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The authors reflect on a report "Transparency and trust in the European pharmaceutical sector" published within issue of the periodical. Topics discussed include relation between transparency and trust in pharmaceutical regulators; need of integrating transparency in effective, evidenced- and science based benefit/risk communication; and need of different regulatory domains to obtain a understanding of the role of the institutional and situational context.

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]

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]

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]

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]

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]

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]

This paper argues that the concept of resilience is a fruitful way of understanding the impact of repressive policies on illegal drug markets. For the purpose of this article, resilience is defined as the ability of market participants to preserve the existing levels of exchanges between buyers and sellers, despite external pressure aimed at disrupting the trade. The first part of the paper highlights how some of the core features of illegal drug markets, a decentralized structure and high prices, contribute to increasing their resilience to attacks. The second part develops a framework that can be used to compare markets on the basis of their resilient properties. Some of the empirical and policy implications of the framework are discussed in the conclusion. [ABSTRACT FROM AUTHOR]

This paper addresses three types of drug policies: drug laws, drug prevention strategies, and drug treatment strategies that might be used to improve drug policies. For each of these three categories, the paper discusses what criminological research tells us about the best practices. Research suggests that drug abuse prevention and treatment have statistically and clinically significant effects. The terms ‘prevention’ and ‘treatment’ are, however, often used indiscriminately and with reference to many different concepts. To assume that everything that is called prevention or treatment is effective would be foolish: not every drug prevention program is effective; not every treatment program has an effect in terms of reducing recidivism. Research has made it possible to identify successful prevention and treatment programs for drug abusers. However, the programs that research would suggest are not always those chosen by practitioners or widely funded by policymakers. [ABSTRACT FROM AUTHOR]

Despite the widespread use of the drug court model, standardized performance measures for drug courts are not uniformly utilized, and rarely include process measures. To ensure that drug courts are being implemented in the most effective manner, the use of performance measurement tools should be considered for wide scale adoption. Drug court effectiveness is moderated by participant characteristics, and is most effective for individuals with the highest substance use needs. Therefore, having quality clinical screening processes is crucial to ensuring that drug courts are serving the population for which they are effective. This paper examines clinical screening in drug courts, to answer the following 1) what is the current state of screening, 2) what works, and 3) why measurement matters. It also proposes a clinical screening performance measure to improve fidelity and ensure appropriate participant enrollment. The creation of a performance measure would create opportunities to improve drug court outcomes, and leverage pay-for-performance models. [ABSTRACT FROM AUTHOR]

Aims: The indicator of availability has been used in the risk assessment (RA) of new psychoactive substances (NPS). This paper aims to examine the pre- and post-control availability of 25I-NBOMe, AH-7921, MDPV and MXE, which were assessed by the EMCDDA.Methods: Data were collected by a semi-automated software tool (I-TREND SASF) on e-shops in national languages (Czech, French, Dutch, Polish and English) that offered shipping of these compounds into the respective countries; frequency analysis was used.Findings: The number of e-shops selling these substances decreased between III/2014 and XII/2015 (except for AH-7921). Both increases and decreases were found on the country-level for all the compounds (except for an overall decrease for MXE). In one instance an NPS disappeared from this market in 2015 (25I-NBOMe in NL); 25I-NBOMe and AH-7921 in France and AH-7921 in Poland appeared for the first time in 2015 after they were put under control. The e-shops listing AH-7921, 25I-NBOMe and MDPV in XII/2015 ranked higher in terms of “popularity” than in III/2014. The IP addresses were more likely to be outside the EU in 2015 than in 2014.Conclusions: We found no evidence that national-level compound bans contributed to the changes in online NPS markets. Indicators of the accessibility, availability, popularity, and IP origin should be considered in RA. Data triangulation with street markets and the darknet is needed as well as more research into the “displacement” and “replacement” effects of control laws. [ABSTRACT FROM PUBLISHER]

Aims: Studying the characteristics of the science-policy nexus in the field of drugs emerged in parallel with an interest in the principles of good governance. Centre-stage is the processes through which policy is informed, especially with regard to the role of non-government actors, contrasting with the widely accepted view that drug policymaking is a prerogative of governments. Through the lens of what is defined as good governance in drug policy, this article examines the processes underpinning the drug-policy change in Belgium between 1996 and 2003. Methods: The paper is based on an analysis of 164 policy documents and 1067 newspaper articles, and 55 interviews with a range of stakeholders including policymakers, professionals, scientists and journalists. Findings: Some distinctive features were found relating to the mechanisms through which evidence was mobilised and eventually informed policy change in Belgium. Evidence-imbued leadership, evaluation, coordination, the engagement of different stakeholders and the role of the parliament played key roles. Conclusions: Several characteristics of good governance make the use of evidence more likely. However, governance processes seem to be challenged in highly sensitive discussions (e.g. on cannabis policy). Another challenge may be how the principles of good governance can be consolidated in the long term. [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]

The precise assessment of treatment efficacy in clinical trials requires scientific instruments that are not only relevant to the target population and treatment, but have been shown to be reliable, valid, and sensitive to change within the intended context of use. This paper describes the background, procedures, and current status of 2 patient-reported outcome (PRO) instruments developed for use in clinical trials of chronic obstructive pulmonary disease (COPD). The first measure, the EXAcerbations of Chronic pulmonary disease Tool (EXACT), was developed under the EXACT-PRO Initiative, a multi-year, multi-sponsor project involving experts in pulmonary medicine, instrument development, and drug development regulatory issues, dedicated to the development of a single, standardized instrument for evaluating the effects of treatment on acute exacerbations of COPD. The second measure, the EXACT-Respiratory Symptoms (E-RS) scale, is a derivative instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD. The EXACT-PRO Initiative was the first PRO instrument development consortia, and the EXACT and E-RS are the first PRO measures to undergo qualification review by the United States Food and Drug Administration (FDA). [ABSTRACT FROM AUTHOR]

This paper reviews the impact of ten years of domestic incorporation of the European Convention on Human Rights (ECHR) on the evolution of the United Kingdom's primary piece of prohibitive drugs legislation, the Misuse of Drugs Act 1971. The significant cases where traditional interpretation of this Act has been challenged in the courts using the Convention are discussed. Structured thematically, this paper looks at the interplay between drug prohibition and human rights in addressing complex issues, such as our right to self-medicate, to practice our religion(s) freely, and to explore our own consciousness. The intention is to expose the untapped potential of the ECHR as a tool with which to fundamentally challenge the (discriminatory) drug policy of the United Kingdom. [ABSTRACT FROM AUTHOR]

This paper examines the reorganization of Finnish drug policy in the light of recent major changes. The analysis is inspired by writings of criminologist David Garland on crime control and governmental control strategies (Garland, 1996, 2000, 2001), and by the British drug debate on the normalization of drug use (Parker, 2005; Parker et al., 1998; Shiner & Newburn, 1999; South, 1999). Garland distinguishes between adaptive and non-adaptive social responses to crime. Adaptive responses generally lower the objectives of public policy because the goals seem unrealistic. If you cannot get the best, you can always strive for the good. Non-adaptive or repressive responses are needed to justify the image of the State as an efficient and competent actor. The conclusion of the paper is that, after a somewhat stormy debate in Finland around the turn of the century, the adaptive and non-adaptive responses have peacefully aligned with each other. This dual-track model has become the new paradigm in Finnish drug policy: Both harm reduction and criminal control approaches are now well established and expansive. Related trends are recognized also in other countries. [ABSTRACT FROM AUTHOR]

Treatment service provision for problem drug users in the Republic of Ireland until the mid-1980s was centralized, specialist and ideologically tending towards abstinence models of intervention. However, in the context of continuing heroin use and its accompanying public health risks, all these features of policy and service provision changed gradually over the next decade. This paper looks in detail at the evolution of the methadone protocol of 1998, which institutionalized and regulated methadone prescribing by general medical practitioners in Ireland. It discusses the main stakeholders, lists the sequence of events and looks analytically at the policy process. It is concluded that the introduction of the methadone protocol was a pragmatic success, albeit one which departed significantly from conventional beliefs about policy transparency in democratic societies. [ABSTRACT FROM AUTHOR]

This paper describes ways to approach the conceptual and practical challenges associated with interpreting the clinical meaning of scores produced by patient reported outcome (PRO) questionnaires, particularly when used to inform efficacy decisions for regulatory approval for oncology products. Score interpretation estimates are not inherent to PRO questionnaires per se, instead, vary dependent upon sample and study design characteristics. Scores from PRO measures can be interpreted at the individual and group level, and each carries its own set of statistics for evaluating differences. Oncology researchers have a variety of methods and data analytic strategies available to support their score interpretation needs, which should be considered in the context of their a priori knowledge of the target patient population, the hypothesized effects of treatment, the study design and assessment schedule, and the inferences and decisions to be made from the PRO data. [ABSTRACT FROM AUTHOR]

Correct use of terms in a manuscript or policy statement is important to meet the objectives of the paper. Inappropriate terms can be counter-productive. The World Health Organization (WHO) recommends the following: 'Terminology in national drug control legislation and policies should be clear and unambiguous in order not to confuse the use of controlled medicines for medical and scientific purposes with misuse' and terminology should always be respectful. This commentary lists English language terminology that can impair access to controlled medicines for the treatment of pain and suffering (an objective of the international substance control conventions), including pain management and the treatment of opioid dependence. The commentary also suggests alternative wording. Assessment of terminology correctness is language sensitive and should therefore be conducted by native speakers. In all language communities, advocates should explore and discuss the terminology with health-care professionals and their clients/patients, and they should promote the use of correct vocabulary. [ABSTRACT FROM AUTHOR]

The drug treatment court as a response to addiction, and restorative justice as a theoretical paradigm, have both emerged as significant influences upon criminal justice and societal and governmental responses to criminal behavior. The drug treatment court includes elements and features of restorative justice. The concept of restorative justice, with its focus on the reintegration of offenders, victims, and community, may be considered a theoretical construct within which to examine, evaluate, and further develop the drug treatment court model of addressing the problem of drug addiction. This examination also raises the question: what is restorative justice? This paper considers the restorative features of drug treatment courts, the limits of restorative justice, and ways in which the drug treatment court may benefit from restorative justice. [ABSTRACT FROM AUTHOR]

The Licensing Act 2003 (covering England and Wales) introduced greater flexibility to the UK licensing laws, including the possibility of 24-h licenses. This paper reports a nation wide survey of 225 (63%) local authority chairs of licensing committees/senior members of licensing teams in England evaluating the short-term impact of the Act. A cumulative impact (saturation) area was only declared in 38 (17%) local authorities. Extended hours applications were more common than new applications in both on- and off-licensed premises. The perception of those surveyed was of 'no change' in the following alcohol-related variables; public noise levels (n = 133, 59%) violence and fights (n = 130, 60%), under-aged drinking (n = 143, 67%), crime (n = 141, 68%), and drink-driving (n = 157, 86%). Contrary to the picture often presented in certain parts of the mass-media, the impact of the Licensing Act appears to be neutral. However, these are likely to be the result of a number of intervening factors, rather than the change to a more liberalized licensing regime. The role of the police would seem to be fundamental. Future research will need to disentangle the impact of these intervening factors and it will be a number of years before the impact of these changes can be assessed. [ABSTRACT FROM AUTHOR]

Illicit drug policy interventions cover treatment, law enforcement, prevention and harm reduction. This paper provides a comprehensive list across these sectors, of known drug policy interventions. One hundred and eight interventions were identified. With such a long and undifferentiated list of drug policy interventions, the ways in which these interventions are then coded and classified is also addressed. Ten different classification schemes are reviewed including summary information on the original sources and backgrounds to the schemes. The authors rated each of the policy interventions against the schemes. Those which proved useful in summarising illicit drug policy interventions included the four pillars approach, the UNODC classification, the demand, supply and harm reduction paradigm, the public health model and the policy instruments model. The list of 108 policy interventions will be of use to policy makers, researchers and practitioners in appreciating the array of drug policy options, and could be used in reviews of policy or practice. The classification schemes reveal the different ways in which drug policy interventions can be clustered and described to different audiences. [ABSTRACT FROM AUTHOR]

Drug policy within the UK has been challenged to a greater degree in the last twelve months than at any time over the last ten years. That challenge consists of reports from the Royal Society of Arts and the UK Drug Policy Commission as well as empirical research on the classification of drugs within the Misuse of Drugs Act. These documents identify major weaknesses in the content, direction and delivery of UK drug policy and propose a new direction of policy and new elements of drug policy. In the case of the RSA report and the report from the UK Drug Policy Commission the principal recommendation is for drug policy to shift from its current tri-partite focus on treatment, prevention and education to focus first and foremost on reducing drug-related harm. This paper critically considers the assessment of drug policy set out within these reports and looks at the possible impact of a drug policy that prioritized harm reduction over prevention and enforcement. [ABSTRACT FROM AUTHOR]

Many security‐related roles that were customarily the responsibility of governments and public police agencies have become commercialized, devolved, or otherwise dispersed. This phenomenon has been described as ‘multilateralization.’ The paper sets out to analyse the multilateralization of policing as it applies to strategies of supply reduction in the area of illicit synthetic drugs, focusing in particular upon amphetamine type substances. Supply reduction can constitute interventions not ordinarily thought of as drug law enforcement and entail a range of technologies underpinned by regulatory theory. Various strategies of engaging external institutions in furtherance of reducing the supply of illicit synthetic drugs are canvassed. The authors provide an analytical framework for understanding how illicit synthetic drugs can be governed through strategies of co‐production and the possible barriers and issues that need to be considered when attempting to engage the crime control capacities of external institutions. [ABSTRACT FROM AUTHOR]

This paper examines generic competition following the enactment of the 1984 Waxman-Hatch Act. Unlike the existing literature, we employ antibiotics as a control group to infer legislation-induced increases in generic competition. Using FDA drug approval data, we find evidence that the Act enhanced generic Competition, resulting in 1.5 times more competition between nonantibiotic drugs than between antibiotics. Moreover, the Act's overall impact is greater for newer drugs than older drugs. [ABSTRACT FROM AUTHOR]

Describes a regulatory approach with detailed guidance on specific sections of the European Clinical Trials Directive for filing Chemistry, Manufacturing, and Controls (CMC) information concerning the drug substance in Phases 1, 2, and 3. Aspects of the Directive which was first proposed as a White Paper in 1991 and published as a draft directive in 1997 in the European Union; Critical drug substance information necessary to support the investigational medicinal product dossier (IMPD) in each clinical study phase; Approach that supports the filing requirements for investigational new drug applications (IND) in the U.S. Department of Health and Human Services.

Risk assessment as a regulatory tool developed during virtually all of the 20th century. During this period there were several critical events such as the passage of the Food and Drug Acts of 1906 and 1938 and the publication of the National Research Council's report Risk Assessment in the Federal Government: Managing the Process, known as the "Red Book," which defined the concepts and principles of risk assessment. This paper reviews the impact of some of the major events in the evolution of risk assessment and concludes with some speculation on the future. Key Words: FDA Laws; Red Book; risk; National Research Council; safety; thresholds. [ABSTRACT FROM AUTHOR]

This paper introduces the term reclamation activism to refer to the processes by which social movements make claims based upon a real or imagined status quo ante during a period of transition. The motivation for a reclamation stance is the perception that a social good—such as some combination of social, economic or political privileges or cultural dominance—is being threatened. The notion is applied to the analysis of a modern social movement, the parents' movement against drug use in the USA. Based upon content analysis of movement literature, the claim is made that the movement is organized in opposition to its image of a 'pro-drug culture' rather than actual patterns of drug use. This oppositional stance is shown to have advantages for the movement over other claims-making strategies. [ABSTRACT FROM AUTHOR]

The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change. [ABSTRACT FROM AUTHOR]

The U.S. Congress passed a new law (PL 101-508) in 1990 requiring the pharmaceutical manufacturers to grant rebates on prescription drugs sold at retail under the federal Medicaid program. The goals include containing Medicaid program costs and expanding access of the indigent to ethical drug treatments. This paper evaluates the impact of HCFA's mandatory federal upper limit (FUL) prices on the retail sales volume of prescription drugs during 1994. Data of the most frequently dispensed drugs, as measured by the National Prescription Audit of IMS America, are used. Regression model results suggest that the competing drug prices impact sales significantly, and Medicaid drug rebates expand access to drug interventions by stimulating retail transactions. Prescription sales are also own-price insensitive (inelastic) in Medicaid and non-Medicaid market segments. The implications of extending Medicaid prescription drug rebates policy to enrollees in the traditional Medicare program are examined. [ABSTRACT FROM AUTHOR]

In the wake of dramatic increases, and demographic shifts, in the misuse of heroin and prescription opioids, drug addiction and accidental overdose have been increasingly framed as public health, not criminal justice, matters in the United States. In turn, many locales hardest hit by fatal overdose have supported so-called 'harm reduction' policies aimed at stemming opiaterelated mortality, while openly disclaiming the propriety of strategies that punish users. Yet, as U.S. overdose deaths achieved another record high in 2015, individual users continue to fear the criminal ramifications of witnessing and even suffering an overdose. Using surveys and interviews among a sample of overdose-experienced individuals outside Pittsburgh, PA, this study reveals a marked reluctance among those at the scene of an overdose to involve emergency services, for fear of not only maltreatment, but also prosecution on homicide charges - a fear revealed to be welljustified in light of the increasing implementation and enforcement of 'fatal drug delivery' laws. Reflecting on Jonathan Simon's depiction of the U.S. as a society 'governed through crime,' this paper considers how an emergent 'war on overdose' may serve to buttress and quietly sustain an unpopular 'war on drugs' through alternative tactics that identify new victims and offenders. [ABSTRACT FROM AUTHOR]

This article analyzes the riskiness attached to illicit drug use by means of a social representations framework. The implications of these social representations are further studied through their associations with views on drug policy: restrictive control and harm reduction measures. The data for the study is from a Finnish Drug Survey (N = 3229). Latent class analysis (LCA) and multinomial logistic regression analysis were used to analyze the data. Four representational profiles of perceived risk were identified: high-risk (70% of respondents), cannabis OK (15%), experimenting OK (10%), and low-risk (2%). All illicit drug use was considered as a moderate or high risk in the high-risk profile. Cannabis was considered less risky than other substances in the cannabis OK profile and experimenting was a less risky way of use in the experimenting OK profile. Most people in the low-risk profile considered the risks related to illicit drug use as nonexistent or minor. These representational profiles were also connected to opinions on drug policy: those who saw the most risks with use tended to support restrictive control measures, while those who considered illicit drug use to be less risky were more accepting toward harm reduction measures. [ABSTRACT FROM AUTHOR]

Global health policymakers have identified Myanmar as a source of high drug resistance and informal pharmaceutical markets in need of tighter state regulation. The World Health Organization drafted a Global Action Plan on antibiotic resistance (often referred to as antimicrobial resistance) that seeks to address it. Myanmar is one of over a hundred countries that has followed the World Health Organization's prescription and drafted its own National Action Plan. Through participating in the everyday life of a family pharmacy, we observed that in practice the outcomes of global plans for AMR, such as regulating access to antibiotics, are shaped by people's limited access to affordable health care, low salaries, and the military's authoritarian role in Myanmar politics. We followed how negotiations between state officials and drug vendors evolved towards a mutual understanding (as opposed to following written rules) after a Food and Drug Administration raid, intended to enforce the regulation of the sales of illegal medicines. Rather than uncritically pushing state-centric action, those working to promote the regulation of medicines must attend more carefully to how different modes of political authority and governance, combined with histories of health provision, shape drug policy in practice. Otherwise, they risk contributing, if not intensifying, already existing health and social injustices, whilst also failing to generate their intended outcomes, such as meaningful changes to antibiotic sales and reductions in resistance. [ABSTRACT FROM AUTHOR]

The Dangerous Drugs Amendment Act (DDAA) 2015 positioned Jamaica at the forefront of international cannabis law reforms in the developing world. The DDAA legalised and regulated commercial cultivation and sale of cannabis for medicinal and therapeutic use, legalised home cultivation and decriminalised personal possession of cannabis. This dramatic policy change came after years of discriminatory drug law enforcement and multiple attempts at cannabis law reform motivated by social justice and cannabis activism. Drawing on ethnographic observations of the implementation of the DDAA and interviews with key cannabis policy stakeholders in Jamaica, we discuss the extent to which the social justice ideals behind the law have translated into practice on the ground. Our analysis focuses on two dimensions of social justice relevant in drug law reform: (1) penalisation and criminal record expungement policies, and (2) economic empowerment and the distribution of wealth (ie the diversity within the new cannabis industry and the transition of traditional illegal ganja farmers to the new legal cannabis economy). Reflecting on the first five years of implementing the DDAA in Jamaica, we explore social justice achievements under the DDAA and discuss persisting structural barriers to economic justice and how they could be addressed. [ABSTRACT FROM AUTHOR]

There has been recent UK media attention on the global impact of the cocaine trade and the morality of personal use of cocaine powder. In this study we investigated whether people who use cocaine engage in moral disengagement (MD) strategies to reduce anticipated guilt associated with use. Participants read text describing the impact of the global cocaine market on others and completed a range of measures including assessments of substance use, MD, anticipated guilt, internalised moral identity, and empathy. We hypothesised that cocaine-related MD would positively predict cocaine use, and this would be partly mediated by anticipated guilt. Complete data were obtained from 254 participants through an anonymous cross-sectional survey (59.8% Female; mean age 30.8 ± 12.6 years). Our hypotheses were supported; (i) MD predicted cocaine use positively and anticipated guilt negatively; (ii) anticipated guilt negatively predicted cocaine use; anticipated guilt partially mediated the relationship between MD and cocaine use. People who use powder cocaine may use MD to reduce the anticipated guilt associated with knowledge of the harms associated with the drugs trade. Campaigns that focus on the morality of cocaine use or ethical choices may therefore have limited impact unless MD is challenged as part of these campaigns. [ABSTRACT FROM AUTHOR]

This paper explores the question of whether and in what ways the law and legal processes work to stabilise addiction as a health problem or ‘disease’. In undertaking this analysis, we also explore the associated gender implications of these practices and the means through which legal processes that stabilise addiction simultaneously stabilise gender. Using the work of science and technologies scholar Bruno Latour, in particular his anthropological analysis of scientific and legal ‘modes of existence’, we explore legal processes of what he calls ‘veridiction’ – or the specific processes by which law distinguishes truth from falsity – associated with addiction. We focus on processes that are largely hidden from public view and as such receive little scrutiny, but through which the meaning of addiction as a disease is secured. Our aim is to consider the role of legal negotiations in establishing agreed facts, and to explore lawyers’ understanding of these processes. We argue that although in public discourse judges are ascribed the status of the law’s key decision-making figures, lawyers’ accounts do not necessarily support this view. Instead, their accounts of the judicial process foreground their own and other lawyers’ role in decisions about addiction, despite an absence of training or education in the area. We also note that lawyers’ accounts suggest little independent oversight – even from judges – of the work lawyers do in stabilising addiction ‘facts’. Based on these observations, we consider the ways such processes of stabilisation impact on women in the legal system whose lives are in some way affected by discourses of addiction as a disease. We argue that legal practices of veridiction are centrally implicated in the making of both gender and health and that elements of these processes, which are not often publicly visible or subjected to scrutiny, require more analysis. [ABSTRACT FROM AUTHOR]

The authors reflect on a report "Transparency and trust in the European pharmaceutical sector" published within issue of the periodical. Topics discussed include relation between transparency and trust in pharmaceutical regulators; need of integrating transparency in effective, evidenced- and science based benefit/risk communication; and need of different regulatory domains to obtain a understanding of the role of the institutional and situational context.

The United States opioid epidemic continues to bring suffering to individuals and families as well as a crushing economic toll to communities. Stakeholders require resources to combat the epidemic. Firms that manufacture, distribute, and market opioids are the primary defendants of lawsuits, which play out in public view. This study investigates the public statements made by firms and media coverage in opioid lawsuits through the lens of their word choices. We use text analysis to uncover the similarities and differences in the language used to discuss the opioid crisis. The results provide guidance for marketing, public relations, and communications. [ABSTRACT FROM AUTHOR]

In the late 1960s and 1970s, countercultural entrepreneurs in the United States sold paraphernalia for enhancing LSD trips or for smoking marijuana at small stores called head shops. These accessories of alternative lifestyles provided hippies with a totemic material culture they could call their own. Head shop owners hoped their countercultural wares and atmosphere would provide hippies with desperately needed public spaces where they could gather in peace without being harassed. More importantly, these entrepreneurs believed their products allowed people to alter their minds – and even their societies – through meaningful drug use. In addition, many head shops made vital contributions to the movement to undermine, reform, and eradicate America’s drug laws. While these businesses were not opposed to turning a profit, their communitarian idealism and political engagement contradict the common charge that so-called hip capitalists were little more than apolitical sell-outs and dupes. Both head shops and the marijuana legalization movement helped each other achieve remarkable levels of financial and political success in the middle of the 1970s. In contrast to their predecessors of the late 1960s, many head shops of the late 1970s embraced profit and financial growth and deemphasized radical politics and counterculture. By the end of the decade, head shops numbered an estimated 30,000 and organized their own trade groups and meetings. Eleven states even decriminalized minor personal possession of marijuana in the 1970s. Although head shops had always faced scrutiny from police and concerned private citizens, it was only at the end of the 1970s that parents’ groups and legislators began to coordinate a national campaign against the so-called “commercialized drug culture” they attributed to these countercultural entrepreneurs. Consequently, the crusade against head shops represented one of the first salvos in the cultural and legislative War on Drugs of the 1980s. [ABSTRACT FROM PUBLISHER]

The authors reflect on a report "Transparency and trust in the European pharmaceutical sector" published within issue of the periodical. Topics discussed include relation between transparency and trust in pharmaceutical regulators; need of integrating transparency in effective, evidenced- and science based benefit/risk communication; and need of different regulatory domains to obtain a understanding of the role of the institutional and situational context.

The escalation of prescription drug abuse in the U.S. has attracted the attention of public health and safety officials as well as others puzzled by how such a tightly regulated enterprise could so easily be breached by those seeking controlled substances for nonmedical use. Prescribers and patients who use, misuse, or, in some cases, redistribute or divert these drugs have figured prominently in government strategies aimed at addressing this issue. This review departs from this paradigm and focuses on wholesale drug distributors, a highly efficient and largely behinds-the-scene link in the supply chain of controlled substances. By law, distributors are required to identify and report to the Drug Enforcement Administration (DEA) orders for controlled substances that are suspicious and may indicate drug diversion. Ten cases are examined in which distributors were each charged with failing to prevent the diversion of millions of doses of controlled substances. Special attention is given to a payment system employed by the industry that may encourage this unlawful commerce. Court records, agency and industry reports, and other published sources are used to document referenced cases and their disposition, and recommendations are offered for improving distributors' compliance with the law. [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]

Where is the national issue of cannabis (marijuana) regulation going? Recent actions at the State level are moving to guide us to a national perspective on how to control this new marketplace. [ABSTRACT FROM AUTHOR]

Following the paradigm shift to recovery in the Anglophone world, recovery is also gaining momentum in drug policy and practice in Flanders (Belgium) and the Netherlands. Since the meaning of recovery is being debated internationally, broadening the assessment of how the recovery framework is applied in policy discourse and how it is implemented in various international contexts is imperative. This comparative policy analysis aims to assess similarities and differences in addiction recovery vision, implementation, and evaluation in Flanders and the Netherlands. The thematic analysis draws upon a triangulation of different data collection methods: a focus group (n = 14) and interviews (n = 21) with key figures in the addictions field, followed by analyses of relevant policy documents (n = 9). Our findings show that a holistic vision of addiction recovery is endorsed in both countries. Although differences in policy development occurred (i.e. centrally driven in Flanders versus 'bottom-up' in the Netherlands), similar challenges emerged concerning recovery-oriented addiction policies. While policymakers in Flanders and the addiction sector in the Netherlands strongly proclaim recovery, structural implementation, dedicated funding, and systematic evaluation of recovery-oriented policies are lacking. This study suggests that systematic inclusion of experts by experience and aligning government and practice level funding and policies are crucial. [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 antifungal resistence of oral candidiasis is a serious clinical issue. The in vivo efficacy of farnesol combined with antifungals for oral candidiasis remains unknown. The possible therapeutic effects of a combination of farnesol and antifungal drugs and the regulation of inflammatory cytokines in murine oral candidiasis were investigated in this study. An experimental oral candidiasis model was constructed using ICR mice. Farnesol at 25 and 50 μM did not change IL-17, IFN-γ and TNF-α production during oral candidiasis compared with that of the control infected mice. The co-applications of farnesol (50 μM) and nystatin, farnesol (4 μM, 8 μM) and itraconazole, farnesol (25, 50 μM), and fluconazole enhanced the therapeutic activity of the antifungal agents alone against oral candidiasis. The effective combinations reduced the number of colony forming units (CFU) of Candida albicans isolated from the oral cavity and oral lesions on the tongue. [ABSTRACT FROM AUTHOR]