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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]

In Australia drug profiling had its formal beginnings during the early 2000s. Initially, this involved the development of a heroin signature program by the Australian Federal Police and the National Measurement Institute, which was then expanded to include cocaine, and by 2007 both programs had reached a mature state. From then, the focus switched to high volume synthetic drugs such as methylamphetamine. This paper describes the expansion of the Australian Illicit Drug Intelligence Program (AIDIP) to include a range of chemical signatures aimed at investigating the clandestine manufacturing methods and precursor chemicals used for synthetic drugs such as methylamphetamine. It also describes the commencement of the Enhanced National Intelligence Picture Illicit Drugs (ENIPID), which was designed to monitor domestic drug seizures in the Australian States and Territories with the goal of establishing links to drug trafficking into Australia. Examples of links between domestic, Border and international seizures are explored. Finally, the changing nature of drug trafficking into Australia during the last decade is considered in the context of how forensic chemistry laboratories need to be adaptable and willing to evolve as the threat from illicit drugs evolves. [ABSTRACT FROM PUBLISHER]

Purpose – The purpose of this paper is to assess the social impact, i.e. the estimated return to the Australian community, of Australian Federal Police (AFP) drug law enforcement effort in general and the relative success of specific policy initiatives. Design/methodology/approach – Benefit-cost analysis (BCA) was employed in the assessment of 2,716 drug investigations that took place between 2000 and 2005. Costs associated with the Australian Customs Service, the legal process and prisons were included. Benefits related to the economic estimate of reduced harm in terms of death and injury, crime, reduced productivity, and pain and suffering associated with the use of illicit drugs. Findings – The results suggest that the Australian community receives $5.80 of benefit in terms of potential harm avoided for every dollar invested in drug law enforcement. Specific policy initiatives were found to result in higher than average returns: investigations involving domestic and international partners ($6.00 and $9.20 respectively), an emphasis on serious and complex crime ($9.20), and intelligence-led policing ($7.90). Research limitation/implications – The estimation of economic benefits is the most contentious area of the study. The AFP is undertaking a review of its estimation of benefits. Originality/value – The results suggest that AFP drug law enforcement provides a positive contribution to the wellbeing of the Australian community. Furthermore, the findings indicate that specific drug law enforcement initiatives enhance the relative effectiveness of drug law enforcement in Australia. The study also provides an example to other public sector agencies of the use of BCA to determine the social impact of their policies. [ABSTRACT FROM AUTHOR]

Background and aims Prohibitions on producing, distributing and selling cannabis are loosening in various jurisdictions around the world. This paper describes the diversification of cannabis supply laws and discusses the challenges to and opportunities for learning from these changes. Methods We document changes in cannabis supply laws that de jure legalized cannabis production for medical and/or non-medical purposes (excluding industrial hemp) in Australasia, Europe, North America and South America. We also highlight challenges to evaluating these legal changes based on our experiences studying cannabis laws and policies in the United States. Findings As of August 2016, two countries have passed laws to legalize large-scale cannabis production for non-medical purposes at the national (Uruguay) or subnational level (four US states). At least nine other countries legally allow (or will soon allow) cannabis to be supplied for medicinal purposes. Most of the changes in cannabis supply laws have occurred since 2010. The data available in most countries are inadequate for rigorously evaluating the changes in cannabis supply laws. Conclusion The evidence base for assessing changes in cannabis supply laws remains weak. Efforts should focus upon collecting information about quantities consumed and market transactions as well as validating self-report surveys. [ABSTRACT FROM AUTHOR]

Background: The use of drug detection dogs and other punitive policing methods remain common at music festivals in Australia and elsewhere, despite concern about iatrogenic effects and recommendations for their overhaul. While drug amnesty bins are a commonly implemented strategy purported to mitigate risk associated with policing, the efficacy of this intervention is debated. This paper investigates two of the most concerning iatrogenic effects of drug policing practices at Australian festivals - internal concealment and panic consumption - and explores the potential efficacy of drug amnesty bins.Methods: A stepped, mixed methods study (qual→QUANT→qual) comprised qualitative interviews with key informants and festivalgoers, and a quantitative online survey completed by almost 2000 Australian festivalgoers (52% male; median age 20 years old). Descriptive statistics were performed alongside bivariable and multivariable logistic regressions predicting internal concealment and panic consumption. Inductive thematic analysis was used to examine the qualitative data.Results: Among respondents who had ever used illicit drugs at festivals (n=1065), 23% reported hiding drugs internally to evade police detection and 17% reported panic consumption. Female respondents and respondents expecting dogs were at greater odds of reporting internal concealment. The qualitative data provided greater insight into the risky nature of internal concealment practices and panic incited by police at the gates. When asked if they would have considered discarding their drugs into a drug amnesty bin had they been concerned about detection, less than a quarter (24%) said they definitely or probably would have.Conclusion: This paper adds to the evidence regarding iatrogenic effects of punitive drug policing practices at festivals. The findings have implications for shifting away from punitive policies to ones focused on public health. Additionally, the findings suggest drug amnesty bins should not be viewed as an adequate response for averting harms from drug policing. [ABSTRACT FROM AUTHOR]

Background Much academic scholarship has explored drug use and ‘addiction’ in the criminal justice system. Methods This paper explores what happens when ‘addicts’ are victims, through an analysis of victims of crime compensation case law within the state of Victoria, Australia. Results We argue that the law enacts a set of unexamined assumptions about the ‘problem’ of addiction, including the assumption that it is incompatible to be both addict and victim. However, courts reconcile this ‘dilemma’ by explaining addiction as an ‘effect’ of trauma, violence or abuse, a seemingly sympathetic rendering of addiction. Although this appears to represent a less stigmatising approach than found in the criminal law, we argue that these processes actually produce new challenges for people who use drugs and ‘addicts’, and that these may be counter to the stated aims and objectives of crimes compensation law. We argue that even legal systems with an explicitly remedial rationale have the potential to generate harms, creating those who use drugs and ‘addicts’ as pathological in certain ways and thereby undermining their claims to citizenship. Our analysis is underpinned by a critical approach to the constitution of social problems based on the work of Carol Bacchi. Conclusion Although the focus is on Australian law, the arguments we develop in this paper are likely to resonate beyond the specific jurisdiction reviewed here, and raise questions about the mutually interdependent role of law and policy in compounding the stigmatisation and marginalisation of people who use drugs and drug ‘addicts’. [ABSTRACT FROM AUTHOR]

The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets. [ABSTRACT FROM AUTHOR]

Aims:This paper examines the epidemiology of ecstasy use and harm in Australia using multiple data sources. Design: The data included (1) Australian Customs Service 3,4-methylenedioxymethamphetamine (MDMA) detections; (2) the National Drug Strategy Household and Australian Secondary Student Alcohol and Drug Surveys; (3) data from Australia’s ecstasy and Related Drugs Reporting System; (4) the number of recorded police incidents for ecstasy possession and distribution collated by the N.S.W. Bureau of Crime Statistics and Research; (5) the number of calls to the Alcohol and Drug Information Service and Family Drug Support relating to ecstasy; (6) the Alcohol and Other Drug Treatment Services National Minimum Dataset on number of treatment episodes for ecstasy, and (7) N.S.W. Division of Analytical Laboratories toxicology data on number of deaths where MDMA was detected. Findings: Recent ecstasy use among adults in the general population has increased, whereas among secondary students it has remained low and stable. The patterns of ecstasy consumption among regular ecstasy users have changed over time. Polydrug use and use for extended periods of time (>48 h) remain common among this group. Frequent ecstasy use is associated with a range of risk behaviours and other problems, which tend to be attributed to a number of drugs along with ecstasy. Few ecstasy users present for treatment for problems related to their ecstasy consumption. Conclusions: Messages and interventions to reduce the risks associated with polydrug use and patterns of extended periods of use are clearly warranted. These messages should be delivered outside of traditional health care settings, as few of these users are engaged with such services. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Abstract: Background: The introduction of political “war on drug” strategies and Prime Ministerial advisory groups increase opportunities for drug policy reform. Yet the strengths and limitations of capitalising upon political opportunities remain unclear. This paper provides a unique insight into the development of an Australian reform, the “Tough on Drugs-Illicit Drug Diversion Initiative.” This reform was one of the major policies to emerge out of the Federal Coalition “Tough on Drugs” strategy. In spite of the rhetoric the Illicit Drug Diversion Initiative (IDDI) has diverted minor drug users away from the traditional criminal justice system. Methods: This paper draws upon interviews with 16 expert policy makers involved in the advocacy and negotiations leading up to the adoption of the IDDI to examine what drove the reform and how and why a pragmatic reform emerged. Results: The IDDI culminated from the presence of five main drivers: a crisis in relation to heroin and crime, antagonism towards the government, a weak but growing evidence-base on the merits of drug diversion, a shift in law enforcement attitudes and persuasive advocacy by a group of non-government experts. This paper contends that the Prime Minister''s new “Tough on Drugs” strategy and expanded governance arrangements created new space for policy actors to intervene in the policy formulation process and to convert the governments proposed “zero tolerance” response into a more humane and potentially effective response. Conclusion: This paper concludes that contrary to popular opinion political venues and politicisation may offer valuable opportunities for drug policy reform. The challenge for researchers and policy advocates is to see how they can best utilise political venues to obtain pragmatic reform. [Copyright &y& Elsevier]

Background: Between 1992 and 2012 dispensing episodes for pharmaceutical opioids (PO) in Australia increased from 500000 to 7500000. In the US, increases in the prescription of PO have been linked to increases in opioid-related morbidity and mortality and transitions to heroin injection. However, Australian data indicate that morbidity and mortality related to PO are relatively low, particularly when compared to heroin and other drugs. This paper explores the characteristics and patterns of non-medical pharmaceutical opioid (NMPO) use among a sample of young people in Sydney, Australia.Methods: During 2015, we conducted in-depth qualitative interviews with 34 young people who use PO non-medically by oral (n=22) and intravenous (n=12) routes of administration.Results: Oral NMPO users were a more affluent group who clustered around the Northern, Inner and Eastern suburbs of Sydney, while the intravenous users came from a range of locations including rural/regional areas of NSW and socioeconomically disadvantaged suburbs of South Western Sydney. Oral users were characterised by intermittent and largely self-limiting NMPO use and reported few health and social consequences. Intravenous users reported heavy and frequent drug, including NMPO, use and a range of adverse health and social consequences including overdose, injecting risk behaviour, hepatitis C virus (HCV) infection and residential instability.Conclusion: Results highlight the significance of social and structural factors in trajectories of opioid use and related harms. Factors such as stable housing and family relationships, disposable income and close social networks observed in young oral NMPO users may help to explain differences in patterns of NMPO use and related outcomes between the two groups. [ABSTRACT FROM AUTHOR]

Background: In 2013 the Queensland Government introduced criminal association and mandatory sentencing laws for members of outlaw motorcycle gangs (OMCGs). Forms of "criminal association" or "anti-bikie" laws have been introduced in several Australian jurisdictions, and recent High Court decisions upholding their constitutionality will ensure that they remain part of our justice landscape. Generally, the aims of these laws are to declare a specific organisation as "criminal" and impose various legal orders and offences that thwart the consorting of members and address organised crime, such as unexplained wealth regimes. There have been significant criticisms of these styles of association laws both here and internationally. The aim of this research is to show the extent of involvement of OMCGs in the drug trade and associated organised crime activity, and whether anti-association laws are an effective response to this type of organised criminal activity.Methods: This paper relied on six years of data outlining the criminal activity of OMCGs from the Queensland Police Service (QPS) obtained under the legislative framework of The Queensland Right to Information Act (RTI) 2009. Information obtained from the Queensland Commission into Organised Crime (2015) and Queensland Taskforce into organised crime legislation (2015) was also used.Results: The data suggest that the role of OMCGs in the drug market has been overstated and is not as dominant as has been portrayed by government agencies and the popular media. Generally, OMCGs account for less than one percent of organised crime type activity. This is also true for drug type offences where OMCGs are responsible for less than one percent of offences. The findings show that the Queensland example has highlighted the ineffectiveness of the criminal association laws and the mandatory sentencing provisions in that they have had little impact on drug market activity and little success in the courts.Conclusion: The analysis presented here is twofold: an examination of the legal ramifications and an evaluation of the investigative utility of such laws from a policy evaluation standpoint. In both cases, there is little evidence to suggest that these laws are an effective or appropriate response. [ABSTRACT FROM AUTHOR]

In June 2012 DMAA (1,3-dimethylamylamine), an ephedrine-like vasoconstricting substance which had been included in many popular sports supplements, became a scheduled substance in Australia, following bans in several other countries. The underlying rationale for this ban was that DMAA use is unsafe. This paper aimed to critically review the available evidence on the acute and/or long-term harms of DMAA. Using five research databases (PubMed, Embase, ProQuest Health and Medical Complete, and Web of Science) and the key terms 'methylhexaneamine', 'DMAA', 'dimethylamylamine', '1,3-dimethylpentylamine' and '2-amino-4-methylhexane', 842 articles were identified once duplicates removed. Sixteen studies met the inclusion criteria and were included in the review. Of the included studies, eight were case studies, which reported on eight patients who presented to emergence departments. All were retrospective in their reporting. The patients displayed various outcomes; while the patients were presenting with serious problems, in most patients conditions subsided on cessation of supplement use. The remaining eight experimental studies were low powered, with a number of studies conducted by a single research group with industry ties, and broadly investigated the effects of DMAA on physiological outcomes. Mixed findings were apparent, although escalations of blood pressure were present on acute dosing, as well as decreases in measures of body weight and body fat. There is a shallow evidence base describing the adverse effects of DMAA and the dose above which such effects may occur. The scheduling of DMAA in many countries may now impede research efforts to determine whether there are safe doses at which DMAA can be consumed. [ABSTRACT FROM AUTHOR]

Introduction and Aims: There have been many changes to cannabis laws across the globe, some dramatic but more often incremental. This study explored the experiences after an incremental cannabis law reform in the Australian Capital Territory, Australia.Method: Semi-structured interviews (n = 30) were conducted in March and April 2021, 14 months after the introduction of cannabis law reform, with people aged 18 and over who had grown and/or consumed cannabis in the previous 12 months. Participants were asked about recent and past cannabis use, growing cannabis and changes to their practices after the introduction of the legislation.Results: Incremental cannabis law change resulted in regulatory grey areas. How people interpreted and navigated such grey areas were connected to their relative privileges, circumstances and histories. Those who were highly policed were more likely to experience the grey areas negatively. Those who were not highly policed found the grey areas confusing or 'half-arse' (insufficiently executed), but mostly experienced the new laws positively through new cannabis cultivation or perceived reduction in stigma and fear of arrest. Those with self-identified privilege were unconcerned with grey areas of the legislation.Discussion and Conclusion: Incremental policy change can result in grey areas that require some navigation. Vulnerable populations appear less likely to experience the full benefits of such incremental drug law reform. It is vital to attend to the inequities that can arise from incremental law reform so that positive experiences are shared across the population regardless of relative privilege. [ABSTRACT FROM AUTHOR]

Background: International drug law enforcement agencies have identified an apparent rise in high level drug traffickers choosing to deal in multiple different drugs. It is hypothesised that this may be a "deliberate modus operandi" and that the formation of "portfolios of trades" may make such traffickers more profitable, harmful and resilient to changes in drug supply and policing. In this paper we provide the first exploration of the extent, nature and harms of poly-drug trafficking at Australian borders.Methods: Two different methods were used. First, we used Australian Federal Police (AFP) data on all commercial level seizures at the Australian border from 1999 to 2012 to identify the proportion of seizures that were poly-drug and trends over time. Second, we used unit-record data on a sub-set of 20 drug trafficking cases and linked-cases (defined as the original drug trafficking case and all other criminal cases that were connected via common offenders and/or suspects) to compare the profiles of poly-drug and mono-drug traffickers, including: the total weight and type of drug seized, the value of assets seized, and the level of involvement in other crime (such as money laundering and corruption).Results: Between 5% and 35% of commercial importations at the Australian border involved poly-drug trafficking. Poly-drug trafficking occurred in almost every year of analysis (1999-2012), but it increased only slightly over time. Compared to mono-drug traffickers poly-drug traffickers were characterised by: larger quantities of drugs seized, larger networks, longer criminal histories and more involvement in other types of serious crime.Conclusion: Some fears about poly-drug traffickers may have been overstated particularly about the inherent escalation of this form of trafficking. Nevertheless, this suggests poly-drug traffickers are likely to pose added risks to governments and law enforcement than mono-drug traffickers. They may necessitate different types of policy responses. [ABSTRACT FROM AUTHOR]

In September 2012, a group known as Australia 21 called for a rethink on the prohibition against illegal drugs. If the response from Australian Federal, State, and Territory Governments is any guide, the call fell on deaf ears. In recent years, even scholarly debate about the merits of prohibition appears to have subsided. This paper acknowledges that social and financial costs of the prohibition against illegal drugs but argues that prohibition also prevents a great deal of harm. The multifarious nature of drug-related harm and the differences between people in the weight assigned to various harms makes it impossible say what policy best minimizes drug-related harm. [ABSTRACT FROM AUTHOR]

There has been growing tension at the intersection of health and economic policy making as global governance has increased across sectors. This tension has been particularly evident between tobacco control and trade policy, as the international norms that frame them—particularly the Framework Convention on Tobacco Control and the World Trade Organization (WTO)—have continued to institutionalize. Using five case studies of major tobacco-related trade disputes from the principal multilateral system of trade govemance—the WTO/General Agreement on Tariffs and Trade—we trace the evolution of these interacting norms over nearly twenty-five years. Our analytic framework focuses on the actors that advance, defend, and challenge these norms. We find that an increasingly broad network, which includes govemments, intergovemmental organizations, nongovemmental organizations, and members of the epistemic community, is playing a more active role in seeking to resolve these tensions. Moreover, key economic actors are beginning to incorporate health more actively into their messaging and activities. We also demonstrate that the most recent resonant messages reflect a more nuanced integration of the two norms. The tobacco control example has direct relevance to related policy areas, including environment, safety, access to medicines, diet, and alcohol. [ABSTRACT FROM AUTHOR]

Abstract: Background: National drug policies are often regarded as inconsequential, rhetorical documents, however this belies the subtlety with which such documents generate discourse and produce (and re-produce) policy issues over time. Critically analysing the ways in which policy language constructs and represents policy problems is important as these discursive constructions have implications for how we are invoked to think about (and justify) possible policy responses. Methods: Taking the case of Australia's National Drug Strategies, this paper used an approach informed by critical discourse analysis theory and aspects of Bacchi's (2009) ‘What's the Problem Represented to be’ framework to critically explore how drug policy problems are constructed and represented through the language of drug policy documents over time. Results: Our analysis demonstrated shifts in the ways that drugs have been ‘problematised’ in Australia's National Drug Strategies. Central to these evolving constructions was the increasing reliance on evidence as a way of ‘knowing the problem’. Furthermore, by analysing the stated aims of the policies, this case demonstrates how constructing drug problems in terms of ‘drug-related harms’ or alternately ‘drug use’ can affect what is perceived to be an appropriate set of policy responses. The gradual shift to constructing drug use as the policy problem altered the concept of harm minimisation and influenced the development of the concepts of demand- and harm-reduction over time. Conclusions: These findings have implications for how we understand policy development, and challenge us to critically consider how the construction and representation of drug problems serve to justify what are perceived to be acceptable responses to policy problems. These constructions are produced subtly, and become embedded slowly over decades of policy development. National drug policies should not merely be taken at face value; appreciation of the construction and representation of drug problems, and of how these ‘problematisations’ are produced, is essential. [Copyright &y& Elsevier]

Aim: To evaluate and document the impacts of re-scheduling codeine to a prescriptiononly medication in Australia in February 2018. Design: Prospective cohort study. Participants completed an on-line survey with a range of outcome measures at four time-points, once before codeine was re-scheduled (November 2017) and three times after the event: 1 month after (February 2018), 4 months after (June 2018) and 12 months after (February 2019). Setting: Australia. Participants: Participants were 260 Australians aged 18 years and above who reported regular over-the-counter (OTC) codeine use and, at the time of the study, were not engaged in treatment for codeine dependence. Measurements: Survey measures included estimates of daily average codeine use (mg) and overall daily average opioid use [calculated using an oral morphine equivalent daily dose (OMEDD, mg)], opioid use disorder with regard to codeine use (using a modified Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV), pain and pain self-efficacy, anxiety and depression and health service use. Findings: A reduction in total daily codeine use (mg) from 64.3 mg [95% confidence interval (CI) = 46.7-81.9] in November 2017 (baseline) to 27.6 mg (95% CI = 19.2-36.0) in February 2019 (final time-point) was observed. A decline in the proportion of participants who met criteria for an opioid use disorder was also evident, with 51.2% (n = 133) at baseline relative to 33.3% (n = 58) at the 12-month follow-up. This study had an overall participant retention rate of 67% at the final time-point. Conclusion: Re-scheduling codeine in Australia has been accompanied by significant reductions in codeine use and prevalence rates of opioid use disorder in a cohort of individuals who regularly use the medication, without apparent adverse impacts on pain or measures of anxiety and depression. [ABSTRACT FROM AUTHOR]

The mantra of "evidence-based policy" is continuing to gain ground, with calls for public policy to be informed by scientific evidence. However, in many areas of public policy the role of evidence and science is highly contested. This is amply demonstrated in the area of illegal drugs policy. Illegal drugs policy, concerned with governments' approaches to controlling the sale and use of drugs such as heroin, cocaine, and cannabis, is a highly contested area, and hence a fruitful case example of the complexity of policy. The features of illicit drug policy explored in this paper are: government actors, which span multiple departments; political ambivalence and multiple stakeholders outside government; community attitudes and a high media profile. These features need to be taken into account in understanding the relationship between policy and research evidence. In this context, the role of research evidence can be fraught. Examination of a number of current 'hot topics' in drug policy demonstrates the variety of ways in which evidence is used in drug policy processes. [ABSTRACT FROM AUTHOR]

The number of drugs with boxed warnings and the detail in the box are much greater in the USA than Australia. US warnings are up to ten times longer and often include a great deal of detail and qualified advice. Australian warnings are usually just a few sentences long and the expected response unequivocal. Other details are relegated to the relevant section within the product information. The restriction of warnings such that they are succinct and used sparingly are explicitly highlighted in the guidelines for boxed warnings in Australia. In addition, the range of other risk management strategies used may be broader. Widespread prescription drug subsidies and mechanisms set up to implement the ''Quality Use of Medicines'' policy provide a complementary range of options. Withdrawal of registration, removal of subsidies for all or selected indications, changed product information and labels, consumer-targeted information, prescriber mail outs, education programmes, restriction to authorised prescribers, and changed pack size and packaging have all been applied at some time in response to safety concerns. The diversity of approaches around the world provides an opportunity for a systematic approach to look at the effects of boxed warnings on prescribing practices so that we might discover what works best. While there are many studies on the effect of warnings from the USA, there are few comparable studies done where different approaches are used. Further, it is not possible to easily examine the total number and purpose of boxed warnings via any government websites. If there were always explicit and potentially verifiable changes in practice as the stated goal for each boxed warning in each jurisdiction and a requirement that the effectiveness of the intervention was measured against these goals, then we might have the evidence base for better policy around boxed warnings. [ABSTRACT FROM AUTHOR]

Issues. Under a federal system of government, political power is separated and distributed between different institutions of government. The distribution of power to enact policies that influence alcohol and other drug use can impact on the associated harm. Approach. A description of the separation of powers under a federal system of government is followed by three case studies of alcohol and other drug policies which have been influenced by the use of power by different institutions of government. Key findings. Whether or not a policy is enacted depends upon who has the power to bring such a policy into being, who has the power to prevent its enactment and whether those with such power choose to use them. Conclusion. The enactment of policy is a political act, needing to be understood by those wishing to see evidence-based policies brought into being. An understanding of the separation of powers under a federal system of government is one aspect of the political process that those who work in the alcohol and other drug field need to understand. [Ryder D. Political and legal institutions and their influence on drug policy: an Australian perspective. Drug Alcohol Rev 2008;27:374-379] [ABSTRACT FROM AUTHOR]

Aim. To estimate how much governments in Australia spend on reducing and dealing with illicit drug problems. Methods. Government documents and supplementary information sources were used to estimate drug-related expenditure for the financial year 2002-03, in Australian dollars. Public sector expenditure on reducing drug problems ('proactive expenditure') was classified into four policy functions: prevention, treatment, harm reduction and enforcement. Expenditure related to the consequences of drug use ('reactive expenditure') was included as a separate category. Results. Spending by Australian governments in financial year 2002-03 on all drug-related activities was estimated to be $3.2 billion. Proactive expenditure was estimated to be $1.3 billion, comprising 55% on enforcement, 23% on prevention, 17% on treatment, 3% on harm reduction and 1% on activities that span several of these functions. Expenditure on dealing with the consequences of drug use was estimated to be $1.9 billion, with the majority the result of crime-related consequences. Conclusion. Several insights result from estimating these expenditures. First, law enforcement is the largest drug policy component, with Australian governments also spending significant amounts on treatment and prevention programmes. Secondly, apart from the prevention component, Australia's drug policy mix is strikingly similar to recent international estimates. Finally, expenditures associated with dealing with the consequences of illicit drugs are large and important for assessing drug-related public sector expenditure. [Moore TJ. The size and mix of government spending on illicit drug policy in Australia. Drug Alcohol Rev 2008;27:404-413] [ABSTRACT FROM AUTHOR]

Background and aims: Over‐the‐counter codeine products were up‐scheduled to prescription only in Australia from February 2018. This trend study aimed to identify changes in codeine supply before and after the February 2018 implementation. Design, setting and cases: Time–series regression analysis of monthly medicine supplies in Australia from 2014 to 2018. The February 2018 up‐scheduling was pre‐specified as the intervention; outlier analysis was used to detect automatically sudden unexpected changes before February 2018. Measurements Per‐capita supplies based on national data for pharmaceutical wholesales and population exposure. Weight of supplies in milligrams for low‐dose codeine (≤ 15 mg per tablet or ≤ 1.92 mg per ml, originally sold over the counter but up‐scheduled after February 2018), high‐dose combination codeine (30 mg per tablet, prescription only throughout the study period) and all codeine. Findings Several level shifts in supply occurred during the 5 years, led by one of −4.4% [95% confidence interval (CI) = −6.6 to −2.1%] in high‐dose codeine in 2015, followed by shifts in low‐dose codeine of −40.0% (CI = −46.9 to −32.3%) and −82.2% (CI = −84.3 to −79.9%), respectively, before and after February 2018. High‐dose codeine supply increased by 4.4% (CI = 1.8–7.1%) immediately after up‐scheduling. Also detected were transient increases and decreases in 2016 and 2017. Compared with pre‐2015 levels, the February 2018 up‐scheduling was associated with reductions of 45.7% (CI = 43.2–48.0%) and 89.3% (CI = 87.9–90.6%), respectively, in all and low‐dose codeine supply but no change in high‐dose codeine supply. The level shifts and transient changes were located around various regulatory activities, including public announcements and expert advisory meetings on up‐scheduling. Conclusion: Up‐scheduling of over‐the‐counter codeine products in Australia in 2018 appears to have been associated with a near halving of Australia's national codeine supply. The transition occurred in multiple forms and phases. [ABSTRACT FROM AUTHOR]

This paper draws attention to the 1998 legislation in Australia which introduced a drug-specific patent term restoration procedure called a supplementary protection certificate. After investigating effective patent life data the results suggest that there is a case for such a measure in New Zealand. [ABSTRACT FROM AUTHOR]

The article presents a paper which examines a print media reporting on drugs and crime in Australia from January 1995-December 1998. It puts emphasis on the covered drug type by the media, the sources used, and the connection in media reporting between drugs and non-drug criminality. It provides suggestions on how media stakeholders and professionals can work for improvement of drug and crime reporting. These include the establishment of guidelines so that drugs and crime are reported based on public interest.

After specific rules establishing whether a molecule is a ‘structural modification’ of a drug molecule, the analogue drug provisions in the various Acts legislated by States and the Commonwealth of Australia rely on rules that determine if a putative drug is ‘structurally similar’ to a dangerous or controlled drug listed by the Act. In some legislation there is a provision for a suitable expert to assert that the two structures are similar. A survey of more than 200 research chemists at UNSW Australia, who are not usually involved in legal matters, asked them to state whether six pairs of molecules were structurally similar or not. There is some correlation with Tanimoto similarity, a measure of similarity often used in pharmaceutical drug discovery, but the use of such an objective measure is not advocated at this time. The concepts of addition of groups, and of replacement of ring structures are discussed in the light of cases and of chemical and general definitions. Regularising the law with chemical understanding and practice is strongly recommended. As similar laws have been enacted in other countries, the conclusions reached here will have interest in jurisdictions outside Australia. [ABSTRACT FROM PUBLISHER]

The author discusses updates on issues related to the marketing of drugs to society in clinical trials. Topics mentioned include the drug acquisition component of the cost of pharmaceutical clinical trials, a concept of penetration pricing developed by economist Joel Dean, and the rising costs of anti-cancer drugs in Australia.

The article focuses on the need of implementation of pharmacist prescribing (PP) in Australia. It notes the importance of PP in providing access to care, improving safety and reducing variability in care delivery. It mentions Third Patient Safety Challenge, Medication Without Harm released by World Health Organization Medication with a goal to reduce medication-related harm. It notes the advancements in digital health initiatives in Australia and its contribution to quality use of medicine.

Background: Despite a complex and multi-faceted alcohol policy environment in Australia, there are few comprehensive reviews of national and state alcohol policies that assess their effectiveness and research support. In mapping the Australian alcohol policy domain and evaluating policy interventions in each of the core policy areas, this article provides a useful resource for researchers. The implications for protecting public health emanating from this mapping and evaluation of alcohol policy are also discussed. Methods: This review considered data from: published primary research; alcohol legislation, strategies and alcohol-related press releases for all levels and jurisdictions of Australian government; international publications by prominent non-governmental organisations; and relevant grey literature. These were organised and evaluated using the established framework offered by Thomas Babor and colleagues. Results: Findings indicated great variability in alcohol initiatives across Australia, many of which do not reflect what is currently considered to be evidence-based best practice. Conclusions: Research showing increasing alcohol-related harms despite steady levels of consumption suggests a need to pursue alcohol policy initiatives that are supported by evidence of harm-reduction. Future initiatives should aim to increase existing alcohol controls in line with suggested best practice in order to protect public health in Australia. [ABSTRACT FROM AUTHOR]

In 2003, the Therapeutic Goods Administration instituted a major recall of products made by Pan Pharmaceuticals Limited. Later that year, an expert committee produced 49 recommendations for complementary medicines reform, many of which were to be implemented by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). In 2008, the Pan Pharmaceuticals affair reached some conclusion in the courts, the ANZTPA had been abandoned and the case for reform had intensified. There was widespread and increasing use of complementary medicines yet consumers were often unaware that, unlike conventional medicines, these medicines were not evaluated for efficacy. The justification of this two-tiered regulatory system was that complementary medicines are relatively low-risk products. However low risk does not mean no risk. A number of consumers have been shown to use these products for conditions where there is no evidence of effect, potentially placing them at risk. In addition, promotion often overstates their benefits while minimising and sometimes denying known adverse effects and drug interactions. Complaint procedures are overloaded and the "sanctions" available do not deter repeat offenders. A number of regulatory reforms have been suggested to overcome these problems; they are reviewed in this paper. [ABSTRACT FROM AUTHOR]

Australia's system for assessing the cost-effectiveness of drugs for listing under the Pharmaceutical Benefits Scheme (PBS) is recognised internationally. A variety of mechanisms, such as evidence-based rules for determining eligibility for initial or continuing subsidy, price-volume agreements, rebates, and caps on government expenditure are used to contain PBS expenditures. In this paper we assess the extent of use of special pricing arrangements in Australia and how and where they are communicated to health professionals and the community. We searched publicly available documents published by the Pharmaceutical Benefits Advisory Committee (PBAC) and the Pharmaceutical Benefits Pricing Authority (PBPA). We found 73 medicines where special pricing arrangements had been applied and where prices appearing on the Schedule of Pharmaceutical Benefits might differ from those considered to be "cost-effective" by the PBAC. Reporting of these special pricing agreements was inconsistent and generally non-transparent. In some, the lack of transparency may have reflected the desire of manufacturers to disguise the true negotiated price, lest it weaken their negotiation position in other jurisdictions. [ABSTRACT FROM AUTHOR]

The article offers news briefs on various issues. The Australian Cricketers' Association and Cricket Australia (CA) are considering 12-month trial of hair testing of players. Canadian provinces are likely to remove OxyContin and OxyNEO from the publicly funded drugs list. FIFA has insisted Brazil government to give the right to sell beer at the Brazil World Cup which is going to be held in 2014. Otto Perez, the Guatemala's new President has joined together with Latin American presidents over the issue of legalizing drugs.

ABSTRACT Aims Decisions on whether and how to 'schedule' drugs (i.e. to determine their legal status and penalties to be applied for sale or possession) are often heavily criticized. We sought to assess more comprehensively the results of such decisions for newly emerging drugs. Methods Through analysis of legislation and secondary sources, we identified 63 substances that have emerged since 1971, including all that have been added to the most restrictive schedule by the United Nations, United States, United Kingdom, Canada, Australia and/or New Zealand. Measurements For each jurisdiction we recorded whether, when, and how the substance was scheduled and note what decisions engendered substantial criticism or controversy within the international treaties' framework of balancing medical benefits with risk of abuse. Findings (i) The rate of emergence of new drugs has been fairly steady. (ii) There is broad cross-national agreement on what should be scheduled. (iii) The United States often acts first. (iv) Temporary bans that delay final decisions by 12-18 months can sometimes allow final decisions to be grounded on a substantially expanded research base. (v) It appears that no more than seven of the decisions reached by the United States with respect to the 63 substances are candidates for being considered errors, and arguably the United States has committed at most one serious Type I and one serious Type II error. Results for other countries are broadly similar. Conclusions The process for determining the legal status of new psychoactive substances appears to function reasonably well, within the framework of international treaty obligations. Most criticisms relate to one or a few substances (e.g. 3,4-methylenedioxymethamphetamine) and/or complaints that the decisions discount benefits that are not recognized by the treaties (e.g. recreational or religious use). [ABSTRACT FROM AUTHOR]

Introduction and Aims. At present there is little research into the use of drug detection dogs. The present study sought to explore the use of detection dogs in Sydney, Australia, utilising multiple data sources. Design and Methods. Data were taken from interviews with 100 regular ecstasy users and 20 key experts as part of the 2006 New South Wales arm of the Ecstasy and Related Drugs Reporting System, and secondary data sources. Results. The majority of regular ecstasy users reported taking some form of precaution if made aware that dogs would be at an event they were attending. A small proportion of the sample reported consuming their drugs when coming into contact with detection dogs. One group of key experts viewed the use of detection dogs as useful; one group disliked the use of detection dogs though cooperated with law enforcement when dogs were used; and one group considered that detection dogs contribute to greater harm. Secondary data sources further suggested that the use of detection dogs do not significantly assist police in identifying and apprehending drug suppliers. Discussion and Conclusions. The present study suggests that regular ecstasy users do not see detection dogs as an obstacle to their drug use. Future research is necessary to explore in greater depth the experiences that drug users have with detection dogs; the effect detection dogs may have on deterring drug consumption; whether encounters with detection dogs contribute to drug-related harm; and the cost–benefit analysis of this law enforcement exercise. [Dunn M, Degenhardt L. The use of drug detection dogs in Sydney, Australia. Drug Alcohol Rev 2009] [ABSTRACT FROM AUTHOR]

The development of policies in relation to unsupervised doses of methadone (take-away doses) should be based upon the best available evidence. There are both risks and benefits associated with take-away doses. This study aimed to explore the relationship between take-away policies and one measure of harm: methadone injection rates. Six different states in Australia were compared in relation to their methadone take-away policy and rates of methadone injection within their population of injecting drug users. At a simplistic level, those states with restrictive and less flexible take-away policies tended to have the lowest reported prevalence of methadone injection. However, this does not fully explain variability in methadone injecting. There were also considerable differences between those states with similar take-away policies. Variables which appear to impact upon methadone injecting rates include: take-away policies, drug preference, drug availability, treatment availability and degree of treatment penetration. Consideration of the benefits, rather than merely the harms, of various take-away policy options may provide an evidence-based platform for take-away policy development. [Ritter A, Di Natale R. The relationship between take-away methadone policies and methadone diversion . Drug Alcohol Rev 2005;24:347 – 352] [ABSTRACT FROM AUTHOR]

The official public policy related to recreational drug use and abuse in Australia is harm minimization or harm reduction. Definitions of harm minimization vary but a general statement is that harm minimization is a policy or programme intended to decrease adverse health, social and economic consequences of drug use, even though the user may continue to use psychoactive drugs. This type of definition is most often compared to a zero-tolerance policy that aims to eliminate all recreational drug abuse by legal and other means. Sociologists have historically scoffed at this latter policy. Unfortunately, what this has meant is that harm minimization in all its forms has not been the object of analytical work on the part of sociologists. [ABSTRACT FROM AUTHOR]

Commentary to: Can new psychoactive substances be regulated effectively? An assessment of the British Psychoactive Substances Bill [ABSTRACT FROM AUTHOR]