Commentary

Current treatment strategies for chronic hepatitis B virus (HBV) infection seek to suppress viral replication by blocking HBV reverse transcription. When circulating HBV viremia is suppressed, clinical outcomes improve, with slowing of fibrosis and reduced rates of hepatocellular carcinoma. However, when treatment is discontinued, viral replication typically rebounds. This is because nucleos(t)ide (NUC) therapy has no effect on existing HBV cccDNA (covalently closed circular DNA) reservoirs.

A functional cure is defined as the absence of HBV DNA and hepatitis B surface antigen (HBsAg), in the absence of antiviral therapy, with or without the development of protective hepatitis B surface antibody (HBsAb). However, rates of viral clearance are extremely low after therapy with IFN and NUC analogs. Strategies to control HBV replication, purge covalently closed circular DNA (cccDNA) reservoirs, and develop long-lasting protective immunity in patients with chronic HBV infection are desperately needed to achieve a functional cure.

Current investigational approaches to curing HBV fall into two different strategies: targeting the virus directly or manipulating the host immune response to aid in clearance.

Targeting the virus

One of the challenges of treating HBV is the stability of HBV DNA inside infected hepatocytes; supercoiled and sequestered in the host cell nucleus, HBV cccDNA is protected from cellular DNA-sensing machinery. Hepatocytes infected with HBV have a long half-life, serving as a reservoir for HBV reactivation. In addition to preventing, inactivating, or disrupting cccDNA, investigational approaches to target the virus also focus on blocking specific steps in viral replication, including viral transcription, entry into uninfected hepatocytes, capsid assembly, and antigen secretion.

Gene therapy approaches, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), clustered regularly interspaced palindromic repeat (CRISP-R) applications, and RNA interference (RNAi) technology may be able to inactivate target cccDNA, silencing or disrupting this viral reservoir.

Various investigational drugs are being studied for their ability to interfere with viral entry, encapsidation, or antigen release. Specific interactions between viral membrane proteins and cellular receptors are attractive targets for blocking HBV entry into host cells. Agents that interfere with assembly of the virus particle may prevent the production of infectious virus. Some innovative therapeutic strategies also seek to block the secretion of HBsAg; chronic exposure to HBsAg can lead to T-cell exhaustion, so this strategy may allow the host to develop a more effective anti-HBV adaptive immune response.

Manipulating host response

The second major strategy of novel HBV therapies involves mediating the host response, reversing immune exhaustion, selectively activating innate and/or adaptive immunity through therapeutic vaccination or passive transfer in order to produce a more effective response that results in viral clearance.

The innate immune response, the first line of defense against viral infections, is activated when toll-like receptors (TLRs) on the surface of innate immune cells are engaged, but TLR signaling is downregulated in chronic HBV infection. Stimulating innate immune cells by activating TLRs may accelerate HBV-specific immune reconstitution and help clear HBV in chronically infected individuals. Likewise, blocking the interaction of PD-1 with its ligands (PD-L1/2) may improve the antiviral function of exhausted T cells.

Reversing immune exhaustion will not work if there are no HBV-specific T cells present. Studies have pointed to the clonal deletion of HBV-specific CD8+ T cells as a mechanism of HBV persistence. T-cell responses may be “trained” to recognize infected cells by expressing HBV-specific chimeric antigen receptors (CARs), which are synthetic engineered receptors that can engage cell-surface molecules.

Therapeutic vaccination additionally presents a promising strategy to address HBV-specific T-cell exhaustion by inducing a potent CD4 T-cell response and counteracting immune tolerance against HBV antigens. Yeast-based vaccines, adenovirus vector and engineered vesicular stomatitis virus vectors have shown to be promising platforms that may be capable of eliciting a functional adaptive immune response in patients with chronic HBV, but their use is often limited by preexisting host immunity.

In summary, current therapies for HBV rarely clear or cure infection. A two-pronged approach of targeting viral and host factors may offer the best chance to reverse the immune tolerance, T-cell exhaustion, and persistent viral reservoir associated with chronic HBV infection.

Rebecca Lee is a second-year medical student at the University of Maryland School of Medicine. Eleanor Wilson, MD, is assistant professor in the Institute of Human Virology at the University of Maryland School of Medicine. Shyam Kottilil, MBBS, PhD, is professor of medicine in the Institute of Human Virology at the University of Maryland School of Medicine.

Current treatment strategies for chronic hepatitis B virus (HBV) infection seek to suppress viral replication by blocking HBV reverse transcription. When circulating HBV viremia is suppressed, clinical outcomes improve, with slowing of fibrosis and reduced rates of hepatocellular carcinoma. However, when treatment is discontinued, viral replication typically rebounds. This is because nucleos(t)ide (NUC) therapy has no effect on existing HBV cccDNA (covalently closed circular DNA) reservoirs.

A functional cure is defined as the absence of HBV DNA and hepatitis B surface antigen (HBsAg), in the absence of antiviral therapy, with or without the development of protective hepatitis B surface antibody (HBsAb). However, rates of viral clearance are extremely low after therapy with IFN and NUC analogs. Strategies to control HBV replication, purge covalently closed circular DNA (cccDNA) reservoirs, and develop long-lasting protective immunity in patients with chronic HBV infection are desperately needed to achieve a functional cure.

Current investigational approaches to curing HBV fall into two different strategies: targeting the virus directly or manipulating the host immune response to aid in clearance.

Targeting the virus

One of the challenges of treating HBV is the stability of HBV DNA inside infected hepatocytes; supercoiled and sequestered in the host cell nucleus, HBV cccDNA is protected from cellular DNA-sensing machinery. Hepatocytes infected with HBV have a long half-life, serving as a reservoir for HBV reactivation. In addition to preventing, inactivating, or disrupting cccDNA, investigational approaches to target the virus also focus on blocking specific steps in viral replication, including viral transcription, entry into uninfected hepatocytes, capsid assembly, and antigen secretion.

Gene therapy approaches, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), clustered regularly interspaced palindromic repeat (CRISP-R) applications, and RNA interference (RNAi) technology may be able to inactivate target cccDNA, silencing or disrupting this viral reservoir.

Various investigational drugs are being studied for their ability to interfere with viral entry, encapsidation, or antigen release. Specific interactions between viral membrane proteins and cellular receptors are attractive targets for blocking HBV entry into host cells. Agents that interfere with assembly of the virus particle may prevent the production of infectious virus. Some innovative therapeutic strategies also seek to block the secretion of HBsAg; chronic exposure to HBsAg can lead to T-cell exhaustion, so this strategy may allow the host to develop a more effective anti-HBV adaptive immune response.

Manipulating host response

The second major strategy of novel HBV therapies involves mediating the host response, reversing immune exhaustion, selectively activating innate and/or adaptive immunity through therapeutic vaccination or passive transfer in order to produce a more effective response that results in viral clearance.

The innate immune response, the first line of defense against viral infections, is activated when toll-like receptors (TLRs) on the surface of innate immune cells are engaged, but TLR signaling is downregulated in chronic HBV infection. Stimulating innate immune cells by activating TLRs may accelerate HBV-specific immune reconstitution and help clear HBV in chronically infected individuals. Likewise, blocking the interaction of PD-1 with its ligands (PD-L1/2) may improve the antiviral function of exhausted T cells.

Reversing immune exhaustion will not work if there are no HBV-specific T cells present. Studies have pointed to the clonal deletion of HBV-specific CD8+ T cells as a mechanism of HBV persistence. T-cell responses may be “trained” to recognize infected cells by expressing HBV-specific chimeric antigen receptors (CARs), which are synthetic engineered receptors that can engage cell-surface molecules.

Therapeutic vaccination additionally presents a promising strategy to address HBV-specific T-cell exhaustion by inducing a potent CD4 T-cell response and counteracting immune tolerance against HBV antigens. Yeast-based vaccines, adenovirus vector and engineered vesicular stomatitis virus vectors have shown to be promising platforms that may be capable of eliciting a functional adaptive immune response in patients with chronic HBV, but their use is often limited by preexisting host immunity.

In summary, current therapies for HBV rarely clear or cure infection. A two-pronged approach of targeting viral and host factors may offer the best chance to reverse the immune tolerance, T-cell exhaustion, and persistent viral reservoir associated with chronic HBV infection.

Rebecca Lee is a second-year medical student at the University of Maryland School of Medicine. Eleanor Wilson, MD, is assistant professor in the Institute of Human Virology at the University of Maryland School of Medicine. Shyam Kottilil, MBBS, PhD, is professor of medicine in the Institute of Human Virology at the University of Maryland School of Medicine.

Current treatment strategies for chronic hepatitis B virus (HBV) infection seek to suppress viral replication by blocking HBV reverse transcription. When circulating HBV viremia is suppressed, clinical outcomes improve, with slowing of fibrosis and reduced rates of hepatocellular carcinoma. However, when treatment is discontinued, viral replication typically rebounds. This is because nucleos(t)ide (NUC) therapy has no effect on existing HBV cccDNA (covalently closed circular DNA) reservoirs.

A functional cure is defined as the absence of HBV DNA and hepatitis B surface antigen (HBsAg), in the absence of antiviral therapy, with or without the development of protective hepatitis B surface antibody (HBsAb). However, rates of viral clearance are extremely low after therapy with IFN and NUC analogs. Strategies to control HBV replication, purge covalently closed circular DNA (cccDNA) reservoirs, and develop long-lasting protective immunity in patients with chronic HBV infection are desperately needed to achieve a functional cure.

Current investigational approaches to curing HBV fall into two different strategies: targeting the virus directly or manipulating the host immune response to aid in clearance.

Targeting the virus

One of the challenges of treating HBV is the stability of HBV DNA inside infected hepatocytes; supercoiled and sequestered in the host cell nucleus, HBV cccDNA is protected from cellular DNA-sensing machinery. Hepatocytes infected with HBV have a long half-life, serving as a reservoir for HBV reactivation. In addition to preventing, inactivating, or disrupting cccDNA, investigational approaches to target the virus also focus on blocking specific steps in viral replication, including viral transcription, entry into uninfected hepatocytes, capsid assembly, and antigen secretion.

Gene therapy approaches, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), clustered regularly interspaced palindromic repeat (CRISP-R) applications, and RNA interference (RNAi) technology may be able to inactivate target cccDNA, silencing or disrupting this viral reservoir.

Various investigational drugs are being studied for their ability to interfere with viral entry, encapsidation, or antigen release. Specific interactions between viral membrane proteins and cellular receptors are attractive targets for blocking HBV entry into host cells. Agents that interfere with assembly of the virus particle may prevent the production of infectious virus. Some innovative therapeutic strategies also seek to block the secretion of HBsAg; chronic exposure to HBsAg can lead to T-cell exhaustion, so this strategy may allow the host to develop a more effective anti-HBV adaptive immune response.

Manipulating host response

The second major strategy of novel HBV therapies involves mediating the host response, reversing immune exhaustion, selectively activating innate and/or adaptive immunity through therapeutic vaccination or passive transfer in order to produce a more effective response that results in viral clearance.

The innate immune response, the first line of defense against viral infections, is activated when toll-like receptors (TLRs) on the surface of innate immune cells are engaged, but TLR signaling is downregulated in chronic HBV infection. Stimulating innate immune cells by activating TLRs may accelerate HBV-specific immune reconstitution and help clear HBV in chronically infected individuals. Likewise, blocking the interaction of PD-1 with its ligands (PD-L1/2) may improve the antiviral function of exhausted T cells.

Reversing immune exhaustion will not work if there are no HBV-specific T cells present. Studies have pointed to the clonal deletion of HBV-specific CD8+ T cells as a mechanism of HBV persistence. T-cell responses may be “trained” to recognize infected cells by expressing HBV-specific chimeric antigen receptors (CARs), which are synthetic engineered receptors that can engage cell-surface molecules.

Therapeutic vaccination additionally presents a promising strategy to address HBV-specific T-cell exhaustion by inducing a potent CD4 T-cell response and counteracting immune tolerance against HBV antigens. Yeast-based vaccines, adenovirus vector and engineered vesicular stomatitis virus vectors have shown to be promising platforms that may be capable of eliciting a functional adaptive immune response in patients with chronic HBV, but their use is often limited by preexisting host immunity.

In summary, current therapies for HBV rarely clear or cure infection. A two-pronged approach of targeting viral and host factors may offer the best chance to reverse the immune tolerance, T-cell exhaustion, and persistent viral reservoir associated with chronic HBV infection.

Rebecca Lee is a second-year medical student at the University of Maryland School of Medicine. Eleanor Wilson, MD, is assistant professor in the Institute of Human Virology at the University of Maryland School of Medicine. Shyam Kottilil, MBBS, PhD, is professor of medicine in the Institute of Human Virology at the University of Maryland School of Medicine.

The importance of postpartum depression, both in terms of its prevalence and the need for appropriate screening and effective treatments, has become an increasingly important area of focus for clinicians, patients, and policymakers. This derives from more than a decade of data on the significant prevalence of the condition, with roughly 10% of women meeting the criteria for major or minor depression during the first 3-6 months post partum.

Over the last 5 years, interest has centered around establishing mechanisms for appropriate perinatal depression screening, most notably the January 2016 recommendation from the U.S. Preventive Services Task Force that all adults should be screened for depression, including the at-risk populations of pregnant and postpartum women. In 2015, the American College of Obstetricians and Gynecologists endorsed screening women for depression and anxiety symptoms at least once during the perinatal period using a validated tool. Unfortunately, we still lack data to support whether screening is effective in getting patients referred for treatment and if it leads to women accessing therapies that will actually get them well.

As we wait for that data and consider ways to best implement enhanced screening, it’s important to take stock of the available treatments for postpartum depression.

Seeking a rapid treatment

The current literature supports efficacy for nonpharmacologic therapies, such as interpersonal psychotherapy and cognitive-behavioral therapy, as well as several antidepressants. The efficacy of antidepressants – such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors – has been demonstrated for postpartum depression, but these agents carry the typical limitations and concerns in terms of side effects and the amount of time required to ascertain if there is benefit. While these are the same challenges seen in treating depression in general, the time to response – often 4-8 weeks – is particularly problematic for postpartum women where the impact of depression on maternal morbidity and child development is so critical.

The field has been clamoring for agents that work more quickly. One possibility in that area is ketamine, which is being studied as a rapid treatment in major depression. The National Institutes of Health also has an initiative underway called RAPID (Rapidly Acting Treatments for Treatment-Resistant Depression), aimed at identifying and testing pharmacologic and nonpharmacologic treatments that produce a response within days rather than weeks.

Recently, considerable interest has focused on SAGE-547, manufactured by Sage Therapeutics, which is a different type of antidepressant. The so-called neurosteriod is an allosteric modulator of the GABA_A (gamma-aminobutyric acid type A) receptors. The product was granted fast-track status by the Food and Drug Administration to speed its development as a possible treatment for superrefractory status epilepticus, but it also is being studied for its potential in treating severe postpartum depression.

Approximately a year ago, there was preliminary evidence from an open-label study suggesting rapid response to SAGE-547 for women who received this medicine intravenously in a controlled hospital environment. And in July 2016, the manufacturer announced in a press release unpublished positive results from a small phase II controlled trial of SAGE-547 for the treatment of severe postpartum depression.

Specifically, this was a placebo-controlled, double-blind randomized trial for 21 women who had severe depressive symptoms with a baseline score of at least 26 on the Hamilton Rating Scale for Depression (HAM-D). For some of the women, postpartum depression was not of new onset, but rather was an extension of depression that had manifested no earlier than the third trimester of pregnancy. A total of 10 women received the drug, while 11 received placebo. Both groups received continuous intravenous infusion over a 60-hour period.

Consistent with the earlier report, participants receiving the active agent had a statistically significant reduction in HAM-D scores at 24 hours, compared with women who received the placebo. Seven out of 10 women who received the active drug achieved remission from depression at 60 hours, compared with only 1 of the 11 patients who received placebo. Even though the results derived from an extremely small sample, the signal for efficacy appears promising.

Of particular interest, there appeared to be a duration of benefit at 30 days’ follow-up. The medicine was well tolerated with no discontinuations due to adverse events, which were most commonly dizziness, sedation, or somnolence. The adverse events were about the same in both the drug and placebo groups.

Next steps

These early results have generated excitement, if not a “buzz,” in the field, given the rapid onset of antidepressant benefit and the apparent duration of the effect. But readers should be mindful that to date, the findings have not been peer reviewed and are available only through a company-issued press release. It is also noteworthy that on clinicaltrials.gov, the projected enrollment was 32, but 21 women enrolled. This may speak to the great difficulty in enrolling the sample and may ultimately reflect on the generalizability of the findings.

One significant challenge with SAGE-547 is the formulation. It’s hardly feasible for severely ill postpartum women to come to the hospital for 60 hours of treatment. The manufacturer will have to produce a reformulated compound that is able to sustain the efficacy signaled in this proof of concept study.

But even more importantly, we will need to see how the drug performs in a larger, rigorous phase IIB or phase III study to know if the signal of promise really translates into a potential viable treatment option for women with severe postpartum depression. When we have results from a randomized controlled trial with a substantially larger number of patients, then we’ll know whether the excitement is justified. It would be a significant advance for the field if this were to be the case.

The field of depression, in general, has been seeking an effective, rapid treatment for some time, and the role of neurosteriods has been spoken about for more than 2 decades. If postpartum women are in fact a subgroup who respond to this class of agents, then that would be an example of truly personalized medicine. But we won’t know that until the manufacturer does an appropriate large trial, which could take 2-4 years.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information and resources and conducts clinical care and research in reproductive mental health. He has no financial relationship with SAGE Therapeutics, but he has been a consultant to manufacturers of psychiatric medications.

The importance of postpartum depression, both in terms of its prevalence and the need for appropriate screening and effective treatments, has become an increasingly important area of focus for clinicians, patients, and policymakers. This derives from more than a decade of data on the significant prevalence of the condition, with roughly 10% of women meeting the criteria for major or minor depression during the first 3-6 months post partum.

Over the last 5 years, interest has centered around establishing mechanisms for appropriate perinatal depression screening, most notably the January 2016 recommendation from the U.S. Preventive Services Task Force that all adults should be screened for depression, including the at-risk populations of pregnant and postpartum women. In 2015, the American College of Obstetricians and Gynecologists endorsed screening women for depression and anxiety symptoms at least once during the perinatal period using a validated tool. Unfortunately, we still lack data to support whether screening is effective in getting patients referred for treatment and if it leads to women accessing therapies that will actually get them well.

As we wait for that data and consider ways to best implement enhanced screening, it’s important to take stock of the available treatments for postpartum depression.

Seeking a rapid treatment

The current literature supports efficacy for nonpharmacologic therapies, such as interpersonal psychotherapy and cognitive-behavioral therapy, as well as several antidepressants. The efficacy of antidepressants – such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors – has been demonstrated for postpartum depression, but these agents carry the typical limitations and concerns in terms of side effects and the amount of time required to ascertain if there is benefit. While these are the same challenges seen in treating depression in general, the time to response – often 4-8 weeks – is particularly problematic for postpartum women where the impact of depression on maternal morbidity and child development is so critical.

The field has been clamoring for agents that work more quickly. One possibility in that area is ketamine, which is being studied as a rapid treatment in major depression. The National Institutes of Health also has an initiative underway called RAPID (Rapidly Acting Treatments for Treatment-Resistant Depression), aimed at identifying and testing pharmacologic and nonpharmacologic treatments that produce a response within days rather than weeks.

Recently, considerable interest has focused on SAGE-547, manufactured by Sage Therapeutics, which is a different type of antidepressant. The so-called neurosteriod is an allosteric modulator of the GABA_A (gamma-aminobutyric acid type A) receptors. The product was granted fast-track status by the Food and Drug Administration to speed its development as a possible treatment for superrefractory status epilepticus, but it also is being studied for its potential in treating severe postpartum depression.

Approximately a year ago, there was preliminary evidence from an open-label study suggesting rapid response to SAGE-547 for women who received this medicine intravenously in a controlled hospital environment. And in July 2016, the manufacturer announced in a press release unpublished positive results from a small phase II controlled trial of SAGE-547 for the treatment of severe postpartum depression.

Specifically, this was a placebo-controlled, double-blind randomized trial for 21 women who had severe depressive symptoms with a baseline score of at least 26 on the Hamilton Rating Scale for Depression (HAM-D). For some of the women, postpartum depression was not of new onset, but rather was an extension of depression that had manifested no earlier than the third trimester of pregnancy. A total of 10 women received the drug, while 11 received placebo. Both groups received continuous intravenous infusion over a 60-hour period.

Consistent with the earlier report, participants receiving the active agent had a statistically significant reduction in HAM-D scores at 24 hours, compared with women who received the placebo. Seven out of 10 women who received the active drug achieved remission from depression at 60 hours, compared with only 1 of the 11 patients who received placebo. Even though the results derived from an extremely small sample, the signal for efficacy appears promising.

Of particular interest, there appeared to be a duration of benefit at 30 days’ follow-up. The medicine was well tolerated with no discontinuations due to adverse events, which were most commonly dizziness, sedation, or somnolence. The adverse events were about the same in both the drug and placebo groups.

Next steps

These early results have generated excitement, if not a “buzz,” in the field, given the rapid onset of antidepressant benefit and the apparent duration of the effect. But readers should be mindful that to date, the findings have not been peer reviewed and are available only through a company-issued press release. It is also noteworthy that on clinicaltrials.gov, the projected enrollment was 32, but 21 women enrolled. This may speak to the great difficulty in enrolling the sample and may ultimately reflect on the generalizability of the findings.

One significant challenge with SAGE-547 is the formulation. It’s hardly feasible for severely ill postpartum women to come to the hospital for 60 hours of treatment. The manufacturer will have to produce a reformulated compound that is able to sustain the efficacy signaled in this proof of concept study.

But even more importantly, we will need to see how the drug performs in a larger, rigorous phase IIB or phase III study to know if the signal of promise really translates into a potential viable treatment option for women with severe postpartum depression. When we have results from a randomized controlled trial with a substantially larger number of patients, then we’ll know whether the excitement is justified. It would be a significant advance for the field if this were to be the case.

The field of depression, in general, has been seeking an effective, rapid treatment for some time, and the role of neurosteriods has been spoken about for more than 2 decades. If postpartum women are in fact a subgroup who respond to this class of agents, then that would be an example of truly personalized medicine. But we won’t know that until the manufacturer does an appropriate large trial, which could take 2-4 years.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information and resources and conducts clinical care and research in reproductive mental health. He has no financial relationship with SAGE Therapeutics, but he has been a consultant to manufacturers of psychiatric medications.

The importance of postpartum depression, both in terms of its prevalence and the need for appropriate screening and effective treatments, has become an increasingly important area of focus for clinicians, patients, and policymakers. This derives from more than a decade of data on the significant prevalence of the condition, with roughly 10% of women meeting the criteria for major or minor depression during the first 3-6 months post partum.

Over the last 5 years, interest has centered around establishing mechanisms for appropriate perinatal depression screening, most notably the January 2016 recommendation from the U.S. Preventive Services Task Force that all adults should be screened for depression, including the at-risk populations of pregnant and postpartum women. In 2015, the American College of Obstetricians and Gynecologists endorsed screening women for depression and anxiety symptoms at least once during the perinatal period using a validated tool. Unfortunately, we still lack data to support whether screening is effective in getting patients referred for treatment and if it leads to women accessing therapies that will actually get them well.

As we wait for that data and consider ways to best implement enhanced screening, it’s important to take stock of the available treatments for postpartum depression.

Seeking a rapid treatment

The current literature supports efficacy for nonpharmacologic therapies, such as interpersonal psychotherapy and cognitive-behavioral therapy, as well as several antidepressants. The efficacy of antidepressants – such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors – has been demonstrated for postpartum depression, but these agents carry the typical limitations and concerns in terms of side effects and the amount of time required to ascertain if there is benefit. While these are the same challenges seen in treating depression in general, the time to response – often 4-8 weeks – is particularly problematic for postpartum women where the impact of depression on maternal morbidity and child development is so critical.

The field has been clamoring for agents that work more quickly. One possibility in that area is ketamine, which is being studied as a rapid treatment in major depression. The National Institutes of Health also has an initiative underway called RAPID (Rapidly Acting Treatments for Treatment-Resistant Depression), aimed at identifying and testing pharmacologic and nonpharmacologic treatments that produce a response within days rather than weeks.

Recently, considerable interest has focused on SAGE-547, manufactured by Sage Therapeutics, which is a different type of antidepressant. The so-called neurosteriod is an allosteric modulator of the GABA_A (gamma-aminobutyric acid type A) receptors. The product was granted fast-track status by the Food and Drug Administration to speed its development as a possible treatment for superrefractory status epilepticus, but it also is being studied for its potential in treating severe postpartum depression.

Approximately a year ago, there was preliminary evidence from an open-label study suggesting rapid response to SAGE-547 for women who received this medicine intravenously in a controlled hospital environment. And in July 2016, the manufacturer announced in a press release unpublished positive results from a small phase II controlled trial of SAGE-547 for the treatment of severe postpartum depression.

Specifically, this was a placebo-controlled, double-blind randomized trial for 21 women who had severe depressive symptoms with a baseline score of at least 26 on the Hamilton Rating Scale for Depression (HAM-D). For some of the women, postpartum depression was not of new onset, but rather was an extension of depression that had manifested no earlier than the third trimester of pregnancy. A total of 10 women received the drug, while 11 received placebo. Both groups received continuous intravenous infusion over a 60-hour period.

Consistent with the earlier report, participants receiving the active agent had a statistically significant reduction in HAM-D scores at 24 hours, compared with women who received the placebo. Seven out of 10 women who received the active drug achieved remission from depression at 60 hours, compared with only 1 of the 11 patients who received placebo. Even though the results derived from an extremely small sample, the signal for efficacy appears promising.

Of particular interest, there appeared to be a duration of benefit at 30 days’ follow-up. The medicine was well tolerated with no discontinuations due to adverse events, which were most commonly dizziness, sedation, or somnolence. The adverse events were about the same in both the drug and placebo groups.

Next steps

These early results have generated excitement, if not a “buzz,” in the field, given the rapid onset of antidepressant benefit and the apparent duration of the effect. But readers should be mindful that to date, the findings have not been peer reviewed and are available only through a company-issued press release. It is also noteworthy that on clinicaltrials.gov, the projected enrollment was 32, but 21 women enrolled. This may speak to the great difficulty in enrolling the sample and may ultimately reflect on the generalizability of the findings.

One significant challenge with SAGE-547 is the formulation. It’s hardly feasible for severely ill postpartum women to come to the hospital for 60 hours of treatment. The manufacturer will have to produce a reformulated compound that is able to sustain the efficacy signaled in this proof of concept study.

But even more importantly, we will need to see how the drug performs in a larger, rigorous phase IIB or phase III study to know if the signal of promise really translates into a potential viable treatment option for women with severe postpartum depression. When we have results from a randomized controlled trial with a substantially larger number of patients, then we’ll know whether the excitement is justified. It would be a significant advance for the field if this were to be the case.

The field of depression, in general, has been seeking an effective, rapid treatment for some time, and the role of neurosteriods has been spoken about for more than 2 decades. If postpartum women are in fact a subgroup who respond to this class of agents, then that would be an example of truly personalized medicine. But we won’t know that until the manufacturer does an appropriate large trial, which could take 2-4 years.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information and resources and conducts clinical care and research in reproductive mental health. He has no financial relationship with SAGE Therapeutics, but he has been a consultant to manufacturers of psychiatric medications.

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

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

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

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

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

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

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

Editor’s note: This is Dr. Chan’s last post for her “Rheum in Bloom” column. She is saying goodbye to New England, leaving the private practice setting for a different challenge.

All too often these days, I find myself fidgeting by the doorway to my exam room, trying to conclude an office visit with one of my patients. When I look at my career at midlife, I realize that in many ways I have become the kind of doctor I never thought I’d be: impatient, occasionally indifferent, at times dismissive or paternalistic.

–Sandeep Jauhar, MD

For as long as I’ve been a doctor, doctors have lamented how much medicine has changed. Columnist Charles Krauthammer, MD, wrote a widely-circulated piece in 2015 with the catchy title “Why Doctors Quit,” attributing physician dissatisfaction to the wasteful and frustrating electronic health record mandate. It is worth noting here that Dr. Krauthammer is a political partisan making a point about government overreach and not really about the state of medicine, but the piece certainly resonated with doctors, judging by the number of times it was shared with me. In Medscape’s physician compensation poll of 2016, only 64% of doctors would choose medicine again. In a separate Medscape poll on burnout, under 30% of physicians felt happy at work.

In Dr. Sandeep Jauhar’s book, “Doctored,” (from which the above quote is taken), he cites several issues: the lack of respect that the profession is afforded, the practice of defensive medicine, inadequate compensation, the lack of independence. He goes further: “... Surveys have shown that 30%-40% of practicing physicians would not choose to enter the medical profession if they were deciding on a career again, and an even higher percentage would not encourage their children to pursue a medical career.” He does not say where he got that information, but it sounds plausible.

I asked peers, mostly people I went through training with and therefore generally belonging to my age group. This small, nonrepresentative sample of young physician parents, many of whom are foreign graduates, seemed to belie Dr. Jauhar’s pessimism. Most of my friends thought medicine is still rewarding. They see our profession as emotionally meaningful and intellectually fulfilling – this despite a surprising number of them having been named in ultimately unsuccessful lawsuits. “The headaches are many, but most professions that make decent money have their own set of headaches and problems,” my allergist friend says. In addition, a career in medicine, they feel, would provide their children financial stability. The consensus was that if their children wanted to, my peers would be nothing but supportive.

I asked my boss about it, too. He is older and very vocal about what he perceives as a hostile working environment. If there was just one demographic that Dr. Krauthammer was speaking for, that is exactly the demographic that my boss belongs to. So I was certain that he had similarly dissuaded his son from going into medicine. But I was wrong.

It isn’t that my boss discouraged his son; it’s that his son was not interested. He says if he thought his son might have enjoyed the work he absolutely would have encouraged it. Because as onerous as our profession has become, it is still a meaningful and rewarding one. And as long as we derive meaning from the work that we do, it is much easier to put up with the unsavory parts.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Editor’s note: This is Dr. Chan’s last post for her “Rheum in Bloom” column. She is saying goodbye to New England, leaving the private practice setting for a different challenge.

All too often these days, I find myself fidgeting by the doorway to my exam room, trying to conclude an office visit with one of my patients. When I look at my career at midlife, I realize that in many ways I have become the kind of doctor I never thought I’d be: impatient, occasionally indifferent, at times dismissive or paternalistic.

–Sandeep Jauhar, MD

For as long as I’ve been a doctor, doctors have lamented how much medicine has changed. Columnist Charles Krauthammer, MD, wrote a widely-circulated piece in 2015 with the catchy title “Why Doctors Quit,” attributing physician dissatisfaction to the wasteful and frustrating electronic health record mandate. It is worth noting here that Dr. Krauthammer is a political partisan making a point about government overreach and not really about the state of medicine, but the piece certainly resonated with doctors, judging by the number of times it was shared with me. In Medscape’s physician compensation poll of 2016, only 64% of doctors would choose medicine again. In a separate Medscape poll on burnout, under 30% of physicians felt happy at work.

In Dr. Sandeep Jauhar’s book, “Doctored,” (from which the above quote is taken), he cites several issues: the lack of respect that the profession is afforded, the practice of defensive medicine, inadequate compensation, the lack of independence. He goes further: “... Surveys have shown that 30%-40% of practicing physicians would not choose to enter the medical profession if they were deciding on a career again, and an even higher percentage would not encourage their children to pursue a medical career.” He does not say where he got that information, but it sounds plausible.

I asked peers, mostly people I went through training with and therefore generally belonging to my age group. This small, nonrepresentative sample of young physician parents, many of whom are foreign graduates, seemed to belie Dr. Jauhar’s pessimism. Most of my friends thought medicine is still rewarding. They see our profession as emotionally meaningful and intellectually fulfilling – this despite a surprising number of them having been named in ultimately unsuccessful lawsuits. “The headaches are many, but most professions that make decent money have their own set of headaches and problems,” my allergist friend says. In addition, a career in medicine, they feel, would provide their children financial stability. The consensus was that if their children wanted to, my peers would be nothing but supportive.

I asked my boss about it, too. He is older and very vocal about what he perceives as a hostile working environment. If there was just one demographic that Dr. Krauthammer was speaking for, that is exactly the demographic that my boss belongs to. So I was certain that he had similarly dissuaded his son from going into medicine. But I was wrong.

It isn’t that my boss discouraged his son; it’s that his son was not interested. He says if he thought his son might have enjoyed the work he absolutely would have encouraged it. Because as onerous as our profession has become, it is still a meaningful and rewarding one. And as long as we derive meaning from the work that we do, it is much easier to put up with the unsavory parts.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Editor’s note: This is Dr. Chan’s last post for her “Rheum in Bloom” column. She is saying goodbye to New England, leaving the private practice setting for a different challenge.

All too often these days, I find myself fidgeting by the doorway to my exam room, trying to conclude an office visit with one of my patients. When I look at my career at midlife, I realize that in many ways I have become the kind of doctor I never thought I’d be: impatient, occasionally indifferent, at times dismissive or paternalistic.

–Sandeep Jauhar, MD

For as long as I’ve been a doctor, doctors have lamented how much medicine has changed. Columnist Charles Krauthammer, MD, wrote a widely-circulated piece in 2015 with the catchy title “Why Doctors Quit,” attributing physician dissatisfaction to the wasteful and frustrating electronic health record mandate. It is worth noting here that Dr. Krauthammer is a political partisan making a point about government overreach and not really about the state of medicine, but the piece certainly resonated with doctors, judging by the number of times it was shared with me. In Medscape’s physician compensation poll of 2016, only 64% of doctors would choose medicine again. In a separate Medscape poll on burnout, under 30% of physicians felt happy at work.

In Dr. Sandeep Jauhar’s book, “Doctored,” (from which the above quote is taken), he cites several issues: the lack of respect that the profession is afforded, the practice of defensive medicine, inadequate compensation, the lack of independence. He goes further: “... Surveys have shown that 30%-40% of practicing physicians would not choose to enter the medical profession if they were deciding on a career again, and an even higher percentage would not encourage their children to pursue a medical career.” He does not say where he got that information, but it sounds plausible.

I asked peers, mostly people I went through training with and therefore generally belonging to my age group. This small, nonrepresentative sample of young physician parents, many of whom are foreign graduates, seemed to belie Dr. Jauhar’s pessimism. Most of my friends thought medicine is still rewarding. They see our profession as emotionally meaningful and intellectually fulfilling – this despite a surprising number of them having been named in ultimately unsuccessful lawsuits. “The headaches are many, but most professions that make decent money have their own set of headaches and problems,” my allergist friend says. In addition, a career in medicine, they feel, would provide their children financial stability. The consensus was that if their children wanted to, my peers would be nothing but supportive.

I asked my boss about it, too. He is older and very vocal about what he perceives as a hostile working environment. If there was just one demographic that Dr. Krauthammer was speaking for, that is exactly the demographic that my boss belongs to. So I was certain that he had similarly dissuaded his son from going into medicine. But I was wrong.

It isn’t that my boss discouraged his son; it’s that his son was not interested. He says if he thought his son might have enjoyed the work he absolutely would have encouraged it. Because as onerous as our profession has become, it is still a meaningful and rewarding one. And as long as we derive meaning from the work that we do, it is much easier to put up with the unsavory parts.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Every 3 months I get a letter from the state, showing me how my controlled prescriptions stack up against those of other neurologists here.

I’ve always been in the “normal” range. Which is good, I guess. In this era, no one wants to be seen as running a pill mill.

But when I compare them over the last year, I notice that my narcotic prescriptions have been gradually declining. Am I reducing my scripts subconsciously, knowing that I’m being watched by regulatory agencies?

It’s quite possible. While I haven’t intentionally been cutting back on narcotics, I have been paying closer attention to who I’m writing them for. This has likely led me to use them more sparingly.

The trouble is that pain is a legitimate problem for many, and NSAIDs have numerous safety issues that limit their use. Acetaminophen has hepatic issues. My previous noncontrolled drug of choice, Tramadol, was reclassified as controlled in 2014.

Narcotic abuse and diversion are serious problems that need attention. But there are also people with legitimate noncancer pain who require them to function with a reasonable quality of life. We all have them in our practice. Sorting them out from abusers is never easy.

Unfortunately, the increased vigilance also affects those who need our help. A recent National Public Radio article noted the difficulty of finding a doctor in Montana who is willing to take on pain patients, with the result that some have to travel out of state to get help.

I’m sure they’re not the only ones, especially in states that have a low population density. And not all patients are going to have the financial resources to travel. Or afford the rates of the dwindling number of physicians willing to frequently prescribe narcotics. These people sadly become collateral damage in the drug wars.

Does this mean I’m going to increase my use of narcotics to help all who come to me? No.

Because, in a world where my licensure (and therefore livelihood) is potentially affected by my prescribing habits, I have to put my family first. This doesn’t mean I’m abandoning any of my current or even future patients, but it does mean I’ll be more vigilant on every controlled script I write.

I don’t know anyone who’d do otherwise in today’s climate.

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

Every 3 months I get a letter from the state, showing me how my controlled prescriptions stack up against those of other neurologists here.

I’ve always been in the “normal” range. Which is good, I guess. In this era, no one wants to be seen as running a pill mill.

But when I compare them over the last year, I notice that my narcotic prescriptions have been gradually declining. Am I reducing my scripts subconsciously, knowing that I’m being watched by regulatory agencies?

It’s quite possible. While I haven’t intentionally been cutting back on narcotics, I have been paying closer attention to who I’m writing them for. This has likely led me to use them more sparingly.

The trouble is that pain is a legitimate problem for many, and NSAIDs have numerous safety issues that limit their use. Acetaminophen has hepatic issues. My previous noncontrolled drug of choice, Tramadol, was reclassified as controlled in 2014.

Narcotic abuse and diversion are serious problems that need attention. But there are also people with legitimate noncancer pain who require them to function with a reasonable quality of life. We all have them in our practice. Sorting them out from abusers is never easy.

Unfortunately, the increased vigilance also affects those who need our help. A recent National Public Radio article noted the difficulty of finding a doctor in Montana who is willing to take on pain patients, with the result that some have to travel out of state to get help.

I’m sure they’re not the only ones, especially in states that have a low population density. And not all patients are going to have the financial resources to travel. Or afford the rates of the dwindling number of physicians willing to frequently prescribe narcotics. These people sadly become collateral damage in the drug wars.

Does this mean I’m going to increase my use of narcotics to help all who come to me? No.

Because, in a world where my licensure (and therefore livelihood) is potentially affected by my prescribing habits, I have to put my family first. This doesn’t mean I’m abandoning any of my current or even future patients, but it does mean I’ll be more vigilant on every controlled script I write.

I don’t know anyone who’d do otherwise in today’s climate.

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

Every 3 months I get a letter from the state, showing me how my controlled prescriptions stack up against those of other neurologists here.

I’ve always been in the “normal” range. Which is good, I guess. In this era, no one wants to be seen as running a pill mill.

But when I compare them over the last year, I notice that my narcotic prescriptions have been gradually declining. Am I reducing my scripts subconsciously, knowing that I’m being watched by regulatory agencies?

It’s quite possible. While I haven’t intentionally been cutting back on narcotics, I have been paying closer attention to who I’m writing them for. This has likely led me to use them more sparingly.

The trouble is that pain is a legitimate problem for many, and NSAIDs have numerous safety issues that limit their use. Acetaminophen has hepatic issues. My previous noncontrolled drug of choice, Tramadol, was reclassified as controlled in 2014.

Narcotic abuse and diversion are serious problems that need attention. But there are also people with legitimate noncancer pain who require them to function with a reasonable quality of life. We all have them in our practice. Sorting them out from abusers is never easy.

Unfortunately, the increased vigilance also affects those who need our help. A recent National Public Radio article noted the difficulty of finding a doctor in Montana who is willing to take on pain patients, with the result that some have to travel out of state to get help.

I’m sure they’re not the only ones, especially in states that have a low population density. And not all patients are going to have the financial resources to travel. Or afford the rates of the dwindling number of physicians willing to frequently prescribe narcotics. These people sadly become collateral damage in the drug wars.

Does this mean I’m going to increase my use of narcotics to help all who come to me? No.

Because, in a world where my licensure (and therefore livelihood) is potentially affected by my prescribing habits, I have to put my family first. This doesn’t mean I’m abandoning any of my current or even future patients, but it does mean I’ll be more vigilant on every controlled script I write.

I don’t know anyone who’d do otherwise in today’s climate.

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

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

I feel honored to join Tyler G. Hughes as co-Editor of the ACS Surgery News and I am excited to work with its Managing Editor, Therese Borden, to bring to its readers breaking information on a broad range of subjects of interest and importance to practicing surgeons. Although we have a great challenge to fill the giant shoes of our immediate predecessor, Layton “Bing” Rikkers, we will do our best to address the vexing clinical, economic, social, and administrative challenges that continue to confront us no matter what our practice type and setting.

I could not ask for a more accomplished and versatile co-Editor than Tyler Hughes. As a general surgeon practicing in the truly rural setting of McPherson, Kan., since 1995, he became an articulate spokesman for rural surgeons across the country during his tenure on the ACS Board of Governors as Kansas’ at-large member. As the crisis in access to general surgical care for rural Americans became increasingly evident, Tyler was asked to speak to the Board of Regents in February 2012, and the first new Advisory Council in 50 years was formed: the Advisory Council for Rural Surgery (ACRS), of which Tyler was named the first Chair. In 4 short years, the ACRS has become a force to promote better communication among rural surgeons and to call attention to the needs of them and their patients.

Tyler’s communication skills have also been put to great use in his role as Editor of the ACS Web Portal and as the inaugural Editor-in-Chief of the ACS Communities, an activity that has met with incredible success in promoting communication among the far-flung individual surgeons who constitute the ACS membership. Along the way, he has also served as an Associate Editor of “Selected Readings in General Surgery” and a member of the steering committee of Evidence Based Reviews in Surgery.

He currently serves as a Director of the American Board of Surgery (ABS). He is therefore familiar with all of the issues of surgical training, certification, and re-certification. He is similarly well versed in the complexities surrounding the implementation of Maintenance of Certification, which remains a “work in progress” that his experience as a practicing, small-town general surgeon will certainly inform.

Tyler has distinguished himself in other leadership positions throughout his more than 30 years as a surgeon, including as President of his 600-member physician group when he initially practiced in Dallas. He has been a Fellow in the ACS for his entire surgical career and holds a deep respect, affection, and loyalty to the College. He possesses mainstream values, true to his upbringing and his long residence in America’s heartland; yet, he understands and respects the divergent views of surgeons across our country. He is also not afraid to tackle challenging problems, which is why I know that our tenure as co-Editors of ACS Surgery News is not likely to become boring.

I feel honored to join Tyler G. Hughes as co-Editor of the ACS Surgery News and I am excited to work with its Managing Editor, Therese Borden, to bring to its readers breaking information on a broad range of subjects of interest and importance to practicing surgeons. Although we have a great challenge to fill the giant shoes of our immediate predecessor, Layton “Bing” Rikkers, we will do our best to address the vexing clinical, economic, social, and administrative challenges that continue to confront us no matter what our practice type and setting.

I could not ask for a more accomplished and versatile co-Editor than Tyler Hughes. As a general surgeon practicing in the truly rural setting of McPherson, Kan., since 1995, he became an articulate spokesman for rural surgeons across the country during his tenure on the ACS Board of Governors as Kansas’ at-large member. As the crisis in access to general surgical care for rural Americans became increasingly evident, Tyler was asked to speak to the Board of Regents in February 2012, and the first new Advisory Council in 50 years was formed: the Advisory Council for Rural Surgery (ACRS), of which Tyler was named the first Chair. In 4 short years, the ACRS has become a force to promote better communication among rural surgeons and to call attention to the needs of them and their patients.

Tyler’s communication skills have also been put to great use in his role as Editor of the ACS Web Portal and as the inaugural Editor-in-Chief of the ACS Communities, an activity that has met with incredible success in promoting communication among the far-flung individual surgeons who constitute the ACS membership. Along the way, he has also served as an Associate Editor of “Selected Readings in General Surgery” and a member of the steering committee of Evidence Based Reviews in Surgery.

He currently serves as a Director of the American Board of Surgery (ABS). He is therefore familiar with all of the issues of surgical training, certification, and re-certification. He is similarly well versed in the complexities surrounding the implementation of Maintenance of Certification, which remains a “work in progress” that his experience as a practicing, small-town general surgeon will certainly inform.

Tyler has distinguished himself in other leadership positions throughout his more than 30 years as a surgeon, including as President of his 600-member physician group when he initially practiced in Dallas. He has been a Fellow in the ACS for his entire surgical career and holds a deep respect, affection, and loyalty to the College. He possesses mainstream values, true to his upbringing and his long residence in America’s heartland; yet, he understands and respects the divergent views of surgeons across our country. He is also not afraid to tackle challenging problems, which is why I know that our tenure as co-Editors of ACS Surgery News is not likely to become boring.

I feel honored to join Tyler G. Hughes as co-Editor of the ACS Surgery News and I am excited to work with its Managing Editor, Therese Borden, to bring to its readers breaking information on a broad range of subjects of interest and importance to practicing surgeons. Although we have a great challenge to fill the giant shoes of our immediate predecessor, Layton “Bing” Rikkers, we will do our best to address the vexing clinical, economic, social, and administrative challenges that continue to confront us no matter what our practice type and setting.

I could not ask for a more accomplished and versatile co-Editor than Tyler Hughes. As a general surgeon practicing in the truly rural setting of McPherson, Kan., since 1995, he became an articulate spokesman for rural surgeons across the country during his tenure on the ACS Board of Governors as Kansas’ at-large member. As the crisis in access to general surgical care for rural Americans became increasingly evident, Tyler was asked to speak to the Board of Regents in February 2012, and the first new Advisory Council in 50 years was formed: the Advisory Council for Rural Surgery (ACRS), of which Tyler was named the first Chair. In 4 short years, the ACRS has become a force to promote better communication among rural surgeons and to call attention to the needs of them and their patients.

Tyler’s communication skills have also been put to great use in his role as Editor of the ACS Web Portal and as the inaugural Editor-in-Chief of the ACS Communities, an activity that has met with incredible success in promoting communication among the far-flung individual surgeons who constitute the ACS membership. Along the way, he has also served as an Associate Editor of “Selected Readings in General Surgery” and a member of the steering committee of Evidence Based Reviews in Surgery.

He currently serves as a Director of the American Board of Surgery (ABS). He is therefore familiar with all of the issues of surgical training, certification, and re-certification. He is similarly well versed in the complexities surrounding the implementation of Maintenance of Certification, which remains a “work in progress” that his experience as a practicing, small-town general surgeon will certainly inform.

Tyler has distinguished himself in other leadership positions throughout his more than 30 years as a surgeon, including as President of his 600-member physician group when he initially practiced in Dallas. He has been a Fellow in the ACS for his entire surgical career and holds a deep respect, affection, and loyalty to the College. He possesses mainstream values, true to his upbringing and his long residence in America’s heartland; yet, he understands and respects the divergent views of surgeons across our country. He is also not afraid to tackle challenging problems, which is why I know that our tenure as co-Editors of ACS Surgery News is not likely to become boring.

As Layton “Bing” Rikkers leaves his post as Editor of ACS Surgery News, it has fallen to Karen Deveney and me to shepherd the paper forward as co-Editors. Dr. Rikkers felt that a combination approach of an academic surgeon and a community surgeon would bring balance to ACS Surgery News that would be representative of the nature of the American College of Surgeons (ACS).

In Karen Deveney we have an accomplished academic surgeon who has wide ranging interests in and out of surgery. Karen was raised in rural Oregon, went to Stanford for undergraduate education, and did her medical school and residency at University of California, San Francisco. Among her cohort in those times of training and her early academic career were Donald Trunkey, George Sheldon, and Brent Eastman, all of whom, like Karen, went on to have a major impact in the world of surgery.

After a stint in the military serving in Germany with her surgeon husband Cliff, Karen eventually landed at Oregon Health and Science University where she went on to serve as Program Director for 20 years at one of the best general surgery training programs in the country. She served as Second Vice-President of the ACS and is the immediate past-President of the Pacific Coast Surgical Association.

Her CV reflects varied academic interests and activities. So, Karen’s contributions to academic surgery are outstanding. But in Karen we also get a person who is alive to the needs of the population beyond the walls of her major medical center. Karen has been a leader in the march to save surgical access for rural populations. She is a founding member of the ACS Advisory Council for Rural Surgery, serving as the Education Pillar Chair of that Council. In her own institution, Karen is a pioneer in developing a model rural surgery track for general surgery residents – first in Grants Pass, Ore. and then in Coos Bay, Ore.

She has been a hardworking general and colorectal surgeon for over 30 years. And, like almost all dedicated surgical educators, she has taken call – enduring the long call schedule of her residents throughout her career.

Karen and I hope to make a good team in this new effort. We are different in many ways, but very much the same in others. We plan a synergy that will unflinchingly recognize the challenges in surgery and facilitate positive discussion and reporting of the solutions for those challenges. Among those challenges are the changing economic structure of surgery, the facilitation of useful quality efforts, and most importantly, the rapid dissemination of significant clinical and scientific information vital to surgeons everywhere.

Dr. Hughes is an ACS Fellow with the department of general surgery, McPherson Hospital, McPherson, Kan., and is the Editor in Chief of ACS Communities. He is also Associate Editor for ACS Surgery News.

As Layton “Bing” Rikkers leaves his post as Editor of ACS Surgery News, it has fallen to Karen Deveney and me to shepherd the paper forward as co-Editors. Dr. Rikkers felt that a combination approach of an academic surgeon and a community surgeon would bring balance to ACS Surgery News that would be representative of the nature of the American College of Surgeons (ACS).

In Karen Deveney we have an accomplished academic surgeon who has wide ranging interests in and out of surgery. Karen was raised in rural Oregon, went to Stanford for undergraduate education, and did her medical school and residency at University of California, San Francisco. Among her cohort in those times of training and her early academic career were Donald Trunkey, George Sheldon, and Brent Eastman, all of whom, like Karen, went on to have a major impact in the world of surgery.

After a stint in the military serving in Germany with her surgeon husband Cliff, Karen eventually landed at Oregon Health and Science University where she went on to serve as Program Director for 20 years at one of the best general surgery training programs in the country. She served as Second Vice-President of the ACS and is the immediate past-President of the Pacific Coast Surgical Association.

Her CV reflects varied academic interests and activities. So, Karen’s contributions to academic surgery are outstanding. But in Karen we also get a person who is alive to the needs of the population beyond the walls of her major medical center. Karen has been a leader in the march to save surgical access for rural populations. She is a founding member of the ACS Advisory Council for Rural Surgery, serving as the Education Pillar Chair of that Council. In her own institution, Karen is a pioneer in developing a model rural surgery track for general surgery residents – first in Grants Pass, Ore. and then in Coos Bay, Ore.

She has been a hardworking general and colorectal surgeon for over 30 years. And, like almost all dedicated surgical educators, she has taken call – enduring the long call schedule of her residents throughout her career.

Karen and I hope to make a good team in this new effort. We are different in many ways, but very much the same in others. We plan a synergy that will unflinchingly recognize the challenges in surgery and facilitate positive discussion and reporting of the solutions for those challenges. Among those challenges are the changing economic structure of surgery, the facilitation of useful quality efforts, and most importantly, the rapid dissemination of significant clinical and scientific information vital to surgeons everywhere.

Dr. Hughes is an ACS Fellow with the department of general surgery, McPherson Hospital, McPherson, Kan., and is the Editor in Chief of ACS Communities. He is also Associate Editor for ACS Surgery News.

As Layton “Bing” Rikkers leaves his post as Editor of ACS Surgery News, it has fallen to Karen Deveney and me to shepherd the paper forward as co-Editors. Dr. Rikkers felt that a combination approach of an academic surgeon and a community surgeon would bring balance to ACS Surgery News that would be representative of the nature of the American College of Surgeons (ACS).

In Karen Deveney we have an accomplished academic surgeon who has wide ranging interests in and out of surgery. Karen was raised in rural Oregon, went to Stanford for undergraduate education, and did her medical school and residency at University of California, San Francisco. Among her cohort in those times of training and her early academic career were Donald Trunkey, George Sheldon, and Brent Eastman, all of whom, like Karen, went on to have a major impact in the world of surgery.

After a stint in the military serving in Germany with her surgeon husband Cliff, Karen eventually landed at Oregon Health and Science University where she went on to serve as Program Director for 20 years at one of the best general surgery training programs in the country. She served as Second Vice-President of the ACS and is the immediate past-President of the Pacific Coast Surgical Association.

Her CV reflects varied academic interests and activities. So, Karen’s contributions to academic surgery are outstanding. But in Karen we also get a person who is alive to the needs of the population beyond the walls of her major medical center. Karen has been a leader in the march to save surgical access for rural populations. She is a founding member of the ACS Advisory Council for Rural Surgery, serving as the Education Pillar Chair of that Council. In her own institution, Karen is a pioneer in developing a model rural surgery track for general surgery residents – first in Grants Pass, Ore. and then in Coos Bay, Ore.

She has been a hardworking general and colorectal surgeon for over 30 years. And, like almost all dedicated surgical educators, she has taken call – enduring the long call schedule of her residents throughout her career.

Karen and I hope to make a good team in this new effort. We are different in many ways, but very much the same in others. We plan a synergy that will unflinchingly recognize the challenges in surgery and facilitate positive discussion and reporting of the solutions for those challenges. Among those challenges are the changing economic structure of surgery, the facilitation of useful quality efforts, and most importantly, the rapid dissemination of significant clinical and scientific information vital to surgeons everywhere.

Dr. Hughes is an ACS Fellow with the department of general surgery, McPherson Hospital, McPherson, Kan., and is the Editor in Chief of ACS Communities. He is also Associate Editor for ACS Surgery News.