Opioid Resource Center

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, and California were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, and California were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, and California were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Polypharmacy and slow metabolism of drugs create a high risk among older adults for substance use disorder, raising the odds of intentional and unintentional overdoses. However, screening, assessment, and treatment for substance use disorder occurs less often in younger adults.
 

Rates of overdose from opioids increased the most among people aged 65 years and older from 2021 to 2022, compared with among younger age groups. Meanwhile, recent data show less than half older adults with opioid use disorder (OUD) receive care for the condition.

“Nobody is immune to developing some kind of use disorder, so don’t just assume that because someone’s 80 years old that there’s no way that they have a problem,” said Sara Meyer, PharmD, a medication safety pharmacist at Novant Health in Winston-Salem, North Carolina. “You never know who’s going to potentially have an issue.”

Clinicians and health systems like Novant are spearheading efforts to best manage older adults who may need opioids because of conditions like chronic pain in an effort to reduce addiction and overdoses.
 

Older Adults Have Unique Needs

A major challenge of treating older adults is their high incidence of chronic pain and multiple complex chronic conditions. As a result, some of the nonopioid medications clinicians might otherwise prescribe, like nonsteroidal anti-inflammatory drugs, cannot be used, according to Caroline Goldzweig, MD, chief medical officer of the Cedars-Sinai Medical Network in Los Angeles, California.

“Before you know it, the only thing left is an opiate, so you can sometimes be between a rock and a hard place,” she said.

But for adults older than 65 years, opioids can carry problematic side effects, including sedation, cognitive impairment, falls, and fractures.

With those factors in mind, part of a yearly checkup or wellness visit should include time to discuss how a patient is managing their chronic pain, according to Timothy Anderson, MD, an assistant professor of medicine at the University of Pittsburgh, Pittsburgh, Pennsylvania, and codirector of the Prescribing Wisely Lab, a research collaboration between that institution and Beth Israel Deaconess Medical Center in Boston.

When considering a prescription for pain medication, Dr. Anderson said he evaluates the potential worst, best, and average outcomes for a patient. Nonopioid options should always be considered first-line treatment. Patients and physicians often struggle with balancing an option that meets a patient’s goals for pain relief but does not put them at a risk for adverse outcomes, he said.
 

Greater Risk

Older adults experience neurophysiologic effects different from younger people, said Benjamin Han, MD, a geriatrician and addiction medicine specialist at the University of California, San Diego.

Seniors also absorb, metabolize, and excrete drugs differently, sometimes affected by decreased production of gastric acid, lean body mass, and renal function. Coupled with complications of other chronic conditions or medications, diagnosing problematic opioid use or OUD can be one of the most challenging experiences in geriatrics, Dr. Han said.

As a result, OUD is often underdiagnosed in these patients, he said. Single-item screening tools like the TAPS and OWLS can be used to assess if the benefits of an opioid outweigh a patient’s risk for addiction.

Dr. Han finds medications like buprenorphine to be relatively safe and effective, along with nonpharmacologic interventions like physical therapy. He also advised clinicians to provide patients with opioid-overdose reversal agents.

“Naloxone is only used for reversing opioid withdrawal, but it is important to ensure that any patient at risk for an overdose, including being on chronic opioids, is provided naloxone and educated on preventing opioid overdoses,” he said.

Steroid injections and medications that target specific pathways, such as neuropathic pain, can be helpful in primary care for these older patients, according to Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine and a research scientist at VA Ann Arbor Health Care, Ann Arbor, Michigan.

She often recommends to her patients online programs that help them maintain strength and mobility, as well as low-impact exercises like tai chi, for pain management.

“This will ensure a much more balanced, patient-centered conversation with whatever decisions you and your patient come to,” Dr. Lagisetty said.
 

New Protocols for Pain Management in Older Adults

At the health system level, clinicians can use treatment agreements for patients taking opioids. At Novant, patients must attest they agree to take the medications only as prescribed and from a specified pharmacy. They promise not to seek opioids from other sources, to submit to random drug screenings, and to communicate regularly with their clinician about any health issues.

If a patient violates any part of this agreement, their clinician can stop the treatment. The system encourages clinicians to help patients find additional care for substance abuse disorder or pain management if it occurs.

Over the past 2 years, Novant also developed an AI prediction model, which generates a score for the risk a patient has in developing substance use disorder or experiencing an overdose within a year of initial opioid prescription. The model was validated by an internal team at the system but has not been independently certified.

If a patient has a high-risk score, their clinician considers additional risk mitigation strategies, such as seeing the patient more frequently or using an abuse deterrent formulation of an opioid. They also have the option of referring the patient to specialists in addiction medicine or neurology. Opioids are not necessarily withheld, according to Dr. Meyer. The tool is now used by clinicians during Medicare annual wellness visits.

And coming later this year are new protocols for pain management in patients aged 80 years and older. Clinicians will target a 50% dose reduction, compared with what a younger patient might receive to account for physiologic differences.

“We know that especially with some opioids like morphine, they’re not going to metabolize that the same way a young person with a young kidney will, so we’re trying to set the clinician up to select a lower starting dose for patients that are older,” Dr. Meyer said.

In 2017, the system implemented a program to reduce prescription of opioids to less than 350 morphine milligram equivalents (MME) per order following any kind of surgery. The health system compared numbers of prescriptions written among surgical colleagues and met with them to discuss alternative approaches. Novant said it continues to monitor the data and follow-up with surgeons who are not in alignment with the goal.

Between 2017 and 2019, patients switching to lower doses after surgeries rose by 20%.

Across the country at Cedars-Sinai Medical Network, leadership in 2016 made the move to deprescribe opioids or lower doses of the drugs to less than 90 MME per day, in accordance with Centers for Disease Control and Prevention guidelines established that year. Patients were referred to their pain program for support and for nonopioid interventions. Pharmacists worked closely with clinicians on safely tapering these medications in patients taking high doses.

The program worked, according to Dr. Goldzweig. Dr. Goldzweig could only find two patients currently taking high-dose opioids in the system’s database out of more than 7000 patients with Medicare Advantage insurance coverage.

“There will always be some patients who have no alternative than opioids, but we established some discipline with urine tox screens and pain agreements, and over time, we’ve been able to reduce the number of high-risk opioid prescriptions,” she said.

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

Polypharmacy and slow metabolism of drugs create a high risk among older adults for substance use disorder, raising the odds of intentional and unintentional overdoses. However, screening, assessment, and treatment for substance use disorder occurs less often in younger adults.
 

Rates of overdose from opioids increased the most among people aged 65 years and older from 2021 to 2022, compared with among younger age groups. Meanwhile, recent data show less than half older adults with opioid use disorder (OUD) receive care for the condition.

“Nobody is immune to developing some kind of use disorder, so don’t just assume that because someone’s 80 years old that there’s no way that they have a problem,” said Sara Meyer, PharmD, a medication safety pharmacist at Novant Health in Winston-Salem, North Carolina. “You never know who’s going to potentially have an issue.”

Clinicians and health systems like Novant are spearheading efforts to best manage older adults who may need opioids because of conditions like chronic pain in an effort to reduce addiction and overdoses.
 

Older Adults Have Unique Needs

A major challenge of treating older adults is their high incidence of chronic pain and multiple complex chronic conditions. As a result, some of the nonopioid medications clinicians might otherwise prescribe, like nonsteroidal anti-inflammatory drugs, cannot be used, according to Caroline Goldzweig, MD, chief medical officer of the Cedars-Sinai Medical Network in Los Angeles, California.

“Before you know it, the only thing left is an opiate, so you can sometimes be between a rock and a hard place,” she said.

But for adults older than 65 years, opioids can carry problematic side effects, including sedation, cognitive impairment, falls, and fractures.

With those factors in mind, part of a yearly checkup or wellness visit should include time to discuss how a patient is managing their chronic pain, according to Timothy Anderson, MD, an assistant professor of medicine at the University of Pittsburgh, Pittsburgh, Pennsylvania, and codirector of the Prescribing Wisely Lab, a research collaboration between that institution and Beth Israel Deaconess Medical Center in Boston.

When considering a prescription for pain medication, Dr. Anderson said he evaluates the potential worst, best, and average outcomes for a patient. Nonopioid options should always be considered first-line treatment. Patients and physicians often struggle with balancing an option that meets a patient’s goals for pain relief but does not put them at a risk for adverse outcomes, he said.
 

Greater Risk

Older adults experience neurophysiologic effects different from younger people, said Benjamin Han, MD, a geriatrician and addiction medicine specialist at the University of California, San Diego.

Seniors also absorb, metabolize, and excrete drugs differently, sometimes affected by decreased production of gastric acid, lean body mass, and renal function. Coupled with complications of other chronic conditions or medications, diagnosing problematic opioid use or OUD can be one of the most challenging experiences in geriatrics, Dr. Han said.

As a result, OUD is often underdiagnosed in these patients, he said. Single-item screening tools like the TAPS and OWLS can be used to assess if the benefits of an opioid outweigh a patient’s risk for addiction.

Dr. Han finds medications like buprenorphine to be relatively safe and effective, along with nonpharmacologic interventions like physical therapy. He also advised clinicians to provide patients with opioid-overdose reversal agents.

“Naloxone is only used for reversing opioid withdrawal, but it is important to ensure that any patient at risk for an overdose, including being on chronic opioids, is provided naloxone and educated on preventing opioid overdoses,” he said.

Steroid injections and medications that target specific pathways, such as neuropathic pain, can be helpful in primary care for these older patients, according to Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine and a research scientist at VA Ann Arbor Health Care, Ann Arbor, Michigan.

She often recommends to her patients online programs that help them maintain strength and mobility, as well as low-impact exercises like tai chi, for pain management.

“This will ensure a much more balanced, patient-centered conversation with whatever decisions you and your patient come to,” Dr. Lagisetty said.
 

New Protocols for Pain Management in Older Adults

At the health system level, clinicians can use treatment agreements for patients taking opioids. At Novant, patients must attest they agree to take the medications only as prescribed and from a specified pharmacy. They promise not to seek opioids from other sources, to submit to random drug screenings, and to communicate regularly with their clinician about any health issues.

If a patient violates any part of this agreement, their clinician can stop the treatment. The system encourages clinicians to help patients find additional care for substance abuse disorder or pain management if it occurs.

Over the past 2 years, Novant also developed an AI prediction model, which generates a score for the risk a patient has in developing substance use disorder or experiencing an overdose within a year of initial opioid prescription. The model was validated by an internal team at the system but has not been independently certified.

If a patient has a high-risk score, their clinician considers additional risk mitigation strategies, such as seeing the patient more frequently or using an abuse deterrent formulation of an opioid. They also have the option of referring the patient to specialists in addiction medicine or neurology. Opioids are not necessarily withheld, according to Dr. Meyer. The tool is now used by clinicians during Medicare annual wellness visits.

And coming later this year are new protocols for pain management in patients aged 80 years and older. Clinicians will target a 50% dose reduction, compared with what a younger patient might receive to account for physiologic differences.

“We know that especially with some opioids like morphine, they’re not going to metabolize that the same way a young person with a young kidney will, so we’re trying to set the clinician up to select a lower starting dose for patients that are older,” Dr. Meyer said.

In 2017, the system implemented a program to reduce prescription of opioids to less than 350 morphine milligram equivalents (MME) per order following any kind of surgery. The health system compared numbers of prescriptions written among surgical colleagues and met with them to discuss alternative approaches. Novant said it continues to monitor the data and follow-up with surgeons who are not in alignment with the goal.

Between 2017 and 2019, patients switching to lower doses after surgeries rose by 20%.

Across the country at Cedars-Sinai Medical Network, leadership in 2016 made the move to deprescribe opioids or lower doses of the drugs to less than 90 MME per day, in accordance with Centers for Disease Control and Prevention guidelines established that year. Patients were referred to their pain program for support and for nonopioid interventions. Pharmacists worked closely with clinicians on safely tapering these medications in patients taking high doses.

The program worked, according to Dr. Goldzweig. Dr. Goldzweig could only find two patients currently taking high-dose opioids in the system’s database out of more than 7000 patients with Medicare Advantage insurance coverage.

“There will always be some patients who have no alternative than opioids, but we established some discipline with urine tox screens and pain agreements, and over time, we’ve been able to reduce the number of high-risk opioid prescriptions,” she said.

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

Polypharmacy and slow metabolism of drugs create a high risk among older adults for substance use disorder, raising the odds of intentional and unintentional overdoses. However, screening, assessment, and treatment for substance use disorder occurs less often in younger adults.
 

Rates of overdose from opioids increased the most among people aged 65 years and older from 2021 to 2022, compared with among younger age groups. Meanwhile, recent data show less than half older adults with opioid use disorder (OUD) receive care for the condition.

“Nobody is immune to developing some kind of use disorder, so don’t just assume that because someone’s 80 years old that there’s no way that they have a problem,” said Sara Meyer, PharmD, a medication safety pharmacist at Novant Health in Winston-Salem, North Carolina. “You never know who’s going to potentially have an issue.”

Clinicians and health systems like Novant are spearheading efforts to best manage older adults who may need opioids because of conditions like chronic pain in an effort to reduce addiction and overdoses.
 

Older Adults Have Unique Needs

A major challenge of treating older adults is their high incidence of chronic pain and multiple complex chronic conditions. As a result, some of the nonopioid medications clinicians might otherwise prescribe, like nonsteroidal anti-inflammatory drugs, cannot be used, according to Caroline Goldzweig, MD, chief medical officer of the Cedars-Sinai Medical Network in Los Angeles, California.

“Before you know it, the only thing left is an opiate, so you can sometimes be between a rock and a hard place,” she said.

But for adults older than 65 years, opioids can carry problematic side effects, including sedation, cognitive impairment, falls, and fractures.

With those factors in mind, part of a yearly checkup or wellness visit should include time to discuss how a patient is managing their chronic pain, according to Timothy Anderson, MD, an assistant professor of medicine at the University of Pittsburgh, Pittsburgh, Pennsylvania, and codirector of the Prescribing Wisely Lab, a research collaboration between that institution and Beth Israel Deaconess Medical Center in Boston.

When considering a prescription for pain medication, Dr. Anderson said he evaluates the potential worst, best, and average outcomes for a patient. Nonopioid options should always be considered first-line treatment. Patients and physicians often struggle with balancing an option that meets a patient’s goals for pain relief but does not put them at a risk for adverse outcomes, he said.
 

Greater Risk

Older adults experience neurophysiologic effects different from younger people, said Benjamin Han, MD, a geriatrician and addiction medicine specialist at the University of California, San Diego.

Seniors also absorb, metabolize, and excrete drugs differently, sometimes affected by decreased production of gastric acid, lean body mass, and renal function. Coupled with complications of other chronic conditions or medications, diagnosing problematic opioid use or OUD can be one of the most challenging experiences in geriatrics, Dr. Han said.

As a result, OUD is often underdiagnosed in these patients, he said. Single-item screening tools like the TAPS and OWLS can be used to assess if the benefits of an opioid outweigh a patient’s risk for addiction.

Dr. Han finds medications like buprenorphine to be relatively safe and effective, along with nonpharmacologic interventions like physical therapy. He also advised clinicians to provide patients with opioid-overdose reversal agents.

“Naloxone is only used for reversing opioid withdrawal, but it is important to ensure that any patient at risk for an overdose, including being on chronic opioids, is provided naloxone and educated on preventing opioid overdoses,” he said.

Steroid injections and medications that target specific pathways, such as neuropathic pain, can be helpful in primary care for these older patients, according to Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine and a research scientist at VA Ann Arbor Health Care, Ann Arbor, Michigan.

She often recommends to her patients online programs that help them maintain strength and mobility, as well as low-impact exercises like tai chi, for pain management.

“This will ensure a much more balanced, patient-centered conversation with whatever decisions you and your patient come to,” Dr. Lagisetty said.
 

New Protocols for Pain Management in Older Adults

At the health system level, clinicians can use treatment agreements for patients taking opioids. At Novant, patients must attest they agree to take the medications only as prescribed and from a specified pharmacy. They promise not to seek opioids from other sources, to submit to random drug screenings, and to communicate regularly with their clinician about any health issues.

If a patient violates any part of this agreement, their clinician can stop the treatment. The system encourages clinicians to help patients find additional care for substance abuse disorder or pain management if it occurs.

Over the past 2 years, Novant also developed an AI prediction model, which generates a score for the risk a patient has in developing substance use disorder or experiencing an overdose within a year of initial opioid prescription. The model was validated by an internal team at the system but has not been independently certified.

If a patient has a high-risk score, their clinician considers additional risk mitigation strategies, such as seeing the patient more frequently or using an abuse deterrent formulation of an opioid. They also have the option of referring the patient to specialists in addiction medicine or neurology. Opioids are not necessarily withheld, according to Dr. Meyer. The tool is now used by clinicians during Medicare annual wellness visits.

And coming later this year are new protocols for pain management in patients aged 80 years and older. Clinicians will target a 50% dose reduction, compared with what a younger patient might receive to account for physiologic differences.

“We know that especially with some opioids like morphine, they’re not going to metabolize that the same way a young person with a young kidney will, so we’re trying to set the clinician up to select a lower starting dose for patients that are older,” Dr. Meyer said.

In 2017, the system implemented a program to reduce prescription of opioids to less than 350 morphine milligram equivalents (MME) per order following any kind of surgery. The health system compared numbers of prescriptions written among surgical colleagues and met with them to discuss alternative approaches. Novant said it continues to monitor the data and follow-up with surgeons who are not in alignment with the goal.

Between 2017 and 2019, patients switching to lower doses after surgeries rose by 20%.

Across the country at Cedars-Sinai Medical Network, leadership in 2016 made the move to deprescribe opioids or lower doses of the drugs to less than 90 MME per day, in accordance with Centers for Disease Control and Prevention guidelines established that year. Patients were referred to their pain program for support and for nonopioid interventions. Pharmacists worked closely with clinicians on safely tapering these medications in patients taking high doses.

The program worked, according to Dr. Goldzweig. Dr. Goldzweig could only find two patients currently taking high-dose opioids in the system’s database out of more than 7000 patients with Medicare Advantage insurance coverage.

“There will always be some patients who have no alternative than opioids, but we established some discipline with urine tox screens and pain agreements, and over time, we’ve been able to reduce the number of high-risk opioid prescriptions,” she said.

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

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.

I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.

On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.

Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.

First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.

However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.

As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.

Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.

I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.

I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.

On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.

Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.

First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.

However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.

As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.

Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.

I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.

I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.

On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.

Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.

First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.

However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.

As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.

Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.

I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.

I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

TOPLINE:

A small pool of major surgeries accounts for a large portion of opioids prescribed to children and teens, according to a new study.

METHODOLOGY:

• The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
• More than 200,000 procedures were included in the study.
• For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).

TAKEAWAY:

• In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
• In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
• Refill rates for children were all 1% or less.
• Refill rates for adolescents ranged from 2.3% to 9.6%.

IN PRACTICE:

“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.

SOURCE:

The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics

LIMITATIONS:

The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.

DISCLOSURES:

Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.

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

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape Medical News series telling these stories.

I had worked a normal 7:00 a.m. to 3:00 p.m. shift in our emergency department. It was a nice day out, so I put my headphones in and started walking home through the Capitol Hill neighborhood in Denver. I passed a couple of buildings and reached an alleyway. At that moment, I glanced over.

Two guys were standing over a third person who was down on the ground. One of the people standing was on the phone. I paused for a second and thought, that doesn’t look right.

The guy on the ground was clearly out. And the other two were looking concerned like they didn’t know what to do.

I walked up the alley and asked, “What’s going on? Can I help?” One of the guys explained that they had just found this man lying here and had already called 911. They sounded a little bit out of their element. They certainly weren’t medically trained.

I leaned down next to the man on the ground. He was probably in his mid-to-late 40s. Unconscious. I always start with, “Hello? Can you hear me?” No response.

I felt for a pulse and he had one, but he didn’t appear to be breathing. I thought, I know what this is. I said, “Sir, I’m going to open your eyes.” I opened his eyes, and his pupils were tiny. It was almost certainly an opioid overdose.

And I had naloxone in my bag.

I got it out and started to assemble it. I didn’t have Narcan, which is the easy one. I had to put this kit together, draw up the medication, and put on the little nasal atomizer.

The two other guys were standing there watching. Then the one on the phone walked down to the end of the alley to where the ambulance was probably going to arrive so he could wave them down.

I gave the man the 4 mg of naloxone, two in each nostril.

He still wasn’t breathing. I did a basic maneuver where you lift his jaw a little bit to help open up the airway.

Suddenly, he started breathing again. I couldn’t do any meaningful measurements of his oxygen saturation or anything like that. I just kind of looked at him and thought, Okay, he has a pulse. He’s breathing now. That’s good.

Luckily, the cavalry arrived soon after that. Our Denver Health paramedics pulled up into the alley, and one of them recognized me from the ER. I explained that I had already given the guy naloxone. They did their assessment, and he still wasn’t breathing well, so they gave him some breaths with a mask and a bag.

We got him onto the gurney and into the back of the ambulance. They started an IV. He seemed to be breathing okay by then, and his numbers looked okay. But he wasn’t awake yet by any means.

I handed off care to them and disposed of my sharp in the ambulance. Then they took him into the ER that I had just left moments ago.

The two other guys had already disappeared. I think they saw the ambulance and thought, our job is done. So, I didn’t end up talking to them at all.

So, just like that ... I started walking home again.

I like to think of myself as a cool, calm, collected person working in the ER. But my heart was definitely going fast at that point. I called my wife to tell her about the crazy thing that just happened, and she could hear in my voice how amped up I was.

In the ER, it’s very common to see patients who need naloxone, have opioid toxicity, or have received Narcan in the community. Luckily, this man was found right away. He had likely overdosed only a few minutes earlier. Those scenarios can go bad very quickly. If there’s no one there, people often die.

That’s why I started carrying naloxone.

There are a lot of programs to get free naloxone out into the community. So, about 2 years earlier, I got some and threw one in my ER bag, one in my office bag, and another in my car. Then I essentially forgot about it. Until I needed it.

Now, I encourage all my friends to have some, and I suggest all medical professionals to keep some with them. Just be prepared. Put it in your backpack, your purse, keep it in the house, in the car, wherever. The nasal autoinjectors are incredibly easy. Like, stick it up the nose, push the big red button. Done.

When we train lay people to administer Narcan, we try to keep it simple. If you see someone, and they’re not responsive, not breathing, just give it. It’s not that there’s no possible harm if you’re wrong. But the benefits so vastly outweigh the risks that we are very aggressive to say, go ahead and give it.

I think we all have a responsibility to care for our communities. Obviously, that can take a lot of different forms. I had the privilege of being in the right place at the right time with the right tool to potentially save a life. That was the form it took for me that day.

Later, I followed up with a friend who took care of the man in the ER. He went through our standard procedure, being monitored to make sure the opioids didn’t outlast the naloxone. We have a lot of resources and next steps for people that have opioid use disorder. He was made aware of those. And then he walked out. I never saw him again.

It’s not the sexy part of our job in emergency medicine, not the super high–intensity adrenaline rush–type work, but a lot of what we do is talk to people like this guy. We counsel them. We think about their longer-term health and not just the overdose. This is an incredibly high-risk population in terms of their mortality risk from the opioid use disorder. It’s astronomical.

I obviously believed in this work before, but that day changed something for me. It added a layer of urgency. Now, when I have a moment in the emergency room to connect with someone, I know the reality — this person sitting in front of me could die in an alley. Maybe not today, but next week or next month.

I have the naloxone in my bag. Just in case.

Patrick Joynt, MD, is an emergency medicine physician with Denver Health in Denver.

Are you a medical professional with a dramatic story outside the clinic? Medscape Medical News would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary to access@webmd.net.

A version of this article appeared on Medscape.com .

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape Medical News series telling these stories.

I had worked a normal 7:00 a.m. to 3:00 p.m. shift in our emergency department. It was a nice day out, so I put my headphones in and started walking home through the Capitol Hill neighborhood in Denver. I passed a couple of buildings and reached an alleyway. At that moment, I glanced over.

Two guys were standing over a third person who was down on the ground. One of the people standing was on the phone. I paused for a second and thought, that doesn’t look right.

The guy on the ground was clearly out. And the other two were looking concerned like they didn’t know what to do.

I walked up the alley and asked, “What’s going on? Can I help?” One of the guys explained that they had just found this man lying here and had already called 911. They sounded a little bit out of their element. They certainly weren’t medically trained.

I leaned down next to the man on the ground. He was probably in his mid-to-late 40s. Unconscious. I always start with, “Hello? Can you hear me?” No response.

I felt for a pulse and he had one, but he didn’t appear to be breathing. I thought, I know what this is. I said, “Sir, I’m going to open your eyes.” I opened his eyes, and his pupils were tiny. It was almost certainly an opioid overdose.

And I had naloxone in my bag.

I got it out and started to assemble it. I didn’t have Narcan, which is the easy one. I had to put this kit together, draw up the medication, and put on the little nasal atomizer.

The two other guys were standing there watching. Then the one on the phone walked down to the end of the alley to where the ambulance was probably going to arrive so he could wave them down.

I gave the man the 4 mg of naloxone, two in each nostril.

He still wasn’t breathing. I did a basic maneuver where you lift his jaw a little bit to help open up the airway.

Suddenly, he started breathing again. I couldn’t do any meaningful measurements of his oxygen saturation or anything like that. I just kind of looked at him and thought, Okay, he has a pulse. He’s breathing now. That’s good.

Luckily, the cavalry arrived soon after that. Our Denver Health paramedics pulled up into the alley, and one of them recognized me from the ER. I explained that I had already given the guy naloxone. They did their assessment, and he still wasn’t breathing well, so they gave him some breaths with a mask and a bag.

We got him onto the gurney and into the back of the ambulance. They started an IV. He seemed to be breathing okay by then, and his numbers looked okay. But he wasn’t awake yet by any means.

I handed off care to them and disposed of my sharp in the ambulance. Then they took him into the ER that I had just left moments ago.

The two other guys had already disappeared. I think they saw the ambulance and thought, our job is done. So, I didn’t end up talking to them at all.

So, just like that ... I started walking home again.

I like to think of myself as a cool, calm, collected person working in the ER. But my heart was definitely going fast at that point. I called my wife to tell her about the crazy thing that just happened, and she could hear in my voice how amped up I was.

In the ER, it’s very common to see patients who need naloxone, have opioid toxicity, or have received Narcan in the community. Luckily, this man was found right away. He had likely overdosed only a few minutes earlier. Those scenarios can go bad very quickly. If there’s no one there, people often die.

That’s why I started carrying naloxone.

There are a lot of programs to get free naloxone out into the community. So, about 2 years earlier, I got some and threw one in my ER bag, one in my office bag, and another in my car. Then I essentially forgot about it. Until I needed it.

Now, I encourage all my friends to have some, and I suggest all medical professionals to keep some with them. Just be prepared. Put it in your backpack, your purse, keep it in the house, in the car, wherever. The nasal autoinjectors are incredibly easy. Like, stick it up the nose, push the big red button. Done.

When we train lay people to administer Narcan, we try to keep it simple. If you see someone, and they’re not responsive, not breathing, just give it. It’s not that there’s no possible harm if you’re wrong. But the benefits so vastly outweigh the risks that we are very aggressive to say, go ahead and give it.

I think we all have a responsibility to care for our communities. Obviously, that can take a lot of different forms. I had the privilege of being in the right place at the right time with the right tool to potentially save a life. That was the form it took for me that day.

Later, I followed up with a friend who took care of the man in the ER. He went through our standard procedure, being monitored to make sure the opioids didn’t outlast the naloxone. We have a lot of resources and next steps for people that have opioid use disorder. He was made aware of those. And then he walked out. I never saw him again.

It’s not the sexy part of our job in emergency medicine, not the super high–intensity adrenaline rush–type work, but a lot of what we do is talk to people like this guy. We counsel them. We think about their longer-term health and not just the overdose. This is an incredibly high-risk population in terms of their mortality risk from the opioid use disorder. It’s astronomical.

I obviously believed in this work before, but that day changed something for me. It added a layer of urgency. Now, when I have a moment in the emergency room to connect with someone, I know the reality — this person sitting in front of me could die in an alley. Maybe not today, but next week or next month.

I have the naloxone in my bag. Just in case.

Patrick Joynt, MD, is an emergency medicine physician with Denver Health in Denver.

Are you a medical professional with a dramatic story outside the clinic? Medscape Medical News would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary to access@webmd.net.

A version of this article appeared on Medscape.com .

Emergencies happen anywhere, anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a Medscape Medical News series telling these stories.

I had worked a normal 7:00 a.m. to 3:00 p.m. shift in our emergency department. It was a nice day out, so I put my headphones in and started walking home through the Capitol Hill neighborhood in Denver. I passed a couple of buildings and reached an alleyway. At that moment, I glanced over.

Two guys were standing over a third person who was down on the ground. One of the people standing was on the phone. I paused for a second and thought, that doesn’t look right.

The guy on the ground was clearly out. And the other two were looking concerned like they didn’t know what to do.

I walked up the alley and asked, “What’s going on? Can I help?” One of the guys explained that they had just found this man lying here and had already called 911. They sounded a little bit out of their element. They certainly weren’t medically trained.

I leaned down next to the man on the ground. He was probably in his mid-to-late 40s. Unconscious. I always start with, “Hello? Can you hear me?” No response.

I felt for a pulse and he had one, but he didn’t appear to be breathing. I thought, I know what this is. I said, “Sir, I’m going to open your eyes.” I opened his eyes, and his pupils were tiny. It was almost certainly an opioid overdose.

And I had naloxone in my bag.

I got it out and started to assemble it. I didn’t have Narcan, which is the easy one. I had to put this kit together, draw up the medication, and put on the little nasal atomizer.

The two other guys were standing there watching. Then the one on the phone walked down to the end of the alley to where the ambulance was probably going to arrive so he could wave them down.

I gave the man the 4 mg of naloxone, two in each nostril.

He still wasn’t breathing. I did a basic maneuver where you lift his jaw a little bit to help open up the airway.

Suddenly, he started breathing again. I couldn’t do any meaningful measurements of his oxygen saturation or anything like that. I just kind of looked at him and thought, Okay, he has a pulse. He’s breathing now. That’s good.

Luckily, the cavalry arrived soon after that. Our Denver Health paramedics pulled up into the alley, and one of them recognized me from the ER. I explained that I had already given the guy naloxone. They did their assessment, and he still wasn’t breathing well, so they gave him some breaths with a mask and a bag.

We got him onto the gurney and into the back of the ambulance. They started an IV. He seemed to be breathing okay by then, and his numbers looked okay. But he wasn’t awake yet by any means.

I handed off care to them and disposed of my sharp in the ambulance. Then they took him into the ER that I had just left moments ago.

The two other guys had already disappeared. I think they saw the ambulance and thought, our job is done. So, I didn’t end up talking to them at all.

So, just like that ... I started walking home again.

I like to think of myself as a cool, calm, collected person working in the ER. But my heart was definitely going fast at that point. I called my wife to tell her about the crazy thing that just happened, and she could hear in my voice how amped up I was.

In the ER, it’s very common to see patients who need naloxone, have opioid toxicity, or have received Narcan in the community. Luckily, this man was found right away. He had likely overdosed only a few minutes earlier. Those scenarios can go bad very quickly. If there’s no one there, people often die.

That’s why I started carrying naloxone.

There are a lot of programs to get free naloxone out into the community. So, about 2 years earlier, I got some and threw one in my ER bag, one in my office bag, and another in my car. Then I essentially forgot about it. Until I needed it.

Now, I encourage all my friends to have some, and I suggest all medical professionals to keep some with them. Just be prepared. Put it in your backpack, your purse, keep it in the house, in the car, wherever. The nasal autoinjectors are incredibly easy. Like, stick it up the nose, push the big red button. Done.

When we train lay people to administer Narcan, we try to keep it simple. If you see someone, and they’re not responsive, not breathing, just give it. It’s not that there’s no possible harm if you’re wrong. But the benefits so vastly outweigh the risks that we are very aggressive to say, go ahead and give it.

I think we all have a responsibility to care for our communities. Obviously, that can take a lot of different forms. I had the privilege of being in the right place at the right time with the right tool to potentially save a life. That was the form it took for me that day.

Later, I followed up with a friend who took care of the man in the ER. He went through our standard procedure, being monitored to make sure the opioids didn’t outlast the naloxone. We have a lot of resources and next steps for people that have opioid use disorder. He was made aware of those. And then he walked out. I never saw him again.

It’s not the sexy part of our job in emergency medicine, not the super high–intensity adrenaline rush–type work, but a lot of what we do is talk to people like this guy. We counsel them. We think about their longer-term health and not just the overdose. This is an incredibly high-risk population in terms of their mortality risk from the opioid use disorder. It’s astronomical.

I obviously believed in this work before, but that day changed something for me. It added a layer of urgency. Now, when I have a moment in the emergency room to connect with someone, I know the reality — this person sitting in front of me could die in an alley. Maybe not today, but next week or next month.

I have the naloxone in my bag. Just in case.

Patrick Joynt, MD, is an emergency medicine physician with Denver Health in Denver.

Are you a medical professional with a dramatic story outside the clinic? Medscape Medical News would love to consider your story for Is There a Doctor in the House? Please email your contact information and a short summary to access@webmd.net.

A version of this article appeared on Medscape.com .

*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.

*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.

Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.

“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
 

How to Identify OUD

Dr. Garment recommended asking a single question to screen for OUD: “How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?”

If the patient says any number above zero, that should trigger suspicion of active OUD. “It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.

If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.

“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
 

Medication for OUD

Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.

Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.

Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.

One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.

Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”

• The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
• Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
• Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.

Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.

Dr. Garment reported no relevant financial conflicts of interest.

*This story was updated on April 29, 2024.

A version of this article appeared on Medscape.com.

*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.

*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.

Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.

“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
 

How to Identify OUD

Dr. Garment recommended asking a single question to screen for OUD: “How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?”

If the patient says any number above zero, that should trigger suspicion of active OUD. “It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.

If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.

“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
 

Medication for OUD

Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.

Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.

Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.

One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.

Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”

• The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
• Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
• Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.

Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.

Dr. Garment reported no relevant financial conflicts of interest.

*This story was updated on April 29, 2024.

A version of this article appeared on Medscape.com.

*The first thing Ann Garment, MD, wants all clinicians to know about buprenorphine is that [where state law permits] any prescriber with a DEA registration number “is able to prescribe buprenorphine and should be ready and willing to prescribe” the medication.

*A change in federal law means that for most providers “there is no longer any extra paperwork or training required to prescribe buprenorphine,” said Dr. Garment, clinical associate professor at New York University and chief of general internal medicine at Bellevue Hospital in New York City, during a presentation on April 19 at the American College of Physicians (ACP-IM) Internal Medicine Meeting 2024.

Dr. Garment, who specializes in opioid use disorder (OUD), described the current “third wave” of increasing opioid overdose deaths fueled by the increase of synthetic opioids in the drug supply. The third wave started in 2013 with the rise in use of fentanyl and tramadol. The 107,000 number of overdose deaths in the United States in 2021 was more than six times that in 1999, and 75% involved opioids.

“Now, more than ever,” Dr. Garment said, “opioid use disorder should be treated from the primary care setting.”
 

How to Identify OUD

Dr. Garment recommended asking a single question to screen for OUD: “How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?”

If the patient says any number above zero, that should trigger suspicion of active OUD. “It’s less sensitive for picking up on people who have a prior opioid use disorder history or are only exhibiting risky opioid use that wouldn’t constitute opioid use disorder yet,” she said.

If someone screens positive, to verify OUD, the Diagnostic and Statistical Manual of Mental Disorders identifies criteria for any substance abuse disorder with two general themes: Loss of control and continued use despite negative consequences.

“If you have a patient who is getting prescribed opioids and they have opioid tolerance or withdrawal, that does not mean they have opioid use disorder,” she said.
 

Medication for OUD

Medication is the top treatment for OUD, according to Dr. Garment. Psychosocial treatments can help some but not all people with OUD, she said. “It is not a requirement for a patient to engage in psychosocial treatment in order to get a medication for opioid use disorder, so please do not let that be a barrier for your patients,” she said.

Buprenorphine has advantages over other medications for OUD, including methadone and naltrexone.

Methadone must be obtained daily at a methadone clinic instead of at a local pharmacy. And escalating doses of methadone carry an increased risk for overdose and respiratory problems and potential drug-drug interactions, Dr. Garment added.

One downside with naltrexone is loss of tolerance, she said. If a patient has been using naltrexone to treat OUD and they decide to resume taking opioids, “they no longer can use the same amount of opioids that they were using before” because they have lost their tolerance and now are at a risk for overdose with their usual amount, she said. What’s more, naltrexone has not been shown to reduce overdose deaths.

Finally, she said, buprenorphine, “is an incredibly safe medication. If anyone in this room has ever prescribed coumadin or insulin, I’m going to tell you: This is much safer.”

• The drug is a partial, as opposed to full, opioid agonist, so as the dose increases, the patient experiences less withdrawal and fewer opioid cravings. As a result, they will hit a ceiling effect that avoids euphoria, respiratory depression, or overdose.
• Buprenorphine is “stickier” than other OUD medications: “If I’m taking buprenorphine and I decide to use some [oxycodone], what’s going to happen is that very little of that, if any, is going to get bound to my opioid receptors because buprenorphine is so sticky and adherent, it’s not going to let other opioids on.”
• Most buprenorphine is co-formulated with naloxone, an opioid antagonist. If a patient tries to get high from buprenorphine and tries to snort or inject it, naloxone will kick in and cancel out the buprenorphine.

Dr. Garment said she obtains urine screens ideally twice a year. If other drugs show up on the test, she said, she speaks with the patient about their drug use. “It’s never a reason to discharge someone from a practice,” she said.

Dr. Garment reported no relevant financial conflicts of interest.

*This story was updated on April 29, 2024.

A version of this article appeared on Medscape.com.

A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product. 

The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said. 

But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider. 

Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.” 

“The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids,” the letter states. 

The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations. 

Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency. 

Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said. 

“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization. 

The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD. 

In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl. 

While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021. 

The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.” 

Slow Rollout

In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test. 

SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage. 

AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test. 

Meanwhile, the false positive rate was 20.8%, the FDA said. 

SOLVD published similar study results in 2021. 

The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits. 

Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting  to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval. 

Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.

“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.

The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD. 

Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis. 

Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said. 

Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said. 

“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.” 

A version of this article appeared on Medscape.com.

A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product. 

The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said. 

But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider. 

Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.” 

“The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids,” the letter states. 

The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations. 

Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency. 

Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said. 

“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization. 

The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD. 

In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl. 

While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021. 

The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.” 

Slow Rollout

In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test. 

SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage. 

AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test. 

Meanwhile, the false positive rate was 20.8%, the FDA said. 

SOLVD published similar study results in 2021. 

The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits. 

Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting  to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval. 

Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.

“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.

The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD. 

Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis. 

Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said. 

Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said. 

“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.” 

A version of this article appeared on Medscape.com.

A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product. 

The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said. 

But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider. 

Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.” 

“The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids,” the letter states. 

The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations. 

Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency. 

Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said. 

“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization. 

The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD. 

In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl. 

While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021. 

The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.” 

Slow Rollout

In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test. 

SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage. 

AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test. 

Meanwhile, the false positive rate was 20.8%, the FDA said. 

SOLVD published similar study results in 2021. 

The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits. 

Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting  to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval. 

Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.

“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.

The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD. 

Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis. 

Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said. 

Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said. 

“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.” 

A version of this article appeared on Medscape.com.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.

Healthcare providers hold wide-ranging opinions about prescribing opioids for chronic cancer pain, and many are haunted by the conflicting factors driving their views, from legal concerns to threats of violence, say the authors of new research.

These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.

“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
 

Who Should Manage Chronic Cancer Pain?

Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.

“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
 

What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?

To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.

These interviews yielded three themes.

First, no “medical home” exists for chronic pain management in cancer survivors.

“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.

Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.

“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”

The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.

“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”

Meanwhile, a palliative care provider described legal pressure from the opposite direction:

“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”

Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
 

What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?

After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.

They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.

Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.

This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.