Addiction Medicine

Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Adam B. Hill, MD, is home on a “staycation” this week. Today, he took a 3-hour nap. I know this because I follow Dr. Hill on Twitter, where he has an active feed, a lot of posts, retweets, and more than 20,000 followers.

I also know from Twitter that he is married and has three young children, that he was once suicidal, and has been treated for major depression and alcoholism. As a palliative care doctor, Dr. Hill was required by his state medical board to blow into a breathalyzer several times a day for 5 years – something he felt quite shamed by – and while I’ve never met him, I felt just a little bit proud of this stranger when he was released from the medical board’s oversight.

Dr. Hill’s memoir, “Long Walk Out of the Woods: A Physician’s Story of Addiction, Depression, Hope, and Recovery” (Central Recovery Press, 2019) is the culmination of his efforts to use his difficulties as a way of offering hope and connection to anyone who struggled as he has, or to anyone who has struggled at all. Like his Twitter feed, it is a display of vulnerability and gratitude by someone who has been through dark times then returned to conquer his monsters.

Courtesy Central Recovery Press

He begins by setting the stage for us. “My name is Adam,” he announces in the preface. He tells us his various titles: human being, husband, father, physician, recovering alcoholic, and psychiatric patient. “In the midst of these struggles, working in modern medicine fractured my identity, stole my authenticity, and left me a shell of the person I wanted to be.”

We learn that he tried to buy a gun, but there was a waiting period and he could not purchase the firearm. Instead, he walked into the woods to drink himself to death, with sleeping pills as an add-on – obviously, he didn’t die, and his journey back from his failed suicidal mission is the meat of the book.

Dr. Hill was a quiet and timid child, and he was bullied at school in a way that has lingered on. He struggles with perfectionism and with a sense of never quite belonging. He was a good student, and later a competitive tennis player who was destined for a regional competition until he broke his ankle after drinking just days before the competition. He did well in college, felt more accepted, and went on to medical school after getting in from the wait list. He went on to do a pediatrics residency, and he and his wife moved from Indiana to North Carolina so he could do a hematology oncology fellowship. It was toward the end of his 2-year fellowship when he tried to purchase a gun, then walked into those woods.

His wife called, asked him to come to dinner, and he left the woods before he’d overdosed. After a meeting with his wife, parents, and sister, he returned to psychiatric care, restarted antidepressants, went to Alcoholics Anonymous, and told his employer that he had a problem. This admission started a distressing series of events, including years of being monitored by state medical boards and being labeled an “impaired physician.”

This is the only thing I didn’t like about Dr. Hill’s memoir: As open as he is about his emotional life, there were pieces missing with respect to what actually happened. At this point, I was befuddled as to why he self-reported his difficulties, and it wasn’t until he talked about starting a second fellowship in palliative care in his home state of Indiana that I could fill in some missing pieces. Dr. Hill and his wife purchased a house, and in November, he started his fellowship. The timing was off from the usual start in July, and I realized that perhaps he had gone to an inpatient setting for a number of months – his disclosure to his employer was voluntary, but his treatment likely interfered with his training and couldn’t be hidden. What else transpired he hints at: bottles hidden, driving while intoxicated, a nurse who gave him IV hydration when he came to work with a hangover.

From here, Dr. Hill’s story becomes every doctor’s nightmare. Settled into his new house and weeks into his fellowship, he is called in and fired: His application for a medical license in Indiana has been denied because of his addiction history. He met with a friend of his father’s who worked in a large pediatrics practice. The meeting went well, but the group felt he was too much of a malpractice risk.

He now needs to pay his mortgage and student loans, so he takes a position in Oklahoma with the Indian Health Service. He’s 700 miles from home, living alone in a hotel room, feeling like the work is beneath him, and the chapter is titled “Exile.” His new boss greets him with, “Listen, we all had our own stories that led us here.” Surprisingly, he likes the work and feels supported. If only it weren’t for all that loneliness, and not surprisingly, he relapses despite the mandated breathalyzer. Six beers later, and Dr. Hill is off to Chicago for a rehab program, then back to Oklahoma to finish off his stint.

What happens next is the second time I wondered about the plot of his life: Through “connections and concession,” he returns to Indiana for the palliative care fellowship, and goes on to work at Riley Children’s Hospital.

When a colleague unexpectedly dies from suicide, Dr. Hill tells others that he, too, once entertained suicidal thoughts. The story from here gets better and better: He uses his history of addiction and depression to help others – patients, their parents, and other medical professionals – to conquer their shame, to share their stories, to feel less alone. He and his wife become parents, he remains sober and healthy, and therapy leads him to a place of self-discovery and success.

Intertwined with telling his story, Dr. Hill takes on some of the institutional issues surrounding addiction and mental illness. He feels shamed and punished by the state medical board that mandates the terms of his medical license. Any physician who reads this book will think twice about revealing a diagnosis of depression or substance use disorder. It’s not a new idea that to protect the public, medical boards should ask about current impairments, not a past history or conditions that have been successfully treated. They should encourage treatment, not punish those who seek care.

Dr. Hill writes about how helpful it has been to allow himself to be vulnerable in the aftermath:


In my experience, the more vulnerability I show, the more opportunities I have to connect to other people. I learned the hard way that when I hide my true self from others, I spiral toward shame. Conversely, when I bury my shame, I begin to accept myself as a beautifully flawed human being, and my perspective on the world reflects that. A turn of the vulnerability dial has opened up connections to other people, while turning away pity, judgment, fear, and shame. Meanwhile, when I am to create spaces for vulnerability, permission is granted to have open and honest conversations about mental health conditions on a larger scale. But I would never have learned these lessons without having been humbled by this disease.


Perhaps the thing I liked best about Dr. Hill’s memoir is that he proposes some solutions. He talks about the importance of fighting stigma, how he finds it everywhere, and how the medical field equates mental illnesses with weakness, thereby perpetuating a self-deprecating cycle in those who have them.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

The federal government has charged a Florida addiction medicine specialist in what it says was a scheme to defraud Medicare and private insurers, charging them roughly $681 million over about a decade for lab tests, office visits, therapy sessions, and other services that were either unnecessary or never delivered.

The Department of Justice and the Attorney for the Southern District of Florida are prosecuting Michael Ligotti, DO, 46, saying that he preyed on individuals seeking substance abuse treatment. They have yet to issue a formal indictment.

“The substance abuse treatment fraud allegedly perpetrated by the defendant sacrificed the genuine care of vulnerable patients at a time when they urgently needed a trusted health care provider,” U.S. Attorney Ariana Fajardo Orshan, Southern District of Florida, said in a statement.

“Health care providers who allow greed to take precedence over their Hippocratic Oath and participate in these schemes are criminals and will be held accountable for their unscrupulous conduct,” she added.

Dr. Ligotti was charged July 31. The prosecutors were seeking to detain him until trial. However, a judge approved his bond today and he is free on bond, according to Ligotti’s attorney, Ben Curtis.

“As is always the case with any criminal matter, the burden of proof rests entirely with the government,” Mr. Curtis said in an interview.

“In this instance, we do not believe the US Department of Justice’s claims – and that is exactly what they are at this point, just one-sided claims – will reconcile with actual evidence at a future trial,” he said.

Mr. Curtis added that Dr. Ligotti “looks forward to establishing his innocence.”

Unnecessary urine tests

The government alleges that Dr. Ligotti played a central role in a scheme in which Medicare and private insurers paid about $121 million to cover some $680 million in charges from 2011 to 2020.

According to the prosecutors, Dr. Ligotti received a fee for becoming a “purported” medical director of about 50 addiction treatment facilities and sober homes – and that he issued 136 separate standing orders for medically unnecessary urinalysis (UA) tests.

The labs allegedly paid occasional kickbacks to the facilities and homes, and those facilities in turn were required to have their patients treated by Dr. Ligotti’s clinic, Whole Health, which is based in Delray Beach, Fla.

This allowed Dr. Ligotti to “bill hundreds of millions of dollars in additional fraudulent treatments, including unnecessary and expensive UAs, costly blood tests, nonexistent therapy sessions, office visits, and other unnecessary services, regardless of whether such treatment and testing were medically necessary and/or actually provided,” alleges the government.

Dr. Ligotti did not review results or use the results to inform patient treatment, according to the Department of Justice.

Urine tests have been exploited before by addiction treatment clinics as a revenue generator. Kaiser Health News reported in 2017 that a single nurse practitioner at one pain clinic in Tennessee generated $1 million in billings to Medicare for drug-related urine tests in a single year.

Also in 2017, The New York Times reported that a single patient had been billed $260,000 for urine tests by his treatment center.

The federal government alleges that Dr. Ligotti also “billed for psychiatric services and therapy sessions that never happened, and that he and his staff were not qualified to conduct.”

In addition, they assert that Dr. Ligotti improperly prescribed controlled substances, including large quantities of buprenorphine/Suboxone, often exceeding the number of patients he was legally authorized to treat or giving it to patients who did not require the medications.

Dr. Ligotti may not be practicing any longer. His clinic’s website features a message that the practice will be closed as of Aug. 7.
 

This article first appeared on Medscape.com.

The federal government has charged a Florida addiction medicine specialist in what it says was a scheme to defraud Medicare and private insurers, charging them roughly $681 million over about a decade for lab tests, office visits, therapy sessions, and other services that were either unnecessary or never delivered.

The Department of Justice and the Attorney for the Southern District of Florida are prosecuting Michael Ligotti, DO, 46, saying that he preyed on individuals seeking substance abuse treatment. They have yet to issue a formal indictment.

“The substance abuse treatment fraud allegedly perpetrated by the defendant sacrificed the genuine care of vulnerable patients at a time when they urgently needed a trusted health care provider,” U.S. Attorney Ariana Fajardo Orshan, Southern District of Florida, said in a statement.

“Health care providers who allow greed to take precedence over their Hippocratic Oath and participate in these schemes are criminals and will be held accountable for their unscrupulous conduct,” she added.

Dr. Ligotti was charged July 31. The prosecutors were seeking to detain him until trial. However, a judge approved his bond today and he is free on bond, according to Ligotti’s attorney, Ben Curtis.

“As is always the case with any criminal matter, the burden of proof rests entirely with the government,” Mr. Curtis said in an interview.

“In this instance, we do not believe the US Department of Justice’s claims – and that is exactly what they are at this point, just one-sided claims – will reconcile with actual evidence at a future trial,” he said.

Mr. Curtis added that Dr. Ligotti “looks forward to establishing his innocence.”

Unnecessary urine tests

The government alleges that Dr. Ligotti played a central role in a scheme in which Medicare and private insurers paid about $121 million to cover some $680 million in charges from 2011 to 2020.

According to the prosecutors, Dr. Ligotti received a fee for becoming a “purported” medical director of about 50 addiction treatment facilities and sober homes – and that he issued 136 separate standing orders for medically unnecessary urinalysis (UA) tests.

The labs allegedly paid occasional kickbacks to the facilities and homes, and those facilities in turn were required to have their patients treated by Dr. Ligotti’s clinic, Whole Health, which is based in Delray Beach, Fla.

This allowed Dr. Ligotti to “bill hundreds of millions of dollars in additional fraudulent treatments, including unnecessary and expensive UAs, costly blood tests, nonexistent therapy sessions, office visits, and other unnecessary services, regardless of whether such treatment and testing were medically necessary and/or actually provided,” alleges the government.

Dr. Ligotti did not review results or use the results to inform patient treatment, according to the Department of Justice.

Urine tests have been exploited before by addiction treatment clinics as a revenue generator. Kaiser Health News reported in 2017 that a single nurse practitioner at one pain clinic in Tennessee generated $1 million in billings to Medicare for drug-related urine tests in a single year.

Also in 2017, The New York Times reported that a single patient had been billed $260,000 for urine tests by his treatment center.

The federal government alleges that Dr. Ligotti also “billed for psychiatric services and therapy sessions that never happened, and that he and his staff were not qualified to conduct.”

In addition, they assert that Dr. Ligotti improperly prescribed controlled substances, including large quantities of buprenorphine/Suboxone, often exceeding the number of patients he was legally authorized to treat or giving it to patients who did not require the medications.

Dr. Ligotti may not be practicing any longer. His clinic’s website features a message that the practice will be closed as of Aug. 7.
 

This article first appeared on Medscape.com.

The federal government has charged a Florida addiction medicine specialist in what it says was a scheme to defraud Medicare and private insurers, charging them roughly $681 million over about a decade for lab tests, office visits, therapy sessions, and other services that were either unnecessary or never delivered.

The Department of Justice and the Attorney for the Southern District of Florida are prosecuting Michael Ligotti, DO, 46, saying that he preyed on individuals seeking substance abuse treatment. They have yet to issue a formal indictment.

“The substance abuse treatment fraud allegedly perpetrated by the defendant sacrificed the genuine care of vulnerable patients at a time when they urgently needed a trusted health care provider,” U.S. Attorney Ariana Fajardo Orshan, Southern District of Florida, said in a statement.

“Health care providers who allow greed to take precedence over their Hippocratic Oath and participate in these schemes are criminals and will be held accountable for their unscrupulous conduct,” she added.

Dr. Ligotti was charged July 31. The prosecutors were seeking to detain him until trial. However, a judge approved his bond today and he is free on bond, according to Ligotti’s attorney, Ben Curtis.

“As is always the case with any criminal matter, the burden of proof rests entirely with the government,” Mr. Curtis said in an interview.

“In this instance, we do not believe the US Department of Justice’s claims – and that is exactly what they are at this point, just one-sided claims – will reconcile with actual evidence at a future trial,” he said.

Mr. Curtis added that Dr. Ligotti “looks forward to establishing his innocence.”

Unnecessary urine tests

The government alleges that Dr. Ligotti played a central role in a scheme in which Medicare and private insurers paid about $121 million to cover some $680 million in charges from 2011 to 2020.

According to the prosecutors, Dr. Ligotti received a fee for becoming a “purported” medical director of about 50 addiction treatment facilities and sober homes – and that he issued 136 separate standing orders for medically unnecessary urinalysis (UA) tests.

The labs allegedly paid occasional kickbacks to the facilities and homes, and those facilities in turn were required to have their patients treated by Dr. Ligotti’s clinic, Whole Health, which is based in Delray Beach, Fla.

This allowed Dr. Ligotti to “bill hundreds of millions of dollars in additional fraudulent treatments, including unnecessary and expensive UAs, costly blood tests, nonexistent therapy sessions, office visits, and other unnecessary services, regardless of whether such treatment and testing were medically necessary and/or actually provided,” alleges the government.

Dr. Ligotti did not review results or use the results to inform patient treatment, according to the Department of Justice.

Urine tests have been exploited before by addiction treatment clinics as a revenue generator. Kaiser Health News reported in 2017 that a single nurse practitioner at one pain clinic in Tennessee generated $1 million in billings to Medicare for drug-related urine tests in a single year.

Also in 2017, The New York Times reported that a single patient had been billed $260,000 for urine tests by his treatment center.

The federal government alleges that Dr. Ligotti also “billed for psychiatric services and therapy sessions that never happened, and that he and his staff were not qualified to conduct.”

In addition, they assert that Dr. Ligotti improperly prescribed controlled substances, including large quantities of buprenorphine/Suboxone, often exceeding the number of patients he was legally authorized to treat or giving it to patients who did not require the medications.

Dr. Ligotti may not be practicing any longer. His clinic’s website features a message that the practice will be closed as of Aug. 7.
 

This article first appeared on Medscape.com.

Ms. L, age 37, presents to psychiatric emergency services with command auditory hallucinations, ideas of reference, and suicidal ideation.

Ms. L has a 22-year history of schizophrenia. Additionally, she has a history of cocaine use disorder (in remission for 12 years), cannabis use disorder (in remission for 6 months), type 2 diabetes mellitus, and hypertension. Her psychotic symptoms are well controlled on a regimen of clozapine, 700 mg/d, and paliperidone palmitate, 156 mg/month. Ms. L says she has been adherent to these medications, and this is confirmed by the assertive community treatment (ACT) team member who administers the medications at Ms. L’s home each day.

On interview, Ms. L reports smoking cannabis each day for the past month and using $400 worth of cocaine over 2 days. She is experiencing intense guilt over these relapses and is admitted to the inpatient adult psychiatry unit. On admission, Ms. L’s clozapine and norclozapine trough levels (drawn approximately 12 hours after last administration documented by the ACT member) are 300 and 275 ng/mL, respectively. Generally, clozapine levels >350 to 420 ng/mL are considered therapeutic, and a clozapine-to-norclozapine ratio of 2:1 is desirable for maximum efficacy and tolerability. Because Ms. L’s clozapine level is <350 and her ratio is approximately 1:1, her clozapine treatment is subtherapeutic.

Because Ms. L has a history of documented adherence to and benefit from her current medication regimen, no changes are made during her 3-week hospital stay. She notices a gradual reduction in auditory hallucinations, no longer wants to harm herself, and is motivated to regain sobriety.

At the time of discharge, Ms. L’s clozapine and norclozapine trough levels are 550 and 250 ng/mL, respectively, which indicates a more favorable clozapine-to-norclozapine ratio of approximately 2:1 and a clozapine level greater than the recommended minimum threshold of 350 ng/mL. While cocaine ingestion presumably played a role in her acute decompensation, the treatment team determined that Ms. L’s relapse to cannabis use likely contributed to low clozapine levels by induction of cytochrome P450 (CYP) 1A2, and subsequently led to the delayed recovery of symptom control.¹

The use of illicit substances is a widespread, growing problem. According to the 2017 National Survey on Drug Use and Health, 11.5% of Americans age ≥12 had used an illicit substance (ie, use of marijuana, cocaine, heroin, hallucinogens, inhalants, or methamphetamine, or misuse of prescription psychotherapeutics) in the past month.² While illicit substance use is of particular public health interest due to a known increase in mortality and health care spending, there has been little discussion of the impact of illicit drug use on concurrent pharmacologic therapy. Just as prescription medications have pharmacokinetic drug–drug interactions with each other, so do illicit substances, though far less is known about their impact on the treatment of medical conditions.

Pharmacokinetic interactions

Key pharmacokinetic interactions have been reported with cocaine, marijuana, amphetamines, and opioids. The Table^1-8 summarizes the metabolism of illicit substances.

Continue to: Cocaine

Cocaine is largely metabolized by serum esterases such as pseudocholinesterase, human carboxylesterase-1 (hCE-1), and human carboxylesterase-2 (hCE-2), to inactive metabolites benzoylecgonine (35% to 45%) and ecgonine (32% to 49%).² However, a smaller portion (2.6% to 6.2%) undergoes hepatic N-demethylation by CYP3A4 to norcocaine.³ Norcocaine is an active metabolite responsible for some of the toxic effects of cocaine (eg, hepatotoxicity).^4,5 Several commonly prescribed medications are known inducers of CYP3A4 (eg, phenytoin, carbamazepine) and may lead to increased levels of the toxic metabolite when used concurrently with cocaine. Additionally, the use of cocaine with acetylcholinesterase inhibitors, such as donepezil, may lead to reduction of serum esterases and shunt cocaine metabolism toward the hepatic pathway, thus increasing norcocaine formation.³

Cannabis. The metabolism and drug–drug interactions of cannabis can be separated by its 2 main components: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A review conducted in 2014 concluded that THC is primarily metabolized by CYP2C9 and 3A4, while CBD is metabolized by CYP2C19 and 3A4.⁶ Oral administration of ketoconazole, a CYP3A4 inhibitor, along with cannabis extract has been shown to increase the maximum concentration (Cmax) and area under the curve (AUC) of THC by 1.2- and 1.8-fold, respectively, while increasing both Cmaxand AUC of CBD by 2-fold.⁶ In addition, CYP2C9 poor metabolizers have been shown to experience significant increases in THC exposure and reductions in metabolite formation, further supporting the role of CYP enzymes in cannabis metabolism.⁶

There is also evidence of enzyme induction by cannabis. Individuals who reported smoking marijuana experienced greater clearance of theophylline, a substrate of CYP1A2, than did those who reported not smoking marijuana.^1,6 As with cigarette smoking, this effect appears to be a direct result of the hydrocarbons found in marijuana smoke rather than the cannabis itself, as there is a lack of evidence for enzyme induction when the drug is orally ingested.⁶

Amphetamine and methamphetamine appear to be both substrates and competitive inhibitors of CYP2D6.⁷ Rats administered quinidine (a strong 2D6 inhibitor) had 2-fold elevations in AUC and decreased clearance of amphetamine and its metabolites.⁸ Amphetamine-related recreational drugs, such as 3,4-methylenedioxy-methamphetamine (MDMA) and 3,4-methylenedioxyamphetamine (MDA), are substrates of CYP2D6 and CYP3A4, while MDMA also undergoes substantial metabolism by CYP1A2.^3,7,9

Opioids. Heroin is metabolized to 6‑monoacetylmorphine (6-MAM) and morphine by hCE-1, hCE-2, and pseudocholinesterase, and has minimal impact on CYP enzymes. However, while morphine is primarily metabolized to inactive metabolites by UGT2B7, it does undergo minor metabolism through CYP3A4 and 2C8 pathways, creating potential for drug interactions with medications that inhibit or induce CYP3A4.¹⁰

Continue to: An underappreciated risk of illicit substance use

 

 

An underappreciated risk of illicit substance use

There is a paucity of evidence regarding the metabolism and pharmacokinetic interactions with illicit substances, and further research is needed. Despite the absence of comprehensive data on the subject, the available information indicates the use of illicit substances may have a significant impact on medications used to treat comorbid conditions. Alternatively, those medications may affect the kinetics of recreationally used substances. The risk of adverse consequences of drug–drug interactions is yet another reason patients should be encouraged to avoid use of substances and seek treatment for substance use disorders. When determining the most appropriate therapy for comorbid conditions for patients who are using illicit substances and are likely to continue to do so, clinicians should take into consideration potential interactions among prescription medications and the specific illicit substances the patient uses.

Related Resources

• Lindsey W, Stewart D, Childress D. Drug interactions between common illicit drugs and prescription therapies. Am J Drug Alcohol Abuse. 2012;38(4):334-343.
• Maurer H, Sauer C, Theobald D. Toxicokinetics of drugs of abuse: current knowledge of the isoenzymes involved in the human metabolism of tetrahydrocannabinol, cocaine, heroin, morphine, and codeine. Ther Drug Monit. 2006;28(3):447-453.
• Dean A. Illicit drugs and drug interactions. Pharmacist. 2006;25(9):684-689.

Drug Brand Names

Carbamazepine • Carbatrol, Tegretol
Clozapine • Clozaril
Donepezil • Aricept
Ketoconazole • Nizoral
Paliperidone palmitate • Invega sustenna
Phenytoin • Dilantin, Phenytek
Quinidine • Cardioquin, Duraquin
Theophylline • Elixophylline, Theochron

Ms. L, age 37, presents to psychiatric emergency services with command auditory hallucinations, ideas of reference, and suicidal ideation.

Ms. L has a 22-year history of schizophrenia. Additionally, she has a history of cocaine use disorder (in remission for 12 years), cannabis use disorder (in remission for 6 months), type 2 diabetes mellitus, and hypertension. Her psychotic symptoms are well controlled on a regimen of clozapine, 700 mg/d, and paliperidone palmitate, 156 mg/month. Ms. L says she has been adherent to these medications, and this is confirmed by the assertive community treatment (ACT) team member who administers the medications at Ms. L’s home each day.

On interview, Ms. L reports smoking cannabis each day for the past month and using $400 worth of cocaine over 2 days. She is experiencing intense guilt over these relapses and is admitted to the inpatient adult psychiatry unit. On admission, Ms. L’s clozapine and norclozapine trough levels (drawn approximately 12 hours after last administration documented by the ACT member) are 300 and 275 ng/mL, respectively. Generally, clozapine levels >350 to 420 ng/mL are considered therapeutic, and a clozapine-to-norclozapine ratio of 2:1 is desirable for maximum efficacy and tolerability. Because Ms. L’s clozapine level is <350 and her ratio is approximately 1:1, her clozapine treatment is subtherapeutic.

Because Ms. L has a history of documented adherence to and benefit from her current medication regimen, no changes are made during her 3-week hospital stay. She notices a gradual reduction in auditory hallucinations, no longer wants to harm herself, and is motivated to regain sobriety.

At the time of discharge, Ms. L’s clozapine and norclozapine trough levels are 550 and 250 ng/mL, respectively, which indicates a more favorable clozapine-to-norclozapine ratio of approximately 2:1 and a clozapine level greater than the recommended minimum threshold of 350 ng/mL. While cocaine ingestion presumably played a role in her acute decompensation, the treatment team determined that Ms. L’s relapse to cannabis use likely contributed to low clozapine levels by induction of cytochrome P450 (CYP) 1A2, and subsequently led to the delayed recovery of symptom control.¹

The use of illicit substances is a widespread, growing problem. According to the 2017 National Survey on Drug Use and Health, 11.5% of Americans age ≥12 had used an illicit substance (ie, use of marijuana, cocaine, heroin, hallucinogens, inhalants, or methamphetamine, or misuse of prescription psychotherapeutics) in the past month.² While illicit substance use is of particular public health interest due to a known increase in mortality and health care spending, there has been little discussion of the impact of illicit drug use on concurrent pharmacologic therapy. Just as prescription medications have pharmacokinetic drug–drug interactions with each other, so do illicit substances, though far less is known about their impact on the treatment of medical conditions.

Pharmacokinetic interactions

Key pharmacokinetic interactions have been reported with cocaine, marijuana, amphetamines, and opioids. The Table^1-8 summarizes the metabolism of illicit substances.

Continue to: Cocaine

Cocaine is largely metabolized by serum esterases such as pseudocholinesterase, human carboxylesterase-1 (hCE-1), and human carboxylesterase-2 (hCE-2), to inactive metabolites benzoylecgonine (35% to 45%) and ecgonine (32% to 49%).² However, a smaller portion (2.6% to 6.2%) undergoes hepatic N-demethylation by CYP3A4 to norcocaine.³ Norcocaine is an active metabolite responsible for some of the toxic effects of cocaine (eg, hepatotoxicity).^4,5 Several commonly prescribed medications are known inducers of CYP3A4 (eg, phenytoin, carbamazepine) and may lead to increased levels of the toxic metabolite when used concurrently with cocaine. Additionally, the use of cocaine with acetylcholinesterase inhibitors, such as donepezil, may lead to reduction of serum esterases and shunt cocaine metabolism toward the hepatic pathway, thus increasing norcocaine formation.³

Cannabis. The metabolism and drug–drug interactions of cannabis can be separated by its 2 main components: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A review conducted in 2014 concluded that THC is primarily metabolized by CYP2C9 and 3A4, while CBD is metabolized by CYP2C19 and 3A4.⁶ Oral administration of ketoconazole, a CYP3A4 inhibitor, along with cannabis extract has been shown to increase the maximum concentration (Cmax) and area under the curve (AUC) of THC by 1.2- and 1.8-fold, respectively, while increasing both Cmaxand AUC of CBD by 2-fold.⁶ In addition, CYP2C9 poor metabolizers have been shown to experience significant increases in THC exposure and reductions in metabolite formation, further supporting the role of CYP enzymes in cannabis metabolism.⁶

There is also evidence of enzyme induction by cannabis. Individuals who reported smoking marijuana experienced greater clearance of theophylline, a substrate of CYP1A2, than did those who reported not smoking marijuana.^1,6 As with cigarette smoking, this effect appears to be a direct result of the hydrocarbons found in marijuana smoke rather than the cannabis itself, as there is a lack of evidence for enzyme induction when the drug is orally ingested.⁶

Amphetamine and methamphetamine appear to be both substrates and competitive inhibitors of CYP2D6.⁷ Rats administered quinidine (a strong 2D6 inhibitor) had 2-fold elevations in AUC and decreased clearance of amphetamine and its metabolites.⁸ Amphetamine-related recreational drugs, such as 3,4-methylenedioxy-methamphetamine (MDMA) and 3,4-methylenedioxyamphetamine (MDA), are substrates of CYP2D6 and CYP3A4, while MDMA also undergoes substantial metabolism by CYP1A2.^3,7,9

Opioids. Heroin is metabolized to 6‑monoacetylmorphine (6-MAM) and morphine by hCE-1, hCE-2, and pseudocholinesterase, and has minimal impact on CYP enzymes. However, while morphine is primarily metabolized to inactive metabolites by UGT2B7, it does undergo minor metabolism through CYP3A4 and 2C8 pathways, creating potential for drug interactions with medications that inhibit or induce CYP3A4.¹⁰

Continue to: An underappreciated risk of illicit substance use

 

 

An underappreciated risk of illicit substance use

There is a paucity of evidence regarding the metabolism and pharmacokinetic interactions with illicit substances, and further research is needed. Despite the absence of comprehensive data on the subject, the available information indicates the use of illicit substances may have a significant impact on medications used to treat comorbid conditions. Alternatively, those medications may affect the kinetics of recreationally used substances. The risk of adverse consequences of drug–drug interactions is yet another reason patients should be encouraged to avoid use of substances and seek treatment for substance use disorders. When determining the most appropriate therapy for comorbid conditions for patients who are using illicit substances and are likely to continue to do so, clinicians should take into consideration potential interactions among prescription medications and the specific illicit substances the patient uses.

Related Resources

• Lindsey W, Stewart D, Childress D. Drug interactions between common illicit drugs and prescription therapies. Am J Drug Alcohol Abuse. 2012;38(4):334-343.
• Maurer H, Sauer C, Theobald D. Toxicokinetics of drugs of abuse: current knowledge of the isoenzymes involved in the human metabolism of tetrahydrocannabinol, cocaine, heroin, morphine, and codeine. Ther Drug Monit. 2006;28(3):447-453.
• Dean A. Illicit drugs and drug interactions. Pharmacist. 2006;25(9):684-689.

Drug Brand Names

Carbamazepine • Carbatrol, Tegretol
Clozapine • Clozaril
Donepezil • Aricept
Ketoconazole • Nizoral
Paliperidone palmitate • Invega sustenna
Phenytoin • Dilantin, Phenytek
Quinidine • Cardioquin, Duraquin
Theophylline • Elixophylline, Theochron

Ms. L, age 37, presents to psychiatric emergency services with command auditory hallucinations, ideas of reference, and suicidal ideation.

Ms. L has a 22-year history of schizophrenia. Additionally, she has a history of cocaine use disorder (in remission for 12 years), cannabis use disorder (in remission for 6 months), type 2 diabetes mellitus, and hypertension. Her psychotic symptoms are well controlled on a regimen of clozapine, 700 mg/d, and paliperidone palmitate, 156 mg/month. Ms. L says she has been adherent to these medications, and this is confirmed by the assertive community treatment (ACT) team member who administers the medications at Ms. L’s home each day.

On interview, Ms. L reports smoking cannabis each day for the past month and using $400 worth of cocaine over 2 days. She is experiencing intense guilt over these relapses and is admitted to the inpatient adult psychiatry unit. On admission, Ms. L’s clozapine and norclozapine trough levels (drawn approximately 12 hours after last administration documented by the ACT member) are 300 and 275 ng/mL, respectively. Generally, clozapine levels >350 to 420 ng/mL are considered therapeutic, and a clozapine-to-norclozapine ratio of 2:1 is desirable for maximum efficacy and tolerability. Because Ms. L’s clozapine level is <350 and her ratio is approximately 1:1, her clozapine treatment is subtherapeutic.

Because Ms. L has a history of documented adherence to and benefit from her current medication regimen, no changes are made during her 3-week hospital stay. She notices a gradual reduction in auditory hallucinations, no longer wants to harm herself, and is motivated to regain sobriety.

At the time of discharge, Ms. L’s clozapine and norclozapine trough levels are 550 and 250 ng/mL, respectively, which indicates a more favorable clozapine-to-norclozapine ratio of approximately 2:1 and a clozapine level greater than the recommended minimum threshold of 350 ng/mL. While cocaine ingestion presumably played a role in her acute decompensation, the treatment team determined that Ms. L’s relapse to cannabis use likely contributed to low clozapine levels by induction of cytochrome P450 (CYP) 1A2, and subsequently led to the delayed recovery of symptom control.¹

The use of illicit substances is a widespread, growing problem. According to the 2017 National Survey on Drug Use and Health, 11.5% of Americans age ≥12 had used an illicit substance (ie, use of marijuana, cocaine, heroin, hallucinogens, inhalants, or methamphetamine, or misuse of prescription psychotherapeutics) in the past month.² While illicit substance use is of particular public health interest due to a known increase in mortality and health care spending, there has been little discussion of the impact of illicit drug use on concurrent pharmacologic therapy. Just as prescription medications have pharmacokinetic drug–drug interactions with each other, so do illicit substances, though far less is known about their impact on the treatment of medical conditions.

Pharmacokinetic interactions

Key pharmacokinetic interactions have been reported with cocaine, marijuana, amphetamines, and opioids. The Table^1-8 summarizes the metabolism of illicit substances.

Continue to: Cocaine

Cocaine is largely metabolized by serum esterases such as pseudocholinesterase, human carboxylesterase-1 (hCE-1), and human carboxylesterase-2 (hCE-2), to inactive metabolites benzoylecgonine (35% to 45%) and ecgonine (32% to 49%).² However, a smaller portion (2.6% to 6.2%) undergoes hepatic N-demethylation by CYP3A4 to norcocaine.³ Norcocaine is an active metabolite responsible for some of the toxic effects of cocaine (eg, hepatotoxicity).^4,5 Several commonly prescribed medications are known inducers of CYP3A4 (eg, phenytoin, carbamazepine) and may lead to increased levels of the toxic metabolite when used concurrently with cocaine. Additionally, the use of cocaine with acetylcholinesterase inhibitors, such as donepezil, may lead to reduction of serum esterases and shunt cocaine metabolism toward the hepatic pathway, thus increasing norcocaine formation.³

Cannabis. The metabolism and drug–drug interactions of cannabis can be separated by its 2 main components: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A review conducted in 2014 concluded that THC is primarily metabolized by CYP2C9 and 3A4, while CBD is metabolized by CYP2C19 and 3A4.⁶ Oral administration of ketoconazole, a CYP3A4 inhibitor, along with cannabis extract has been shown to increase the maximum concentration (Cmax) and area under the curve (AUC) of THC by 1.2- and 1.8-fold, respectively, while increasing both Cmaxand AUC of CBD by 2-fold.⁶ In addition, CYP2C9 poor metabolizers have been shown to experience significant increases in THC exposure and reductions in metabolite formation, further supporting the role of CYP enzymes in cannabis metabolism.⁶

There is also evidence of enzyme induction by cannabis. Individuals who reported smoking marijuana experienced greater clearance of theophylline, a substrate of CYP1A2, than did those who reported not smoking marijuana.^1,6 As with cigarette smoking, this effect appears to be a direct result of the hydrocarbons found in marijuana smoke rather than the cannabis itself, as there is a lack of evidence for enzyme induction when the drug is orally ingested.⁶

Amphetamine and methamphetamine appear to be both substrates and competitive inhibitors of CYP2D6.⁷ Rats administered quinidine (a strong 2D6 inhibitor) had 2-fold elevations in AUC and decreased clearance of amphetamine and its metabolites.⁸ Amphetamine-related recreational drugs, such as 3,4-methylenedioxy-methamphetamine (MDMA) and 3,4-methylenedioxyamphetamine (MDA), are substrates of CYP2D6 and CYP3A4, while MDMA also undergoes substantial metabolism by CYP1A2.^3,7,9

Opioids. Heroin is metabolized to 6‑monoacetylmorphine (6-MAM) and morphine by hCE-1, hCE-2, and pseudocholinesterase, and has minimal impact on CYP enzymes. However, while morphine is primarily metabolized to inactive metabolites by UGT2B7, it does undergo minor metabolism through CYP3A4 and 2C8 pathways, creating potential for drug interactions with medications that inhibit or induce CYP3A4.¹⁰

Continue to: An underappreciated risk of illicit substance use

 

 

An underappreciated risk of illicit substance use

There is a paucity of evidence regarding the metabolism and pharmacokinetic interactions with illicit substances, and further research is needed. Despite the absence of comprehensive data on the subject, the available information indicates the use of illicit substances may have a significant impact on medications used to treat comorbid conditions. Alternatively, those medications may affect the kinetics of recreationally used substances. The risk of adverse consequences of drug–drug interactions is yet another reason patients should be encouraged to avoid use of substances and seek treatment for substance use disorders. When determining the most appropriate therapy for comorbid conditions for patients who are using illicit substances and are likely to continue to do so, clinicians should take into consideration potential interactions among prescription medications and the specific illicit substances the patient uses.

Related Resources

• Lindsey W, Stewart D, Childress D. Drug interactions between common illicit drugs and prescription therapies. Am J Drug Alcohol Abuse. 2012;38(4):334-343.
• Maurer H, Sauer C, Theobald D. Toxicokinetics of drugs of abuse: current knowledge of the isoenzymes involved in the human metabolism of tetrahydrocannabinol, cocaine, heroin, morphine, and codeine. Ther Drug Monit. 2006;28(3):447-453.
• Dean A. Illicit drugs and drug interactions. Pharmacist. 2006;25(9):684-689.

Drug Brand Names

Carbamazepine • Carbatrol, Tegretol
Clozapine • Clozaril
Donepezil • Aricept
Ketoconazole • Nizoral
Paliperidone palmitate • Invega sustenna
Phenytoin • Dilantin, Phenytek
Quinidine • Cardioquin, Duraquin
Theophylline • Elixophylline, Theochron

References

1. US Preventive Services Task Force. Unhealthy drug use: screening [final recommendation statement]. Published June 9, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-screening. Accessed July 28, 2020.
2. US Preventive Services Task Force. Illicit drug use in children, adolescents, and young adults: primary care-based interventions [final recommendation statement]. Published May 26, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-primary-care-interventions-for-children-and-adolescents. Accessed July 28, 2020.
3. US Preventive Services Task Force. Prevention and cessation of tobacco use in children and adolescents: primary care interventions [final recommendation statement]. Published April 28, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed July 28, 2020.
4. National Institute on Drug Abuse. NIDA Quick Screen v 1.0. www.drugabuse.gov/sites/default/files/pdf/nmassist.pdf. Accessed July 28, 2020.
5. US Preventive Services Task Force. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions [update in progress]. Published September 21, 2015. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed July 28, 2020.

References

1. US Preventive Services Task Force. Unhealthy drug use: screening [final recommendation statement]. Published June 9, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-screening. Accessed July 28, 2020.
2. US Preventive Services Task Force. Illicit drug use in children, adolescents, and young adults: primary care-based interventions [final recommendation statement]. Published May 26, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-primary-care-interventions-for-children-and-adolescents. Accessed July 28, 2020.
3. US Preventive Services Task Force. Prevention and cessation of tobacco use in children and adolescents: primary care interventions [final recommendation statement]. Published April 28, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed July 28, 2020.
4. National Institute on Drug Abuse. NIDA Quick Screen v 1.0. www.drugabuse.gov/sites/default/files/pdf/nmassist.pdf. Accessed July 28, 2020.
5. US Preventive Services Task Force. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions [update in progress]. Published September 21, 2015. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed July 28, 2020.

References

1. US Preventive Services Task Force. Unhealthy drug use: screening [final recommendation statement]. Published June 9, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-screening. Accessed July 28, 2020.
2. US Preventive Services Task Force. Illicit drug use in children, adolescents, and young adults: primary care-based interventions [final recommendation statement]. Published May 26, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-primary-care-interventions-for-children-and-adolescents. Accessed July 28, 2020.
3. US Preventive Services Task Force. Prevention and cessation of tobacco use in children and adolescents: primary care interventions [final recommendation statement]. Published April 28, 2020. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed July 28, 2020.
4. National Institute on Drug Abuse. NIDA Quick Screen v 1.0. www.drugabuse.gov/sites/default/files/pdf/nmassist.pdf. Accessed July 28, 2020.
5. US Preventive Services Task Force. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions [update in progress]. Published September 21, 2015. https://uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed July 28, 2020.

In the past 5 years, there has been a significant drop in the use of prescription opioids and in deaths associated with such use; but at the same time there’s been a dramatic increase in fatalities involving illicit opioids and stimulants, a new report from the American Medical Association (AMA) Opioid Task Force shows.

Although the medical community has made some important progress against the opioid epidemic, with a 37% reduction in opioid prescribing since 2013, illicit drugs are now the dominant reason why drug overdoses kill more than 70,000 people each year, the report says.

In an effort to improve the situation, the AMA Opioid Task Force is urging the removal of barriers to evidence-based care for patients who have pain and for those who have substance use disorders (SUDs). The report notes that “red tape and misguided policies are grave dangers” to these patients.

“It is critically important as we see drug overdoses increasing that we work towards reducing barriers of care for substance use abusers,” Task Force Chair Patrice A. Harris, MD, said in an interview.

“At present, the status quo is killing far too many of our loved ones and wreaking havoc in our communities,” she said.

Dr. Harris noted that “a more coordinated/integrated approach” is needed to help individuals with SUDs.

“It is vitally important that these individuals can get access to treatment. Everyone deserves the opportunity for care,” she added.

Dramatic increases

The report cites figures from the Centers for Disease Control and Prevention that indicate the following regarding the period from the beginning of 2015 to the end of 2019:

• Deaths involving illicitly manufactured  and fentanyl analogues increased from 5,766 to 36,509.
• Deaths involving stimulants such as  increased from 4,402 to 16,279.
• Deaths involving cocaine increased from 5,496 to 15,974.
• Deaths involving heroin increased from 10,788 to 14,079.
• Deaths involving prescription opioids decreased from 12,269 to 11,904.

The report notes that deaths involving prescription opioids peaked in July 2017 at 15,003.

Some good news

In addition to the 37% reduction in opioid prescribing in recent years, the AMA lists other points of progress, such as a large increase in prescription drug monitoring program registrations. More than 1.8 million physicians and other healthcare professionals now participate in these programs.

Also, more physicians are now certified to treat opioid use disorder. More than 85,000 physicians, as well as a growing number of nurse practitioners and physician assistants, are now certified to treat patients in the office with buprenorphine. This represents an increase of more than 50,000 from 2017.

Access to naloxone is also increasing. More than 1 million naloxone prescriptions were dispensed in 2019 – nearly double the amount in 2018. This represents a 649% increase from 2017.

“We have made some good progress, but we can’t declare victory, and there are far too many barriers to getting treatment for substance use disorder,” Dr. Harris said.

“Policymakers, public health officials, and insurance companies need to come together to create a system where there are no barriers to care for people with substance use disorder and for those needing pain medications,” she added.

At present, prior authorization is often needed before these patients can receive medication. “This involves quite a bit of administration, filling in forms, making phone calls, and this is stopping people getting the care they need,” said Dr. Harris.

“This is a highly regulated environment. There are also regulations on the amount of methadone that can be prescribed and for the prescription of buprenorphine, which has to be initiated in person,” she said.

Will COVID-19 bring change?

Dr. Harris noted that some of these regulations have been relaxed during the COVID-19 crisis so that physicians could ensure that patients have continued access to medication, and she suggested that this may pave the way for the future.

“We need now to look at this carefully and have a conversation about whether these relaxations can be continued. But this would have to be evidence based. Perhaps we can use experience from the COVID-19 period to guide future policy on this,” she said.

The report highlights that despite medical society and patient advocacy, only 21 states and the District of Columbia have enacted laws that limit public and private insurers from imposing prior authorization requirements on SUD services or medications.

The Task Force urges removal of remaining prior authorizations, step therapy, and other inappropriate administrative burdens that delay or deny care for Food and Drug Administration–approved medications used as part of medication-assisted treatment for opioid use disorder.

The organization is also calling for better implementation of mental health and substance use disorder parity laws that require health insurers to provide the same level of benefits for mental health and SUD treatment and services that they do for medical/surgical care.

At present, only a few states have taken meaningful action to enact or enforce those laws, the report notes.

The Task Force also recommends the implementation of systems to track overdose and mortality trends to provide equitable public health interventions. These measures would include comprehensive, disaggregated racial and ethnic data collection related to testing, hospitalization, and mortality associated with opioids and other substances.

“We know that ending the drug overdose epidemic will not be easy, but if policymakers allow the status quo to continue, it will be impossible,” Dr. Harris said.

“This is particularly important given concerns that the COVID-19 pandemic is worsening the drug overdose epidemic. Physicians will continue to do our part. We urge policymakers to do theirs,” she added.
 

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

In the past 5 years, there has been a significant drop in the use of prescription opioids and in deaths associated with such use; but at the same time there’s been a dramatic increase in fatalities involving illicit opioids and stimulants, a new report from the American Medical Association (AMA) Opioid Task Force shows.

Although the medical community has made some important progress against the opioid epidemic, with a 37% reduction in opioid prescribing since 2013, illicit drugs are now the dominant reason why drug overdoses kill more than 70,000 people each year, the report says.

In an effort to improve the situation, the AMA Opioid Task Force is urging the removal of barriers to evidence-based care for patients who have pain and for those who have substance use disorders (SUDs). The report notes that “red tape and misguided policies are grave dangers” to these patients.

“It is critically important as we see drug overdoses increasing that we work towards reducing barriers of care for substance use abusers,” Task Force Chair Patrice A. Harris, MD, said in an interview.

“At present, the status quo is killing far too many of our loved ones and wreaking havoc in our communities,” she said.

Dr. Harris noted that “a more coordinated/integrated approach” is needed to help individuals with SUDs.

“It is vitally important that these individuals can get access to treatment. Everyone deserves the opportunity for care,” she added.

Dramatic increases

The report cites figures from the Centers for Disease Control and Prevention that indicate the following regarding the period from the beginning of 2015 to the end of 2019:

• Deaths involving illicitly manufactured  and fentanyl analogues increased from 5,766 to 36,509.
• Deaths involving stimulants such as  increased from 4,402 to 16,279.
• Deaths involving cocaine increased from 5,496 to 15,974.
• Deaths involving heroin increased from 10,788 to 14,079.
• Deaths involving prescription opioids decreased from 12,269 to 11,904.

The report notes that deaths involving prescription opioids peaked in July 2017 at 15,003.

Some good news

In addition to the 37% reduction in opioid prescribing in recent years, the AMA lists other points of progress, such as a large increase in prescription drug monitoring program registrations. More than 1.8 million physicians and other healthcare professionals now participate in these programs.

Also, more physicians are now certified to treat opioid use disorder. More than 85,000 physicians, as well as a growing number of nurse practitioners and physician assistants, are now certified to treat patients in the office with buprenorphine. This represents an increase of more than 50,000 from 2017.

Access to naloxone is also increasing. More than 1 million naloxone prescriptions were dispensed in 2019 – nearly double the amount in 2018. This represents a 649% increase from 2017.

“We have made some good progress, but we can’t declare victory, and there are far too many barriers to getting treatment for substance use disorder,” Dr. Harris said.

“Policymakers, public health officials, and insurance companies need to come together to create a system where there are no barriers to care for people with substance use disorder and for those needing pain medications,” she added.

At present, prior authorization is often needed before these patients can receive medication. “This involves quite a bit of administration, filling in forms, making phone calls, and this is stopping people getting the care they need,” said Dr. Harris.

“This is a highly regulated environment. There are also regulations on the amount of methadone that can be prescribed and for the prescription of buprenorphine, which has to be initiated in person,” she said.

Will COVID-19 bring change?

Dr. Harris noted that some of these regulations have been relaxed during the COVID-19 crisis so that physicians could ensure that patients have continued access to medication, and she suggested that this may pave the way for the future.

“We need now to look at this carefully and have a conversation about whether these relaxations can be continued. But this would have to be evidence based. Perhaps we can use experience from the COVID-19 period to guide future policy on this,” she said.

The report highlights that despite medical society and patient advocacy, only 21 states and the District of Columbia have enacted laws that limit public and private insurers from imposing prior authorization requirements on SUD services or medications.

The Task Force urges removal of remaining prior authorizations, step therapy, and other inappropriate administrative burdens that delay or deny care for Food and Drug Administration–approved medications used as part of medication-assisted treatment for opioid use disorder.

The organization is also calling for better implementation of mental health and substance use disorder parity laws that require health insurers to provide the same level of benefits for mental health and SUD treatment and services that they do for medical/surgical care.

At present, only a few states have taken meaningful action to enact or enforce those laws, the report notes.

The Task Force also recommends the implementation of systems to track overdose and mortality trends to provide equitable public health interventions. These measures would include comprehensive, disaggregated racial and ethnic data collection related to testing, hospitalization, and mortality associated with opioids and other substances.

“We know that ending the drug overdose epidemic will not be easy, but if policymakers allow the status quo to continue, it will be impossible,” Dr. Harris said.

“This is particularly important given concerns that the COVID-19 pandemic is worsening the drug overdose epidemic. Physicians will continue to do our part. We urge policymakers to do theirs,” she added.
 

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

In the past 5 years, there has been a significant drop in the use of prescription opioids and in deaths associated with such use; but at the same time there’s been a dramatic increase in fatalities involving illicit opioids and stimulants, a new report from the American Medical Association (AMA) Opioid Task Force shows.

Although the medical community has made some important progress against the opioid epidemic, with a 37% reduction in opioid prescribing since 2013, illicit drugs are now the dominant reason why drug overdoses kill more than 70,000 people each year, the report says.

In an effort to improve the situation, the AMA Opioid Task Force is urging the removal of barriers to evidence-based care for patients who have pain and for those who have substance use disorders (SUDs). The report notes that “red tape and misguided policies are grave dangers” to these patients.

“It is critically important as we see drug overdoses increasing that we work towards reducing barriers of care for substance use abusers,” Task Force Chair Patrice A. Harris, MD, said in an interview.

“At present, the status quo is killing far too many of our loved ones and wreaking havoc in our communities,” she said.

Dr. Harris noted that “a more coordinated/integrated approach” is needed to help individuals with SUDs.

“It is vitally important that these individuals can get access to treatment. Everyone deserves the opportunity for care,” she added.

Dramatic increases

The report cites figures from the Centers for Disease Control and Prevention that indicate the following regarding the period from the beginning of 2015 to the end of 2019:

• Deaths involving illicitly manufactured  and fentanyl analogues increased from 5,766 to 36,509.
• Deaths involving stimulants such as  increased from 4,402 to 16,279.
• Deaths involving cocaine increased from 5,496 to 15,974.
• Deaths involving heroin increased from 10,788 to 14,079.
• Deaths involving prescription opioids decreased from 12,269 to 11,904.

The report notes that deaths involving prescription opioids peaked in July 2017 at 15,003.

Some good news

In addition to the 37% reduction in opioid prescribing in recent years, the AMA lists other points of progress, such as a large increase in prescription drug monitoring program registrations. More than 1.8 million physicians and other healthcare professionals now participate in these programs.

Also, more physicians are now certified to treat opioid use disorder. More than 85,000 physicians, as well as a growing number of nurse practitioners and physician assistants, are now certified to treat patients in the office with buprenorphine. This represents an increase of more than 50,000 from 2017.

Access to naloxone is also increasing. More than 1 million naloxone prescriptions were dispensed in 2019 – nearly double the amount in 2018. This represents a 649% increase from 2017.

“We have made some good progress, but we can’t declare victory, and there are far too many barriers to getting treatment for substance use disorder,” Dr. Harris said.

“Policymakers, public health officials, and insurance companies need to come together to create a system where there are no barriers to care for people with substance use disorder and for those needing pain medications,” she added.

At present, prior authorization is often needed before these patients can receive medication. “This involves quite a bit of administration, filling in forms, making phone calls, and this is stopping people getting the care they need,” said Dr. Harris.

“This is a highly regulated environment. There are also regulations on the amount of methadone that can be prescribed and for the prescription of buprenorphine, which has to be initiated in person,” she said.

Will COVID-19 bring change?

Dr. Harris noted that some of these regulations have been relaxed during the COVID-19 crisis so that physicians could ensure that patients have continued access to medication, and she suggested that this may pave the way for the future.

“We need now to look at this carefully and have a conversation about whether these relaxations can be continued. But this would have to be evidence based. Perhaps we can use experience from the COVID-19 period to guide future policy on this,” she said.

The report highlights that despite medical society and patient advocacy, only 21 states and the District of Columbia have enacted laws that limit public and private insurers from imposing prior authorization requirements on SUD services or medications.

The Task Force urges removal of remaining prior authorizations, step therapy, and other inappropriate administrative burdens that delay or deny care for Food and Drug Administration–approved medications used as part of medication-assisted treatment for opioid use disorder.

The organization is also calling for better implementation of mental health and substance use disorder parity laws that require health insurers to provide the same level of benefits for mental health and SUD treatment and services that they do for medical/surgical care.

At present, only a few states have taken meaningful action to enact or enforce those laws, the report notes.

The Task Force also recommends the implementation of systems to track overdose and mortality trends to provide equitable public health interventions. These measures would include comprehensive, disaggregated racial and ethnic data collection related to testing, hospitalization, and mortality associated with opioids and other substances.

“We know that ending the drug overdose epidemic will not be easy, but if policymakers allow the status quo to continue, it will be impossible,” Dr. Harris said.

“This is particularly important given concerns that the COVID-19 pandemic is worsening the drug overdose epidemic. Physicians will continue to do our part. We urge policymakers to do theirs,” she added.
 

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

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Ingram Publishing/Thinkstock

A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.

The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.

This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.

“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.

Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.

“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.

“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” The increase in anxiety pre-dated the pandemic and appears to be contributing to further mental health concerns in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.

Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.

“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.

Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.

“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.

Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.

On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.

“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”

Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.

Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.

“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”

Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

The COVID-19 pandemic has changed life in numerous ways, including use of telehealth services for patients in all specialties. But telepsychiatry is an area not likely to go away even after the pandemic is over, according to Sanjay Gupta, MD.

Jean-philippe WALLET/Getty Images

The use of telepsychiatry has escalated significantly,” said Dr. Gupta, of the DENT Neurologic Institute, in Amherst, N.Y., in a bonus virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

About 90% of clinicians are performing telepsychiatry, Dr. Gupta noted, through methods such as phone consults, email, and video chat. As patients with psychiatric issues grapple with issues related to COVID-19 involving lockdowns, restrictions on travel, and consumption of news, they are presenting with addiction, depression, paranoia, mood lability, and other problems.

One issue immediately facing clinicians is whether to keep patients on long-acting injectables as a way to maintain psychological stability in patients with bipolar disorder, schizophrenia, and alcoholism – something Dr. Gupta and session moderator Henry A. Nasrallah, MD, advocated. “We should never stop the long-acting injectable to switch them to oral medication. Those patients are very likely to relapse,” Dr. Nasrallah said.

During the pandemic, clinicians need to find “safe and novel ways of providing the injection,” and several methods have been pioneered. For example, if a patient with schizophrenia is on lockdown, a nurse can visit monthly or bimonthly to administer an injection, check on the patient’s mental status, and assess whether that patient needs an adjustment to their medication. Other clinics are offering “drive-by” injections to patients who arrive by car, and a nurse wearing a mask and a face shield administers the injection from the car window. Monthly naltrexone also can be administered using one of these methods, and telepsychiatry can be used to monitor patients, Dr. Gupta noted at the meeting, presented by Global Academy for Medical Education.

“In my clinic, what happens is the injection room is set up just next to the door, so they don’t have to walk deep into the clinic,” Dr. Gupta said. “They walk in, go to the left, [and] there’s the injection room. They sit, get an injection, they’re out. It’s kept smooth.”
 

Choosing the right telehealth option

Clinicians should be aware of important regulatory changes that occurred that made widespread telehealth more appealing during the COVID-19 pandemic. Payment parity with in-office visits makes telehealth a viable consideration, while some states have begun offering telehealth licenses to practice across state lines. There is wide variation with regard to which states provide licensure and prescribing privileges for out-of-state clinicians without seeing those patients in person. “The most important thing: The psychiatry service is provided in the state where the patient is located,” Dr. Gupta said. Clinicians should check with that state’s board to figure out specific requirements. “Preferably if you get it in writing, it’s good for you,” he said.

Deciding who the clinician is seeing – consulting with patients or other physicians/clinicians – and what type of visits a clinician will conduct is an important step in transitioning to telepsychiatry. Visits from evaluation through ongoing care are possible through telepsychiatry, or a clinician can opt to see just second opinion visits, Dr. Gupta said. It is also important to consider the technical ability of the patient to do video conferencing.

As HIPAA requirements for privacy have relaxed, clinicians now have an array of teleconferencing options to choose from; platforms such as FaceTime, Doximity, Vidyo, Doxy.me, Zoom, and video chat through EMR are popular options. However, when regular HIPAA requirements are reinstated after the pandemic, clinicians will need to find a compliant platform and sign a business associate agreement to stay within the law.

“Right now, my preferred use is FaceTime,” Dr. Gupta said. “Quick, simple, easy to use. A lot of people have an iPhone, and they know how to do it. I usually have the patient call me and I don’t use my personal iPhone; my clinic has an iPhone.”

How a clinician looks during a telepsychiatry visit is also important. Lighting, position of the camera, and clothing should all be considered. Keep the camera at eye level, test the lighting in the room where the call will take place, and use artificial lighting sources behind a computer, Dr. Gupta said. Other tips for telepsychiatry visits include silencing devices and microphones before a session begins, wearing solid-colored clothes, and having an identification badge visible to the patient. Sessions should be free of background distractions, such as a dog barking or a child interrupting, with the goal of creating an environment where the patient feels free to answer questions.

Contingency planning is a must for video visits, Dr. Gupta said. “I think the simplest thing is to see the patient. But all the stuff that’s the wraparound is really hard, because issues can arise suddenly, and we need to plan.” If a patient has a medical issue or becomes actively suicidal during a session, it is important to know contact information for the local police and crisis services. Clinicians also must plan for technology failure and provide alternative options for continuing the sessions, such as by phone.
 

Selecting patients for telepsychiatry

Not all patients will make the transition to telepsychiatry. “You can’t do telepsychiatry with everyone. It is a risk, so pick and choose,” Dr. Gupta said.

“Safety is a big consideration for conducting a telepsychiatry visit, especially when other health care providers are present. For example, when performing telehealth visits in a clinic, nursing home, or correctional facility, “I feel a lot more comfortable if there’s another health care clinician there,” Dr. Gupta said.

Clinicians may want to avoid a telepsychiatry visit for a patient in their own home for reasons of safety, reliability, and privacy. A longitudinal history with collateral information from friends or relatives can be helpful, but some subtle signs and body language may get missed over video, compared with an in-person visit. “Telepsychiatry can be a barrier at times. If there is substance abuse, we may not smell alcohol. Sometimes you may not see if the patient is using substances. You have to really reconsider if [there] is violence and self-injurious behavior,” he said.

Discussing the pros and cons of telepsychiatry is important to obtaining patient consent. While consent requirements have relaxed under the COVID-19 pandemic, consent should ideally be obtained in writing, but can also be obtained verbally during a crisis. A plan should be developed for what will happen in the case of technology failure. “The patient should also know you’re maintaining privacy, you’re maintaining confidentiality, but there is a risk of hacking,” Dr. Gupta said. “Those things can happen, [and] there are no guarantees.”

If a patient is uncomfortable after beginning telepsychiatry, moving to in-person visits is also an option. “Many times, I do that if I’m not getting a good handle on things,” Dr. Gupta said. Situations where patients insist on in-patient visits over telepsychiatry are rare in his experience, Dr. Gupta noted, and are usually the result of the patient being unfamiliar with the technology. In cases where a patient cannot be talked through a technology barrier, visits can be done in the clinic while taking proper precautions.

“If it is a first-time visit, then I do it in the clinic,” Dr. Gupta said. “They come in, they have a face mask, and we use our group therapy room. The patients sit in a social-distanced fashion. But then, you document why you did this in-person visit like that.”

Documentation during COVID-19 also includes identifying the patient at the first visit, the nature of the visit (teleconference or other), parties present, referencing the pandemic, writing the location of the patient and the clinician, noting the patient’s satisfaction, evaluating the patient’s mental status, and recording what technology was used and any technical issues that were encountered.

Some populations of patients are better suited to telepsychiatry than others. It is more convenient for chronically psychiatrically ill patients in group homes and their staff to communicate through telepsychiatry, Dr. Gupta said. Consultation liaison in hospitals and emergency departments through telepsychiatry can limit the spread of infection, while increased access and convenience occurs as telepsychiatry is implemented in correctional facilities and nursing homes.

“What we are doing now, some of it is here to stay,” Dr. Gupta said.

In situations where a patient needs to switch providers, clinicians should continue to follow that patient until his first patient visit with that new provider. It is also important to set boundaries and apply some level of formality to the telepsychiatry visit, which means seeing the patient in a secure location where he can speak freely and privately.

“The best practices are [to] maintain faith [and] fidelity of the psychiatric assessment,” Dr. Gupta said. “Keep the trust and do your best to maintain patient privacy, because the privacy is not the same as it may be in a face-to-face session when you use televideo.”

Global Academy and this news organization are owned by the same parent company.

Dr. Gupta reported no relevant financial disclosures. Dr. Nasrallah disclosed serving as a consultant for and on the speakers bureaus of several pharmaceutical companies, including Alkermes, Janssen, and Lundbeck. He also disclosed serving on the speakers bureau of Otsuka.

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

This year, medical media has been dominated by reporting on the devastating COVID-19 pandemic. Many studies and analyses have shown that staying at home, social distancing, quarantining of close contacts, and wearing face masks and face shields are effective ways of preventing spread.

Although initially there were no known effective treatments for severe COVID-19 infection (other than oxygen and ventilator support), we now know that dexamethasone,¹ remdesivir,² and convalescent plasma³ are effective in lessening the severity of illness and perhaps preventing death. That said, we will continue to struggle with COVID-19 for the foreseeable future.

We must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

But other medical illnesses actually predominate in terms of morbidity and mortality, even during this pandemic. For example, although there has been an average of roughly 5600 COVID-19-related deaths per week for the past 4 months,⁴ there are, on average, more than 54,000 deaths per week in the United States from other causes.⁵ This means that we must continue to tend to the other health care needs of our patients even as we deal with COVID-19.

In that light, JFP continues to publish practical, evidence-based clinical reviews designed to keep family physicians and other primary health care clinicians up to date on a variety of topics. For instance, in this issue of JFP, we have articles on:

• Opioid prescribing. Although opioids have risks, they remain potent medications for relief from acute pain, as well as cancer-related pain and chronic pain not sufficiently treated with other medications. Mahvan et al provide expert advice on maximizing benefit and minimizing the risks of opioid prescribing.
• Secondary ischemic stroke prevention. For patients who have suffered a transient ischemic attack or minor stroke, a mainstay of prevention is antiplatelet therapy. Aspirin alone used to be the treatment of choice, but research has demonstrated the value of adding another antiplatelet agent. Helmer et al’s thorough review reminds us that the antiplatelet drug of choice, in addition to aspirin, is clopidogrel, which should be used only for the first 30 days after the event because of an increased bleeding risk.
• Combatting Clostridioides difficile infection. CDI has been a difficult condition to treat, especially in high-risk patients. Zukauckas et al provide a comprehensive review of diagnosis and management. Vancomycin is now the drug of choice, and fecal transplant is highly effective in preventing recurrent CDI.

This diverse range of timely, practical, evidence-based guidance—in addition to coverage of COVID-19 and other rapidly emerging medical news stories—can all be found on our Web site at www.mdedge.com/familymedicine. We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.

If US pharmacies were permitted to dispense methadone for opioid use disorder (OUD) it would improve national access to treatment and save costs, new research suggests.

Under current federal regulations, only opioid treatment programs (OTPs) are permitted to dispense methadone maintenance treatment. This stands in sharp contrast to how methadone is dispensed in Canada, Australia, and the United Kingdom, where patients can obtain daily doses of methadone maintenance from community pharmacies.

“It’s challenging for patients in many parts of the US to access methadone treatment,” Robert Kleinman, MD, of Stanford University School of Medicine, Stanford, California, said in a JAMA Psychiatry podcast.

“It’s important for policymakers to consider strategies that enhance access to methadone maintenance treatment, in that it’s associated with large reductions in mortality from opioid use disorder. One possibility is to use pharmacies as dispensing sites,” said Kleinman.

The study was published online July 15 in JAMA Psychiatry.

An Hour vs 10 Minutes

Kleinman examined how pharmacy-based dispensing would affect drive times to the nearest OTP for the general US population. The analysis included all 1682 OTP locations, 69,475 unique pharmacy locations, and 72,443 census tracts.

The average drive time to OTPs in the US is 20.4 minutes vs a drive time of 4.5 minutes to pharmacies.

Driving times to OTPs are particularly long in nonmetropolitan counties while pharmacies remain “relatively easily accessible” in nonmetropolitan counties, he said.

In “micropolitan” counties, for example, the drive time to OTPs was 48.4 minutes vs 7 minutes to pharmacies. In the most rural counties, the drive time to OTPs is 60.9 minutes vs 9.1 minutes to pharmacies.

“This suggests that pharmacy-based dispensing has the potential to reduce urban or rural inequities, and access to methadone treatment,” Kleinman said.

In a mileage cost analysis, Kleinman determined that the average cost of one-way trip to an OTP in the US is $3.12 compared with 45 cents to a pharmacy. In the most rural counties, the average cost one-way is $11.10 vs $1.27 to a pharmacy.

Kleinman says decreasing drive times, distance, and costs for patients seeking methadone treatment by allowing pharmacies to dispense the medication may help achieve several public health goals.

“Patients dissuaded from obtaining treatment because of extended travel, particularly patients with disabilities, unreliable access to transportation, or from rural regions, would have reduced barriers to care. Quality of life may be increased for the more than 380,000 individuals currently receiving methadone treatment if less time is spent commuting,” he writes.

Time for Change

The authors of an accompanying editorial, say the “regulatory burden” on methadone provision in the US “effectively prohibits the integration of methadone prescribing into primary care, even in rural communities where there may exist no specialty substance use treatment options.”

However, federal and state agencies are starting to take action to expand geographic access to methadone treatment, note Paul Joudrey, MD, MPH, and coauthors from Yale School of Medicine, New Haven, Connecticut.

The US Drug Enforcement Administration has proposed allowing mobile methadone units, and Ohio and Kentucky have passed laws to allow greater use of federally qualified health centers and other facilities for methadone dispensing.

“While these policies are welcomed, the results here by Kleinman and others suggest they fall short of needed expansion if patients’ rights to evidence-based care for OUD are to be ensured. Importantly, even with broad adoption of mobile or pharmacy-based dispensing, patients would still face a long drive time to a central OTP before starting methadone,” Joudrey and colleagues write.

In their view, the only way to address this barrier is to modify federal law, and this “should be urgently pursued in the context of the ongoing overdose epidemic. It is time for policies that truly support methadone treatment for OUD as opposed to focusing on diversion.”

This article first appeared on Medscape.com.

If US pharmacies were permitted to dispense methadone for opioid use disorder (OUD) it would improve national access to treatment and save costs, new research suggests.

Under current federal regulations, only opioid treatment programs (OTPs) are permitted to dispense methadone maintenance treatment. This stands in sharp contrast to how methadone is dispensed in Canada, Australia, and the United Kingdom, where patients can obtain daily doses of methadone maintenance from community pharmacies.

“It’s challenging for patients in many parts of the US to access methadone treatment,” Robert Kleinman, MD, of Stanford University School of Medicine, Stanford, California, said in a JAMA Psychiatry podcast.

“It’s important for policymakers to consider strategies that enhance access to methadone maintenance treatment, in that it’s associated with large reductions in mortality from opioid use disorder. One possibility is to use pharmacies as dispensing sites,” said Kleinman.

The study was published online July 15 in JAMA Psychiatry.

An Hour vs 10 Minutes

Kleinman examined how pharmacy-based dispensing would affect drive times to the nearest OTP for the general US population. The analysis included all 1682 OTP locations, 69,475 unique pharmacy locations, and 72,443 census tracts.

The average drive time to OTPs in the US is 20.4 minutes vs a drive time of 4.5 minutes to pharmacies.

Driving times to OTPs are particularly long in nonmetropolitan counties while pharmacies remain “relatively easily accessible” in nonmetropolitan counties, he said.

In “micropolitan” counties, for example, the drive time to OTPs was 48.4 minutes vs 7 minutes to pharmacies. In the most rural counties, the drive time to OTPs is 60.9 minutes vs 9.1 minutes to pharmacies.

“This suggests that pharmacy-based dispensing has the potential to reduce urban or rural inequities, and access to methadone treatment,” Kleinman said.

In a mileage cost analysis, Kleinman determined that the average cost of one-way trip to an OTP in the US is $3.12 compared with 45 cents to a pharmacy. In the most rural counties, the average cost one-way is $11.10 vs $1.27 to a pharmacy.

Kleinman says decreasing drive times, distance, and costs for patients seeking methadone treatment by allowing pharmacies to dispense the medication may help achieve several public health goals.

“Patients dissuaded from obtaining treatment because of extended travel, particularly patients with disabilities, unreliable access to transportation, or from rural regions, would have reduced barriers to care. Quality of life may be increased for the more than 380,000 individuals currently receiving methadone treatment if less time is spent commuting,” he writes.

Time for Change

The authors of an accompanying editorial, say the “regulatory burden” on methadone provision in the US “effectively prohibits the integration of methadone prescribing into primary care, even in rural communities where there may exist no specialty substance use treatment options.”

However, federal and state agencies are starting to take action to expand geographic access to methadone treatment, note Paul Joudrey, MD, MPH, and coauthors from Yale School of Medicine, New Haven, Connecticut.

The US Drug Enforcement Administration has proposed allowing mobile methadone units, and Ohio and Kentucky have passed laws to allow greater use of federally qualified health centers and other facilities for methadone dispensing.

“While these policies are welcomed, the results here by Kleinman and others suggest they fall short of needed expansion if patients’ rights to evidence-based care for OUD are to be ensured. Importantly, even with broad adoption of mobile or pharmacy-based dispensing, patients would still face a long drive time to a central OTP before starting methadone,” Joudrey and colleagues write.

In their view, the only way to address this barrier is to modify federal law, and this “should be urgently pursued in the context of the ongoing overdose epidemic. It is time for policies that truly support methadone treatment for OUD as opposed to focusing on diversion.”

This article first appeared on Medscape.com.

If US pharmacies were permitted to dispense methadone for opioid use disorder (OUD) it would improve national access to treatment and save costs, new research suggests.

Under current federal regulations, only opioid treatment programs (OTPs) are permitted to dispense methadone maintenance treatment. This stands in sharp contrast to how methadone is dispensed in Canada, Australia, and the United Kingdom, where patients can obtain daily doses of methadone maintenance from community pharmacies.

“It’s challenging for patients in many parts of the US to access methadone treatment,” Robert Kleinman, MD, of Stanford University School of Medicine, Stanford, California, said in a JAMA Psychiatry podcast.

“It’s important for policymakers to consider strategies that enhance access to methadone maintenance treatment, in that it’s associated with large reductions in mortality from opioid use disorder. One possibility is to use pharmacies as dispensing sites,” said Kleinman.

The study was published online July 15 in JAMA Psychiatry.

An Hour vs 10 Minutes

Kleinman examined how pharmacy-based dispensing would affect drive times to the nearest OTP for the general US population. The analysis included all 1682 OTP locations, 69,475 unique pharmacy locations, and 72,443 census tracts.

The average drive time to OTPs in the US is 20.4 minutes vs a drive time of 4.5 minutes to pharmacies.

Driving times to OTPs are particularly long in nonmetropolitan counties while pharmacies remain “relatively easily accessible” in nonmetropolitan counties, he said.

In “micropolitan” counties, for example, the drive time to OTPs was 48.4 minutes vs 7 minutes to pharmacies. In the most rural counties, the drive time to OTPs is 60.9 minutes vs 9.1 minutes to pharmacies.

“This suggests that pharmacy-based dispensing has the potential to reduce urban or rural inequities, and access to methadone treatment,” Kleinman said.

In a mileage cost analysis, Kleinman determined that the average cost of one-way trip to an OTP in the US is $3.12 compared with 45 cents to a pharmacy. In the most rural counties, the average cost one-way is $11.10 vs $1.27 to a pharmacy.

Kleinman says decreasing drive times, distance, and costs for patients seeking methadone treatment by allowing pharmacies to dispense the medication may help achieve several public health goals.

“Patients dissuaded from obtaining treatment because of extended travel, particularly patients with disabilities, unreliable access to transportation, or from rural regions, would have reduced barriers to care. Quality of life may be increased for the more than 380,000 individuals currently receiving methadone treatment if less time is spent commuting,” he writes.

Time for Change

The authors of an accompanying editorial, say the “regulatory burden” on methadone provision in the US “effectively prohibits the integration of methadone prescribing into primary care, even in rural communities where there may exist no specialty substance use treatment options.”

However, federal and state agencies are starting to take action to expand geographic access to methadone treatment, note Paul Joudrey, MD, MPH, and coauthors from Yale School of Medicine, New Haven, Connecticut.

The US Drug Enforcement Administration has proposed allowing mobile methadone units, and Ohio and Kentucky have passed laws to allow greater use of federally qualified health centers and other facilities for methadone dispensing.

“While these policies are welcomed, the results here by Kleinman and others suggest they fall short of needed expansion if patients’ rights to evidence-based care for OUD are to be ensured. Importantly, even with broad adoption of mobile or pharmacy-based dispensing, patients would still face a long drive time to a central OTP before starting methadone,” Joudrey and colleagues write.

In their view, the only way to address this barrier is to modify federal law, and this “should be urgently pursued in the context of the ongoing overdose epidemic. It is time for policies that truly support methadone treatment for OUD as opposed to focusing on diversion.”

This article first appeared on Medscape.com.

CASE

Marcelo G* is a 46-year-old man who presented to our family medicine clinic with a complex medical history including end-stage renal disease (ESRD) and hemodialysis, chronic anemia, peripheral vascular disease, venous thromboembolism and anticoagulation, major depressive disorder, osteoarthritis, and lumbosacral radiculopathy. His current medications included vitamin B complex, cholecalciferol, atorvastatin, warfarin, acetaminophen, diclofenac gel, and capsaicin cream. Mr. G reported bothersome bilateral knee and back pain despite physical therapy and consistent use of his current medications in addition to occasional intra-articular glucocorticoid injections. He mentioned that he had benefited in the past from intermittent opioid use.

How would you manage this patient’s care?

*The patient’s name has been changed to protect his identity.

In 2013, an estimated 191 million prescriptions for ­opioids were written by health care providers, which is the equivalent of all adults living in the United States having their own opioid prescription.¹ This large expansion in opioid prescribing and use has also led to a rise in opioid overdose deaths, whether from prescribed or illicit use.¹ The Centers for Disease Control and Prevention (CDC) points out that each day, approximately 128 Americans die from an opioid overdose.¹ Deaths that occur from opioid overdose often involve the prescribed opioids methadone, oxycodone, and hydrocodone, the illicit opioid heroin, and, of particular concern, prescription and illicit fentanyl.¹

IMAGE: © JOE GORMAN

Family physicians write more opioid prescriptions than any other specialty, and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact.

The extent of this problem has sparked the development of health safety initiatives and research efforts. Through production quotas, the US Drug Enforcement Administration (DEA) reduced the number of opioids produced across all schedule I and schedule II lists in 2017 by as much as 25%.² The DEA again reduced the amounts produced in 2018.³ For 2020, the DEA has determined that the production quotas and assessment of annual needs are sufficient.⁴

The CDC has also promoted access to naloxone and prevention initiatives; pharmacies in some states have standing orders for naloxone, and medical personnel and law enforcement now carry it.^1,5 Finally, new research has identified risk factors that influence one’s potential for addiction, such as mental illness, history of substance and alcohol abuse, and a low income.⁶ Interestingly, while numerous initiatives and strategies have been implemented across health systems, there is little evidence that demonstrates how implementation of safe prescribing strategies has affected overall patient safety and avoidance of opioid-related harms.

Nevertheless, concerns related to ­opioids are especially important for primary care ­providers, who manage many patients with acute and chronic diseases and disorders that require pain control.⁷ Family physicians write more opioid prescriptions than any ­other specialty,⁸ and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact. This article provides a guide to safe opioid prescribing.

Continue to: Use the patient interview to ensure that Tx aligns with patient goals

 

 

Use the patient interview to ensure that Tx aligns with patient goals

For patients presenting with chronic pain, conduct a complete general history and physical examination that includes a review of available records; a medical, surgical, social, family, medication, and allergy history; a review of systems; and documentation of any psychiatric comorbidities (ie, depression, anxiety, psychiatric disorders, personality traits). Inquiries about social history and current medications should explore the possibility of previous and current substance use and misuse.

While causes of pain can be assessed through physical examination and diagnostic tests, the patient interview is an invaluable source of information. No single means of assessment has consistently demonstrated superiority over another in measuring pain, and numerous standard assessment tools are available (TABLE 1^9-13).¹⁴ Unidimensional tools are often easy and quick ways to assess pain intensity. Multidimensional tools, although more time intensive, are designed to gather more subjective information about the patient’s pain. Finally, use an instrument such as the 9-item Patient Health Questionnaire (PHQ-9) to screen patients for psychological distress.^15,16

Use state prescription drug monitoring programs and urine drug testing to confirm patient compliance.

Provide an environment for patients to openly discuss their experiences, expectations, preferences, fears, and coping efforts, as well as the impact that pain has had on their lives.^17,18 Without this foundational understanding, medical treatment may work against the patient’s goals. An empathic approach allows for effective communication, shared decision making, and ultimately, an avenue for individualized therapy.

Balancing treatment with risk mitigation

The challenge of managing chronic pain is to balance treating the patient with the basic principle of nonmaleficence (primum non nocere: “first, do no harm”). The literature has shown that risk factors such as a family history of substance abuse or sexual abuse, younger age, and psychological disease may be linked to greater risk for opioid misuse.^19,20 However, despite the many risk-screening tools available, no single instrument has reliably and accurately predicted those at higher propensity for prescription addiction. In fact, risk-screening tools as a whole remain unregulated by the US Food and Drug Administration (FDA) and other authorities.²¹ Still, screening tools provide useful information as one component of the risk-mitigation process.

Screening tools. The tools most commonly used clinically to stratify risk prior to prescribing opioids are the 5-item Opioid Risk Tool (ORT),²² the revised 24-item Screener and Opioid Assessment for Patients with Pain (SOAPP-R),²³ which are patient self-administered assessments, and the 7-item clinician-administered DIRE (Diagnosis, Intractability, Risk, Efficacy).²⁴ Given the subtle differences in criteria and the time required for each of these risk assessments, we recommend choosing one based on site-specific resources and overall clinician comfort.²⁵ Risk stratification helps to determine the optimal frequency and intensity of monitoring, not necessarily to deny care to “high-risk” patients.

Continue to: In fact, just as the "universal precautions"...

In fact, just as the “universal precautions” approach has been applied to infection control, many have suggested using a similar approach to pain management. Risk screening should never be misunderstood as an attempt to diminish or undermine the patient’s burden of pain. By routinely conducting thorough and respectful inquiries of risk factors for all patients, clinicians can reduce stigma, improve care, and contain overall risk.^26,27

Monitoring programs and patient agreements. In addition to risk-screening tools, the CDC recommends using state prescription drug monitoring programs (PDMP) and urine drug testing (UDT) data to confirm the use of prescribed and illicit substances.²⁸ All 50 states have implemented PDMPs.²⁹ Consider incorporating these components into controlled-substance agreements, which ultimately aim to promote safety and trust between patients and providers. Of course, such agreements do not eliminate all risks associated with opioid prescribing, nor do they guarantee the absence of adverse outcomes. However, when used correctly, they can provide safeguards to reduce misuse and abuse. They also have the potential to preserve the patient-provider relationship, as opposed to providers cursorily refusing to prescribe opioids altogether. The term “controlled-substance agreement” is preferable to “pain contract” or “narcotic contract” as the latter 2 terms may feel stigmatizing and threatening.³⁰

Risk evaluation and mitigation strategy (REMS). In an effort to ensure that benefits of opioid analgesics continue to outweigh the risks, the FDA approved the extended-release (ER)/long-acting (LA) opioid analgesics shared system REMS. Under this REMS, a consortium of ER/LA opioid manufacturers is mandated to provide prescriber education in the form of accredited continuing education and patient educational materials, available at https://opioidanalgesicrems.com/RpcUI/home.u.

CASE

After reviewing Mr. G’s chart and conducting a history, we learned that his bilateral knee osteoarthritis was atraumatic and likely due to overuse—although possibly affected by major trauma in a motor vehicle accident 5 years earlier. Imaging also revealed multilevel disc degeneration contributing to his radicular back pain, which seemed to be worse on days after working as a caterer. Poor lifting form at work may have contributed to his pain. Nevertheless, he had been consistent with medical follow-up and denied current or past use of illicit substances. Per the numeric rating scale (NRS), he reported 8 out of 10 pain in his knees and 6 out of 10 in his back. In addition to obtaining a PHQ-9 score of 4, we conducted a DIRE assessment and obtained a score of 19 out of a possible 21, indicating that he may be a good candidate for long-term opioid analgesia.

Criteria for prescribing opioids and for guiding treatment goals

Prescribing an opioid requires establishing a medical necessity based on 3 criteria:³¹

• pain of moderate-to-severe degree
• a physical diagnosis or suspected organic problem
• documented treatment failure of a noncontrolled substance, adjuvant agents, physician-ordered physical therapy, structured exercise program, and interventional techniques.

Continue to: Treatment goals should be established...

Treatment goals should be established and understood by the prescriber and patient prior to initiation of opioids.²⁸ Overarching treatment goals for all opioids prescribed are pain relief (but not necessarily a focus on pain scores), improvement in functional activity, and minimization of adverse effects, with the latter 2 goals taking precedence.³¹ To assess outcomes, formally measure progress toward goals from baseline evaluations. This can be achieved through repeated use of validated tools such as those mentioned earlier, or may be more broadly considered as progress toward employment status or increasing participation in activities.³¹ All pain management plans involving opioids should include continued efforts with nonpharmacologic therapy (eg, exercise therapy, weight loss, behavioral training) and nonopioid pharmacologic therapy (eg, nonsteroidal anti-­inflammatory drugs, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants).²⁸

Have an “exit strategy.” As part of goal setting, also consider how therapy will be discontinued if benefits do not outweigh the risks of harm.²⁸ Weigh functional status gains against adverse opioid consequences using the PEG scale (pain, enjoyment of life, and general activity) (TABLE 2³²).³³ Improvements of 30% from baseline have been deemed clinically meaningful by some,³² but not all benefits will be easy to quantify. At the start of treatment dialogue, use the term “therapeutic trial” instead of ”treatment plan” to more effectively convey that opioids will be continued only if safe and effective, and will be prescribed at the lowest effective dose as one component of the multimodal approach to pain.³⁰

Initiation of treatment: Opioid selection and dosing

When initiating opioid therapy, prescribe an immediate-release, short-acting agent instead of an ER/LA formulation.²⁸

For moderate pain, first consider tramadol, codeine, tapentadol, or hydrocodone.³¹ Second-line agents for moderate pain are hydrocodone or oxycodone.³¹

For severe pain, first-line agents include hydrocodone, oxycodone, hydromorphone, or morphine.³¹ Second-line agents for severe pain are fentanyl and, with careful supervision or referral to a pain specialist, methadone or buprenorphine.³¹

Continue to: Of special note...

Of special note, methadone should not be the first choice for ER/LA opioid due to its unique long half-life and ability to prolong the QT interval.³⁴ Only clinicians familiar with its use should prescribe methadone, while referring to the drug’s clinical practice guideline for further advice.

At the start, prescribe the lowest effective dosage (referring to the product labeling for guidance) and calculate total daily dose in terms of morphine milligram equivalents (MME) (TABLE 3^35-37).²⁸ Exercise caution when considering opioids for patients with respiratory sleep disorders and for patients ≥ 65 years due to altered pharmacokinetics in the elderly population.³⁸ Also make dose adjustments for renal and hepatic insufficiency (TABLE 4³⁵).

All pain management involving opioids should include nonpharmacologic components, such as exercise and weight loss.

Doses between 20 to 50 MME/d are considered relatively low dosages.²⁸ Be cautious when prescribing an opioid at any dosage, and reassess evidence of individual benefits and risks before increasing the dosage to ≥ 50 MME/d.²⁸ Regard a dosage of 90 MME/d as maximal.²⁸ While there is no analgesic ceiling, doses greater than 90 MME/d are associated with risk for overdose and should prompt referral to a pain specialist.³¹ Veterans Administration guidelines cite strong evidence that risk for overdose and death significantly increases at a range of 20 to 50 MME/d.³³ Daily doses exceeding 90 MME/d should be documented with rational justification.²⁸

CASE

Noncontrolled medications are preferred in the treatment of chronic pain. However, the utility of adjuvant options such as NSAIDs, duloxetine, or gabapentin were limited in Mr. G’s case due to his ESRD. Calcium channel α2-δ ligands may have been effective in reducing symptoms of neuropathic pain but would have had limited efficacy against osteoarthritis. Based on his low risk for opioid misuse, we decided to start Mr. G on oxycodone 2.5 mg PO, every 6 hours as needed for moderate-to-severe pain, and to follow up in 1 month. We also explained proper lifting form to him and encouraged him to continue with physical therapy.

Deciding to continue therapy with opioids

There is a lack of convincing evidence that opioid use beyond 6 months improves quality of life; patients do not report a significant reduction in pain beyond this time.²⁸ Thus, a repeat evaluation of continued medical necessity is essential before deciding in favor of ongoing, long-term treatment with opioids. Continue prescribing opioids only if there is meaningful pain relief and improved function that outweighs the harms that may be expected for a given patient.³¹ With all patients, consider prescribing naloxone to accompany dispensed opioid prescriptions.²⁸ This is particularly important for those at risk for misuse (history of overdose, history of substance use disorder, dosages ≥ 50 MME/d, or concurrent benzodiazepine use). Resources for prescribing naloxone in primary care settings can be found through Prescribe to Prevent at http://prescribetoprevent.org. Due to the established risk of overdose, avoid, if possible, concomitant prescriptions of benzodiazepines and opioids.³¹

Continue to: Follow-up and monitoring

 

 

Follow-up and monitoring

Responsiveness to opioids varies greatly among individuals.^38,39 An opioid that leads to a therapeutic analgesic effect in one patient may cause adverse events or toxicity in another. Periodically reassess the appropriateness of chronic opioid therapy and modify treatment based on its ability to meet therapeutic goals. While practice behaviors and clinic policies vary across institutions, risk stratification can provide guidance on the frequency and intensity of follow-up and monitoring. Kaye et al²¹ describe a triage system in which low-risk patients may be managed by a primary care provider with routine follow-up and reassessment every 3 months.²¹ Moderate-risk patients may warrant additional management by specialists and a monthly follow-up. High-risk patients may need referrals to interdisciplinary pain centers or addiction specialists.²¹

Along these lines, the CDC recommends conducting a PDMP review and UDT before initiating therapy, followed by a periodic PDMP (every 1-3 months) and a UDT at least annually. Keep in mind, providers should follow their state-specific regulations, as monitoring requirements may vary. In addition, clinicians should always be alert to adverse reactions (TABLE 4³⁵) and sudden behavior changes such as respiratory depression, nausea, constipation, pruritus, cognitive impairment, falls, motor vehicle accidents, and aberrant behaviors. Under these circumstances, consider a dose reduction and, in certain cases, discontinuation.

Additionally, in cases of pain unresponsive to escalating opioid doses, include opioid-induced hyperalgesia (OIH) in the differential. Dose reductions, opioid rotations, and office-based detoxifications are all options for the treatment of OIH.⁴⁰ Assessment of pain and function can be accomplished using the PEG scale (TABLE 2).³²

CASE

Two weeks into Mr. G’s initial regimen, he called to report no change in pain or functional status. We increased his dose to 5 mg PO every 6 hours as needed. At his 1-month follow-up appointment, he reported his pain as 6/10 and no adverse effects. We again increased his dose to 10 mg PO every 6 hours as needed, with follow-up in another month.

Discontinuation and tapering of opioids

Indications for discontinuing opioids are patient request, resolution of pain, doses ≥ 90 MME/d (in which case a pain specialist should be consulted), inadequate response, untoward adverse effects, and abuse and misuse.^1,31,41 However, providers may also face the challenge of working with patients for whom the benefit of opioid therapy is uncertain but who do not have an absolute contraindication. Guidance on this matter may be found in a 2017 systematic review of studies on reducing or discontinuing long-term opioid therapy.⁴² Although evidence on the whole was low quality, it showed that tapering or discontinuing opioids may actually reduce pain and improve function and quality of life.

Continue to: When working with a patient to taper treatment

When working with a patient to taper treatment, consider using a multidisciplinary approach. Also, assess the patient’s pain level and perception of needs for opioids, make clear the substantial effort that will be asked of the patient, and agree on coping strategies the patient can use to manage the taper.^31,43 While the evidence does not appear to support one tapering regimen over another, we can offer some recommendations on ways to individualize a tapering regimen (TABLE 5).^{1,31,41,43,44}

General recommendations. Gradually reduce the original MME dose by 5% to 10% every week to every 4 weeks, with frequent follow-up and adjustments as needed based on the individual’s response.^1,31,41,43 In the event that the patient does not tolerate this dose-reduction schedule, tapering can be slowed further.³¹ Avoid abrupt discontinuation.³³ Opioid abstinence syndrome, a myriad of symptoms caused by deprivation of opioids in physiologically dependent individuals, ­although rare, can occur during tapering and can be managed with clonidine 0.1 to 0.2 mg orally every 6 hours or transdermal clonidine patch 0.1 mg/24 hours weekly during the taper.³¹

Methadone should not be the first choice for an extended-release/long-acting opioid due to its long half-life and ability to prolong the QT interval.

Tapering of long-term opioid treatment is not without risk. Immediate risks include withdrawal syndrome, hyperalgesia, and dropout, while ongoing issues are potential relapse, problems in increasing and maintaining function, and medicolegal implications.⁴³ Withdrawal symptoms begin 2 to 3 half-lives after the last dose of opioid, and resolution varies depending on the duration of use, the most recent dose, and speed of tapering.⁴³ In general, a patient needs 20% to 25% of the previous day’s dose to prevent withdrawal symptoms.³¹ Increased pain appears to be a brief, time-limited occurance.⁴³ Dropout and relapse tend to be attributed to patient factors such as depressive symptoms and higher pain scores at initiation of the taper.⁴³ Low pain at the end of tapering has been shown to predict long-term abstinence from opioids.⁴³

CASE

Two months into his oxycodone regimen, Mr. G reported improved functional status at his catering job and overall improved quality of life. He had improved his lifting form and was attending biweekly physical therapy sessions. His pain score was 3/10. He expressed a desire to “not get hooked on opioids,” and mentioned he had “tried stopping the medicine last week” but experienced withdrawal symptoms. We discussed and prescribed the following 5-week taper plan: 2.5 mg reduction of oxycodone per dose, every 2 weeks x 2. Then 2.5 mg PO every 6 hours as needed x 1 week before stopping.

Organizing your approach

As part of goal setting, consider how therapy will be discontinued if benefits do not outweigh the risks of harm.

To optimize the chance for success in opioid treatment and to heighten vigilance and minimize harm to patients, we believe an organized approach is key (TABLE 6^{14,22-24,28,30-32}), particularly since this class of medication lacks strong evidence to support its long-term use.

CORRESPONDENCE 
Tracy Mahvan, PharmD, BCGP, University of Wyoming, School of Pharmacy, 1000 East University Avenue, Laramie, WY 82071; tbaher@uwyo.edu.

CASE

Marcelo G* is a 46-year-old man who presented to our family medicine clinic with a complex medical history including end-stage renal disease (ESRD) and hemodialysis, chronic anemia, peripheral vascular disease, venous thromboembolism and anticoagulation, major depressive disorder, osteoarthritis, and lumbosacral radiculopathy. His current medications included vitamin B complex, cholecalciferol, atorvastatin, warfarin, acetaminophen, diclofenac gel, and capsaicin cream. Mr. G reported bothersome bilateral knee and back pain despite physical therapy and consistent use of his current medications in addition to occasional intra-articular glucocorticoid injections. He mentioned that he had benefited in the past from intermittent opioid use.

How would you manage this patient’s care?

*The patient’s name has been changed to protect his identity.

In 2013, an estimated 191 million prescriptions for ­opioids were written by health care providers, which is the equivalent of all adults living in the United States having their own opioid prescription.¹ This large expansion in opioid prescribing and use has also led to a rise in opioid overdose deaths, whether from prescribed or illicit use.¹ The Centers for Disease Control and Prevention (CDC) points out that each day, approximately 128 Americans die from an opioid overdose.¹ Deaths that occur from opioid overdose often involve the prescribed opioids methadone, oxycodone, and hydrocodone, the illicit opioid heroin, and, of particular concern, prescription and illicit fentanyl.¹

IMAGE: © JOE GORMAN

Family physicians write more opioid prescriptions than any other specialty, and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact.

The extent of this problem has sparked the development of health safety initiatives and research efforts. Through production quotas, the US Drug Enforcement Administration (DEA) reduced the number of opioids produced across all schedule I and schedule II lists in 2017 by as much as 25%.² The DEA again reduced the amounts produced in 2018.³ For 2020, the DEA has determined that the production quotas and assessment of annual needs are sufficient.⁴

The CDC has also promoted access to naloxone and prevention initiatives; pharmacies in some states have standing orders for naloxone, and medical personnel and law enforcement now carry it.^1,5 Finally, new research has identified risk factors that influence one’s potential for addiction, such as mental illness, history of substance and alcohol abuse, and a low income.⁶ Interestingly, while numerous initiatives and strategies have been implemented across health systems, there is little evidence that demonstrates how implementation of safe prescribing strategies has affected overall patient safety and avoidance of opioid-related harms.

Nevertheless, concerns related to ­opioids are especially important for primary care ­providers, who manage many patients with acute and chronic diseases and disorders that require pain control.⁷ Family physicians write more opioid prescriptions than any ­other specialty,⁸ and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact. This article provides a guide to safe opioid prescribing.

Continue to: Use the patient interview to ensure that Tx aligns with patient goals

 

 

Use the patient interview to ensure that Tx aligns with patient goals

For patients presenting with chronic pain, conduct a complete general history and physical examination that includes a review of available records; a medical, surgical, social, family, medication, and allergy history; a review of systems; and documentation of any psychiatric comorbidities (ie, depression, anxiety, psychiatric disorders, personality traits). Inquiries about social history and current medications should explore the possibility of previous and current substance use and misuse.

While causes of pain can be assessed through physical examination and diagnostic tests, the patient interview is an invaluable source of information. No single means of assessment has consistently demonstrated superiority over another in measuring pain, and numerous standard assessment tools are available (TABLE 1^9-13).¹⁴ Unidimensional tools are often easy and quick ways to assess pain intensity. Multidimensional tools, although more time intensive, are designed to gather more subjective information about the patient’s pain. Finally, use an instrument such as the 9-item Patient Health Questionnaire (PHQ-9) to screen patients for psychological distress.^15,16

Use state prescription drug monitoring programs and urine drug testing to confirm patient compliance.

Provide an environment for patients to openly discuss their experiences, expectations, preferences, fears, and coping efforts, as well as the impact that pain has had on their lives.^17,18 Without this foundational understanding, medical treatment may work against the patient’s goals. An empathic approach allows for effective communication, shared decision making, and ultimately, an avenue for individualized therapy.

Balancing treatment with risk mitigation

The challenge of managing chronic pain is to balance treating the patient with the basic principle of nonmaleficence (primum non nocere: “first, do no harm”). The literature has shown that risk factors such as a family history of substance abuse or sexual abuse, younger age, and psychological disease may be linked to greater risk for opioid misuse.^19,20 However, despite the many risk-screening tools available, no single instrument has reliably and accurately predicted those at higher propensity for prescription addiction. In fact, risk-screening tools as a whole remain unregulated by the US Food and Drug Administration (FDA) and other authorities.²¹ Still, screening tools provide useful information as one component of the risk-mitigation process.

Screening tools. The tools most commonly used clinically to stratify risk prior to prescribing opioids are the 5-item Opioid Risk Tool (ORT),²² the revised 24-item Screener and Opioid Assessment for Patients with Pain (SOAPP-R),²³ which are patient self-administered assessments, and the 7-item clinician-administered DIRE (Diagnosis, Intractability, Risk, Efficacy).²⁴ Given the subtle differences in criteria and the time required for each of these risk assessments, we recommend choosing one based on site-specific resources and overall clinician comfort.²⁵ Risk stratification helps to determine the optimal frequency and intensity of monitoring, not necessarily to deny care to “high-risk” patients.

Continue to: In fact, just as the "universal precautions"...

In fact, just as the “universal precautions” approach has been applied to infection control, many have suggested using a similar approach to pain management. Risk screening should never be misunderstood as an attempt to diminish or undermine the patient’s burden of pain. By routinely conducting thorough and respectful inquiries of risk factors for all patients, clinicians can reduce stigma, improve care, and contain overall risk.^26,27

Monitoring programs and patient agreements. In addition to risk-screening tools, the CDC recommends using state prescription drug monitoring programs (PDMP) and urine drug testing (UDT) data to confirm the use of prescribed and illicit substances.²⁸ All 50 states have implemented PDMPs.²⁹ Consider incorporating these components into controlled-substance agreements, which ultimately aim to promote safety and trust between patients and providers. Of course, such agreements do not eliminate all risks associated with opioid prescribing, nor do they guarantee the absence of adverse outcomes. However, when used correctly, they can provide safeguards to reduce misuse and abuse. They also have the potential to preserve the patient-provider relationship, as opposed to providers cursorily refusing to prescribe opioids altogether. The term “controlled-substance agreement” is preferable to “pain contract” or “narcotic contract” as the latter 2 terms may feel stigmatizing and threatening.³⁰

Risk evaluation and mitigation strategy (REMS). In an effort to ensure that benefits of opioid analgesics continue to outweigh the risks, the FDA approved the extended-release (ER)/long-acting (LA) opioid analgesics shared system REMS. Under this REMS, a consortium of ER/LA opioid manufacturers is mandated to provide prescriber education in the form of accredited continuing education and patient educational materials, available at https://opioidanalgesicrems.com/RpcUI/home.u.

CASE

After reviewing Mr. G’s chart and conducting a history, we learned that his bilateral knee osteoarthritis was atraumatic and likely due to overuse—although possibly affected by major trauma in a motor vehicle accident 5 years earlier. Imaging also revealed multilevel disc degeneration contributing to his radicular back pain, which seemed to be worse on days after working as a caterer. Poor lifting form at work may have contributed to his pain. Nevertheless, he had been consistent with medical follow-up and denied current or past use of illicit substances. Per the numeric rating scale (NRS), he reported 8 out of 10 pain in his knees and 6 out of 10 in his back. In addition to obtaining a PHQ-9 score of 4, we conducted a DIRE assessment and obtained a score of 19 out of a possible 21, indicating that he may be a good candidate for long-term opioid analgesia.

Criteria for prescribing opioids and for guiding treatment goals

Prescribing an opioid requires establishing a medical necessity based on 3 criteria:³¹

• pain of moderate-to-severe degree
• a physical diagnosis or suspected organic problem
• documented treatment failure of a noncontrolled substance, adjuvant agents, physician-ordered physical therapy, structured exercise program, and interventional techniques.

Continue to: Treatment goals should be established...

Treatment goals should be established and understood by the prescriber and patient prior to initiation of opioids.²⁸ Overarching treatment goals for all opioids prescribed are pain relief (but not necessarily a focus on pain scores), improvement in functional activity, and minimization of adverse effects, with the latter 2 goals taking precedence.³¹ To assess outcomes, formally measure progress toward goals from baseline evaluations. This can be achieved through repeated use of validated tools such as those mentioned earlier, or may be more broadly considered as progress toward employment status or increasing participation in activities.³¹ All pain management plans involving opioids should include continued efforts with nonpharmacologic therapy (eg, exercise therapy, weight loss, behavioral training) and nonopioid pharmacologic therapy (eg, nonsteroidal anti-­inflammatory drugs, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants).²⁸

Have an “exit strategy.” As part of goal setting, also consider how therapy will be discontinued if benefits do not outweigh the risks of harm.²⁸ Weigh functional status gains against adverse opioid consequences using the PEG scale (pain, enjoyment of life, and general activity) (TABLE 2³²).³³ Improvements of 30% from baseline have been deemed clinically meaningful by some,³² but not all benefits will be easy to quantify. At the start of treatment dialogue, use the term “therapeutic trial” instead of ”treatment plan” to more effectively convey that opioids will be continued only if safe and effective, and will be prescribed at the lowest effective dose as one component of the multimodal approach to pain.³⁰

Initiation of treatment: Opioid selection and dosing

When initiating opioid therapy, prescribe an immediate-release, short-acting agent instead of an ER/LA formulation.²⁸

For moderate pain, first consider tramadol, codeine, tapentadol, or hydrocodone.³¹ Second-line agents for moderate pain are hydrocodone or oxycodone.³¹

For severe pain, first-line agents include hydrocodone, oxycodone, hydromorphone, or morphine.³¹ Second-line agents for severe pain are fentanyl and, with careful supervision or referral to a pain specialist, methadone or buprenorphine.³¹

Continue to: Of special note...

Of special note, methadone should not be the first choice for ER/LA opioid due to its unique long half-life and ability to prolong the QT interval.³⁴ Only clinicians familiar with its use should prescribe methadone, while referring to the drug’s clinical practice guideline for further advice.

At the start, prescribe the lowest effective dosage (referring to the product labeling for guidance) and calculate total daily dose in terms of morphine milligram equivalents (MME) (TABLE 3^35-37).²⁸ Exercise caution when considering opioids for patients with respiratory sleep disorders and for patients ≥ 65 years due to altered pharmacokinetics in the elderly population.³⁸ Also make dose adjustments for renal and hepatic insufficiency (TABLE 4³⁵).

All pain management involving opioids should include nonpharmacologic components, such as exercise and weight loss.

Doses between 20 to 50 MME/d are considered relatively low dosages.²⁸ Be cautious when prescribing an opioid at any dosage, and reassess evidence of individual benefits and risks before increasing the dosage to ≥ 50 MME/d.²⁸ Regard a dosage of 90 MME/d as maximal.²⁸ While there is no analgesic ceiling, doses greater than 90 MME/d are associated with risk for overdose and should prompt referral to a pain specialist.³¹ Veterans Administration guidelines cite strong evidence that risk for overdose and death significantly increases at a range of 20 to 50 MME/d.³³ Daily doses exceeding 90 MME/d should be documented with rational justification.²⁸

CASE

Noncontrolled medications are preferred in the treatment of chronic pain. However, the utility of adjuvant options such as NSAIDs, duloxetine, or gabapentin were limited in Mr. G’s case due to his ESRD. Calcium channel α2-δ ligands may have been effective in reducing symptoms of neuropathic pain but would have had limited efficacy against osteoarthritis. Based on his low risk for opioid misuse, we decided to start Mr. G on oxycodone 2.5 mg PO, every 6 hours as needed for moderate-to-severe pain, and to follow up in 1 month. We also explained proper lifting form to him and encouraged him to continue with physical therapy.

Deciding to continue therapy with opioids

There is a lack of convincing evidence that opioid use beyond 6 months improves quality of life; patients do not report a significant reduction in pain beyond this time.²⁸ Thus, a repeat evaluation of continued medical necessity is essential before deciding in favor of ongoing, long-term treatment with opioids. Continue prescribing opioids only if there is meaningful pain relief and improved function that outweighs the harms that may be expected for a given patient.³¹ With all patients, consider prescribing naloxone to accompany dispensed opioid prescriptions.²⁸ This is particularly important for those at risk for misuse (history of overdose, history of substance use disorder, dosages ≥ 50 MME/d, or concurrent benzodiazepine use). Resources for prescribing naloxone in primary care settings can be found through Prescribe to Prevent at http://prescribetoprevent.org. Due to the established risk of overdose, avoid, if possible, concomitant prescriptions of benzodiazepines and opioids.³¹

Continue to: Follow-up and monitoring

 

 

Follow-up and monitoring

Responsiveness to opioids varies greatly among individuals.^38,39 An opioid that leads to a therapeutic analgesic effect in one patient may cause adverse events or toxicity in another. Periodically reassess the appropriateness of chronic opioid therapy and modify treatment based on its ability to meet therapeutic goals. While practice behaviors and clinic policies vary across institutions, risk stratification can provide guidance on the frequency and intensity of follow-up and monitoring. Kaye et al²¹ describe a triage system in which low-risk patients may be managed by a primary care provider with routine follow-up and reassessment every 3 months.²¹ Moderate-risk patients may warrant additional management by specialists and a monthly follow-up. High-risk patients may need referrals to interdisciplinary pain centers or addiction specialists.²¹

Along these lines, the CDC recommends conducting a PDMP review and UDT before initiating therapy, followed by a periodic PDMP (every 1-3 months) and a UDT at least annually. Keep in mind, providers should follow their state-specific regulations, as monitoring requirements may vary. In addition, clinicians should always be alert to adverse reactions (TABLE 4³⁵) and sudden behavior changes such as respiratory depression, nausea, constipation, pruritus, cognitive impairment, falls, motor vehicle accidents, and aberrant behaviors. Under these circumstances, consider a dose reduction and, in certain cases, discontinuation.

Additionally, in cases of pain unresponsive to escalating opioid doses, include opioid-induced hyperalgesia (OIH) in the differential. Dose reductions, opioid rotations, and office-based detoxifications are all options for the treatment of OIH.⁴⁰ Assessment of pain and function can be accomplished using the PEG scale (TABLE 2).³²

CASE

Two weeks into Mr. G’s initial regimen, he called to report no change in pain or functional status. We increased his dose to 5 mg PO every 6 hours as needed. At his 1-month follow-up appointment, he reported his pain as 6/10 and no adverse effects. We again increased his dose to 10 mg PO every 6 hours as needed, with follow-up in another month.

Discontinuation and tapering of opioids

Indications for discontinuing opioids are patient request, resolution of pain, doses ≥ 90 MME/d (in which case a pain specialist should be consulted), inadequate response, untoward adverse effects, and abuse and misuse.^1,31,41 However, providers may also face the challenge of working with patients for whom the benefit of opioid therapy is uncertain but who do not have an absolute contraindication. Guidance on this matter may be found in a 2017 systematic review of studies on reducing or discontinuing long-term opioid therapy.⁴² Although evidence on the whole was low quality, it showed that tapering or discontinuing opioids may actually reduce pain and improve function and quality of life.

Continue to: When working with a patient to taper treatment

When working with a patient to taper treatment, consider using a multidisciplinary approach. Also, assess the patient’s pain level and perception of needs for opioids, make clear the substantial effort that will be asked of the patient, and agree on coping strategies the patient can use to manage the taper.^31,43 While the evidence does not appear to support one tapering regimen over another, we can offer some recommendations on ways to individualize a tapering regimen (TABLE 5).^{1,31,41,43,44}

General recommendations. Gradually reduce the original MME dose by 5% to 10% every week to every 4 weeks, with frequent follow-up and adjustments as needed based on the individual’s response.^1,31,41,43 In the event that the patient does not tolerate this dose-reduction schedule, tapering can be slowed further.³¹ Avoid abrupt discontinuation.³³ Opioid abstinence syndrome, a myriad of symptoms caused by deprivation of opioids in physiologically dependent individuals, ­although rare, can occur during tapering and can be managed with clonidine 0.1 to 0.2 mg orally every 6 hours or transdermal clonidine patch 0.1 mg/24 hours weekly during the taper.³¹

Methadone should not be the first choice for an extended-release/long-acting opioid due to its long half-life and ability to prolong the QT interval.

Tapering of long-term opioid treatment is not without risk. Immediate risks include withdrawal syndrome, hyperalgesia, and dropout, while ongoing issues are potential relapse, problems in increasing and maintaining function, and medicolegal implications.⁴³ Withdrawal symptoms begin 2 to 3 half-lives after the last dose of opioid, and resolution varies depending on the duration of use, the most recent dose, and speed of tapering.⁴³ In general, a patient needs 20% to 25% of the previous day’s dose to prevent withdrawal symptoms.³¹ Increased pain appears to be a brief, time-limited occurance.⁴³ Dropout and relapse tend to be attributed to patient factors such as depressive symptoms and higher pain scores at initiation of the taper.⁴³ Low pain at the end of tapering has been shown to predict long-term abstinence from opioids.⁴³

CASE

Two months into his oxycodone regimen, Mr. G reported improved functional status at his catering job and overall improved quality of life. He had improved his lifting form and was attending biweekly physical therapy sessions. His pain score was 3/10. He expressed a desire to “not get hooked on opioids,” and mentioned he had “tried stopping the medicine last week” but experienced withdrawal symptoms. We discussed and prescribed the following 5-week taper plan: 2.5 mg reduction of oxycodone per dose, every 2 weeks x 2. Then 2.5 mg PO every 6 hours as needed x 1 week before stopping.

Organizing your approach

As part of goal setting, consider how therapy will be discontinued if benefits do not outweigh the risks of harm.

To optimize the chance for success in opioid treatment and to heighten vigilance and minimize harm to patients, we believe an organized approach is key (TABLE 6^{14,22-24,28,30-32}), particularly since this class of medication lacks strong evidence to support its long-term use.

CORRESPONDENCE 
Tracy Mahvan, PharmD, BCGP, University of Wyoming, School of Pharmacy, 1000 East University Avenue, Laramie, WY 82071; tbaher@uwyo.edu.

CASE

Marcelo G* is a 46-year-old man who presented to our family medicine clinic with a complex medical history including end-stage renal disease (ESRD) and hemodialysis, chronic anemia, peripheral vascular disease, venous thromboembolism and anticoagulation, major depressive disorder, osteoarthritis, and lumbosacral radiculopathy. His current medications included vitamin B complex, cholecalciferol, atorvastatin, warfarin, acetaminophen, diclofenac gel, and capsaicin cream. Mr. G reported bothersome bilateral knee and back pain despite physical therapy and consistent use of his current medications in addition to occasional intra-articular glucocorticoid injections. He mentioned that he had benefited in the past from intermittent opioid use.

How would you manage this patient’s care?

*The patient’s name has been changed to protect his identity.

In 2013, an estimated 191 million prescriptions for ­opioids were written by health care providers, which is the equivalent of all adults living in the United States having their own opioid prescription.¹ This large expansion in opioid prescribing and use has also led to a rise in opioid overdose deaths, whether from prescribed or illicit use.¹ The Centers for Disease Control and Prevention (CDC) points out that each day, approximately 128 Americans die from an opioid overdose.¹ Deaths that occur from opioid overdose often involve the prescribed opioids methadone, oxycodone, and hydrocodone, the illicit opioid heroin, and, of particular concern, prescription and illicit fentanyl.¹

IMAGE: © JOE GORMAN

Family physicians write more opioid prescriptions than any other specialty, and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact.

The extent of this problem has sparked the development of health safety initiatives and research efforts. Through production quotas, the US Drug Enforcement Administration (DEA) reduced the number of opioids produced across all schedule I and schedule II lists in 2017 by as much as 25%.² The DEA again reduced the amounts produced in 2018.³ For 2020, the DEA has determined that the production quotas and assessment of annual needs are sufficient.⁴

The CDC has also promoted access to naloxone and prevention initiatives; pharmacies in some states have standing orders for naloxone, and medical personnel and law enforcement now carry it.^1,5 Finally, new research has identified risk factors that influence one’s potential for addiction, such as mental illness, history of substance and alcohol abuse, and a low income.⁶ Interestingly, while numerous initiatives and strategies have been implemented across health systems, there is little evidence that demonstrates how implementation of safe prescribing strategies has affected overall patient safety and avoidance of opioid-related harms.

Nevertheless, concerns related to ­opioids are especially important for primary care ­providers, who manage many patients with acute and chronic diseases and disorders that require pain control.⁷ Family physicians write more opioid prescriptions than any ­other specialty,⁸ and they are therefore uniquely positioned to protect patients, improve the quality of their care, and ultimately produce a meaningful public health impact. This article provides a guide to safe opioid prescribing.

Continue to: Use the patient interview to ensure that Tx aligns with patient goals

 

 

Use the patient interview to ensure that Tx aligns with patient goals

For patients presenting with chronic pain, conduct a complete general history and physical examination that includes a review of available records; a medical, surgical, social, family, medication, and allergy history; a review of systems; and documentation of any psychiatric comorbidities (ie, depression, anxiety, psychiatric disorders, personality traits). Inquiries about social history and current medications should explore the possibility of previous and current substance use and misuse.

While causes of pain can be assessed through physical examination and diagnostic tests, the patient interview is an invaluable source of information. No single means of assessment has consistently demonstrated superiority over another in measuring pain, and numerous standard assessment tools are available (TABLE 1^9-13).¹⁴ Unidimensional tools are often easy and quick ways to assess pain intensity. Multidimensional tools, although more time intensive, are designed to gather more subjective information about the patient’s pain. Finally, use an instrument such as the 9-item Patient Health Questionnaire (PHQ-9) to screen patients for psychological distress.^15,16

Use state prescription drug monitoring programs and urine drug testing to confirm patient compliance.

Provide an environment for patients to openly discuss their experiences, expectations, preferences, fears, and coping efforts, as well as the impact that pain has had on their lives.^17,18 Without this foundational understanding, medical treatment may work against the patient’s goals. An empathic approach allows for effective communication, shared decision making, and ultimately, an avenue for individualized therapy.

Balancing treatment with risk mitigation

The challenge of managing chronic pain is to balance treating the patient with the basic principle of nonmaleficence (primum non nocere: “first, do no harm”). The literature has shown that risk factors such as a family history of substance abuse or sexual abuse, younger age, and psychological disease may be linked to greater risk for opioid misuse.^19,20 However, despite the many risk-screening tools available, no single instrument has reliably and accurately predicted those at higher propensity for prescription addiction. In fact, risk-screening tools as a whole remain unregulated by the US Food and Drug Administration (FDA) and other authorities.²¹ Still, screening tools provide useful information as one component of the risk-mitigation process.

Screening tools. The tools most commonly used clinically to stratify risk prior to prescribing opioids are the 5-item Opioid Risk Tool (ORT),²² the revised 24-item Screener and Opioid Assessment for Patients with Pain (SOAPP-R),²³ which are patient self-administered assessments, and the 7-item clinician-administered DIRE (Diagnosis, Intractability, Risk, Efficacy).²⁴ Given the subtle differences in criteria and the time required for each of these risk assessments, we recommend choosing one based on site-specific resources and overall clinician comfort.²⁵ Risk stratification helps to determine the optimal frequency and intensity of monitoring, not necessarily to deny care to “high-risk” patients.

Continue to: In fact, just as the "universal precautions"...

In fact, just as the “universal precautions” approach has been applied to infection control, many have suggested using a similar approach to pain management. Risk screening should never be misunderstood as an attempt to diminish or undermine the patient’s burden of pain. By routinely conducting thorough and respectful inquiries of risk factors for all patients, clinicians can reduce stigma, improve care, and contain overall risk.^26,27

Monitoring programs and patient agreements. In addition to risk-screening tools, the CDC recommends using state prescription drug monitoring programs (PDMP) and urine drug testing (UDT) data to confirm the use of prescribed and illicit substances.²⁸ All 50 states have implemented PDMPs.²⁹ Consider incorporating these components into controlled-substance agreements, which ultimately aim to promote safety and trust between patients and providers. Of course, such agreements do not eliminate all risks associated with opioid prescribing, nor do they guarantee the absence of adverse outcomes. However, when used correctly, they can provide safeguards to reduce misuse and abuse. They also have the potential to preserve the patient-provider relationship, as opposed to providers cursorily refusing to prescribe opioids altogether. The term “controlled-substance agreement” is preferable to “pain contract” or “narcotic contract” as the latter 2 terms may feel stigmatizing and threatening.³⁰

Risk evaluation and mitigation strategy (REMS). In an effort to ensure that benefits of opioid analgesics continue to outweigh the risks, the FDA approved the extended-release (ER)/long-acting (LA) opioid analgesics shared system REMS. Under this REMS, a consortium of ER/LA opioid manufacturers is mandated to provide prescriber education in the form of accredited continuing education and patient educational materials, available at https://opioidanalgesicrems.com/RpcUI/home.u.

CASE

After reviewing Mr. G’s chart and conducting a history, we learned that his bilateral knee osteoarthritis was atraumatic and likely due to overuse—although possibly affected by major trauma in a motor vehicle accident 5 years earlier. Imaging also revealed multilevel disc degeneration contributing to his radicular back pain, which seemed to be worse on days after working as a caterer. Poor lifting form at work may have contributed to his pain. Nevertheless, he had been consistent with medical follow-up and denied current or past use of illicit substances. Per the numeric rating scale (NRS), he reported 8 out of 10 pain in his knees and 6 out of 10 in his back. In addition to obtaining a PHQ-9 score of 4, we conducted a DIRE assessment and obtained a score of 19 out of a possible 21, indicating that he may be a good candidate for long-term opioid analgesia.

Criteria for prescribing opioids and for guiding treatment goals

Prescribing an opioid requires establishing a medical necessity based on 3 criteria:³¹

• pain of moderate-to-severe degree
• a physical diagnosis or suspected organic problem
• documented treatment failure of a noncontrolled substance, adjuvant agents, physician-ordered physical therapy, structured exercise program, and interventional techniques.

Continue to: Treatment goals should be established...

Treatment goals should be established and understood by the prescriber and patient prior to initiation of opioids.²⁸ Overarching treatment goals for all opioids prescribed are pain relief (but not necessarily a focus on pain scores), improvement in functional activity, and minimization of adverse effects, with the latter 2 goals taking precedence.³¹ To assess outcomes, formally measure progress toward goals from baseline evaluations. This can be achieved through repeated use of validated tools such as those mentioned earlier, or may be more broadly considered as progress toward employment status or increasing participation in activities.³¹ All pain management plans involving opioids should include continued efforts with nonpharmacologic therapy (eg, exercise therapy, weight loss, behavioral training) and nonopioid pharmacologic therapy (eg, nonsteroidal anti-­inflammatory drugs, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants).²⁸

Have an “exit strategy.” As part of goal setting, also consider how therapy will be discontinued if benefits do not outweigh the risks of harm.²⁸ Weigh functional status gains against adverse opioid consequences using the PEG scale (pain, enjoyment of life, and general activity) (TABLE 2³²).³³ Improvements of 30% from baseline have been deemed clinically meaningful by some,³² but not all benefits will be easy to quantify. At the start of treatment dialogue, use the term “therapeutic trial” instead of ”treatment plan” to more effectively convey that opioids will be continued only if safe and effective, and will be prescribed at the lowest effective dose as one component of the multimodal approach to pain.³⁰

Initiation of treatment: Opioid selection and dosing

When initiating opioid therapy, prescribe an immediate-release, short-acting agent instead of an ER/LA formulation.²⁸

For moderate pain, first consider tramadol, codeine, tapentadol, or hydrocodone.³¹ Second-line agents for moderate pain are hydrocodone or oxycodone.³¹

For severe pain, first-line agents include hydrocodone, oxycodone, hydromorphone, or morphine.³¹ Second-line agents for severe pain are fentanyl and, with careful supervision or referral to a pain specialist, methadone or buprenorphine.³¹

Continue to: Of special note...

Of special note, methadone should not be the first choice for ER/LA opioid due to its unique long half-life and ability to prolong the QT interval.³⁴ Only clinicians familiar with its use should prescribe methadone, while referring to the drug’s clinical practice guideline for further advice.

At the start, prescribe the lowest effective dosage (referring to the product labeling for guidance) and calculate total daily dose in terms of morphine milligram equivalents (MME) (TABLE 3^35-37).²⁸ Exercise caution when considering opioids for patients with respiratory sleep disorders and for patients ≥ 65 years due to altered pharmacokinetics in the elderly population.³⁸ Also make dose adjustments for renal and hepatic insufficiency (TABLE 4³⁵).

All pain management involving opioids should include nonpharmacologic components, such as exercise and weight loss.

Doses between 20 to 50 MME/d are considered relatively low dosages.²⁸ Be cautious when prescribing an opioid at any dosage, and reassess evidence of individual benefits and risks before increasing the dosage to ≥ 50 MME/d.²⁸ Regard a dosage of 90 MME/d as maximal.²⁸ While there is no analgesic ceiling, doses greater than 90 MME/d are associated with risk for overdose and should prompt referral to a pain specialist.³¹ Veterans Administration guidelines cite strong evidence that risk for overdose and death significantly increases at a range of 20 to 50 MME/d.³³ Daily doses exceeding 90 MME/d should be documented with rational justification.²⁸

CASE

Noncontrolled medications are preferred in the treatment of chronic pain. However, the utility of adjuvant options such as NSAIDs, duloxetine, or gabapentin were limited in Mr. G’s case due to his ESRD. Calcium channel α2-δ ligands may have been effective in reducing symptoms of neuropathic pain but would have had limited efficacy against osteoarthritis. Based on his low risk for opioid misuse, we decided to start Mr. G on oxycodone 2.5 mg PO, every 6 hours as needed for moderate-to-severe pain, and to follow up in 1 month. We also explained proper lifting form to him and encouraged him to continue with physical therapy.

Deciding to continue therapy with opioids

There is a lack of convincing evidence that opioid use beyond 6 months improves quality of life; patients do not report a significant reduction in pain beyond this time.²⁸ Thus, a repeat evaluation of continued medical necessity is essential before deciding in favor of ongoing, long-term treatment with opioids. Continue prescribing opioids only if there is meaningful pain relief and improved function that outweighs the harms that may be expected for a given patient.³¹ With all patients, consider prescribing naloxone to accompany dispensed opioid prescriptions.²⁸ This is particularly important for those at risk for misuse (history of overdose, history of substance use disorder, dosages ≥ 50 MME/d, or concurrent benzodiazepine use). Resources for prescribing naloxone in primary care settings can be found through Prescribe to Prevent at http://prescribetoprevent.org. Due to the established risk of overdose, avoid, if possible, concomitant prescriptions of benzodiazepines and opioids.³¹

Continue to: Follow-up and monitoring

 

 

Follow-up and monitoring

Responsiveness to opioids varies greatly among individuals.^38,39 An opioid that leads to a therapeutic analgesic effect in one patient may cause adverse events or toxicity in another. Periodically reassess the appropriateness of chronic opioid therapy and modify treatment based on its ability to meet therapeutic goals. While practice behaviors and clinic policies vary across institutions, risk stratification can provide guidance on the frequency and intensity of follow-up and monitoring. Kaye et al²¹ describe a triage system in which low-risk patients may be managed by a primary care provider with routine follow-up and reassessment every 3 months.²¹ Moderate-risk patients may warrant additional management by specialists and a monthly follow-up. High-risk patients may need referrals to interdisciplinary pain centers or addiction specialists.²¹

Along these lines, the CDC recommends conducting a PDMP review and UDT before initiating therapy, followed by a periodic PDMP (every 1-3 months) and a UDT at least annually. Keep in mind, providers should follow their state-specific regulations, as monitoring requirements may vary. In addition, clinicians should always be alert to adverse reactions (TABLE 4³⁵) and sudden behavior changes such as respiratory depression, nausea, constipation, pruritus, cognitive impairment, falls, motor vehicle accidents, and aberrant behaviors. Under these circumstances, consider a dose reduction and, in certain cases, discontinuation.

Additionally, in cases of pain unresponsive to escalating opioid doses, include opioid-induced hyperalgesia (OIH) in the differential. Dose reductions, opioid rotations, and office-based detoxifications are all options for the treatment of OIH.⁴⁰ Assessment of pain and function can be accomplished using the PEG scale (TABLE 2).³²

CASE

Two weeks into Mr. G’s initial regimen, he called to report no change in pain or functional status. We increased his dose to 5 mg PO every 6 hours as needed. At his 1-month follow-up appointment, he reported his pain as 6/10 and no adverse effects. We again increased his dose to 10 mg PO every 6 hours as needed, with follow-up in another month.

Discontinuation and tapering of opioids

Indications for discontinuing opioids are patient request, resolution of pain, doses ≥ 90 MME/d (in which case a pain specialist should be consulted), inadequate response, untoward adverse effects, and abuse and misuse.^1,31,41 However, providers may also face the challenge of working with patients for whom the benefit of opioid therapy is uncertain but who do not have an absolute contraindication. Guidance on this matter may be found in a 2017 systematic review of studies on reducing or discontinuing long-term opioid therapy.⁴² Although evidence on the whole was low quality, it showed that tapering or discontinuing opioids may actually reduce pain and improve function and quality of life.

Continue to: When working with a patient to taper treatment

When working with a patient to taper treatment, consider using a multidisciplinary approach. Also, assess the patient’s pain level and perception of needs for opioids, make clear the substantial effort that will be asked of the patient, and agree on coping strategies the patient can use to manage the taper.^31,43 While the evidence does not appear to support one tapering regimen over another, we can offer some recommendations on ways to individualize a tapering regimen (TABLE 5).^{1,31,41,43,44}

General recommendations. Gradually reduce the original MME dose by 5% to 10% every week to every 4 weeks, with frequent follow-up and adjustments as needed based on the individual’s response.^1,31,41,43 In the event that the patient does not tolerate this dose-reduction schedule, tapering can be slowed further.³¹ Avoid abrupt discontinuation.³³ Opioid abstinence syndrome, a myriad of symptoms caused by deprivation of opioids in physiologically dependent individuals, ­although rare, can occur during tapering and can be managed with clonidine 0.1 to 0.2 mg orally every 6 hours or transdermal clonidine patch 0.1 mg/24 hours weekly during the taper.³¹

Methadone should not be the first choice for an extended-release/long-acting opioid due to its long half-life and ability to prolong the QT interval.

Tapering of long-term opioid treatment is not without risk. Immediate risks include withdrawal syndrome, hyperalgesia, and dropout, while ongoing issues are potential relapse, problems in increasing and maintaining function, and medicolegal implications.⁴³ Withdrawal symptoms begin 2 to 3 half-lives after the last dose of opioid, and resolution varies depending on the duration of use, the most recent dose, and speed of tapering.⁴³ In general, a patient needs 20% to 25% of the previous day’s dose to prevent withdrawal symptoms.³¹ Increased pain appears to be a brief, time-limited occurance.⁴³ Dropout and relapse tend to be attributed to patient factors such as depressive symptoms and higher pain scores at initiation of the taper.⁴³ Low pain at the end of tapering has been shown to predict long-term abstinence from opioids.⁴³

CASE

Two months into his oxycodone regimen, Mr. G reported improved functional status at his catering job and overall improved quality of life. He had improved his lifting form and was attending biweekly physical therapy sessions. His pain score was 3/10. He expressed a desire to “not get hooked on opioids,” and mentioned he had “tried stopping the medicine last week” but experienced withdrawal symptoms. We discussed and prescribed the following 5-week taper plan: 2.5 mg reduction of oxycodone per dose, every 2 weeks x 2. Then 2.5 mg PO every 6 hours as needed x 1 week before stopping.

Organizing your approach

As part of goal setting, consider how therapy will be discontinued if benefits do not outweigh the risks of harm.

To optimize the chance for success in opioid treatment and to heighten vigilance and minimize harm to patients, we believe an organized approach is key (TABLE 6^{14,22-24,28,30-32}), particularly since this class of medication lacks strong evidence to support its long-term use.

CORRESPONDENCE 
Tracy Mahvan, PharmD, BCGP, University of Wyoming, School of Pharmacy, 1000 East University Avenue, Laramie, WY 82071; tbaher@uwyo.edu.