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This document is a preface to a special issue of the journal Pharmaceutics on the topic of drug transporters and their regulation and roles in therapeutic strategies. The preface provides an overview of the importance of drug transporters in human physiology and diseases, as well as in the efficacy of medicines. It highlights several articles included in the special issue that cover various aspects of drug transporters, including their structure, function, regulation, and impact on drug interactions and diseases. The preface expresses gratitude to the authors for their contributions to the field of drug transport. [Extracted from the article]

Nanotechnology plays a pivotal role in the biomedical field, especially in the synthesis and regulation of drug particle size. Reducing drug particles to the micron or nanometer scale can enhance bioavailability. Supercritical fluid technology, as a green drug development strategy, is expected to resolve the challenges of thermal degradation, uneven particle size, and organic solvent residue faced by traditional methods such as milling and crystallization. This paper provides an insight into the application of super-stable homogeneous intermix formulating technology (SHIFT) and super-table pure-nanomedicine formulation technology (SPFT) developed based on supercritical fluids for drug dispersion and micronization. These technologies significantly enhance the solubility and permeability of hydrophobic drugs by controlling the particle size and morphology, and the modified drugs show excellent therapeutic efficacy in the treatment of hepatocellular carcinoma, pathological scarring, and corneal neovascularization, and their performance and efficacy are highlighted when administered through multiple routes of administration. Overall, supercritical fluids have opened a green and efficient pathway for clinical drug development, which is expected to reduce side effects and enhance therapeutic efficacy. [ABSTRACT FROM AUTHOR]

[Display omitted] • Hydrogel containing viologen-based hyperbranched polyamide amines with dual drug loading capacity. • Wearable Patch (Patch-DT) uses hydrogel as the drug-carrying cathode and magnesium flakes as the anode. • Patch-DT enables release of two drugs simultaneously, overcoming the limitations of monotherapy. • Visible drug monitoring through wearable Patch's electrochromic properties. Wearable drug delivery systems (DDS) have made significant advancements in the field of precision medicine, offering precise regulation of drug dosage, location, and timing. The performance qualities that wearable DDS has always strived for are simplicity, efficiency, and intelligence. This paper proposes a wearable dual-drug synergistic release patch. The patch is powered by a built-in magnesium battery and utilizes a hydrogel containing viologen-based hyperbranched polyamidoamine as both a cathode material and an integrated drug reservoir. This design allows for the simultaneous release of both dexamethasone and tannic acid, overcoming the limitations of monotherapy and ensuring effective synergy for on-demand therapy. In a mouse model with praziquimod-induced psoriasis, the patch demonstrated therapeutic efficacy at a low voltage. The inflammatory skin returned to normal after 5 days with the on-demand release of dual drugs. This work provides a promising treatment option considering its straightforward construction and the therapeutic advantages of dual-drug synergy. [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]

Using the 'war on drugs' in Colombia as its case study, this paper reflects on the recent findings and recommendations of Colombia's Truth Commission to make a case for a transformative approach to end ongoing cycles of drugs-related violence. In Colombia, the armed conflict and repressive prohibitionist drug policies are deeply entangled, and violence is ongoing. A peaceful future, we contend, requires thinking about a world in which we can live well with drugs. This would be a clear break from the goal of a 'drug free' world that has prevailed under the repressive prohibitionist regime. Legal regulation of drug markets is proposed here as a form of long-overdue reparations for victim groups in Colombia, which could address and repair past inequality and harms engendered by prohibition, and improve the living conditions of people involved in, and impacted by, illegal drug markets. Colombia, with its unique historical trajectory, has much to contribute towards future projections on the global legal regulation of drug markets. By positioning legal regulation of drug markets as reparation, this paper contributes to debates on drug policy reform and reparative justice, arguing that the two are very much connected. • The Colombian truth commission (CEV) concluded that the county's conflict has been transformed by the 'war on drugs'. • This chapter analyses the CEV's recommendation to transition towards a legally regulated drug market to end violence in Colombia. • Drug policy reform is not an end in itself; it should help to create a fairer and more inclusive world. • This chapter makes an important contribution from the Global South to debates about drug legalisation. [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]

• 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]

This article tests the impact of deterrence and normative variables in the estimation of drug use among both detected drug users and university students. Consistent with perceptual deterrence research, we expect: (a) a stronger effect of normative variables on estimation of drug use compared to deterrence variables and (b) that any deterrent effect would be restricted to detected drug users. In Portugal, we conducted a cross-sectional survey with detected drug users (N = 147) and with a sample of university students (N = 247). The main results show that normative variables outperform deterrent variables as predictors of intention to use drugs. Descriptive norms have a greater influence on the estimation of drug use in both groups, and proximal social norms have robust effects among university students. Core elements of the deterrence model are not related to the intention to use drugs. Personal certainty of being caught has even an unexpected positive correlation with this intention. A small deterrent effect is limited to the general certainty variable and only among more law-abiding people. The overall findings are consistent with a normative perspective on law compliance and highlight the importance of including all different normative and deterrent variables in models estimating drug use. [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them. Methods: We sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross‐sectional analysis of US FDA oncology drug approvals (2006–2023). We searched for OS data in registration trials and the peer‐reviewed literature. Results: We found 392 oncology drug approvals. Eighty‐seven (22%) drug approvals were based on OS, 147 drug approvals were later tested for OS benefit (38% of all approvals and 48% of drugs approved on a surrogate), and 130 (33%) have yet to be tested for OS benefit. Of the 147 drug approvals later tested for OS, 109 (28% of all approvals and 74% of drugs later tested for OS) have yet to show OS benefit, whereas 38 (10% of all approvals and 26% of drugs later tested for OS benefit) were later shown to have OS benefit. In total, 125 out of 392 (32%) drugs approved for any indication have been shown to improve OS benefit at some point, and 267 (68%) have yet to show approval. Conclusion: About 32% of all oncology drug approvals have evidence for an improvement in OS. Higher standards are needed in drug regulation to ensure that approved drugs are delivering better patient outcomes, specifically in regards to survival. [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]

Since 2011, the misuse or abuse of etomidate has gradually increased when propofol was designated a controlled drug under the Narcotics Control Act in Korea. Accordingly, the Ministry of Food and Drug Safety announced that etomidate would be under the 'Regulation on the designation of drugs that may cause concerns of misuse or abuse' rule in June 2020, which is less stringent than the Narcotics Control Act. Therefore, this review investigates potential misuse or abuse cases of etomidate to consider strengthening its management. A literature search was conducted to compare etomidate with other sedatives in their efficacy and side effects, as well as identify the adverse health outcomes, abuse cases, and analytical methods of etomidate. Etomidate has an equal or higher sedative efficacy and lower risk of adverse cardiopulmonary events than propofol. However, major adverse effects of etomidate include adrenocortical suppression and unproven associated deaths, as well as myoclonus requiring pre-treatment. Although the issue of abuse and misuse of etomidate is emerging in recent years, there are few academic reports on these issues and analytical methods in the forensic field. In order to effectively manage the misuse or abuse of etomidate, it is necessary to continuously monitor related cases with great interest and to be more intensively studied on its abuse potential. [ABSTRACT FROM AUTHOR]

In several controversial drug approval decisions in recent years, the Food & Drug Administration ("FDA") has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency's determination whether a drug is "safe" and "effective" does not seem to depend on whether its approval also supports innovation. But FDA'suse of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of its regulation of drugs. In this Article, we investigate the broad set of innovation-related judgments that FDA has been making and argue that there are serious concerns with the major innovation role FDA has been playing, at least as the Agency is currently constituted. We conclude that FDA should not separately weigh innovation in decisions about a product's safety and effectiveness. In other areas, health policymakers could reasonably decide that FDA should have either a larger or a smaller role than it currently does in shaping the development of novel drugs. But policymakers should do so while thoughtfully considering both the opportunities and challenges of FDA actively considering innovation incentives in its decisions; those challenges have been rarely considered in the literature and policy discourse. Further, we argue that whether policymakers aim to bolster or limit the ways that FDA considers innovation in its regulatory decisions, changes are needed to the Agency's structure to support its ability to make reasoned judgments based on relevant expertise. [ABSTRACT FROM AUTHOR]

Feminist scholars critique food and drug law as a site of gender bias and regulatory neglect. The historical exclusion of women from clinical trials by the FDA prioritized male bodies as the object of clinical research and therapies. Likewise, the FDA's prior restriction on access to contraceptive birth control illustrates how patriarchal and paternalistic attitudes within the Agency can harm women's reproductiue health. However, there is little analysis of how race and gender intersect in this domain. This Article uses the regulation of skin-tightening cosmetics products to illustrate why and how intersectionality matters in food and drug law. While the inadequate regulation of cosmetics has a disparate impact on women's health, it is women of color who predominantly use skin-lightening products, similar to some hair care products that are disproportionately marketed to women of color. Additionally, skin-lightening products are often toxic because they contain mercury and other harmful substances. The skin-lightening industry has also historically (and contemporarily) targeted women of color with racist and colorist aduertising messages that idealize light skin as the pinnacle of beauty. The inadequate regulation of cosmetics illustrates why intersectional analysis is essential in food and drug law. An intersectional lens uncouers the various underlying forces that produce a disparate health impact for women of color: systemic racism in health, racially targeted marketing, and hegemonic beauty norms shaped by race and skin color constructs. The increased toxicity of these products also ouerexposes women of color to more serious health risks from cosmetics. While cosmetics reform has ushered in new regulations that improue the Agency's authority to regulate cosmetics, the health risks posed to women of color from toxic personal care products in general deserves urgent attention in food and drug discourses. Intersectional analysis uncouers the contours of this urgency and offers an important response to the de-prioritization of women of color within food and drug law discourses. [ABSTRACT FROM AUTHOR]

Background: Drug use is a major public health issue in India. Significant changes in the approach toward drug use have happened in the last few decades. Despite this, no systematic attempt has been made to document the same in the scientific literature. This narrative review attempts to discuss the major drug laws, policies, and national programs of the Government of India (GoI). Methods: A thorough search was conducted to look for policies, programs, acts, and notifications related to substance use/drug use on various websites of different ministries of the GoI. Acts, programs, and policies addressing substance use were identified. Results: Various drug laws, programs, and acts from the GoI provide a multipronged approach to curbing the procurement of drug use along with its prevention and cure. The Ministry of Social Justice and Empowerment (MoSJE) is the nodal ministry for drug demand reduction. The enactment of the Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985 and Policy 2012 and the implementation of India's Drug De-Addiction Program (DDAP) are important landmarks in this journey. Conclusion: The GoI initiatives for reducing the mental health burden in this country in general and substance use disorders (SUDs), in particular, are immense. The acts/statutes/laws/notifications are all interlinked. Stakeholders in mental health, public health, and policy-making need to upgrade themselves with the relevant statutes to curb the menace of drug use. [ABSTRACT FROM AUTHOR]