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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]

Membrane transport proteins are involved in the absorption, disposition, efficacy, and/or toxicity of many drugs. Numerous mechanisms (e.g., nuclear receptors, epigenetic gene regulation, microRNAs, alternative splicing, post‐translational modifications, and trafficking) regulate transport protein levels, localization, and function. Various factors associated with disease, medications, and dietary constituents, for example, may alter the regulation and activity of transport proteins in the intestine, liver, kidneys, brain, lungs, placenta, and other important sites, such as tumor tissue. This white paper reviews key mechanisms and regulatory factors that alter the function of clinically relevant transport proteins involved in drug disposition. Current considerations with in vitro and in vivo models that are used to investigate transporter regulation are discussed, including strengths, limitations, and the inherent challenges in predicting the impact of changes due to regulation of one transporter on compensatory pathways and overall drug disposition. In addition, translation and scaling of in vitro observations to in vivo outcomes are considered. The importance of incorporating altered transporter regulation in modeling and simulation approaches to predict the clinical impact on drug disposition is also discussed. Regulation of transporters is highly complex and, therefore, identification of knowledge gaps will aid in directing future research to expand our understanding of clinically relevant molecular mechanisms of transporter regulation. This information is critical to the development of tools and approaches to improve therapeutic outcomes by predicting more accurately the impact of regulation‐mediated changes in transporter function on drug disposition and response. [ABSTRACT FROM AUTHOR]

The Medicines and Healthcare products Regulatory Agency was established in April 2003 by the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). This paper describes the scientific and organizational basis for the merger and describes the various challenges facing this new Agency. [ABSTRACT FROM AUTHOR]

Proposes that supply-reduction drug policy concentrate on impeding the reintroduction into the banking system of small-denomination paper currency generated in street-level drug sales. Details of the drug policy debate; Laws and regulations on money laundering; Objections to the proposed policy.

Focuses on the white paper presented to the Norwegian Parliament, by the Norweigan government on February 1998, pertaining to the country's drug policy. Indication that drug policy is a great concern in many countries; Problems associated with reversing a restricted drug policy; Process used to produce a white paper; Information on the paper presented by the Norweigan government.

The article offers information on the project of Harmonization of Medicines Regulation in Africa (AMRHI) proposed by the World Health Organization (WHO). The project aims to improve health in the African region by increasing access to safe and effective medicines of good quality, which can be accomplished by strengthening the technical and administrative capacity of participating national medicines regulatory authorities.

Assesses the proper role of regulatory compliance as a strategy for constraining the traditional functions of tort law in the U.S. Distinction between regulatory compliance and regulatory preemption; Comparative institutional perspectives on regulatory compliance; Discussion on Food and Drug Administration regulation on prescription drugs.

Focuses on the effect of governmental control on drug safety and the process of drug regulation in the United States. Role of Food and Drug Administrations on the introduction of drugs; Background of drug regulation; Impact of the legislation on the drug industries.

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]

Reports on the Dutch government's amendment of its white-paper on drugs policy. Experimental heroin maintenance to addicts with short life-expectancy; Proposal allowing coffee-shop owners to keep a few hundred grams of soft drugs; Limitation of number of such coffee-shops; Proposal allowing soft-drug users to possess no more than five grams; Proposal allowing home cultivation of nederweid (cannabis).

Copyright of Evaluation & Analysis of Drug-Use in Hospitals of China is the property of Evaluation & Analysis of Drug-Use in Hospitals of China Editorial Board and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

Copyright of Colección is the property of Pontificia Universidad Catolica Argentina and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

[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]

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]

Narcotic drugs and substance abuse have been considered a menace across the world for many decades. The world saw drug addiction or substance abuse as a crime rather than as a medical-legal challenge faced by individuals. However, in the last few years, this perception seems to have transformed from a punitive approach to a reformatory and rehabilitative approach. Most surveys suggest that drug use peaks amongst the age group of 18-25 years. Surveys also indicate a high rate of initiation of drug use amongst adolescents. The importance of the issue is manifest from the fact that 50% of the Indian population is below the age of 25 years and around 65% is below the age of 35 years, and it is expected that the average age of the Indian population would be 29 years by the year 2020. In this paper, the authors have attempted to trace the journey of the NDPS Act and shed light on the issues such as lack of rehabilitation and pendency, which have marred the success of the Act. This paper seeks to analyse the drug laws of India which were enacted to deal with the menace of drug abuse as well as to fulfil its international obligations. Simultaneously, the authors have attempted to bring forth the key factors which seem to have shattered the intent and objectives behind this piece of legislation. The authors have weighed the Act against International Conventions and tried to test its congruity with the rehabilitative approach. Relying on various reports, domestic and global judicial developments and other reliable sources, the authors have attempted to bring forth the challenges which are being faced in dealing with the matters relating to narcotic drugs and substance abuse under the NDPS Act and other ancillary laws and provide some suggestions thereon. [ABSTRACT FROM AUTHOR]

Copyright of Collected Papers of the Faculty of Law in Split / Zbornik Radova Pravnog Fakulteta u Splitu is the property of Split Faculty of Law and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance. [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]

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]

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]

Greek-letter student social groups, better known as fraternities and sororities, are a ubiquitous feature on many American higher education campuses. These organizations, especially fraternities, have a reputation for encouraging unruly and improper behaviour among both members and non-members. This paper investigates the effect of the degree of prevalence of these Greek organizations at a campus, as measured by the percentage of students who are members of fraternities and sororities, on the instances of liquor and drug law violations on campuses, as measured by the number of arrests for liquor and drug laws violations. Using a unique dataset, which combines data from three sources, we address any potential selection bias by including several controls associated with party culture and through the inclusion of institution-level fixed effects. We find that a larger percentage of students in fraternities (but not sororities) is associated with an increase in the number of arrests for drug law violations. A larger percentage of students in sororities (but not the percentage of students in fraternities) is associated with a larger number of arrests for liquor law violations. This result is highly significant and is robust across various specifications. [ABSTRACT FROM AUTHOR]

Tuberculosis is a chronic and lethal infectious disease caused by Mycobacterium tuberculosis. In previous decades, most studies in this area focused on the pathogenesis and drug targets for disease treatments. However, the emergence of drug-resistant strains has increased the difficulty of clinical trials over time. Now, more post-translational modified proteins in Mycobacterium tuberculosis have been discovered. Evidence suggests that these proteins have the ability to influence tuberculosis drug resistance. Hence, this paper systematically summarizes updated research on the impacts of protein acylation and phosphorylation on the acquisition of drug resistance in Mycobacterium tuberculosis through acylation and phosphorylation protein regulating processes. This provides us with a better understanding of the mechanism of antituberculosis drugs and may contribute to a reduction the harm that tuberculosis brings to society, as well as aiding in the discovery of new drug targets and therapeutic regimen adjustments in the future. [ABSTRACT FROM AUTHOR]

The paper addresses the issue of excessive price abuse under Article 102(a) of the Treaty on the Functioning of the European Union (TFEU), by drawing inspiration from a recent stream of cases (developed first at the national and then at the EU level) involving pharmaceutical companies marketing off-patent drugs. In particular, the two 'most advanced' cases are analysed: Aspen in Italy and Pfizer/Flynn in the United Kingdom. This new-found attention towards exploitative practices in the form of excessive and unfair pricing by dominant undertakings that have traditionally been subject to a cautious antitrust scrutiny seems worth exploring for a number of reasons, as illustrated in the paper. Ultimately, it is argued that this further 'interference' of competition law into the realms of regulation may be actually justified, albeit subject to precise conditions for enforcement, and may pursue policy objectives in the wider context of EU health law. [ABSTRACT FROM AUTHOR]

In order to fully understand and appreciate today's drug problem in the UK, the foundations of drug legislation and the history of drug evolution require exploration. This paper critically examines the history of drug policy and the growth of heroin addiction from the perspective of a novice researcher who works closely with intravenous drug users in relation to leg ulceration and wound care in the acute setting. Today's drug policy has come a long way in understanding the problems of heroin addiction and establishing services to meet intravenous drug users' needs and the needs of society. This paper highlights the early warning signs of drug addiction and growth within the UK from an early stage with key areas such as who the early users were and how addiction grew so rapidly between 1920 and 1960. Current policy and decision makers as well as clinicians and researchers in this field must understand the impacts of past policy and embed it within their decisions surrounding drug policy today. [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]

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]

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]

Inflammation is a possible cause of variability in drug response and toxicity due to altered regulation in drug‐metabolizing enzymes and transporters (DMETs) in humans. Here, we evaluate the clinical and in vitro evidence on inflammation‐mediated modulation of DMETs, and the impact on drug metabolism in humans. Furthermore, we identify and discuss the gaps in our current knowledge. A systematic literature search on PubMed, Embase, and grey literature was performed in the period of February to September 2020. A total of 203 papers was included. In vitro studies in primary human hepatocytes revealed strong evidence that CYP3A4 is strongly downregulated by inflammatory cytokines IL‐6 and IL‐1β. CYP1A2, CYP2C9, CYP2C19, and CYP2D6 were downregulated to a lesser extent. In clinical studies, acute and chronic inflammatory diseases were observed to cause downregulation of CYP enzymes in a similar pattern. However, there is no clear correlation between in vitro studies and clinical studies, mainly because most in vitro studies use supraphysiological cytokine doses. Moreover, clinical studies demonstrate considerable variability in terms of methodology and inconsistencies in evaluation of the inflammatory state. In conclusion, we find inflammation and pro‐inflammatory cytokines to be important factors in regulation of drug‐metabolizing enzymes and transporters. The observed downregulation is clinically relevant, and we emphasize caution when treating patients in an inflammatory state with narrow therapeutic index drugs. Further research is needed to identify the full extent of inflammation‐mediated changes in DMETs and to further support personalized medicine. [ABSTRACT FROM AUTHOR]

Copyright of Angle Health Law Review is the property of Angle Publishing Co., Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

On the 24th of August 2014 the state of Kerala announced that alcohol will be progressively banned through different phases, with a plan of implementing a complete ban by 2025. The ban was eased in July 2017; yet, it sparked heated debates about its impacts on the tourism industry, which highlighted the strong nexus between alcohol and tourism. Despite animated discussions continued online for months after the announcement of the ban, there have not been studies assessing the impact of the ban on tourism/tourists. Through a thematic analysis of online texts published on TripAdvisor, this paper explores tourists' perceptions and opinions of the implementation of the 'Dry Law' in Kerala. Moreover, this work also investigates whether the ban discouraged potential tourists to visit Kerala. Overall, our analysis reveals that the ban did not discourage potential tourists to visit Kerala, although many regarded the possibility of having moderate amounts of alcohol on holiday as pleasant. Importantly, our study also contends that the narratives about the 'Dry Law' produced and propagated online were often representative of political structures of power, which linked tourism to alcohol irrespective of the real impact of the ban on tourism. [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]

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]

Background: Regulatory assessment of anthroposophic medicinal products (AMPs) can be challenging due to their specific features. Objective: The aim of this paper is therefore to provide adequate scientific information on AMPs for regulatory purposes. Methods: A literature review was executed with database searches in PubMed, Cinahl, Merkurstab, Anthromedics, and https://iaap-pharma.org/. Search terms were: anthroposophic medicinal products, anthroposophic medicines, anthroposophic pharmacy. There was no language restriction; searches were executed from onset until June 11, 2020. In addition, experts were invited to suggest relevant literature. Results: Eighty-seven of 660 identified publications were included. The system of anthroposophic medicine (AM) with its conceptual background and various aspects of AMPs was described: definition, pharmaceutical properties, an example of AMP development, use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, scientific and regulatory assessment. Conclusion: AMPs are part of the integrative whole medical system of AM. AMPs are manufactured according to Good Manufacturing Practice and national drug regulations and have an excellent safety status; the limited available evidence suggests clinical benefits. Current drug regulation of AMPs in the EU and most European countries does not take the special properties of AMPs into account. Future research should focus on appropriate methodologies for the evaluation of effects of AMPs as part of the AM whole medical system, the scientific quality of its non-atomistic holistic ontological position, and the integration of AM and conventional medicine in clinical practice. Future policies should focus on appropriate ways of addressing regulatory challenges to AMPs. [ABSTRACT FROM AUTHOR]

A balanced approach using an integrated combination of strategies, namely, demand reduction, supply reduction and harm reduction, was suggested to be implemented in a balanced way to the policy vision of a South Africa 'free of substance abuse'. Responding on the call for a comprehensive review of the National Drug Master Plan 2013–2017 to ensure consistency in policy approach, this article explores the integrative propositional analysis (IPA)‐based analysis to evaluate 'how systemic' and integrated were the policy strategies applied. The analysis draws insights from the internal consistency of the policy and provides complementary evidence on the systemic breakdown of the policy, which correlates with previous studies. The findings are indicative of the usefulness of the IPA‐based tools to more pragmatically develop policy that better reflects the systemic/integrated relationship of the three strategies based on their conceptual systemic integrity. This research has implications for interdisciplinary scholars and practitioners, of policy and theory. [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]

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]

The Canadian government recently sanctioned a supervised consumption site (SCS) that is currently in Vancouver, British Columbia. The government is open to sanctioning more sites across the country; however, by law the federal health minister must consider whether such facilities are supported by local governments representing the cities where the sites are proposed to be located. Until 2016, the government of Canada's largest city, Toronto, did not support SCSs. Drawing on Lenton cannabis policy research, this study analyses government documents, policy papers, scientific reports, and newspaper articles and secondary literature to identify some of the significant barriers that minimised the likelihood that Toronto's council would support SCSs between 2003 and 2016. The report compares conditions in Toronto to those of Vancouver where SCSs have enjoyed council support since 2001. This study find that three conditions play an important role in explaining why SCSs were supported in Vancouver 14 years before they were endorsed in Toronto: (1) Strong public support; (2) Favourable electoral conditions; and (3) Law enforcement support. Changes in Toronto surrounding these conditions help explain why its council endorsed SCSs in 2016. This study concludes that Lenton's research holds utility as a socio-legal theory of municipal drug policy change. [ABSTRACT FROM AUTHOR]

This paper takes a critical look at progress and prospects regarding the sociology of pharmaceuticals over the years. Key themes examined include: (i) medicalisation and pharmaceuticalisation; (ii) regulation; (iii) consumption and consumerism; (iv) expectations and innovation. Papers in the monograph are also introduced and discussed in relation to these themes. The paper concludes with some further comments and reflections on progress and prospects in this field, emphasising the continuing importance of sociological engagement with these personal and political issues in the 21st century. [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]

We introduce this special issue firstly by tracing drugs from their traditional, cultural and religious uses through to their roles as commodities in colonial relations and now the global economy. We secondly explore the shifting nature of drugs and drug use in different places and times as shaped by politics, especially state regulation and the law. Thirdly, given the complexity as well as contingency of drugs, we survey a wide range of relevant theoretical approaches, but suggest that a critical analysis attend to their spatial framing and geography. Fourthly, and finally, we summarize the eight papers comprising this collection. [ABSTRACT FROM PUBLISHER]

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]

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]