Federal Practitioner

Veterans enrolled in the US Department of Veterans Affairs (VA) who have been referred to Community Care no longer need a second review from a VA clinician according to a new policy. The provision implements language from the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act. VA officials hope that it will speed up access to community care.

The move expands on the 2019 MISSION Act, which allows eligible veterans to access health care from non-VA clinicians that is paid for by the VA when it is in their “best medical interest.” Those decisions, however, were not considered final until reviewed by a second VA doctor.

The Dole Act prohibits VA administrators from overriding a VA doctor’s referral for a patient to receive outside care. According to the law, the ban on administrative review will remain in place for 2 years, after which the VA must report on its effects to Congress. The VA announced it would begin training employees to ensure the community care referral process is followed in compliance with the Dole Act. 

Analysis from the Veterans Healthcare Policy Institute claims the best medical interest criterion “is to be considered when a veteran's health and/or well-being would be compromised if they were not able to be seen in the community for the requested clinical service.”

During a March hearing, Rep. Julia Brownley (D-CA), ranking Democrat on the House Veterans’ Affairs subcommittee on health, said any veteran who seeks residential treatment should get it, but noted the VA has not developed a fee schedule for community treatment centers. In at least 1 case, she said, the department was charged up to $6000 a day for 1 patient. Brownley also noted that the VA doesn't track the timeliness or quality of medical care in community residential treatment facilities.

“We have no way of knowing the level of treatment or support they are getting,” she said. “We must find a balance between community care and VA direct care. In my opinion, we have not found that balance when it comes to residential rehabilitation treatment facilities.”

At the same hearing, chair of the House Veterans Affairs health subcommittee Rep. Mariannette Miller-Meeks (R-IA) said more change is needed—specifically to ensure that veterans also can access private residential substance abuse treatment centers. Some, she said, “are told they cannot access community care unless a VA facility fails to meet a 20-day threshold—forcing them to wait, even when immediate, alternative options exist."

The House of Representatives passed H.R. 1969, the No Wrong Door for Veterans Act, in May, which expands the VA suicide prevention grant program. However, the Senate has yet to take up the legislation. “I’ve seen firsthand how difficult it can be for veterans in crisis to navigate a complicated system when every second counts,” Miller-Meeks said. “The No Wrong Door for Veterans Act ensures that our heroes are never turned away or left without help. It streamlines access, strengthens coordination, and reaffirms our promise to those who served.”

Veterans enrolled in the US Department of Veterans Affairs (VA) who have been referred to Community Care no longer need a second review from a VA clinician according to a new policy. The provision implements language from the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act. VA officials hope that it will speed up access to community care.

The move expands on the 2019 MISSION Act, which allows eligible veterans to access health care from non-VA clinicians that is paid for by the VA when it is in their “best medical interest.” Those decisions, however, were not considered final until reviewed by a second VA doctor.

The Dole Act prohibits VA administrators from overriding a VA doctor’s referral for a patient to receive outside care. According to the law, the ban on administrative review will remain in place for 2 years, after which the VA must report on its effects to Congress. The VA announced it would begin training employees to ensure the community care referral process is followed in compliance with the Dole Act. 

Analysis from the Veterans Healthcare Policy Institute claims the best medical interest criterion “is to be considered when a veteran's health and/or well-being would be compromised if they were not able to be seen in the community for the requested clinical service.”

During a March hearing, Rep. Julia Brownley (D-CA), ranking Democrat on the House Veterans’ Affairs subcommittee on health, said any veteran who seeks residential treatment should get it, but noted the VA has not developed a fee schedule for community treatment centers. In at least 1 case, she said, the department was charged up to $6000 a day for 1 patient. Brownley also noted that the VA doesn't track the timeliness or quality of medical care in community residential treatment facilities.

“We have no way of knowing the level of treatment or support they are getting,” she said. “We must find a balance between community care and VA direct care. In my opinion, we have not found that balance when it comes to residential rehabilitation treatment facilities.”

At the same hearing, chair of the House Veterans Affairs health subcommittee Rep. Mariannette Miller-Meeks (R-IA) said more change is needed—specifically to ensure that veterans also can access private residential substance abuse treatment centers. Some, she said, “are told they cannot access community care unless a VA facility fails to meet a 20-day threshold—forcing them to wait, even when immediate, alternative options exist."

The House of Representatives passed H.R. 1969, the No Wrong Door for Veterans Act, in May, which expands the VA suicide prevention grant program. However, the Senate has yet to take up the legislation. “I’ve seen firsthand how difficult it can be for veterans in crisis to navigate a complicated system when every second counts,” Miller-Meeks said. “The No Wrong Door for Veterans Act ensures that our heroes are never turned away or left without help. It streamlines access, strengthens coordination, and reaffirms our promise to those who served.”

Veterans enrolled in the US Department of Veterans Affairs (VA) who have been referred to Community Care no longer need a second review from a VA clinician according to a new policy. The provision implements language from the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act. VA officials hope that it will speed up access to community care.

The move expands on the 2019 MISSION Act, which allows eligible veterans to access health care from non-VA clinicians that is paid for by the VA when it is in their “best medical interest.” Those decisions, however, were not considered final until reviewed by a second VA doctor.

The Dole Act prohibits VA administrators from overriding a VA doctor’s referral for a patient to receive outside care. According to the law, the ban on administrative review will remain in place for 2 years, after which the VA must report on its effects to Congress. The VA announced it would begin training employees to ensure the community care referral process is followed in compliance with the Dole Act. 

Analysis from the Veterans Healthcare Policy Institute claims the best medical interest criterion “is to be considered when a veteran's health and/or well-being would be compromised if they were not able to be seen in the community for the requested clinical service.”

During a March hearing, Rep. Julia Brownley (D-CA), ranking Democrat on the House Veterans’ Affairs subcommittee on health, said any veteran who seeks residential treatment should get it, but noted the VA has not developed a fee schedule for community treatment centers. In at least 1 case, she said, the department was charged up to $6000 a day for 1 patient. Brownley also noted that the VA doesn't track the timeliness or quality of medical care in community residential treatment facilities.

“We have no way of knowing the level of treatment or support they are getting,” she said. “We must find a balance between community care and VA direct care. In my opinion, we have not found that balance when it comes to residential rehabilitation treatment facilities.”

At the same hearing, chair of the House Veterans Affairs health subcommittee Rep. Mariannette Miller-Meeks (R-IA) said more change is needed—specifically to ensure that veterans also can access private residential substance abuse treatment centers. Some, she said, “are told they cannot access community care unless a VA facility fails to meet a 20-day threshold—forcing them to wait, even when immediate, alternative options exist."

The House of Representatives passed H.R. 1969, the No Wrong Door for Veterans Act, in May, which expands the VA suicide prevention grant program. However, the Senate has yet to take up the legislation. “I’ve seen firsthand how difficult it can be for veterans in crisis to navigate a complicated system when every second counts,” Miller-Meeks said. “The No Wrong Door for Veterans Act ensures that our heroes are never turned away or left without help. It streamlines access, strengthens coordination, and reaffirms our promise to those who served.”

Community-based organizations that provide suicide-prevention services can now access about $52.5 million in US Department of Veterans Affairs (VA) grants. The grant is part of the 3-year Staff Sergeant Fox Suicide Prevention Grant Program, which honors Parker Gordon Fox, a sniper instructor at the U.S. Army Infantry School at Fort Benning, Georgia, who died by suicide in 2020. In consecutive Congressional hearings, lawmakers called for the reauthorization of the program to address gaps in VA care.

“It has been a game-changer for so many veterans,” Sen. Richard Blumenthal (D-CT) said. 

The money provides or coordinates primarily nonclinical suicide prevention services, including outreach and linkage to VA and community resources. Services also may include baseline mental health screenings, case management and peer support, education on suicide risk, VA benefits assistance, and emergency clinical services.

Since its inception in 2022, the program has awarded $157.5 million to 95 organizations in 43 states, US territories, and tribal lands. Speaking before the House Committee on Veterans’ Affairs on May 15, VA Secretary Doug Collins praised the Fox program for bringing “different voices into the conversation,” but added it wasn’t enough. He noted that the veteran suicide rate has not changed since 2008, despite the VA annually spending $588 million on suicide prevention over the past few years.

In an op-ed, Russell Lemle, a senior policy analyst at the Veterans Healthcare Policy Institute, disputed Collins' characterization of veteran suicides. Between 2008 and 2022 (the last year for which complete data is available), US deaths by suicide increased 37% while the number of veteran deaths by suicide fell 2%. “This data collection was the single best part of the program,” he argued, calling for reauthorization to continue requiring data-targeted solutions.

According to a 2024 VA interim report on the Fox grant program, grantees had completed > 16,590 outreach contacts and engaged 3204 participants as of September 30, 2023. An additional 864 individuals were onboarding at the time of the report.

The current version of the grant program requires grantees to use validated tools, including the VA Data Collection Tool, and other assessments furnished by VA to determine the effectiveness of the suicide prevention services. They must also provide each participant with a satisfaction survey and submit periodic and annual financial and performance reports.

Despite the Trump administration’s cuts and cancellations to the federal workforce and federal programs, Collins told the Senate committee he is firmly on the side of working with community-based organizations like the Fox grant program to broaden the VA’s reach: “I want to use grants and programs like [the Fox grant program] to reach out beyond the scope of where we’re currently reaching, to say how can we actually touch the veteran that’s not being touched right now by these programs,” Collins said. “We’ve got to do better at using the grants, using our programs to go outside the normal bubble and use others to help get the word out.” 

Grant applications are due in July and VA will choose awardees in September. Organizations can apply for grants worth up to $750,000 and may apply to renew awards from year to year throughout the length of the program.

Community-based organizations that provide suicide-prevention services can now access about $52.5 million in US Department of Veterans Affairs (VA) grants. The grant is part of the 3-year Staff Sergeant Fox Suicide Prevention Grant Program, which honors Parker Gordon Fox, a sniper instructor at the U.S. Army Infantry School at Fort Benning, Georgia, who died by suicide in 2020. In consecutive Congressional hearings, lawmakers called for the reauthorization of the program to address gaps in VA care.

“It has been a game-changer for so many veterans,” Sen. Richard Blumenthal (D-CT) said. 

The money provides or coordinates primarily nonclinical suicide prevention services, including outreach and linkage to VA and community resources. Services also may include baseline mental health screenings, case management and peer support, education on suicide risk, VA benefits assistance, and emergency clinical services.

Since its inception in 2022, the program has awarded $157.5 million to 95 organizations in 43 states, US territories, and tribal lands. Speaking before the House Committee on Veterans’ Affairs on May 15, VA Secretary Doug Collins praised the Fox program for bringing “different voices into the conversation,” but added it wasn’t enough. He noted that the veteran suicide rate has not changed since 2008, despite the VA annually spending $588 million on suicide prevention over the past few years.

In an op-ed, Russell Lemle, a senior policy analyst at the Veterans Healthcare Policy Institute, disputed Collins' characterization of veteran suicides. Between 2008 and 2022 (the last year for which complete data is available), US deaths by suicide increased 37% while the number of veteran deaths by suicide fell 2%. “This data collection was the single best part of the program,” he argued, calling for reauthorization to continue requiring data-targeted solutions.

According to a 2024 VA interim report on the Fox grant program, grantees had completed > 16,590 outreach contacts and engaged 3204 participants as of September 30, 2023. An additional 864 individuals were onboarding at the time of the report.

The current version of the grant program requires grantees to use validated tools, including the VA Data Collection Tool, and other assessments furnished by VA to determine the effectiveness of the suicide prevention services. They must also provide each participant with a satisfaction survey and submit periodic and annual financial and performance reports.

Despite the Trump administration’s cuts and cancellations to the federal workforce and federal programs, Collins told the Senate committee he is firmly on the side of working with community-based organizations like the Fox grant program to broaden the VA’s reach: “I want to use grants and programs like [the Fox grant program] to reach out beyond the scope of where we’re currently reaching, to say how can we actually touch the veteran that’s not being touched right now by these programs,” Collins said. “We’ve got to do better at using the grants, using our programs to go outside the normal bubble and use others to help get the word out.” 

Grant applications are due in July and VA will choose awardees in September. Organizations can apply for grants worth up to $750,000 and may apply to renew awards from year to year throughout the length of the program.

Community-based organizations that provide suicide-prevention services can now access about $52.5 million in US Department of Veterans Affairs (VA) grants. The grant is part of the 3-year Staff Sergeant Fox Suicide Prevention Grant Program, which honors Parker Gordon Fox, a sniper instructor at the U.S. Army Infantry School at Fort Benning, Georgia, who died by suicide in 2020. In consecutive Congressional hearings, lawmakers called for the reauthorization of the program to address gaps in VA care.

“It has been a game-changer for so many veterans,” Sen. Richard Blumenthal (D-CT) said. 

The money provides or coordinates primarily nonclinical suicide prevention services, including outreach and linkage to VA and community resources. Services also may include baseline mental health screenings, case management and peer support, education on suicide risk, VA benefits assistance, and emergency clinical services.

Since its inception in 2022, the program has awarded $157.5 million to 95 organizations in 43 states, US territories, and tribal lands. Speaking before the House Committee on Veterans’ Affairs on May 15, VA Secretary Doug Collins praised the Fox program for bringing “different voices into the conversation,” but added it wasn’t enough. He noted that the veteran suicide rate has not changed since 2008, despite the VA annually spending $588 million on suicide prevention over the past few years.

In an op-ed, Russell Lemle, a senior policy analyst at the Veterans Healthcare Policy Institute, disputed Collins' characterization of veteran suicides. Between 2008 and 2022 (the last year for which complete data is available), US deaths by suicide increased 37% while the number of veteran deaths by suicide fell 2%. “This data collection was the single best part of the program,” he argued, calling for reauthorization to continue requiring data-targeted solutions.

According to a 2024 VA interim report on the Fox grant program, grantees had completed > 16,590 outreach contacts and engaged 3204 participants as of September 30, 2023. An additional 864 individuals were onboarding at the time of the report.

The current version of the grant program requires grantees to use validated tools, including the VA Data Collection Tool, and other assessments furnished by VA to determine the effectiveness of the suicide prevention services. They must also provide each participant with a satisfaction survey and submit periodic and annual financial and performance reports.

Despite the Trump administration’s cuts and cancellations to the federal workforce and federal programs, Collins told the Senate committee he is firmly on the side of working with community-based organizations like the Fox grant program to broaden the VA’s reach: “I want to use grants and programs like [the Fox grant program] to reach out beyond the scope of where we’re currently reaching, to say how can we actually touch the veteran that’s not being touched right now by these programs,” Collins said. “We’ve got to do better at using the grants, using our programs to go outside the normal bubble and use others to help get the word out.” 

Grant applications are due in July and VA will choose awardees in September. Organizations can apply for grants worth up to $750,000 and may apply to renew awards from year to year throughout the length of the program.

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

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

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

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

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

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

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.¹Alcohol-related deaths increased by 49% between 2006 and 2019.² This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.³ This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.⁴

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.⁵

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.^6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.⁸ Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.^9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.¹²

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.¹³ At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. ^15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. ¹⁷ This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.¹⁸ Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).¹⁹

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.²⁰ Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.¹⁹ Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.²¹ These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.²²

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.²³

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. ^15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.²⁴

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.¹Alcohol-related deaths increased by 49% between 2006 and 2019.² This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.³ This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.⁴

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.⁵

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.^6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.⁸ Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.^9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.¹²

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.¹³ At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. ^15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. ¹⁷ This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.¹⁸ Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).¹⁹

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.²⁰ Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.¹⁹ Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.²¹ These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.²²

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.²³

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. ^15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.²⁴

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.¹Alcohol-related deaths increased by 49% between 2006 and 2019.² This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.³ This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.⁴

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.⁵

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.^6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.⁸ Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.^9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.¹²

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.¹³ At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. ^15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. ¹⁷ This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.¹⁸ Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).¹⁹

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.²⁰ Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.¹⁹ Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.²¹ These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.²²

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.²³

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. ^15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.²⁴

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

Peer-review, evidence-based, detailed gene/drug clinical practice guidelines suggest that genetic variations can impact how individuals metabolize medications, which is sometimes included in medication prescribing information.^1-3 Pharmacogenomic testing identifies genetic markers so medication selection and dosing can be tailored to each individual by identifying whether a specific medication is likely to be safe and effective prior to prescribing.⁴

Pharmacogenomics can be a valuable tool for personalizing medicine but has had suboptimal implementation since its discovery. The US Department of Veterans Affairs (VA) health care system reviewed the implementation of the Pharmacogenomic Testing for Veterans (PHASER) program. This review identified clinician barriers pre- and post-PHASER program implementation; staffing issues, competing clinical priorities, and inadequate PHASER program resources were the most frequently reported barriers to implementation of pharmacogenomic testing.⁵

Another evaluation of the implementation of the PHASER program that surveyed VA patients found that patients could be separated into 3 groups. Acceptors of pharmacogenomic testing emphasized potential health benefits of testing. Patients that declined testing often cited concerns for genetic information affecting insurance coverage, being misused, or being susceptible to data breach. The third group—identified as contemplators—reported the need for clinician outreach to impact their decision on whether or not to receive pharmacogenomic testing.⁶ These studies suggest that removing barriers by providing ample pharmacogenomics resources to clinicians, in addition to detailed training on how to offer and follow up with patients regarding pharmacogenomic testing, is crucial to successful implementation of the PHASER program.

PHASER

In 2019, the VA began working with Sanford Health to establish the PHASER program and offer pharmacogenomic testing. PHASER has since expanded to 25 VA medical centers, including the VA Central Ohio Healthcare System (VACOHCS).^7,8 Pharmacogenomic testing through PHASER is conducted using a standardized laboratory panel that includes 12 different medication classes.⁹ The drug classes include certain anti-infective, anticoagulant, antiplatelet, cardiovascular, cholesterol, gastrointestinal, mental health, neurological, oncology, pain, transplant, and other miscellaneous medications. Medications are correlated to each class and assessed for therapeutic impacts based on gene panel results.

Clinical recommendations for medication-gene interactions can range from monitoring for increased risk of adverse effects or therapeutic failure to recommending avoiding a medication. For example, patients who test positive for the HLA-B gene have significantly increased risk of hypersensitivity to abacavir, an HIV treatment.¹⁰

Similarly, patients who cannot adequately metabolize cytochrome P450 2C19 should consider avoiding clopidogrel as they are unlikely to convert clopidogrel to its active prodrug, which reduces its effectiveness.¹¹ Pharmacists can play a critical role educating patients about pharmacogenomic testing, especially within hematology and oncology.¹² Patients can benefit from this testing even if they are not currently taking medications with known concerns as they could be prescribed in the future. The SLCO1B1 gene-drug test, for example, can identify risk for statin-associated muscle symptoms.¹³

Clinical pharmacist practitioners (CPPs) can increase access to genetic testing because they interact with patients in a variety of settings and can order this laboratory test.^12,14 Recent research has demonstrated that most VA patients carry ≥ 1 genetic variant that may influence medication decisions and that half of veterans are prescribed a medication with known gene-drug interactions.¹⁵ CPP ordering of pharmacogenomic tests at the VACOHCS outpatient clinic was evaluated through collection of baseline data from March 8, 2023, to September 8, 2023. A goal was identified to increase orders by 50% for a patient care quality improvement initiative and use CPPs to increase access to pharmacogenomic testing. The purpose of this quality improvement initiative was to expand access to pharmacogenomic testing through process implementation and improvement within CPP-led clinic settings.

Gap Analysis

Lean Six Sigma A3 methodology was used to identify ways to increase the use of pharmacogenomic testing for veterans at VACOHCS and develop an improved process for increased ordering of pharmacogenomic testing. Lean Six Sigma A3 methodology is a stepwise approach to process improvement that helps identify gaps in efficiency, sustainable changes, and eliminate waste.¹⁶ Baseline data were collected from March 8, 2023, to September 8, 2023, to determine the frequency of CPPs ordering pharmacogenomic laboratory panels during clinic appointments. The ordering of pharmacogenomic panels was monitored by the VACOHCS PHASER coordinator.

CPPs were surveyed to identify perceived barriers to PHASER implementation. A gap analysis was conducted using Lean Six Sigma A3 methodology. Gap analyses use lean tools such as a Fishbone Diagram to illustrate and identify the gap between current state and ideal state. (Figure 1).The following barriers were identified: lack of clinician education materials, lack of a standardized patient screening process, time constraints on patient education and ordering, higher priority clinical needs, forgetting to order, lack of comfort with pharmacogenomics ordering and education, lack of support for the initiative, and increased workload and burnout. Among these perceived barriers, higher priority clinical needs, forgetting to order, and time constraints ranked highest in importance among CPPs. 

In line with Lean Six Sigma A3 methodology, several tests of change were used to improve pharmacogenomic testing ordering. These changes focused on increasing patient and clinician awareness, facilitating discussion, educating clinicians, and simplifying documentation to ease time constraints. Several strategies were employed postimplementation (Figure 2). Prefilled templates simplified documentation. These templates helped identify patients without pharmacogenomic testing, provided reminders, and saved documentation time during visits. CPPs also received training and materials on PHASER ordering and documentation within encounter notes. Additionally, patient-directed advertisements were displayed in CPP examination rooms to help inspire and facilitate discussion between veterans and CPPs.

Process Improvement Data

The quality improvement project goal was to increase PHASER orders by 50% after 3 months. PHASER orders increased from 87 at baseline (March 8, 2023, to September 8, 2023) to 196 during the intervention (November 16, 2023, to February 16, 2024), a 125% increase. Changes were consistent and sustained with 65 orders the first month, 67 orders the second month, and 64 orders the third month.

Discussion

Using Lean Six Sigma A3 methodology for a quality improvement process to increase PHASER orders by CPPs revealed barriers and guided potential solutions to overcome these barriers. Interventions included additional CPP training and ordering, tools for easier identification of potential patients, documentation best practices, patient-directed advertisements to facilitate conversations. These interventions required about 8 hours for preparation, distribution, development, and interpretation of surveys, education, and documentation materials. The financial impact of these interventions was already included in allotted office materials budgeted and provided. Additional funding was not needed to provide patient-directed advertisements or education materials. The VACOHCS pharmacogenomics CPP discusses PHASER test results with patients at a separate appointment.

Future directions include educating other CPPs to assist in discussing results with veterans. Overall, the changes implemented to improve the PHASER ordering process were low effort and exemplify the ease of streamlining future initiatives, allowing for sustained optimal implementation of pharmacogenomic testing.

Conclusions

A quality improvement initiative resulted in increased PHASER orders and a clearly defined process, allowing for a continued increase and sustained support. Perceived barriers were identified, and the changes implemented were often low effort but exhibited a sustained impact. The insights gleaned from this process will shape future process development initiatives and continue to sustain pharmacogenomic testing ordering by CPPs. This process will be extended to other VACOHCS clinical departments to further support increased access to pharmacogenomic testing, reduce medication trial and error, and reduce hospitalizations from adverse effects for veterans.

Peer-review, evidence-based, detailed gene/drug clinical practice guidelines suggest that genetic variations can impact how individuals metabolize medications, which is sometimes included in medication prescribing information.^1-3 Pharmacogenomic testing identifies genetic markers so medication selection and dosing can be tailored to each individual by identifying whether a specific medication is likely to be safe and effective prior to prescribing.⁴

Pharmacogenomics can be a valuable tool for personalizing medicine but has had suboptimal implementation since its discovery. The US Department of Veterans Affairs (VA) health care system reviewed the implementation of the Pharmacogenomic Testing for Veterans (PHASER) program. This review identified clinician barriers pre- and post-PHASER program implementation; staffing issues, competing clinical priorities, and inadequate PHASER program resources were the most frequently reported barriers to implementation of pharmacogenomic testing.⁵

Another evaluation of the implementation of the PHASER program that surveyed VA patients found that patients could be separated into 3 groups. Acceptors of pharmacogenomic testing emphasized potential health benefits of testing. Patients that declined testing often cited concerns for genetic information affecting insurance coverage, being misused, or being susceptible to data breach. The third group—identified as contemplators—reported the need for clinician outreach to impact their decision on whether or not to receive pharmacogenomic testing.⁶ These studies suggest that removing barriers by providing ample pharmacogenomics resources to clinicians, in addition to detailed training on how to offer and follow up with patients regarding pharmacogenomic testing, is crucial to successful implementation of the PHASER program.