How Should the Use of Opioids Be Regulated to Motivate Better Clinical Practice?

This article describes historical and political reasons for-and devastating consequences of-US opioid prescribing policy since the 1990s, which has restricted opioid prescribing for pain less than for treating opioid use disorder (OUD) treatment. This article considers merits and drawbacks of a new diagnostic category and proposes a regulatory and clinical framework for prescribing long-term opioid therapy for pain and for prescribing opioids to treat OUD.

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.

"In Sweden you are worthless. In Denmark you get an identity again" - on being perceived and received as a person who uses drugs in different drug policy settings.

BACKGROUND: Policies to address substance use differ greatly between settings, where goals may range from zero-tolerance to harm reduction. Different approaches impact formats of care, policing, and even interpersonal interactions, and may play a role in the labelling and stigmatization of people who use drugs (PWUD). Where Sweden has a more restrictive policy, aiming to have a society free from drugs, Denmark has embraced harm reduction principles. The aim of this study was to explore PWUDs' experiences of interpersonal interactions, policing, and service formats in the two countries. METHODS: The data consists of 17 qualitative semi-structured interviews with Swedish PWUD who have been in both Sweden and Denmark. Recruitment took place at harm reduction sites in both countries, and through snowball sampling. RESULTS: Participants reflected on how they were perceived by those in public spaces, and received by care systems and personnel. In public settings in Sweden, participants felt they were ignored, rendered invisible, and lost their humanity. In Denmark, they were perceived and acknowledged, valued as people. This was simultaneously linked to being embodied by the availability of differing service offerings and policing practices, which solidified their "right to be out" in public. Reflecting on their reception in the treatment system, strict formatting in Sweden caused participants to feel that an identity was projected upon them, limiting their opportunities or growth of new facets of identity. Care relations in Denmark fostered more opportunity for autonomy and trust. CONCLUSION: A zero-tolerance policy and associated public discourses could solidify and universalize stigmatizing categorizations as a central feature of PWUD identity and reception from those around them, exacerbating social exclusion. Conversely, harm reduction-centered policies fostered positive interactions between individuals with care providers, public, and police, which may promote inclusion, empowerment, and wellbeing.

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.

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.

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 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.

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.

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.

'It has gotten a lot better, but it is still bad': Experiences with the police among marginalized PWUDs in a context of depenalization.

Based on a survey (n = 249) and qualitative interviews (n = 38) with marginalized people who use drugs (PWUDs) in Copenhagen, Denmark, we investigate the experiences of this group with the police in a context where drug possession had been depenalized in and around drug consumption rooms (DCRs). Our findings point to positive experiences with the police, especially with the local community police in the depenalization zone, who refrained from drug law enforcement and practiced 'harm reduction policing.' However, marginalized PWUDs also reported that they were still targeted for drug possession by other sections of the police despite the depenalization policy. Specifically, the drug squad of the police would continue to confiscate illicit drugs for investigatory purposes to counter organized drug crime, as well as continue to target user-dealers who were not formally included in the depenalization policy. The findings illustrate how marginalized PWUDs still found themselves in a precarious legal situation without any legal rights to possess the drugs that they were dependent on, even though possession of drugs had been depenalized in and around DCRs.

Acceptability and anticipated effectiveness of a safe supply of opioids, among people who inject opioids in King County, WA.

BACKGROUND: Opioid overdose mortality in the US has exceeded one million deaths over the last two decades. A regulated opioid supply may help prevent future overdose deaths by reducing exposure to the unregulated opioid supply. We examined the acceptability, delivery model preference, and anticipated effectiveness of different regulated opioid models among people in the Seattle area who inject opioids. METHODS: We enrolled people who inject drugs in the 2022 Seattle-area National HIV Behavior Surveillance (NHBS) survey. Participants were recruited between July and December 2022 using respondent-driven sampling. Participants who reported injecting opioids (N = 453) were asked whether regulated opioids would be acceptable, their preferred model of receiving regulated opioids, and the anticipated change in individual overdose risk from accessing a regulated opioid supply. RESULTS: In total, 369 (81 %) participants who injected opioids reported that a regulated opioid supply would be acceptable to them. Of the 369 who found a regulated opioid supply to be acceptable, the plurality preferred a take-home model where drugs are prescribed (35 %), followed closely by a dispensary model that required no prescription (28 %), and a prescribed model where drugs need to be consumed on site (13 %), a model where no prescription is required and drugs can be accessed in a community setting with a one-time upfront payment was the least preferred model (5 %). Most participants (69 %) indicated that receiving a regulated opioid supply would be "a lot less risky" than their current supply, 20 % said, "a little less risky", 10 % said no difference, and 1 % said a little or a lot more risky. CONCLUSION: A regulated opioid supply would be acceptable to most participants, and participants reported it would greatly reduce their risk of overdose. As overdose deaths continue to increase in Washington state pragmatic and effective solutions that reduce exposure to unregulated drugs are needed.

Uneven effects of twenty years of Chile's cannabis policy implementation in cannabis onset.

BACKGROUND: In Chile, Laws 19366 and 20000, implemented in 1995 and 2005 respectively, regulated and sanctioned cannabis' personal use, cultivation and trafficking. METHODS: We use thirteen biannual cross-sectional national surveys data from 1994 to 2018 to examine the effect of Laws 19366 and 20000-using the rate of individuals incarcerated per 100000 population due to drug-related crimes as proxy-on the age of onset of cannabis use over time. We estimate the effect of these policies using a mixed proportional hazards framework that models the transition to first cannabis use in 47,832 individuals aged 12-21. RESULTS: Overall, changes in these laws did not affect the transition to first cannabis use. However, increases in the rate of individuals incarcerated were associated with decreases on the age of onset of cannabis use in females and individuals living in affluent neighborhoods or in specific regions. CONCLUSION: We find no evidence of cannabis policy changes affecting the age of onset of cannabis use across all individuals aged 12-21. Policy effects associated with decreases in cannabis onset age in females and individuals from affluent neighborhoods or specific regions can be explained by using theoretical frames that recognize specific dynamics of cannabis supply and demand.

Factors influencing the effects of policies and interventions to promote the appropriate use of medicines in high-income countries: A rapid realist review.

BACKGROUND: The appropriate use of medicines has long been recognized as a fundamental component of medicine policies. We aimed to extract lessons from published research on how policy contexts and mechanisms can affect the outcomes of national- or health-system level interventions to promote appropriate medicine use (defined as an increase in underutilized medications or decrease in inappropriate medication use). METHODS: We conducted a rapid realist review of published evidence concerning system-level policies to promote the appropriate use of medicines in high-income countries with universal prescription drug coverage. We searched MEDLINE and Embase to identify relevant publications. We used a realist evaluation framework to identify contexts, mechanisms, and outcomes for each intervention and to hypothesize which policy contexts and mechanisms supported successful outcomes in terms of relative changes in the prevalence of use of the specific medication classes targeted. RESULTS: From 1,318 identified studies, 18 met our inclusion criteria. 13 distinct policies were identified. Three main policy-related factors underpinned successful interventions: involving providers and patients through program interventions; central coordination through national agencies dedicated to medicine policies; and the establishment of an explicit and integrated national medicine policy strategy. CONCLUSION: Policymakers can improve coordination of national pharmaceutical policies to reduce harms from inappropriate medicines use, thus improving health outcomes through cost-effective programs.