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Issues: Non-medical cannabis policies are changing, including towards legalisation-with-regulation frameworks. New Zealand will hold a public referendum on cannabis legalisation in 2020. We reviewed data on cannabis use and health/social harms; policy reform options; experiences with and outcomes of reforms elsewhere; and other relevant considerations towards informing policy choices in the upcoming referendum., Approach: Relevant epidemiological, health, social, criminal justice and policy studies and data were identified and comprehensively reviewed., Key Findings: Cannabis use is common (including in New Zealand) and associated with risks for health and social harms, mainly concentrated in young users; key harms are attributable to criminalisation. 'Decriminalisation' reforms have produced ambivalent results. Existing cannabis legalisation frameworks vary considerably in main parameters. Legalisation offers some distinct advantages, for example regulated use, products and user education, yet outcomes depend on essential regulation parameters, including commercialisation, and policy ecologies. While major changes in use are not observed, legalisation experiences are inconclusive to date, including mixed health and social outcomes, with select harms increasing and resilient illegal markets. It is unclear whether legalisation reduces cannabis exposure or social harms (e.g. from enforcement) for youth., Implications/conclusions: No conclusive overall evidence on the outcomes of legalisation elsewhere exists, nor is evidence easily transferable to other settings. Legalisation offers direct social justice benefits for adults, yet overall public health impacts are uncertain. Legalisation may not categorically improve health or social outcomes for youth. Legalisation remains a well-intended, while experimental policy option towards more measured and sensible cannabis control and overall greater policy coherence, requiring close monitoring and possible adjustments depending on setting-specific outcomes., (© 2020 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Backgrounds and Aims: Iran has 2.1 and 1.8% of its 15-64-year-old population living with illicit substance and opioid use disorders, respectively. To address these problems, Iran has been developing a large and multi-modality addiction treatment system, spanning the time before and after the Islamic Revolution., Methods: Iran's current drug treatment scene is a combination of services, ranging from medical/harm reduction services to punitive/criminal justice programs. Included in this array of services are drop-in centers providing low-threshold harm reduction services, such as distribution of sterile needles and syringes; opioid maintenance treatment clinics providing methadone, buprenorphine and opium tincture; and abstinence-based residential centers. We will review the evolution of this system in four phases., Results: In 1980, Iran's revolutionary government shut down all voluntary treatment programs and replaced them with residential correctional programs. The first shift in the addiction treatment policies came 15 years later after facing the negative consequences. Addiction is viewed as a disease, and new voluntary treatment centers offering non-agonist medications and psychosocial services were established. With an increased number of people who inject drugs and HIV/AIDS epidemics, in the second shift an extensive move towards harm reduction strategies and opioid-maintenance programs has been implemented to reduce HIV-related high-risk behavior. The emergence of a methamphetamine use crisis creating an increased number of socially marginalized addicted people resulted in public and political demands for stricter policies and ended in the third shift starting in 2010, with extended compulsory court-based residential programs. Currently, there is a new shift towards reducing the severity of criminal penalties for drug use/sales and promoting proposals for opium legalization., Conclusion: Iran's evolutionary experience in developing a large addiction treatment program in a complex combination of medical/harm reduction and punitive/criminal justice addiction treatment can be examined in its political, clinical and pragmatic context., (© 2019 Society for the Study of Addiction.)

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand., (© 2016 The British Pharmacological Society.)

The use of antibiotics in agriculture, particularly in food-producing animals, is pervasive and represents the overwhelming majority of antibiotic use worldwide. The link between antibiotic use in animals and antibiotic resistance in humans is unequivocal. Transmission can occur by ingesting undercooked meats harboring resistant bacteria, by direct contact of animals by animal handlers, and by various other means. Antibiotics used in aquaculture and antifungals used in horticulture are also an evolving threat to human health. Regulations aimed at decreasing the amount of antibiotics used in food production to limit the development of antibiotic resistance have recently been implemented. However, further action is needed to minimize antibiotic use in agriculture. This article describes the extent of this current problem and serves as the official position of the Society of Infectious Diseases Pharmacists on this urgent threat to human health., (© 2016 Pharmacotherapy Publications, Inc.)

Background: Marijuana policies are rapidly evolving. In the United States, recreational use of marijuana is now legal in 4 states and medical marijuana is legal in 23 states. Research evaluating such policies has focused primarily on how policies affect issues of price, access to, use, and consequences of marijuana. Due to potential spillover effects, researchers also need to examine how marijuana policies may impact use and consequences of alcohol., Methods: The current paper is a critical review of articles evaluating alcohol outcomes associated with marijuana decriminalization, medical marijuana legalization, and nonmedical or recreational marijuana legalization. We identified articles and reports through (1) online searches of EBSCO host database including Academic Search Premier, Econlit, Legal Collection, Medline, PsycARTICLES, and PsycINFO, as well as PubMed and Google Scholar databases; (2) review of additional articles cited in papers identified through electronic searches; and (3) targeted searches of state and local government records regarding marijuana law implementation. We reviewed studies with respect to their data sources and sample characteristics, methodology, and the margin of alcohol and marijuana use, timing of policy change, and the aspects of laws examined., Results: The extant literature provides some evidence for both substitution (i.e., more liberal marijuana policies related to less alcohol use as marijuana becomes a substitute) and complementary (i.e., more liberal marijuana policies related to increases in both marijuana and alcohol use) relationships in the context of liberalization of marijuana policies in the United States., Conclusions: Impact of more liberal marijuana policies on alcohol use is complex, and likely depends on specific aspects of policy implementation, including how long the policy has been in place. Furthermore, evaluation of marijuana policy effects on alcohol use may be sensitive to the age group studied and the margin of alcohol use examined. Design of policy evaluation research requires careful consideration of these issues., (Copyright © 2015 by the Research Society on Alcoholism.)

In 1998 the United Nations General Assembly Special Session resolved that governments would reduce drug production and consumption greatly within 10 years. With that period now elapsed, there is an interest in reviewing how successful this was and considering how drug policy could be improved. The demand for drugs in the world has stabilized mainly as a result of the interaction of epidemic forces, culture and economic development. Supply has become more concentrated and the menu of drugs has changed surprisingly slowly. Drug policy is shifting to a more explicitly tolerant configuration in Europe and a few other countries, but retains its ferocity in most of the world. The most prominent innovations under discussion have limited potential effects (heroin maintenance), have as yet been unproductive of policy interventions ('addiction is a brain disease') or have no political appeal (legalization). The option with the most scope is increased effort at diverting arrested drug users out of criminal justice systems. No prevention, treatment or enforcement strategies have demonstrated an ability to substantially affect the extent of drug use and addiction. The best that government interventions can do is to reduce the damaging consequences of drug use and drug control. More attention should be given to reductions in the intensity of drug enforcement, which has many unintended adverse consequences and yields few of the claimed gains.

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.

1. Drug development has moved into a new era--a time of particular interest in individualization of treatment and dose-response--that is of particular interest to clinical pharmacologists. 2. Clinical pharmacologists' skills are especially applicable to identifying subgroup differences in pharmacokinetics and the consequences of those differences through such techniques as the pharmacokinetic screen and evaluation of metabolic differences and drug-drug interactions. Clinical pharmacologists also can contribute to the discovery of true differences in pharmacodynamic response. 3. Clinical pharmacologists are trained to take a broad view of drugs, recognizing that they not only have the pharmacologic property of primary interest but often other properties as well, that a 'drug' is really many drugs (isomers, active metabolites) with different properties, and that the properties of drugs should affect how they are dosed and used.

1. The clinical pharmacologist in drug regulation has many roles to play. These include responsibilities for the premarketing assessment of a new product's efficacy and safety, for scrutiny of the summary of Product Characteristics, and for monitoring its performance after marketing. Furthermore, the clinical pharmacologist has a subsidiary responsibility in examining the results of preclinical pharmacological and toxicological studies. 2. Clinical pharmacologists in regulatory authorities have one further, and crucial, responsibility--humility. From their training and experience they will (or should) know of their own scientific limitations and of the necessity for seeking help and advice from other disciplines.

1. The Japanese pharmaceutical administration system, and recommendations for the improvement of clinical trial methodology following the implementation of GCP guidelines in Japan are described with special reference to three recent developments in Japanese drug regulation. 2. The implementation of GCP guidelines has not been fully satisfactory and clinical trials in Japan still run into problems. The Ministry of Health and Welfare has recently established a Committee on Safety of Medicines after serious trouble with a new drug was experienced. The Committee released an interim report on the reform of clinical trials supervision and the system for examination of New Drug Applications. 3. ICH-GCP guidelines will be implemented in Japan in the next few years. The principal differences between Japanese GCP and ICH-GCP guidelines, and their effects on clinical trials in Japan with reference to the acceptability of ICH-GCP, are discussed. 4. The final proposals on the National Health Insurance drug pricing method and the appropriate use of drugs by the Central Social Insurance Medical Council are anticipated to have a significant impact on the drug market. The changes in pricing system, especially premiums for innovative drugs, and the implications for the drug market are considered. 5. In these changed circumstances, the importance of the role of clinical pharmacologists in the framework of the new drug regulations in Japan is reviewed.