It started with a rolled ankle during a routine Army training exercise. Shannon Hubbard never imagined it was the prologue to one of the most debilitating pain conditions known to exist, called ­­­­­­­complex regional pain syndrome.

wildpixel/Thinkstock

The condition causes the nervous system to go haywire, creating pain disproportionate to the actual injury. It also can affect how the body regulates temperature and blood flow.

For Ms. Hubbard, it manifested years ago following surgery on her foot – a common way for it to take hold.

“My leg feels like it’s on fire pretty much all the time. It spreads to different parts of your body,” the 47-year-old veteran said.

Ms. Hubbard props up her leg, careful not to graze it against the kitchen table in her home east of Phoenix. It’s red and swollen, still scarred from an ulcer that landed her in the hospital a few months ago.

“That started as a little blister and 4 days later, it was like the size of a baseball,” she said. “They had to cut it open and then it got infected, and because I have blood flow issues, it doesn’t heal.”

She knows it’s likely to happen again.

“Over the past 3 years, I’ve been prescribed over 60 different medications and combinations; none have even touched the pain,” she said.

Ms. Hubbard said she’s had injections and even traveled across the country for infusions of ketamine, an anesthetic that can be used for pain in extreme cases. Her doctors have discussed amputating her leg because of the frequency of the infections.

“All I can do is manage the pain,” she said. “Opioids have become the best solution.”

For about 9 months, Ms. Hubbard was on a combination of short- and long-acting opioids. She said it gave her enough relief to start leaving the house again and doing physical therapy.

But in April that changed. At her monthly appointment, her pain doctor informed her the dose was being lowered. “They had to take one of the pills away,” she said.

Ms. Hubbard knew the rules were part of Arizona’s new opioid law, which places restrictions on prescribing and limits the maximum dose for most patients. She also knew the law wasn’t supposed to affect her – an existing patient with chronic pain.

She argued with the doctor, without success. “They didn’t indicate there was any medical reason for cutting me back. It was simply because of the pressure of the opioid rules.”

Her dose was lowered from 100 morphine milligram equivalents daily (MME) to 90, the highest dose allowed for many new patients in Arizona. She said her pain has been “terrible” ever since.

“It just hurts,” she said. “I don’t want to walk, I pretty much don’t want to do anything.”

Ms. Hubbard’s condition may be extreme, but her situation isn’t unique. Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Increasingly, some patients with chronic pain like Ms. Hubbard say they are becoming collateral damage.
 

New limits on prescribing

More than two dozen states have implemented laws or policies limiting opioid prescriptions in some way. The most common is to restrict a patient’s first prescription to a number of pills that should last a week or less. But some states like Arizona have gone further by placing a ceiling on the maximum dose for most patients.

The Arizona Opioid Epidemic Act, the culmination of months of outreach and planning by state health officials, was passed earlier this year with unanimous support.

It started in June 2017, when Arizona Gov. Doug Ducey, a Republican, declared a public health emergency, citing new data, showing that two people were dying every day in the state from opioid overdoses.

He has pledged to come after those responsible for the rising death toll.

“All bad actors will be held accountable – whether they are doctors, manufacturers, or just plain drug dealers,” the governor said in his annual State of the State address, in January 2018.

He cited statistics from one rural county in which four doctors prescribed 6 million pills in a single year, concluding “something has gone terribly, terribly wrong.”

Later in January, Gov. Ducey called a special session of the Arizona legislature and, in less than a week, he signed the Arizona Opioid Epidemic Act into law. He called it the “most comprehensive and thoughtful package any state has passed to address this issue and crisis to date.”

The law expands access to addiction treatment, ramps up oversight of prescribing and protects from prosecution drug users who call 911 to report an overdose, among other things.

Initially, Arizona’s major medical associations cautioned against what they saw as too much interference in clinical practice, especially since opioid prescriptions already were on the decline.

Gov. Ducey’s administration offered assurances that the law would “maintain access for chronic pain sufferers and others who rely on these drugs.” Restrictions would apply to new patients only. Cancer, trauma, end-of-life, and other serious cases were exempt. Ultimately, the medical establishment came out in favor of the law.
 

Pressure on doctors

Since the law’s passage, some doctors in Arizona report feeling pressure to lower patient doses, even for patients who have been on stable regimens of opioids for years without trouble.

Julian Grove, MD, knows the nuances of Arizona’s new law better than most physicians. A pain physician, Dr. Grove worked with the state on the prescribing rules.

“We moved the needle to a degree so that many patients wouldn’t be as severely affected,” said Dr. Grove, president of the Arizona Pain Society. “But I’ll be the first to say, this has certainly caused a lot of patients problems [and] anxiety.”

“Many people who are prescribing medications have moved to a much more conservative stance and, unfortunately, pain patients are being negatively affected.”

Like many states, Arizona has looked to its prescription-monitoring program as a key tool for tracking overprescribing. State law requires prescribers to check the online database. Report cards are sent out comparing each prescriber to the rest of their cohort. Clinicians consider their scores when deciding how to manage patients’ care, he said.

“A lot of practitioners are reducing opioid medications, not from a clinical perspective, but more from a legal and regulatory perspective for fear of investigation,” Dr. Grove said. “No practitioner wants to be the highest prescriber.”

Arizona’s new prescribing rules don’t apply to board-certified pain specialists like Dr. Grove, who are trained to care for patients with complex chronic pain. But, he said, the reality is that doctors – even pain specialists – were already facing pressure on many fronts to curtail opioids – from the Drug Enforcement Agency to health insurers down to state medical boards.

The new state law has made the reduction of opioids only “more fast and furious,” he said.

Dr. Grove traces the hypervigilance back to guidelines put out by the Centers for Disease Control and Prevention in 2016. The CDC spelled out the risks associated with higher doses of opioids and advised clinicians when starting a patient on opioids to prescribe the lowest effective dosage.

Sally Satel, MD, a psychiatrist and a fellow at the American Enterprise Institute, said those guidelines stipulated the decision to lower a patient’s dose should be decided on a case-by-case basis, not by means of a blanket policy.

“[The guidelines] have been grossly misinterpreted,” Dr. Satel said.

The guidelines were not intended for pain specialists, but rather for primary care physicians, a group that accounted for nearly half of all opioids dispensed from 2007 to 2012.

“There is no mandate to reduce doses on people who have been doing well,” Dr. Satel said.

In the rush to address the nation’s opioid overdose crisis, she said, the CDC’s guidelines have become the model for many regulators and state legislatures. “It’s a very, very unhealthy, deeply chilled environment in which doctors and patients who have chronic pain can no longer work together,” she said.

Dr. Satel called the notion that new prescribing laws will reverse the tide of drug overdose deaths “misguided.”

The rate of opioid prescribing nationally has declined in recent years, though it still soars above the levels of the 1990s. Meanwhile, more people are dying from illicit drugs like heroin and fentanyl than prescription opioids.

In Arizona, more than 1,300 people have died from opioid-related overdoses since June 2017, according to preliminary state numbers. Only a third of those deaths involved just a prescription painkiller.

Heroin is now almost as common as oxycodone in overdose cases in Arizona.
 

A range of views

Some physicians support the new rules, said Pete Wertheim, executive director of the Arizona Osteopathic Medical Association.

“For some, it has been a welcome relief,” he said. “They feel like it has given them an avenue, a means to confront patients.” Some doctors tell him it’s an opportunity to have a tough conversation with patients they believe to be at risk for addiction or overdose because of the medication.

The organization is striving to educate its members about Arizona’s prescribing rules and the exemptions. But, he said, most doctors now feel the message is clear: “We don’t want you prescribing opioids.”

Long before the law passed, Mr. Wertheim said, physicians were already telling him that they had stopped prescribing, because they “didn’t want the liability.”

He worries the current climate around prescribing will drive doctors out of pain management, especially in rural areas. There’s also a fear that some patients who can’t get prescription pills will try stronger street drugs, said Gerald Harris II, MD, an addiction treatment specialist in Glendale, Ariz.

Dr. Harris said he has seen an increase in referrals from doctors concerned that their patients with chronic pain are addicted to opioids. He receives new patients – almost daily, he said – whose physicians have stopped prescribing altogether.

“Their doctor is afraid and he’s cut them off,” Dr. Harris said. “Unfortunately, a great many patients turn to street heroin and other drugs to self-medicate because they couldn’t get the medications they need.”

Arizona’s Department of Health Services is working to reassure providers and dispel the myths, said Cara M. Christ, MD, who heads the agency and helped design the state’s opioid response. She pointed to the recently launched Opioid Assistance and Referral Line, created to help health care providers with complex cases. The state has also released a set of detailed prescribing guidelines for doctors.

Dr. Christ characterizes this as an “adjustment period” while physicians learn the new rules.

“The intent was never to stop prescribers from utilizing opioids,” she said. “It’s really meant to prevent a future generation from developing opioid use disorder, while not impacting current chronic pain patients.”

Dr. Christ said she just hasn’t heard of many patients losing access to medicine.

It’s still too early to gauge the law’s success, she said, but opioid prescriptions continue to decline in Arizona.

Arizona saw a 33% reduction in the number of opioid prescriptions in April, compared with the same period last year, state data show. Dr. Christ’s agency reports that more people are getting help for addiction: There has been about a 40% increase in hospitals referring patients for behavioral health treatment following an overdose.

Shannon Hubbard, the woman living with complex regional pain syndrome, considers herself fortunate that her doctors didn’t cut back her painkiller dose even more.

“I’m actually kind of lucky that I have such a severe case because at least they can’t say I’m crazy or it’s in my head,” she said.

Ms. Hubbard is well aware that people are dying every day from opioids. One of her family members struggles with heroin addiction, and she’s helping raise his daughter. But she’s adamant that there’s a better way to address the crisis.

“What they are doing is not working. They are having no effect on the guy who is on the street shooting heroin and is really in danger of overdosing,” she said. “Instead, they are hurting people that are actually helped by the drugs.”
 

This story is part of a partnership that includes KJZZ, NPR, and Kaiser Health News. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

It started with a rolled ankle during a routine Army training exercise. Shannon Hubbard never imagined it was the prologue to one of the most debilitating pain conditions known to exist, called ­­­­­­­complex regional pain syndrome.

wildpixel/Thinkstock

The condition causes the nervous system to go haywire, creating pain disproportionate to the actual injury. It also can affect how the body regulates temperature and blood flow.

For Ms. Hubbard, it manifested years ago following surgery on her foot – a common way for it to take hold.

“My leg feels like it’s on fire pretty much all the time. It spreads to different parts of your body,” the 47-year-old veteran said.

Ms. Hubbard props up her leg, careful not to graze it against the kitchen table in her home east of Phoenix. It’s red and swollen, still scarred from an ulcer that landed her in the hospital a few months ago.

“That started as a little blister and 4 days later, it was like the size of a baseball,” she said. “They had to cut it open and then it got infected, and because I have blood flow issues, it doesn’t heal.”

She knows it’s likely to happen again.

“Over the past 3 years, I’ve been prescribed over 60 different medications and combinations; none have even touched the pain,” she said.

Ms. Hubbard said she’s had injections and even traveled across the country for infusions of ketamine, an anesthetic that can be used for pain in extreme cases. Her doctors have discussed amputating her leg because of the frequency of the infections.

“All I can do is manage the pain,” she said. “Opioids have become the best solution.”

For about 9 months, Ms. Hubbard was on a combination of short- and long-acting opioids. She said it gave her enough relief to start leaving the house again and doing physical therapy.

But in April that changed. At her monthly appointment, her pain doctor informed her the dose was being lowered. “They had to take one of the pills away,” she said.

Ms. Hubbard knew the rules were part of Arizona’s new opioid law, which places restrictions on prescribing and limits the maximum dose for most patients. She also knew the law wasn’t supposed to affect her – an existing patient with chronic pain.

She argued with the doctor, without success. “They didn’t indicate there was any medical reason for cutting me back. It was simply because of the pressure of the opioid rules.”

Her dose was lowered from 100 morphine milligram equivalents daily (MME) to 90, the highest dose allowed for many new patients in Arizona. She said her pain has been “terrible” ever since.

“It just hurts,” she said. “I don’t want to walk, I pretty much don’t want to do anything.”

Ms. Hubbard’s condition may be extreme, but her situation isn’t unique. Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Increasingly, some patients with chronic pain like Ms. Hubbard say they are becoming collateral damage.
 

New limits on prescribing

More than two dozen states have implemented laws or policies limiting opioid prescriptions in some way. The most common is to restrict a patient’s first prescription to a number of pills that should last a week or less. But some states like Arizona have gone further by placing a ceiling on the maximum dose for most patients.

The Arizona Opioid Epidemic Act, the culmination of months of outreach and planning by state health officials, was passed earlier this year with unanimous support.

It started in June 2017, when Arizona Gov. Doug Ducey, a Republican, declared a public health emergency, citing new data, showing that two people were dying every day in the state from opioid overdoses.

He has pledged to come after those responsible for the rising death toll.

“All bad actors will be held accountable – whether they are doctors, manufacturers, or just plain drug dealers,” the governor said in his annual State of the State address, in January 2018.

He cited statistics from one rural county in which four doctors prescribed 6 million pills in a single year, concluding “something has gone terribly, terribly wrong.”

Later in January, Gov. Ducey called a special session of the Arizona legislature and, in less than a week, he signed the Arizona Opioid Epidemic Act into law. He called it the “most comprehensive and thoughtful package any state has passed to address this issue and crisis to date.”

The law expands access to addiction treatment, ramps up oversight of prescribing and protects from prosecution drug users who call 911 to report an overdose, among other things.

Initially, Arizona’s major medical associations cautioned against what they saw as too much interference in clinical practice, especially since opioid prescriptions already were on the decline.

Gov. Ducey’s administration offered assurances that the law would “maintain access for chronic pain sufferers and others who rely on these drugs.” Restrictions would apply to new patients only. Cancer, trauma, end-of-life, and other serious cases were exempt. Ultimately, the medical establishment came out in favor of the law.
 

Pressure on doctors

Since the law’s passage, some doctors in Arizona report feeling pressure to lower patient doses, even for patients who have been on stable regimens of opioids for years without trouble.

Julian Grove, MD, knows the nuances of Arizona’s new law better than most physicians. A pain physician, Dr. Grove worked with the state on the prescribing rules.

“We moved the needle to a degree so that many patients wouldn’t be as severely affected,” said Dr. Grove, president of the Arizona Pain Society. “But I’ll be the first to say, this has certainly caused a lot of patients problems [and] anxiety.”

“Many people who are prescribing medications have moved to a much more conservative stance and, unfortunately, pain patients are being negatively affected.”

Like many states, Arizona has looked to its prescription-monitoring program as a key tool for tracking overprescribing. State law requires prescribers to check the online database. Report cards are sent out comparing each prescriber to the rest of their cohort. Clinicians consider their scores when deciding how to manage patients’ care, he said.

“A lot of practitioners are reducing opioid medications, not from a clinical perspective, but more from a legal and regulatory perspective for fear of investigation,” Dr. Grove said. “No practitioner wants to be the highest prescriber.”

Arizona’s new prescribing rules don’t apply to board-certified pain specialists like Dr. Grove, who are trained to care for patients with complex chronic pain. But, he said, the reality is that doctors – even pain specialists – were already facing pressure on many fronts to curtail opioids – from the Drug Enforcement Agency to health insurers down to state medical boards.

The new state law has made the reduction of opioids only “more fast and furious,” he said.

Dr. Grove traces the hypervigilance back to guidelines put out by the Centers for Disease Control and Prevention in 2016. The CDC spelled out the risks associated with higher doses of opioids and advised clinicians when starting a patient on opioids to prescribe the lowest effective dosage.

Sally Satel, MD, a psychiatrist and a fellow at the American Enterprise Institute, said those guidelines stipulated the decision to lower a patient’s dose should be decided on a case-by-case basis, not by means of a blanket policy.

“[The guidelines] have been grossly misinterpreted,” Dr. Satel said.

The guidelines were not intended for pain specialists, but rather for primary care physicians, a group that accounted for nearly half of all opioids dispensed from 2007 to 2012.

“There is no mandate to reduce doses on people who have been doing well,” Dr. Satel said.

In the rush to address the nation’s opioid overdose crisis, she said, the CDC’s guidelines have become the model for many regulators and state legislatures. “It’s a very, very unhealthy, deeply chilled environment in which doctors and patients who have chronic pain can no longer work together,” she said.

Dr. Satel called the notion that new prescribing laws will reverse the tide of drug overdose deaths “misguided.”

The rate of opioid prescribing nationally has declined in recent years, though it still soars above the levels of the 1990s. Meanwhile, more people are dying from illicit drugs like heroin and fentanyl than prescription opioids.

In Arizona, more than 1,300 people have died from opioid-related overdoses since June 2017, according to preliminary state numbers. Only a third of those deaths involved just a prescription painkiller.

Heroin is now almost as common as oxycodone in overdose cases in Arizona.
 

A range of views

Some physicians support the new rules, said Pete Wertheim, executive director of the Arizona Osteopathic Medical Association.

“For some, it has been a welcome relief,” he said. “They feel like it has given them an avenue, a means to confront patients.” Some doctors tell him it’s an opportunity to have a tough conversation with patients they believe to be at risk for addiction or overdose because of the medication.

The organization is striving to educate its members about Arizona’s prescribing rules and the exemptions. But, he said, most doctors now feel the message is clear: “We don’t want you prescribing opioids.”

Long before the law passed, Mr. Wertheim said, physicians were already telling him that they had stopped prescribing, because they “didn’t want the liability.”

He worries the current climate around prescribing will drive doctors out of pain management, especially in rural areas. There’s also a fear that some patients who can’t get prescription pills will try stronger street drugs, said Gerald Harris II, MD, an addiction treatment specialist in Glendale, Ariz.

Dr. Harris said he has seen an increase in referrals from doctors concerned that their patients with chronic pain are addicted to opioids. He receives new patients – almost daily, he said – whose physicians have stopped prescribing altogether.

“Their doctor is afraid and he’s cut them off,” Dr. Harris said. “Unfortunately, a great many patients turn to street heroin and other drugs to self-medicate because they couldn’t get the medications they need.”

Arizona’s Department of Health Services is working to reassure providers and dispel the myths, said Cara M. Christ, MD, who heads the agency and helped design the state’s opioid response. She pointed to the recently launched Opioid Assistance and Referral Line, created to help health care providers with complex cases. The state has also released a set of detailed prescribing guidelines for doctors.

Dr. Christ characterizes this as an “adjustment period” while physicians learn the new rules.

“The intent was never to stop prescribers from utilizing opioids,” she said. “It’s really meant to prevent a future generation from developing opioid use disorder, while not impacting current chronic pain patients.”

Dr. Christ said she just hasn’t heard of many patients losing access to medicine.

It’s still too early to gauge the law’s success, she said, but opioid prescriptions continue to decline in Arizona.

Arizona saw a 33% reduction in the number of opioid prescriptions in April, compared with the same period last year, state data show. Dr. Christ’s agency reports that more people are getting help for addiction: There has been about a 40% increase in hospitals referring patients for behavioral health treatment following an overdose.

Shannon Hubbard, the woman living with complex regional pain syndrome, considers herself fortunate that her doctors didn’t cut back her painkiller dose even more.

“I’m actually kind of lucky that I have such a severe case because at least they can’t say I’m crazy or it’s in my head,” she said.

Ms. Hubbard is well aware that people are dying every day from opioids. One of her family members struggles with heroin addiction, and she’s helping raise his daughter. But she’s adamant that there’s a better way to address the crisis.

“What they are doing is not working. They are having no effect on the guy who is on the street shooting heroin and is really in danger of overdosing,” she said. “Instead, they are hurting people that are actually helped by the drugs.”
 

This story is part of a partnership that includes KJZZ, NPR, and Kaiser Health News. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

It started with a rolled ankle during a routine Army training exercise. Shannon Hubbard never imagined it was the prologue to one of the most debilitating pain conditions known to exist, called ­­­­­­­complex regional pain syndrome.

wildpixel/Thinkstock

The condition causes the nervous system to go haywire, creating pain disproportionate to the actual injury. It also can affect how the body regulates temperature and blood flow.

For Ms. Hubbard, it manifested years ago following surgery on her foot – a common way for it to take hold.

“My leg feels like it’s on fire pretty much all the time. It spreads to different parts of your body,” the 47-year-old veteran said.

Ms. Hubbard props up her leg, careful not to graze it against the kitchen table in her home east of Phoenix. It’s red and swollen, still scarred from an ulcer that landed her in the hospital a few months ago.

“That started as a little blister and 4 days later, it was like the size of a baseball,” she said. “They had to cut it open and then it got infected, and because I have blood flow issues, it doesn’t heal.”

She knows it’s likely to happen again.

“Over the past 3 years, I’ve been prescribed over 60 different medications and combinations; none have even touched the pain,” she said.

Ms. Hubbard said she’s had injections and even traveled across the country for infusions of ketamine, an anesthetic that can be used for pain in extreme cases. Her doctors have discussed amputating her leg because of the frequency of the infections.

“All I can do is manage the pain,” she said. “Opioids have become the best solution.”

For about 9 months, Ms. Hubbard was on a combination of short- and long-acting opioids. She said it gave her enough relief to start leaving the house again and doing physical therapy.

But in April that changed. At her monthly appointment, her pain doctor informed her the dose was being lowered. “They had to take one of the pills away,” she said.

Ms. Hubbard knew the rules were part of Arizona’s new opioid law, which places restrictions on prescribing and limits the maximum dose for most patients. She also knew the law wasn’t supposed to affect her – an existing patient with chronic pain.

She argued with the doctor, without success. “They didn’t indicate there was any medical reason for cutting me back. It was simply because of the pressure of the opioid rules.”

Her dose was lowered from 100 morphine milligram equivalents daily (MME) to 90, the highest dose allowed for many new patients in Arizona. She said her pain has been “terrible” ever since.

“It just hurts,” she said. “I don’t want to walk, I pretty much don’t want to do anything.”

Ms. Hubbard’s condition may be extreme, but her situation isn’t unique. Faced with skyrocketing drug overdoses, states are cracking down on opioid prescribing. Increasingly, some patients with chronic pain like Ms. Hubbard say they are becoming collateral damage.
 

New limits on prescribing

More than two dozen states have implemented laws or policies limiting opioid prescriptions in some way. The most common is to restrict a patient’s first prescription to a number of pills that should last a week or less. But some states like Arizona have gone further by placing a ceiling on the maximum dose for most patients.

The Arizona Opioid Epidemic Act, the culmination of months of outreach and planning by state health officials, was passed earlier this year with unanimous support.

It started in June 2017, when Arizona Gov. Doug Ducey, a Republican, declared a public health emergency, citing new data, showing that two people were dying every day in the state from opioid overdoses.

He has pledged to come after those responsible for the rising death toll.

“All bad actors will be held accountable – whether they are doctors, manufacturers, or just plain drug dealers,” the governor said in his annual State of the State address, in January 2018.

He cited statistics from one rural county in which four doctors prescribed 6 million pills in a single year, concluding “something has gone terribly, terribly wrong.”

Later in January, Gov. Ducey called a special session of the Arizona legislature and, in less than a week, he signed the Arizona Opioid Epidemic Act into law. He called it the “most comprehensive and thoughtful package any state has passed to address this issue and crisis to date.”

The law expands access to addiction treatment, ramps up oversight of prescribing and protects from prosecution drug users who call 911 to report an overdose, among other things.

Initially, Arizona’s major medical associations cautioned against what they saw as too much interference in clinical practice, especially since opioid prescriptions already were on the decline.

Gov. Ducey’s administration offered assurances that the law would “maintain access for chronic pain sufferers and others who rely on these drugs.” Restrictions would apply to new patients only. Cancer, trauma, end-of-life, and other serious cases were exempt. Ultimately, the medical establishment came out in favor of the law.
 

Pressure on doctors

Since the law’s passage, some doctors in Arizona report feeling pressure to lower patient doses, even for patients who have been on stable regimens of opioids for years without trouble.

Julian Grove, MD, knows the nuances of Arizona’s new law better than most physicians. A pain physician, Dr. Grove worked with the state on the prescribing rules.

“We moved the needle to a degree so that many patients wouldn’t be as severely affected,” said Dr. Grove, president of the Arizona Pain Society. “But I’ll be the first to say, this has certainly caused a lot of patients problems [and] anxiety.”

“Many people who are prescribing medications have moved to a much more conservative stance and, unfortunately, pain patients are being negatively affected.”

Like many states, Arizona has looked to its prescription-monitoring program as a key tool for tracking overprescribing. State law requires prescribers to check the online database. Report cards are sent out comparing each prescriber to the rest of their cohort. Clinicians consider their scores when deciding how to manage patients’ care, he said.

“A lot of practitioners are reducing opioid medications, not from a clinical perspective, but more from a legal and regulatory perspective for fear of investigation,” Dr. Grove said. “No practitioner wants to be the highest prescriber.”

Arizona’s new prescribing rules don’t apply to board-certified pain specialists like Dr. Grove, who are trained to care for patients with complex chronic pain. But, he said, the reality is that doctors – even pain specialists – were already facing pressure on many fronts to curtail opioids – from the Drug Enforcement Agency to health insurers down to state medical boards.

The new state law has made the reduction of opioids only “more fast and furious,” he said.

Dr. Grove traces the hypervigilance back to guidelines put out by the Centers for Disease Control and Prevention in 2016. The CDC spelled out the risks associated with higher doses of opioids and advised clinicians when starting a patient on opioids to prescribe the lowest effective dosage.

Sally Satel, MD, a psychiatrist and a fellow at the American Enterprise Institute, said those guidelines stipulated the decision to lower a patient’s dose should be decided on a case-by-case basis, not by means of a blanket policy.

“[The guidelines] have been grossly misinterpreted,” Dr. Satel said.

The guidelines were not intended for pain specialists, but rather for primary care physicians, a group that accounted for nearly half of all opioids dispensed from 2007 to 2012.

“There is no mandate to reduce doses on people who have been doing well,” Dr. Satel said.

In the rush to address the nation’s opioid overdose crisis, she said, the CDC’s guidelines have become the model for many regulators and state legislatures. “It’s a very, very unhealthy, deeply chilled environment in which doctors and patients who have chronic pain can no longer work together,” she said.

Dr. Satel called the notion that new prescribing laws will reverse the tide of drug overdose deaths “misguided.”

The rate of opioid prescribing nationally has declined in recent years, though it still soars above the levels of the 1990s. Meanwhile, more people are dying from illicit drugs like heroin and fentanyl than prescription opioids.

In Arizona, more than 1,300 people have died from opioid-related overdoses since June 2017, according to preliminary state numbers. Only a third of those deaths involved just a prescription painkiller.

Heroin is now almost as common as oxycodone in overdose cases in Arizona.
 

A range of views

Some physicians support the new rules, said Pete Wertheim, executive director of the Arizona Osteopathic Medical Association.

“For some, it has been a welcome relief,” he said. “They feel like it has given them an avenue, a means to confront patients.” Some doctors tell him it’s an opportunity to have a tough conversation with patients they believe to be at risk for addiction or overdose because of the medication.

The organization is striving to educate its members about Arizona’s prescribing rules and the exemptions. But, he said, most doctors now feel the message is clear: “We don’t want you prescribing opioids.”

Long before the law passed, Mr. Wertheim said, physicians were already telling him that they had stopped prescribing, because they “didn’t want the liability.”

He worries the current climate around prescribing will drive doctors out of pain management, especially in rural areas. There’s also a fear that some patients who can’t get prescription pills will try stronger street drugs, said Gerald Harris II, MD, an addiction treatment specialist in Glendale, Ariz.

Dr. Harris said he has seen an increase in referrals from doctors concerned that their patients with chronic pain are addicted to opioids. He receives new patients – almost daily, he said – whose physicians have stopped prescribing altogether.

“Their doctor is afraid and he’s cut them off,” Dr. Harris said. “Unfortunately, a great many patients turn to street heroin and other drugs to self-medicate because they couldn’t get the medications they need.”

Arizona’s Department of Health Services is working to reassure providers and dispel the myths, said Cara M. Christ, MD, who heads the agency and helped design the state’s opioid response. She pointed to the recently launched Opioid Assistance and Referral Line, created to help health care providers with complex cases. The state has also released a set of detailed prescribing guidelines for doctors.

Dr. Christ characterizes this as an “adjustment period” while physicians learn the new rules.

“The intent was never to stop prescribers from utilizing opioids,” she said. “It’s really meant to prevent a future generation from developing opioid use disorder, while not impacting current chronic pain patients.”

Dr. Christ said she just hasn’t heard of many patients losing access to medicine.

It’s still too early to gauge the law’s success, she said, but opioid prescriptions continue to decline in Arizona.

Arizona saw a 33% reduction in the number of opioid prescriptions in April, compared with the same period last year, state data show. Dr. Christ’s agency reports that more people are getting help for addiction: There has been about a 40% increase in hospitals referring patients for behavioral health treatment following an overdose.

Shannon Hubbard, the woman living with complex regional pain syndrome, considers herself fortunate that her doctors didn’t cut back her painkiller dose even more.

“I’m actually kind of lucky that I have such a severe case because at least they can’t say I’m crazy or it’s in my head,” she said.

Ms. Hubbard is well aware that people are dying every day from opioids. One of her family members struggles with heroin addiction, and she’s helping raise his daughter. But she’s adamant that there’s a better way to address the crisis.

“What they are doing is not working. They are having no effect on the guy who is on the street shooting heroin and is really in danger of overdosing,” she said. “Instead, they are hurting people that are actually helped by the drugs.”
 

This story is part of a partnership that includes KJZZ, NPR, and Kaiser Health News. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.

The committee voted 16-3 that there was insufficient evidence of efficacy to support mepolizumab’s use as an add-on therapy for COPD patients guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.

However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.

Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.

The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.

Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.

In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.

In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.

Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.

Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.

Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.

“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.

By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.

Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.

Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.

The committee voted 16-3 that there was insufficient evidence of efficacy to support mepolizumab’s use as an add-on therapy for COPD patients guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.

However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.

Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.

The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.

Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.

In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.

In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.

Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.

Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.

Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.

“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.

By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.

Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.

Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.

The committee voted 16-3 that there was insufficient evidence of efficacy to support mepolizumab’s use as an add-on therapy for COPD patients guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.

However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.

Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.

The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.

Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.

In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.

In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.

Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.

Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.

Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.

“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.

By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.

Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.

ATLANTA – It’s possible to reduce chest x-rays for routine pediatric asthma exacerbations in the ED, but accomplishing this goal takes more than a new clinical practice guideline, according to a quality improvement team at the Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn.

M. Alexander Otto/MDedge News

The team eventually reduced the chest x-ray rate for pediatric asthma exacerbations from 30% to 15% without increasing 3-day all-cause readmissions, but it took some sleuthing in the ED and good relations with staff. “We were way out in left field when we started this. Working in silos is never ideal,” said senior project member David Johnson, MD, a pediatric hospitalist and assistant professor of pediatrics at Vanderbilt.

It’s been known for a while that chest x-rays are almost always a waste of time and money for asthma exacerbations, and national guidelines recommend against them. X-rays don’t improve outcomes and needlessly expose children to radiation.

In 2014, some of the providers at Vanderbilt, which has about 1,700 asthma encounters a year, realized that the institution’s 30% x-ray rate was a problem. The quality improvement team hoped a new guideline would address the issue, but that didn’t happen. “We roll out clinical practice guidelines” from on high, “and think people will magically change their behavior,” but they don’t, Dr. Johnson said at the annual Pediatric Hospital Medicine meeting.

The guideline was not being fully implemented. So the team asked the ED what was the standard procedure for a child presenting with asthma exacerbation. It turned out that the ED had a dyspnea order set that the team ”had no idea existed.” Chest x-rays were at the top of the list; next came blood gases, ventilation-perfusion scans, and leg Dopplers, he said.

The investigators tried to get rid of the whole order set but were unsuccessful. The ED department did, however, let the team eliminate chest x-rays in the default order set in July 2015. That helped, but more changes were needed.

The next conversation was to figure out why x-rays were being ordered in the first place. ED staff said they were worried about missing something, especially pneumonia. They also thought they were helping hospitalists by getting x-rays before sending kids to the ward even though, in reality, it didn’t matter whether x-rays were done a few hours later on the floor. ED providers also said that ill-appearing children often got better after a few hours but were kept back from discharge because x-ray results were still pending and that sometimes these results revealed problems at 3 a.m. that had nothing to do with why the patients were in the ED but still required a work-up.

This discussion opened a door. The ED staff didn’t want to order unnecessary x-rays, either. That led to talks about letting kids declare themselves a bit before x-rays were ordered. ED staff liked the idea, so the guidelines were updated in early 2016 to say that chest x-rays should only be ordered if there is persistent severe respiratory distress with hypoxia, there are focal findings that don’t improve after 12 hours of treatment, or there were concerns for pneumomediastinum or collapsed lung. The updated guidelines were posted in work areas and brought home by resident education. A reminder was added to the electronic medical record system that popped up when someone tried to order a chest x-ray for an child with asthma.

It worked. Chest x-ray rates in asthma fell to 15%, and have remained there since.

“We gave them permission to take their foot off the throttle and wait a little bit, and we don’t have more kids bouncing back from reduced x-rays.” The approach is “probably generalizable everywhere,” Dr. Johnson said.

It was essential that an ED fellow, Caroline Watnick, MD, led the effort and eventually bridged the gap between hospitalists and ED providers. In the end, “the change wasn’t something from the outside,” Dr. Johnson said.

There was no industry funding, and Dr. Johnson didn’t have any disclosures. The Pediatric Hospital Medicine meeting is sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

aotto@mdedge.com

ATLANTA – It’s possible to reduce chest x-rays for routine pediatric asthma exacerbations in the ED, but accomplishing this goal takes more than a new clinical practice guideline, according to a quality improvement team at the Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn.

M. Alexander Otto/MDedge News

The team eventually reduced the chest x-ray rate for pediatric asthma exacerbations from 30% to 15% without increasing 3-day all-cause readmissions, but it took some sleuthing in the ED and good relations with staff. “We were way out in left field when we started this. Working in silos is never ideal,” said senior project member David Johnson, MD, a pediatric hospitalist and assistant professor of pediatrics at Vanderbilt.

It’s been known for a while that chest x-rays are almost always a waste of time and money for asthma exacerbations, and national guidelines recommend against them. X-rays don’t improve outcomes and needlessly expose children to radiation.

In 2014, some of the providers at Vanderbilt, which has about 1,700 asthma encounters a year, realized that the institution’s 30% x-ray rate was a problem. The quality improvement team hoped a new guideline would address the issue, but that didn’t happen. “We roll out clinical practice guidelines” from on high, “and think people will magically change their behavior,” but they don’t, Dr. Johnson said at the annual Pediatric Hospital Medicine meeting.

The guideline was not being fully implemented. So the team asked the ED what was the standard procedure for a child presenting with asthma exacerbation. It turned out that the ED had a dyspnea order set that the team ”had no idea existed.” Chest x-rays were at the top of the list; next came blood gases, ventilation-perfusion scans, and leg Dopplers, he said.

The investigators tried to get rid of the whole order set but were unsuccessful. The ED department did, however, let the team eliminate chest x-rays in the default order set in July 2015. That helped, but more changes were needed.

The next conversation was to figure out why x-rays were being ordered in the first place. ED staff said they were worried about missing something, especially pneumonia. They also thought they were helping hospitalists by getting x-rays before sending kids to the ward even though, in reality, it didn’t matter whether x-rays were done a few hours later on the floor. ED providers also said that ill-appearing children often got better after a few hours but were kept back from discharge because x-ray results were still pending and that sometimes these results revealed problems at 3 a.m. that had nothing to do with why the patients were in the ED but still required a work-up.

This discussion opened a door. The ED staff didn’t want to order unnecessary x-rays, either. That led to talks about letting kids declare themselves a bit before x-rays were ordered. ED staff liked the idea, so the guidelines were updated in early 2016 to say that chest x-rays should only be ordered if there is persistent severe respiratory distress with hypoxia, there are focal findings that don’t improve after 12 hours of treatment, or there were concerns for pneumomediastinum or collapsed lung. The updated guidelines were posted in work areas and brought home by resident education. A reminder was added to the electronic medical record system that popped up when someone tried to order a chest x-ray for an child with asthma.

It worked. Chest x-ray rates in asthma fell to 15%, and have remained there since.

“We gave them permission to take their foot off the throttle and wait a little bit, and we don’t have more kids bouncing back from reduced x-rays.” The approach is “probably generalizable everywhere,” Dr. Johnson said.

It was essential that an ED fellow, Caroline Watnick, MD, led the effort and eventually bridged the gap between hospitalists and ED providers. In the end, “the change wasn’t something from the outside,” Dr. Johnson said.

There was no industry funding, and Dr. Johnson didn’t have any disclosures. The Pediatric Hospital Medicine meeting is sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

aotto@mdedge.com

ATLANTA – It’s possible to reduce chest x-rays for routine pediatric asthma exacerbations in the ED, but accomplishing this goal takes more than a new clinical practice guideline, according to a quality improvement team at the Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn.

M. Alexander Otto/MDedge News

The team eventually reduced the chest x-ray rate for pediatric asthma exacerbations from 30% to 15% without increasing 3-day all-cause readmissions, but it took some sleuthing in the ED and good relations with staff. “We were way out in left field when we started this. Working in silos is never ideal,” said senior project member David Johnson, MD, a pediatric hospitalist and assistant professor of pediatrics at Vanderbilt.

It’s been known for a while that chest x-rays are almost always a waste of time and money for asthma exacerbations, and national guidelines recommend against them. X-rays don’t improve outcomes and needlessly expose children to radiation.

In 2014, some of the providers at Vanderbilt, which has about 1,700 asthma encounters a year, realized that the institution’s 30% x-ray rate was a problem. The quality improvement team hoped a new guideline would address the issue, but that didn’t happen. “We roll out clinical practice guidelines” from on high, “and think people will magically change their behavior,” but they don’t, Dr. Johnson said at the annual Pediatric Hospital Medicine meeting.

The guideline was not being fully implemented. So the team asked the ED what was the standard procedure for a child presenting with asthma exacerbation. It turned out that the ED had a dyspnea order set that the team ”had no idea existed.” Chest x-rays were at the top of the list; next came blood gases, ventilation-perfusion scans, and leg Dopplers, he said.

The investigators tried to get rid of the whole order set but were unsuccessful. The ED department did, however, let the team eliminate chest x-rays in the default order set in July 2015. That helped, but more changes were needed.

The next conversation was to figure out why x-rays were being ordered in the first place. ED staff said they were worried about missing something, especially pneumonia. They also thought they were helping hospitalists by getting x-rays before sending kids to the ward even though, in reality, it didn’t matter whether x-rays were done a few hours later on the floor. ED providers also said that ill-appearing children often got better after a few hours but were kept back from discharge because x-ray results were still pending and that sometimes these results revealed problems at 3 a.m. that had nothing to do with why the patients were in the ED but still required a work-up.

This discussion opened a door. The ED staff didn’t want to order unnecessary x-rays, either. That led to talks about letting kids declare themselves a bit before x-rays were ordered. ED staff liked the idea, so the guidelines were updated in early 2016 to say that chest x-rays should only be ordered if there is persistent severe respiratory distress with hypoxia, there are focal findings that don’t improve after 12 hours of treatment, or there were concerns for pneumomediastinum or collapsed lung. The updated guidelines were posted in work areas and brought home by resident education. A reminder was added to the electronic medical record system that popped up when someone tried to order a chest x-ray for an child with asthma.

It worked. Chest x-ray rates in asthma fell to 15%, and have remained there since.

“We gave them permission to take their foot off the throttle and wait a little bit, and we don’t have more kids bouncing back from reduced x-rays.” The approach is “probably generalizable everywhere,” Dr. Johnson said.

It was essential that an ED fellow, Caroline Watnick, MD, led the effort and eventually bridged the gap between hospitalists and ED providers. In the end, “the change wasn’t something from the outside,” Dr. Johnson said.

There was no industry funding, and Dr. Johnson didn’t have any disclosures. The Pediatric Hospital Medicine meeting is sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

aotto@mdedge.com

Summer is often a time when we can take a break from our usual frenetic schedules. It is a time to catch up on nonurgent reading. I just completed 3 books of interest, including Bad Blood, by John Carreyrou, What the Eyes Don’t See, by Mona Hanna-Attisha, and Overcharged, by Charles Silver and David Hyman.

The common thread among them is their focus on the interplay among American medicine, politics, money, and denial of science. Carreyrou is a Wall Street Journal investigative reporter who describes the spectacular rise and ignominious fall of Theranos, a privately held company in the business of blood testing and diagnostics. Theranos claimed to have a secret process enabling them to run over 200 diagnostic blood tests on blood derived from a finger prick. At its peak, the company was valued at $10 billion but their secret process proved to be false science. They are now subject to multiple lawsuits and their leaders are under criminal investigation.

Dr. Attisha’s book describes the decisions made by Michigan political and administrative leaders that resulted in high levels of lead in Flint’s water supply. Dr. Attisha is a pediatrician in Flint who documented elevated lead levels in her small patients. When she tried to bring this to public attention, her data was met with enormous backlash by leaders who tried to deny facts and discredit her personally. Neurological damage from childhood lead poisoning is not reversible.

Hyman and Silver’s book (published by the Cato Institute) asserts that politics, third-party payers, and the health care industry, together, have devised a system of wealth transfer from taxpayers to health care providers. It provides examples where this system (that separates payment from health value) does real harm to individual people and the nation. Reading this book makes us think about who should hold the assets from which first-dollar medical payments derive. It reminded me of the famous saying by James Madison, “If all men were angels, there would be no need for government.”

In some circles, science, data, and the scientific method are not valued. In the end, as these books point out, everyone can be entitled to their opinion, but no one has the power to alter facts.

John I. Allen, MD, MBA, AGAF
Editor in Chief

Summer is often a time when we can take a break from our usual frenetic schedules. It is a time to catch up on nonurgent reading. I just completed 3 books of interest, including Bad Blood, by John Carreyrou, What the Eyes Don’t See, by Mona Hanna-Attisha, and Overcharged, by Charles Silver and David Hyman.

The common thread among them is their focus on the interplay among American medicine, politics, money, and denial of science. Carreyrou is a Wall Street Journal investigative reporter who describes the spectacular rise and ignominious fall of Theranos, a privately held company in the business of blood testing and diagnostics. Theranos claimed to have a secret process enabling them to run over 200 diagnostic blood tests on blood derived from a finger prick. At its peak, the company was valued at $10 billion but their secret process proved to be false science. They are now subject to multiple lawsuits and their leaders are under criminal investigation.

Dr. Attisha’s book describes the decisions made by Michigan political and administrative leaders that resulted in high levels of lead in Flint’s water supply. Dr. Attisha is a pediatrician in Flint who documented elevated lead levels in her small patients. When she tried to bring this to public attention, her data was met with enormous backlash by leaders who tried to deny facts and discredit her personally. Neurological damage from childhood lead poisoning is not reversible.

Hyman and Silver’s book (published by the Cato Institute) asserts that politics, third-party payers, and the health care industry, together, have devised a system of wealth transfer from taxpayers to health care providers. It provides examples where this system (that separates payment from health value) does real harm to individual people and the nation. Reading this book makes us think about who should hold the assets from which first-dollar medical payments derive. It reminded me of the famous saying by James Madison, “If all men were angels, there would be no need for government.”

In some circles, science, data, and the scientific method are not valued. In the end, as these books point out, everyone can be entitled to their opinion, but no one has the power to alter facts.

John I. Allen, MD, MBA, AGAF
Editor in Chief

Summer is often a time when we can take a break from our usual frenetic schedules. It is a time to catch up on nonurgent reading. I just completed 3 books of interest, including Bad Blood, by John Carreyrou, What the Eyes Don’t See, by Mona Hanna-Attisha, and Overcharged, by Charles Silver and David Hyman.

The common thread among them is their focus on the interplay among American medicine, politics, money, and denial of science. Carreyrou is a Wall Street Journal investigative reporter who describes the spectacular rise and ignominious fall of Theranos, a privately held company in the business of blood testing and diagnostics. Theranos claimed to have a secret process enabling them to run over 200 diagnostic blood tests on blood derived from a finger prick. At its peak, the company was valued at $10 billion but their secret process proved to be false science. They are now subject to multiple lawsuits and their leaders are under criminal investigation.

Dr. Attisha’s book describes the decisions made by Michigan political and administrative leaders that resulted in high levels of lead in Flint’s water supply. Dr. Attisha is a pediatrician in Flint who documented elevated lead levels in her small patients. When she tried to bring this to public attention, her data was met with enormous backlash by leaders who tried to deny facts and discredit her personally. Neurological damage from childhood lead poisoning is not reversible.

Hyman and Silver’s book (published by the Cato Institute) asserts that politics, third-party payers, and the health care industry, together, have devised a system of wealth transfer from taxpayers to health care providers. It provides examples where this system (that separates payment from health value) does real harm to individual people and the nation. Reading this book makes us think about who should hold the assets from which first-dollar medical payments derive. It reminded me of the famous saying by James Madison, “If all men were angels, there would be no need for government.”

In some circles, science, data, and the scientific method are not valued. In the end, as these books point out, everyone can be entitled to their opinion, but no one has the power to alter facts.

John I. Allen, MD, MBA, AGAF
Editor in Chief

LAKE TAHOE, CALIF. – The way Susan C. Taylor, MD, sees it, rule No. 1 when examining the hair and scalp of young ethnic patients is to foster a sense of cultural competence.

At the annual meeting of the Society for Pediatric Dermatology, Dr. Taylor, a dermatologist at the University of Pennsylvania, Philadelphia, defined culturally competent care as a patient-centered approach in which clinicians establish a rapport with the patient and the caregiver. “It’s important that we ask the right questions,” she said. “In doing so, we have to be familiar with common hair care practices. It’s important that we respect our patients’ values, their goals, their health needs, and, of course, their cultural background. Finally, we have to engage in shared decision making. That’s where we can improve compliance and lead to an overall very satisfactory patient visit.”

To illustrate this point, she discussed the case of a four-year-old black female with a 9-month history of bad dandruff. The child’s mother reports thick flakes that never go away. She takes pride in caring for her daughter’s hair, and shampoos it every two weeks. “She tells me that during the 2.5 hours that it takes her on Saturdays to shampoo, detangle, and comb her daughter’s hair, which she then braids or cornrows and adorns with barrettes or balls, it is a great bonding experience for the two of them,” Dr. Taylor said. “The flakes are temporarily better after she ‘greases’ her daughter’s scalp, but after 2-3 days, they are back.”

In a case like this, Dr. Taylor recommends asking the parent or caregiver to join you while you examine the scalp. This way, the focus becomes the child’s scalp, and the parent is not just staring at your expressions. “The child also observes the pediatric dermatologist and parent/caregiver working together as a team,” she said. “You also want to ask the parent to remove the hair adornments. This makes the child feel more comfortable. It also allows you to observe how the hair is being managed. Are the adornments being removed gently? Is there aggressive pulling of the hair when they take out the braids? Is the child visibly wincing in pain? If the latter two happen this is a teachable moment. You can point out, ‘It looks like Susie is in pain. Let’s do it a little more gently. That might prevent further hair breakage.’ ”

The differential diagnosis of a scaly pediatric scalp includes infrequent shampooing, seborrheic dermatitis, tinea capitis, atopic dermatitis, psoriasis, and sebopsoriasis. The type of hairstyle also factors in. For example, cornrows are a popular hair styling option among ethnic patients. “These are very popular and very time consuming and may lead to infrequent shampooing,” she said. “If they’re put in very tightly or if they have beads or other adornments, it can lead to traction alopecia.” Twists, meanwhile, can create tension on the hair, while puffs can cause traction alopecia if they’re pulled too tightly. “Although dreadlocks are more common among adolescents, we’re seeing them more commonly in young children,” she said. “They can be very long and wavy and lead to traction alopecia.”

The time required to shampoo, detangle, and style tightly coiled African American hair can be significant. For example, in children with cornrows or braids with extensions, Dr. Taylor said that it might require 30 minutes to as long as 2 or 3 hours to remove their current hairstyle, followed by shampooing and conditioning. “Detangling can take at least 15 minutes. In tightly coiled African American hair, studies have demonstrated that detangling while the hair is wet is best, because you have fewer forces on that comb and the hair is less likely to break, as opposed to detangling when the hair is dry. After the wet hair is detangled and the conditioner is rinsed out, a leave-in conditioner is often applied. Then the hair is detangled again, which can take up to an hour, followed by styling, which can take 1-3 hours. That gives you some insight as to why there can often be infrequent shampooing.”

The recommended frequency of shampooing depends on the hairstyle selected. Many children with braids and extensions will have those braids and extensions taken out every six to 12 weeks, “but that doesn’t mean that the scalp can’t be shampooed,” Dr. Taylor said. “The scalp should be shampooed more often. Economics and socioeconomic status play into the frequency of shampooing. For example, if a parent or a caregiver sends a child to a hair stylist, that can range in price from $45 to $65 or more. Time also factors in. In the black community in particular, it’s a ritual on a Saturday to get your hair done. If the parent or caregiver works on weekends, that’s going to impact the frequency of shampooing.”

Dr. Taylor underscored the importance of framing the history-taking process to avoid common pitfall questions like “Do you wash the child’s hair every day or every other day?” or “Do you use dandruff shampoo every day?” It is important to remember that “the parent’s inherent perception is of a doctor who does not have my hair probably does not understand my hair or my child’s hair,” she said. “It’s unlikely that you’re going to find a parent who shampoos their child’s hair every day or every other day. Maybe once a week, probably biweekly. It’s important to ask culturally competent questions.”

She also advises against asking about shampooing when you’re examining the child’s hair, “because there’s going to be the perception that you may think the scalp is dirty,” Dr. Taylor explained. “You probably want to ask that when gathering the history of present illness. The culturally competent question is going to be, ‘Do you wash her/his hair weekly, every other week, monthly, or does it depend on the hair style?’ ”

Body language is also important. “Don’t lean in from afar when examining the patient,” she said. “Get up close and touch the child’s hair.” If you choose to wear surgical gloves for the exam “don’t hold your hands in the surgical scrub position,” she recommended. “Hold your hands in a more neutral position. I think it’s important to touch the hair.”

Referring back to the 4-year-old black child with bad dandruff, she said that a diagnosis of seborrheic dermatitis is unlikely since that condition usually occurs during puberty. “You should have a high index of suspicion for tinea capitis,” she said. “If the patient has occipital lymphadenopathy plus scaling of the scalp or alopecia, that’s enough to presumptively treat for tinea capitis. There are studies that support that.”

For established tinea capitis, Dr. Taylor advises parents to wash barrettes and other hair adornments in hot soapy water or in the dishwasher. She also recommends disposal of hair oil, pomade, and grease and shampooing the child’s hair with ketoconazole and use a conditioner to decrease household and patient spread, which decreases transmissible fungal spores. “There’s a misperception that the application of hair oils and grease can increase the rate of tinea capitis,” she noted. “That’s not true. However, if hair grease and hair oil is applied to the scalp within one week of culture, it could produce a false negative culture.”

For established seborrheic dermatitis, antifungal shampoos including ketoconazole, ciclopirox, and selenium sulfide may be too drying for ethnic hair, “which already has a propensity to break,” she said. “Instead, we recommend a 5-10 minute scalp contact time with the shampoo and avoid contact with strands of hair. Shampoo hair strands with a conditioning shampoo followed by a conditioner to limit hair breakage. We suggest once weekly or biweekly shampooing.”

Dr. Taylor disclosed that she has advisory board and/or investigator relationships with Aclaris Therapeutics, Allergan, Beiersdorf, Croma Pharmaceuticals, Galderma, Isdin, Johnson & Johnson, and Unilever. She also acknowledged Candrice R. Heath, MD, a dermatologist based in Newark, Delaware, for her assistance with the presentation content.

dbrunk@mdedge.com







 

LAKE TAHOE, CALIF. – The way Susan C. Taylor, MD, sees it, rule No. 1 when examining the hair and scalp of young ethnic patients is to foster a sense of cultural competence.

At the annual meeting of the Society for Pediatric Dermatology, Dr. Taylor, a dermatologist at the University of Pennsylvania, Philadelphia, defined culturally competent care as a patient-centered approach in which clinicians establish a rapport with the patient and the caregiver. “It’s important that we ask the right questions,” she said. “In doing so, we have to be familiar with common hair care practices. It’s important that we respect our patients’ values, their goals, their health needs, and, of course, their cultural background. Finally, we have to engage in shared decision making. That’s where we can improve compliance and lead to an overall very satisfactory patient visit.”

To illustrate this point, she discussed the case of a four-year-old black female with a 9-month history of bad dandruff. The child’s mother reports thick flakes that never go away. She takes pride in caring for her daughter’s hair, and shampoos it every two weeks. “She tells me that during the 2.5 hours that it takes her on Saturdays to shampoo, detangle, and comb her daughter’s hair, which she then braids or cornrows and adorns with barrettes or balls, it is a great bonding experience for the two of them,” Dr. Taylor said. “The flakes are temporarily better after she ‘greases’ her daughter’s scalp, but after 2-3 days, they are back.”

In a case like this, Dr. Taylor recommends asking the parent or caregiver to join you while you examine the scalp. This way, the focus becomes the child’s scalp, and the parent is not just staring at your expressions. “The child also observes the pediatric dermatologist and parent/caregiver working together as a team,” she said. “You also want to ask the parent to remove the hair adornments. This makes the child feel more comfortable. It also allows you to observe how the hair is being managed. Are the adornments being removed gently? Is there aggressive pulling of the hair when they take out the braids? Is the child visibly wincing in pain? If the latter two happen this is a teachable moment. You can point out, ‘It looks like Susie is in pain. Let’s do it a little more gently. That might prevent further hair breakage.’ ”

The differential diagnosis of a scaly pediatric scalp includes infrequent shampooing, seborrheic dermatitis, tinea capitis, atopic dermatitis, psoriasis, and sebopsoriasis. The type of hairstyle also factors in. For example, cornrows are a popular hair styling option among ethnic patients. “These are very popular and very time consuming and may lead to infrequent shampooing,” she said. “If they’re put in very tightly or if they have beads or other adornments, it can lead to traction alopecia.” Twists, meanwhile, can create tension on the hair, while puffs can cause traction alopecia if they’re pulled too tightly. “Although dreadlocks are more common among adolescents, we’re seeing them more commonly in young children,” she said. “They can be very long and wavy and lead to traction alopecia.”

The time required to shampoo, detangle, and style tightly coiled African American hair can be significant. For example, in children with cornrows or braids with extensions, Dr. Taylor said that it might require 30 minutes to as long as 2 or 3 hours to remove their current hairstyle, followed by shampooing and conditioning. “Detangling can take at least 15 minutes. In tightly coiled African American hair, studies have demonstrated that detangling while the hair is wet is best, because you have fewer forces on that comb and the hair is less likely to break, as opposed to detangling when the hair is dry. After the wet hair is detangled and the conditioner is rinsed out, a leave-in conditioner is often applied. Then the hair is detangled again, which can take up to an hour, followed by styling, which can take 1-3 hours. That gives you some insight as to why there can often be infrequent shampooing.”

The recommended frequency of shampooing depends on the hairstyle selected. Many children with braids and extensions will have those braids and extensions taken out every six to 12 weeks, “but that doesn’t mean that the scalp can’t be shampooed,” Dr. Taylor said. “The scalp should be shampooed more often. Economics and socioeconomic status play into the frequency of shampooing. For example, if a parent or a caregiver sends a child to a hair stylist, that can range in price from $45 to $65 or more. Time also factors in. In the black community in particular, it’s a ritual on a Saturday to get your hair done. If the parent or caregiver works on weekends, that’s going to impact the frequency of shampooing.”

Dr. Taylor underscored the importance of framing the history-taking process to avoid common pitfall questions like “Do you wash the child’s hair every day or every other day?” or “Do you use dandruff shampoo every day?” It is important to remember that “the parent’s inherent perception is of a doctor who does not have my hair probably does not understand my hair or my child’s hair,” she said. “It’s unlikely that you’re going to find a parent who shampoos their child’s hair every day or every other day. Maybe once a week, probably biweekly. It’s important to ask culturally competent questions.”

She also advises against asking about shampooing when you’re examining the child’s hair, “because there’s going to be the perception that you may think the scalp is dirty,” Dr. Taylor explained. “You probably want to ask that when gathering the history of present illness. The culturally competent question is going to be, ‘Do you wash her/his hair weekly, every other week, monthly, or does it depend on the hair style?’ ”

Body language is also important. “Don’t lean in from afar when examining the patient,” she said. “Get up close and touch the child’s hair.” If you choose to wear surgical gloves for the exam “don’t hold your hands in the surgical scrub position,” she recommended. “Hold your hands in a more neutral position. I think it’s important to touch the hair.”

Referring back to the 4-year-old black child with bad dandruff, she said that a diagnosis of seborrheic dermatitis is unlikely since that condition usually occurs during puberty. “You should have a high index of suspicion for tinea capitis,” she said. “If the patient has occipital lymphadenopathy plus scaling of the scalp or alopecia, that’s enough to presumptively treat for tinea capitis. There are studies that support that.”

For established tinea capitis, Dr. Taylor advises parents to wash barrettes and other hair adornments in hot soapy water or in the dishwasher. She also recommends disposal of hair oil, pomade, and grease and shampooing the child’s hair with ketoconazole and use a conditioner to decrease household and patient spread, which decreases transmissible fungal spores. “There’s a misperception that the application of hair oils and grease can increase the rate of tinea capitis,” she noted. “That’s not true. However, if hair grease and hair oil is applied to the scalp within one week of culture, it could produce a false negative culture.”

For established seborrheic dermatitis, antifungal shampoos including ketoconazole, ciclopirox, and selenium sulfide may be too drying for ethnic hair, “which already has a propensity to break,” she said. “Instead, we recommend a 5-10 minute scalp contact time with the shampoo and avoid contact with strands of hair. Shampoo hair strands with a conditioning shampoo followed by a conditioner to limit hair breakage. We suggest once weekly or biweekly shampooing.”

Dr. Taylor disclosed that she has advisory board and/or investigator relationships with Aclaris Therapeutics, Allergan, Beiersdorf, Croma Pharmaceuticals, Galderma, Isdin, Johnson & Johnson, and Unilever. She also acknowledged Candrice R. Heath, MD, a dermatologist based in Newark, Delaware, for her assistance with the presentation content.

dbrunk@mdedge.com







 

LAKE TAHOE, CALIF. – The way Susan C. Taylor, MD, sees it, rule No. 1 when examining the hair and scalp of young ethnic patients is to foster a sense of cultural competence.

At the annual meeting of the Society for Pediatric Dermatology, Dr. Taylor, a dermatologist at the University of Pennsylvania, Philadelphia, defined culturally competent care as a patient-centered approach in which clinicians establish a rapport with the patient and the caregiver. “It’s important that we ask the right questions,” she said. “In doing so, we have to be familiar with common hair care practices. It’s important that we respect our patients’ values, their goals, their health needs, and, of course, their cultural background. Finally, we have to engage in shared decision making. That’s where we can improve compliance and lead to an overall very satisfactory patient visit.”

To illustrate this point, she discussed the case of a four-year-old black female with a 9-month history of bad dandruff. The child’s mother reports thick flakes that never go away. She takes pride in caring for her daughter’s hair, and shampoos it every two weeks. “She tells me that during the 2.5 hours that it takes her on Saturdays to shampoo, detangle, and comb her daughter’s hair, which she then braids or cornrows and adorns with barrettes or balls, it is a great bonding experience for the two of them,” Dr. Taylor said. “The flakes are temporarily better after she ‘greases’ her daughter’s scalp, but after 2-3 days, they are back.”

In a case like this, Dr. Taylor recommends asking the parent or caregiver to join you while you examine the scalp. This way, the focus becomes the child’s scalp, and the parent is not just staring at your expressions. “The child also observes the pediatric dermatologist and parent/caregiver working together as a team,” she said. “You also want to ask the parent to remove the hair adornments. This makes the child feel more comfortable. It also allows you to observe how the hair is being managed. Are the adornments being removed gently? Is there aggressive pulling of the hair when they take out the braids? Is the child visibly wincing in pain? If the latter two happen this is a teachable moment. You can point out, ‘It looks like Susie is in pain. Let’s do it a little more gently. That might prevent further hair breakage.’ ”

The differential diagnosis of a scaly pediatric scalp includes infrequent shampooing, seborrheic dermatitis, tinea capitis, atopic dermatitis, psoriasis, and sebopsoriasis. The type of hairstyle also factors in. For example, cornrows are a popular hair styling option among ethnic patients. “These are very popular and very time consuming and may lead to infrequent shampooing,” she said. “If they’re put in very tightly or if they have beads or other adornments, it can lead to traction alopecia.” Twists, meanwhile, can create tension on the hair, while puffs can cause traction alopecia if they’re pulled too tightly. “Although dreadlocks are more common among adolescents, we’re seeing them more commonly in young children,” she said. “They can be very long and wavy and lead to traction alopecia.”

The time required to shampoo, detangle, and style tightly coiled African American hair can be significant. For example, in children with cornrows or braids with extensions, Dr. Taylor said that it might require 30 minutes to as long as 2 or 3 hours to remove their current hairstyle, followed by shampooing and conditioning. “Detangling can take at least 15 minutes. In tightly coiled African American hair, studies have demonstrated that detangling while the hair is wet is best, because you have fewer forces on that comb and the hair is less likely to break, as opposed to detangling when the hair is dry. After the wet hair is detangled and the conditioner is rinsed out, a leave-in conditioner is often applied. Then the hair is detangled again, which can take up to an hour, followed by styling, which can take 1-3 hours. That gives you some insight as to why there can often be infrequent shampooing.”

The recommended frequency of shampooing depends on the hairstyle selected. Many children with braids and extensions will have those braids and extensions taken out every six to 12 weeks, “but that doesn’t mean that the scalp can’t be shampooed,” Dr. Taylor said. “The scalp should be shampooed more often. Economics and socioeconomic status play into the frequency of shampooing. For example, if a parent or a caregiver sends a child to a hair stylist, that can range in price from $45 to $65 or more. Time also factors in. In the black community in particular, it’s a ritual on a Saturday to get your hair done. If the parent or caregiver works on weekends, that’s going to impact the frequency of shampooing.”

Dr. Taylor underscored the importance of framing the history-taking process to avoid common pitfall questions like “Do you wash the child’s hair every day or every other day?” or “Do you use dandruff shampoo every day?” It is important to remember that “the parent’s inherent perception is of a doctor who does not have my hair probably does not understand my hair or my child’s hair,” she said. “It’s unlikely that you’re going to find a parent who shampoos their child’s hair every day or every other day. Maybe once a week, probably biweekly. It’s important to ask culturally competent questions.”

She also advises against asking about shampooing when you’re examining the child’s hair, “because there’s going to be the perception that you may think the scalp is dirty,” Dr. Taylor explained. “You probably want to ask that when gathering the history of present illness. The culturally competent question is going to be, ‘Do you wash her/his hair weekly, every other week, monthly, or does it depend on the hair style?’ ”

Body language is also important. “Don’t lean in from afar when examining the patient,” she said. “Get up close and touch the child’s hair.” If you choose to wear surgical gloves for the exam “don’t hold your hands in the surgical scrub position,” she recommended. “Hold your hands in a more neutral position. I think it’s important to touch the hair.”

Referring back to the 4-year-old black child with bad dandruff, she said that a diagnosis of seborrheic dermatitis is unlikely since that condition usually occurs during puberty. “You should have a high index of suspicion for tinea capitis,” she said. “If the patient has occipital lymphadenopathy plus scaling of the scalp or alopecia, that’s enough to presumptively treat for tinea capitis. There are studies that support that.”

For established tinea capitis, Dr. Taylor advises parents to wash barrettes and other hair adornments in hot soapy water or in the dishwasher. She also recommends disposal of hair oil, pomade, and grease and shampooing the child’s hair with ketoconazole and use a conditioner to decrease household and patient spread, which decreases transmissible fungal spores. “There’s a misperception that the application of hair oils and grease can increase the rate of tinea capitis,” she noted. “That’s not true. However, if hair grease and hair oil is applied to the scalp within one week of culture, it could produce a false negative culture.”

For established seborrheic dermatitis, antifungal shampoos including ketoconazole, ciclopirox, and selenium sulfide may be too drying for ethnic hair, “which already has a propensity to break,” she said. “Instead, we recommend a 5-10 minute scalp contact time with the shampoo and avoid contact with strands of hair. Shampoo hair strands with a conditioning shampoo followed by a conditioner to limit hair breakage. We suggest once weekly or biweekly shampooing.”

Dr. Taylor disclosed that she has advisory board and/or investigator relationships with Aclaris Therapeutics, Allergan, Beiersdorf, Croma Pharmaceuticals, Galderma, Isdin, Johnson & Johnson, and Unilever. She also acknowledged Candrice R. Heath, MD, a dermatologist based in Newark, Delaware, for her assistance with the presentation content.

dbrunk@mdedge.com







 

CHICAGO – In a busy clinic it can be hard to find the time to stop, talk, and listen. But doing so will “pay dividends in time spent later – and in reduced complications” of nail surgery, according to Molly A. Hinshaw, MD.

Dr. Hinshaw, director of the nail clinic at the University of Wisconsin–Madison, shared her clinical pearls for patient care through the entire nail surgery process at the American Academy of Dermatology summer meeting.

“One pearl is the importance of patient education before we start,” Dr. Hinshaw said. Preoperatively, she takes time to talk through the entire surgery and expected postoperative course. Critically, she reassures patients that pain will be controlled; she also reviews in detail what the pharmacologic and nonpharmacologic pain control strategies will be.

In addition, it’s important to address patients’ natural anxiety about what the surgical site will look and feel like and how healing will progress, particularly in those first few days after surgery. “I offer a first dressing change in my practice, either at 24 or 48 hours. This can be very anxiolytic for the patient,” she said.

At the preoperative stage, Dr. Hinshaw also tells patients that, from a healing and pain management standpoint, to make sure they plan “to have a restful 48 hours after surgery.” Her patient instructions for the immediate postoperative period include keeping the limb elevated and avoiding unnecessary activity with the affected limb while the digit, whether a finger or toe, is still anesthetized. To stay on top of the pain, the appropriate oral pain medication should be started once sensation starts to return to the digit. She recommends patients also take a dose of their pain medication at bedtime, as this will help them get a restful night of sleep.

“One thing that I’ve learned over the years is that throbbing and a little bit of swelling after surgery is not uncommon,” said Dr. Hinshaw, who uses elastic self-adherent wrap for the top layer of wound dressings after nail surgery. She tells her patients, “if you’re feeling throbbing, you’re welcome to unwrap it and rewrap it more loosely.” Just giving the patient the ability to find a comfortable level of pressure on the affected digit is often enough to alleviate the throbbing, as opposed to treating that throbbing with pain medication.

Dr. Hinshaw said she’s learned to tailor her postoperative analgesia to the surgery and to the patient. With all patients, she is sure to make medication and dosing choices that take comorbidities and potential drug-drug interactions into account. She does not ask patients to stop anticoagulation before nail procedures.

For phenolization procedures and punch biopsies, she’ll advise patients to use acetaminophen or NSAIDs. Some procedures are going to have a more painful recovery course, said Dr. Hinshaw, so she’ll use an opioid such as hydrocodone with acetaminophen for shave excisions and fusiform longitudinal excisions.

The physician and patient can also plan ahead for a brief course of more potent opioids for some procedures. “Certainly for lateral longitudinal excisions, they will need narcotic pain management for at least 48 hours after surgery,” she noted. “It’s a painful surgery.”

Other procedures that will need more postoperative analgesia include flaps and nail unit grafts, she said. In general, NSAIDs are useful to add after the first 24 hours. In addition, “I always call my patients the day after surgery to see how they’re doing. This helps identify any issues and questions early and is comforting to the patient,” she added.

Dr. Hinshaw disclosed that she has an ownership stake in and sits on the board of directors of Accure Medical.

koakes@mdedge.com

CHICAGO – In a busy clinic it can be hard to find the time to stop, talk, and listen. But doing so will “pay dividends in time spent later – and in reduced complications” of nail surgery, according to Molly A. Hinshaw, MD.

Dr. Hinshaw, director of the nail clinic at the University of Wisconsin–Madison, shared her clinical pearls for patient care through the entire nail surgery process at the American Academy of Dermatology summer meeting.

“One pearl is the importance of patient education before we start,” Dr. Hinshaw said. Preoperatively, she takes time to talk through the entire surgery and expected postoperative course. Critically, she reassures patients that pain will be controlled; she also reviews in detail what the pharmacologic and nonpharmacologic pain control strategies will be.

In addition, it’s important to address patients’ natural anxiety about what the surgical site will look and feel like and how healing will progress, particularly in those first few days after surgery. “I offer a first dressing change in my practice, either at 24 or 48 hours. This can be very anxiolytic for the patient,” she said.

At the preoperative stage, Dr. Hinshaw also tells patients that, from a healing and pain management standpoint, to make sure they plan “to have a restful 48 hours after surgery.” Her patient instructions for the immediate postoperative period include keeping the limb elevated and avoiding unnecessary activity with the affected limb while the digit, whether a finger or toe, is still anesthetized. To stay on top of the pain, the appropriate oral pain medication should be started once sensation starts to return to the digit. She recommends patients also take a dose of their pain medication at bedtime, as this will help them get a restful night of sleep.

“One thing that I’ve learned over the years is that throbbing and a little bit of swelling after surgery is not uncommon,” said Dr. Hinshaw, who uses elastic self-adherent wrap for the top layer of wound dressings after nail surgery. She tells her patients, “if you’re feeling throbbing, you’re welcome to unwrap it and rewrap it more loosely.” Just giving the patient the ability to find a comfortable level of pressure on the affected digit is often enough to alleviate the throbbing, as opposed to treating that throbbing with pain medication.

Dr. Hinshaw said she’s learned to tailor her postoperative analgesia to the surgery and to the patient. With all patients, she is sure to make medication and dosing choices that take comorbidities and potential drug-drug interactions into account. She does not ask patients to stop anticoagulation before nail procedures.

For phenolization procedures and punch biopsies, she’ll advise patients to use acetaminophen or NSAIDs. Some procedures are going to have a more painful recovery course, said Dr. Hinshaw, so she’ll use an opioid such as hydrocodone with acetaminophen for shave excisions and fusiform longitudinal excisions.

The physician and patient can also plan ahead for a brief course of more potent opioids for some procedures. “Certainly for lateral longitudinal excisions, they will need narcotic pain management for at least 48 hours after surgery,” she noted. “It’s a painful surgery.”

Other procedures that will need more postoperative analgesia include flaps and nail unit grafts, she said. In general, NSAIDs are useful to add after the first 24 hours. In addition, “I always call my patients the day after surgery to see how they’re doing. This helps identify any issues and questions early and is comforting to the patient,” she added.

Dr. Hinshaw disclosed that she has an ownership stake in and sits on the board of directors of Accure Medical.

koakes@mdedge.com

CHICAGO – In a busy clinic it can be hard to find the time to stop, talk, and listen. But doing so will “pay dividends in time spent later – and in reduced complications” of nail surgery, according to Molly A. Hinshaw, MD.

Dr. Hinshaw, director of the nail clinic at the University of Wisconsin–Madison, shared her clinical pearls for patient care through the entire nail surgery process at the American Academy of Dermatology summer meeting.

“One pearl is the importance of patient education before we start,” Dr. Hinshaw said. Preoperatively, she takes time to talk through the entire surgery and expected postoperative course. Critically, she reassures patients that pain will be controlled; she also reviews in detail what the pharmacologic and nonpharmacologic pain control strategies will be.

In addition, it’s important to address patients’ natural anxiety about what the surgical site will look and feel like and how healing will progress, particularly in those first few days after surgery. “I offer a first dressing change in my practice, either at 24 or 48 hours. This can be very anxiolytic for the patient,” she said.

At the preoperative stage, Dr. Hinshaw also tells patients that, from a healing and pain management standpoint, to make sure they plan “to have a restful 48 hours after surgery.” Her patient instructions for the immediate postoperative period include keeping the limb elevated and avoiding unnecessary activity with the affected limb while the digit, whether a finger or toe, is still anesthetized. To stay on top of the pain, the appropriate oral pain medication should be started once sensation starts to return to the digit. She recommends patients also take a dose of their pain medication at bedtime, as this will help them get a restful night of sleep.

“One thing that I’ve learned over the years is that throbbing and a little bit of swelling after surgery is not uncommon,” said Dr. Hinshaw, who uses elastic self-adherent wrap for the top layer of wound dressings after nail surgery. She tells her patients, “if you’re feeling throbbing, you’re welcome to unwrap it and rewrap it more loosely.” Just giving the patient the ability to find a comfortable level of pressure on the affected digit is often enough to alleviate the throbbing, as opposed to treating that throbbing with pain medication.

Dr. Hinshaw said she’s learned to tailor her postoperative analgesia to the surgery and to the patient. With all patients, she is sure to make medication and dosing choices that take comorbidities and potential drug-drug interactions into account. She does not ask patients to stop anticoagulation before nail procedures.

For phenolization procedures and punch biopsies, she’ll advise patients to use acetaminophen or NSAIDs. Some procedures are going to have a more painful recovery course, said Dr. Hinshaw, so she’ll use an opioid such as hydrocodone with acetaminophen for shave excisions and fusiform longitudinal excisions.

The physician and patient can also plan ahead for a brief course of more potent opioids for some procedures. “Certainly for lateral longitudinal excisions, they will need narcotic pain management for at least 48 hours after surgery,” she noted. “It’s a painful surgery.”

Other procedures that will need more postoperative analgesia include flaps and nail unit grafts, she said. In general, NSAIDs are useful to add after the first 24 hours. In addition, “I always call my patients the day after surgery to see how they’re doing. This helps identify any issues and questions early and is comforting to the patient,” she added.

Dr. Hinshaw disclosed that she has an ownership stake in and sits on the board of directors of Accure Medical.

koakes@mdedge.com

Case

An 85-year-old man with long-standing chronic obstructive pulmonary disease (COPD) has a witnessed aspiration event while undergoing an outpatient procedure requiring conscious sedation. He is admitted to the hospital for observation overnight. The next morning, he feels well, but his oxygen saturation dips to 85% with ambulation. He reports this is not new for him, but he vehemently does not want supplemental oxygen.

Background

Patients with COPD and severe resting hypoxemia – arterial oxygen partial pressure less than or equal to 55 mm Hg or peripheral capillary oxygen saturation (SpO₂₎ less than or equal to 88% – commonly are prescribed supplemental oxygen. The evidence supporting this practice is limited to two small trials from the 1970s that showed a survival benefit of long-term oxygen therapy (LTOT) in this population,^1,2 but these trials may not be generalizable to patients today.

For patients with COPD and mild to moderate resting hypoxemia (SpO_2, 89%-93%) or patients with exercise-induced hypoxemia, LTOT has not been shown to improve survival, although it may improve symptoms of dyspnea, exercise tolerance, and other patient reported outcomes. Given the costs, risks, and burdens associated with LTOT, a high-quality clinical trial assessing the effects of LTOT on clinically meaningful outcomes, such as survival or hospitalization, in patients with COPD and moderate hypoxemia has been long overdue.
 

Overview of the data

The utility of long-term treatment with supplemental oxygen in patients with stable COPD and moderate resting or exercise-induced desaturation was examined by the Long-Term Oxygen Treatment Trial (LOTT) Research Group. Results were published in the New England Journal of Medicine in October 2016 in the article, “A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation.”³

The study was initially designed to test whether the use of supplemental oxygen would lead to longer time until death as compared with no supplemental oxygen in the subgroup of COPD patients with stable disease and moderate resting desaturation (defined as resting SpO₂ of 89%-93%). However, because of an enrollment of only 34 patients after 7 months, the trial was redesigned to include exercise-induced desaturation (defined as SpO₂ of greater than or equal to 80% for at least 5 minutes, and less than 90% for at least 10 seconds, on a 6-minute walk test) and the secondary outcome of all-cause hospitalization. Hospitalization for any cause was combined with mortality into a new composite primary outcome.

This study was a randomized, controlled trial which enrolled patients at a total of 14 regional clinical centers and their associated sites for a total of 42 centers in the United States. The experimental arm consisted of a long term supplemental oxygen group, and the control group did not receive long term supplemental oxygen. Patients were assigned to groups in a 1:1 ratio and the study was not blinded. Patients with moderate resting desaturation were prescribed 24 hour oxygen at 2 L/min, and patients with moderate exercise-induced desaturation were prescribed oxygen at 2 L/min during exercise and sleep only. The primary outcome was a composite outcome of time until death or time until first hospitalization for any cause. There were multiple secondary outcomes, including incidence of COPD exacerbation, incidence of severe resting desaturation and severe exercise-induced desaturation, quality of life, sleep quality, depression and anxiety, adherence to regimen, 6-minute walk distance, spirometric measurements, risk of cardiovascular disease, and neurocognitive function.

Data were gathered via yearly visits, biannual telephone interviews, and questionnaires mailed at 4 months and 16 months. Adherence was assessed by inquiring about oxygen use every 4 months. If patients in the supplemental oxygen group used stationary oxygen concentrators, logs of meter readings were kept as well. The necessary final sample size was calculated using a time to composite event survival model with the use of the log-rank test statistic.

A total of 738 patients were enrolled in the trial between January 2009 and September 2015 and were followed for 1-6 years. A total of 97% of participants had at least 1 year of follow-up. Out of the 738 randomized patients, 133 (18%) had only resting desaturations, 319 (43%) had only exercise-induced desaturations, and 286 (39%) had both resting and exercise-induced desaturations. Baseline characteristics including age, sex, race, smoking status, quality of life scores, resting SpO_2, and nadir SpO₂ during the 6-minute walk test were similar between the two groups. The only significant difference noted by the authors between the two groups was a lower BODE (body mass index, airflow obstruction, dyspnea, and exercise) index, which was lower in the group with no supplemental oxygen.

In the time-to-event analysis, there was no significant difference between the two groups in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval, 0.79-1.12; P = .52). There were no significant differences in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91-1.13), COPD exacerbations (RR 1.08; 95% CI, 0.98-1.19), and COPD related hospitalizations (RR, 0.99; 95% CI, 0.83-1.17). There were also no differences between the experimental and control groups in quality of life, lung function, and 6-minute walk distance. There were no significant differences in the subgroups classified by desaturation profile, sex, race, nadir SpO₂ during the 6-minute walk test, and forced expiratory volume in 1 second.

The findings in this study show that, in the subgroup of chronic obstructive pulmonary disease patients with stable COPD and moderate resting or exercise-induced desaturation, supplemental oxygen did not affect the time to death or first hospitalization, time to death, time to first hospitalization, time to first COPD exacerbation, time to first hospitalization for a COPD exacerbation, rate of all hospitalizations, rate of all COPD exacerbations, or changes in metrics surrounding quality of life, anxiety/depression, or functional status. This supports earlier studies that demonstrated that long-term treatment with oxygen does not result in longer survival than does no long-term treatment with oxygen in patients with COPD and resting SpO₂ of more than 88%.

The results of this study are a departure from previous studies that had shown improved mortality in patients with COPD and severe desaturation who were treated with LTOT. The authors hypothesized that this may have been caused by physiological effects of oxygen saturation on pulmonary vasoconstriction, release of mediators, and ventilator drive, which occur at an O₂ saturation of 88% or less and may be more significant in patients with chronic hypoxemia. This trial also contrasted previous studies that had shown that oxygen therapy may reduce dyspnea in COPD patients with mild or no hypoxia because the LOTT trial showed no improvement in quality of life, anxiety, and depression measures in patients treated with long-term oxygen as compared with those treated with no oxygen.

Some limitations of the study included the absence of highly symptomatic patients or patients who the providers believed were too ill to participate, the effect of the unblinded nature of the study on outcomes that were patient reported, the lack of assessment of immediate effects of oxygen on exercise performance or symptoms, possible variability in amount of oxygen delivered, and the fact that patients may have overestimated their oxygen use.

In patients with stable COPD and moderate resting or exercise induced desaturation, long-term supplemental oxygen did not provide any benefit in regard to time until death or first hospitalization or any of the other measured outcomes.

Application of data to the case

Our patient has stable COPD and had only moderate exercise-induced desaturation. Long-term supplemental oxygen would not produce a benefit for him.

This study shows us that it would not increase his survival at this point; however, if he were to have worsening exercise-induced or new resting desaturation at some point in the future, supplemental oxygen would then be beneficial. At this point supplemental oxygen would not even affect his rate of hospitalization for COPD- or non-COPD–related reasons. Perhaps most importantly, adding oxygen therapy would not affect his overall quality of life, including his functional status and mood.
 

Bottom line

The addition of supplemental oxygen is not helpful for patients with COPD who have chronic stable moderate hypoxia.

Dr. Farber is a medical instructor in the Duke University Health System in Durham, N.C. Dr. Sata is a medical instructor in the Duke University Hospital. Dr. Wachter is an assistant professor of medicine at Duke University. Dr. Sharma is associate medical director for clinical education in hospital medicine at Duke Regional Hospital and an assistant professor of medicine at Duke University.

References

1. Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: A clinical trial. Ann Intern Med. 1980 Sep;93(3):391-8.

2. Medical Research Council Working Party. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema: Report of the Medical Research Council Working Party. Lancet 1981 Mar 28;1(8222):681-6.

3. Long-term oxygen treatment trial research group et al. A randomized trial of long-term oxygen for COPD with moderate desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-27.

Additional reading

Stoller JK et al. Oxygen therapy for patients with COPD: Current evidence and the Long-term Oxygen Treatment Trial. Chest. 2010 July;138:179-87.

Qaseem A et al. Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91.

Ameer F et al. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014 Jun 24;(6):CD000238.

Vestbo J et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65.

Quiz: Does this patient need oxygen?

You are caring for a 72-year-old man with stable COPD who was admitted for cellulitis. He is improving clinically on appropriate antibiotics, and he has been stable on room air every time you examine him. The nurse pages you on the day of discharge – a Sunday – informing you that his oxygen saturation dropped to 88% while he was walking the halls this morning. She asks whether he needs to stay in the hospital so you can arrange home supplemental oxygen therapy. What should you do?

A. Keep him in the hospital until you can arrange home oxygen therapy.

B. Discharge him home Sunday but have the oxygen company go out to his house first thing on Monday.

C. Discharge him home without supplemental oxygen therapy.

D. Check an arterial blood gas to help decide if you should set up oxygen therapy.

The answer is C. He meets the description of stable COPD with mild to moderate exercise-induced desaturation. The LOTT trial supports our clinical decision that he would not benefit from supplemental oxygen therapy at this point.

Key Points

• Long-term oxygen therapy (LTOT) is beneficial in patients with COPD and severe resting hypoxemia (arterial oxygen partial pressure ≤ 55 mm Hg or SpO₂ ≤ 88%) and should be prescribed to improve survival in this population.
• Patients with COPD and mild to moderate resting hypoxemia or exercised-induced hypoxemia should not be routinely prescribed LTOT given the associated costs, risks, and burdens and the lack of evidence of benefit.

Case

An 85-year-old man with long-standing chronic obstructive pulmonary disease (COPD) has a witnessed aspiration event while undergoing an outpatient procedure requiring conscious sedation. He is admitted to the hospital for observation overnight. The next morning, he feels well, but his oxygen saturation dips to 85% with ambulation. He reports this is not new for him, but he vehemently does not want supplemental oxygen.

Background

Patients with COPD and severe resting hypoxemia – arterial oxygen partial pressure less than or equal to 55 mm Hg or peripheral capillary oxygen saturation (SpO₂₎ less than or equal to 88% – commonly are prescribed supplemental oxygen. The evidence supporting this practice is limited to two small trials from the 1970s that showed a survival benefit of long-term oxygen therapy (LTOT) in this population,^1,2 but these trials may not be generalizable to patients today.

For patients with COPD and mild to moderate resting hypoxemia (SpO_2, 89%-93%) or patients with exercise-induced hypoxemia, LTOT has not been shown to improve survival, although it may improve symptoms of dyspnea, exercise tolerance, and other patient reported outcomes. Given the costs, risks, and burdens associated with LTOT, a high-quality clinical trial assessing the effects of LTOT on clinically meaningful outcomes, such as survival or hospitalization, in patients with COPD and moderate hypoxemia has been long overdue.
 

Overview of the data

The utility of long-term treatment with supplemental oxygen in patients with stable COPD and moderate resting or exercise-induced desaturation was examined by the Long-Term Oxygen Treatment Trial (LOTT) Research Group. Results were published in the New England Journal of Medicine in October 2016 in the article, “A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation.”³

The study was initially designed to test whether the use of supplemental oxygen would lead to longer time until death as compared with no supplemental oxygen in the subgroup of COPD patients with stable disease and moderate resting desaturation (defined as resting SpO₂ of 89%-93%). However, because of an enrollment of only 34 patients after 7 months, the trial was redesigned to include exercise-induced desaturation (defined as SpO₂ of greater than or equal to 80% for at least 5 minutes, and less than 90% for at least 10 seconds, on a 6-minute walk test) and the secondary outcome of all-cause hospitalization. Hospitalization for any cause was combined with mortality into a new composite primary outcome.

This study was a randomized, controlled trial which enrolled patients at a total of 14 regional clinical centers and their associated sites for a total of 42 centers in the United States. The experimental arm consisted of a long term supplemental oxygen group, and the control group did not receive long term supplemental oxygen. Patients were assigned to groups in a 1:1 ratio and the study was not blinded. Patients with moderate resting desaturation were prescribed 24 hour oxygen at 2 L/min, and patients with moderate exercise-induced desaturation were prescribed oxygen at 2 L/min during exercise and sleep only. The primary outcome was a composite outcome of time until death or time until first hospitalization for any cause. There were multiple secondary outcomes, including incidence of COPD exacerbation, incidence of severe resting desaturation and severe exercise-induced desaturation, quality of life, sleep quality, depression and anxiety, adherence to regimen, 6-minute walk distance, spirometric measurements, risk of cardiovascular disease, and neurocognitive function.

Data were gathered via yearly visits, biannual telephone interviews, and questionnaires mailed at 4 months and 16 months. Adherence was assessed by inquiring about oxygen use every 4 months. If patients in the supplemental oxygen group used stationary oxygen concentrators, logs of meter readings were kept as well. The necessary final sample size was calculated using a time to composite event survival model with the use of the log-rank test statistic.

A total of 738 patients were enrolled in the trial between January 2009 and September 2015 and were followed for 1-6 years. A total of 97% of participants had at least 1 year of follow-up. Out of the 738 randomized patients, 133 (18%) had only resting desaturations, 319 (43%) had only exercise-induced desaturations, and 286 (39%) had both resting and exercise-induced desaturations. Baseline characteristics including age, sex, race, smoking status, quality of life scores, resting SpO_2, and nadir SpO₂ during the 6-minute walk test were similar between the two groups. The only significant difference noted by the authors between the two groups was a lower BODE (body mass index, airflow obstruction, dyspnea, and exercise) index, which was lower in the group with no supplemental oxygen.

In the time-to-event analysis, there was no significant difference between the two groups in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval, 0.79-1.12; P = .52). There were no significant differences in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91-1.13), COPD exacerbations (RR 1.08; 95% CI, 0.98-1.19), and COPD related hospitalizations (RR, 0.99; 95% CI, 0.83-1.17). There were also no differences between the experimental and control groups in quality of life, lung function, and 6-minute walk distance. There were no significant differences in the subgroups classified by desaturation profile, sex, race, nadir SpO₂ during the 6-minute walk test, and forced expiratory volume in 1 second.

The findings in this study show that, in the subgroup of chronic obstructive pulmonary disease patients with stable COPD and moderate resting or exercise-induced desaturation, supplemental oxygen did not affect the time to death or first hospitalization, time to death, time to first hospitalization, time to first COPD exacerbation, time to first hospitalization for a COPD exacerbation, rate of all hospitalizations, rate of all COPD exacerbations, or changes in metrics surrounding quality of life, anxiety/depression, or functional status. This supports earlier studies that demonstrated that long-term treatment with oxygen does not result in longer survival than does no long-term treatment with oxygen in patients with COPD and resting SpO₂ of more than 88%.

The results of this study are a departure from previous studies that had shown improved mortality in patients with COPD and severe desaturation who were treated with LTOT. The authors hypothesized that this may have been caused by physiological effects of oxygen saturation on pulmonary vasoconstriction, release of mediators, and ventilator drive, which occur at an O₂ saturation of 88% or less and may be more significant in patients with chronic hypoxemia. This trial also contrasted previous studies that had shown that oxygen therapy may reduce dyspnea in COPD patients with mild or no hypoxia because the LOTT trial showed no improvement in quality of life, anxiety, and depression measures in patients treated with long-term oxygen as compared with those treated with no oxygen.

Some limitations of the study included the absence of highly symptomatic patients or patients who the providers believed were too ill to participate, the effect of the unblinded nature of the study on outcomes that were patient reported, the lack of assessment of immediate effects of oxygen on exercise performance or symptoms, possible variability in amount of oxygen delivered, and the fact that patients may have overestimated their oxygen use.

In patients with stable COPD and moderate resting or exercise induced desaturation, long-term supplemental oxygen did not provide any benefit in regard to time until death or first hospitalization or any of the other measured outcomes.

Application of data to the case

Our patient has stable COPD and had only moderate exercise-induced desaturation. Long-term supplemental oxygen would not produce a benefit for him.

This study shows us that it would not increase his survival at this point; however, if he were to have worsening exercise-induced or new resting desaturation at some point in the future, supplemental oxygen would then be beneficial. At this point supplemental oxygen would not even affect his rate of hospitalization for COPD- or non-COPD–related reasons. Perhaps most importantly, adding oxygen therapy would not affect his overall quality of life, including his functional status and mood.
 

Bottom line

The addition of supplemental oxygen is not helpful for patients with COPD who have chronic stable moderate hypoxia.

Dr. Farber is a medical instructor in the Duke University Health System in Durham, N.C. Dr. Sata is a medical instructor in the Duke University Hospital. Dr. Wachter is an assistant professor of medicine at Duke University. Dr. Sharma is associate medical director for clinical education in hospital medicine at Duke Regional Hospital and an assistant professor of medicine at Duke University.

References

1. Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: A clinical trial. Ann Intern Med. 1980 Sep;93(3):391-8.

2. Medical Research Council Working Party. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema: Report of the Medical Research Council Working Party. Lancet 1981 Mar 28;1(8222):681-6.

3. Long-term oxygen treatment trial research group et al. A randomized trial of long-term oxygen for COPD with moderate desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-27.

Additional reading

Stoller JK et al. Oxygen therapy for patients with COPD: Current evidence and the Long-term Oxygen Treatment Trial. Chest. 2010 July;138:179-87.

Qaseem A et al. Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91.

Ameer F et al. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014 Jun 24;(6):CD000238.

Vestbo J et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65.

Quiz: Does this patient need oxygen?

You are caring for a 72-year-old man with stable COPD who was admitted for cellulitis. He is improving clinically on appropriate antibiotics, and he has been stable on room air every time you examine him. The nurse pages you on the day of discharge – a Sunday – informing you that his oxygen saturation dropped to 88% while he was walking the halls this morning. She asks whether he needs to stay in the hospital so you can arrange home supplemental oxygen therapy. What should you do?

A. Keep him in the hospital until you can arrange home oxygen therapy.

B. Discharge him home Sunday but have the oxygen company go out to his house first thing on Monday.

C. Discharge him home without supplemental oxygen therapy.

D. Check an arterial blood gas to help decide if you should set up oxygen therapy.

The answer is C. He meets the description of stable COPD with mild to moderate exercise-induced desaturation. The LOTT trial supports our clinical decision that he would not benefit from supplemental oxygen therapy at this point.

Key Points

• Long-term oxygen therapy (LTOT) is beneficial in patients with COPD and severe resting hypoxemia (arterial oxygen partial pressure ≤ 55 mm Hg or SpO₂ ≤ 88%) and should be prescribed to improve survival in this population.
• Patients with COPD and mild to moderate resting hypoxemia or exercised-induced hypoxemia should not be routinely prescribed LTOT given the associated costs, risks, and burdens and the lack of evidence of benefit.

Case

An 85-year-old man with long-standing chronic obstructive pulmonary disease (COPD) has a witnessed aspiration event while undergoing an outpatient procedure requiring conscious sedation. He is admitted to the hospital for observation overnight. The next morning, he feels well, but his oxygen saturation dips to 85% with ambulation. He reports this is not new for him, but he vehemently does not want supplemental oxygen.

Background

Patients with COPD and severe resting hypoxemia – arterial oxygen partial pressure less than or equal to 55 mm Hg or peripheral capillary oxygen saturation (SpO₂₎ less than or equal to 88% – commonly are prescribed supplemental oxygen. The evidence supporting this practice is limited to two small trials from the 1970s that showed a survival benefit of long-term oxygen therapy (LTOT) in this population,^1,2 but these trials may not be generalizable to patients today.

For patients with COPD and mild to moderate resting hypoxemia (SpO_2, 89%-93%) or patients with exercise-induced hypoxemia, LTOT has not been shown to improve survival, although it may improve symptoms of dyspnea, exercise tolerance, and other patient reported outcomes. Given the costs, risks, and burdens associated with LTOT, a high-quality clinical trial assessing the effects of LTOT on clinically meaningful outcomes, such as survival or hospitalization, in patients with COPD and moderate hypoxemia has been long overdue.
 

Overview of the data

The utility of long-term treatment with supplemental oxygen in patients with stable COPD and moderate resting or exercise-induced desaturation was examined by the Long-Term Oxygen Treatment Trial (LOTT) Research Group. Results were published in the New England Journal of Medicine in October 2016 in the article, “A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation.”³

The study was initially designed to test whether the use of supplemental oxygen would lead to longer time until death as compared with no supplemental oxygen in the subgroup of COPD patients with stable disease and moderate resting desaturation (defined as resting SpO₂ of 89%-93%). However, because of an enrollment of only 34 patients after 7 months, the trial was redesigned to include exercise-induced desaturation (defined as SpO₂ of greater than or equal to 80% for at least 5 minutes, and less than 90% for at least 10 seconds, on a 6-minute walk test) and the secondary outcome of all-cause hospitalization. Hospitalization for any cause was combined with mortality into a new composite primary outcome.

This study was a randomized, controlled trial which enrolled patients at a total of 14 regional clinical centers and their associated sites for a total of 42 centers in the United States. The experimental arm consisted of a long term supplemental oxygen group, and the control group did not receive long term supplemental oxygen. Patients were assigned to groups in a 1:1 ratio and the study was not blinded. Patients with moderate resting desaturation were prescribed 24 hour oxygen at 2 L/min, and patients with moderate exercise-induced desaturation were prescribed oxygen at 2 L/min during exercise and sleep only. The primary outcome was a composite outcome of time until death or time until first hospitalization for any cause. There were multiple secondary outcomes, including incidence of COPD exacerbation, incidence of severe resting desaturation and severe exercise-induced desaturation, quality of life, sleep quality, depression and anxiety, adherence to regimen, 6-minute walk distance, spirometric measurements, risk of cardiovascular disease, and neurocognitive function.

Data were gathered via yearly visits, biannual telephone interviews, and questionnaires mailed at 4 months and 16 months. Adherence was assessed by inquiring about oxygen use every 4 months. If patients in the supplemental oxygen group used stationary oxygen concentrators, logs of meter readings were kept as well. The necessary final sample size was calculated using a time to composite event survival model with the use of the log-rank test statistic.

A total of 738 patients were enrolled in the trial between January 2009 and September 2015 and were followed for 1-6 years. A total of 97% of participants had at least 1 year of follow-up. Out of the 738 randomized patients, 133 (18%) had only resting desaturations, 319 (43%) had only exercise-induced desaturations, and 286 (39%) had both resting and exercise-induced desaturations. Baseline characteristics including age, sex, race, smoking status, quality of life scores, resting SpO_2, and nadir SpO₂ during the 6-minute walk test were similar between the two groups. The only significant difference noted by the authors between the two groups was a lower BODE (body mass index, airflow obstruction, dyspnea, and exercise) index, which was lower in the group with no supplemental oxygen.

In the time-to-event analysis, there was no significant difference between the two groups in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval, 0.79-1.12; P = .52). There were no significant differences in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91-1.13), COPD exacerbations (RR 1.08; 95% CI, 0.98-1.19), and COPD related hospitalizations (RR, 0.99; 95% CI, 0.83-1.17). There were also no differences between the experimental and control groups in quality of life, lung function, and 6-minute walk distance. There were no significant differences in the subgroups classified by desaturation profile, sex, race, nadir SpO₂ during the 6-minute walk test, and forced expiratory volume in 1 second.

The findings in this study show that, in the subgroup of chronic obstructive pulmonary disease patients with stable COPD and moderate resting or exercise-induced desaturation, supplemental oxygen did not affect the time to death or first hospitalization, time to death, time to first hospitalization, time to first COPD exacerbation, time to first hospitalization for a COPD exacerbation, rate of all hospitalizations, rate of all COPD exacerbations, or changes in metrics surrounding quality of life, anxiety/depression, or functional status. This supports earlier studies that demonstrated that long-term treatment with oxygen does not result in longer survival than does no long-term treatment with oxygen in patients with COPD and resting SpO₂ of more than 88%.

The results of this study are a departure from previous studies that had shown improved mortality in patients with COPD and severe desaturation who were treated with LTOT. The authors hypothesized that this may have been caused by physiological effects of oxygen saturation on pulmonary vasoconstriction, release of mediators, and ventilator drive, which occur at an O₂ saturation of 88% or less and may be more significant in patients with chronic hypoxemia. This trial also contrasted previous studies that had shown that oxygen therapy may reduce dyspnea in COPD patients with mild or no hypoxia because the LOTT trial showed no improvement in quality of life, anxiety, and depression measures in patients treated with long-term oxygen as compared with those treated with no oxygen.

Some limitations of the study included the absence of highly symptomatic patients or patients who the providers believed were too ill to participate, the effect of the unblinded nature of the study on outcomes that were patient reported, the lack of assessment of immediate effects of oxygen on exercise performance or symptoms, possible variability in amount of oxygen delivered, and the fact that patients may have overestimated their oxygen use.

In patients with stable COPD and moderate resting or exercise induced desaturation, long-term supplemental oxygen did not provide any benefit in regard to time until death or first hospitalization or any of the other measured outcomes.

Application of data to the case

Our patient has stable COPD and had only moderate exercise-induced desaturation. Long-term supplemental oxygen would not produce a benefit for him.

This study shows us that it would not increase his survival at this point; however, if he were to have worsening exercise-induced or new resting desaturation at some point in the future, supplemental oxygen would then be beneficial. At this point supplemental oxygen would not even affect his rate of hospitalization for COPD- or non-COPD–related reasons. Perhaps most importantly, adding oxygen therapy would not affect his overall quality of life, including his functional status and mood.
 

Bottom line

The addition of supplemental oxygen is not helpful for patients with COPD who have chronic stable moderate hypoxia.

Dr. Farber is a medical instructor in the Duke University Health System in Durham, N.C. Dr. Sata is a medical instructor in the Duke University Hospital. Dr. Wachter is an assistant professor of medicine at Duke University. Dr. Sharma is associate medical director for clinical education in hospital medicine at Duke Regional Hospital and an assistant professor of medicine at Duke University.

References

1. Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: A clinical trial. Ann Intern Med. 1980 Sep;93(3):391-8.

2. Medical Research Council Working Party. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema: Report of the Medical Research Council Working Party. Lancet 1981 Mar 28;1(8222):681-6.

3. Long-term oxygen treatment trial research group et al. A randomized trial of long-term oxygen for COPD with moderate desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-27.

Additional reading

Stoller JK et al. Oxygen therapy for patients with COPD: Current evidence and the Long-term Oxygen Treatment Trial. Chest. 2010 July;138:179-87.

Qaseem A et al. Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91.

Ameer F et al. Ambulatory oxygen for people with chronic obstructive pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014 Jun 24;(6):CD000238.

Vestbo J et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65.

Quiz: Does this patient need oxygen?

You are caring for a 72-year-old man with stable COPD who was admitted for cellulitis. He is improving clinically on appropriate antibiotics, and he has been stable on room air every time you examine him. The nurse pages you on the day of discharge – a Sunday – informing you that his oxygen saturation dropped to 88% while he was walking the halls this morning. She asks whether he needs to stay in the hospital so you can arrange home supplemental oxygen therapy. What should you do?

A. Keep him in the hospital until you can arrange home oxygen therapy.

B. Discharge him home Sunday but have the oxygen company go out to his house first thing on Monday.

C. Discharge him home without supplemental oxygen therapy.

D. Check an arterial blood gas to help decide if you should set up oxygen therapy.

The answer is C. He meets the description of stable COPD with mild to moderate exercise-induced desaturation. The LOTT trial supports our clinical decision that he would not benefit from supplemental oxygen therapy at this point.

Key Points

• Long-term oxygen therapy (LTOT) is beneficial in patients with COPD and severe resting hypoxemia (arterial oxygen partial pressure ≤ 55 mm Hg or SpO₂ ≤ 88%) and should be prescribed to improve survival in this population.
• Patients with COPD and mild to moderate resting hypoxemia or exercised-induced hypoxemia should not be routinely prescribed LTOT given the associated costs, risks, and burdens and the lack of evidence of benefit.

Astrocyte glutamine synthetase may play an important role in the etiology of mesial temporal lobe epilepsy suggests a recent review in the Journal of Neuroscience Research.

• Investigators from the Yale School of Medicine and Southern Illinois School of Medicine believe that inhibition, loss, or dysfunction of the enzyme in astrocytes may be one of the causative factors responsible for mesial temporal lobe epilepsy.
• Their review of the scientific evidence included a study of astrocyte abnormalities related to aquaporin 4, potassium channel Kir4.1, monocarboxylate transporters MCT1 and MCT2, amino acid transporters EAAT1 and EAA2, and glutamine synthetase.
• Their theory on the role of glutamine synthetase prompted the researchers to suggest that the mechanisms that control the enzyme may be worth consideration as targets for new antiepileptic drugs.

Eid T, Lee TW, Patrylo P, Zaveri HP. Astrocytes and glutamine synthetase in epileptogenesis [published online ahead of print July 18, 2018]. J Neurosci Res. 2018: doi: 10.1002/jnr.24267.   

Astrocyte glutamine synthetase may play an important role in the etiology of mesial temporal lobe epilepsy suggests a recent review in the Journal of Neuroscience Research.

• Investigators from the Yale School of Medicine and Southern Illinois School of Medicine believe that inhibition, loss, or dysfunction of the enzyme in astrocytes may be one of the causative factors responsible for mesial temporal lobe epilepsy.
• Their review of the scientific evidence included a study of astrocyte abnormalities related to aquaporin 4, potassium channel Kir4.1, monocarboxylate transporters MCT1 and MCT2, amino acid transporters EAAT1 and EAA2, and glutamine synthetase.
• Their theory on the role of glutamine synthetase prompted the researchers to suggest that the mechanisms that control the enzyme may be worth consideration as targets for new antiepileptic drugs.

Eid T, Lee TW, Patrylo P, Zaveri HP. Astrocytes and glutamine synthetase in epileptogenesis [published online ahead of print July 18, 2018]. J Neurosci Res. 2018: doi: 10.1002/jnr.24267.   

Astrocyte glutamine synthetase may play an important role in the etiology of mesial temporal lobe epilepsy suggests a recent review in the Journal of Neuroscience Research.

• Investigators from the Yale School of Medicine and Southern Illinois School of Medicine believe that inhibition, loss, or dysfunction of the enzyme in astrocytes may be one of the causative factors responsible for mesial temporal lobe epilepsy.
• Their review of the scientific evidence included a study of astrocyte abnormalities related to aquaporin 4, potassium channel Kir4.1, monocarboxylate transporters MCT1 and MCT2, amino acid transporters EAAT1 and EAA2, and glutamine synthetase.
• Their theory on the role of glutamine synthetase prompted the researchers to suggest that the mechanisms that control the enzyme may be worth consideration as targets for new antiepileptic drugs.

Eid T, Lee TW, Patrylo P, Zaveri HP. Astrocytes and glutamine synthetase in epileptogenesis [published online ahead of print July 18, 2018]. J Neurosci Res. 2018: doi: 10.1002/jnr.24267.   

The presence of interictal ripples in an intracranial EEG may serve as useful biomarkers suggests an analysis of data from 27 children who underwent epilepsy surgery.

• The average rate of onset ripples located inside a resected area of the brain predicted a patient’s outcome (odds ratio, 5.37, P=.02)
• Mean onset ripple rate was associated with the Engel class metric for measuring outcomes.
• Resection of the onset ripple zone was linked to good surgical outcomes (P=.047).
• On the other hand, there was no correlation between spread ripple zone, isolated-ripple zone, or spike zones and outcomes.

Tamilia E, Park EH, Percivati S, et al. Surgical resection of ripple onset predicts outcome in pediatric epilepsy [published online ahead of print July 18, 2018]. Ann Neurol.  2018: doi: 10.1002/ana.25295

The presence of interictal ripples in an intracranial EEG may serve as useful biomarkers suggests an analysis of data from 27 children who underwent epilepsy surgery.

• The average rate of onset ripples located inside a resected area of the brain predicted a patient’s outcome (odds ratio, 5.37, P=.02)
• Mean onset ripple rate was associated with the Engel class metric for measuring outcomes.
• Resection of the onset ripple zone was linked to good surgical outcomes (P=.047).
• On the other hand, there was no correlation between spread ripple zone, isolated-ripple zone, or spike zones and outcomes.

Tamilia E, Park EH, Percivati S, et al. Surgical resection of ripple onset predicts outcome in pediatric epilepsy [published online ahead of print July 18, 2018]. Ann Neurol.  2018: doi: 10.1002/ana.25295

The presence of interictal ripples in an intracranial EEG may serve as useful biomarkers suggests an analysis of data from 27 children who underwent epilepsy surgery.

• The average rate of onset ripples located inside a resected area of the brain predicted a patient’s outcome (odds ratio, 5.37, P=.02)
• Mean onset ripple rate was associated with the Engel class metric for measuring outcomes.
• Resection of the onset ripple zone was linked to good surgical outcomes (P=.047).
• On the other hand, there was no correlation between spread ripple zone, isolated-ripple zone, or spike zones and outcomes.

Tamilia E, Park EH, Percivati S, et al. Surgical resection of ripple onset predicts outcome in pediatric epilepsy [published online ahead of print July 18, 2018]. Ann Neurol.  2018: doi: 10.1002/ana.25295

Magnetoencephalography (MEG) and network-based analyses can help characterize absence epilepsy in children according to a study that looked at 16 patients between ages 6 and 12 years who had absence epilepsy.

• Researchers found functional/anatomical hubs in a network that contained bilateral precuneus, left thalamus, three anterior cerebellar subunits of lobule IV-V, vermis, and lobule III.
• Their analysis suggests that these hubs, which are highly connected brain areas, exist in focal cortical, subcortical, and cerebellar areas during absence seizures.
• The existence of hubs in thalami, precuneus and cingulate cortex suggest bilaterally distributed networks of cortical and subcortical regions that may be responsible for seizures.
• Hubs in the anterior cerebellum may be related to terminating motor automatism seen in absence seizures.

Youssofzadeh, V, Agler W, Tenney JF, Kadis DS. Whole-brain MEG connectivity-based analyses reveals critical hubs in childhood absence epilepsy. Epilepsy Res. 2018;145:102-109.

Magnetoencephalography (MEG) and network-based analyses can help characterize absence epilepsy in children according to a study that looked at 16 patients between ages 6 and 12 years who had absence epilepsy.

• Researchers found functional/anatomical hubs in a network that contained bilateral precuneus, left thalamus, three anterior cerebellar subunits of lobule IV-V, vermis, and lobule III.
• Their analysis suggests that these hubs, which are highly connected brain areas, exist in focal cortical, subcortical, and cerebellar areas during absence seizures.
• The existence of hubs in thalami, precuneus and cingulate cortex suggest bilaterally distributed networks of cortical and subcortical regions that may be responsible for seizures.
• Hubs in the anterior cerebellum may be related to terminating motor automatism seen in absence seizures.

Youssofzadeh, V, Agler W, Tenney JF, Kadis DS. Whole-brain MEG connectivity-based analyses reveals critical hubs in childhood absence epilepsy. Epilepsy Res. 2018;145:102-109.

Magnetoencephalography (MEG) and network-based analyses can help characterize absence epilepsy in children according to a study that looked at 16 patients between ages 6 and 12 years who had absence epilepsy.

• Researchers found functional/anatomical hubs in a network that contained bilateral precuneus, left thalamus, three anterior cerebellar subunits of lobule IV-V, vermis, and lobule III.
• Their analysis suggests that these hubs, which are highly connected brain areas, exist in focal cortical, subcortical, and cerebellar areas during absence seizures.
• The existence of hubs in thalami, precuneus and cingulate cortex suggest bilaterally distributed networks of cortical and subcortical regions that may be responsible for seizures.
• Hubs in the anterior cerebellum may be related to terminating motor automatism seen in absence seizures.

Youssofzadeh, V, Agler W, Tenney JF, Kadis DS. Whole-brain MEG connectivity-based analyses reveals critical hubs in childhood absence epilepsy. Epilepsy Res. 2018;145:102-109.