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Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease‐related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice. [ABSTRACT FROM AUTHOR]

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country’s domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance. [ABSTRACT FROM AUTHOR]

Through literature retrieval summary, this paper has analyzed the progress of medicine supply policy for rare disease drug in China in the past 5 years and the patterns of medicine supply policy for rare disease drugs implemented by various local governments. The United States and other developed countries have an early start in the definition, regulations and drug development incentives of rare diseases, and also have established a relatively robust system of medicine supply for rare disease. China is gradually establishing medicine supply policy for rare disease drug to promote access to medicines for patients with rare diseases. In order to establish a systematic policy system for rare diseases, this paper proposes that China can further promote the improvement from the aspects of system guarantee, resource guarantee and implementation guarantee to ensure drug accessibility for patients with rare diseases. [ABSTRACT FROM AUTHOR]

Objective: The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme's interaction with the communications of health professionals and buyer's clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme. Methods: An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer's clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines. Results: Representations made directly to the public by health practitioners or on buyer's clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws. Conclusions: The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer's clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action. What is known about the topic?. The personal importation scheme has not been studied extensively. This paper investigates whether recent updates to the advertising laws will affect the operation of the personal importation scheme and health practitioners' ability to refer to it in public. What does this paper add? This paper represents the first ever analysis of the way in which the personal importation scheme interacts with health practitioners' statements, buyer's clubs, and the internet. What are the implications for practitioners ? The study finds that health practitioners who promote the availability of unapproved medicines through the personal importation scheme outside professional consultations are likely to be liable to enforcement action from the Therapeutic Goods Administration. [ABSTRACT FROM AUTHOR]

This systematic review explored the multifaceted impact of drug price regulation on patient access to essential medicines. Recognizing the complexity of this relationship, the paper investigates the influence of various types of drug price regulation mechanisms, the disparities across different geographical regions and health-care systems, and the differential effects between branded and generic drugs. Our findings illustrate that the effects of drug price regulation are not universally uniform or predictable, but rather, they are highly context dependent. Direct price control measures can, on the one hand, improve accessibility through affordability; yet on the other hand, potentially disrupt drug supply. Indirect price control methods, such as reference pricing and value-based pricing, while designed to spur competition, can be hampered by administrative complexities and potentially stifle pharmaceutical innovation. Despite the pervasive use of drug price regulation, access to essential medicines remains disparate and inequitable, indicating a need for a comprehensive approach that includes health system reforms, improved health literacy, and greater collaboration between stakeholders. Future research should further investigate the enduring disparities in patient access to medicines, the long-term effects of various pricing mechanisms, and their interplay with the evolving pharmaceutical industry and health-care landscapes. [ABSTRACT FROM AUTHOR]

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow. [ABSTRACT FROM AUTHOR]

The medicalisation of marijuana has occurred rapidly, albeit nonuniformly, across the US and around the world over the past 3 decades. This paper centres on the medicalisation of marijuana in Minnesota—which has one of the most restrictive programs in the country—as a case for evaluating the negotiation of institutional boundaries with the shift from criminalisation to medicalisation after nearly a century of criminal prohibition. Drawing upon Foucauldian discourse analyses of the medical and law enforcement associations' position statements and legislative hearings that shaped medical marijuana policy in Minnesota, this paper demonstrates a symbiotic convergence between medicine and law enforcement through the deployment of shared discursive strategies in their opposition to medical marijuana that reinforce marijuana's criminalised status by solidifying the boundaries between proper medicine and dangerous drugs. Criminal justice and medical institutions draw upon one another's definitions, logics, and practices in a mutually constitutive manner, while still maintaining distinct user subjects and institutional interventions for each based on the user's access to state‐approved forms of marijuana. The consequences for the governing of marijuana in Minnesota are explored, as well as the broader implications for the sociological study of medicalisation and criminalisation with respect to the governance of drugs and health. [ABSTRACT FROM AUTHOR]

Throughout history, medicinal and aromatic plants have been used extensively to cure a variety of ailments. This article provides a comprehensive overview of Cannabis sativa, specifically focusing on its legislative status, decriminalization, phytochemistry, antimicrobial activity, and safety. The study begins by briefly outlining the plant's history, including its cultivation, harvesting, and storage methods. The review analyzes extensively the antimicrobial properties of Cannabis sativa and its derivatives, specifically examining their reported antiviral, antibacterial, antifungal, and antiparasitic capabilities, which have been documented in databases such as Scopus, ScienceDirect, PubMed, and Web of Science. The paper also discusses trends in studies about the plant object of the study, the different bioactive compounds that were identified in the plant (phenolic acids, flavonoids, alkaloids, cannabinoids, and terpenes), and safe consumption in several cannabis-based products including candies, desserts, wine and as food flavoring. Furthermore, this study has reported information about the legalization and decriminalization of cannabis use across the globe with a specific focus on Morocco because it has the largest cultivated area of C. sativa plant. However, some substances with potential antimicrobial properties were not investigated in this review due to the lack of data on their activity. The authors hope that their efforts will inspire future studies on the therapeutic uses of Cannabis sativa and its derivatives, ultimately leading to improved health outcomes. [ABSTRACT FROM AUTHOR]

Thailand's antimicrobial stewardship strategy has focussed on promoting 'rational drug use' in the public sector, to reduce the threat of drug resistance and control healthcare expenditure. The strategy's next ambition is to attend to the private sector, where antibiotics are widely available over the counter without prescription. Using ethnographic and survey data, this paper follows antibiotics through community pharmacies, to explore drug distribution and access, and identify potential challenges for stewardship. We extend the analytical frame beyond 'irrational' dispenser-customer transactions, to explore the logics of practice of a multiplicity of actors in the context of a highly competitive pharmaceutical market. Highlighting the role of the pharmaceutical industry in mystifying medicines, we show how antibiotics are collapsed into a category of 'strong medicines' and requested by customers using 'prescriptions by proxy'. We further examine how Thailand's drug regulation and classificatory systems, historically orientated around access to medicines, enable the proliferation of antibiotics in the context of contemporary efforts to control distribution. Recognising the negotiations involved in dispensing antibiotics in a pluralistic health system, we attempt to reconfigure allocations of responsibility, advocating for stewardship approaches that take into account local ecologies of care, as well as implications for access, equity, and accountability. [ABSTRACT FROM AUTHOR]

Global momentum for drug law reform is building. But how might such reform be achieved? Many argue that human rights offer a possible normative framework for guiding such reform. There has been very little research on whether human rights processes can actually achieve such aims, however. This paper responds to this knowledge gap. It explores how one human rights mechanism—the "parliamentary rights scrutiny process"—deals with alcohol and other drugs. We consider how four Australian parliaments scrutinized proposed new laws that would deal with alcohol and other drugs for their human rights "compatibility." We find that laws that would limit the rights of people who use alcohol and other drugs were routinely seen as justifiable on the basis that alcohol and other drugs were inherently "unsafe." Crucially, safety was conceptualized in a gender-neutral way, without regard to the potential role of gender, including specific masculinities, in the production of phenomena such as family violence and sexual violence and other public safety problems. Instead, such problems were regularly constituted as consequences, simply, of alcohol or other drug consumption. In making this argument, we build on the pioneering work of David Moore and colleagues (e.g., 2020). Their work asks important questions about how the causes of violence are constituted across different settings, including research and policy. Drawing on ideas from scholars such as Carol Bacchi and John Law, they identify "gendering practices" and "collateral realities" in research and policy on violence, in which the role of men and masculinities are routinely obscured, displaced or rendered invisible. We find similar problems underway within human rights law. In highlighting these gendering practices and collateral realities, we aim to draw attention to the limitations of some human rights processes and the need for more work in this area. [ABSTRACT FROM AUTHOR]

Although college enrollment and completion rates have increased over the past 30 years, access to higher education has not been uniform across racial groups. In addition to racial gaps, differences in tertiary education outcomes exist by gender. Gender gaps in college enrollment are larger in the Latinx community than in other racial or ethnic groups. In this paper, we use the October Current Population Survey (CPS) supplements for the years 1984–1992 and state and federal drug laws to measure the impact of the passage of the 1986 Anti-Drug Abuse Act on the likelihood of college enrollment for young Latino men. Following the passage of the federal law, some states changed their drug laws around marijuana and cocaine possession and distribution. We use this variation in state law in order to explore whether states that have more lenient marijuana and cocaine laws also have a higher likelihood of college enrollment. We find that there was a four percentage point decline in both the likelihood of high school completion and that of college enrollment for Latinx men after the passage of the 1986 Anti-Drug Abuse Act. Findings have implications for modifications to state drug laws and addressing the ways in which these laws impact educational attainment for students underrepresented in higher education. [ABSTRACT FROM AUTHOR]

This paper uses SIDE theory and an information seeking lens to examine the types of information and support messages (N = 126,977 posts) veterans seek on the social networking site Reddit regarding medical marijuana use. A combination of automated text analysis strategies paired with thematic analysis produced eight themes: Doctor Patient Conversations, Drug Test, Legality, Legal Policy, Prescription Drug Use/Other Substance Use, Point of View, Reasons for Use, and V.A. Findings reveal that a large portion of veterans discuss how medical marijuana can be used to self-medicate for a number of issues, including PTSD, anxiety, and sleep deprivation. Results also highlighted missing topics within veterans' conversations about medical marijuana use. For instance, veterans rarely discuss the strategies they use to talk to their doctor about their medical marijuana use. Practical implications and directions for future research are offered. [ABSTRACT FROM AUTHOR]

Many nations and jurisdictions have legalized non-medical adult use of cannabis, or are considering doing so. This paper contributes to knowledge of adult use legalization's associations with cannabis use disorder (CUD) treatment utilization. This study collected data from a dataset of all publicly funded substance use disorder treatment delivered in California from 2010 to 2021 (1,460,066 episodes). A logistic regression model estimates adult use legalization's impacts on CUD treatment utilization using an individual-level pre-post time series model, including individual and county-level characteristics and county and year-fixed effects. Adult use legalization was associated with a significant decrease in the probability of admission to CUD treatment (average marginal effect (AME): −0.005, 95 % CI: −0.009, 0.000). Adult use legalization was also associated with a decrease in the probability of admission to CUD treatment for males (AME: −0.025, 95 % CI: −0.027, −0.023) Medi-Cal beneficiaries (AME: −0.025, 95 % CI: −0.027, −0.023) adults ages 21+ (AME: −0.011, 95 % CI: −0.014, −0.009) and Whites (AME: −0.012, 95 % CI: −0.015, −0.010), and an increase in the probability of admission to CUD treatment for patients referred from the criminal justice system (AME: 0.017, 95 % CI: 0.015, 0.020) and Blacks (AME: 0.004, 95 % CI: 0.000, 0.007) and Hispanics (AME: 0.009, 95 % CI: 0.006, 0.011). Adult use legalization is associated with declining CUD treatment admissions, even though cannabis-related problems are becoming more prevalent. Policies and practices that protect public health, and engage people with CUD in treatment are needed. • Pre-legalization, 19 % of SUD admissions were CUD, compared to 9 % post-legalization. • Adult use legalization was associated with a decrease in CUD treatment admissions. • Differences existed in legalization's associations on different demographic groups. [ABSTRACT FROM AUTHOR]

Synthetic cannabinoids (i.e. Spice) are a major public health problem in UK prisons, however, research in this area is limited. Here we aimed to draw comparisons between people with and without experience of using synthetic cannabinoids in prison, to characterise the features of, and motivations for use within this setting and evaluate support for different treatment interventions. Questionnaires were administered to 122 people in a category-B prison for adult males in England between July 2022 and March 2023. Participants were asked questions related to their sociodemographic and custodial characteristics, use of synthetic cannabinoids (and other drugs) inside and outside of prison and psychological distress was measured via the Brief Symptom Inventory (BSI-18). Those that had ever used synthetic cannabinoids in prison completed additional questions related to features of use, motivations for use and support for various interventions. In total 46.7 % (n = 57) of participants reported use of synthetic cannabinoids in prison and this group experienced significantly greater levels of psychological distress compared to those reporting no use (mean (± standard deviation) BSI-18 scores = 23.7 (±16.7) vs 12.8 (±13.6), p < 0.001). Participants mostly reported using paper-based preparations (77.4 %) and use via e-cigarettes (75.9 %). The most strongly endorsed motivations for use included to alleviate boredom (91.1 % strongly agree/agree), to make the sentence pass faster (89.3 % strongly agree/agree) and to cope with stress (80.4 % strongly agree/agree). The interventions that received most support were strategies to better manage time and medication to manage withdrawal. The use of synthetic cannabinoids in UK prisons typically involves the use of paper-based preparations via e-cigarettes, and use is associated with greater levels of psychological distress. Motivations for use were mostly pragmatic (e.g. to alleviate boredom or cope with stress) and interventions should prioritise increasing the time individuals spend out of cells and in meaningful activity. [ABSTRACT FROM AUTHOR]

Cannabis liberalization is a fascinating case study in moral-legal re-negotiation. From broad international examples of decriminalization to specific local legalization models, numerous criminological questions are emerging. This paper describes three significant challenges for cannabis liberalization. These include persistent inequalities associated with policing cannabis, the invisibility of coercive care and control within diversion, and the hazards associated with illusory policy reform. We present Cannabis Criminology as a multidisciplinary effort to understand the prohibition, decriminalization, legalization, and nascent regulation of cannabis in ways that acknowledge but transcend law-based paradigms. Consistent with criminology's multiple and sometimes contradictory dimensions, we outline five thematic areas that can inform the study of cannabis. These include law, society, and social control, police and policing cannabis, race, ethnicity and intrusion, the economics of cannabis use, and cannabis and criminal behavior. Finally, we conclude that privileging the views of people who use cannabis can provoke more inclusive, participatory, and otherwise imaginative efforts. [ABSTRACT FROM AUTHOR]

In both the United Kingdom and United States of America legislation has been proposed or enacted which claims to provide patients with a 'right' of access to experimental drugs and treatments where there is no other hope. In this paper we will explore this narrative and consider the steps taken in the United States to shift to a more rights driven legal framework. The paper will critically assess the United States model and the similarly framed 'Saatchi' model in the United Kingdom; demonstrating that, despite the rights-based narrative, these laws do not represent a significant change in access to treatment for patients. Rather, the reality is that this 'right to try' paradigm represents a patient advocate narrative that is deeply flawed. It fails to implement any meaningful change, exposes vulnerable patients to risk of harm and, potentially, delays safe development of potentially life-saving treatment regimes. [ABSTRACT FROM AUTHOR]

The paper focuses on the development of a multifractal theoretical model for explaining drug release dynamics (drug release laws and drug release mechanisms of cellular and channel-type) through scale transitions in scale space correlated with experimental data. The mathematical model has been developed for a hydrogel system prepared from chitosan and an antimicrobial aldehyde via covalent imine bonds. The reversible nature of the imine linkage points for a progressive release of the antimicrobial aldehyde is controlled by the reaction equilibrium shifting to the reagents, which in turn is triggered by aldehyde consumption in the inhibition of the microbial growth. The development of the mathematical model considers the release dynamic of the aldehyde in the scale space. Because the release behavior is dictated by the intrinsic properties of the polymer–drug complex system, they were explained in scale space, showing that various drug release dynamics laws can be associated with scale transitions. Moreover, the functionality of a Schrödinger-type differential equation in the same scale space reveals drug release mechanisms of channels and cellular types. These mechanisms are conditioned by the intensity of the polymer–drug interactions. It was demonstrated that the proposed mathematical model confirmed a prolonged release of the aldehyde, respecting the trend established by in vitro release experiments. At the same time, the properties of the hydrogel recommend its application in patients with intrauterine adhesions (IUAs) complicated by chronic endometritis as an alternative to the traditional antibiotics or antifungals. [ABSTRACT FROM AUTHOR]

The word "psychedelic" (psyche (i.e., the mind or soul) and delos (i.e., to show)) has Greek origin and was first coined by psychiatrist Humphry Osmond in 1956, who had been conducting research on lysergic acid diethylamide (LSD) at the time. Psychedelic drugs such as N,N-DMT/DMT (N,N-dimethyltryptamine), 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine), LSD (lysergic acid diethylamide), MDMA (3,4-methylenedioxymethamphetamine) and psilocybin have had significant value as an entheogen in spiritual, religious (shamanic) and sociocultural rituals in Central and South American cultures for thousands of years. In the 1960s, the globalization of these drugs and their subsequent spread outside of their indigenous, old-world cultures, led to the subsequent implementation of strict drug control laws in many Western countries. Even today, psychedelics are still classified as Schedule I drugs, resulting in a still lingering negative stigmatization/perception, vilification, and ultimate criminalization of psychedelics. This controversy still lingers and still limits scientific research and full medical acceptance. For many years up until recently, the spiritual, religious and medicinal value of these drugs could not be explored in a scientific context. More recently, a second wave of psychedelic research is now focusing on psychedelics as neuropharmaceuticals to treat alcohol and tobacco addiction, general mood and anxiety disorders and cancer-related depression. There is now a vast array of promising evidence-based data to confirm the years of anecdotal evidence of the medicinal values of psychedelics. Natural therapeutic alternatives such as psychedelic drugs may provide a safe and efficacious alternate to conventional drugs used to treat mood and anxiety disorders. In a Western context in particular, psychedelic drugs as therapeutic agents for mood and anxiety disorders are becoming increasingly of interest amidst increasing rates of such disorders globally, changing social constructions, the implementation of government regulations and increasing investment opportunities, that ultimately allow for the scientific study to generate evidenced-based data. Alternative psychotherapeutic interventions are gaining interest also, because of their low physiological toxicity, relatively low abuse potential, safe psychological effects, and no associated persisting adverse physiological or psychological effects during and after use. On the other hand, conventional psychotic drugs and anti-depressants are becoming less favorable because of their adverse side effects. Psychedelic neuropharmaceutical interventions may with medical oversight be the solution to conventional psychiatric disorders such as depression and anxiety, and an alternative to conventional psychiatric treatment options. This paper will review the therapeutic potential of psychedelic drugs as alternative therapeutic options for mood and anxiety disorders in a controlled, clinical setting, where the chances of adverse psychological episodes occurring are mitigated. [ABSTRACT FROM AUTHOR]

This paper reflects on some of the ethical dilemmas that social workers face when assessing risk in relation to those using substances. It explores how legislation and societal factors can impact not just on people's choices and decisions but also on their 'vulnerability' and access to services. Vulnerability, a contested term, is linked, in this paper, to assessment of risk. There are ethical issues that arise when assessing risk with people who use Anabolic Androgenic Steroids (AAS) from both service user and professional perspectives. These ethical issues concern a person's right to choose and make potentially harmful decisions. The paper argues that using substances such as AAS in and of itself does not suffice to make a person vulnerable but this does not mean that people using AAS are not in need of support. It suggests that there may be some groups of people who are more at risk to starting AAS use and that social workers should be aware of these. It also recommends the need for further qualitative research to understand the reasons for starting use and support to help people stop using AAS. [ABSTRACT FROM AUTHOR]

• First trends analysis of data from the national Canadian Cannabis Survey. • Past-year cannabis use increased since non-medical cannabis legalization in Canada. • The proportion of past-year consumers using cannabis frequently is unchanged. • Past-year use of edibles, drinks and vape pens/cartridges has increased. • Legal purchasing is displacing the illicit cannabis market in Canada. Cannabis use for non-medical purposes was legalized and regulated in Canada through the Cannabis Act in October 2018. This paper examined trends in use of cannabis for non-medical purposes and related indicators from pre- to post-legalization in Canada (2018–2022). Data from 5 years of the Canadian Cannabis Survey, an annual web-based survey administered to Canadians 16 years of age or older, were used in the analysis (n 2018 =12,952; n 2019 =11,922; n 2020 =10,821; n 2021 =10,733; n 2022 =10,048). Cannabis measures include questions about use, types of products, sources, risk perceptions and beliefs, and exposure to public education campaigns and health warnings. Adjusted logistic regression models tested differences in outcomes over time. Past 12-month cannabis consumption increased among Canadians from 22 % in 2018 to 27 % in 2022 (AOR=1.41;99 % CI:1.28–1.54). Similarly, daily/almost daily (DAD) consumption increased from 5 % in 2018 to 7 % in 2022 (AOR=1.36;99 % CI:1.16–1.59). Consumption of dried flower, hash/kief, and concentrates/extracts (e.g., wax, shatter, budder) decreased since 2018, whereas consumption of edibles, beverages and vape pens/cartridges increased (p < 0.001). Legal purchasing increased from 4 % in 2018 to 69 % in 2022, while accessing cannabis through social and illegal sources decreased over time (p < 0.001). More Canadians are reporting cannabis consumption since legalization and regulation of cannabis for non-medical purposes, continuing a pre-existing trend despite an increase in awareness of the risks of consuming cannabis. Trends in product use indicate a transition from dried flower and concentrates/extracts towards consumption of cannabis foods, drinks and vape pens/cartridges. The legal market is increasingly displacing the illicit cannabis market in Canada. [ABSTRACT FROM AUTHOR]

There have been several recent commentaries which have highlighted the relevance of the postcolonial perspective to drug prohibition and called for the decolonisation of drug policy (Daniels et al., 2021 ; Hillier, Winkler & Lavallée, 2020 ; Lasco, 2022 ; Mills, 2019). While these are significant interventions in the field, sparse drugs scholarship has engaged more directly with well-developed literature and concepts from Critical Indigenous Studies (Moreton-Robinson, 2016) and Indigenous Standpoint Theory (Moreton-Robinson, 2013 ; Nakata, 2007) and reflected on its applicability to the drug and alcohol field. In contrast to the postcolonial perspective, which understands colonisation as a historical event with contemporary impacts, Indigenous scholarship conceptualises colonisation as an active and ongoing part of how the settler-state continues to impose itself. From this vantage point I explore coloniality as a system of power and reflect on the way prohibition acts as a key arm of the settler-colonial state. The paper explores the way concepts like vulnerability, marginality, overrepresentation, disproportionality and addiction involve colonial violence, knowledge practices and narratives which are central to the way coloniality is maintained and continues to assert itself in contemporary settler societies. [ABSTRACT FROM AUTHOR]

Purpose: Access to medication for opioid use disorder (MOUD) varies across the rural-urban continuum. The Hub & Spoke Model (H&S) emerged to address these gaps in service whereby hubs with staff expertise in MOUD support delivery of specialized care to a network of spoke locations, often located in rural communities with workforce shortages. This paper presents a case study of efforts to implement the hub and spoke model in a frontier and rural (FAR) state: Montana. Methods: The primary data are structured interviews with 65 MOUD program staff in hub and spoke locations within Montana. Both inductive and deductive coding were used to analyze the transcripts. Findings: Using the H&S structure to expand access to MOUD in Montana led to mixed results. There were consistent themes identified in the interviews about the reasons why hubs struggled to successfully recruit spokes, including (1) geographic barriers, (2) a lack of interest among medical providers, (3) fears about excessive demand, (4) concerns about the financial viability of the model, and (5) a preference for informal technical assistance rather than a formal H&S relationship. In addition to these 5 themes, efforts to implement H&S across different medical systems were unsuccessful, whereas the H&S model worked more effectively when H&S locations were within the same organization. Conclusion: This case study identified limits to the H&S model utility in supporting states' abilities to expand access to MOUD treatment and offers suggestions for adapting it to accommodate variation across divergent rural contexts. We conclude with recommendations for strategies that may assist in expansion of MOUD in rural communities that are like those found in Montana. [ABSTRACT FROM AUTHOR]

Widespread use of cannabis as a drug and passage of legislation on its use should lead to an increase in the number of scientific publications on cannabis. The aim of this study was to compare trends in scientific publication for papers on medical cannabis, papers on cannabis in general, and all papers between the years 2000 and 2017. A search of PubMed and Web of Science was conducted. The overall number of scientific publications in PubMed increased 2.5-fold. In contrast, the number of publications on cannabis increased 4.5-fold and the number of publications on medical cannabis increased almost 9-fold. The number of publications on medical cannabis in Web of science increased even more (10-fold). The most significant number of publications was in the field of psychiatry. In the fields of neurology and cancer treatment there was a significant increase in the years 2011–2013. There was a rise in the number of publications on children and the elderly after 2013. The specific indications with the largest number of publications were HIV (261), chronic pain (179), multiple sclerosis (118), nausea and vomiting (102), and epilepsy (88). More than half of the publications on medical cannabis originated from the United States, followed by Canada. More than 66% of the publications were original studies. The spike in the number of scientific publications on medical cannabis since 2013 is encouraging. In light of this trend the authors expect an even greater increase in the number of publications in this area in coming years. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to consider youth gangs and county lines with reference to the current drive for a public health response to these issues. Design/methodology/approach: This viewpoint paper traces the development of gang and serious youth violence responses in England, exploring the shift from a punitive to safeguarding response to young people affected by these issues. Findings: Drawing on the learning from both Scotland and the USA, this paper considers the relevance of a public health model to responding to youth gangs and county lines, highlighting the key facets of such an approach. Originality/value: This paper provides a historical context to the issues surrounding previous responses to youth gangs and goes on to consider the practicalities and relevance of a public health model response. [ABSTRACT FROM AUTHOR]

Background: In the past decades, economic sanctions imposed on Iran for its nuclear program. The embargo made difficulty in foreign trade and led to lack of timely access to medicines. As the internationally-led sanctions caused to the shortage of medicine there, healthcare systems need to applied the new policies for maintaining health service quality especially in pharmaceutical sector. Objectives: This paper is about policies applied in Iran health system during the crisis reached its peak in 2012 as a good experience for guarantying access to pharmaceutical products. Methods: Through interviewing experts and managers in pharmaceutical regulatory system, the implemented policies in targeted historical period were extracted, then quantitative data were analyzed to show the impact of the policies on the access and affordability of medicines before and after their implementation in Iran food and drug administration (IFDA). This paper tries to show strategies employed by to tackle the crisis caused by sanctions and to offer practical policies to make medicines more accessible at the time of crisis. Results: In order to reduce the harmful effects of this crisis, IFDA proposed some changes at different levels ranging from organizational procedures to parliament legislations. The main achievements of IFDA were making drugs easily available are as follows, significantly reducing prices, decreasing the share of market regarding the imported medicines, facilitating the manufacture of domestic medicines, encouraging foreign investment in manufacturing drugs domestically, controlling the shortage of drugs, and finally giving financial support to all patients in general and to those patients who had problem paying for drugs in particular. Conclusion: These experiences which made the Iran pharmaceutical sector survive during the international sanctions, can be considered as a good example of resilience strategies in similar situations. [ABSTRACT FROM AUTHOR]

Graphical abstract Highlights • The importance of adopting a risk-based approach has been tackled. • The analytical quality by design is thoroughly described in every step. • Recent papers regarding the application of a risk-based approach have been reviewed. Abstract Pharmaceutical regulatory bodies increasingly require the implementation of systematic approaches in pharmaceutical product development. Quality control methods play a key role in the control strategy of drugs manufacturing to assure their quality. A risk-based approach in the analytical method development is strongly recommended to ensure that the method performances fit the purpose of the method during its entire life-cycle. In the last decade, analytical quality by design (AQbD), as risk management oriented methodology, has been progressively integrated with method development for fulfilling this objective. This approach has successfully allowed the quality to be designed into the analytical processes by obtaining a deep understanding of the procedures. In this paper the AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed. Recent publications regarding how AQbD has been applied in separation techniques were reviewed. The different development strategies have been also showcased, highlighting their advantages and disadvantages, in order to give a useful overview. [ABSTRACT FROM AUTHOR]

Cannabis legalization in some U.S.A. states has catapulted the mass production of concentrates, with tetrahydrocannabinol (THC) concentrations ranging from 50-90%. A major public health concern is that these products will increase cannabis-related harms such as use disorders, psychotic symptoms, and accidental poisonings. This paper describes and contextualizes the results of a study requested by the WA State Legislature to understand perspectives of WA stakeholders on the topic. Concept Mapping (CM), a mixed-methods research approach that supports people-centered policy decisions was utilized. The goal of the study was to explore stakeholders' concern levels and support of policies to address the availability of high THC cannabis products. For analysis purposes, stakeholders were categorized into three groups: community, professionals, and cannabis advocates. CM generated an inventory of policy ideas for regulating high-potency cannabis from a variety of stakeholders. Notably, stakeholders from community and professional groups supported environmental policy changes such as such as taxation, increasing minimum age for high concentration cannabis products, and advertising prohibition. Meanwhile, cannabis advocates (mostly industry actors) opposed taxation per THC content, proposed lowering taxes, and supported policies with low population impact such as educating parents, teachers, and youth. Support for regulating high concentration THC products varied by stakeholder group. Consistent with how other health compromising industries have historically acted, cannabis industry stakeholders rejected regulation of their products. Future studies should explore non-cannabis industry stakeholders' willingness to work towards minimizing the influence of the cannabis industry in policy development processes to assure public health regulations prevail. [ABSTRACT FROM AUTHOR]

Research on values is gaining in popularity within drug policy scholarship. To date, research has focused on analysing values within policy, through documentary analysis and interviews with key stakeholders. We extend this research enquiry to investigate the values that emerge from drug policy debate with those who have lived and/or living experience of using drugs. We used workshop data collected from the ESRC-funded Drug Policy Voices project as the basis for our analysis. Within the workshops, participants were given a range of drug policy scenarios to discuss. We selected three scenarios for this paper which discussed policies related to cannabis, heroin, and MDMA/ecstasy. We coded the workshop data using Schwartz's ten basic values, which is a framework that perceives values as the core 'motivators of action' that underpin choices, attitudes and behaviours. We found that the values of 'self-direction', 'security' and 'conformity' were prominent across this participant group, when discussing these policy topics. Yet the drug policy preferences discussed in the workshops revealed that it is the combinations of values that nuance preferences. Security combined with self-direction supports policies that enhance personal responsibility for change; self-direction combined with hedonism supports freedom to use drugs, whereas self-direction combined with conformity and achievement supports recovery policies; and conformity combined with tradition and power supports abstinence-based drug prevention. Schwartz's ten basic values provided a useful framework for surfacing values that underpin drug policy preferences. These exploratory findings demonstrate that identifying values within dialogue is a complex process and reinforces opposing values can explain policy preference differences. More importantly, policy preferences were underpinned by combinations of values including those that are apparently opposing in Schwartz's circumplex. [ABSTRACT FROM AUTHOR]

The recent benefit–risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit–risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit–risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators. [ABSTRACT FROM AUTHOR]

Background: In Belgium, Cannabis Social Clubs (CSCs) collectively organize the cultivation and distribution of cannabis for the personal use of their members. In this paper we seek to improve understanding of the motivations and practices of cannabis growers operating within CSCs, shedding light on the cultivation process.Methods: We draw on data gathered through face-to-face semi-structured interviews with the directors of seven active Belgian CSCs (n = 21) and CSC growers (n = 23). These data are complemented by additional fieldwork and a review of policies relating to CSCs', including bylaws and growing protocols.Findings: The Belgian CSCs rely on single and multiple in-house grower arrangements. Most CSC growers had been cultivating cannabis prior to joining their current CSC, albeit growing in different contexts (non-commercial and commercial). The CSC growers discussed both ideological and pragmatic motives for operating within a CSC. Cultivation took place indoors and followed organic practices. Despite their small-scale (20 plants on average), the grow sites used specialized equipment. The growers reported receiving financial compensation to cover production costs.Conclusion: This paper offers new insights into a particular sector of domestic cannabis cultivation - CSC growers and their practices within those collectives - which has not been studied previously. The Belgian CSCs have decentralized production among small-scale grow sites, at a size comparable to that found in other small-scale cultivation studies. In terms of motivations and practices, CSC growers share some features typically ascribed to small-scale cannabis cultivators. At the same time, CSC growers seemed particularly engaged with the CSC model and willing to adhere to the (self-)regulated practices developed by the organizations. This had implications for the way cultivation was organized and for the role of the grower within the CSC. [ABSTRACT FROM AUTHOR]

This paper highlights a significant gender disparity within Ireland’s illicit drug landscape, which is predominantly composed of men. Irish men’s historical gender invisibility contributed to their predominance as drug users being overlooked. Thus, this paper focuses a masculinities lens on Irish men’s recreational use of illicit drugs, making their drug taking visible as a gendered activity. The study utilised a qualitative methodology, with masculinities theory forming the primary theoretical and analytical lens. Nine focus groups were conducted with Irish men exploring their views on illicit drugs. Twenty in-depth interviews were completed with men who identified as illicit recreational drug users, exploring their drug-taking histories and experiences. Findings demonstrate how the use of illicit drugs can symbolically communicate messages about the drug taker. The study reveals masculinities are an interpretative lens employed by men when trying to understand their own or other men’s drug taking. It is argued that men’s drug taking and masculinities intersect. In homosocial contexts, men’s recreational use of illicit drugs can contribute to them demonstrating masculinities to other drug-taking men; however, outside of these contexts, the same behaviours can be viewed by non-drug takers as emasculating. [ABSTRACT FROM AUTHOR]

Background: Antibiotics have played an essential role in decreasing morbidity and mortality from infectious diseases. However, indiscriminate use and unrestricted access is contributing to the emergence of bacterial resistance. This paper reports on a situational analysis of antimicrobial use and resistance in Ghana, with focus on policy and regulation.Methods: Relevant policy documents, reports, regulations and enactments were reviewed. PubMed and Google search engines were used to extract relevant published papers. Websites of stakeholders such as Ministry of Health (MOH) and its agencies were also reviewed. An interview guide was used to elicit responses from selected officials from these sectors.Results: Laws and guidelines to control the use of antimicrobials in humans were available but not for animals. There was no National Antimicrobial Policy (NAP). A health practice regulatory law mandates Physicians, Physician Assistants, Midwives and trained Nurses to prescribe antimicrobials. However, antibiotics are widely prescribed and dispensed by unauthorised persons, suggesting weak enforcement of the laws. Antibiotics were also supplied to and from unapproved medicine outlets. The Standard Treatment Guidelines (STG), Essential Medicines List (EML) and the National Health Insurance Scheme Medicines List (NHISML) provide restrictions regarding levels of prescribing of antimicrobials. However, existing guidelines on antibiotic use are mostly not adhered to. The use of Automatic Stop Orders to avoid wastage in the hospitals is also not practiced. Data on use of antibiotics for individuals are not readily available in most facilities. Again, there are no standards or guidelines on veterinary use of antibiotics. Surveillance systems for consumption of antibiotics and resistance monitoring were not in place in most health facilities. However, there is an ongoing national action to create awareness on bacteria resistance, strengthening knowledge through research and surveillance and development of NAP in line with global action plan on antimicrobial resistance.Conclusion: Absence of national antimicrobial policy, weak regulatory environment and non-adherence to practice standards may have contributed to increased and unregulated access to antimicrobials in Ghana, a catalyst for development and spread of antimicrobial resistance. [ABSTRACT FROM AUTHOR]

Background: Recent decades have seen substantial changes in the UK cannabis landscape, including increased domestic production, the ascendancy of stronger strains (namely 'skunk') and the drug's reclassification under the 1971 Misuse of Drugs Act. Resultantly, cannabis retains significance in the consciousness, priorities and policy agendas of communities, drug services and criminal justice agencies.Methods: This paper presents an empirical study, which examined both perceptions and impacts of cannabis cultivation and its control within a North-West English borough. It draws on qualitative research with samples of professionals, practitioners, resident groups, cannabis users, cannabis users' families and cannabis cultivators themselves.Findings: The findings suggest that cannabis cultivation was not a uniformly familiar concept to respondents, who had limited knowledge and experience of its production. Across all participant groups, the transmission of accurate information was lacking, with individuals instead drawing on the reductionist drug discourse (Taylor, 2016) to fill knowledge deficits. Consequently, some participants conflated cannabis cultivation with wider prohibitionist constructions of drug markets, resulting in the diffusion of misinformation and an amplification of anxieties. In contrast, other participants construed cultivation as making economic sense during austerity, justifying such tolerance through inverse adherence to the same narrow socio-cultural construction of drugs i.e. that cultivation carried comparatively less harms than real drug markets. Enforcement mechanisms also drew on generic prohibitionist conceptions, assuming cultivators to be unconstrained, autonomous actors in need of punishment; a belief which lacked nuanced understanding of the local terrain where vulnerable individuals cultivating under duress played a key role in the supply chain.Conclusion: The paper concludes with a call for the provision of accessible information/education; the need to challenge and reconceptualise the assumed autonomy and resultant punity directed at all cannabis cultivators; and a subsequent need to reassess established forms of legal (and increasingly social) enforcement. [ABSTRACT FROM AUTHOR]

Context Until the last decade of the 20th century, France had no equivalent to the US Food and Drug Administration. In this paper we describe and interpret the complex series of events that led to the passage by the French Parliament in December 1992 of a law incorporating such an agency, the Agence du Médicament (literally, 'medicines agency'). The broad aim of this project was to learn how public health policy change comes about by detailed analysis of a specific instance. More specifically, we aimed to better understand the circumstances under which public health crisis leads to significant public health policy reform. Methods This paper is based on detailed analysis of primary documents (eg, archived French health ministry papers, recorded parliamentary debates, government reports, newspaper articles) and oral history interviews covering a period from 1988 to 1993. Thematic analysis of these materials was initially grounded in theories of organizational change, moving to constructs that emerged from the data themselves. Findings Policy entrepreneurs positioned to frame adverse events and seize opportunities are key to public health policy reform. However, whether these entrepreneurs will have the requisite institutional power is contingent both on political structure and on the power of competing institutional actors. Health crises may catalyze institutional reform, but our analysis suggests that whether reform occurs, or even whether adverse episodes are labeled as crises, is highly contingent on circumstances of history, political structure, and political ideology and is extremely difficult to predict or control. Conclusions Actors positioned to shape public health policy need to have a detailed understanding of the circumstances that facilitate or impede policy reform. Health crises are now more often global than not. Comparative, theoretically grounded, cross-national research that looks in detail at how different countries respond to similar health crises would be extremely valuable in informing both policymakers and researchers. [ABSTRACT FROM AUTHOR]

Background: This paper provides a critical review of the decision‐making process of the Ontario Ministry of Health and Long‐Term Care (MOHLTC) regarding which migraine treatment drugs will be covered under the Ontario Drug Benefit Formulary (ODB). Main Text: Under MOHLTC policy, triptans and OnabotulinumtoxinA are available to patients only through the Exceptional Access Program (EAP). This policy, and justifications for it, are examined with reference to clinical guidelines, patient experiences, and health policy literature. The contexts and consequences of compromised access are outlined. Improvements in access to these treatments are suggested by highlighting how a country with similar healthcare infrastructure – Australia – employs policies that more adequately meet the needs of migraine patients as they secure treatments. Conclusions: Despite clinically significant gains in the discovery of safe and effective migraine‐specific treatments the ODB thus far has failed to align its practice with current clinical recommendations. This forces patients to rely heavily on medication that, while still effective for some, is potentially suboptimal. This review concludes it is prudent, at minimum, to follow clinical recommendations that advocate for the removal of triptans from EAP and recategorize them as Limited Use drugs. Ideally, moving them to a general benefit would further remove the barriers experienced by patients attempting to access this treatment. [ABSTRACT FROM AUTHOR]

• The Norwegian government proposed a drug decriminalization reform. • The shift from the justice sector to the health sector would only be partial. • The police would retain their role in drug law enforcement after the reform. • Illicit drug use continued to be fundamentally pathologized in the proposed reform. • The most profound aspect of the reform was its emphasis on consent in interventions. In 2018 the Norwegian government appointed a committee to prepare the implementation of a drug decriminalization reform. The overall goal of the committee was to propose a model where responsibility for society's response to the use and possession of illegal drugs for personal use would be transferred from the justice sector to the health service, under the catchphrase 'from punishment to help'. While the proposal ultimately did not get the necessary backing in parliament, the proposed reform still constitutes a very comprehensive and recent proposal for reforming national drug policy and it provides an ideal case for studying contemporary discourses on 'drug decriminalization'. The analysis of this reform proposal is guided by the post-structuralist "What's the Problem Represented to be" (WPR) approach, which is used for investigating the problem representation(s) in the proposal, as well as the rationalities, practices and deep-seated assumptions underpinning these. In doing this, the paper explores how the strategy represents both changes and continuities in discourses around illicit drugs and the people who use them. Based on the WPR approach, two problem representations in the proposal are identified: the 'problem of illicit drug use' and the 'problem of criminalization'. However, the 'problem of illicit drug use' is argued to be the authoritative representation, that takes precedence over the other. In that regard, the paper points to how the proposed shift from the justice sector to the health sector would only be partial, given that the role of the police and drug law enforcement would be retained in the reform. Furthermore, the paper points to how illicit drug use continued to be fundamentally pathologized in the proposed reform. The paper concludes with a discussion about the overall ambition of shifting from a crime-centered to a health-centered approach to people who use drugs and some reflections on the potential of an additional rights-based approach is provided. [ABSTRACT FROM AUTHOR]

• Random drug testing in schools has been part of Philippine policies since the 2000s. • During Duterte's drug war, it was implemented and scaled up by education agencies. • It has impacted students by placing them at risk of stigma and fatal violence. • It has impacted schools by necessitating human and financial resources. • Drug testing in schools has political and social efficacy amid a drug-free paradigm. With the stated aims of promoting "drug-free" campuses and "instilling in the minds of students" that drugs are harmful, drug testing in schools has been a feature of the Philippines' punitive drug regime for two decades, gaining prominence during the Duterte administration's war on drugs (2016-2022). Drawing on key informant interviews and a desk review of news articles and official documents, this paper presents a historical overview of this policy as well as its impacts on students, educational institutions, and Philippine society. The paper finds that the group most affected by drug testing in schools are the students themselves, who are placed at risk of discrimination and alienation. Schools are also affected by the policy, as it requires expending their human and financial resources. More broadly, the policy perpetuates longstanding popular notions on drugs, children, and the overall idea that individuals carry the "burden of proof" to demonstrate their worthiness for societal inclusion. Drug testing in Philippine schools is ineffective and misguided in its objectives, but it has received widespread support because of its social and political efficacies. [ABSTRACT FROM AUTHOR]

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access. [ABSTRACT FROM AUTHOR]

Collective efforts among governments and regional organizations is a vital part of the fight against piracy that represents a security threat to all nationstates with respect to freedom to navigate the high seas. This paper provides a concise overview of piracy, contemporary maritime drug laws, and cases among the circuit courts to illustrate the procedural concerns that affect fundamental constitutional principles of jurisdiction. A possible solution to existing substantive and procedural due process issues is establishment of a regional judicial institution with broad powers to preside over criminal prosecutions that include maritime crimes. The suggestion may be a viable means to resolve some concerns with respect to jurisdictional principles, regional stability, and the need for a comprehensive, coordinated response within the Western Hemisphere. Establishing a tribunal to preside over enforcement practices alleviates dependency on the existing legal framework that may not fully resolve jurisdictional issues associated with maritime drug trafficking. In addition, a regional tribunal minimizes the need for the United States to function as the only viable, sovereign nation-state in the Americas to ensure that pirates engaged in illicit trades are not roaming the high seas with impunity. [ABSTRACT FROM AUTHOR]

Collective efforts among governments and regional organizations is a vital part of the fight against piracy that represents a security threat to all nationstates with respect to freedom to navigate the high seas. This paper provides a concise overview of piracy, contemporary maritime drug laws, and cases among the circuit courts to illustrate the procedural concerns that affect fundamental constitutional principles of jurisdiction. A possible solution to existing substantive and procedural due process issues is establishment of a regional judicial institution with broad powers to preside over criminal prosecutions that include maritime crimes. The suggestion may be a viable means to resolve some concerns with respect to jurisdictional principles, regional stability, and the need for a comprehensive, coordinated response within the Western Hemisphere. Establishing a tribunal to preside over enforcement practices alleviates dependency on the existing legal framework that may not fully resolve jurisdictional issues associated with maritime drug trafficking. In addition, a regional tribunal minimizes the need for the United States to function as the only viable, sovereign nation-state in the Americas to ensure that pirates engaged in illicit trades are not roaming the high seas with impunity. [ABSTRACT FROM AUTHOR]

Eleven US States and the District of Columbia legally allow personal (i.e., recreational) cannabis use by adults, and an additional 22 states allow use of cannabis for medicinal purposes. Of these jurisdictions, only two do not have some form of legalized gambling available (https://www.casino.org/local/guide/). In contrast to this rapid increase in legally available marijuana is the limited knowledge about the intersection of cannabis use and gambling. This paper strives to define the current status of the relevant literatures and consider the implication for future gambling research. We describe the research literature on the prevalence of cannabis use and co-existing gambling problems and the effects of cannabis use on gambling-related cognitive functions and decision-making. We also discuss clinical considerations with treating problem gamblers with a cannabis use disorder. Finally, the potential implications for responsible gambling practices and policies and the most pressing gaps in the research literature are offered. [ABSTRACT FROM AUTHOR]

In an era which marks an exceptional phase of growth in science and technology, the acute disparities in access to healthcare still persist. So where on one hand scientific advancement in medicine aims at increasing life expectancy, on the other hand there are millions who are denied access to existing medicines. Patents on medicines also pose a significant barrier to access new drugs, especially in low and middle income countries which already suffer from poor health financing mechanisms. The patent laws were built on the assumption of incentivizing the innovators by rewarding them with the exclusive right to produce, sell or market the innovation. The basic premise for granting patents was based on the thought that it would increase investment in research and development promoting dynamic gains through newer innovations. However, evidence found to support this justification is meager. So in a situation where the drug gap still persists and we aim to achieve sustainable development goals by 2030, this paper attempts to focus on understanding how compulsory licensing has been used in selected cases to alleviate the major legal and political barriers to access medicines. The methodology comprises of cross-country comparison of patent framework and compulsory licensing cases. The sample selected for study includes both developed as well as developing countries. The aim is to evaluate the policy approaches used by selected countries to grant compulsory licenses and to identify the best practices for evidence-based policy making on international issues related to pharmaceutical patents. In each case, a driving factor has been the international extension of patent laws through trade agreements; first bilaterally (US-Canada) and subsequently internationally (1995 Uruguay round, under which low- and middle-income countries were granted a grace period until 2005 to comply). [ABSTRACT FROM AUTHOR]

Background: Cannabis policies should be relevant to communities most impacted by them. Home cultivation policies can engage people who grow cannabis and build on their motivation to supply a safe product. This paper aims to examine the laws pertaining to "home" (i.e. personal, small-scale) cannabis cultivation internationally and their different aspects, and to discuss the potential of these policies to be expanded into community-level cannabis supply models.Methods: We reviewed relevant laws and regulations in states/countries that legalised, decriminalised or applied other non-prohibitive approaches to home cannabis cultivation.Findings: Non-prohibitive approaches to home cannabis cultivation have been adopted in at least 27 jurisdictions. Twelve jurisdictions "de jure" legalised home cultivation (three U.S. states and Antigua and Barbuda legalised only home cultivation; six U.S. states, Uruguay and Canada legalised commercial sales as well). Eight states/countries "de facto" (Belgium, the Netherlands) or "de jure" decriminalised it (Czech Republic, Spain, Jamaica, and three Australian states). "De jure" depenalisation was in place in Chile and Brazil and recent court rulings yielded "de facto" depenalisation or "de facto" legalisation in five other jurisdictions (South Africa, Mexico, Colombia, Costa Rica and Georgia). Varying number of plants (per person and per property) and the circumstances of cultivation were in place. The key limitations of the regulations included (i) possession thresholds for the produce from home cultivations, (ii) rules about sharing the produce, and (iii) potentially disproportionate sanctions for non-authorised behaviours. Despite currently being limited, home cultivation policies might have the capacity to engage cannabis networks that already exist in the community and like that, enhance their participation in legitimate policy schemes.Conclusions: Rules around pooled cultivation and sharing could be made fit for purpose to accommodate community supply of cannabis. Home cultivation policies could serve as a basis for community-level cannabis supply models and as such, for more inclusive cannabis policies. [ABSTRACT FROM AUTHOR]

Background: In 2015, a new Liberal Government came to power in Canada, elected on a platform that included legalization and regulation of cannabis for recreational purposes. Their legislation, based on recommendations from a Federal Task Force on Marijuana Legalization and Regulation, is due in early April 2017.Methods: This commentary utilizes Canadian Federal policy papers, previous literature, and internal and international agreements to examine two key areas critical to the development of a nationwide regulated market for cannabis in Canada; the need to overcome restrictions to legalizing cannabis in United Nations' drug control treaties, and the unique challenges that non-medical cannabis creates for navigating interprovincial trade policies in Canada.Results: Irrespective of UN conventions that appear to prohibit legalization of cannabis the Government is preparing to bring forward legislation as this article goes to print. At the same time significant squabbles impede the selling of even beer and wine inter-provincially in Canada. This paper identifies the challenges facing Canadian legalization efforts, but also shows how the legalization legislation may provide opportunities to engender significant change beyond the simple legalization of a specific drug.Conclusion: This commentary does not argue for any specific course of action for Canada, but rather explores the nuance of legalization absent from the declaration in the Liberal party platform. The paper argues that Canada's efforts may hasten the dismantling of the UN drug control structure, and provide renewed opportunities for intern-provincial trade in Canada. [ABSTRACT FROM AUTHOR]

Background: This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state's institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context.Results: This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in regulatory infrastructure. Human capacity across many developing countries remains limited. Most notably, variation among states is stark. Countries that have been leaders in establishing global norms do not appear to have influenced their neighbors in establishing regional patterns. Finally, in contrast to traditional theories of international norms diffusion, global standard-setters such as the United States or European Union appear to have surprisingly little influence on standard setting across our survey.Conclusions: Our research has implications for the framing of technical support on public health initiatives aimed at strengthening local public institutions in medicine and offers a new methodological approach for analyzing drug regulation systems in developing countries. [ABSTRACT FROM AUTHOR]

The human absorption, distribution, metabolism and elimination study administering radiolabeled drugs to human volunteers is an important clinical study in the development program of new drug candidates. The manufacture of radiolabeled Active Pharmaceutical Ingredients is covered by national drug laws and may come within the scope of regulatory GMP requirements. Additionally, authorities may request an appropriate environmental zoning to minimize the risk of microbiological contaminations particularly during the synthesis of radiolabeled Active Pharmaceutical Ingredients intended for parenteral application. Thus, a radioactive clean room lab facility in line with both GMP and radiation safety regulations was installed and the environmental zoning validated by appropriate testing of technical parameters and microbial and particle monitoring. The considerations detailed in this paper cover only GMP aspects related to the synthesis of radioactive drug substance. The subsequent, final formulation step in the overall process for manufacturing of radioactive drug product for any kind of administration is not within the scope of this paper. Under these qualified and controlled environmental conditions, we are now in a position to provide radiolabeled drug substances for all kinds of drug administration including both po and iv. [ABSTRACT FROM AUTHOR]

Public health advocates aim to maximise affordable access to good quality essential medicines. This goal often conflicts with the profitseeking ambitions of the pharmaceutical industry. Since the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights agreement, the extension and enforcement of intellectual property (IP) rights has become the dominant discourse in global medicines governance. Public health advocates operating within this framework face significant obstacles and challenges. This paper presents an historical perspective to the contemporary debate over medicines and patents by examining the evolution of international medicines governance between the 1940s and 1970s. This research indicates that debates around IP and medicines were more advanced in terms of equity and access in the 1960s and 1970s than they are today. While acknowledging the existence of obstacles and challenges for advocates, the paper argues that alternative frameworks can and should be reasserted in global debates about medicines governance. [ABSTRACT FROM AUTHOR]

Background: Canada has announced that it will legalize cannabis on October 17, 2018, and as a result of this impending drug law reform the need to develop prevention resources and drug education - in schools, in public health, and for parents - has emerged as a public concern and a policy priority. Set against this context, the aim of our paper is to amplify the parent perspective on preventing problematic adolescent cannabis use, but also to interrogate the idea of 'parents as the best prevention' that has taken hold in discussions about the potential consequences of legalization for youth.Methods: In 2016 we undertook an exploratory, qualitative interview study in Vancouver, British Columbia (n = 16) with parents of adolescents who had used cannabis. Building on our past research developing educator-led resources to support an open dialogue about cannabis in the classroom, in this study we asked parents about the supports and resources they needed to inform their discussions about cannabis with their adolescent children, as well the challenges they faced in responding to cannabis use when they believed it had become problematic.Findings: Across the interviews, parents mobilized discourses of risk and responsibility for preventing problematic cannabis use that appeared to reinstate individualizing accounts of substance use. Many echoed normative ideas about health, the risks of cannabis use, and 'good' parenting, sidestepping social inequities around drug use, and thus implicating parents and families as solely responsible for preventing adolescent drug use.Conclusion: Our analysis suggests how parents have been largely disempowered and unsupported when it comes to addressing adolescent drug use in the family context. Even as they expressed their awareness that formal supports and resources to assist them were lacking, parents also assigned blame to themselves - or to other parents - for 'failing' to prevent problematic cannabis use. [ABSTRACT FROM AUTHOR]

The legalisation of cannabis on the American continent in recent years has reinvigorated calls for cannabis law reform in many countries. Yet researchers have described potentially negative public health and social impacts of profit driven commercial markets for cannabis. Consequently, they have suggested exploring a number of alternative regulatory options, such as "not-for-profit" or "for-benefit" organisations. However, many of these new models are yet to be developed in detail. This paper presents a "community enterprise" model for recreational cannabis based on the alcohol licensing trusts which have existed in New Zealand for many decades. Alcohol licensing trusts are community-owned entities which operate alcohol retail outlets and return a portion of their profits back to local communities in the form of grants, loans and donations. The principal benefits of the "community trust" model are suppressing the commercial incentive to expand the market, establishing statutory obligations to distribute revenue back to the community, and establishing community governance over alcohol sales. The removal of a strong commercial incentive and community accountability may also contribute to lower levels of availability, higher prices and less harm. A further benefit is providing the local community with some oversight of a trust's commercial activities via community elections of the trust board and the ability to call a "community poll" to vote on the future existence of the trust. Our proposed community cannabis licensing trust model seeks to address some of the challenges experienced by alcohol licensing trusts in New Zealand, including the lack of general oversight and balancing the commercial and social aims of the trusts. A limitation of this model includes a lack of research and evaluation of the existing alcohol licensing trusts and further research in this area would inform the application of the model to cannabis. [ABSTRACT FROM AUTHOR]