Alcohol, Opioids, & other Substance Disorders

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Alcohol, Opioids, & other Substance Disorders

Post by trader32176 »

Medical diagnoses of “diseases of despair” increase in Pennsylvania

11/10/20 ... laims.aspx

Medical diagnoses involving alcohol-related disorders, substance-related disorders and suicidal thoughts and behaviors – commonly referred to as diseases of despair – increased in Pennsylvania health insurance cbetween the years 2007 and 2018, according to researchers from Penn State Clinical and Translational Science Institute and Highmark Health Enterprise Analytics.

Princeton economists Anne Case and Angus Deaton proposed the concept of deaths of despair in 2015. Case and Deaton's research observed a decline in life expectancy of middle-aged white men and women between 1999 and 2015 – the first such decline since the flu pandemic of 1918.

They theorized that this decline is associated with the social and economic downturn in rural communities and small towns.

These changes include loss of industry, falling wages, lower marriage rates, increasing barriers to higher education, an increase in one-parent homes and a loss of social infrastructure.

" It is theorized that these changes have fostered growing feelings of despair including disillusionment, precariousness and resignation in many peoples' lives. Despair can trigger emotional, cognitive, behavioral and even biological changes, increasing the likelihood of diseases that can progress and ultimately culminate in deaths of despair."

- Daniel George, Associate Professor of Humanities and Public Health Sciences, Penn State College of Medicine

With the Commonwealth's considerable rural and small-town population, particularly around Penn State campuses, Penn State Clinical and Translational Science Institute led a research study to understand the rate of diseases of despair in Pennsylvania. Institute researchers collaborated with Highmark Health, one of the state's largest health insurance providers. Highmark provides employer-sponsored, individual, Affordable Care Act and Medicare plans.

Highmark Health's Enterprise Analytics team analyzed the claims of more than 12 million people on their plans from 2007 to 2018. Penn State did not have access to Highmark member data or individual private health information.

Although the insurance claims included members from neighboring states, including West Virginia, Delaware and Ohio, the majority of the claims were from Pennsylvania residents. Researchers reported their results in BMJ Open.

The researchers defined diseases of despair as diagnoses related to alcohol use, substance use and suicidal thoughts or behaviors.
They searched the claims data for the International Classification of Diseases (ICD) codes related to these diagnoses. ICD codes form a standardized system maintained by the World Health Organization and are used in health records and for billing.

The researchers found that the rate of diagnoses related to diseases of despair increased significantly in the Highmark claims in the past decade. Nearly one in 20 people in the study sample was diagnosed with a disease of despair.

Between 2009 and 2018, the rates of alcohol-, substance- and suicide-related diagnoses increased by 37 percent, 94 percent and 170 percent, respectively. Following Case and Deaton's findings, the researchers saw the most substantial percentage increase in disease of despair diagnoses among men ages 35 to 74, followed by women ages 55 to 74 and 18 to 34.

The rate of alcohol-related diagnoses significantly increased among men and women ages 18 and over. The most dramatic increases were among men and women ages 55 to 74. Rates increased for men in this age group by 50 percent and 80 percent for women.

The rate of substance-related diagnoses roughly doubled for men and women ages 35 to 54 and increased by 170 percent in ages 55 to 74. In 2018, the most recent year of claims included in the study, rates of substance-use diagnoses were highest in 18-to-34-year-olds.

The rate of diagnoses related to suicidal thoughts and behaviors increased for all age groups. Among 18-to-34-year-olds, rates increased by at least 200 percent. The rate for all other age groups increased by at least 60 percent.

The type of insurance patients had also mattered. People with Medicare insurance had 1.5 times higher odds of having a disease of despair diagnosis and those with Affordable Care Act insurance had 1.3 times higher odds.

One increase stood out to researchers: among infants, substance-related diagnoses doubled.

"This increase was entirely attributable to neonatal abstinence syndrome and corresponded closely with increases in substance-related disorders among women of childbearing age," said Emily Brignone, senior research scientist, Highmark Health Enterprise Analytics.

Neonatal abstinence syndrome occurs when a baby withdraws from substances, especially opioids, exposed to in the womb.

Future research can concentrate on identifying "hot spots" of diseases of despair diagnoses in the Commonwealth to then study the social and economic conditions in these areas. With this data, researchers can potentially create predictive models to identify communities at risk and develop interventions.

"We found a broad view of who is impacted by increases in diseases of despair, which cross racial, ethnic and geographic groups," said Dr. Jennifer Kraschnewski, professor of medicine, public health sciences and pediatrics. "Although originally thought to mostly affect rural communities, these increases in all middle-aged adults across the rural-urban continuum likely foreshadows future premature deaths."
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Re: Alcohol, Opioids, & other Substance Disorders

Post by trader32176 »

Recommendations to help ensure access to high-quality opioid use disorder treatment

2/25/21 ... tment.aspx

On January 14, 2021, the Department of Health and Human Services (HHS) submitted notice to the Federal Register that it would issue practice guidelines that exempt physicians from the requirement to apply for a waiver to prescribe buprenorphine to treat opioid use disorder (OUD) in up to 30 patients at one time. This exemption has been placed on hold by the Biden administration and may require legislative change to implement. An exemption to the X-waiver has the potential to help reverse the morbidity and mortality associated with the opioid overdose epidemic, although without accompanying changes and attention it will not be enough.

The combination of the COVID-19 pandemic and the opioid overdose epidemic fueled by high-potency synthetic opioids have led to increased overdoses. However, national and state leadership, health professions schools, and health care systems in the US have not responded sufficiently. More than 83,000 drug overdose deaths occurred in the US in a 1-year period ending in June 2020, the highest number of overdose deaths ever recorded in a 12-month period, and an increase of more than 21% compared with the previous year.

Nationally, 67% of opioid overdose deaths involved fentanyl in 2018 and drug overdoses increased most among non-Hispanic Black individuals. Despite these devastating losses, access to evidence-based care to prevent opioid overdose and treat OUD remains highly regulated, restricted, and very limited, particularly among Black individuals with OUD and in rural communities. It is estimated that only 18% of individuals with OUD in the US receive highly effective medications, such as buprenorphine or methadone, to treat OUD. For many, the COVID-19 pandemic has further limited access to medications for OUD (MOUD).

Unlike other medical conditions, treatment of OUD has substantial and unique restrictions imposed by US federal and state laws. Such restrictions do not facilitate access to care; on the contrary, they impede it. Methadone for OUD must be administered or dispensed by an accredited, registered, and certified opioid treatment program. The Drug Addiction Treatment Act of 2000 (DATA 2000) requires that prescribers of buprenorphine apply for a waiver (ie, X-waiver) to prescribe once certain educational and practice requirements have been met. However, this restriction has outlived any usefulness.

Although appropriate training is essential to care for any disease, federal law does not require such training or registration to prescribe for other diseases (and more specifically, not for prescribing opioids for other indications such as pain). However, health professions schools are mandated by entities such as the Association of American Medical Colleges (AAMC) and the Accreditation Council for Graduate Medical Education (ACGME) to provide training to treat most other diseases. As of 2018, only 1 of 191 medical schools provided training to their students that was sufficient to meet the DATA 2000 training requirement.

Additionally, neither AAMC nor the ACGME require competency in OUD evaluation and treatment in medical education. Together, the absence of health professions school and graduate education; prescribing restrictions; stigma and misinformation among patients, families, and health care professionals; archaic payment structures and systems that emphasize acute care models over long-term treatment; care largely separate and uncoordinated from the rest of health care; and lack of support for patients' psychosocial needs have impeded the large expansion of MOUD treatment that is required to meet the need.

In an effort to address the vast need for MOUD treatment accessibility in the US, the HHS exemption proposed changes as follows. Physicians would need to place an "X" on the prescription, note that the prescription is to treat OUD, maintain separate records for such patients, prescribe to patients in the state in which they practice, and limit prescribing to no more than 30 patients at one time. Physicians who want to treat more than 30 individuals with OUD would need to seek additional training through the current 8-hour DATA 2000 mechanism. Notably, these guidelines do not apply to the large workforce of advanced practice clinicians who remain mandated to complete 24 hours of training to prescribe buprenorphine.

Relaxing restrictions on physician prescribing does have the potential to expand access to treatment and reduce opioid overdose deaths as it has in other countries. For example, in France, buprenorphine became available in 1995 and an estimated 3% of patients with OUD were treated that year with MOUD; by 2006, 67% of the 180000 people with OUD were treated with methadone (n=26000) or buprenorphine (n = 95000) in a setting with relaxed MOUD regulations. Rates of prescribing continue to be high, although over time, initiation of prescribing has shifted somewhat from primary care to specialized addiction treatment centers. While there are some cautionary tales from the rapid expansion of buprenorphine prescribing in France, such as subtherapeutic buprenorphine dosing, it has been estimated that a similar increase in prescribing in the US that occurred in France could have potentially led to an estimated 37000 fewer deaths in 2018 alone if it were used appropriately, adherence was high, and the same conditions were being treated in the US as in France.

Inaction is not an option when 40% of counties in the US do not have a single prescriber of MOUD. The proposed 2021 HHS guidelines represented progress toward MOUD expansion; however, they were far from enough to address the opioid overdose crisis. The US needs to normalize the treatment of OUD among health care professionals and individuals with OUD. Practicing health care professionals should be encouraged and incentivized to prescribe and obtain any needed training or support. OUD identification, evaluation, and treatment education should be integrated in all health care professions schools and should be implemented throughout all health care systems. It is also important to emphasize that medical management of OUD is effective, that buprenorphine alone at therapeutic doses can improve outcomes and prevent overdose, and that detoxification alone is insufficient to prevent overdose and treat OUD.

Buprenorphine prescribing by trained health care professionals can promote high-quality care and the new exemption could increase that prescribing. However, much more will need to be done. These additional steps include eliminating limits on the number of patients who could be treated by individual clinicians. One estimate suggests that by eliminating patient limits, the US could potentially treat nearly 800?000 additional individuals with OUD. Further needed actions include allowing prescribing by advanced practice clinicians; advocating for addiction training efforts at health professions schools, postgraduate programs, and as part of continuing education to make up for previously absent training; allowing office-based methadone treatment to ensure expansion to all types of MOUD; enforcing parity of benefits and insurance coverage for treatment; and addressing the stigma of addiction and addiction treatment. The effects of regulatory changes should be studied after implementation.

Recommendations to help ensure access to high-quality medication treatment for opioid use disorder (OUD)

Pass federal legislation to ensure lasting changes on a national scale
Eliminate buprenorphine patient limits and Drug Enforcement Administration audits that discourage prescribing; include advanced practice clinician prescribers in any legislative change; and remove restrictions on methadone prescribing and dispensing outside opioid treatment programs
Improve and provide training for prescribers and health professional teams at all levels
Incentivize training and offset clinician training time; provide a menu of training options appropriate to the needs of the clinician; integrate substantial training into specialty-specific health professions schools, postgraduate programs, continuing education, and maintenance of certification; include patient perspectives in all training; and provide experiential learning, such as apprenticeship models (eg, with mentors), in practice.
Expand access to all forms of OUD treatment shown to have efficacy
Increase access to strategies that reduce consequences of drug use ("harm reduction"); increase access to methadone treatment (eg, via primary care clinicians and pharmacies); and increase access to all treatment options (beyond specialty treatment programs) including medications
Address stigma and include patients receiving medications for OUD (MOUD) in educational campaigns
Enforce Parity (Mental Health Parity and Addiction Equity Act) to ensure equitable coverage and reimbursement for addiction and behavioral health treatments
Ensure equitable access to MOUD in all treatment settings
Study the effects of regulatory changes after implementation

Comprehensive treatment for OUD, including medical, psychiatric, and social services, can and should be provided by experienced clinicians and should be expanded, but MOUD urgently needs to be more accessible. The proposed HHS exemption would offer progress toward achieving that goal even though it was not, as written, a panacea. Improving access while ensuring high-quality care for individuals with OUD to sustain lasting reductions in opioid overdose deaths will require implementing these guidelines and additional strategies, many of which have been suggested for decades. As the new administration considers how to move forward, enacting an improved version of these guidelines and durable legislative changes to ensure access to high-quality MOUD offers a possibility to meaningfully address the overdose crisis.


Yale University

Journal reference:

Weimer, M.B., et al. (2021) Removing One Barrier to Opioid Use Disorder Treatment, Is It Enough?. JAMA.
Posts: 1755
Joined: Fri Jun 26, 2020 5:22 am

Re: Alcohol, Opioids, & other Substance Disorders

Post by trader32176 »

Therapeutic Solutions International Files Patent on NeuroLeukin™ Personalized Immunotherapy for Opioid Addiction

Campbell Neurosciences Division Expands its "Regenerative Psychiatry" Approach to Address the $179 Billion Dollar Prescription Opioid Epidemic

12/21/20 ... 96771.html

OCEANSIDE, Calif., Dec. 21, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today novel data and filing of a patent covering utilization of its NeuroLeukin™ product for altering molecular pathways associated with opioid addiction. In a series of animal experiments NeuroLeukin™ was demonstrated to reduce activation of TLR-4, which is one of the major innate immune pathways associated with opioid tolerance and addiction1.

It is estimated that the current opioid use epidemic costs the health care system approximately $179 Billion annually2. Campbell Neurosciences, the Company's Division focused on suicide prevention has previously filed intellectual property on utilizing NeuroLeukin™ to reduce suicidal ideations.

"The common biochemical pathways of opioid addiction and suicidal ideation should be no surprise given the inherent relationship between these two conditions," said Dr. James Veltmeyer, Chief Medical Officer of the Company and co-inventor of the patent. "Currently we have 2 clinical trials on the Federal website dealing with immunological quantification of psychiatric disorders: suicide and gambling. We are excited to take NeuroLeukin™ into the clinic, which to my knowledge represents the first immunotherapeutic approach for opioid addiction."

"Immunotherapy, which at one point was considered on the fringe of medicine, has blossomed into what is expected to be a 126-billion-dollar annual market in 20263, given its recent successes in the treatment of cancer," said Famela Ramos, Vice President of Business Development and co-inventor of the patent. "We are excited to position ourselves as the potential leaders in applying immunotherapy to mental disorders, an approach that we like to call "regenerative psychiatry."

"Having seen many close friends of mine suffer the horrible effects of opioid addiction, I am proud to be co-inventor on an approach which has the potential to revolutionize the way drug addiction is seen by the medical community," said Wais Kaihani, consultant to the Company.

"I am thankful for our internationally renowned scientific advisory board, which is comprised of immunologists and neurobiologists, that have stimulated our Company to enter such an unexplored space in which very little therapeutic interventions exist," said Timothy Dixon, President and CEO of the Company and co-inventor. "We are 100% dedicated to ending the opioid crisis or catalyzing development of novel approaches to accelerate an end to this tragic and avoidable loss of life."
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