Federal opioid agonist therapy policy: interrupted time series analysis of the impact of the methadone exemption removal across eight provinces in Canada.

BACKGROUND: Federal deregulation of opioid agonist therapies are an attractive policy option to improve access to opioid use disorder care and achieve widespread beneficial impacts on growing opioid-related harms. There have been few evaluations of such policy interventions and understanding effects can help policy planning across jurisdictions. METHODS: Using health administrative data from eight of ten Canadian provinces, this study evaluated the impacts of Health Canada's decision in May 2018 to rescind the requirement for Canadian health professionals to obtain an exemption from the Canadian Drugs and Substance Act to prescribe methadone for opioid use disorder. Over the study period of June 2017 to May 2019, we used descriptive statistics to capture overall trends in the number of agonist therapy prescribers across provinces and we used interrupted time series analysis to determine the effect of this decision on the trajectories of the agonist therapy prescribing workforces. RESULTS: There were important baseline differences in the numbers of agonist therapy prescribers. The province with the highest concentration of prescribers had 7.5 more prescribers per 100,000 residents compared to the province with the lowest. All provinces showed encouraging growth in the number of prescribers through the study period, though the fastest growing province grew 4.5 times more than the slowest. Interrupted time series analyses demonstrated a range of effects of the federal policy intervention on the provinces, from clearly positive changes to possibly negative effects. CONCLUSIONS: Federal drug regulation policy change interacted in complex ways with provincial health professional regulation and healthcare delivery, kaleidoscoping the effects of federal policy intervention. For Canada and other health systems such as the US, federal policy must account for significant subnational variation in OUD epidemiology and drug regulation to maximize intended beneficial effects and mitigate the risks of negative effects.

Breaking Free From the "War on Drugs": Examples From Three Leader States.

While the federal government continues to pursue a punitive "War on Drugs," some states have adopted evidence-based, human-focused approaches to reducing drug-related harm. This article discusses recent legal changes in three states that can serve as models for others interested in reducing, rather than increasing, individual and community harm.

State Driving Under the Influence of Drugs Laws.

Drug-impaired driving is a growing problem in the U.S. States regulate drug-impaired driving in different ways. Some do not name specific drugs or amounts. Others do identify specific drugs and may regulate cannabis separately. We provide up-to-date information about these state laws.

Regulatory Framework for Cannabis: A Position Paper From the American College of Physicians.

Cannabis, also known as marijuana, is the dried flowers, stems, seeds, and leaves of the Cannabis sativa plant. It contains more than 100 compounds, including tetrahydrocannabinol, which has psychoactive effects. Federal law prohibits the possession, distribution, and use of cannabis outside limited research activities, but most states have legalized cannabis for medical or recreational use. However, research into the potential therapeutic and adverse health effects of cannabis has been limited, in part because of the drug's federal legal status. In this position paper, the American College of Physicians (ACP) calls for the decriminalization of possession of small amounts of cannabis for personal use and outlines a public health approach to controlling cannabis in jurisdictions where it is legal. ACP recommends the rigorous evaluation of the health effects and potential therapeutic uses of cannabis and cannabinoids as well as research into the effects of legalization on cannabis use. It also calls for evidence-based medical education related to cannabis and increased resources for treatment of cannabis use disorder.

A content analysis of legal policy responses to xylazine in the illicit drug supply in the United States.

BACKGROUND: Xylazine is a veterinary sedative that is quickly spreading in the U.S. illicit drug supply and is increasingly associated with fatal overdoses and severe wounds. In response, xylazine has been deemed an emerging public health threat and several policy initiatives have been introduced to combat its spread and negative broad health impact. We aimed to synthesize trends in all-time U.S. policy responses to xylazine in the drug supply. METHODS: In April 2024, we systematically identified and categorized proposed and enacted policy initiatives that related to human xylazine consumption by searching LexisNexis and Thomas Reuters Westlaw legal databases. RESULTS: Of 58 unique policy initiatives, most were introduced in 2023 (n = 37/58, 64 %) and concentrated in Northeastern states. Penalties for xylazine possession, often tied to state drug scheduling changes, were the most common provision (n = 34/58; 59 %) and Schedule III was the most frequently proposed scheduling level (n = 17/30; 57 %). Other provisions included proposals to enhance: test strip access (n = 11/58; 19 %), public awareness and education (n = 3/58; 5 %), xylazine-specific research (n = 4/58; 7 %), and surveillance (n = 8/58; 14 %). CONCLUSION: U.S. state and federal policy responses to xylazine grew rapidly in 2023, were most concentrated in states affected most by xylazine, and scheduling was the most commonly proposed policy approach. Research measuring policy effects should be prioritized as policies are implemented.

Comparing methadone policy and practice in France and the US: Implications for US policy reform.

Despite being among the most effective treatments for opioid use disorder, methadone is largely unavailable in the United States, due primarily to federal and other policies that limit its availability and regulate clinical decisions about doses, visit frequency, and drug testing. There is unprecedented momentum to change decades-old US methadone policies. Yet uncertainty remains as to whether reforms will be adopted and how policies will be implemented. France has among the best methadone access and lowest overdose death rates worldwide. 87 % of French people with opioid use disorder receive methadone or buprenorphine, versus an estimated 13-20 % in the US. France's opioid-related overdose rates are far lower than the US. This article compares French and US systems, including current and proposed US policies, and underscores potential implications for US policymakers. In France, methadone can be initiated in specialty addiction settings and hospitals, with subsequent handoff to primary care. Methadone can be dispensed in community pharmacies and filled like other opioids, without requirements for supervised dosing. Decisions about visit frequency, medication doses, and drug testing are governed by clinical best practices and patient-clinician shared decision-making. In the US, methadone for opioid use disorder is regulated unlike any other medication (including methadone for pain) and is governed by strict federal controls, including from law enforcement and healthcare. With few exceptions, methadone for opioid use disorder is only available in Opioid Treatment Programs. US clinicians cannot prescribe methadone for opioid use disorder. Federal rules determine minimum visit frequency, initial dose limits, and other conditions of treatment, which states may further limit. Policies assert strong influence on patient experience, treatment access, and health outcomes. Despite being less restrictive than the US, the French model includes limits designed to avoid or minimize potential harms. French policies have important implications for potential US reforms.

Decriminalization or police mission creep? Critical appraisal of law enforcement involvement in British Columbia, Canada's decriminalization framework.

The unregulated drug toxicity crisis in British Columbia (BC), Canada, has claimed over 14,000 lives since 2016. The crisis is shaped by prohibitionist policies that has led to the contamination of the unregulated drug supply, resulting in a surge of fatal and non-fatal overdose events. The criminalization of drug users exacerbates this situation, pushing individuals into carceral systems for the possession of and/or social practices related to drug use. This commentary examines the involvement of policing in the development, and throughout the first 15 months of its implementation, of BC's decriminalization framework. We highlight concerns regarding police discretion, the expansion of scope, and the interweaving of carceral logics into policies that purport to be public health-oriented.

Canada's THC unit: Applications for the legal cannabis market.

The legalization of cannabis in Canada has accelerated the need for a standardized approach to measuring and communicating the amount of delta-9-tetrahydrocannabinol (THC) in cannabis products. This article offers an overview of the considerations associated with establishing and implementing a standard THC unit in the Canadian context. The article begins by discussing the applications of a standard THC unit, emphasizing its potential use in product labelling, consumer education, and product reporting and surveillance. The article then examines key considerations for identifying what a Canadian THC unit should be set at, specifically within the context of a country with a regulated commercial cannabis market. This is followed by a discussion of additional considerations related to the adoption of a Canadian THC unit, including its use across various product formats and modes of administration. A significant focus of this article is on prioritizing public health and safety and informed decision-making among adult consumers as the legal cannabis market evolves. Collaboration among various stakeholders, such as government agencies, industry, and public health professionals, is highlighted as crucial for a successful transition to the use of Canada's THC unit.

The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures.

PURPOSE: To evaluate the impact of rescheduling hydrocodone combination products (HCPs) from schedule III of the Controlled Substances Act to the more restrictive schedule II on unintentional pediatric exposures (≤5 years old). METHODS: Using U.S. data on outpatient retail pharmacy dispensing, emergency department (ED) visits, and poison center (PC) exposure cases, we assessed trends in prescriptions dispensed and unintentional pediatric exposure cases involving hydrocodone (rescheduled from III to II) compared to oxycodone (schedule II) and codeine (schedule III for combination products) using descriptive and interrupted time-series (ITS) analyses during the 16 quarters before and after the October 2014 rescheduling of HCPs. RESULTS: Dispensing of hydrocodone products was declining before rescheduling but declined more steeply post-rescheduling. In ITS analyses, both hydrocodone and oxycodone had significant slope decreases in PC case rates in the post versus pre-period that was larger for hydrocodone, while codeine had a small but significant slope increase in PC case rates. An estimated 4202 ED visits for pediatric hydrocodone exposures occurred in the pre-period and 2090 visits occurred in the post-period, a significant decrease of 50.3%. Oxycodone exposures showed no significant decrease. CONCLUSIONS: Pediatric hydrocodone unintentional exposure ED visits and PC cases decreased after HCP rescheduling more than would be expected had the pre-rescheduling trend continued; the acceleration in the decrease in hydrocodone PC cases was partially offset by a slowing in the decrease in codeine-involved cases. The trend changes were likely due to multiple factors, including changes in dispensing that followed the rescheduling. Unintentional pediatric medication exposures and poisonings remain a public health concern requiring ongoing, multifaceted mitigation efforts.

Diverting Data and Drugs: A Narrative Review of the Mallinckrodt Documents.

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.

Navigating the nexus between British Columbia's public consumption and decriminalization policies of illegal drugs.

In January 2023, the province of British Columbia (BC) decriminalized the possession of certain illegal drugs for personal use. The province's primary intent was to reduce the stigma associated with drug use, as well as barriers for people who use drugs (PWUD) to access treatment and supports. However, less than ten months into the decriminalization policy, due to growing concerns about public safety voiced by municipal governments and communities, the provincial government made amendments to the policy to ban the public consumption of illicit drugs in additional locations, and subsequently introduced additional legislation, Bill 34, aimed at regulating public consumption of drugs in public spaces. Some communities have also implemented local bylaws similarly regulating public drug use. Bill 34 and local bylaws may serve as tools to promote community health and safety and minimize direct and indirect harms associated with public drug use. However, such legislation may re-criminalize PWUD and reinforce negative perceptions surrounding drug use, especially if these policies are not paired with strategies to expand the availability and accessibility of critical harm reduction and housing services. Without ample access to these services, limitations on public drug use can potentially displace individuals to areas where they are more likely to use alone, further exposing them to substance use-related harms, and undermining the goals of decriminalization. The potential effects of these restrictions may also disproportionately impact marginalized populations. As of April 2024, Bill 34 remains on hold. Moving forward, it will be important to monitor this bill, as well as other public consumption bylaws and legislation, and their impact on BC's overall decriminalization initiative. Decision-makers are urged to increase engagement with PWUD and relevant stakeholders in the design and implementation of policies pertaining to public consumption to ensure that they effectively address the evolving needs and realities of PWUD, and align with decriminalization goals.

How Does Narcotic Control Impact upon Human Individual Rights: An Islamic and International Human Rights Perspectives.

Illegal trafficking of narcotics and problems associated with illegal substance abuse have attracted great deal of attention over the years. However, there are concerns about how to solve this problem while still respecting individual rights. In general terms, it has been alleged by numerous international observers that in many instances human rights have not been fully respected or observed in the fight against illicit drugs. When it comes to Shari'a law, the fundamental premise is that narcotics abuse and trafficking is clearly in violation of Islamic principles. This article highlights the importance of adopting a human rights-based approach to policies regarding narcotics and discusses the potential conflict and the State's obligation to enforce laws which protect their citizens with individual citizen's rights. It focuses on Islamic laws and takes Saudi Arabia as an example given the fact that the Saudi Arabia bases its constitution on Sharia.

The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report.

In the Netherlands, drug regulatory science is a vibrant national and internationally oriented community. In this review, we present the factors that have contributed to this successful collaboration between relevant stakeholders and that led to a surge of activities around how regulatory science became embedded in the ecosystem of medicines research, clinical pharmacology, policymaking and regulation. We distinguished three pivotal episodes: (i) TI Pharma Escher-project, (ii) Dutch Medicines Evaluation Board as catalyst of the big jump, and (iii) Regulatory Science Network Netherlands and multistakeholder engagement. The research agenda has been influenced by the dynamic evolution of legal frameworks in Europe, such as the EU orphan medicines legislation of 2001 and the EU pharmacovigilance legislation of 2012. All these developments have inspired and have raised pertinent regulatory sciences questions. Furthermore, clinical pharmacology as a discipline has been very influential in shaping regulatory science, contributing to discussions on the level of clinical evidence that is necessary to justify marketing approval of a new medicine. With a growing interest of multiple parties such as academics, European Medicines Agency, national agencies, patient organizations and EFPIA, connecting regulatory science activities is key.

Towards a social harm approach in drug policy.

In this paper, we explore how the social harm approach can be adapted within drug policy scholarship. Since the mid-2000s, a group of critical criminologists have moved beyond the concept of crime and criminology, towards the study of social harm. This turn proceeds decades of research that highlights the inequities within the criminal legal system, the formation of laws that protect the privileged and punish the disadvantaged, and the systemic challenge of the effectiveness of retribution and punishment at addressing harm in the community. The purpose of this paper is to first identify parallels between the social harm approach and critical drug scholarship, and second to advocate for the adoption of a social harm lens in drug policy scholarship. In the paper, we draw out the similarities between social harm and drug policy literatures, as well as outline what the study of social harm can bring to an analysis of drug policy. This includes a discussion on the ontology of drug crime, the myth of drug crime and the ineffective use of the crime control system in response to drug use. The paper then discusses how these conversations in critical criminology and critical drugs scholarship can be brought together to inform future drug policy research. This reflection details the link between social harm and the impingement of human flourishing, explores the role of decolonizing drug policy, advocates for the centralization of lived experience within the research process and outlines how this might align with harm reduction approaches. We conclude by arguing that the social harm approach challenges the idea that neutrality is the goal in drug policy and explicitly seeks to expand new avenues in activist research and social justice approaches to policymaking.