Common Sense for Drug Policy Blog

New Methadone Regulations Go Into Effect Oct. 2 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):

"For decades, strict rules required most methadone patients to line up at special clinics every morning to sip their daily dose of the liquid medicine while being watched. The rules, built on distrust of people in the grip of opioid addiction, were meant to prevent overdoses and diversion — the illicit selling or sharing of methadone.

"The COVID-19 pandemic changed the risk calculation. To prevent the spread of the coronavirus at crowded clinics, emergency rules allowed patients to take methadone unsupervised at home.

"Research showed the looser practice was safe. Overdose deaths and drug diversion didn’t increase. And people stayed in treatment longer.

"With evidence mounting, the U.S. government made the changes permanent early this year. Oct. 2 is the date when clinics must comply with the new rules — unless they’re in a state with more restrictive regulations."

According to the notice published in the Federal Register on Feb. 2, 2024, "Medications for the Treatment of Opioid Use Disorder":

"The final rule draws on experience from the COVID-19 Public Health Emergency (PHE), as well as more than 20 years of practice-based research. The COVID-19 PHE necessitated changes to policy guidance and legal exemptions to protect the public's health, promote physical distancing and to preserve patient and OTP staff safety. In March 2020, SAMHSA published guidance regarding flexibilities that could be leveraged in the provision of unsupervised doses of methadone and the use of telehealth when initiating buprenorphine.[7] These flexibilities represented the first substantial change to OTP treatment and medication delivery standards in more than 20 years, and their role in facilitating access to treatment is supported by research.

"This final rule not only makes these COVID-19-related flexibilities permanent, but also updates standards to reflect an accreditation and treatment environment that has evolved since part 8 went into effect in 2001. Accordingly, the Department is updating part 8 to promote practitioner autonomy; remove discriminatory or outdated language; create a patient-centered perspective; and reduce barriers to receiving care. These elements have been identified in the literature and in feedback as being essential to promoting effective treatment in OTPs.[8 9 10

"To this end, the definition of a practitioner has been modified to refer to a provider who is appropriately licensed by the State to prescribe (including dispense) medications. Admission criteria have been updated, as required by section 1252(b) of the `Consolidated Appropriations Act, 2023', to remove significant barriers to entry, such as the one-year requirement for opioid use disorder (OUD),[11] while also defining the scope and purpose of the `initial' and `periodic' medical examinations. The final rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth and harm reduction activities. In addition, outdated terms such as `detoxification' have been revised to remove stigmatizing language.

"The Department promotes practitioner autonomy and individualized care by finalizing the provision containing the criteria for unsupervised doses of methadone. This includes removal from sole consideration the length of time an individual has been in treatment and requirements for rigid reliance on toxicology testing results that demonstrate complete and sustained abstinence from all substances prone to misuse. Based on the clinical judgment of the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment. This change recognizes the importance of the practitioner-patient relationship and is consistent with modern substance use disorder treatment standards.[12] It also allows for greater flexibility in creating plans of care that promote recovery activities such as employment or education, while also eliminating the barrier of frequent OTP visits for individuals without access to reliable transportation.[13]"

SAMHSA Releases 2023 NSDUH Substance Use Estimates

The US Substance Abuse and Mental Health Services Administration (SAMHSA) released its 2023 National Survey on Drug Use and Health (NSDUH) Annual Report on July 30, 2024.

According to SAMHSA's news release:

"The 2023 NSDUH Report includes the following selected key findings.

"Mental Health:

  • "Among adults aged 18 or older in 2023, 22.8% (or 58.7 million people) had any mental illness (AMI) in the past year.
  • "4.5 million youth (ages 12 to 17) had a major depressive episode in the past year, of which nearly 1 in 5 also had a substance use disorder.
  • "Among adults aged 18 or older in 2023, 5.0% (or 12.8 million people) had serious thoughts of suicide, 1.4% (or 3.7 million people) made a suicide plan, and 0.6% (or 1.5 million people) attempted suicide in the past year.
  • "Multiracial adults aged 18 or older were more likely than adults in most other racial or ethnic groups to have AMI, serious mental illness (SMI), and serious thoughts of suicide.
  • "Estimates of suicidal thoughts and behaviors among adults in 2023 were comparable to 2022 and 2021.

"Substance Use:

  • "In 2023, 3.1% of people (8.9 million) misused opioids in the past year, which is similar to 2022 and 2021 (3.2% and 8.9 million, 3.4% and 9.4 million respectively).
  • "Among the 134.7 million people aged 12 or older who currently used alcohol in 2023, 61.4 million people (or 45.6%) had engaged in binge drinking in the past month.
  • "Marijuana was the most commonly used illicit drug, with 21.8% of people aged 12 or older (or 61.8 million people) using it in the past year.
  • "American Indian or Alaska Native and Multiracial people were more likely than most other racial or ethnic groups to have used substances or to have had an SUD in the past year.
  • "In 2023, 9.4% of people aged 12 or older vaped nicotine in the past month, up from 8.3% in 2022.
    • "In the past year, more people initiated vaping (5.9 million people) compared to any other substance.
    • "Nicotine vaping estimates from 2021 are not comparable with estimates from 2022 and 2023.

"Services and Recovery:

  • "31.9% of adolescents aged 12 to 17 (or 8.3 million people) received mental health treatment in the past year, an increase of more than 500,000 from 2022.
  • "23.0% of adults aged 18 or older (or 59.2 million people) received mental health treatment in the past year, an increase of 3.4 million from 2022.
  • "Among people aged 12 or older in 2023 who were classified as needing substance use treatment in the past year, about 1 in 4 (23.6% or 12.8 million people) received substance use treatment in the past year. People were classified as needing substance use treatment in the past year if they had a substance use disorder (SUD) or received substance use treatment in the past year.
  • "30.5 million adults aged 18 or older (or 12.0%) perceived that they ever had a substance use problem. Among these adults, 73.1% (or 22.2 million people) considered themselves to be in recovery or to have recovered.
  • "64.4 million adults aged 18 or older (or 25.3%) perceived that they ever had a mental health issue. Among these adults, 66.6% (or 42.7 million people) considered themselves to be in recovery or to have recovered.
  • "There were no racial ethnic differences among adults aged 18 or older in 2023 who perceived that they ever had a substance use problem or problem with their mental health who considered themselves to be in recovery or to have recovered from their drug or alcohol use problem or mental health issue."

It should be noted that NSDUH estimates of substance use and of treatment need are based on self-reports of behaviors which may be stigmatized and even legally proscribed.

NPR Compares Portugal's Drug Policies With The US

National Public Radio reported recently on drug use, overdose, and drug policies in Portugal ("How Portugal eased its opioid epidemic, while U.S. drug deaths skyrocketed," Feb. 24, 2024), noting the stark contrast between outcomes in Portugal and the US:

"In the U.S., drug deaths are shatteringly common, killing roughly 112,000 people a year. In Portugal, weeks sometimes go by in the entire country without a single fatal overdose.

"Portugal has roughly the same population as the state of New Jersey. But while New Jersey alone sees nearly 3,000 fatal drug overdoses a year, Portugal averages around 80."

As reporter Brian Mann noted:

"What's different in Portugal? In the late 1990s, the country faced an explosion of heroin use. The drug was causing roughly 350 overdose deaths a year and sparked a wave of HIV/AIDS and other diseases linked to dirty needles.

"Portugal's leaders responded by pivoting away from the U.S. drug war model, which prioritized narcotics seizures, arrests and lengthy prison sentences for drug offenders.

"Instead, Portugal focused scarce public dollars on health care, drug treatment, job training and housing. The system, integrated into the country's taxpayer-funded national health care system, is free and relatively easy to navigate."

Here's how it works:

"Cops still work aggressively to break up major drug gangs and arrest people committing drug-related crimes like theft. They also disrupt open-air drug markets like the ones that have emerged in some U.S. cities.

"But when street cops in Portugal encounter people using small, personal-use amounts of drugs, there's no arrest. Instead, police schedule meetings for drug users with teams of counselors.

"While these sessions aren't compulsory, police are trained in strategies designed to encourage people to attend.

"'In the beginning, most policemen were very, very skeptical about this policy,' said Artur Vaz, who leads Portugal's national police unit focused on drug trafficking.

"In the U.S., this role for law enforcement, serving as a bridge to social service programs, has faced a backlash and is often seen as ineffectual.

"In Oregon, for example, where small amounts of drugs were decriminalized in 2020, police regularly hand out information cards referring people to a drug counseling hotline. Court data shows drug users rarely call."

What the article fails to note is that Portugal's system has built its success over a period of two decades. Oregon's decriminalization resulted from the passage of Ballot Measure 110, which was approved in the November 2020 general election and went into effect at the beginning of 2021. The Oregon Association of Chiefs of Police was one of the organizations that opposed the measure in the general election.

The article notes that the debate is far from settled:

"There are now efforts underway to recriminalize drugs, and toughen law enforcement's response, in California and Oregon.

"Humphreys, at Stanford University, says he still supports dramatically expanding access to addiction care, similar to Portugal's model.

"But he doesn't support decriminalization and believes police and criminal courts in the U.S. will need to play a more aggressive role forcing people with severe addiction off the streets and into treatment.

"'They don't have relationships, they're isolated, so if there's no law [enforcement] pressure, there's no pressure at all,' he said.

"Miguel Moniz, the anthropologist at the Institute of Social Sciences, University of Lisbon, disagrees. He says the data shows Portugal's approach, combining decriminalization and health care, is more humane and more successful.

"People in Portugal are now 45 times less likely to die from drug overdoses, compared with people in the U.S. — and street crime in cities like Lisbon has dropped.

"'There's an impression in the U.S. that if you decriminalize drugs, it's a Wild West where everyone uses drugs,' Moniz said. "That hasn't been the case in Portugal."

"But as the death toll from the U.S. overdose crisis mounts, Moniz voiced skepticism that American policymakers will have the political will or patience to pivot to a focus on health care and social services.

"'There's a different political environment in the U.S," Moniz said. 'The way health care is funded is completely different. The role of police in American society is different. So to talk about the Portuguese experience [being adopted in the U.S.] is complicated.'"

Canadian Safe Supply Activists Arrested

Police in Vancouver, BC have raided shops alleged to be involved in providing a safe supply of drugs, resulting in the arrests of three drug policy activists.

The Mainlander reported on October 30, 2023 ("DULF Saves Lives: Solidarity Links"):

"On October 25th, 2023, the Vancouver Police Department raided the homes and arrested two people allegedly behind the Drug User Liberation Front (DULF). DULF is one of the few initiatives working to fix the social crisis driven by the unpredictability of the drug supply in British Columbia. The toxic supply has killed 13,000 people since 2016. DULF has been public in their work to provide a community-based regulated supply in the absence of any level of government or health authority taking appropriate action to save lives. Collective branches of the state and public-private social sector organizations have predominantly stood against any work being done to end the crisis."

A number of individuals and organizations involved in public health, harm reduction, and drug policy reform have expressed their outrage over the arrests and their support of DULF and its safe supply mission. See for example:

"Nationwide Support Rallies as Vancouver Police Target Safe Drug Supply Program," Canadian Drug Policy Coalition, October 27, 2023:

"Advocates, community organizations and concerned members of the public across the country are adding their names to an open letter condemning the October 25 arrests of members of the Drug User Liberation Front (DULF)."

"Nurses Condemn the Arrests of Safe Supply Providers," The Tyee, October 31, 2023:

"DULF’s efforts ought to be acknowledged as life-saving given that the alternative for many people who use drugs is turning to an unregulated, poisoned and therefore unpredictable drug supply. Compassion club models offer a far safer avenue, and there have been no overdose deaths reported in relation to substances procured through DULF.

"As with other safe supply programs, DULF members have reported an improved quality of life alongside fewer experiences of overdose, hospitalization and drug-related violence, including negative interactions with police. This program offers a low-barrier, person-centred and impactful intervention that is mitigating overdose risk while contributing to broader improvements in health and social well-being.

"These gains should be not criminalized but celebrated, supported and evaluated through continued research."

On November 1, 2023, longtime drug policy reform activist Dana Larsen was arrested by Vancouver police in raids on three shops that he operated in the city. The Vancouver Sun reported ("Vancouver police bust three storefronts selling psilocybin and psychedelics"):

"Longtime pot activist Dana Larsen has publicly promoted his foray into the retail of mushrooms and other psychedelics such as DMT, LSD, peyote and kratom. He launched storefronts at the locations that were raided Wednesday starting in 2019.

"Larsen claims his operations are 'under attack by the city,' and is urging supporters to attend a public hearing about the business licences on Dec. 6 at city hall."

UK Commons Committee Endorses Harm Reduction, Calls for Overhaul of UK Drug Laws

The UK House of Commons Home Affairs Committee released a drugs report on August 31, 2023 that calls for a major overhaul of UK drug laws and endorses harm reduction policies including drug safety checking and safe consumption sites.

According to the Committee news release ("Reform law and expand treatment options to tackle cost of drugs on society – Home Affairs Committee finds," August 31, 2023):

"In a report published today, the Committee calls for a new legislative and funding framework that enables practical, risk-reducing interventions such as establishing a pilot drug consumption facility and drug testing at festivals. It further calls from a move away from an abstinence-only approach towards harm reduction with improved cross-working between police, health and social services.  

"The Committee found that law enforcement should continue to do all it can to stamp out the illicit trade of controlled drugs, but will need to be bolstered by a stronger public health response that helps people escape drug addiction and related criminality. The total cost of drugs to society is estimated to be £19 billion, more than twice the value of the illicit drug trade."

There has been little response to the report internationally. It's a different matter within the UK however, particularly in Scotland. The MP for Glasgow Central, Alison Thewliss (Scottish National Party), wrote on Sept. 4, 2023 ("Pilot drug consumption room must follow report recommending it, says SNP MP"):

"The Scottish Government has been fiercely tackling the issue, with its latest proposals including the establishment of safe consumption rooms. Similar policies have had resounding success in other countries around the world.

"And after a report from a Westminster committee called for the establishment of safe consumption rooms in Glasgow, it’s clear that the UK government can no longer ignore the need for urgent reform of drug laws.

"The UK Home Affairs Committee published a report which calls for a review of drug classification and a new health-led approach to tackling drugs with a trial of safe consumption rooms to reduce the harm of dangerous drugs. The Scottish Government already treats problematic drug use as a public health emergency, however drugs laws are currently reserved to Westminster."

Ms. Thewliss further observed: "The creaking, decrepit Misuse of Drugs Act is over fifty years old and must now be reviewed as a matter of urgency. Criminalising drug users has done nothing but entrench a problem that sees far too many people die each year."

While the report is welcome news, advocates point out that action is still lacking and is needed desperately. The Daily Record reported on Sept. 1, 2023 ("Drugs crusader slams lack of action on drugs reforms as he visits model facilities in Denmark"):

"Drugs campaigner Peter Krykant has blasted the Scottish and UK governments for standing still on reforms.

"Krykant launched his own mobile Drug Consumption Room in Glasgow three years ago - and the Daily Record was on board to record the events. But our Lord Advocate is still working on a legal framework to open Drug Consumption Rooms - more than two years after it was announced that Scotland would go it alone on the measures."

Cannabis Use Disorder Among Primary Care Patients in Washington State

Researchers have found indications of high rates of cannabis use disorder among primary care patients in the state of Washington. Prevalence of Cannabis Use Disorder and Reasons for Use Among Adults in a US State Where Recreational Cannabis Use Is Legal was published at the journal JAMA Network Open on August 29, 2023.

"The study was conducted in Kaiser Permanente Washington, a large health system in Washington State where recreational cannabis use has been legal since 2012. Primary care patients who completed a confidential survey about cannabis use were included in the study. Survey design, sampling, procedures, weighting, and sample characterization, including comparison of respondents to eligible primary care sample and nonrespondents, have been reported previously.13 Briefly, 5000 patients 18 years and older were randomly selected from 108 950 eligible patients with electronic health record documentation of completing a cannabis screen as part of routine primary care from March 28, 2019, to September 12, 2019 (Figure). The single-item screen asks about the frequency of past-year cannabis use (ie, none, less than monthly, monthly, weekly, and daily).22"

The researchers found:

"Among patients who used cannabis, the prevalence of patient reasons for cannabis use included 42.4% (95% CI, 31.2%-54.3%) reporting medical use only, 25.1% (95% CI, 17.8%-34.2%) reporting nonmedical use only, and 32.5% (95% CI, 25.3%-40.8%) reporting both reasons for use. Patients reporting medical use only tended to be older (mean [SD] age, 53.6 [14.6] years), were mostly female (142 [76.5%]), retired (67 [33.6%]), and mostly had Medicare (84 [33.7%]). The prevalence of patients who reported any medical cannabis use (ie, medical use only or both reasons for use) was 74.7% (95% CI, 65.7%-82.1%), while the prevalence of any reported nonmedical cannabis use (ie, nonmedical use only or both reasons for use) was 57.5% (95% CI, 45.6%-68.6%).

"The prevalence of any CUD was 21.3% (95% CI, 15.4%-28.6%) and did not differ depending on patient reasons for use (Table 2). The prevalence of moderate to severe CUD was 6.5% (95% CI, 5.0%-8.6%) and differed across groups: 1.3% (95% CI, 0.0%-2.8%) for medical use only; 7.2% (95% CI, 3.9%-10.4%) for nonmedical use only; and 7.5% (95% CI, 5.7%-9.4%) both reasons for use (P = .01). For all groups, the most prevalent CUD symptoms were tolerance, uncontrolled escalation of use and craving. Compared with patients with medical use only, patients with nonmedical use only or both reasons for use were more likely to report withdrawal, use in hazardous situations, continue use despite consequences, time spent on use, interference with obligations, and activities given up.

"The most common primary mode of use was application for patients with medical use only, 36.1% (95% CI, 21.2%-51.0%), and inhalation for patients with nonmedical use only and both reasons for use, 59.5% (95% CI, 43.5%-75.6%) and 69.4% (95% CI, 60.4%-78.5%), respectively (Table 3). Patients who reported both reasons for use were more likely to use cannabis 3 or more times per day (95% CI, 39.7% vs 4.5%-14.0%), with 71.8% using cannabis 4 or more days per week (95% CI, 63.7%-79.9%). Post hoc sensitivity analyses to remove patients whose only mode of cannabis use was applied (n = 22) did not meaningfully impact the prevalence of any CUD or moderate to severe CUD, 25.0% (95% CI, 18.3%-33.0%) and 7.7% (95% CI, 5.9%-10.0%), respectively, or differences in prevalence by reason for use, and did not change results of significance testing (eTable 1 in Supplement 1)."

A Caring, Compassionate and Human Rights Informed Drug Policy for Scotland

On July 7, 2023, the Government of Scotland issued a paper entitled "A Caring, Compassionate and Human Rights Informed Drug Policy for Scotland." The paper "outlines what a progressive, evidence-based drugs policy would look like with public health and the reduction of harm as its underlying principles."

According to the paper:

"In January 2021, Scotland’s then First Minister Nicola Sturgeon announced a National Mission to reduce drug deaths and improve lives, to be spearheaded by a dedicated Minister for Drugs Policy.11 This is supported by an additional investment of £250 million over the five-year life of the Parliament.12

"The Mission takes a holistic, public health response to the challenge. This includes mobilising an emergency response, focusing on harm reduction and preventing fatal overdoses; reducing risk by improving treatment and recovery services; and reducing vulnerability by addressing the social determinants of health by improving access to quality housing, social security, employment and social connection. It also recognises the need to address stigma, respond to the voices of people with lived and living experience and support a resilient workforce.

"Approaching this issue from a public health, and not a criminal justice, perspective is key. The rise in drug deaths has been significant enough to contribute to the fall in life expectancy in Scotland. From 2017-2019 to 2019-2021, drug misuse reduced life expectancy by 5.9 weeks for males and 2.5 weeks for females.13 Drug use disorders pose a sizable threat to Scotland’s population health and wellbeing, and were the third leading cause of health loss in the most recent Scottish Burden of Disease Study, surpassed only by ischaemic heart disease and Alzheimer’s and dementias in healthy life lost as a result of disability and premature death (number of Disability Adjusted Life Years), (Figure 1).14"

Among its recommendations, the paper endorses expanded harm reduction services and the decriminalization of simple possession of drugs:

"This paper argues how the reform of the UK’s drug laws offers an opportunity to contribute to a public health approach. It begins with a summary of how drug laws can affect drug harms, before calling for immediate legislative changes to support harm reduction measures; arguing for decriminalisation of possession for personal supply; and examining the opportunities for a future debate on strict regulated markets."

UPDATE: Justice Department Finally Announces Application Form for Marijuana Pardon Certificates

The Department of Justice has finally made available the application form to apply to receive a pardon for federal marijuana possession convictions. The DOJ announced on March 2, 2023

"The online application will be available on the Office of the Pardon Attorney’s website: Application for Certificate of Pardon. The web form allows eligible persons to submit documentation to the Office of the Pardon Attorney and receive a certificate indicating the person was pardoned on Oct. 6, 2022, for simple possession of marijuana. 

"The President’s pardon, effective Oct. 6, 2022, may assist pardoned persons by removing civil or legal disabilities — such as restrictions on the right to vote, to hold office or to sit on a jury — that are imposed because of the pardoned conviction. The application released today may also be helpful as proof of pardon for those who seek to obtain licenses, bonding or employment." Form: Certificate of Pardon for the Offense of Simple Possession of Marijuana on or before October 6, 2022

Thousands Receive Pardon For Federal Marijuana Possession Convictions

On October 6, 2022, the White House issued a blanket pardon to people who had received a federal conviction for simple possession of marijuana. According to the proclamation signed by President Joseph Biden:

"Acting pursuant to the grant of authority in Article II, Section 2, of the Constitution of the United States, I, Joseph R. Biden Jr., do hereby grant a full, complete, and unconditional pardon to (1) all current United States citizens and lawful permanent residents who committed the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1), on or before the date of this proclamation, regardless of whether they have been charged with or prosecuted for this offense on or before the date of this proclamation; and (2) all current United States citizens and lawful permanent residents who have been convicted of the offense of simple possession of marijuana in violation of the Controlled Substances Act, as currently codified at 21 U.S.C. 844 and as previously codified elsewhere in the United States Code, or in violation of D.C. Code 48–904.01(d)(1); which pardon shall restore to them full political, civil, and other rights."

The President's clemency powers extend only to federal convictions. In a statement accompanying the pardon proclamation, the President urged states to follow suit:

"Second, I am urging all Governors to do the same with regard to state offenses. Just as no one should be in a Federal prison solely due to the possession of marijuana, no one should be in a local jail or state prison for that reason, either."

Further:

"Third, I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law."

The President's statement concludes that "Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs."