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‘Magic mushrooms’ for therapy? Vets help sway conservatives
Matthew Butler, who spent 27 years in the Army, holds a 2014 photograph of himself during his last deployment in Kabul Afghanistan, on Wednesday, March 30, 2022, in Sandy, Utah. Butler is now one of the military veterans in several U.S. states who are helping convince conservative lawmakers to take cautious steps toward allowing the therapeutic use of hallucinogenic mushrooms and other psychedelic drugs. The therapeutic used of so-called magic mushrooms and other psychedelic drugs is making inroads in several U.S. states, including some with conservative leaders, as new research points to their therapeutic value and military veterans who have used them to treat post-traumatic stress disorder become advocates. (AP Photo/Rick Bowmer
SALT LAKE CITY (AP) — Matthew Butler spent 27 years in the Army, but it took a day in jail to convince him his post-traumatic stress disorder was out of control.
The recently retired Green Beret had already tried antidepressants, therapy and a support dog. But his arrest for punching a hole in his father’s wall after his family tried to stage an intervention in Utah made it clear none of it was working. “I had a nice house, I had a great job, whatever, but I was unable to sleep, had frequent nightmares, crippling anxiety, avoiding crowds,” he said. “My life was a wreck.”He eventually found psychedelic drugs, and he says they changed his life. “I was able to finally step way back and go, ‘Oh, I see what’s going on here. I get it now,’” said Butler, now 52. Today his run-ins with police have ended, he’s happily married and reconciled with his parents.
Butler, who lives in the Salt Lake City suburbs, is among military veterans in several U.S. states helping to persuade lawmakers to study psychedelic mushrooms for therapeutic use.
Conservative Utah has become at least the fourth state over the last two years to approve studying the potential medical use of psychedelics, which are still federally illegal. A string of cities have also decriminalized so-called magic mushrooms and an explosion of investment money is flowing into the arena. Oregon is so far the only state to legalize the therapeutic use of psilocybin, the psychedelic active ingredient in certain mushrooms. But studying them for therapy has made inroads not only in blue states like Hawaii, Connecticut and Maryland, but also GOP-led Texas, Utah and Oklahoma, which passed a study bill through the state House this year.
The progress stands in contrast to medical marijuana, which Utah lawmakers refused to allow until a ballot measure helped push it through. However, the proposal to study a broad range of psychedelic drugs passed easily this year.
Texas has yet to legalize medical marijuana, but former Republican Gov. Rick Perry helped shepherd through a bill last year to use $1.4 million to fund a study of psilocybin for treating PTSD.
“The stigma attached to psilocybin and most psychedelics dates back to the 60s and 70s. It’s been very hard for them to overcome,” said Democratic Rep. Alex Dominguez, who sponsored the bill. “My approach was, ‘Let’s find the group that all sides claim that they are supportive of.’ And that would be veterans.”
He also heard from conservatives like Perry who support the use of psilocybin to treat PTSD — and let advocates from that end of the political spectrum take the lead publicly. Maryland also gave bipartisan approval to spending $1 million this year to fund alternative therapies for veterans, including psychedelics. Democratic sponsor Sen. Sarah Elfreth, whose district includes the U.S. Naval Academy, noted the spike in suicides among veterans.
“I don’t envision the VA acting anytime soon,” she said. “We’re at a true crisis level and it’s time for the states to step up.”
Psilocybin has been decriminalized in nearby Washington, D.C., as well as Denver, which decriminalized it in 2019, followed by Oakland and Santa Cruz in California, Ann Arbor, Michigan, and Cambridge, Massachusetts. There’s also plenty of venture capital being invested from people who have had positive experiences and are “highly motivated” to invest in psychedelics as treatment, said John Krystal, the chair of psychiatry at Yale University. Rhode Island lawmakers are weighing a proposal to decriminalize psilocybin this year, and in Colorado there’s an effort to get statewide decriminalization on the ballot. But similar measures have stalled in Statehouses elsewhere, including California and Maine.
Studying psychedelics, though, has gained more traction. In Oklahoma, a bill from Republican Reps. Daniel Pae and Logan Phillips would legalize research on psilocybin.
“I believe the research will show that there is a way to use this drug safely and responsibly, and it could save the lives of thousands of Oklahomans,” Pae said in a statement. The bill passed the House last month and is now under consideration in the Senate.
It’s a stunning turnaround for a field that captivated researchers in the 1950s and 1960s, before mushrooms and LSD became known as recreational drugs. They were federally outlawed during the Nixon administration, sending research to a screeching halt. New studies, though, have indicated psilocybin could be useful in the treatment of everything from major depression to alcoholism, said Ben Lewis, an assistant professor of psychiatry at the University of Utah Huntsman Mental Health Institute.
“People are referring to this current period of time as the psychedelic Renaissance,” he said. Up to 30% of depression sufferers are considered resistant to current treatment, and there have been few recent leaps forward in drug innovation, he added. The risk of addiction or overdose is considered low with psychedelics, especially under medical supervision, and while some cardiac conditions can present a physical risk, many people’s physical reactions aren’t dangerous.
But there are serious psychological risks, especially for people with certain forms of mental illness or a family history of conditions like schizophrenia or bipolar disorder. “Then there’s a possibility that a high-dose psychedelic experience could sort of trigger that and lead to long-lasting mental health issues,” said Albert Garcia-Romeu, an assistant professor at Johns Hopkins University School of Medicine.
Classic psychedelics include LSD, mescaline, psilocybin and ayahuasca. Plant-based psychedelics have long been used in indigenous cultures around the world. Today, their therapeutic use at Johns Hopkins is carefully monitored, Garcia-Romeu said. Patients are rigorously screened and typically have at least three appointments: one for preparation, a second to take the drugs and a third to work through the psychedelic experience.
For Butler, the 2018 arrest at his parents’ home was a turning point. He started researching new ways to deal with the PTSD he has suffered since deploying six times to Iraq and Afghanistan and working in counterterrorism and hostage rescues in Somalia for the U.S. Special Forces before retiring as a lieutenant colonel in 2017.
Eventually he came across ayahuasca, long a part of traditional cultures in South America. Last summer, he took part in a ceremony involving the psychoactive brew, overseen by a woman knowledgeable about its effects. She talked to him as the experience took hold, including a feeling of euphoria, the sight of geometric shapes and a sense he was entering his subconscious.
She spoke to him about his childhood and how the military had shaped his life.
“It really was as simple as having an experienced person who understood the medicine, who understood that subconscious space and understood PTSD. It was as simple as listening to her,” he said.
He credits that single session with getting his PTSD about 80% under control, though he occasionally does another if he finds his symptoms returning.
About two-thirds to three-quarters of people in studies have experienced significant improvements in their symptoms, Garcia-Romeu said. Those are promising results, especially for quitting smoking, where current treatments only work for about one-third of people, he said.
The Food and Drug Administration designated psilocybin a “breakthrough therapy” in 2018, a label that’s designed to speed the development and review of drugs to treat a serious condition. MDMA, often called ecstasy, also has that designation for treatment of PTSD.
How quickly states move from study to wider availability remains to be seen. Connecticut recommended legal medical use only after psilocybin is approved by the FDA, which may take until 2025 or later as the agency works through its process, including risk assessment.
Approval is important to safety as well as access, the Connecticut assessment said — without it, many insurance companies likely wouldn’t cover the treatment, leaving it open only to the wealthy.
In Utah, the study team is expected to complete its work in the fall.
“We’ll see what can and can’t be done,” said Republican Rep. Brady Brammer, who sponsored the bill. “If if they feel like it’s safe, it’ll be an interesting ride.”
__
Associated Press writers Brian Witte in Annapolis, Maryland; Sean Murphy in Oklahoma City; Susan Haigh in Hartford, Connecticut, and Jim Vertuno in Austin, Texas, contributed to this report.
SALT LAKE CITY (AP) — Matthew Butler spent 27 years in the Army, but it took a day in jail to convince him his post-traumatic stress disorder was out of control.
The recently retired Green Beret had already tried antidepressants, therapy and a support dog. But his arrest for punching a hole in his father’s wall after his family tried to stage an intervention in Utah made it clear none of it was working. “I had a nice house, I had a great job, whatever, but I was unable to sleep, had frequent nightmares, crippling anxiety, avoiding crowds,” he said. “My life was a wreck.”He eventually found psychedelic drugs, and he says they changed his life. “I was able to finally step way back and go, ‘Oh, I see what’s going on here. I get it now,’” said Butler, now 52. Today his run-ins with police have ended, he’s happily married and reconciled with his parents.
Butler, who lives in the Salt Lake City suburbs, is among military veterans in several U.S. states helping to persuade lawmakers to study psychedelic mushrooms for therapeutic use.
Conservative Utah has become at least the fourth state over the last two years to approve studying the potential medical use of psychedelics, which are still federally illegal. A string of cities have also decriminalized so-called magic mushrooms and an explosion of investment money is flowing into the arena. Oregon is so far the only state to legalize the therapeutic use of psilocybin, the psychedelic active ingredient in certain mushrooms. But studying them for therapy has made inroads not only in blue states like Hawaii, Connecticut and Maryland, but also GOP-led Texas, Utah and Oklahoma, which passed a study bill through the state House this year.
The progress stands in contrast to medical marijuana, which Utah lawmakers refused to allow until a ballot measure helped push it through. However, the proposal to study a broad range of psychedelic drugs passed easily this year.
Texas has yet to legalize medical marijuana, but former Republican Gov. Rick Perry helped shepherd through a bill last year to use $1.4 million to fund a study of psilocybin for treating PTSD.
“The stigma attached to psilocybin and most psychedelics dates back to the 60s and 70s. It’s been very hard for them to overcome,” said Democratic Rep. Alex Dominguez, who sponsored the bill. “My approach was, ‘Let’s find the group that all sides claim that they are supportive of.’ And that would be veterans.”
He also heard from conservatives like Perry who support the use of psilocybin to treat PTSD — and let advocates from that end of the political spectrum take the lead publicly. Maryland also gave bipartisan approval to spending $1 million this year to fund alternative therapies for veterans, including psychedelics. Democratic sponsor Sen. Sarah Elfreth, whose district includes the U.S. Naval Academy, noted the spike in suicides among veterans.
“I don’t envision the VA acting anytime soon,” she said. “We’re at a true crisis level and it’s time for the states to step up.”
Psilocybin has been decriminalized in nearby Washington, D.C., as well as Denver, which decriminalized it in 2019, followed by Oakland and Santa Cruz in California, Ann Arbor, Michigan, and Cambridge, Massachusetts. There’s also plenty of venture capital being invested from people who have had positive experiences and are “highly motivated” to invest in psychedelics as treatment, said John Krystal, the chair of psychiatry at Yale University. Rhode Island lawmakers are weighing a proposal to decriminalize psilocybin this year, and in Colorado there’s an effort to get statewide decriminalization on the ballot. But similar measures have stalled in Statehouses elsewhere, including California and Maine.
Studying psychedelics, though, has gained more traction. In Oklahoma, a bill from Republican Reps. Daniel Pae and Logan Phillips would legalize research on psilocybin.
“I believe the research will show that there is a way to use this drug safely and responsibly, and it could save the lives of thousands of Oklahomans,” Pae said in a statement. The bill passed the House last month and is now under consideration in the Senate.
It’s a stunning turnaround for a field that captivated researchers in the 1950s and 1960s, before mushrooms and LSD became known as recreational drugs. They were federally outlawed during the Nixon administration, sending research to a screeching halt. New studies, though, have indicated psilocybin could be useful in the treatment of everything from major depression to alcoholism, said Ben Lewis, an assistant professor of psychiatry at the University of Utah Huntsman Mental Health Institute.
“People are referring to this current period of time as the psychedelic Renaissance,” he said. Up to 30% of depression sufferers are considered resistant to current treatment, and there have been few recent leaps forward in drug innovation, he added. The risk of addiction or overdose is considered low with psychedelics, especially under medical supervision, and while some cardiac conditions can present a physical risk, many people’s physical reactions aren’t dangerous.
But there are serious psychological risks, especially for people with certain forms of mental illness or a family history of conditions like schizophrenia or bipolar disorder. “Then there’s a possibility that a high-dose psychedelic experience could sort of trigger that and lead to long-lasting mental health issues,” said Albert Garcia-Romeu, an assistant professor at Johns Hopkins University School of Medicine.
Classic psychedelics include LSD, mescaline, psilocybin and ayahuasca. Plant-based psychedelics have long been used in indigenous cultures around the world. Today, their therapeutic use at Johns Hopkins is carefully monitored, Garcia-Romeu said. Patients are rigorously screened and typically have at least three appointments: one for preparation, a second to take the drugs and a third to work through the psychedelic experience.
For Butler, the 2018 arrest at his parents’ home was a turning point. He started researching new ways to deal with the PTSD he has suffered since deploying six times to Iraq and Afghanistan and working in counterterrorism and hostage rescues in Somalia for the U.S. Special Forces before retiring as a lieutenant colonel in 2017.
Eventually he came across ayahuasca, long a part of traditional cultures in South America. Last summer, he took part in a ceremony involving the psychoactive brew, overseen by a woman knowledgeable about its effects. She talked to him as the experience took hold, including a feeling of euphoria, the sight of geometric shapes and a sense he was entering his subconscious.
She spoke to him about his childhood and how the military had shaped his life.
“It really was as simple as having an experienced person who understood the medicine, who understood that subconscious space and understood PTSD. It was as simple as listening to her,” he said.
He credits that single session with getting his PTSD about 80% under control, though he occasionally does another if he finds his symptoms returning.
About two-thirds to three-quarters of people in studies have experienced significant improvements in their symptoms, Garcia-Romeu said. Those are promising results, especially for quitting smoking, where current treatments only work for about one-third of people, he said.
The Food and Drug Administration designated psilocybin a “breakthrough therapy” in 2018, a label that’s designed to speed the development and review of drugs to treat a serious condition. MDMA, often called ecstasy, also has that designation for treatment of PTSD.
How quickly states move from study to wider availability remains to be seen. Connecticut recommended legal medical use only after psilocybin is approved by the FDA, which may take until 2025 or later as the agency works through its process, including risk assessment.
Approval is important to safety as well as access, the Connecticut assessment said — without it, many insurance companies likely wouldn’t cover the treatment, leaving it open only to the wealthy.
In Utah, the study team is expected to complete its work in the fall.
“We’ll see what can and can’t be done,” said Republican Rep. Brady Brammer, who sponsored the bill. “If if they feel like it’s safe, it’ll be an interesting ride.”
__
Associated Press writers Brian Witte in Annapolis, Maryland; Sean Murphy in Oklahoma City; Susan Haigh in Hartford, Connecticut, and Jim Vertuno in Austin, Texas, contributed to this report.
CDC proposes softer guidance on opioid prescriptions
The nation’s top public health agency on Thursday proposed changing — and in some instances, softening — guidelines for U.S. doctors prescribing oxycodone and other opioid painkillers.
NEW YORK (AP) — The Centers for Disease Control and Prevention’s previous guidance, issued six years ago, helped slow the kind of prescribing that ignited the worst overdose epidemic in U.S. history. But it also caused some doctors to become too quick to cut off patients taking prescription painkillers and too strict in keeping the drugs from patients who might benefit, CDC officials said.
“We began to hear how the guidelines were being misused and misapplied” said the CDC’s Christopher Jones, a co-author of the draft guidance.
The proposed changes, contained in a 229-page draft update in the Federal Register, would roll back some suggested limits on the drugs. Their publication opens a 60-day public comment period. The CDC will consider comments before finalizing the updated guidance.
“We began to hear how the guidelines were being misused and misapplied” said the CDC’s Christopher Jones, a co-author of the draft guidance.
The proposed changes, contained in a 229-page draft update in the Federal Register, would roll back some suggested limits on the drugs. Their publication opens a 60-day public comment period. The CDC will consider comments before finalizing the updated guidance.
Cardiac arrest–related deaths have risen precipitously during the pandemic — and the reason may have to do with a mystery of coronavirus, an increase in drug overdoses, or both.
Indeed, those are two main theories explicating the rise in cardiac arrests, both compelling. First, because SARS-CoV-2 infects blood vessels, at least some of the cardiac arrest deaths may be from coronavirus infection. A second, equally sinister suspicion is that a percentage of the cardiac arrests over the past twelve months could have been "occult" opioid overdoses — a medical term that means that the drug-related cause of cardiac arrest was not recorded nor discernible. Even before the pandemic, researchers suspected opioid overdoses were being "disguised" as cardiac arrests. Earlier this month, researchers published a paper in the journal Resuscitation that found 10 percent of out-of-hospital cardiac arrests from February 2011 through December 2017 in San Francisco were actually occult opioid overdoses. The paper adds on to ongoing evidence that opioid overdoses are being masqueraded as cardiac arrests is prevalent across the country.
Indeed, since the pandemic, opioid overdoses have increased along with cardiac arrests. That's led some to wonder whether opioid overdoses are being reported as cardiac arrests.
"The way to think of it is that paramedics will arrive on scene, they called for cardiac arrests and will start resuscitating the patient, using protocols that are directed at resuscitating the heart," said Dr. Robert Rodriguez, who is the author of the study and a professor of emergency medicine at the University of California, San Francisco, in an interview. "So what we have shown is a certain percentage of those patients that they assume that they're assuming are cardiac arrests turned out to be narcotic overdoses."
At the beginning of the pandemic, one-third of the country's "excess deaths" were not directly due to COVID-19, according to an analysis in the Journal of the American College of Cardiology. Public health experts define excess deaths as the difference between the actual number of deaths in a specific time period and the expected numbers based on historic trends. Specifically, comparing data from January 1 to June 2, 2020, with the same timeframe from 2019, showed that deaths by ischemic heart disease increased across the country after the onset of the pandemic.
Certainly, the pandemic has been a stressful time and is affecting everyday health in a myriad of ways—especially those in low-income and marginalized communities. As Bob Hennelly reported for Salon in April, EMS workers noted that before the pandemic they would see one or two cardiac arrest calls per shift. In the beginning of the pandemic, they were attending to as many as thirteen cardiac arrest calls per shift. At the time, they suspected it was COVID-19 related. But could those deaths be related to something else — perhaps a concurrent crisis of opioid overdoses during the pandemic. The Centers for Disease Control and Prevention reports that more than 81,000 deaths between June 2019 and May 2020 were linked to drug overdoses — an 18 percent jump compared to the previous 12-month period. But when first responders attend to what is initially believed to be a cardiac arrest, the protocol doesn't include administering Naloxone, which can rapidly reverse an opioid overdose. Rarely do people die immediately over an opioid overdose, as it often takes hours.
Rodriguez said if EMS responds to 350,000 adult cardiac arrests cases in the United States a year then, assuming 10 percent of those are opioid overdoses, 35,000 lives could be saved by administering Naloxone. That's an optimistic estimate; Rodriguez's more conservative numbers suggests 1,750 lives would be saved if the Naloxone doesn't work on everyone.
Rodriguez is hoping that his paper will help inspire first responders to cardiac arrests to include Naloxone in the resuscitation protocol. There is no risk to administering it, even if a person isn't having a heart attack. CLICK FOR COMPLETE ARTICLE
THC microdosing reduces chronic pain in world-first clinical trial
By Rich Haridy
A clinical trial found single small THC doses did reduce acute sensations of pain compared to placebo
New research published in the European Journal of Pain is offering some of the first clinical trial insights into the efficacy of microdosing THC to treat chronic pain. The results of the small trial suggest minute doses of THC may confer clinically apparent reductions in pain sensation without inducing psychoactive side effects.
A microdose is generally known as a subtherapeutic dose of a drug, and the term has more recently become synonymous with tiny, regular dosing of psychedelics such as LSD. The practice has been anecdotally popular, however, little research has been conducted to rigorously test how useful these imperceptible doses of psychedelic drugs actually can be.
So, an Israeli pharma-tech company named Syqe Medical set out to try to answer the THC microdose question, and solve the problem of imprecise cannabis dosing. The Syqe Inhaler is a first-of-its-kind product that reportedly enables precise dosing of low-levels of THC.
A randomized, double‐blinded, and placebo‐controlled trial recruited a cohort of 27 subjects with chronic neuropathic pain. Across three separate test days each subject received one inhaled dose, containing either 500 micrograms (0.5 mg) of THC, 1,000 micrograms (1 mg) of THC, or a placebo.
“Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150‐min,” the researchers write in the published study. “The 1‐mg dose showed a significant pain decrease compared to the placebo.” CLICK FOR COMPLETE ARTICLE
By Rich Haridy Researchers report 20 micrograms of LSD delivers similar analgesic results to opioids such as oxycodone and morphine in an acute pain test
Researchers report 20 micrograms of LSD delivers similar analgesic results to opioids such as oxycodone and morphine in an acute pain test.
An incredible, first-of-its-kind trial testing the pain-killing properties of LSD microdoses has delivered the compelling suggestion that tiny, non-psychedelic doses of this infamous drug could serve as an effective analgesic.
Back in the 1960s, during the original heyday of psychedelic science, one of the more fascinating research areas for LSD was its unexpected efficacy as an analgesic. Researcher Eric Kast was one of the pioneer investigators on the topic, publishing over a dozen key papers exploring the ways pain perception is influenced by LSD.
Decades later, as the freeze on psychedelic research begins to thaw, the idea of LSD as a pain-reliever still sits on the fringes of psychedelic science. No modern clinical researcher has returned to Kast’s ideas, however, anecdotal cases have begun to emerge highlighting some people self-medicating with LSD microdoses to treat chronic pain.
This new study, led by researchers from Maastricht University with assistance from the Beckley Foundation, is the first clinical trial to revisit this topic in more than 50 years. Unlike Kast’s prior work, this new research focused on microdoses of LSD rather than larger, actively psychedelic doses. CLICK FOR COMPLETE STORY
For Immediate Release:July 23, 2020The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.
“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose. We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting opioid overdose and death in the hands of those who need it most – those at increased risk of opioid overdose and their friends and family.”
The required labeling changes announced in a Drug Safety Communication recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients being prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose. A naloxone prescription should also be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
The FDA is requiring that these recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone.
The FDA is working with other federal, state and local officials as well as health care professionals, patients and communities nationwide to help increase availability of naloxone and combat opioid overdoses. Patients should talk to their health care professional about how to obtain naloxone according to their state’s requirements or guidelines. The U.S. Department of Health and Human Services has ongoing efforts to fight the opioid crisis and expand the use of naloxone. This includes: better targeting of overdose reversing drugs as part of a 5-Point Strategy to Combat the Opioids Crisis.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.
“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose. We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting opioid overdose and death in the hands of those who need it most – those at increased risk of opioid overdose and their friends and family.”
The required labeling changes announced in a Drug Safety Communication recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients being prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose. A naloxone prescription should also be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
The FDA is requiring that these recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone.
The FDA is working with other federal, state and local officials as well as health care professionals, patients and communities nationwide to help increase availability of naloxone and combat opioid overdoses. Patients should talk to their health care professional about how to obtain naloxone according to their state’s requirements or guidelines. The U.S. Department of Health and Human Services has ongoing efforts to fight the opioid crisis and expand the use of naloxone. This includes: better targeting of overdose reversing drugs as part of a 5-Point Strategy to Combat the Opioids Crisis.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
US Substance Abuse and Mental Health Services Administration (SAMHSA) announces At-home treatment of opioid use disorderhttps://www.medscape.com/viewarticle/927248
UPDATED March 21, 2020 // In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced at-home treatment of opioid use disorder (OUD).
The agency issued a directive to allow some patients in opioid treatment programs (OTP) to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, for treatment of opioid use disorder (OUD).
The agency also said states are now allowed to request up to 14 days of take-home medication for patients who are less stable but who can, in the judgement of OTP clinicians, safely handle this level of take-home medication.
An FAQ section on the SAMHSA website offers detailed, up-to-date guidance for providing methadone and buprenorphine treatment.
www.samhsa.gov
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DISCLAIMER STATEMENT: 100MillionWays is a project of Players Philanthropy Fund, (Federal Tax ID: 27-6601178), a Maryland charitable trust with federal tax-exempt status as a public charity under Section 501(c)(3) of the Internal Revenue Code. Contributions to 100MillionWays are tax-deductible to the fullest extent of the law.
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