[The development of regulation of pharmaceuticals turn-over in EU and the USA in 1992-2020. Report 2. Development of normative legal base of pharmaceuticals turn-over in EU in 1992-2001].

The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 is considered. This stage is characterized by passing Directives (laws of indirect action) that were obligatory for implementation through their inclusion into national normative legal bases. In 2001 the passed laws were compiled into EU Pharmaceutical Code (Directive 2001/83) that regulates main sections of pharmaceuticals turn-over from their production to pharmaceutical control. The adoption of Code laid the foundation for EU legislation in the field of medications.

State Driving Under the Influence of Drugs Laws.

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

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

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

Rural and urban differences in marijuana use following passages of medical marijuana laws.

INTRODUCTION: Understanding differences in post-legalization patterns of marijuana between rural and urban environments has the potential to go a long way towards targeting intervention efforts aimed at reducing marijuana use disorders. METHODS: Data come from the National Survey on Drug Use and Health (NSDUH, 2015-2019, N = 210,392). Survey-weighted multivariable linear and logistic regression analyses were used to assess the relationship between key marijuana-related variables and the status of medical marijuana use in each state with interaction terms for rural versus urban status. RESULTS: Among the entire sample, the prevalence of marijuana abuse and dependence were 0.7% and 1.8%, respectively. Among marijuana users, the average number of days on which marijuana was used was 131.3 (SD = 136.3) days. Those living in states with legalized medical marijuana reported use on a greater number of days (B = 10.69; 95% CI: 5.26, 16.13) with frequency of use increasing as rurality increased, compared to a core based statistical area (CBSA) of ≥1 million: a CBSA of <1 million residents (B = 23.02; 95% CI: 17.38, 28.66) and non-CBSA (B = 37.62; 95% CI: 22.66, 52.58). We also observed lower odds of driving under the influence of marijuana in states where medical marijuana was legal (aOR = 0.86; 95% CI: 0.77, 0.95). CONCLUSION: We observed an increase in the frequency of marijuana use and a decrease in driving under the influence of marijuana in states with legalized medical marijuana use relative to those states where it remained illegal. We also observed key moderation based on rural-urban status. This body of results suggests that problematic marijuana use may be on the rise following the legalization of marijuana use, but also that corresponding protective attitudes exist.

Road hazard: a systematic review of traffic injuries following recreational cannabis legalization.

PURPOSE: Acute cannabis use is associated with impaired driving performance and increased risk of motor vehicle crashes. Following the Canadian Cannabis Act's implementation, it is essential to understand how recreational cannabis legalization impacts traffic injuries, with a particular emphasis on Canadian emergency departments. This study aims to assess the impact of recreational cannabis legalization on traffic-related emergency department visits and hospitalizations in the broader context of North America. METHODS: A systematic review was conducted according to best practices and reported using PRISMA 2020 guidelines. The protocol was registered on July 5, 2022 (PROSPERO CRD42022342126). MEDLINE(R) ALL (OvidSP), Embase (OvidSP), CINAHL (EBSCOHost), and Scopus were searched without language or date restrictions up to October 12, 2023. Studies were included if they examined cannabis-related traffic-injury emergency department visits and hospitalizations before and after recreational cannabis legalization. The risk of bias was assessed. Meta-analysis was not possible due to heterogeneity. RESULTS: Seven studies were eligible for the analysis. All studies were conducted between 2019 and 2023 in Canada and the United States. We found mixed results regarding the impact of recreational cannabis legalization on emergency department visits for traffic injuries. Four of the studies included reported increases in traffic injuries after legalization, while the remaining three studies found no significant change. There was a moderate overall risk of bias among the studies included. CONCLUSIONS: This systematic review highlights the complexity of assessing the impact of recreational cannabis legalization on traffic injuries. Our findings show a varied impact on emergency department visits and hospitalizations across North America. This underlines the importance of Canadian emergency physicians staying informed about regional cannabis policies. Training on identifying and treating cannabis-related impairments should be incorporated into standard protocols to enhance response effectiveness and patient safety in light of evolving cannabis legislation.

RéSUMé: OBJECTIF: La consommation aiguë de cannabis est associée à une conduite avec facultés affaiblies et à un risque accru d'accidents de la route. À la suite de la mise en œuvre de la Loi canadienne sur le cannabis, il est essentiel de comprendre l'incidence de la légalisation du cannabis à des fins récréatives sur les blessures de la route, en mettant l'accent sur les services d'urgence canadiens. Cette étude vise à évaluer l'impact de la légalisation du cannabis à des fins récréatives sur les visites et les hospitalisations aux urgences liées à la circulation dans le contexte plus large de l'Amérique du Nord. MéTHODES: Une revue systématique a été menée selon les meilleures pratiques et a été rapportée en utilisant les directives PRISMA 2020. Le protocole a été enregistré le 5 juillet 2022 (PROSPERO CRD42022342126). MEDLINE(R) ALL (OvidSP), Embase (OvidSP), CINAHL (EBSCOHost) et Scopus ont été fouillés sans restriction de langue ou de date jusqu'au 12 octobre 2023. Des études ont été incluses si elles examinaient les visites aux urgences et les hospitalisations avant et après la légalisation du cannabis à des fins récréatives. Le risque de biais a été évalué. La méta-analyse n'était pas possible en raison de l'hétérogénéité. RéSULTATS: Sept études étaient admissibles à l'analyse. Toutes les études ont été menées entre 2019 et 2023 au Canada et aux États-Unis. Nous avons trouvé des résultats mitigés concernant l'impact de la légalisation du cannabis récréatif sur les visites aux urgences pour les blessures de la route. Quatre des études incluaient une augmentation des accidents de la route après la légalisation, tandis que les trois autres études n'ont révélé aucun changement significatif. Le risque global de biais était modéré parmi les études incluses. CONCLUSIONS: Cet examen systématique met en évidence la complexité de l'évaluation de l'impact de la légalisation du cannabis récréatif sur les blessures de la route. Nos résultats montrent un impact varié sur les visites aux urgences et les hospitalisations en Amérique du Nord. Cela souligne l'importance pour les médecins d'urgence canadiens de se tenir informés des politiques régionales sur le cannabis. La formation sur l'identification et le traitement des déficiences liées au cannabis devrait être intégrée aux protocoles normalisés afin d'améliorer l'efficacité de l'intervention et la sécurité des patients à la lumière de l'évolution de la législation sur le cannabis.

State Cannabis and Psychedelic Legislation and Microdosing Interest in the US.

Importance: Despite growing interest in psychedelics, there is a lack of routine population-based surveillance of psychedelic microdosing (taking "subperceptual" doses of psychedelics, approximately one-twentieth to one-fifth of a full dose, over prolonged periods). Analyzing Google search queries can provide insights into public interest and help address this gap. Objective: To analyze trends in public interest in microdosing in the US through Google search queries and assess their association with cannabis and psychedelic legislative reforms. Design, Setting, and Participants: In this cross-sectional study, a dynamic event-time difference-in-difference time series analysis was used to assess the impact of cannabis and psychedelic legislation on microdosing search rates from January 1, 2010, to December 31, 2023. Google search rates mentioning "microdosing," "micro dosing," "microdose," or "micro dose" within the US and across US states were measured in aggregate. Exposure: Enactment of (1) local psychedelic decriminalization laws; (2) legalization of psychedelic-assisted therapy and statewide psychedelic decriminalization; (3) statewide medical cannabis use laws; (4) statewide recreational cannabis use laws; and (5) all cannabis and psychedelic use restricted. Main Outcome and Measures: Microdosing searches per 10 million Google queries were measured, examining annual and monthly changes in search rates across the US, including frequency and nature of related searches. Results: Searches for microdosing in the US remained stable until 2014, then increased annually thereafter, with a cumulative increase by a factor of 13.4 from 2015 to 2023 (7.9 per 10 million to 105.6 per 10 million searches, respectively). In 2023, there were 3.0 million microdosing searches in the US. Analysis at the state level revealed that local psychedelic decriminalization laws were associated with an increase in search rates by 22.4 per 10 million (95% CI, 7.5-37.2), statewide psychedelic therapeutic legalization and decriminalization were associated with an increase in search rates by 28.9 per 10 million (95% CI, 16.5-41.2), statewide recreational cannabis laws were associated with an increase in search rates by 40.9 per 10 million (95% CI, 28.6-53.3), and statewide medical cannabis laws were associated with an increase in search rates by 11.5 per 10 million (95% CI, 6.0-16.9). From August through December 2023, 27.0% of the variation in monthly microdosing search rates between states was explained by differences in cannabis and psychedelics legal status. Conclusion and Relevance: This cross-sectional study found that state-led legislative reforms on cannabis and psychedelics were associated with increased public interest in microdosing psychedelics.

Road safety implications of the partial legalisation of cannabis in Germany: protocol for a quasi-experimental study.

INTRODUCTION: Germany is reforming its legal approach to cannabis, allowing the possession and cultivation of cannabis for recreational purposes. The objective of this study is to investigate the impact of the policy reform on (1) The prevalence of cannabis use in the general population and (2) Driving under the influence of cannabis (DUIC) among regular users. METHODS AND ANALYSIS: A quasi-experimental research design will be employed, with repeated cross-sectional surveys on self-reported DUIC and cannabis use conducted at three measurement points in Germany (intervention group) and Austria (control group) over a 2-year observation period (2023-2025). Data will be collected from approximately 50 000 individuals aged between 18 years and 64 years. To minimise reporting biases in the measurement of DUIC, we will use direct and indirect assessments via crosswise model and motor vehicle accident data from official statistics. In a difference-in-difference framework, regression analyses and interrupted time series analysis will be carried out for hypothesis testing. ETHICS AND DISSEMINATION: Participants will be informed about voluntary participation, data protection laws and the option to delete data on request. Ethical approval was obtained from the Local Psychological Ethics Committee of the Centre for Psychosocial Medicine in Hamburg, Germany (reference number: 0686). Findings will be disseminated through scientific networks and will be key for a comprehensive evaluation of the cannabis law reform. The findings will facilitate the design and implementation of road safety measures.

Understanding youth and young adult cannabis use in Canada post-legalization: a scoping review on a public health issue.

BACKGROUND: Canada legalized recreational cannabis in 2018, and one of the primary objectives of the Cannabis Act was to protect youth by reducing their access to cannabis and providing public education. Canada has the highest prevalence of cannabis use worldwide, particularly among youth and young adults under the age of 25. Cannabis use is linked with many adverse effects for youth and young adults including psychosis, anxiety, depression, respiratory distress, cannabinoid hyperemesis syndrome, and impaired cognitive performance. Despite the high prevalence of cannabis use and the evolution of policies in Canada and globally, significant knowledge and research gaps remain regarding youth and young adult cannabis use. The aim of this scoping review is to map the extent, nature, and range of evidence available on youth and young adult cannabis use in Canada since its legalization, in order to strengthen policies, services, treatments, training, and public education strategies. METHODS: Using a scoping review framework developed by Arksey and O'Malley, along with the PRISMA-ScR guidelines, we conducted a rigorous search in five academic databases: MEDLINE, Embase, APA PsycINFO, CINAHL and Web of Science Core Collection. We included empirical studies that collected data in Canada after the legalization of recreational cannabis (October 2018) and focused on youth or young adults < 30. Two reviewers independently screened articles in two stages and extracted relevant information from articles meeting the inclusion criteria. RESULTS: Of the 47 articles meeting our inclusion criteria, 92% used quantitative methods, 6% were qualitative, and 2% used a mixed-methods approach. Over two-thirds (68%) used secondary data. These studies were categorized into six focus areas: (1) prevalence, patterns, and trends, (2) cannabis-related injuries and emergency department (ED) visits, (3) rates and patterns during the pandemic, (4) perceptions of cannabis use, (5) prevention tools, and (6) cannabis-related offenses. Key findings from the studies reviewed include an increase in cannabis use among 18-24-year-olds post-legalization, with mixed results for youth under 18. ED visits for intentional and unintentional cannabis-related injuries have increased in young children and teens. Perception studies show a mix of concern and normalization of cannabis use. Though limited, prevention studies are promising in raising awareness. A decline in cannabis-related offenses was noted by one study. The review highlights several research gaps, including the need for more qualitative data, disaggregation of demographic data, intervention research, and comprehensive studies on the physical and mental health impacts of cannabis use among youth and young adults. CONCLUSION: Maintaining a public health approach is critical, with a focus on reducing the high prevalence of cannabis use among youth and young adults. This involves implementing prevention strategies to minimize harms, enhancing public education, minimizing commercialization, reducing youth access to cannabis, promoting guidelines for lower-risk cannabis use and harm reduction strategies, and increasing training for healthcare providers.

State Cannabis Legalization and Trends in Cannabis-Related Disorders in US Older Adults, 2017 to 2022.

This cross-sectional study examines trends in health care encounters with cannabis-related disorders among Medicare beneficiaries from 2017 to 2022.

[Opportunities associated with cannabis sales pilot trials : the Cann-L project]. / Essais-pilotes de vente de cannabis : exemple du projet Cann-L.

In the context of an international trend of cannabis legalisation and regulation, Switzerland is now allowing strictly supervised local pilot trials of cannabis sales. One of these is the Cann-L project in Lausanne, which will evaluate the impact on cannabis consumption of an access to a non-profit, public health-oriented distribution model. Opening in December 2023, it already has more than 500 participants whose profiles differ from those usually found in population surveys. In addition, around twenty people have already contacted the study's referring doctor, demonstrating a need and interest in advice and support.

Dans le contexte d'une « vague ¼ de légalisation et régulation du cannabis au niveau international, la Suisse permet désormais la mise en œuvre d'essais pilotes locaux de vente de cannabis strictement encadrés. L'un d'entre eux est le projet lausannois Cann-L évaluant l'effet sur la consommation de cannabis de l'accès à un modèle de vente à but non lucratif orienté sur la santé publique. Ouvert en décembre 2023, il compte déjà plus de 500 participant-e-s dont le profil se différencie de celui que l'on observe habituellement dans les enquêtes populationnelles. En outre, une vingtaine de personnes ont déjà fait appel au médecin référent de l'étude, montrant ainsi un besoin et un intérêt pour des conseils et un accompagnement.

Traceability and control as levers to prevent leakage from legal circulation when legalizing medical cannabis.

OBJECTIVE: Aim: To reveal traceability and control as levers to prevent leakage from legal circulation when legalizing medical cannabis. PATIENTS AND METHODS: Materials and Methods: The methodological basis of this research work is based on a systematic approach. Methods of structural and logical analysis, bibliosemantic, abstraction and generalization were used in this article. RESULTS: Results: The analysis of the regulatory framework and regulatory initiatives in the field of circulation of narcotic drugs, in particular, cannabis (in total 56 documents) demonstrated repeated attempts to reform it in Ukraine in order to increase the availability and efficiency of medical and pharmaceutical services. Recently adopted law on the legalization of medical cannabis pays special attention to the traceability of the circulation of medical cannabis and cannabis-based medicines (CbMs) by digitalization and creation of the appropriate electronic information system. CONCLUSION: Conclusions: With the adoption of the law on the legalization of medical cannabis Ukraine became the 57th country in the world to legalize such cannabis. The study and analysis of the regulatory framework of Ukraine, taking into account the best world practices, showed that the legalization of medical cannabis will allow for providing more effective care to many patients including wounded defenders.

Changes in the incidence of cannabis-related disorders after the Cannabis Act and the COVID-19 pandemic in Québec, Canada.

BACKGROUND: The Canadian Cannabis Act (CCA, implemented in October 2018) and the COVID-19 pandemic (April 2020) might have contributed to cannabis-related harms in Québec, known for its stringent cannabis legal framework. We explored changes in incidence rates of cannabis-related disorders (CRD) diagnoses associated with these events in Québec. METHODS: We utilized linked administrative health data to identify individuals aged 15 year+ newly diagnosed with CRD during hospitalizations, emergency, and outpatients clinics across Québec, from January 2010 and March 2022 (147 months). Interrupted time-series analyses (ITSA) assessed differences (as percentage changes) in sex- and age-standardized, and sex-stratified, monthly incidence rates (per 100,000 population) attributed to the CCA and the COVID-19 pandemic, compared to counterfactual scenarios where pre-events trends would continue unchanged. RESULTS: The overall monthly mean rates of incident diagnoses nearly doubled from the pre-CCA period (1.56 per 100,000 population) to the COVID-19 pandemic period (3.02 per 100,000 population). ITSA revealed no statistically significant level or slope changes between adjacent study periods, except for a decrease in the slope of incidence rates among males by 1.84 % (95 % CI -3.41 to -0.24) during the COVID-19 pandemic compared to the post-CCA period. During the post-CCA period, the trends of incidence rates in the general and male populations grew significantly by 1.22 % (95 % CI 0.08 to 2.35) and 1.44 % (0.04 to 2.84) per month, respectively. Similarly significant increases were observed for the general and female populations during the COVID-19 pandemic, with monthly rates rising by 1.43 % (95 % CI 0.75 to 2.12) and 1.75 % (95 % CI 0.13 to 3.37), respectively. These increases more than doubled pre-CCA rates. CONCLUSIONS: The incidence rates of CRD diagnoses across Québec appears to have increased following the implementation of the CCA and during the COVID-19 pandemic. Our findings echo public health concerns regarding potential cannabis-related harms and are consistent with previous Canadian studies.

International property rights for Cannabis landraces and terroir products. The case of Moroccan Cannabis and hashish.

BACKGROUND: In recent years, the cannabis industry has evolved from a world defined by the simplicity and ubiquity of illegality of recreational drug cannabis to a world marked by the legal and geographic complexity of ongoing depenalisation, decriminalisation, and legalisation processes. Within this landscape where drug Cannabis plants and their many derivatives see their legal status change, Cannabis cultigens and end products are increasingly likely to becoming subject to protection by intellectual property rights. This article delves into the implications of these changes for traditional Cannabis farmers, particularly in the Global South, as they face economic and legal threats amidst global legalisation efforts. It examines the potential role of appellations of origin in protecting local Cannabis cultigens and end products, focusing on Moroccan Cannabis and hashish as a case study. METHODS: The text resorts to the treaties and agreements regulating international property rights and plant variety protection, but also to the concepts of terroir and landrace and their definitions, in order to determine, by way of treaty interpretation and conceptual analysis, what type of legal and economic protections can apply to Cannabis landraces and terroir products. The analysis is also based on previous empirical research published by the author. RESULTS: The text argues that appellations of origin are the best intellectual property protections possible for landraces and terroir products because what needs to be protected is not innovation and individual ownership, but tradition and collective ownership, and because appellations of origin are suitable collective intellectual property rights. It shows that appellations of origin are best suited to protect terroir products and landraces because their originality and distinctiveness are place-based originality and distinctiveness. CONCLUSION: The text concludes that appellations or origin offer the only existing intellectual property protection for preserving the distinctiveness of terroir cannabis products, and for landrace conservation. It acknowledges that neither appellations of origin nor existing plant variety protection laws can be legal forms of control of third parties' uses of landraces but that appellations of origin can help protect terroir products and landraces by way of their associated agro-ecosystems.

United States marijuana legalization and opioid mortality trends before and during the first year of the COVID-19 pandemic.

BACKGROUND: To determine if marijuana legalization was associated with reduced opioid mortality. STUDY DESIGN: The United States (US) opioid mortality trend during the 2010-2019 decade was compared in states and District of Columbia (jurisdictions) that had implemented marijuana legalization with states that had not. Acceleration of opioid mortality during 2020, the first year of the coronavirus disease 2019 (COVID-19) pandemic, was also compared in recreational and medicinal-only legalizing jurisdictions. METHODS: Joinpoint methodology was applied to the Centers for Disease Control and Prevention WONDER data. Trends in legalizing jurisdictions were cumulative aggregates. RESULTS: The overall opioid and fentanyl death rates and the percentage of opioid deaths due to fentanyl increased more during 2010-2019 in jurisdictions that legalized marijuana than in those that did not (pairwise comparison p = 0.007, 0.05, and 0.006, respectively). By 2019, the all-opioid and fentanyl death rates were 44 and 50 percent greater in the legalizing than in the nonlegalizing jurisdictions, respectively. When the COVID-19 pandemic hit in 2020, jurisdictions that implemented recreational marijuana legalization before 2019 had significantly greater increases in both overall opioid and fentanyl death rates than jurisdictions with medicinal-only legalization. For all-opioids, the mean (95 percent confidence interval) 2019-to-2020 increases were 46.5 percent (36.6, 56.3 percent) and 29.1 percent (20.2, 37.9 percent), respectively (p = 0.02). For fentanyl, they were 115.6 percent (80.2, 151.6 percent) and 55.4 percent (31.6, 79.2 percent), respectively (p = 0.01). CONCLUSIONS: During the past decade, marijuana legalization in the US was associated at the jurisdiction level with a greater acceleration in opioid death rate. An even greater increase in opioid mortality occurred in recreational-legalizing jurisdictions with the onset of the COVID-19 pandemic. Marijuana legalization is correlated with worsening of the US opioid epidemic.

Clinician perspectives on adolescent cannabis-related beliefs and behaviors following recreational cannabis legalization.

BACKGROUND: As more states legalize cannabis, studies are needed to understand the potential impacts of recreational cannabis legalization (RCL) on adolescents from the perspective of clinicians who care for them. METHODS: This qualitative study characterized clinician perspectives on whether cannabis legalization is associated with changes in adolescents' cannabis use beliefs, behaviors, and consequences. Semi-structured qualitative interviews were conducted with 32 clinicians in a large healthcare organization from 9/6/2022-12/21/2022. Video-recorded interviews were transcribed and analyzed using thematic analysis. RESULTS: The 32 participants (56.3 % female, mean [SD] age, 45.9 [7.6] years; 65.3 % non-Hispanic White) were from Addiction Medicine (n = 13), Psychiatry/Mental Health (n = 7), Pediatrics (n = 5), and the Emergency Department (n = 7). Clinicians described post-RCL increases in adolescent cannabis use, use of non-combustible modes and high-potency products, and younger age of first use. Clinicians reported social, physical, and policy changes, including changes in social norms, appealing advertisements, marketing, and easier access. Many noted fewer perceived harms among adolescents and greater self-medication post-RCL. They described how RCL contributed to increased parental cannabis use and permissiveness around adolescent use. Finally, many described post-RCL increases in cannabis hyperemesis syndrome, and several noted increased cannabis-related psychosis and acute intoxication, and decreased court-mandated treatment. CONCLUSIONS: Clinicians from diverse specialties described post-RCL increases in adolescent cannabis use and cannabis-related consequences, alongside changes in social norms, access, marketing and advertisements, and decreased perceptions of harms. Findings can inform strategies to support adolescents in the context of increased cannabis availability and acceptability post-legalization and support the development of hypotheses for broader-scale quantitative work.