Exploitation of supply chain monitoring loopholes fueled US opioid epidemic, study finds

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Newswise — BLOOMINGTON, Ind. — New research from the Indiana University Kelley School of Business explains how pharmaceutical companies were able to saturate the country with massive quantities of opioids, despite efforts by the Drug Enforcement Administration to regulate their supply.

The research identifies a loophole in the DEA’s monitoring system exploited by some pharmaceutical companies, leading to an oversupply of opioid drugs in communities. The hallmark of this activity was high supply chain complexity, such as pharmacies with dozens of distributors across the country.

The same research also documents how the opioid epidemic — commonly regarded as a national public health crisis among white Americans — had a much deeper impact in Black communities, where overdose deaths tripled from 2014 to 2020.

“We believe we are the first to uncover insights into the supply chain mechanisms that were used to evade the DEA and fuel the opioid crisis,” said Jonathan Helm, professor of operations and decision technologies and the W.W. Grainger Inc. Faculty Fellow at the Kelley School. “Up until now, the focus has been on each of the pharmaceutical companies individually, ignoring the huge impact of the broader supply chain.”

“No one was looking at it from a supply chain perspective,” added Iman Attari, a Kelley School doctoral candidate in operations and decision technologies and the paper’s corresponding author.

Attari, Helm and Jorge Mejia, an associate professor in the Kelley School, analyzed information in the 2019 release of the DEA’s Automation of Reports and Consolidated Orders System — commonly known as the ARCOS database — which tracked each shipment in the U.S. opioid supply chain from 2006 to 2014.

Their paper, “Hiding Behind Complexity: Supply Chain, Oversight, Race, and the Opioid Crisis,” appears in the latest issue of the journal Production and Operations Management.

The researchers uncovered how supply chain complexity may have facilitated the influx of large qualities of opioids into the market, undetected by the DEA. Their research combined ARCOS data about pharmacies’ opioid dispensing and supply chain structures with county-level demographics and socioeconomic factors.

Using a fixed effect model, they found that a one-unit increase across three dimensions of supply chain complexity was associated with a 16% increase in opioid dispensing.

DEA monitoring involves using ARCOS to collect data on all shipments of controlled substances, and requiring manufacturers and distributors to report suspicious orders of unusual size and frequency.

“The issue was that pharmacies wanting to have large shipments were very smart about it,” Attari said. “Instead of placing an order for a large shipment from one single distributor, they broke down that large order across multiple distributors. They got smaller shipments from different distributors; when added up, it was a huge order. Each distributor is only going to see the data from the pharmacy that links themselves to it, and not to shipments from other distributors.”

As a result, the DEA monitoring system failed. By using more suppliers, pharmacies were able to evade detection.

Another factor they studied was the location of distributors. Because of the DEA’s structure, with 23 often independently operated field divisions spread across the U.S., the researchers found that a lack of coordination and aggregation of information among them was another factor in overlooking potentially suspicious activity.

“Even if a supplier reports a suspicious order in one division, other divisions that the pharmacy orders from are unlikely to be informed,” they wrote.

“It cannot be just ‘business,’ because when you look at it from a business standpoint, it makes more sense to work with one distributor because you benefit from economy of scale,” Attari said. “It is expected for a pharmacy to have one or two distributors, or at most three distributors of opioid drugs.

“When we saw pharmacies in the data set with 25 distributors — all over the U.S. — that was a strong indication that they were trying to mess with the monitoring system.”

The research found that supply chain complexity had a stronger association with the increase in opioid dispensing in non-white communities. A 10% increase in the non-white proportion of the population yielded a 3.39% increase in the overall dispensing by pharmacies with high supply chain complexity.

“Communities of color have been historically under-resourced and neglected by many government and social services,” the researchers wrote. “In the context of the opioid crisis, it appears that the DEA has spent more effort arresting non-White drug users than on regulating the flow of opioids from pharmaceutical companies into non-White communities.”

To be certain that their analysis was distinguishing between legitimate medical use and non-medical, recreational demand, they compared statistics for the reformulated OxyContin, which was redesigned to prevent abuse.

“In a novel approach, we leverage the fact that different pharmacies received their first shipment of reformulated OxyContin at different times and use a difference-in-differences model to estimate the heterogeneous effect of the shock on dispensing,” they wrote. “As the reformulated OxyContin stifled (non-medical) demand, high-complexity pharmacies experienced a 15.31% greater reduction in dispensing compared to lower-complexity pharmacies, suggesting that their excess dispensing was indeed satisfying non-medical/recreational demand.”

As a follow-up to this paper, the researchers are investigating the dynamics between major chain pharmacies and their distributors, and how they may facilitate the oversupply by pharmacies. Their initial findings suggest that the pharmacies’ practice of self-distribution, where they distribute opioids from their own distribution centers, combined with their close ties to large distributors, also may have led to excessive opioid dispensing without adequate oversight by the DEA.

Multiracial individuals face unique challenges that may lead to high rates of alcohol and other drug use

Newswise — Multiracial or mixed-race individuals – having parents or ancestors of different races – currently comprise more than 10 percent of the U.S. population. There is very little research on Multiracial individuals even though young adults in this group report high rates of alcohol and other drug (AOD) use: binge drinking, illicit drug use other than cannabis, and drug use disorders. New research explores what factors may contribute to high rates of substance use among this population. Results will be shared at the 47th annual scientific meeting of the Research Society on Alcohol (RSA) in Minneapolis, Minnesota.

“Multiracial people are a fast-growing racial demographic group in the U.S.,” said Tessa Nalven, a graduate student at the University of Rhode Island, “but are often rendered nearly invisible as a race. Yet Multiracial young adults often report their race as being among their most salient identities. Within the context of their high rates of AOD use, I hope to draw attention to their voices to help advocate for findings solutions to their unique concerns and challenges.”

Nalven will discuss her study’s findings at the RSA meeting on Sunday, 23 June 2024.

In the fall of 2021, she conducted four semi-structured, online focus groups with 22 (17 females, 5 males) Multiracial young adults 18 to 25 years of age with the objective of uncovering factors related to their AOD use. All study participants had self-reported previous six-month AOD use, and were recruited with the intention of collecting a diverse and heterogeneous sample.

“Multiracial young adults often report their race feels impactful across all aspects of their lives,” said Nalven, “resulting in feeling excluded and misunderstood in many contexts, which they also believe relates to high rates of AOD use. My study found that Multiracial young adults ascribe their high rates of substance use to: one, racial discrimination; two, environmental influences; three, identity development difficulties; four, struggles with fitting in; and five, mental health challenges.”

Nalven added that these unique social and environmental factors associated with AOD use in Multiracial young adults require unique interventions. “Interventions to ameliorate the disproportionate rates of AOD use among Multiracial young adults should address ways to respond to discrimination and mental health or racial identity concerns,” she said. “Moreover, systemic interventions are needed to educate communities to foster inclusive environments and reduce discrimination and inequitable treatment of Multiracial people.”

Nalven observed that the field of addiction research, and the science around mental-health concerns as a whole, have been too focused on single-racial – and primarily White – groups. “I believe there is important utility in studying Multiracial people as a cohesive group, without parsing out their separate identities; to examine the similarities – both strengths and struggles – that Multiracial young adults experience as a result of their similar lived experiences in the context of a monoracial and White-centric society.”

LGBTQ+ students in collegiate recovery programs are doing very well but have unique needs

Original post: Newswise - Substance Abuse LGBTQ+ students in collegiate recovery programs are doing very well but have unique needs

Newswise — Compared to their cisgender/heterosexual peers, LGBTQ+ college students are at an elevated risk of substance use and mental health challenges. While collegiate recovery programs provide an array of support to students in recovery from substance use disorders, scarce research has examined the unique needs of LGBTQ+ students within this population. New findings regarding the psychosocial and recovery functioning of LGBTQ+ and cisgender/heterosexual students receiving support will be shared on Sunday, 23 June 2024 at the 47th annual scientific meeting of the Research Society on Alcohol (RSA) in Minneapolis, Minnesota.

“LGBTQ+ college students in general experience higher levels of discrimination based on their gender identity or sexual orientation,” explained Mer Francis, assistant professor of social work at Virginia Commonwealth University, “and are more likely to have experienced various forms of trauma such as bullying, rejection from family members and peers, and unstable housing prior to entering college than average college students. These compounded experiences of trauma and discrimination are related to [having] nearly 2.5 times the risk of developing a substance use disorder, and about 2.3 times the risk of developing a mood disorder during their lifetime. 

Francis noted that a large percentage of participants in his study identified as LGBTQ+: 40.6% overall; 38.9% lesbian, gay, bisexual, or queer; and 16.8% transgender or gender-expansive. “This is comparable to what we are seeing in the general college population these days,” he said. “This is a large portion of the collegiate recovery population that we don’t know all that much about, and it is important for recovery directors to know what their specific needs are so they can tailor programming to meet those needs.”

Francis and his colleagues examined participant data for 529 students from the National Longitudinal Collegiate Recovery Study that was drawn from 58 collegiate recovery programs across the US, Canada, and the UK. Participants shared their life experiences, including time abstinent, mental health history, grade point average, access to support, stability and resources, as well as the extent to which they felt their identity was supported during recovery.

Francis said there were three key findings. “One, while LGBTQ+ college students in recovery tend to have less severe substance use disorders than their non-LGBTQ+ peers, they may need additional support for mental health disorders. Two, more LGBTQ+ students were in early recovery compared to cisgender/heterosexual students, while more cisgender/heterosexual students were in stable recovery after five years than LGBTQ+ students. Three, collegiate recovery programs are doing a good job of supporting their LGBTQ+ students and their identities.”

Francis expects these findings will help directors of collegiate recovery programs and other service providers who support students in recovery. “These providers can use this information to tailor programming to meet the specific needs of LGBTQ+ students by creating identity-specific recovery groups where students can share common experiences, increasing linkages to services for mental health and trauma experiences, and examining staffing, policies, and practices that may help LGBTQ+ students feel more welcomed and supported.”

Chilling discovery: Cold-sensing protein may pave the way for safer pain relief

EMBARGOED: FOR RELEASE 14:00 (2:00 pm) U.S. Eastern Time Friday, 21 June 2024

Chilling discovery: Cold-sensing protein may pave the way for safer pain relief

New ASU study reveals evolution of human cold and menthol sensing protein, offering hope for future non-addictive pain therapies.

Newswise — Chronic pain affects millions worldwide, and current treatments often rely on opioids, which carry risks of addiction and overdose. 

Non-addictive alternatives could revolutionize pain management, and new research targeting the human protein which regulates cold sensations, brings scientists closer to developing pain medications that don’t affect body temperature and don’t carry the risks of addiction. 

Research published in Science Advances on June 21, led by Wade Van Horn, professor in Arizona State University’s School of Molecular Sciences and Biodesign Center for Personalized Diagnostics, has uncovered new insights into the main human cold and menthol sensor TRPM8 (transient receptor potential melastatin 8). Using techniques from many fields like biochemistry and biophysics, their study revealed that it was a chemical sensor before it became a cold temperature sensor.

“If we can start to understand how to decouple the chemical sensing of cold from actual cold sensing, in theory, we could make side-effect-free drugs,” said Van Horn whose research focuses on membrane proteins involved in human health and disease. “By understanding the evolutionary history of TRPM8, we hope to contribute to designing better drugs that offer relief without the dangerous side effects associated with current painkillers.” 

When a person touches a metal desk and it feels cold, the human body activates TRPM8. For cancer patients who are on certain kinds of chemotherapeutics, touching a desk can hurt. TRPM8 is also involved in many other types of pain as well, including chronic neuropathic and inflammatory pain. 

By further understanding this specificity of the chemical sensing of cold versus physically sensing cold, scientists can target relief without triggering the temperature regulation side effects often seen in TRPM8 clinical trials for pain treatments. 

In the research, the team used ancestral sequence reconstruction, a time machine for proteins of sorts, compiling the family tree of TRPM8 that exists today and then used that information to determine what the proteins from long-extinct animals might have looked like. 

Using computational methods to resurrect ancestral primate, mammalian, and vertebrate TRPM8, the researchers were able to understand how TRPM8 has changed over hundreds of millions of years by comparing the sequences of current proteins to predict the sequences of their ancient ancestors. Additionally, the combination of lab experiments and computational studies enable the researchers to identify critical places in TRPM8 that allow a more clear understanding of temperature sensing, which can be tested in subsequent experiments. 

“Comparative dynamics analysis of ancestral and human TRPM8 also supports the experimental data and will allow us to identify critical sites in temperature sensing, which we will be testing soon,” said Banu Ozkan, professor in ASU’s Department of Physics, who was involved in the study.

The team then expressed these ancestral TRPM8s in human cells and characterized them using various cellular and electrophysiology techniques.

“Ancestral protein-based studies allow us to focus on the lineage of most interest, such as human TRPM8, to alleviate concerns arising in drug discovery from speciation differences, like in mice and humans,” said first author on the study Dustin Luu, an ASU School of Molecular Sciences doctoral alumnus, and current postdoctoral fellow in ASU’s Biodesign Center for Personalized Diagnostics.

Luu continued: “We discovered that surprisingly menthol sensing appeared way before cold sensing. The difference in appearance and attenuation of these activation modes suggest they are separate and can be disentangled with further research enabling new pain therapies without the adverse side effect in thermal sensing and thermal regulation, which has plagued TRPM8-targeted clinical trials.”

As science continues to uncover the mysteries of our biological mechanisms, studies like this exemplify how evolutionary biology and modern pharmacology can collaborate to address pressing medical needs and improve the quality of life for those suffering from chronic pain.

Additional researchers involved in the study include Nikhil Ramesh, and I. Can Kazan from Arizona State University’s Department of Physics; Karan Shah from ASU’s School of Molecular Sciences; Gourab Lahiri and Miyeko Mana from ASU’s School of Life Sciences. 

Surgeon General Wants Social Media Warning Label

Newswise — In an op-ed published in The New York Times, U.S. Surgeon General Vivek Murthy called on Congress to require a social media warning label. This would be similar to those of tobacco and alcohol products. 

In the op-ed, Murthy mentioned the toll social media is having on the mental health among young people. 

According to Murthy, he would like the warning to include an alert to users about the potential mental health harms of websites and apps. 

George Washington University has experts available who can offer insight and analysis. If you would like to schedule an interview, please contact Katelyn Deckelbaum, [email protected].

Lorenzo Norris, is an associate professor of psychiatry and behavioral sciences and chief wellness officer at the GW School of Medicine and Health Sciences.

Amir Afkhami, an expert in psychiatry, holds a joint appointment at the GW School of Medicine and Health Sciences and the Milken Institute School of Public Health. An expert in psychiatry, much of his current work focuses on psychiatric services and education, behavioral health policy, and the mental health consequences of conflict.

Lorien Abroms is a professor of prevention and community health at the GW Milken Institute School of Public Health. She has studied how social media and digital communication technology can be used for health promotion. She can also talk about the potential for negative impact on teens and young adults.Tony Roberson, an associate professor of nursing at the GW School of Nursing, is a mental health expert. He is an expert on anxiety, depression and childhood development. 

Vikram Bhargava, assistant professor of strategic management & public policy, is an expert on technology addiction and his research centers around the distinctive ethics and policy issues that technology gives rise to in organizational contexts. Bhargava authored a research article in Business Ethics Quarterly, titled  “Ethics of the Attention Economy: The Problem of Social Media Addiction“, which dives into why scholars, policy makers, and the managers of social media companies should treat social media addiction as a serious moral problem. It also contextualizes social media addiction in comparison to other addictive products, like cigarettes or alcohol.

Increasing Use and Awareness of Oral Nicotine Pouches Detailed

Newswise — WASHINGTON – A rigorous, comprehensive synthesis of evidence from 62 studies related to the use of oral nicotine pouches by Georgetown University’s Lombardi Comprehensive Cancer Center scientists and colleagues provides a much-needed assessment of how these products could lead to potential harmful consequences if used by young people.

Oral nicotine pouches were first introduced in the U.S. in the past decade and are pre-portioned white granular packets containing nicotine placed between the gums and lips, marketed as tobacco-free, and are sold in various flavors and nicotine strengths.

The findings appeared in Nicotine and Tobacco Research on June 17, 2024.

“Oral nicotine pouches are rapidly increasing in popularity. While they may present a less harmful nicotine alternative for cigarette users, there is considerable concern about them becoming a new form of nicotine dependence, especially in youth who don’t use tobacco or nicotine,” says the study’s corresponding author Nargiz Travis, MSPH, Project Director for the Center for the Assessment of Tobacco Regulations (CAsToR) at Georgetown Lombardi. “As with electronic cigarettes, the wide variety of flavors and aggressive marketing campaigns that we are seeing, especially via social media, have the potential to appeal to youth, providing a new pathway to nicotine dependence.”

The investigator’s analysis was based on 45 academic and 17 industry-funded studies, mostly from the U.S. Sales of the products have been concentrated in Scandinavia and the U.S., mainly because of the established smokeless tobacco market in these regions.

In the U.S., the researchers found, based on nationally representative surveys, that through 2023, oral nicotine pouches were currently used by 1.5% of all youth while lifetime use by young people was under 2.5%. In terms of awareness of the products, between 35% to 42% of U.S. adolescents and young adults have heard of oral nicotine pouches and 9% to 21% of tobacco-naïve (non-tobacco users) youth surveyed were not opposed to trying them. U.S. adult usage estimates varied widely across surveys; in 2023, 0.8-3% of Americans currently used the products while 3-16% used them at some point in time. In view of rising nicotine pouch sales trends in 2024, their use in the U.S. population has likely increased.

The investigators’ findings suggest fewer harmful chemical compounds are present in the pouches and occur at lower levels than in cigarettes and smokeless tobacco, with the exception of formaldehyde. However, an analysis of 37 oral nicotine pouches of different brands, nicotine strengths, and flavors yielded a wide range of total nicotine content from 0.89 to 6.73 milligrams per pouch.

“Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products,” says Travis. “In the U.S., oral nicotine pouches are currently neither authorized by the FDA for marketing as a modified-risk product nor approved as a cessation product. It is important to know that nicotine is an addictive chemical with harmful health effects, regardless of whether it is synthetic, meaning tobacco-free, or derived from tobacco.

One of the studies included in the authors’ analysis was a U.S. survey of young adults 18-34 years of age, many of whom used cigarettes and e-cigarettes. The survey found that among those who had tried nicotine pouches, curiosity about the product (28%), flavors (26%), and the ability to use in places where other tobacco products are prohibited (26%) were among the main reasons for trying the pouches. The availability of flavors (31%) was the main motive for use in another U.S. sample of adult current nicotine pouch users.

Leading brands of the products are currently owned by major tobacco companies. The authors note that a substantial investment in marketing by the companies suggests that oral nicotine pouches are becoming increasingly important to the tobacco industry.

“As more evidence on oral nicotine patches becomes available, and more importantly, more independent studies become published, it will

be essential to conduct further analyses comparing the findings of industry vs. non-industry sponsored research and critically assess the quality and risk of bias of such studies,” concludes Travis.

###

Other authors in addition to Travis include Hayoung Oh, Radhika Ranganathan and David Levy at Georgetown Lombardi Comprehensive Cancer Center. Kenneth Warner is at the University of Michigan; Rafael Meza is at the BC Cancer Research Centre, Vancouver, Canada; Maciej Goniewicz is at Roswell Park Comprehensive Cancer Center, Buffalo, NY; and Jamie Hartmann-Boyce is at the University of Massachusetts Amherst.

This work was supported by National Cancer Institute and Food and Drug Administration grant #U54CA229974.

Goniewicz received a research grant from Pfizer and served as a member of the scientific advisory board to Johnson & Johnson. The other authors declared no conflicts of interest related to the study.

About Georgetown University’s Lombardi Comprehensive Cancer Center

Georgetown’s Lombardi Comprehensive Cancer Center is designated by the National Cancer Institute (NCI) as a comprehensive cancer center. A part of Georgetown University Medical Center, Georgetown Lombardi is the only comprehensive cancer center in the Washington D.C. area. It serves as the research engine for MedStar Health, Georgetown University’s clinical partner. Georgetown Lombardi is also an NCI recognized consortium with John Theurer Cancer Center/Hackensack Meridian Health in Bergen County, New Jersey. The consortium reflects an integrated cancer research enterprise with scientists and physician-researchers from both locations. Georgetown Lombardi seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic, translational and clinical research, patient care, community education and outreach to service communities throughout the Washington region, while its consortium member John Theurer Cancer Center/Hackensack Meridian Health serves communities in northern New Jersey. Georgetown Lombardi is a member of the NCI Community Oncology Research Program (UG1CA239758). Georgetown Lombardi is supported in part by a National Cancer Institute Cancer Center Support Grant (P30CA051008). Connect with Georgetown Lombardi on Facebook (Facebook.com/GeorgetownLombardi) and Twitter (@LombardiCancer).

About Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health.  Connect with GUMC on Facebook  (Facebook.com/GUMCUpdate) and Twitter (@gumedcenter).

Firearms and mental health: 8 top facts to know

Newswise — Two issues have surged in awareness across America in recent years: the toll of firearm injuries and deaths, and the impact of mental health conditions. 

These two issues intersect in multiple ways – and a growing number of people are directly or indirectly affected by one or both of them. 

That’s why it’s important for you to know some key things about the risk of firearm-related incidents involving people with mental health conditions, and take steps to reduce that risk, say three experts from Michigan Medicine, the University of Michigan’s academic medical center, and the Institute for Firearm Injury Prevention who have training and experience in both fields. 

The group discusses these risks and risk-reduction steps in depth during a recent livestream

Below are some key takeaways from that chat with Victor Hong, M.D., director of Psychiatric Emergency Services at U-M Health, child psychologist and firearm injury prevention researcher Cynthia Ewell Foster, Ph.D., and Mark Ilgen, Ph.D., director of U-M Addiction Treatment Services.

1. Suicide is the top concern when it comes to mental health and firearms – but not the only one

More than half of all firearm deaths in the United States are suicides, and firearms are involved in half of all suicide deaths. 

Not all people who die by suicide have a formal mental health diagnosis, so it’s important for everyone to know the warning signs of suicide and what to do if someone they know is showing some or all of these signs. 

There are some warning signs specific to children and teens too.

These signs include worsening or severe depression symptoms, expressing hopelessness or feelings of being a burden, extreme mood swings, an increase in use of drugs and alcohol, taking risks, seeming to be out of touch with reality, as well as speaking, writing or posting on social media about wanting to die, “unalive” themselves, or not live any longer.

2. Easy access to firearms increases risk 

Being able to get access to a loaded handgun or long gun – their own or someone else’s – greatly increases the risk of suicide death for people experiencing a mental health crisis or suicidal thoughts and impulses. 

Why?

“There’s a speed and irreversibility of firearm usage in a suicide attempt that is very unique,” said Hong, who leads a team that offers 24/7/365 care for psychiatric emergencies of all kinds. 

“When somebody is in a mental health crisis and it’s clear that those imminent warning signs of suicide are there, firearms at the very least need to be secured in some fashion.” 

Hong’s team members screen nearly every patient seeking emergency mental health care at U-M Health for firearm access.

If there are firearms in their home, those should be locked with a gun lock or in a gun safe, with ammunition stored elsewhere. 

Many police stations, sheriff’s offices and other locations make gun locks available for free; the Project Childsafe website is one way to find local agencies that provide them.

Even better: temporarily remove firearms from all the places a person in crisis can access, and secure them in another location, whether that’s a gun shop, a law enforcement agency or the home of a trusted person who will keep them locked with ammunition stored separately.   

Firearm owners should also keep their weapons secured if a child or teen might have access to them, to prevent needless tragedy including suicide and accidental or intentional shootings. 

Michigan law now requires this.

“Everybody has a role to play in suicide prevention in this country, and one of the most important things we can all do is to be sure that we’re storing our firearms safely at all times and controlling who has access to them,” said Ewell Foster. 

“If you look at kids in this country who have died by suicide, and you look at where they’re getting those firearms, they are getting them from people who love them. They’re getting them from their house, their parents, their grandparents, their aunts and uncles.”

Ilgen likens suicide risk to a graph with a curve that rises slowly or sharply to a peak – with the top of the curve being the moment where they are at highest risk of harming themselves. 

“If someone enters that upward slope at a time where they have very easy access to something that’s very lethal, that’s when things get very concerning quickly,” he said.

“Even a step that isn’t foolproof but can slow access can buy someone a few minutes or hours before they might act on a suicidal thought. That can make all the difference in helping to keep someone safe and getting someone through that curve” and help them avoid death or injury. 

3. Help is always available for a person in crisis

The 988 Suicide and Crisis Lifeline can be reached by dialing 988 from any phone, by texting 988 from any mobile phone, or using the webchat function at 988lifeline.org

It offers live help around the clock, every day of the year and can connect the person in crisis, or a person assisting the person in crisis, to local services, too. 

The 988 service includes specialized options for veterans, members of the LGBTQ+ community, people who speak Spanish and other languages, and people who are Deaf or hard of hearing.

No matter whether someone reaches out to 988 or to a trusted family member, friend, teacher, coach, clergy member or health care provider, it’s important for everyone to know that there are effective treatments available for mental health conditions of all kinds, and that there is hope.

4. Some groups of people have an elevated risk of firearm suicide

Middle-aged and older men account for most of the suicide deaths in Michigan and other states, and most of these deaths are due to firearms. 

Native Americans, and Black youth, as well as young people living in rural areas, also have higher rates of firearm suicide than other groups, says Ewell Foster. 

In order to reach some of those groups with messages about storing firearms safely and seeking help when they need it in a crisis, Ewell Foster and her colleagues have been working to understand which messengers will be most effective for different groups, and how to tailor messages to them.

Ilgen, who is also affiliated with the VA Ann Arbor Healthcare System, notes that veterans are also at higher risk of firearm suicide. 

In fact, 70% of all veteran suicide deaths are firearm-related. 

The VA has created multiple programs to try to prevent these tragedies among veterans who receive care from VA clinics and hospitals. 

5. Drug and alcohol problems raise firearm injury and death risk

While many people may think of depression, bipolar disorder and post traumatic stress disorder as the mental health conditions most closely linked to a risk of firearm suicide, Ilgen notes that an increasing amount of evidence points to high risk among people who have substance use issues and use drugs or alcohol heavily. 

“Substance use disorders are impairing – making your judgment a little cloudy – and they’re stigmatized, and that can make someone more likely to be suicidal,” he said. 

“If they’re progressing rapidly from not thinking at all about suicide to engaging in a suicidal behavior, that that’s more likely to occur if they’re using substances and more risky if they have access to a particularly lethal means like a firearm.”

He also worries that one of the approaches used in some addiction treatment programs – having the patient’s loved ones tell them in a formal session what the patient’s addiction has done to harm those around them – may be counterproductive or even dangerous. 

Doing this could increase the chance the patient feels like a burden to others, and turns toward suicide.

6. Risk factors for suicide and firearm violence toward others can be similar 

When you hear about a violent event on the news that involves firearms used against other people, you might assume that the shooter has a mental illness. 

But Hong notes that it’s important to know that people with serious mental illnesses are more likely to be victims of firearm violence than perpetrators. 

That said, some of the same risk factors and warning signs that someone may be at high risk of turning a firearm on themselves also could signal a risk that they will use a firearm against someone else. 

That’s why Hong and his psychiatric emergency team screen for those risk factors, as well as firearm access, when a patient comes to them in crisis. 

Murder-suicides, in which a person kills a loved one immediately before killing themselves, often happen because someone has decided they don’t want to continue living and that they want to take loved ones or others with them, Hong says. 

7. “Red Flag” laws can help reduce risk in extreme situations 

What can someone do if they’re very concerned that a loved one, friend or co-worker who owns firearms could be at high risk of hurting themselves or others, but that person does not see the risk or want to secure their firearms voluntarily?

In a growing number of states, including Michigan, public safety and court officials can be asked to determine next steps under an Extreme Risk Protection Order law, also known as ERPO or “red flag” law. 

Michigan’s ERPO law went into effect in February 2024. 

The U-M Institute for Firearm Injury Prevention has a free online toolkit that explains the law and how individuals can use it to petition a judge to authorize law enforcement to remove firearms from a person’s possession in an orderly way. 

It’s located at firearminjury.umich.edu/erpo-toolkit.

“This is an evidence-based policy intervention that can prevent a host of adverse outcomes with firearms,” saidEwell Foster, who has spent time with family members of those who have suffered a tragic loss of a loved one from a firearm injury that could have been prevented. 

Prior to Michigan’s ERPO law, she said, “I’ve had moms of young adult males who have a high risk of suicide say, ‘I’m so worried, I’ve asked him to get rid of his firearm and I feel like there’s nothing I can do.’ When people are at risk their loved ones are worried about them and ERPO is another tool in our toolkit to try to support someone who’s at risk.” 

She notes that U-M researcher April Zeoli, Ph.D., policy core director at the institute and associate professor in of the School of Public Health, is one of the nation’s top experts on studying what happens in states that enact ERPO laws, and helped inform the policy process that led to Michigan’s law. 

“It’s really important for folks to know that there are legal checks and balances as part of this law, and that it’s not like someone is going to show up at a person’s house and take away their firearms,” immediately after someone files an ERPO petition, she explains. 

Hong added, “This is not an effort to remove firearms from law-abiding citizens who are low-risk, minding their own business. 

This is really for people for whom there are numerous red flags and risk factors of potential harm to self and others.” 

He also notes that removal of firearms by law enforcement only takes place after a judge rules based on the evidence, and that the removal is temporary.

8. Everyone can make a difference

Ewell Foster likens this moment, when awareness of firearm injury and mental health are both rising, to a time decades ago when there was rising awareness and action around drunk driving. 

“Our society has gotten comfortable saying to one another, ‘Hey, I think you’ve had too much to drink, I’m going to take your car keys and how about I run you home,’ and that’s a socially acceptable thing to do now in this country,” she said. 

“I think we need to work on getting there around mental health and normalizing saying things like, ‘I really care about you, I’ve noticed these changes in you, I’m even wondering if you’re thinking about suicide. How can I help you?’”

“So much of what we’ve learned about how to protect people is about these caring behaviors, and actively working to be sure they feel like they have belonging and connectedness,” she said. 

“I want people to feel empowered that they can reach out and ask, and they can make sure their firearms are stored safely.”

High out-of-pocket costs may be barrier to filling naloxone prescriptions, study shows

Original post: Newswise - Substance Abuse High out-of-pocket costs may be barrier to filling naloxone prescriptions, study shows

BYLINE: Kate Barnes

Newswise — Patients are less likely to fill prescriptions for naloxone when they face increases in out-of-pocket costs, according to research by the University of Michigan.

Published in the Journal of the American Medical Association, the study utilized data from a national pharmacy transactions database from November 2020 to March 2021. Researchers found that about 1 in 3 naloxone prescriptions for privately insured and Medicare patients were not filled.

Naloxone, an opioid antagonist that can reverse overdose, is a critical tool in preventing overdose deaths. Nationally, opioid overdoses account for more than 78,000 deaths annually, according to provisional data from the U.S. Centers for Disease Control and Prevention. In Michigan, that number totaled more than 2,200 in 2023.

The rate of nonfilled prescriptions across the country jumped abruptly on Jan. 1, 2021—the date on which deductibles reset in many private and Medicare plans—as did the amount patients had to pay to fill prescriptions. The researchers estimate that a $10 increase in out-of-pocket cost would decrease the rate of filling prescriptions by about 2-3 percentage points.

“Minimizing barriers to accessing naloxone is a crucial step toward slowing the U.S. opioid epidemic. Our study suggests that minimizing the out-of-pocket cost of naloxone prescriptions could help achieve this goal,” said study lead author Kao-Ping Chua, Ph.D., M.D., assistant professor at the U-M Medical School and School of Public Health.

Chua and colleagues note that barriers to naloxone dispensing other than cost also play a key role in addressing this issue, such as stigma about the medication. For example, the study also found that 7%-8.5% of naloxone prescriptions were not filled even when they were free to patients.

A Michigan-specific strategy seeking to mitigate barriers to naloxone access and use was announced late last year, when the state issued an updated statewide standing order. As written in the order, community-based organizations are now able to host or provide naloxone distribution sites without the previously required oversight of a pharmacy. These “naloxone vending machines” provide the lifesaving medication for free and increase access for those in need without a prescription.

Chua is co-director of Research and Data Domain at the U-M Opioid Research Institute (ORI) and faculty member at the Susan B. Meister Child Health Evaluation and Research Center (CHEAR) and Institute for Healthcare Policy and Innovation (IHPI).

Co-authors include: Thuy Nguyen of ORI, IHPI and U-M School of Public Health; Amy Bohnert of ORI, IHPI and U-M Medical School; Pooja Lagisetty of ORI, IHPI and U-M Medical School; Sijia He of CHEAR; and Rena Conti of Boston University.

The study was funded by the National Institute on Drug Abuse (R01DA056438-02) and the Gorman Scholar Award from the U-M Medical School. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Study: Association Between Cost Sharing and Naloxone Prescription Dispensing (DOI: 10.1001/jama.2024.8378)

ADHD meds may help pregnant patients control opioid use disorder

BYLINE: Mark Reynolds

Newswise — Opioid overdoses for pregnant people are at an all-time high in the United States, even as overall numbers are improving. Attention deficit hyperactivity disorder (ADHD) is highly correlated with substance use disorders, yet treatment protocols to help expecting parents manage opioid use disorders and ADHD together are essentially nonexistent.

New research from Washington University School of Medicine in St. Louis may help change that. A study published in Nature Mental Health indicates that patients with opioid use disorders and ADHD who remain on their ADHD medications during their pregnancies are far more likely to adhere to treatment for opioid use, and far less likely to overdose, than are patients who stop taking ADHD medications.

This research is a step toward developing urgently needed resources and treatment guidelines, said Kevin Xu, MD, an assistant professor of psychiatry and the study’s first author. “We have really never seen such rates of overdose among reproductive-age and pregnant people,” Xu said.

According to data from the National Institutes of Health (NIH), rates of overdose deaths doubled among pregnant and postpartum people in recent years (rising to 6.1 deaths per 100,00 in 2021, from 3.1 deaths per 100,000 in 2018). Opioid overdose accounts for about 10% of all pregnancy-related deaths. Despite research indicating that nearly one in four people diagnosed with ADHD also has a substance use disorder, there is little research available to physicians or their patients to guide how they can safely manage both conditions during pregnancy.

That lack of research struck psychiatry resident Tiffani Berkel, MD, PhD, as she was trying to advise patients navigating their pregnancies, which led her to approach Xu and propose this study.

“It’s very common for pregnant patients to ask their doctors, ‘Is this medication safe?’” Berkel said. “The physicians have to say, ‘We don’t know.’ That’s not very reassuring to a pregnant person. They have to do this risk-benefit analysis themselves.”

By examining de-identified prescription and Medicaid databases, Berkel, Xu and their co-authors focused on 168 pregnant patients who were receiving methadone or buprenorphine for opioid use disorder treatment and taking medications for ADHD. They analyzed how long the patients maintained their opioid use disorder treatments and how often they required emergency room care related to opioid use.

Because methadone clinics frequently require patients to stop taking any ADHD medications, there were not enough patients in that group to do a proper analysis. For patients treated with buprenorphine, the differences between patients who remained on their ADHD medications during their pregnancies and those who discontinued were striking: Those who continued with their ADHD medications stayed roughly two months longer on buprenorphine than did patients no longer taking ADHD medications. In line with that result, the researchers found there were fewer emergency room visits related to substance use disorder among patients taking ADHD medications: 41% of patients who continued their ADHD treatments went to the ER compared with 54% of those who stopped.

The reasons for the difference will need further investigation, but Berkel said one potential explanation is that ADHD drugs help control impulsivity and are therefore likely to improve patients’ ability to manage their substance use disorder treatments – with the additional benefit of improved attendance for regular pregnancy checkups.

Co-author Jeannie Kelly, MD, an associate professor of obstetrics & gynecology in the Division of Maternal-Fetal Medicine & Ultrasound, said that research like this serves a real-world medical need to better understand the potential consequences of discontinuing ADHD treatments for patients with substance use disorders. Kelly, Xu and Berkel treat patients at Barnes-Jewish Hospital.

“Treatment of ADHD is a huge knowledge gap in obstetrics and even more so in patients with substance use disorder,” Kelly said. “In obstetrics, a knowledge gap frequently leads to reluctance to treat because of unknown risks to the fetus. However, it’s also really important to discuss the risks of not treating, because untreated disease also can have huge implications for mom’s and baby’s health.”

Researchers to Develop Predictive Model for Opioid Addiction in High-Risk Patients

BYLINE: Andrea Siedsma

Newswise — Opioids are a broad group of effective pain-relieving medicines that can become highly addictive in some individuals. According to government sources, nearly 40 million people are addicted to illicit drugs worldwide. In 2017, the U.S. Department of Health and Human Services declared the opioid crisis a national public health emergency. To combat the opioid epidemic, researchers at University of California San Diego School of Medicine will develop an AI model that will more accurately predict opioid addiction in high-risk patients.

The project is funded through a three-year contract with Wellcome Leap as part of a $50 million groundbreaking initiative, called Untangling Addiction. The goal is to revolutionize how we understand opioid addiction and leverage innovative tools, such as artificial intelligence and predictive modeling, to intervene. UC San Diego School of Medicine was one of 14 locations worldwide to receive the funding.

“Controlled opioids in the health care setting are still an important part of adequate pain control and used for standard care. However, it is critical to know who is receiving these drugs and the risk it carries with some patients,” said Rodney Gabriel, MD, lead researcher for the project, chief of perioperative informatics in the Department of Anesthesiology at UC San Diego School of Medicine and clinical director of anesthesiology at UC San Diego Health.

“The AI model will help to identify who is most at risk for an opioid addiction and implement useful resources to help manage their opioid regimen. This way, we can better manage pain in this patient population and also avoid the potentially dangerous downstream consequences of addiction.”

The model will use generative artificial intelligence (GenAI), which can produce various types of content. It offers a more holistic approach, which can help with understanding and predicting multiple aspects of a patient’s prior and future behaviors.

“GenAI provides more sophisticated ways to predict multiple outcomes based on patterns discovered from large patient datasets,” Gabriel said. “We want to better predict risk of addiction the moment a patient is given an opioid prescription to the moment they would start to become addicted.”

Researchers will develop electronic health record (EHR) foundation models in a secure platform, which will leverage large multi-institutional datasets to incorporate genomic, social determinants of health, clinical, procedural and demographic data to predict the development of opioid use disorder and related outcomes among any patient initially prescribed an opioid.

“Anesthesiologists have access to a variety of secure data, which we review to safely get a patient through surgery. Dr. Gabriel’s research focus is how AI-assisted knowledge of a patient’s risks can optimize their overall care, and in this particular instance, decrease the chances of addiction,” said Ruth Waterman, MD, chair of the Department of Anesthesiology at UC San Diego School of Medicine and anesthesiologist at UC San Diego Health.

“What will be gained from this project will be translatable to many other areas of a patient’s health care journey, resulting in better outcomes and care.”

When the predictive tool is ready to be tested in clinical settings, Gabriel and his team will partner with the Joan & Irwin Jacobs Center for Health Innovation at UC San Diego Health (JCHI), which provides a unique environment for integrating AI approaches into clinical care.

“JCHI will be an indispensable resource for computational, technical and collaborative needs,” said Gabriel. “Our project aligns with the vision of JCHI, in which we leverage AI to make impactful and significant changes for the future of medicine.”

For Karandeep Singh, MD, who was named the inaugural chief health AI officer at UC San Diego Health, real-world evaluations of GenAI’s potential are critical.

“Generative AI has the potential to help us better understand people’s risk, but this idea hasn’t really been put to the test in most areas of medicine,” said Singh. “This project will be key towards helping us understand the potential of generative AI in identifying opioid risk.”

The ultimate goal of the project is to develop a commercially available genomic and microbiome panel that clinicians can use to easily assess opioid addiction, as well as to develop automated approaches using AI to integrate into EHR systems.

“This will allow us to make real-time predictions of risk throughout a patient’s entirety of care and lead the way in the prevention of opioid addiction,” said Gabriel.

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