Tom Collins is a freelance writer in South Florida who has written about medical topics from nasty infections to ethical dilemmas, runaway tumors to tornado-chasing doctors. He travels the globe gathering conference health news and lives in West Palm Beach.

Checklists, colleagues key when psychiatric patient overdoses

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BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

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BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

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Technical issues inhibit data collection on fentanyl

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BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

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BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

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Understanding properties of fentanyl, other opioids key to treatment

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Naloxone increasingly coming up short, expert says

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani, associate professor of clinical psychiatry at Columbia University, New York
Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten, professor of psychiatry at Baylor College of Medicine, Houston
Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

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Naloxone increasingly coming up short, expert says

Naloxone increasingly coming up short, expert says

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani, associate professor of clinical psychiatry at Columbia University, New York
Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten, professor of psychiatry at Baylor College of Medicine, Houston
Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani, associate professor of clinical psychiatry at Columbia University, New York
Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten, professor of psychiatry at Baylor College of Medicine, Houston
Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

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Drug test results ‘should not dictate treatment’

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– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health-University of South Carolina Medical Group
Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

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– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health-University of South Carolina Medical Group
Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health-University of South Carolina Medical Group
Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

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Rural teleprescribing for opioid use disorder shows success

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– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore of Yale University, New Haven, Conn.
Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

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– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore of Yale University, New Haven, Conn.
Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore of Yale University, New Haven, Conn.
Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

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Psilocybin yields encouraging results in addiction studies

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Fri, 01/18/2019 - 18:11

– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz
Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

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– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz
Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz
Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

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Paradigm shifts in palliative care

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Thu, 10/18/2018 - 14:42

Better engagement with patients essential

 

A 57-year-old man is admitted to the hospital with new back pain, which has been getting worse over the past 6 days. He had been diagnosed with stage 4 lung cancer in mid-2017 and underwent treatment with a platinum-based double therapy.

The man also has a history of heroin use – as recently as two years earlier – and he was divorced not long ago. He has been using an old prescription for Vicodin to treat himself, taking as many as 10-12 tablets a day.

This man is an example of the kind of complicated patient hospitalists are called on to treat – complex pain in an era when opioid abuse is considered a public scourge. How is a hospitalist to handle a case like this?

Pain cases are far from the only types of increasingly complex, often palliative cases in which hospitalists are being asked to provide help. Care for the elderly is also becoming increasingly difficult as the U.S. population ages and as hospitalists step in to provide care in the absence of geriatricians. .

Pain management in the opioid era and the need for new approaches in elderly care were highlighted at the Hospital Medicine 2018 annual conference, with experts drawing attention to subtleties that are often overlooked in these sometimes desperate cases.

James Risser, MD, medical director of palliative care at Regions Hospital in Minneapolis, said the complex problems of the 57-year-old man with back pain amounted to an example of “pain’s greatest hits.”

That particular case underscores the need to identify individual types of pain, he said, because they all need to be handled differently. If hospitalists don’t consider all the different aspects of pain, a patient might endure more suffering than necessary.

“All of this pain is swirling around in a very complicated patient,” Dr. Risser said, noting that it is important to “tease out the individual parts” of a complex patient’s history.

“Pain is a very complicated construct, from the physical to the neurological to the emotional,” Dr. Risser said. “Pain is a subjective experience, and the way people interact with their pain really depends not just on physical pain but also their psychological state, their social state, and even their spiritual state.”

Understanding this array of causes has led Dr. Risser to approach the problem of pain from different angles – including perspectives that might not be traditional, he said.

“One of the things that I’ve gotten better at is taking a spiritual history,” he said. “I don’t know if that’s part of everybody’s armamentarium. But if you’re dealing with people who are very, very sick, sometimes that’s the fundamental fabric of how they live and how they die. If there are unresolved issues along those lines, it’s possible they could be experiencing their pain in a different or more severe way.”
 

Varieties of pain

Treatment depends on the pain type, Dr. Risser said. Somatic pain often responds to nonsteroidal anti-inflammatories or steroids.

Illustration of pills falling out of a bottle
ah_designs/Getty Images

Neuropathic pain usually responds poorly to anti-inflammatories and to opioids. There is some research suggesting methadone could be helpful, but the data are not very strong. The most common medications prescribed are antiseizure medications and antidepressants, such as gabapentin and serotonin, and norepinephrine reuptake inhibitors.

The question of cancer pain versus noncancer pain can be tricky, Dr. Risser said. If a person’s life expectancy is limited, there can be a reason, or even a requirement, to use higher-risk medications. But, he said, that doesn’t mean the patient still won’t have problems with overuse of pain medication.

“We have a lot of patients now living post cancer who have been put on methadone or have been put on Oxycontin, and now we’re trying to figure out what to do with them,” he said. “I don’t think it’s that clear anymore that there’s a massive difference between cancer and noncancer pain, especially for those survivors.”

Clinicians, he said, should “fix what can be fixed” – and with the right tools. “If you have a patient who’s got severe lower abdominal pain because they have a bladder full or urine, really the treatment would probably not be … opioids. It probably would be a Foley catheter,” he said.

Hospitalists should treat patients based on sound principles of pain management, Dr. Risser said, but “while you try to create a diagnostic framework, know that people continually defy the boxes we put them in.”

Dr. Amy Davis, clinical associate professor at Drexel
Dr. Amy Davis

Indeed, in an era of pain-medication addiction, it might be a good idea to worry about prescribing opioids, but clinicians have to remember that their goal is to help patients get relief – and that they themselves bring biases to the table, said Amy Davis, DO, MS, of Drexel University, Philadelphia.

In a presentation at HM18, Dr. Davis displayed images of a variety of patients on a large screen – different races and genders, some in business attire, some rougher around the edges.

“Would pain decisions change based on what people look like?” she asked. “Can you really spot who the drug traffickers are? We need to remember that our biases play a huge role not only in the treatment of our patients but in their outcomes. I’m challenging everybody to start thinking about these folks not as drug-seekers but as comfort-seekers.”

When it comes right down to it, she said, patients want a better life, not their drug of choice.

“That is the nature of the disease. [The illegal drug] is not what they’re looking for in reality because that does not provide a good quality of life,” Dr. Davis said. “The [practice of medicine] is supposed to be about helping people live their lives, not just checking off boxes.”

People with an opioid use disorder are physically different, she said. The processing of pain stimuli by their brain and spinal cord is physically altered – they have an increased perception of pain and lower pain tolerance.

“This is not a character flaw,” Dr. Davis affirmed. The increased sensitivity to pain does not resolve with opioid cessation; it can last for decades. Clinicians may need to spend more time interacting with certain patients to get a sense of the physical and nonphysical pain from which they suffer.

“Consistent, open, nonjudgmental communication improves not only the information we gather from patients and families, but it actually changes the adherence,” Dr. Davis said. “Ultimately the treatment outcomes are what all of this is about.”
 

 

 

Paradigm shift

Another palliative care role that hospitalists often find themselves in is “comforter” of elderly patients.

Dan Burke Photography
Dr. Ryan Greysen


Ryan Greysen, MD, MHS, chief of hospital medicine at the University of Pennsylvania, Philadelphia, said hospitals must respond to a shift in the paradigm of elderly care. To explain the nature of this change, he referenced the “paradigm shift” model devised by the philosopher of science Thomas Kuhn, PhD. According to Kuhn, science proceeds in a settled pattern for many years, but on the rare occasions, when there is a fundamental drift in thinking, new problems present themselves and put the old model in a crisis mode, which prompts an intellectual revolution and a shift in the paradigm itself.

“This is a way of thinking about changes in scientific paradigms, but I think it works in clinical practice as well,” Dr. Greysen said.

The need for a paradigm shift in the care of elderly inpatients has largely to do with demographics. By 2050, the number of people aged 65 years and older is expected to be about 80 million, roughly double what it was in 2000. The number of people aged 85 years and up is expected to be about 20 million, or about four times the total in 2000.

In 2010, 40% of the hospitalized population was over 65 years. In 2030, that will flip: Only 40% of inpatients will be under 65 years. This will mean that hospitalists must care for more patients who are older, and the patients themselves will have more complicated medical issues.

“To be ready for the aging century, we must be better able to adapt and address those things that affect seniors,” Dr. Greysen said. With the number of geriatricians falling, much more of this care will fall to hospitalists, he said.

More attention must be paid to the potential harms of hospital-based care to older patients: decreased muscle strength and aerobic capacity, vasomotor instability, lower bone density, poor ventilation, altered thirst and nutrition, and fragile skin, among others, Dr. Greysen said.

In a study published in 2015, Dr. Greysen assessed outcomes for elderly patients who were assessed before hospitalization for functional impairment. The more impaired they were, the more likely they were to be readmitted within 30 days of discharge – from a 13.5% readmission rate for those with no impairment up to 18.2% for those considered to have “dependency” in three or more activities of daily living.1

In another analysis, severe functional impairment – dependency in at least two activities of daily living – was associated with more post-acute care Medicare costs than neurological disorders or renal failure.2

Acute care for the elderly (ACE) programs, which have care specifically tailored to the needs of older patients, have been found to be associated with less functional decline, shorter lengths of stay, fewer adverse events, and lower costs and readmission rates, Dr. Greysen said.

These programs are becoming more common, but they are not spreading as quickly as perhaps they should, he said. In part, this is because of the “know-do” gap, in which practical steps that have been shown to work are not actually implemented because of assumptions that they are already in place or the mistaken belief that simple steps could not possibly make a difference.

Part of the paradigm shift that’s needed, Dr. Greysen said, is an appreciation of the concept of “posthospitalization syndrome,” which is composed of several domains: sleep, function, nutrition, symptom burden such as pain and discomfort, cognition, level of engagement, psychosocial status including emotional stress, and treatment burden including the adverse effects of medications.

Better patient engagement in discharge planning – including asking patients about whether they’ve had help reading hospital discharge–related documents, their level of education, and how often they are getting out of bed – is one necessary step toward change. Surveys of satisfaction using tablets and patient portals is another option, Dr. Greysen said.

The patients of the future will likely prompt their own change, he said, quoting from a 2013 publication.

“Possibly the most promising predictor for change in delivery of care is change in the patients themselves,” the authors wrote. “Baby boomers have redefined the norms at every stage of their lives. ... They will expect providers to engage them in shared decision making, elicit their health care goals and treatment preferences, communicate with providers across sites, and provide needed social supports.”3

 

 

References

1. Greysen SR et al. Functional impairment and hospital readmission in medicare seniors. JAMA Intern Med. 2015 Apr;175(4):559-65.

2. Greysen SR et al. Functional impairment: An unmeasured marker of medicare costs for postacute care of older adults. J Am Geriatr Soc. 2017 Sep;65(9):1996-2002.

3. Laura A. Levit, Erin P. Balogh, Sharyl J. Nass, and Patricia A. Ganz, eds. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. (Washington (DC): National Academies Press (US), 2013 Dec 27).

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Better engagement with patients essential

Better engagement with patients essential

 

A 57-year-old man is admitted to the hospital with new back pain, which has been getting worse over the past 6 days. He had been diagnosed with stage 4 lung cancer in mid-2017 and underwent treatment with a platinum-based double therapy.

The man also has a history of heroin use – as recently as two years earlier – and he was divorced not long ago. He has been using an old prescription for Vicodin to treat himself, taking as many as 10-12 tablets a day.

This man is an example of the kind of complicated patient hospitalists are called on to treat – complex pain in an era when opioid abuse is considered a public scourge. How is a hospitalist to handle a case like this?

Pain cases are far from the only types of increasingly complex, often palliative cases in which hospitalists are being asked to provide help. Care for the elderly is also becoming increasingly difficult as the U.S. population ages and as hospitalists step in to provide care in the absence of geriatricians. .

Pain management in the opioid era and the need for new approaches in elderly care were highlighted at the Hospital Medicine 2018 annual conference, with experts drawing attention to subtleties that are often overlooked in these sometimes desperate cases.

James Risser, MD, medical director of palliative care at Regions Hospital in Minneapolis, said the complex problems of the 57-year-old man with back pain amounted to an example of “pain’s greatest hits.”

That particular case underscores the need to identify individual types of pain, he said, because they all need to be handled differently. If hospitalists don’t consider all the different aspects of pain, a patient might endure more suffering than necessary.

“All of this pain is swirling around in a very complicated patient,” Dr. Risser said, noting that it is important to “tease out the individual parts” of a complex patient’s history.

“Pain is a very complicated construct, from the physical to the neurological to the emotional,” Dr. Risser said. “Pain is a subjective experience, and the way people interact with their pain really depends not just on physical pain but also their psychological state, their social state, and even their spiritual state.”

Understanding this array of causes has led Dr. Risser to approach the problem of pain from different angles – including perspectives that might not be traditional, he said.

“One of the things that I’ve gotten better at is taking a spiritual history,” he said. “I don’t know if that’s part of everybody’s armamentarium. But if you’re dealing with people who are very, very sick, sometimes that’s the fundamental fabric of how they live and how they die. If there are unresolved issues along those lines, it’s possible they could be experiencing their pain in a different or more severe way.”
 

Varieties of pain

Treatment depends on the pain type, Dr. Risser said. Somatic pain often responds to nonsteroidal anti-inflammatories or steroids.

Illustration of pills falling out of a bottle
ah_designs/Getty Images

Neuropathic pain usually responds poorly to anti-inflammatories and to opioids. There is some research suggesting methadone could be helpful, but the data are not very strong. The most common medications prescribed are antiseizure medications and antidepressants, such as gabapentin and serotonin, and norepinephrine reuptake inhibitors.

The question of cancer pain versus noncancer pain can be tricky, Dr. Risser said. If a person’s life expectancy is limited, there can be a reason, or even a requirement, to use higher-risk medications. But, he said, that doesn’t mean the patient still won’t have problems with overuse of pain medication.

“We have a lot of patients now living post cancer who have been put on methadone or have been put on Oxycontin, and now we’re trying to figure out what to do with them,” he said. “I don’t think it’s that clear anymore that there’s a massive difference between cancer and noncancer pain, especially for those survivors.”

Clinicians, he said, should “fix what can be fixed” – and with the right tools. “If you have a patient who’s got severe lower abdominal pain because they have a bladder full or urine, really the treatment would probably not be … opioids. It probably would be a Foley catheter,” he said.

Hospitalists should treat patients based on sound principles of pain management, Dr. Risser said, but “while you try to create a diagnostic framework, know that people continually defy the boxes we put them in.”

Dr. Amy Davis, clinical associate professor at Drexel
Dr. Amy Davis

Indeed, in an era of pain-medication addiction, it might be a good idea to worry about prescribing opioids, but clinicians have to remember that their goal is to help patients get relief – and that they themselves bring biases to the table, said Amy Davis, DO, MS, of Drexel University, Philadelphia.

In a presentation at HM18, Dr. Davis displayed images of a variety of patients on a large screen – different races and genders, some in business attire, some rougher around the edges.

“Would pain decisions change based on what people look like?” she asked. “Can you really spot who the drug traffickers are? We need to remember that our biases play a huge role not only in the treatment of our patients but in their outcomes. I’m challenging everybody to start thinking about these folks not as drug-seekers but as comfort-seekers.”

When it comes right down to it, she said, patients want a better life, not their drug of choice.

“That is the nature of the disease. [The illegal drug] is not what they’re looking for in reality because that does not provide a good quality of life,” Dr. Davis said. “The [practice of medicine] is supposed to be about helping people live their lives, not just checking off boxes.”

People with an opioid use disorder are physically different, she said. The processing of pain stimuli by their brain and spinal cord is physically altered – they have an increased perception of pain and lower pain tolerance.

“This is not a character flaw,” Dr. Davis affirmed. The increased sensitivity to pain does not resolve with opioid cessation; it can last for decades. Clinicians may need to spend more time interacting with certain patients to get a sense of the physical and nonphysical pain from which they suffer.

“Consistent, open, nonjudgmental communication improves not only the information we gather from patients and families, but it actually changes the adherence,” Dr. Davis said. “Ultimately the treatment outcomes are what all of this is about.”
 

 

 

Paradigm shift

Another palliative care role that hospitalists often find themselves in is “comforter” of elderly patients.

Dan Burke Photography
Dr. Ryan Greysen


Ryan Greysen, MD, MHS, chief of hospital medicine at the University of Pennsylvania, Philadelphia, said hospitals must respond to a shift in the paradigm of elderly care. To explain the nature of this change, he referenced the “paradigm shift” model devised by the philosopher of science Thomas Kuhn, PhD. According to Kuhn, science proceeds in a settled pattern for many years, but on the rare occasions, when there is a fundamental drift in thinking, new problems present themselves and put the old model in a crisis mode, which prompts an intellectual revolution and a shift in the paradigm itself.

“This is a way of thinking about changes in scientific paradigms, but I think it works in clinical practice as well,” Dr. Greysen said.

The need for a paradigm shift in the care of elderly inpatients has largely to do with demographics. By 2050, the number of people aged 65 years and older is expected to be about 80 million, roughly double what it was in 2000. The number of people aged 85 years and up is expected to be about 20 million, or about four times the total in 2000.

In 2010, 40% of the hospitalized population was over 65 years. In 2030, that will flip: Only 40% of inpatients will be under 65 years. This will mean that hospitalists must care for more patients who are older, and the patients themselves will have more complicated medical issues.

“To be ready for the aging century, we must be better able to adapt and address those things that affect seniors,” Dr. Greysen said. With the number of geriatricians falling, much more of this care will fall to hospitalists, he said.

More attention must be paid to the potential harms of hospital-based care to older patients: decreased muscle strength and aerobic capacity, vasomotor instability, lower bone density, poor ventilation, altered thirst and nutrition, and fragile skin, among others, Dr. Greysen said.

In a study published in 2015, Dr. Greysen assessed outcomes for elderly patients who were assessed before hospitalization for functional impairment. The more impaired they were, the more likely they were to be readmitted within 30 days of discharge – from a 13.5% readmission rate for those with no impairment up to 18.2% for those considered to have “dependency” in three or more activities of daily living.1

In another analysis, severe functional impairment – dependency in at least two activities of daily living – was associated with more post-acute care Medicare costs than neurological disorders or renal failure.2

Acute care for the elderly (ACE) programs, which have care specifically tailored to the needs of older patients, have been found to be associated with less functional decline, shorter lengths of stay, fewer adverse events, and lower costs and readmission rates, Dr. Greysen said.

These programs are becoming more common, but they are not spreading as quickly as perhaps they should, he said. In part, this is because of the “know-do” gap, in which practical steps that have been shown to work are not actually implemented because of assumptions that they are already in place or the mistaken belief that simple steps could not possibly make a difference.

Part of the paradigm shift that’s needed, Dr. Greysen said, is an appreciation of the concept of “posthospitalization syndrome,” which is composed of several domains: sleep, function, nutrition, symptom burden such as pain and discomfort, cognition, level of engagement, psychosocial status including emotional stress, and treatment burden including the adverse effects of medications.

Better patient engagement in discharge planning – including asking patients about whether they’ve had help reading hospital discharge–related documents, their level of education, and how often they are getting out of bed – is one necessary step toward change. Surveys of satisfaction using tablets and patient portals is another option, Dr. Greysen said.

The patients of the future will likely prompt their own change, he said, quoting from a 2013 publication.

“Possibly the most promising predictor for change in delivery of care is change in the patients themselves,” the authors wrote. “Baby boomers have redefined the norms at every stage of their lives. ... They will expect providers to engage them in shared decision making, elicit their health care goals and treatment preferences, communicate with providers across sites, and provide needed social supports.”3

 

 

References

1. Greysen SR et al. Functional impairment and hospital readmission in medicare seniors. JAMA Intern Med. 2015 Apr;175(4):559-65.

2. Greysen SR et al. Functional impairment: An unmeasured marker of medicare costs for postacute care of older adults. J Am Geriatr Soc. 2017 Sep;65(9):1996-2002.

3. Laura A. Levit, Erin P. Balogh, Sharyl J. Nass, and Patricia A. Ganz, eds. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. (Washington (DC): National Academies Press (US), 2013 Dec 27).

 

A 57-year-old man is admitted to the hospital with new back pain, which has been getting worse over the past 6 days. He had been diagnosed with stage 4 lung cancer in mid-2017 and underwent treatment with a platinum-based double therapy.

The man also has a history of heroin use – as recently as two years earlier – and he was divorced not long ago. He has been using an old prescription for Vicodin to treat himself, taking as many as 10-12 tablets a day.

This man is an example of the kind of complicated patient hospitalists are called on to treat – complex pain in an era when opioid abuse is considered a public scourge. How is a hospitalist to handle a case like this?

Pain cases are far from the only types of increasingly complex, often palliative cases in which hospitalists are being asked to provide help. Care for the elderly is also becoming increasingly difficult as the U.S. population ages and as hospitalists step in to provide care in the absence of geriatricians. .

Pain management in the opioid era and the need for new approaches in elderly care were highlighted at the Hospital Medicine 2018 annual conference, with experts drawing attention to subtleties that are often overlooked in these sometimes desperate cases.

James Risser, MD, medical director of palliative care at Regions Hospital in Minneapolis, said the complex problems of the 57-year-old man with back pain amounted to an example of “pain’s greatest hits.”

That particular case underscores the need to identify individual types of pain, he said, because they all need to be handled differently. If hospitalists don’t consider all the different aspects of pain, a patient might endure more suffering than necessary.

“All of this pain is swirling around in a very complicated patient,” Dr. Risser said, noting that it is important to “tease out the individual parts” of a complex patient’s history.

“Pain is a very complicated construct, from the physical to the neurological to the emotional,” Dr. Risser said. “Pain is a subjective experience, and the way people interact with their pain really depends not just on physical pain but also their psychological state, their social state, and even their spiritual state.”

Understanding this array of causes has led Dr. Risser to approach the problem of pain from different angles – including perspectives that might not be traditional, he said.

“One of the things that I’ve gotten better at is taking a spiritual history,” he said. “I don’t know if that’s part of everybody’s armamentarium. But if you’re dealing with people who are very, very sick, sometimes that’s the fundamental fabric of how they live and how they die. If there are unresolved issues along those lines, it’s possible they could be experiencing their pain in a different or more severe way.”
 

Varieties of pain

Treatment depends on the pain type, Dr. Risser said. Somatic pain often responds to nonsteroidal anti-inflammatories or steroids.

Illustration of pills falling out of a bottle
ah_designs/Getty Images

Neuropathic pain usually responds poorly to anti-inflammatories and to opioids. There is some research suggesting methadone could be helpful, but the data are not very strong. The most common medications prescribed are antiseizure medications and antidepressants, such as gabapentin and serotonin, and norepinephrine reuptake inhibitors.

The question of cancer pain versus noncancer pain can be tricky, Dr. Risser said. If a person’s life expectancy is limited, there can be a reason, or even a requirement, to use higher-risk medications. But, he said, that doesn’t mean the patient still won’t have problems with overuse of pain medication.

“We have a lot of patients now living post cancer who have been put on methadone or have been put on Oxycontin, and now we’re trying to figure out what to do with them,” he said. “I don’t think it’s that clear anymore that there’s a massive difference between cancer and noncancer pain, especially for those survivors.”

Clinicians, he said, should “fix what can be fixed” – and with the right tools. “If you have a patient who’s got severe lower abdominal pain because they have a bladder full or urine, really the treatment would probably not be … opioids. It probably would be a Foley catheter,” he said.

Hospitalists should treat patients based on sound principles of pain management, Dr. Risser said, but “while you try to create a diagnostic framework, know that people continually defy the boxes we put them in.”

Dr. Amy Davis, clinical associate professor at Drexel
Dr. Amy Davis

Indeed, in an era of pain-medication addiction, it might be a good idea to worry about prescribing opioids, but clinicians have to remember that their goal is to help patients get relief – and that they themselves bring biases to the table, said Amy Davis, DO, MS, of Drexel University, Philadelphia.

In a presentation at HM18, Dr. Davis displayed images of a variety of patients on a large screen – different races and genders, some in business attire, some rougher around the edges.

“Would pain decisions change based on what people look like?” she asked. “Can you really spot who the drug traffickers are? We need to remember that our biases play a huge role not only in the treatment of our patients but in their outcomes. I’m challenging everybody to start thinking about these folks not as drug-seekers but as comfort-seekers.”

When it comes right down to it, she said, patients want a better life, not their drug of choice.

“That is the nature of the disease. [The illegal drug] is not what they’re looking for in reality because that does not provide a good quality of life,” Dr. Davis said. “The [practice of medicine] is supposed to be about helping people live their lives, not just checking off boxes.”

People with an opioid use disorder are physically different, she said. The processing of pain stimuli by their brain and spinal cord is physically altered – they have an increased perception of pain and lower pain tolerance.

“This is not a character flaw,” Dr. Davis affirmed. The increased sensitivity to pain does not resolve with opioid cessation; it can last for decades. Clinicians may need to spend more time interacting with certain patients to get a sense of the physical and nonphysical pain from which they suffer.

“Consistent, open, nonjudgmental communication improves not only the information we gather from patients and families, but it actually changes the adherence,” Dr. Davis said. “Ultimately the treatment outcomes are what all of this is about.”
 

 

 

Paradigm shift

Another palliative care role that hospitalists often find themselves in is “comforter” of elderly patients.

Dan Burke Photography
Dr. Ryan Greysen


Ryan Greysen, MD, MHS, chief of hospital medicine at the University of Pennsylvania, Philadelphia, said hospitals must respond to a shift in the paradigm of elderly care. To explain the nature of this change, he referenced the “paradigm shift” model devised by the philosopher of science Thomas Kuhn, PhD. According to Kuhn, science proceeds in a settled pattern for many years, but on the rare occasions, when there is a fundamental drift in thinking, new problems present themselves and put the old model in a crisis mode, which prompts an intellectual revolution and a shift in the paradigm itself.

“This is a way of thinking about changes in scientific paradigms, but I think it works in clinical practice as well,” Dr. Greysen said.

The need for a paradigm shift in the care of elderly inpatients has largely to do with demographics. By 2050, the number of people aged 65 years and older is expected to be about 80 million, roughly double what it was in 2000. The number of people aged 85 years and up is expected to be about 20 million, or about four times the total in 2000.

In 2010, 40% of the hospitalized population was over 65 years. In 2030, that will flip: Only 40% of inpatients will be under 65 years. This will mean that hospitalists must care for more patients who are older, and the patients themselves will have more complicated medical issues.

“To be ready for the aging century, we must be better able to adapt and address those things that affect seniors,” Dr. Greysen said. With the number of geriatricians falling, much more of this care will fall to hospitalists, he said.

More attention must be paid to the potential harms of hospital-based care to older patients: decreased muscle strength and aerobic capacity, vasomotor instability, lower bone density, poor ventilation, altered thirst and nutrition, and fragile skin, among others, Dr. Greysen said.

In a study published in 2015, Dr. Greysen assessed outcomes for elderly patients who were assessed before hospitalization for functional impairment. The more impaired they were, the more likely they were to be readmitted within 30 days of discharge – from a 13.5% readmission rate for those with no impairment up to 18.2% for those considered to have “dependency” in three or more activities of daily living.1

In another analysis, severe functional impairment – dependency in at least two activities of daily living – was associated with more post-acute care Medicare costs than neurological disorders or renal failure.2

Acute care for the elderly (ACE) programs, which have care specifically tailored to the needs of older patients, have been found to be associated with less functional decline, shorter lengths of stay, fewer adverse events, and lower costs and readmission rates, Dr. Greysen said.

These programs are becoming more common, but they are not spreading as quickly as perhaps they should, he said. In part, this is because of the “know-do” gap, in which practical steps that have been shown to work are not actually implemented because of assumptions that they are already in place or the mistaken belief that simple steps could not possibly make a difference.

Part of the paradigm shift that’s needed, Dr. Greysen said, is an appreciation of the concept of “posthospitalization syndrome,” which is composed of several domains: sleep, function, nutrition, symptom burden such as pain and discomfort, cognition, level of engagement, psychosocial status including emotional stress, and treatment burden including the adverse effects of medications.

Better patient engagement in discharge planning – including asking patients about whether they’ve had help reading hospital discharge–related documents, their level of education, and how often they are getting out of bed – is one necessary step toward change. Surveys of satisfaction using tablets and patient portals is another option, Dr. Greysen said.

The patients of the future will likely prompt their own change, he said, quoting from a 2013 publication.

“Possibly the most promising predictor for change in delivery of care is change in the patients themselves,” the authors wrote. “Baby boomers have redefined the norms at every stage of their lives. ... They will expect providers to engage them in shared decision making, elicit their health care goals and treatment preferences, communicate with providers across sites, and provide needed social supports.”3

 

 

References

1. Greysen SR et al. Functional impairment and hospital readmission in medicare seniors. JAMA Intern Med. 2015 Apr;175(4):559-65.

2. Greysen SR et al. Functional impairment: An unmeasured marker of medicare costs for postacute care of older adults. J Am Geriatr Soc. 2017 Sep;65(9):1996-2002.

3. Laura A. Levit, Erin P. Balogh, Sharyl J. Nass, and Patricia A. Ganz, eds. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. (Washington (DC): National Academies Press (US), 2013 Dec 27).

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Hospitalist NPs and PAs note progress

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But remain underutilized

 


Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

Noam Shabani, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit
Noam Shabani

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner in the section of hospital medicine at the University of Chicago
Tracy Cardin

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Nicolas Houghton, nurse practitioner/physician assistant manager at Cleveland Clinic
Nicolas Houghton

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

 

 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

 

 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

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But remain underutilized

But remain underutilized

 


Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

Noam Shabani, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit
Noam Shabani

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner in the section of hospital medicine at the University of Chicago
Tracy Cardin

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Nicolas Houghton, nurse practitioner/physician assistant manager at Cleveland Clinic
Nicolas Houghton

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

 

 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

 

 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

 


Nurse practitioners (NPs) and physician assistants (PAs) have become a more prominent part of the hospitalist workforce, and at many institutions, they account for a large proportion of patient care and have a powerful effect on a patient’s experience. But NP and PA roles in hospital medicine continue to evolve – and understanding what they do is still, at times, a work in progress.

Noam Shabani, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit
Noam Shabani

One myth that persists regarding NPs and PAs is that, if you’ve seen one, you’ve seen them all.

At the 2018 Annual Conference of the Society of Hospital Medicine, Noam Shabani, MS, PA-C, lead physician assistant at Massachusetts General Hospital’s Hospital Medicine Unit, Boston, offered an example to help shatter this misperception.

Mr. Shabani described a 28-year-old woman who had a bachelor’s in biology with a premed track and spent 4 years as a paramedic before attending the physician assistant program at Duke University, Durham, N.C. As a new PA graduate, she was hired as a hospitalist at a community hospital in Kentucky.

Given this new PA’s clinical experience and formal education, there are certain skills she should bring to the table: the ability to develop a differential diagnosis and a good understanding of disease pathophysiology and the mechanisms of action of drugs. And because of her paramedic experience, she should be comfortable with making urgent clinical care decisions and should be proficient with electrocardiograms, as well as chest and abdominal x-rays.

But compared with a newly graduated NP with registered nurse (RN) floor experience, the PA is likely to be less familiar with hospital mechanics and systems, with leading goal of care discussions with patients and families, and with understanding nuances involved with transitions of care.

The subtle differences between NPs and PAs don’t end there. Because of the progressive policies and recently updated bylaws at the Kentucky hospital where the PA was hired, this health care professional can see patients and write notes independently without a physician signature. But because she practices in Kentucky, she is not allowed to prescribe Schedule II medications, per state law.

“This example demonstrates how nuanced and multi-layered the process of integrating NPs and PAs into hospitalist groups can be,” Mr. Shabani said.
 

Goals, roles, and expectations

Physician assistants and nurse practitioners have reported that their job descriptions, and the variety of roles they can play within HM teams, are becoming better understood by hospitalist physicians and administrators. However, they also have acknowledged that both PAs and NPs are still underutilized.

Tricia Marriott, PA-C, MPAS, an orthopedic service line administrator at Saint Mary’s Hospital in Waterbury, Conn., and an expert in NP and PA policy, has noticed growing enlightenment about PAs and NPs in her travels to conferences in recent years.

“I’m no longer explaining what a PA is and what an NP is, and the questions have become very sophisticated,” she said at HM18. “However, I spent the last two days in the exhibit hall, and some of the conversations I had with physicians are interesting in that the practice and utilization styles have not become sophisticated. So I think there is a lot of opportunity out there.”

Mr. Shabani said the hospitalist care provided by PAs and NPs sits “at the intersection” of state regulations, hospital bylaws, department utilization, and – of course – clinical experience and formal medical education.

“What this boils down to is first understanding these factors, followed by strategizing recruitment and training as a response,” he said.

Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner in the section of hospital medicine at the University of Chicago
Tracy Cardin

Tracy Cardin, ACNP-BC, SFHM, associate director of clinical integration at Adfinitas Health in Hanover, Md., and a Society of Hospital Medicine board member, said that, even though she usually sees and hears about a 10%-15% productivity gap between physicians and PAs or NPs, there is no good reason that an experienced PA or NP should not be able to handle the same patient load as a physician hospitalist – if that’s the goal.

“Part of it is about communication of expectation,” she said, noting that organizations must provide the training to allows NPs and PAs to reach prescribed goals along with an adequate level of administrative support. “I think we shouldn’t accept those gaps in productivity.”

Nicolas Houghton, DNP, ACNP-BC, CFRN, nurse practitioner/physician assistant manager at the Cleveland Clinic, thinks that it is completely reasonable for health care organizations to have an expectation that, at the 3- to 5-year mark, NPs and PAs “are really going to be functioning at very high levels that may be nearly indistinguishable.”

Nicolas Houghton, nurse practitioner/physician assistant manager at Cleveland Clinic
Nicolas Houghton

Dr. Houghton and Mr. Shabani agreed that, while they had considerably different duties at the start of their careers, they now have clinical roles which mirror one another.

For example, they agreed on these basics: NPs must be a certified RN, while a PA can have any undergraduate degree with certain prerequisite courses such as biology and chemistry. All PAs are trained in general medicine, while NPs specialize in areas such as acute care, family medicine, geriatrics, and women’s health. NPs need 500 didactic hours and 500-700 clinical hours in their area of expertise, while physician assistants need 1,000 didactic and 2,000 clinical hours spread over many disciplines.

For NP’s, required clinical rotations depend on the specialty, while all PAs need to complete rotations in inpatient medicine, emergency medicine, primary care, surgery, psychiatry, pediatrics, and ob.gyn. Also, NPs can practice independently in 23 states and the District of Columbia, while PAs must have a supervising physician. About 10% of NPs work in hospital settings, and about 39% of PAs work in hospital settings, they said.

Dr. Houghton and Mr. Shabani emphasized that Medicare does recognize NP and PA services as physician services. The official language, in place since 1998, is that their services “are the type that are considered physician’s services if furnished by a doctor of medicine or osteopathy.”

Mr. Shabani said this remained a very relevant issue. “I can’t overstate how important this is,” he said.
 

 

 

Debunking myths

Several myths continue to persist about PAs and NPs, Ms. Marriott said. Some administrators and physicians believe that they can’t see new patients, that a physician must see every patient, that a physician cosignature means that a claim can be submitted under the physician’s name, that reimbursement for services provided by PAs and NPs “leaves 15% on the table,” and that patients won’t be happy being seen by a PA or an NP. All of those things are false, she said.

“We really need to improve people’s understanding in a lot of different places – it’s not just at the clinician level,” she said. “It goes all the way through the operations team, and the operations team has some very old-fashioned thinking about what PAs and NPs really are, which is – they believe – clinical support staff.”

But she suggested that the phrase “working at the top of one’s license” can be used too freely – individual experience and ability will encompass a range of practices, she said.

“I’m licensed to drive a car,” she said. “But you do not want me in the Daytona 500. I am not capable of driving a race car.”

She cautioned that nurse practitioner care must still involve an element of collaboration, according to the Medicaid benefit policy manual, even if they work in states that allow NPs to provide “independent” care. They must have documentation “indicating the relationships that they have with physicians to deal with issues outside their scope of practice,” the manual says.

“Don’t ask me how people prove it,” Ms. Marriott said. “Just know that, if someone were to audit you, then you would need to show what this looks like.”

Regarding the 15% myth, she showed a calculation: Data from the Medical Group Management Association show that median annual compensation for a physician is $134 an hour and that it’s approximately $52 an hour for a PA or NP. An admission history and physical that takes an hour can be reimbursed at $102 for a physician and at 85% of that – $87 – for a PA or NP. That leaves a deficit of $32 for the physician and a surplus of $35 for the PA or NP.

“If you properly deploy your PAs and NPs, you’re going to generate positive margins,” Ms. Marriott said.

Physicians often scurry about seeing all the patients that have already been seen by a PA, she said, because they think they must capture the extra 15% reimbursement. But that is unnecessary, she said.

“Go do another admission. You should see patients because of their clinical condition. My point is not that you go running around because you want to capture the extra 15% – because that provides no additional medically necessary care.”
 

Changing practice

Many institutions continue to be hamstrung by their own bylaws in the use of NPs and PAs. It’s true that a physician doesn’t have to see every patient, unless it’s required in a hospital’s rules, Ms. Marriott noted.

“Somebody step up, get on the bylaws committee, and say, ‘Let’s update these.’ ” she said.

As for patient satisfaction, access and convenience routinely rank higher on the patient priority lists than provider credentials. “The patient wants to get off the gurney in the ED and get to a room,” she said.

But changing hospital bylaws and practices is also about the responsible use of health care dollars, Ms. Marriott affirmed.

“More patients seen in a timely fashion, and quality metrics improvement: Those are all things that are really, really important,” she said. “As a result, [if bylaws and practice patterns are changed] the physicians are hopefully going to be happier, certainly the administration is going to be happier, and the patients are going to fare better.”

Scott Faust, MS, APRN, CNP, an acute care nurse practitioner at Health Partners in St. Paul, Minn., said that teamwork without egos is crucial to success for all providers on the hospital medicine team, especially at busier moments.

“Nobody wants to be in this alone,” he said. “I think the hospitalist teams that work well are the ones that check their titles at the door.”

PAs and NPs generally agree that, as long as all clinical staffers are working within their areas of skill without being overly concerned about specific titles and roles, hospitals and patients will benefit.

“I’ve had physicians at my organization say ‘We need to have an NP and PA set of educational requirements,’ and I said, ‘We have some already for physicians, right? Why aren’t we using that?’ ” Dr. Houghton said. “I think we should have the same expectations clinically. At the end of the day, the patient deserves the same outcomes and the same care, whether they’re being cared for by a physician, an NP, or a PA.”


 

 

 

Onboarding NPs and PAs

According to SHM’s Nurse Practitioner/Physician Assistant Committee, the integration of a new NP or PA hire, whether experienced or not, requires up-front organization and planning for the employee as he or she enters into a new practice.

To that end, the NP/PA Committee created a toolkit to aid health care organizations in their integration of NP and PA staffers into hospital medicine practice groups. The document includes resources for recruiting and interviewing NPs and PAs, information about orientation and onboarding, detailed descriptions of models of care to aid in the utilization of NPs and PAs, best practices for staff retention, insights on billing and reimbursement, and ideas for program evaluation.

Readers can download the Onboarding Toolkit in PDF format at shm.hospitalmedicine.org/acton/attachment/25526/f-040f/1/-/-/-/-/SHM_NPPA_OboardingToolkit.pdf.

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Researchers identify potential sickle cell disease target

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Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.

Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.

The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.

“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.

HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.

The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.

“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.

SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
 

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Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.

Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.

The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.

“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.

HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.

The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.

“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.

SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
 

 

Researchers have identified a repressor of fetal hemoglobin (HbF), which they assert could offer a therapeutic target for patients with sickle cell disease (SCD) and some forms of beta thalassemia, according to a new paper published in Science.

Strategies to boost HbF have so far been limited to gene therapy and hydroxyurea, which has been shown to have limited efficacy.

The finding was made using a tailored CRISPR screen of adult human erythroid cells; the CRISPR screen targeted protein kinases, which are controllable by small molecules, which makes them more feasible for treatment therapeutically, researchers wrote.

“Using an improved CRISPR-Cas9 domain-focused screening approach, we identified the erythroid-specific kinase HRI [heme-regulated inhibitor] as a potentially druggable target that is involved in HbF silencing,” wrote Gerd A. Blobel, MD, PhD, of Children’s Hospital of Philadelphia and his colleagues.

HRI is an erythroid-specific kinase that controls protein translation. Once identified, depleting HRI resulted in an increase of HbF production and reduced sickling in cultured erythroid cells. Researchers said that diminished expression of the transcription factor BCL11A, an HbF repressor, accounted for the effects of HRI depletion.

The results with erythroid cell cultures suggest that HRI loss is well tolerated, but the mechanism of inducing fetal hemoglobin is still not fully understood, the researchers noted. Also, while HRI may be targetable, the extent of the benefits of this targeting are not yet known.

“It remains to be seen whether HRI inhibition in SCD patients would elevate HbF levels sufficiently to improve outcomes,” the researchers wrote. “HRI inhibition elevated HbF levels to a point at which it reduced cell sickling in culture, suggesting that pharmacologic HRI inhibitors may provide clinical benefit in SCD patients. Moreover, in light of our results, combining HRI inhibition with an additional pharmacologic HbF inducer may improve the therapeutic index. "Funding was provided by NIH training grants and Cold Spring Harbor Laboratory. Three of the authors reported that they are inventors on a patent submitted by the Children’s Hospital of Philadelphia that covers the therapeutic targeting of HRI for hemoglobinopathies.

SOURCE: Grevet J et al. Science. 2018 Jul 20. doi: 10.1126/science.aao0932.
 

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Melanoma survival shorter in those given high dose glucocorticoids for ipilimumab-induced hypophysitis

Possible risks of overtreating a side effect
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Melanoma patients who took high doses of glucocorticoids for hypophysitis induced by the checkpoint-inhibitor ipilimumab had a lower overall survival time and a shorter time to treatment failure than did patients taking low-dose steroids for the adverse event, according to a new retrospective analysis in Cancer.

“Treatment with high-dose glucocorticoids does not appear to confer any obvious advantage to patients with IH (ipilimumab-induced hypophysitis) and may negatively affect tumor response to CPI (checkpoint-inhibitor therapy),” wrote Alexander Faje, MD, a neuroendocrinologist at Massachusetts General Hospital, Boston. “We recommend against the routine use of higher doses in these patients and that such treatment should be reserved for clinical indications like visual compromise or perhaps for intractable headache.”

Hypophysitis after treatment with a CTLA-4 inhibitor, such as ipilimumab, can approach 12%, though it is much less common with the checkpoint inhibitors that target PD-1 and PD-L1. Past studies examining the effects of glucocorticoids for immune-related adverse events have compared patients with severe events to those with minimal or no events. Since emergence of hypophysitis correlates with better overall survival, this is a flawed approach, the researchers said.

For their study, the researchers compared groups of patients with the same immune-related adverse events who received treatment with varying amounts of glucocorticoids.

They reviewed outcomes for 64 melanoma patients who had received ipilimumab monotherapy and were diagnosed with ipilimumab-induced hypophysitis treated in the Partners Healthcare system. Fourteen patients had received low-dose glucocorticoids, defined as a maximum average daily dose of 7.5 mg of prednisone or the equivalent. Fifty patients received high-dose glucocorticoids, defined as anything above that amount.

Overall survival and time to treatment failure were significantly higher in the low-dose group than the high-dose group (P = .002 for OS and P = .001 for TTF). Median overall survival was 23.3 months and time to treatment failure was 11.4 months in those given high-dose steroids. Median overall survival had not been reached in those given low-dose steroids.

While the findings are preliminary, the authors noted they may have implications for managing other immune-related adverse events. “Although the use of lower doses of immunosuppressive medications may be less of an option in many circumstances for other (immune-related adverse events), therapeutic parsimony would seem desirable with more tailored regimens as the biologic mechanisms underpinning these processes are further elucidated.”

SOURCE: Faje AT et al. Cancer. 2018 Jul 5.

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The study results provide further evidence that hypophysitis appears to be an adverse effect of ipilimumab therapy that is linked with improved outcomes in melanoma. As hypophysitis tends to be self-limited, it can be treated safely with replacement therapy rather than high-dose steroid therapy, which was associated with reduced overall survival.

But the low number of patients on low-dose glucocorticoids – just 14 – is a limitation of the study and the group’s favorable outcomes could have been due to chance alone. Further, the 7.5-mg cut-off for high- vs. low-dose steroid therapy is somewhat arbitrary.

In support of the study’s overall conclusions, however, exploratory analyses have produced similar findings at somewhat higher cut-offs.

As the mechanism of hypophysitis is somewhat distinct compared with other immune-checkpoint toxicities, it might not be appropriate to generalize these findings to other toxic responses to these drugs.

The mechanisms of toxicities related to immune-checkpoint inhibitors are still not well defined. Unraveling those mechanisms may identify patients at high risk and hold the potential for aiding in the design of novel therapeutics that unleash antitumor immunity. Glucocorticoids are a fairly effective treatment for immune-related toxicities but remain a blunt, nonspecific way to suppress aberrant immunity. Designing inhibitors of culprit cellular populations or cytokines may combat toxicity without compromising the efficacy of immune therapy or promoting systemic immunosuppression.
 

Douglas B. Johnson, MD, is with Vanderbilt University Medical Center and Vanderbilt Ingram Cancer Center, Nashville, Tenn. He made his remarks in an editorial (Cancer 2018 Jul 5. doi: 10.1002/cncr.31627.

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The study results provide further evidence that hypophysitis appears to be an adverse effect of ipilimumab therapy that is linked with improved outcomes in melanoma. As hypophysitis tends to be self-limited, it can be treated safely with replacement therapy rather than high-dose steroid therapy, which was associated with reduced overall survival.

But the low number of patients on low-dose glucocorticoids – just 14 – is a limitation of the study and the group’s favorable outcomes could have been due to chance alone. Further, the 7.5-mg cut-off for high- vs. low-dose steroid therapy is somewhat arbitrary.

In support of the study’s overall conclusions, however, exploratory analyses have produced similar findings at somewhat higher cut-offs.

As the mechanism of hypophysitis is somewhat distinct compared with other immune-checkpoint toxicities, it might not be appropriate to generalize these findings to other toxic responses to these drugs.

The mechanisms of toxicities related to immune-checkpoint inhibitors are still not well defined. Unraveling those mechanisms may identify patients at high risk and hold the potential for aiding in the design of novel therapeutics that unleash antitumor immunity. Glucocorticoids are a fairly effective treatment for immune-related toxicities but remain a blunt, nonspecific way to suppress aberrant immunity. Designing inhibitors of culprit cellular populations or cytokines may combat toxicity without compromising the efficacy of immune therapy or promoting systemic immunosuppression.
 

Douglas B. Johnson, MD, is with Vanderbilt University Medical Center and Vanderbilt Ingram Cancer Center, Nashville, Tenn. He made his remarks in an editorial (Cancer 2018 Jul 5. doi: 10.1002/cncr.31627.

Body

 

The study results provide further evidence that hypophysitis appears to be an adverse effect of ipilimumab therapy that is linked with improved outcomes in melanoma. As hypophysitis tends to be self-limited, it can be treated safely with replacement therapy rather than high-dose steroid therapy, which was associated with reduced overall survival.

But the low number of patients on low-dose glucocorticoids – just 14 – is a limitation of the study and the group’s favorable outcomes could have been due to chance alone. Further, the 7.5-mg cut-off for high- vs. low-dose steroid therapy is somewhat arbitrary.

In support of the study’s overall conclusions, however, exploratory analyses have produced similar findings at somewhat higher cut-offs.

As the mechanism of hypophysitis is somewhat distinct compared with other immune-checkpoint toxicities, it might not be appropriate to generalize these findings to other toxic responses to these drugs.

The mechanisms of toxicities related to immune-checkpoint inhibitors are still not well defined. Unraveling those mechanisms may identify patients at high risk and hold the potential for aiding in the design of novel therapeutics that unleash antitumor immunity. Glucocorticoids are a fairly effective treatment for immune-related toxicities but remain a blunt, nonspecific way to suppress aberrant immunity. Designing inhibitors of culprit cellular populations or cytokines may combat toxicity without compromising the efficacy of immune therapy or promoting systemic immunosuppression.
 

Douglas B. Johnson, MD, is with Vanderbilt University Medical Center and Vanderbilt Ingram Cancer Center, Nashville, Tenn. He made his remarks in an editorial (Cancer 2018 Jul 5. doi: 10.1002/cncr.31627.

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Possible risks of overtreating a side effect
Possible risks of overtreating a side effect

 

Melanoma patients who took high doses of glucocorticoids for hypophysitis induced by the checkpoint-inhibitor ipilimumab had a lower overall survival time and a shorter time to treatment failure than did patients taking low-dose steroids for the adverse event, according to a new retrospective analysis in Cancer.

“Treatment with high-dose glucocorticoids does not appear to confer any obvious advantage to patients with IH (ipilimumab-induced hypophysitis) and may negatively affect tumor response to CPI (checkpoint-inhibitor therapy),” wrote Alexander Faje, MD, a neuroendocrinologist at Massachusetts General Hospital, Boston. “We recommend against the routine use of higher doses in these patients and that such treatment should be reserved for clinical indications like visual compromise or perhaps for intractable headache.”

Hypophysitis after treatment with a CTLA-4 inhibitor, such as ipilimumab, can approach 12%, though it is much less common with the checkpoint inhibitors that target PD-1 and PD-L1. Past studies examining the effects of glucocorticoids for immune-related adverse events have compared patients with severe events to those with minimal or no events. Since emergence of hypophysitis correlates with better overall survival, this is a flawed approach, the researchers said.

For their study, the researchers compared groups of patients with the same immune-related adverse events who received treatment with varying amounts of glucocorticoids.

They reviewed outcomes for 64 melanoma patients who had received ipilimumab monotherapy and were diagnosed with ipilimumab-induced hypophysitis treated in the Partners Healthcare system. Fourteen patients had received low-dose glucocorticoids, defined as a maximum average daily dose of 7.5 mg of prednisone or the equivalent. Fifty patients received high-dose glucocorticoids, defined as anything above that amount.

Overall survival and time to treatment failure were significantly higher in the low-dose group than the high-dose group (P = .002 for OS and P = .001 for TTF). Median overall survival was 23.3 months and time to treatment failure was 11.4 months in those given high-dose steroids. Median overall survival had not been reached in those given low-dose steroids.

While the findings are preliminary, the authors noted they may have implications for managing other immune-related adverse events. “Although the use of lower doses of immunosuppressive medications may be less of an option in many circumstances for other (immune-related adverse events), therapeutic parsimony would seem desirable with more tailored regimens as the biologic mechanisms underpinning these processes are further elucidated.”

SOURCE: Faje AT et al. Cancer. 2018 Jul 5.

 

Melanoma patients who took high doses of glucocorticoids for hypophysitis induced by the checkpoint-inhibitor ipilimumab had a lower overall survival time and a shorter time to treatment failure than did patients taking low-dose steroids for the adverse event, according to a new retrospective analysis in Cancer.

“Treatment with high-dose glucocorticoids does not appear to confer any obvious advantage to patients with IH (ipilimumab-induced hypophysitis) and may negatively affect tumor response to CPI (checkpoint-inhibitor therapy),” wrote Alexander Faje, MD, a neuroendocrinologist at Massachusetts General Hospital, Boston. “We recommend against the routine use of higher doses in these patients and that such treatment should be reserved for clinical indications like visual compromise or perhaps for intractable headache.”

Hypophysitis after treatment with a CTLA-4 inhibitor, such as ipilimumab, can approach 12%, though it is much less common with the checkpoint inhibitors that target PD-1 and PD-L1. Past studies examining the effects of glucocorticoids for immune-related adverse events have compared patients with severe events to those with minimal or no events. Since emergence of hypophysitis correlates with better overall survival, this is a flawed approach, the researchers said.

For their study, the researchers compared groups of patients with the same immune-related adverse events who received treatment with varying amounts of glucocorticoids.

They reviewed outcomes for 64 melanoma patients who had received ipilimumab monotherapy and were diagnosed with ipilimumab-induced hypophysitis treated in the Partners Healthcare system. Fourteen patients had received low-dose glucocorticoids, defined as a maximum average daily dose of 7.5 mg of prednisone or the equivalent. Fifty patients received high-dose glucocorticoids, defined as anything above that amount.

Overall survival and time to treatment failure were significantly higher in the low-dose group than the high-dose group (P = .002 for OS and P = .001 for TTF). Median overall survival was 23.3 months and time to treatment failure was 11.4 months in those given high-dose steroids. Median overall survival had not been reached in those given low-dose steroids.

While the findings are preliminary, the authors noted they may have implications for managing other immune-related adverse events. “Although the use of lower doses of immunosuppressive medications may be less of an option in many circumstances for other (immune-related adverse events), therapeutic parsimony would seem desirable with more tailored regimens as the biologic mechanisms underpinning these processes are further elucidated.”

SOURCE: Faje AT et al. Cancer. 2018 Jul 5.

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Key clinical point: Significantly lower overall survival and shorter time to treatment failure was seen in melanoma patients taking higher doses of glucocorticoids for ipilimumab-induced hypophysitis than in those taking lower doses.

Major finding: Median overall survival was 23.3 months and time to treatment failure was 11.4 months in those given high-dose steroids. Median overall survival had not been reached in those given low-dose steroids.

Study details: A retrospective review of 64 melanoma patients on single-agent ipilimumab therapy who were given glucocorticoids for ipilimumab-induced hypophysitis.

Disclosures: No funding source disclosed. The authors made no disclosures related to the submitted work.

Source: Faje AT et al. Cancer 2018 Jul 5.

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