Opioid Resource Center

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.

On a November morning in 2022, James Messenger opened wide and swallowed a capsule like no other.

Messenger was no stranger to taking pills.

He’d first experimented with prescription opioids as a teenager in Morgantown, West Virginia, battled addiction on-and-off since, and known more than 70 people who had fatally overdosed. So, when asked to test a new “smart pill” that could detect an overdose in progress and call for help, he didn’t hesitate to join the study.

“I’ve lost pretty much every good friend I’ve ever had to this,” said Mr. Messenger. “This pill could save a lot of lives.”

The new Vitals Monitoring capsule he tested is just one example in a growing effort to radically rethink what the humble pill is capable of.

As far back as 1965, scientists introduced the Heidelberg capsule, an electronic pill that measured acidity from within the gut. In 1994, the University of Buffalo coined the term “smart pill” with a device promising to ferry medicine to a precise spot in the intestine, “like the tiny ship in the film Fantastic Voyage.” And in 2001, the US Food and Drug Administration (FDA) approved the first video capsule endoscope, a miniature-camera-toting pill that enabled noninvasive imaging of the small intestine.

Despite these milestones, the smart pill revolution has been slow to catch on due to cost, technological limitations, and some resistance among clinicians and patients.

But now, nearly 300 iterations are in various stages of development, according to a 2022 analysis. Advances in materials, imaging, and artificial intelligence (AI) are helping address everything from sleep apnea to HIV/AIDS to gut disorders via real-time tracking and real-time help.

“These technologies could enable us to shift the paradigm from ‘Let’s wait until the patient comes to us and find out what happened’ to ‘Let’s see how things are changing in real time, intervene now, and personalize that intervention,’ ” said Peter Chai, MD, associate professor of emergency medicine and health technology researcher at Brigham and Women’s Hospital in Boston.
 

Tracking Vitals From the Inside Out

Already, overdose-reversal agents like naloxone are saving lives. But more than 60% of overdoses occur when no one is around to administer them.

“While we need to focus on treatment, we also need to come up with more acute ways to save individuals when treatment doesn’t work or relapse occurs,” said James J. Mahoney III, PhD, director of addictions research at the Rockefeller Neuroscience Institute at West Virginia University (WVU), Morgantown.

Enter Celero Systems, a Massachusetts-based digital health company that has developed a vitamin-sized capsule packed with tiny sensors, microprocessors, and a radio antenna. It can measure breathing, heart rate, and core temperature — all from deep within the gut.

Respiratory distress is a hallmark early sign of an overdose. But it can be hard to monitor from a distance, especially in populations without access to a charged smartwatch.

Dr. Mahoney imagines a day when patients at risk could be given a weekly pill like Celero’s. If their respiratory rate drops below a dangerous level, it could alert loved ones or, better yet, release an overdose-reversal drug.

“It’s early days,” stressed Dr. Mahoney, whose team has been conducting pilot tests of the pill. “But initial data look promising.”

For one study, published in the journal Device in November 2023, the research team administered an overdose of fentanyl to anesthetized pigs with the pill in their stomachs. The capsule was able to detect respiratory depression within a minute and alert researchers via their laptop in time to step in.

When they gave the pill to 10 volunteers undergoing sleep studies at WVU, they found it could detect respiration rate with an accuracy of 93% compared with external monitoring devices — a feature that could also help diagnose sleep apnea or chronic obstructive pulmonary disease without expensive, intrusive tests.

Accuracy for heart rate was nearly 97%.

In another yet-to-be published trial, Dr. Mahoney tested the device with 10 volunteers in a residential treatment center to determine how well it could be tolerated.

Among the participants was Mr. Messenger, who said the thought of being tracked didn’t bother him.

“It was simple — just like taking a multivitamin,” said Mr. Messenger, now 34, sober, and working as a peer recovery support specialist at a hospital in his hometown. “It could be a great way to keep people alive long enough for them to get their head wrapped around the idea of treatment.”
 

Boosting Medication Adherence

At Brigham and Women’s Hospital, Dr. Chai is experimenting with a different smart pill — one he believes could help curb the ongoing HIV/AIDS epidemic.

Developed by Florida-based etectRx, the ID-Cap consists of a gelatin capsule embedded with a tiny radiofrequency transmitter, similar to the kind in retail antitheft devices. The capsule can be filled with a variety of medications. When swallowed, stomach acid dissolves the gel and activates the transmitter, which sends a signal to a receiver on a smartwatch, smartphone, or wall-mounted reader to confirm the medication was taken. If it isn’t, the patient’s smartphone or smart speaker might nudge them with a reminder or a family member might be notified.

In recent trials of men at a high risk for HIV, the system improved adherence to the once-daily prevention regimen pre-exposure prophylaxis (PrEP) by double digits.

“PrEP is almost 99% effective in preventing HIV, but you have to take it,” said Dr. Chai, who led the trials. “That seems like such a simple thing, but anyone who is chronically on medication can tell you just how difficult it can be.”

The pill is not the first designed to improve adherence. In 2017, the FDA approved the first digital ingestion tracking system, Abilify MyCite, for the treatment of schizophrenia and bipolar disorder. But its maker, Proteus Digital Health, filed for bankruptcy in 2020 after struggling to recruit patients willing to be tracked. (Some expressed privacy concerns. Others disliked the uncomfortable patch that received and forwarded the signal.)

More recent designs have been streamlined to ditch the patch, said etectRx senior vice president of operations Chris Carnes, PhD. And the cost of making a pill this kind of “smart” has come down to about a dollar.

So far, said Dr. Chai, in the patients he’s worked with, perceived benefits generally outweigh privacy concerns.

Studies are now underway in patients with heart disease and tuberculosis, and the company hopes to move into the aging and memory care space where medication-adherence is a serious problem.

“For us, or any company in this space, to succeed, you have to have a strong business case,” said Dr. Carnes. “If family members can keep their loved ones at home a little longer at an additional cost of $30 a month, that’s a no-brainer.”
 

Pillcams 2.0

Twenty-three years ago, the first video capsule endoscopy made it possible to image the small intestine via a tiny camera you swallow.

Such “pillcams” offered a more patient-friendly way to diagnose small bowel disorders, such as gastrointestinal bleeding and Crohn’s disease. Rather than undergoing sedation or anesthesia, as required during tube-based endoscopy, patients can go about their day as the pill painlessly passes through their gastrointestinal (GI) tract, capturing and recording data and images.

But the pills have their downsides.

Because they move passively, driven by movement in the intestine, they can miss trouble spots. Their ability to image the esophagus, stomach, and colon has proven limited. And unlike other procedures, like colonoscopy, they can’t intervene with therapy, like removing polyps.

The pillcam “had so much promise, to sort of revolutionize endoscopy, but it never really got the adoption that it seemed like it might,” said Andrew Meltzer, MD, professor of emergency medicine at the GW School of Medicine and Health Sciences in Washington.

That could soon change, he said, thanks to advances in locomotion and AI.

In a recent study of 40 patients, Dr. Meltzer tested a new magnetically controlled capsule endoscopy. Standing at a patient’s side, he could use a joystick to steer the pill around the stomach, capturing images in real time.

The pilot study, published in June 2023, found that the pill clearly identified six key stomach landmarks accurately 95% of the time and didn’t miss any lesions caught with traditional endoscopy. Notably, 80% of the patients preferred the pillcam over the tube.

“They are awake. They can go to work as soon as they leave. And it’s easy for them to tolerate,” Dr. Meltzer said.

More research is necessary, but Dr. Meltzer believes the technology could be particularly useful in the emergency department, allowing doctors to rule out high-risk bleeds in the stomach on the spot without admitting patients unnecessarily or making them return for a traditional scope.

“It has the potential to increase screening and provide more cost-effective care in emergencies,” he said.

It could also be useful in the telemedicine space, allowing a doctor to “drive” the pill from afar to diagnose a distant patient.

Someday, AI could enable the capsule to drive itself, so a doctor could merely press a button and wait. Or it could be adapted to treat what it finds, like administering a drug or cauterizing a bleed.

“If we can come up with a Mars rover which can explore other planets, we should be able to have something that can explore the stomach remotely,” Dr. Meltzer said.
 

Swallowing the Future

At the California Institute of Technology, researchers have developed a “location-aware” smart pill that uses magnetic fields to help pinpoint its location in the twists and turns of intestines. This could be useful for monitoring food in the GI tract to determine why things aren’t moving.

Other researchers are using AI models to enhance the transmission of video from inside the body and reduce the time it takes to interpret images.

One group at the Massachusetts Institute of Technology has developed a vibrating weight loss capsule designed to stimulate receptors in the gut to signal the brain that the person is full.

Not everyone is a fan of the smart-pill revolution. Some critics have raised concerns about privacy. Others fear that doctors risk yielding too much power to technology. Even those who are excited about the pills’ possibilities temper their optimism with caution.

None of these smart pills have gone mainstream yet in clinical practice, said Vivek Kaul, MD, professor of medicine at the University of Rochester Medical Center, Rochester, New York, and secretary general of the World Gastroenterology Organization.

Clinical validation, accessibility, and insurance coverage “will be critical in shaping their role,” he said. “But overall, it would be fair to state that this technology has come of age and the future is bright.”
 

A version of this article appeared on Medscape.com.

On a November morning in 2022, James Messenger opened wide and swallowed a capsule like no other.

Messenger was no stranger to taking pills.

He’d first experimented with prescription opioids as a teenager in Morgantown, West Virginia, battled addiction on-and-off since, and known more than 70 people who had fatally overdosed. So, when asked to test a new “smart pill” that could detect an overdose in progress and call for help, he didn’t hesitate to join the study.

“I’ve lost pretty much every good friend I’ve ever had to this,” said Mr. Messenger. “This pill could save a lot of lives.”

The new Vitals Monitoring capsule he tested is just one example in a growing effort to radically rethink what the humble pill is capable of.

As far back as 1965, scientists introduced the Heidelberg capsule, an electronic pill that measured acidity from within the gut. In 1994, the University of Buffalo coined the term “smart pill” with a device promising to ferry medicine to a precise spot in the intestine, “like the tiny ship in the film Fantastic Voyage.” And in 2001, the US Food and Drug Administration (FDA) approved the first video capsule endoscope, a miniature-camera-toting pill that enabled noninvasive imaging of the small intestine.

Despite these milestones, the smart pill revolution has been slow to catch on due to cost, technological limitations, and some resistance among clinicians and patients.

But now, nearly 300 iterations are in various stages of development, according to a 2022 analysis. Advances in materials, imaging, and artificial intelligence (AI) are helping address everything from sleep apnea to HIV/AIDS to gut disorders via real-time tracking and real-time help.

“These technologies could enable us to shift the paradigm from ‘Let’s wait until the patient comes to us and find out what happened’ to ‘Let’s see how things are changing in real time, intervene now, and personalize that intervention,’ ” said Peter Chai, MD, associate professor of emergency medicine and health technology researcher at Brigham and Women’s Hospital in Boston.
 

Tracking Vitals From the Inside Out

Already, overdose-reversal agents like naloxone are saving lives. But more than 60% of overdoses occur when no one is around to administer them.

“While we need to focus on treatment, we also need to come up with more acute ways to save individuals when treatment doesn’t work or relapse occurs,” said James J. Mahoney III, PhD, director of addictions research at the Rockefeller Neuroscience Institute at West Virginia University (WVU), Morgantown.

Enter Celero Systems, a Massachusetts-based digital health company that has developed a vitamin-sized capsule packed with tiny sensors, microprocessors, and a radio antenna. It can measure breathing, heart rate, and core temperature — all from deep within the gut.

Respiratory distress is a hallmark early sign of an overdose. But it can be hard to monitor from a distance, especially in populations without access to a charged smartwatch.

Dr. Mahoney imagines a day when patients at risk could be given a weekly pill like Celero’s. If their respiratory rate drops below a dangerous level, it could alert loved ones or, better yet, release an overdose-reversal drug.

“It’s early days,” stressed Dr. Mahoney, whose team has been conducting pilot tests of the pill. “But initial data look promising.”

For one study, published in the journal Device in November 2023, the research team administered an overdose of fentanyl to anesthetized pigs with the pill in their stomachs. The capsule was able to detect respiratory depression within a minute and alert researchers via their laptop in time to step in.

When they gave the pill to 10 volunteers undergoing sleep studies at WVU, they found it could detect respiration rate with an accuracy of 93% compared with external monitoring devices — a feature that could also help diagnose sleep apnea or chronic obstructive pulmonary disease without expensive, intrusive tests.

Accuracy for heart rate was nearly 97%.

In another yet-to-be published trial, Dr. Mahoney tested the device with 10 volunteers in a residential treatment center to determine how well it could be tolerated.

Among the participants was Mr. Messenger, who said the thought of being tracked didn’t bother him.

“It was simple — just like taking a multivitamin,” said Mr. Messenger, now 34, sober, and working as a peer recovery support specialist at a hospital in his hometown. “It could be a great way to keep people alive long enough for them to get their head wrapped around the idea of treatment.”
 

Boosting Medication Adherence

At Brigham and Women’s Hospital, Dr. Chai is experimenting with a different smart pill — one he believes could help curb the ongoing HIV/AIDS epidemic.

Developed by Florida-based etectRx, the ID-Cap consists of a gelatin capsule embedded with a tiny radiofrequency transmitter, similar to the kind in retail antitheft devices. The capsule can be filled with a variety of medications. When swallowed, stomach acid dissolves the gel and activates the transmitter, which sends a signal to a receiver on a smartwatch, smartphone, or wall-mounted reader to confirm the medication was taken. If it isn’t, the patient’s smartphone or smart speaker might nudge them with a reminder or a family member might be notified.

In recent trials of men at a high risk for HIV, the system improved adherence to the once-daily prevention regimen pre-exposure prophylaxis (PrEP) by double digits.

“PrEP is almost 99% effective in preventing HIV, but you have to take it,” said Dr. Chai, who led the trials. “That seems like such a simple thing, but anyone who is chronically on medication can tell you just how difficult it can be.”

The pill is not the first designed to improve adherence. In 2017, the FDA approved the first digital ingestion tracking system, Abilify MyCite, for the treatment of schizophrenia and bipolar disorder. But its maker, Proteus Digital Health, filed for bankruptcy in 2020 after struggling to recruit patients willing to be tracked. (Some expressed privacy concerns. Others disliked the uncomfortable patch that received and forwarded the signal.)

More recent designs have been streamlined to ditch the patch, said etectRx senior vice president of operations Chris Carnes, PhD. And the cost of making a pill this kind of “smart” has come down to about a dollar.

So far, said Dr. Chai, in the patients he’s worked with, perceived benefits generally outweigh privacy concerns.

Studies are now underway in patients with heart disease and tuberculosis, and the company hopes to move into the aging and memory care space where medication-adherence is a serious problem.

“For us, or any company in this space, to succeed, you have to have a strong business case,” said Dr. Carnes. “If family members can keep their loved ones at home a little longer at an additional cost of $30 a month, that’s a no-brainer.”
 

Pillcams 2.0

Twenty-three years ago, the first video capsule endoscopy made it possible to image the small intestine via a tiny camera you swallow.

Such “pillcams” offered a more patient-friendly way to diagnose small bowel disorders, such as gastrointestinal bleeding and Crohn’s disease. Rather than undergoing sedation or anesthesia, as required during tube-based endoscopy, patients can go about their day as the pill painlessly passes through their gastrointestinal (GI) tract, capturing and recording data and images.

But the pills have their downsides.

Because they move passively, driven by movement in the intestine, they can miss trouble spots. Their ability to image the esophagus, stomach, and colon has proven limited. And unlike other procedures, like colonoscopy, they can’t intervene with therapy, like removing polyps.

The pillcam “had so much promise, to sort of revolutionize endoscopy, but it never really got the adoption that it seemed like it might,” said Andrew Meltzer, MD, professor of emergency medicine at the GW School of Medicine and Health Sciences in Washington.

That could soon change, he said, thanks to advances in locomotion and AI.

In a recent study of 40 patients, Dr. Meltzer tested a new magnetically controlled capsule endoscopy. Standing at a patient’s side, he could use a joystick to steer the pill around the stomach, capturing images in real time.

The pilot study, published in June 2023, found that the pill clearly identified six key stomach landmarks accurately 95% of the time and didn’t miss any lesions caught with traditional endoscopy. Notably, 80% of the patients preferred the pillcam over the tube.

“They are awake. They can go to work as soon as they leave. And it’s easy for them to tolerate,” Dr. Meltzer said.

More research is necessary, but Dr. Meltzer believes the technology could be particularly useful in the emergency department, allowing doctors to rule out high-risk bleeds in the stomach on the spot without admitting patients unnecessarily or making them return for a traditional scope.

“It has the potential to increase screening and provide more cost-effective care in emergencies,” he said.

It could also be useful in the telemedicine space, allowing a doctor to “drive” the pill from afar to diagnose a distant patient.

Someday, AI could enable the capsule to drive itself, so a doctor could merely press a button and wait. Or it could be adapted to treat what it finds, like administering a drug or cauterizing a bleed.

“If we can come up with a Mars rover which can explore other planets, we should be able to have something that can explore the stomach remotely,” Dr. Meltzer said.
 

Swallowing the Future

At the California Institute of Technology, researchers have developed a “location-aware” smart pill that uses magnetic fields to help pinpoint its location in the twists and turns of intestines. This could be useful for monitoring food in the GI tract to determine why things aren’t moving.

Other researchers are using AI models to enhance the transmission of video from inside the body and reduce the time it takes to interpret images.

One group at the Massachusetts Institute of Technology has developed a vibrating weight loss capsule designed to stimulate receptors in the gut to signal the brain that the person is full.

Not everyone is a fan of the smart-pill revolution. Some critics have raised concerns about privacy. Others fear that doctors risk yielding too much power to technology. Even those who are excited about the pills’ possibilities temper their optimism with caution.

None of these smart pills have gone mainstream yet in clinical practice, said Vivek Kaul, MD, professor of medicine at the University of Rochester Medical Center, Rochester, New York, and secretary general of the World Gastroenterology Organization.

Clinical validation, accessibility, and insurance coverage “will be critical in shaping their role,” he said. “But overall, it would be fair to state that this technology has come of age and the future is bright.”
 

A version of this article appeared on Medscape.com.

On a November morning in 2022, James Messenger opened wide and swallowed a capsule like no other.

Messenger was no stranger to taking pills.

He’d first experimented with prescription opioids as a teenager in Morgantown, West Virginia, battled addiction on-and-off since, and known more than 70 people who had fatally overdosed. So, when asked to test a new “smart pill” that could detect an overdose in progress and call for help, he didn’t hesitate to join the study.

“I’ve lost pretty much every good friend I’ve ever had to this,” said Mr. Messenger. “This pill could save a lot of lives.”

The new Vitals Monitoring capsule he tested is just one example in a growing effort to radically rethink what the humble pill is capable of.

As far back as 1965, scientists introduced the Heidelberg capsule, an electronic pill that measured acidity from within the gut. In 1994, the University of Buffalo coined the term “smart pill” with a device promising to ferry medicine to a precise spot in the intestine, “like the tiny ship in the film Fantastic Voyage.” And in 2001, the US Food and Drug Administration (FDA) approved the first video capsule endoscope, a miniature-camera-toting pill that enabled noninvasive imaging of the small intestine.

Despite these milestones, the smart pill revolution has been slow to catch on due to cost, technological limitations, and some resistance among clinicians and patients.

But now, nearly 300 iterations are in various stages of development, according to a 2022 analysis. Advances in materials, imaging, and artificial intelligence (AI) are helping address everything from sleep apnea to HIV/AIDS to gut disorders via real-time tracking and real-time help.

“These technologies could enable us to shift the paradigm from ‘Let’s wait until the patient comes to us and find out what happened’ to ‘Let’s see how things are changing in real time, intervene now, and personalize that intervention,’ ” said Peter Chai, MD, associate professor of emergency medicine and health technology researcher at Brigham and Women’s Hospital in Boston.
 

Tracking Vitals From the Inside Out

Already, overdose-reversal agents like naloxone are saving lives. But more than 60% of overdoses occur when no one is around to administer them.

“While we need to focus on treatment, we also need to come up with more acute ways to save individuals when treatment doesn’t work or relapse occurs,” said James J. Mahoney III, PhD, director of addictions research at the Rockefeller Neuroscience Institute at West Virginia University (WVU), Morgantown.

Enter Celero Systems, a Massachusetts-based digital health company that has developed a vitamin-sized capsule packed with tiny sensors, microprocessors, and a radio antenna. It can measure breathing, heart rate, and core temperature — all from deep within the gut.

Respiratory distress is a hallmark early sign of an overdose. But it can be hard to monitor from a distance, especially in populations without access to a charged smartwatch.

Dr. Mahoney imagines a day when patients at risk could be given a weekly pill like Celero’s. If their respiratory rate drops below a dangerous level, it could alert loved ones or, better yet, release an overdose-reversal drug.

“It’s early days,” stressed Dr. Mahoney, whose team has been conducting pilot tests of the pill. “But initial data look promising.”

For one study, published in the journal Device in November 2023, the research team administered an overdose of fentanyl to anesthetized pigs with the pill in their stomachs. The capsule was able to detect respiratory depression within a minute and alert researchers via their laptop in time to step in.

When they gave the pill to 10 volunteers undergoing sleep studies at WVU, they found it could detect respiration rate with an accuracy of 93% compared with external monitoring devices — a feature that could also help diagnose sleep apnea or chronic obstructive pulmonary disease without expensive, intrusive tests.

Accuracy for heart rate was nearly 97%.

In another yet-to-be published trial, Dr. Mahoney tested the device with 10 volunteers in a residential treatment center to determine how well it could be tolerated.

Among the participants was Mr. Messenger, who said the thought of being tracked didn’t bother him.

“It was simple — just like taking a multivitamin,” said Mr. Messenger, now 34, sober, and working as a peer recovery support specialist at a hospital in his hometown. “It could be a great way to keep people alive long enough for them to get their head wrapped around the idea of treatment.”
 

Boosting Medication Adherence

At Brigham and Women’s Hospital, Dr. Chai is experimenting with a different smart pill — one he believes could help curb the ongoing HIV/AIDS epidemic.

Developed by Florida-based etectRx, the ID-Cap consists of a gelatin capsule embedded with a tiny radiofrequency transmitter, similar to the kind in retail antitheft devices. The capsule can be filled with a variety of medications. When swallowed, stomach acid dissolves the gel and activates the transmitter, which sends a signal to a receiver on a smartwatch, smartphone, or wall-mounted reader to confirm the medication was taken. If it isn’t, the patient’s smartphone or smart speaker might nudge them with a reminder or a family member might be notified.

In recent trials of men at a high risk for HIV, the system improved adherence to the once-daily prevention regimen pre-exposure prophylaxis (PrEP) by double digits.

“PrEP is almost 99% effective in preventing HIV, but you have to take it,” said Dr. Chai, who led the trials. “That seems like such a simple thing, but anyone who is chronically on medication can tell you just how difficult it can be.”

The pill is not the first designed to improve adherence. In 2017, the FDA approved the first digital ingestion tracking system, Abilify MyCite, for the treatment of schizophrenia and bipolar disorder. But its maker, Proteus Digital Health, filed for bankruptcy in 2020 after struggling to recruit patients willing to be tracked. (Some expressed privacy concerns. Others disliked the uncomfortable patch that received and forwarded the signal.)

More recent designs have been streamlined to ditch the patch, said etectRx senior vice president of operations Chris Carnes, PhD. And the cost of making a pill this kind of “smart” has come down to about a dollar.

So far, said Dr. Chai, in the patients he’s worked with, perceived benefits generally outweigh privacy concerns.

Studies are now underway in patients with heart disease and tuberculosis, and the company hopes to move into the aging and memory care space where medication-adherence is a serious problem.

“For us, or any company in this space, to succeed, you have to have a strong business case,” said Dr. Carnes. “If family members can keep their loved ones at home a little longer at an additional cost of $30 a month, that’s a no-brainer.”
 

Pillcams 2.0

Twenty-three years ago, the first video capsule endoscopy made it possible to image the small intestine via a tiny camera you swallow.

Such “pillcams” offered a more patient-friendly way to diagnose small bowel disorders, such as gastrointestinal bleeding and Crohn’s disease. Rather than undergoing sedation or anesthesia, as required during tube-based endoscopy, patients can go about their day as the pill painlessly passes through their gastrointestinal (GI) tract, capturing and recording data and images.

But the pills have their downsides.

Because they move passively, driven by movement in the intestine, they can miss trouble spots. Their ability to image the esophagus, stomach, and colon has proven limited. And unlike other procedures, like colonoscopy, they can’t intervene with therapy, like removing polyps.

The pillcam “had so much promise, to sort of revolutionize endoscopy, but it never really got the adoption that it seemed like it might,” said Andrew Meltzer, MD, professor of emergency medicine at the GW School of Medicine and Health Sciences in Washington.

That could soon change, he said, thanks to advances in locomotion and AI.

In a recent study of 40 patients, Dr. Meltzer tested a new magnetically controlled capsule endoscopy. Standing at a patient’s side, he could use a joystick to steer the pill around the stomach, capturing images in real time.

The pilot study, published in June 2023, found that the pill clearly identified six key stomach landmarks accurately 95% of the time and didn’t miss any lesions caught with traditional endoscopy. Notably, 80% of the patients preferred the pillcam over the tube.

“They are awake. They can go to work as soon as they leave. And it’s easy for them to tolerate,” Dr. Meltzer said.

More research is necessary, but Dr. Meltzer believes the technology could be particularly useful in the emergency department, allowing doctors to rule out high-risk bleeds in the stomach on the spot without admitting patients unnecessarily or making them return for a traditional scope.

“It has the potential to increase screening and provide more cost-effective care in emergencies,” he said.

It could also be useful in the telemedicine space, allowing a doctor to “drive” the pill from afar to diagnose a distant patient.

Someday, AI could enable the capsule to drive itself, so a doctor could merely press a button and wait. Or it could be adapted to treat what it finds, like administering a drug or cauterizing a bleed.

“If we can come up with a Mars rover which can explore other planets, we should be able to have something that can explore the stomach remotely,” Dr. Meltzer said.
 

Swallowing the Future

At the California Institute of Technology, researchers have developed a “location-aware” smart pill that uses magnetic fields to help pinpoint its location in the twists and turns of intestines. This could be useful for monitoring food in the GI tract to determine why things aren’t moving.

Other researchers are using AI models to enhance the transmission of video from inside the body and reduce the time it takes to interpret images.

One group at the Massachusetts Institute of Technology has developed a vibrating weight loss capsule designed to stimulate receptors in the gut to signal the brain that the person is full.

Not everyone is a fan of the smart-pill revolution. Some critics have raised concerns about privacy. Others fear that doctors risk yielding too much power to technology. Even those who are excited about the pills’ possibilities temper their optimism with caution.

None of these smart pills have gone mainstream yet in clinical practice, said Vivek Kaul, MD, professor of medicine at the University of Rochester Medical Center, Rochester, New York, and secretary general of the World Gastroenterology Organization.

Clinical validation, accessibility, and insurance coverage “will be critical in shaping their role,” he said. “But overall, it would be fair to state that this technology has come of age and the future is bright.”
 

A version of this article appeared on Medscape.com.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

For the first time, methamphetamines and cocaine have overtaken heroin and prescription opioids in illicit drug use involving fentanyl nationwide and in nearly every state, a new report suggested.

The use of methamphetamine among people who also use fentanyl reached a record high in 2023, urinary drug tests (UDTs) showed, while the use of prescription opioids in that same group reached an historic low. 

Investigators said the data offer further evidence that the US is experiencing a predicted “fourth wave” of the opioid crisis.

The report came on the heels of new data from the Centers for Disease Control and Prevention (CDC) that showed the preferred method of fentanyl-related illicit drug use shifted from intravenous injection to smoking.

“The rise in cocaine and methamphetamine nationally does not seem to be driven by one or even a few regions of the country,” authors of the 2024 Health Signals Report wrote. “Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences.”

The report, published online on February 22 by San Diego–based drug testing lab Millennium Health, is an analysis of urine specimens from 4.1 million unique patients aged ≥ 18 years, collected in all 50 states from 2013 to 2023. 
 

A Year of Firsts

Last year, 60% of specimens that contained fentanyl also contained methamphetamine, an increase of 875% since 2015, according to Millennium’s report. It’s the first time that methamphetamine and cocaine were detected more often in urine drug tests than heroin and prescription opioids.

About a quarter of fentanyl-positive specimens also contained cocaine, 17% heroin and just 7% prescription opioids.

Almost all the fentanyl-positive specimens were positive for at least one additional substance; almost half contained three or more. Xylazine, an animal sedative known as “tranq,” was detected in nearly 14% of fentanyl-positive specimens.

“These combinations increase overdose vulnerability and may lessen responses to overdose reversal agents, making treatment as challenging as any time in history,” Millennium Senior VP and Chief Clinical Officer, Angela G. Huskey, PharmD, CPE, said in a statement.

The Millennium data back up what has been increasingly reported by the CDC and others. As reported in September by this news organization, in 2010, stimulants were co-involved in less than 1% of fentanyl overdose deaths. By 2021, stimulant-fentanyl use accounted for 32% of all fatal fentanyl overdoses.

In July 2023, the CDC reported a significant spike in overdose deaths involving cocaine or other psychostimulants and opioids from 2011 to 2021. In 2021, 79% of overdose deaths involving cocaine also involved an opioid and 66% of overdose deaths involving psychostimulants also involved an opioid, according to the CDC.

There were more overdose deaths from stimulants combined with opioids than from opioids alone in 2022, according to the CDC’s State Unintentional Drug Overdose Reporting System, which includes reports from 30 jurisdictions.
 

Smoking Overtakes Injection

The route of administration for opioids and stimulants — whether used alone or in combination, has also changed, the CDC recently reported. In 2022, just 16% of overdose deaths involved injection drug use, down from 23% in 2020, according to the analysis, which included data from 28 jurisdictions. For deaths involving illegally manufactured fentanyl, just 12% of deaths involved IV drug use.

By 2022, “smoking was the most commonly documented route of use in overdose deaths,” CDC researchers wrote in their report. Almost a quarter of deaths that year involved smoking.

The increase in smoking was seen for all substances, including opioids, fentanyl and combinations of fentanyl and stimulants, reported the agency.

Users might be switching to smoking from injections because there is a perception of fewer adverse health effects such as abscesses, reduced cost and stigma, sense of more control over quantity consumed per use, and “a perception of reduced overdose risk,” the researchers wrote.

Smoking still “carries substantial overdose risk because of rapid drug absorption,” they added.

Some harm reduction programs are adapting to the change in use patterns by providing safer smoking supplies and by changing messaging to warn of the dangers associated with smoking drugs, the CDC report noted.
 

A version of this article appeared on Medscape.com.

For the first time, methamphetamines and cocaine have overtaken heroin and prescription opioids in illicit drug use involving fentanyl nationwide and in nearly every state, a new report suggested.

The use of methamphetamine among people who also use fentanyl reached a record high in 2023, urinary drug tests (UDTs) showed, while the use of prescription opioids in that same group reached an historic low. 

Investigators said the data offer further evidence that the US is experiencing a predicted “fourth wave” of the opioid crisis.

The report came on the heels of new data from the Centers for Disease Control and Prevention (CDC) that showed the preferred method of fentanyl-related illicit drug use shifted from intravenous injection to smoking.

“The rise in cocaine and methamphetamine nationally does not seem to be driven by one or even a few regions of the country,” authors of the 2024 Health Signals Report wrote. “Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences.”

The report, published online on February 22 by San Diego–based drug testing lab Millennium Health, is an analysis of urine specimens from 4.1 million unique patients aged ≥ 18 years, collected in all 50 states from 2013 to 2023. 
 

A Year of Firsts

Last year, 60% of specimens that contained fentanyl also contained methamphetamine, an increase of 875% since 2015, according to Millennium’s report. It’s the first time that methamphetamine and cocaine were detected more often in urine drug tests than heroin and prescription opioids.

About a quarter of fentanyl-positive specimens also contained cocaine, 17% heroin and just 7% prescription opioids.

Almost all the fentanyl-positive specimens were positive for at least one additional substance; almost half contained three or more. Xylazine, an animal sedative known as “tranq,” was detected in nearly 14% of fentanyl-positive specimens.

“These combinations increase overdose vulnerability and may lessen responses to overdose reversal agents, making treatment as challenging as any time in history,” Millennium Senior VP and Chief Clinical Officer, Angela G. Huskey, PharmD, CPE, said in a statement.

The Millennium data back up what has been increasingly reported by the CDC and others. As reported in September by this news organization, in 2010, stimulants were co-involved in less than 1% of fentanyl overdose deaths. By 2021, stimulant-fentanyl use accounted for 32% of all fatal fentanyl overdoses.

In July 2023, the CDC reported a significant spike in overdose deaths involving cocaine or other psychostimulants and opioids from 2011 to 2021. In 2021, 79% of overdose deaths involving cocaine also involved an opioid and 66% of overdose deaths involving psychostimulants also involved an opioid, according to the CDC.

There were more overdose deaths from stimulants combined with opioids than from opioids alone in 2022, according to the CDC’s State Unintentional Drug Overdose Reporting System, which includes reports from 30 jurisdictions.
 

Smoking Overtakes Injection

The route of administration for opioids and stimulants — whether used alone or in combination, has also changed, the CDC recently reported. In 2022, just 16% of overdose deaths involved injection drug use, down from 23% in 2020, according to the analysis, which included data from 28 jurisdictions. For deaths involving illegally manufactured fentanyl, just 12% of deaths involved IV drug use.

By 2022, “smoking was the most commonly documented route of use in overdose deaths,” CDC researchers wrote in their report. Almost a quarter of deaths that year involved smoking.

The increase in smoking was seen for all substances, including opioids, fentanyl and combinations of fentanyl and stimulants, reported the agency.

Users might be switching to smoking from injections because there is a perception of fewer adverse health effects such as abscesses, reduced cost and stigma, sense of more control over quantity consumed per use, and “a perception of reduced overdose risk,” the researchers wrote.

Smoking still “carries substantial overdose risk because of rapid drug absorption,” they added.

Some harm reduction programs are adapting to the change in use patterns by providing safer smoking supplies and by changing messaging to warn of the dangers associated with smoking drugs, the CDC report noted.
 

A version of this article appeared on Medscape.com.

For the first time, methamphetamines and cocaine have overtaken heroin and prescription opioids in illicit drug use involving fentanyl nationwide and in nearly every state, a new report suggested.

The use of methamphetamine among people who also use fentanyl reached a record high in 2023, urinary drug tests (UDTs) showed, while the use of prescription opioids in that same group reached an historic low. 

Investigators said the data offer further evidence that the US is experiencing a predicted “fourth wave” of the opioid crisis.

The report came on the heels of new data from the Centers for Disease Control and Prevention (CDC) that showed the preferred method of fentanyl-related illicit drug use shifted from intravenous injection to smoking.

“The rise in cocaine and methamphetamine nationally does not seem to be driven by one or even a few regions of the country,” authors of the 2024 Health Signals Report wrote. “Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences.”

The report, published online on February 22 by San Diego–based drug testing lab Millennium Health, is an analysis of urine specimens from 4.1 million unique patients aged ≥ 18 years, collected in all 50 states from 2013 to 2023. 
 

A Year of Firsts

Last year, 60% of specimens that contained fentanyl also contained methamphetamine, an increase of 875% since 2015, according to Millennium’s report. It’s the first time that methamphetamine and cocaine were detected more often in urine drug tests than heroin and prescription opioids.

About a quarter of fentanyl-positive specimens also contained cocaine, 17% heroin and just 7% prescription opioids.

Almost all the fentanyl-positive specimens were positive for at least one additional substance; almost half contained three or more. Xylazine, an animal sedative known as “tranq,” was detected in nearly 14% of fentanyl-positive specimens.

“These combinations increase overdose vulnerability and may lessen responses to overdose reversal agents, making treatment as challenging as any time in history,” Millennium Senior VP and Chief Clinical Officer, Angela G. Huskey, PharmD, CPE, said in a statement.

The Millennium data back up what has been increasingly reported by the CDC and others. As reported in September by this news organization, in 2010, stimulants were co-involved in less than 1% of fentanyl overdose deaths. By 2021, stimulant-fentanyl use accounted for 32% of all fatal fentanyl overdoses.

In July 2023, the CDC reported a significant spike in overdose deaths involving cocaine or other psychostimulants and opioids from 2011 to 2021. In 2021, 79% of overdose deaths involving cocaine also involved an opioid and 66% of overdose deaths involving psychostimulants also involved an opioid, according to the CDC.

There were more overdose deaths from stimulants combined with opioids than from opioids alone in 2022, according to the CDC’s State Unintentional Drug Overdose Reporting System, which includes reports from 30 jurisdictions.
 

Smoking Overtakes Injection

The route of administration for opioids and stimulants — whether used alone or in combination, has also changed, the CDC recently reported. In 2022, just 16% of overdose deaths involved injection drug use, down from 23% in 2020, according to the analysis, which included data from 28 jurisdictions. For deaths involving illegally manufactured fentanyl, just 12% of deaths involved IV drug use.

By 2022, “smoking was the most commonly documented route of use in overdose deaths,” CDC researchers wrote in their report. Almost a quarter of deaths that year involved smoking.

The increase in smoking was seen for all substances, including opioids, fentanyl and combinations of fentanyl and stimulants, reported the agency.

Users might be switching to smoking from injections because there is a perception of fewer adverse health effects such as abscesses, reduced cost and stigma, sense of more control over quantity consumed per use, and “a perception of reduced overdose risk,” the researchers wrote.

Smoking still “carries substantial overdose risk because of rapid drug absorption,” they added.

Some harm reduction programs are adapting to the change in use patterns by providing safer smoking supplies and by changing messaging to warn of the dangers associated with smoking drugs, the CDC report noted.
 

A version of this article appeared on Medscape.com.

At the request of the US Food and Drug Administration (FDA), Emergent BioSolutions has extended the shelf life of the rapid opioid overdose reversal agent, naloxone (4 mg) nasal spray (Narcan), from 3 to 4 years.

Naloxone is “an important tool” in addressing opioid overdoses, and this extension supports the FDA’s “efforts to ensure more OTC naloxone products remain available to the public,” Marta Sokolowska, PhD, with the FDA Center for Drug Evaluation and Research, said in a statement.

Naloxone nasal spray was first approved by the FDA in 2015 as a prescription drug. Last spring, the agency approved the drug for over-the-counter use.

The FDA approved an initial shelf-life extension for naloxone nasal spray (from 2 to 3 years) in August 2020.

The shelf-life extension to 4 years applies only to naloxone (4 mg) nasal spray products produced after January 17, 2024.

“The shelf life of products that were produced and distributed prior to this announcement is not affected and remains unchanged. Prescribers, patients, and caregivers are advised to continue to abide by the expiration date printed on each product’s packaging and within the product’s labeling,” the FDA advised.

“FDA’s request for this shelf-life extension is a testament to the agency’s continuing progress toward implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths,” the agency said.

According to the US Centers for Disease Control and Prevention, from 1999 to 2021, nearly 645,000 people died from an overdose involving any opioid, including prescription and illicit opioids.

A version of this article appeared on Medscape.com.

At the request of the US Food and Drug Administration (FDA), Emergent BioSolutions has extended the shelf life of the rapid opioid overdose reversal agent, naloxone (4 mg) nasal spray (Narcan), from 3 to 4 years.

Naloxone is “an important tool” in addressing opioid overdoses, and this extension supports the FDA’s “efforts to ensure more OTC naloxone products remain available to the public,” Marta Sokolowska, PhD, with the FDA Center for Drug Evaluation and Research, said in a statement.

Naloxone nasal spray was first approved by the FDA in 2015 as a prescription drug. Last spring, the agency approved the drug for over-the-counter use.

The FDA approved an initial shelf-life extension for naloxone nasal spray (from 2 to 3 years) in August 2020.

The shelf-life extension to 4 years applies only to naloxone (4 mg) nasal spray products produced after January 17, 2024.

“The shelf life of products that were produced and distributed prior to this announcement is not affected and remains unchanged. Prescribers, patients, and caregivers are advised to continue to abide by the expiration date printed on each product’s packaging and within the product’s labeling,” the FDA advised.

“FDA’s request for this shelf-life extension is a testament to the agency’s continuing progress toward implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths,” the agency said.

According to the US Centers for Disease Control and Prevention, from 1999 to 2021, nearly 645,000 people died from an overdose involving any opioid, including prescription and illicit opioids.

A version of this article appeared on Medscape.com.

At the request of the US Food and Drug Administration (FDA), Emergent BioSolutions has extended the shelf life of the rapid opioid overdose reversal agent, naloxone (4 mg) nasal spray (Narcan), from 3 to 4 years.

Naloxone is “an important tool” in addressing opioid overdoses, and this extension supports the FDA’s “efforts to ensure more OTC naloxone products remain available to the public,” Marta Sokolowska, PhD, with the FDA Center for Drug Evaluation and Research, said in a statement.

Naloxone nasal spray was first approved by the FDA in 2015 as a prescription drug. Last spring, the agency approved the drug for over-the-counter use.

The FDA approved an initial shelf-life extension for naloxone nasal spray (from 2 to 3 years) in August 2020.

The shelf-life extension to 4 years applies only to naloxone (4 mg) nasal spray products produced after January 17, 2024.

“The shelf life of products that were produced and distributed prior to this announcement is not affected and remains unchanged. Prescribers, patients, and caregivers are advised to continue to abide by the expiration date printed on each product’s packaging and within the product’s labeling,” the FDA advised.

“FDA’s request for this shelf-life extension is a testament to the agency’s continuing progress toward implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to encourage harm reduction and innovation in reducing controlled substance-related overdoses and deaths,” the agency said.

According to the US Centers for Disease Control and Prevention, from 1999 to 2021, nearly 645,000 people died from an overdose involving any opioid, including prescription and illicit opioids.

A version of this article appeared on Medscape.com.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email vstern@medscape.net to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email vstern@medscape.net to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email vstern@medscape.net to share experiences with prior authorization or other challenges receiving care.