchers in Germany conducted a prospective, randomized study that favored omission of drains. However, a closer look at demographics shows that about one-fourth of participants had chronic pancreatitis, which is associated with a low risk of fistula (Ann Surg. 2016;263:440-9). In addition, they found no significant difference in fistula rates between patients who underwent pancreaticojejunostomy or pancreaticoduodenectomy. Interestingly, the authors noted that surgeons were reluctant to omit drains in many situations, even in a clinical trial context.

Furthermore, a systematic review of nine studies with nearly 3,000 patients suggests it is still necessary to place abdominal drains during pancreatic resection, researchers at the Medical College of Xi’an Jiaotong University in China reported (World J Gastroenterol. 2015;21:5719-34). The authors cited a significant increase in morbidity among patients in whom drains were omitted (odds ratio, 2.39).

Perhaps the cleverest way to address this controversy with drains during pancreatic resection comes from researchers at the University of Pennsylvania. They looked at surgical risk factors to gain a more nuanced view. They used the Fistula Risk Score (FRS) to stratify patients and re-examined the outcomes of the multicenter U.S. study I cited earlier that was stopped early because of differences in mortality rates. The University of Pennsylvania research found that FRS correlated well with outcomes, suggesting its use as a mitigation strategy in patients at moderate to high risk for developing clinically relevant postoperative pancreatic fistula (J Gastrointest Surg. 2015;19:21-30). In other words, they suggest routine prophylactic drainage for patients at moderate to high risk but also suggest that there may be no need for prophylactic drainage for negligible to low risk patients.

I would like to conclude that drains appear essential in many cases, including for moderate to higher risk patients. We need to tailor our practices as surgeons regarding placement of drains during pancreatectomy or pancreaticoduodenectomy. Our goal remains to create opportunities for prolonged survival and better quality of life for our patients.

Dr. Dervenis is head of the Department of Surgical Oncology at the Metropolitan Hospital in Athens, Greece. He is also chair of the hepato-pancreato-biliary surgical unit. He reported no disclosures.

No, drain placement is not always necessary.

Drain placement is not essential during all pancreatectomies. The practice is so historically entrenched in our specialty that I need you to check your dogma at the door and take a look at the data with an open mind.

There are many, many retrospective studies that examine drainage versus no drainage. All of these studies have shown the same thing: There is no difference in many outcomes, including mortality. There may be a difference in terms of complicated, postoperative fistulae, which are difficult to manage in patients who have drains.

Researchers at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City conducted the first prospective trial addressing this issue (Ann. Surg. 2001;234:487-94). They evaluated 179 patients, randomizing 88 patients to receive intraoperative drains. Patients in the cohort with drains were more likely to develop a significant intra-abdominal abscess, collection, or fistula.

Another prospective randomized trial from Germany compared the reintervention rate, an endpoint I like, among 439 patients (Ann Surg. 2016;264:528-37). There was no statistically significant difference between the drain or no drain groups, further suggesting that drains are not essential in all cases.

We also need to take a closer look at the study Dr. Dervenis cited (Ann Surg. 2014:259:605-12). It’s true this trial was stopped early because of a higher mortality rate of 12% in the no drain group, but the difference was not statistically significant (P = .097). There was no difference in the fistula rate.

When you look at these data, there are a couple of conclusions you can reach. One conclusion is that a trial of 130 people designed for 750 found something uniquely different that had never been reported in any retrospective series, including one by the study’s senior author that demonstrated drains are essential (HPB [Oxford]. 2011;13:503-10). Another conclusion is that drains are not needed, and there is a very good chance this is a false positive finding. Look at the reasons the 10 participants died. I’m not sure a drain would have helped some of the patients without them, and some of the patients who had drains still died.

A study looking at practice at my institution, MSKCC, shows that drains are still used about half the time, indicating they are not essential. (Ann. Surg. 2013 Dec;258[6]:1051-8). Drains were more commonly used for pancreaticoduodenectomy and when the surgeon thought there might be a problem, such as a soft gland, difficult time in the OR, or a small pancreatic duct.

If you look at these data, this pans out in every retrospective study I’ve seen comparing drain versus no drain – the patients with drains tend to have higher morbidity. Among the 1,122 resection patients in the MSKCC study, those without operative drains had significantly lower rates of grade 3 complications and overall morbidity and fewer readmissions and lower rates of grade 3 or higher pancreatic fistula. Mortality and reintervention rates were no different.

I also looked at our most recent data, between 2010 and 2015. Now we are using intraoperative drains even less often. They are not considered essential at this point.

There are multiple retrospective and well-designed prospective, randomized trials that show no benefit to routine drainage following pancreatectomy. Acceptance of randomized clinical data is slow, particularly when it flies in the face of what you were taught by your mentors over the past 40 or 50 years. I encourage you to look at these data carefully and utilize them in your practice.

 

Dr. Allen is associate director for clinical programs at David M. Rubenstein Center for Pancreatic Cancer Research and the Murray F. Brennan chair in surgery at Memorial Sloan-Kettering Cancer Center in New York City. He reported no disclosures.

 

“I’m giving you a bad review on Yelp over this.”

He said that, and I honestly didn’t care.

When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.

Thinkstock/image altered

Not surprisingly, he didn’t see how this was his fault. He told me that my staff, if they were competent, should have reverified his insurance coverage when we made the reminder call. (I don’t know any offices that do such a thing.)

I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.

But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.

He said no.

I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.

Not surprisingly, he again said no.

Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.

No. I am here to help you. I will not be bullied into doing so. I also can’t see people for free. Heaven knows, any of us who take hospital call do enough of that as is. I have rent, staff salaries, and my kids’ education expenses. I’m pretty sure the bank that holds my mortgage wouldn’t forgive a missed payment if I threatened to write a bad Yelp review about them.

Predictably, he left. And wrote the review on a rate-a-doc site.

Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.

I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.

And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

“I’m giving you a bad review on Yelp over this.”

He said that, and I honestly didn’t care.

When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.

Thinkstock/image altered

Not surprisingly, he didn’t see how this was his fault. He told me that my staff, if they were competent, should have reverified his insurance coverage when we made the reminder call. (I don’t know any offices that do such a thing.)

I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.

But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.

He said no.

I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.

Not surprisingly, he again said no.

Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.

No. I am here to help you. I will not be bullied into doing so. I also can’t see people for free. Heaven knows, any of us who take hospital call do enough of that as is. I have rent, staff salaries, and my kids’ education expenses. I’m pretty sure the bank that holds my mortgage wouldn’t forgive a missed payment if I threatened to write a bad Yelp review about them.

Predictably, he left. And wrote the review on a rate-a-doc site.

Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.

I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.

And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

“I’m giving you a bad review on Yelp over this.”

He said that, and I honestly didn’t care.

When he called for the appointment, he told my staff he was on a PPO plan that I’m contracted with. But when he came in 2 weeks later, he had a completely different card: an HMO that I’ve never been affiliated with.

Thinkstock/image altered

Not surprisingly, he didn’t see how this was his fault. He told me that my staff, if they were competent, should have reverified his insurance coverage when we made the reminder call. (I don’t know any offices that do such a thing.)

I’m an adult neurologist, and don’t see anyone under 18. If you’re an adult, you need to start taking responsibility for your actions. One of them should be knowing what your medical insurance is. This is your job. Not ours. When you tell us what your insurance is, we take you at your word.

But I’m here to help people, and he said he really needed to see me. So I offered to see him at my cash discount rate.

He said no.

I then said I’d see him, and bill it to his insurance to see if they paid anything, and we could work out what he still might owe after that. I was genuinely trying to help him.

Not surprisingly, he again said no.

Then he made me this counteroffer: See me for free, and I won’t post a negative online review about you.

No. I am here to help you. I will not be bullied into doing so. I also can’t see people for free. Heaven knows, any of us who take hospital call do enough of that as is. I have rent, staff salaries, and my kids’ education expenses. I’m pretty sure the bank that holds my mortgage wouldn’t forgive a missed payment if I threatened to write a bad Yelp review about them.

Predictably, he left. And wrote the review on a rate-a-doc site.

Does the bad review bother me? Not at all. The nature of medicine is such that you can’t please everyone. And those you do please likely won’t write a review.

I come here each day to do my best to help people. Threatening me to start a medical relationship will find you going nowhere.

And taking responsibility for your own actions, like I tell my kids, is a big part of being a grownup.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.

Creatas Images

To assist physicians and other prescribers in their discussions with patients, Food and Drug Administration’s Medicine and Pregnancy website provides valuable patient education resources to facilitate the conversation. For example, the consumer Medicine and Pregnancy fact sheet provides four simple tips to patients when talking to their health care providers about using prescription and over-the-counter medicines. The site also includes information on food safety, breast pumps, and tips for new moms, and it offers useful tips for providers, as well. Below are some examples:

• Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
• Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
• Assist pregnant patients with changing medications as needed.
• Advise pregnant patients if they need to take more or less of their medicines.
• Advise patients about medicines that can and cannot be used when they start breastfeeding.
• Encourage patients to talk about any problems they have with their medicine.
• Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
• Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.

The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.

The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish

and other languages; medicine booklets; online videos; and fact sheets, tips, and more at their Medication Safety for Women page.

Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.

Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.

 

 

There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.

Creatas Images

To assist physicians and other prescribers in their discussions with patients, Food and Drug Administration’s Medicine and Pregnancy website provides valuable patient education resources to facilitate the conversation. For example, the consumer Medicine and Pregnancy fact sheet provides four simple tips to patients when talking to their health care providers about using prescription and over-the-counter medicines. The site also includes information on food safety, breast pumps, and tips for new moms, and it offers useful tips for providers, as well. Below are some examples:

• Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
• Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
• Assist pregnant patients with changing medications as needed.
• Advise pregnant patients if they need to take more or less of their medicines.
• Advise patients about medicines that can and cannot be used when they start breastfeeding.
• Encourage patients to talk about any problems they have with their medicine.
• Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
• Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.

The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.

The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish

and other languages; medicine booklets; online videos; and fact sheets, tips, and more at their Medication Safety for Women page.

Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.

Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.

 

 

There are about 6 million pregnancies in the United States each year, and it’s estimated that 50% of pregnant women take at least one medicine. Physicians play an important role in helping their pregnant patients make informed health choices, especially when it comes to the safe use of medications.

Creatas Images

To assist physicians and other prescribers in their discussions with patients, Food and Drug Administration’s Medicine and Pregnancy website provides valuable patient education resources to facilitate the conversation. For example, the consumer Medicine and Pregnancy fact sheet provides four simple tips to patients when talking to their health care providers about using prescription and over-the-counter medicines. The site also includes information on food safety, breast pumps, and tips for new moms, and it offers useful tips for providers, as well. Below are some examples:

• Emphasize that patients should always talk to their health care provider before taking any medicines, herbs, or vitamins. The website provides tips on how to start the conversation with patients about what medicines, herbs, or vitamins to avoid when pregnant.
• Encourage patients to check the drug label and other information that comes with their medicine to learn about possible risks for women who are pregnant or breastfeeding.
• Assist pregnant patients with changing medications as needed.
• Advise pregnant patients if they need to take more or less of their medicines.
• Advise patients about medicines that can and cannot be used when they start breastfeeding.
• Encourage patients to talk about any problems they have with their medicine.
• Report any serious problems your pregnant patients have had after taking a medicine to the FDA. It falls to physicians to report to the FDA any cases of serious side effects, problems with product quality, and product-use errors or with any of the following products: human drugs, medical devices, blood products and other biologics (except vaccines), and/or medical foods.
• Encourage patients to enroll in a Pregnancy Exposure Registry, if applicable at the FDA website, which collects information on pregnancy outcomes in women who already are taking medications. Observational studies of the patients that physicians help enroll in a pregnancy exposure registry can improve drug safety information for medicines used during pregnancy and can be used to update drug labeling. The observational studies included with the registries can also help physicians make medicine recommendations for use during pregnancy. The list includes contact information for each registry. Physicians can check online to see if there is a registry for their patients’ medicine.

The FDA website also provides information about the Pregnancy and Lactation Labeling Final Rule, which requires changes to the content and format for information presented in prescription drug labeling. The changes are implemented to help health care providers assess risk versus benefit and in subsequent counseling of pregnant women and nursing mothers.

The FDA offers free medicine safety and pregnancy resources for pregnant women, including downloadable infographics; a Medicines Record Keeper brochure in English, Spanish

and other languages; medicine booklets; online videos; and fact sheets, tips, and more at their Medication Safety for Women page.

Pregnancy is an exciting time for women, but they may have questions and concerns about how medicines they take will affect their babies. Our pregnancy website can help make a woman’s pregnancy happier and healthier.

Dr. Yao is the director of the division of pediatrics and maternal health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research at the FDA, in Silver Spring, Md.