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The paper addresses the impacts of armed violence, based on Primary Health Care, in a neighborhood in the city of Rio de Janeiro, Brazil. This is a qualitative exploratory study developed in two services aiming to identify the main types of violence, their impacts and the strategies used to cope with the phenomenon. The production of information included data collection in the service records, conducting semi-structured interviews, focus groups and feedback seminar. Armed violence, among all expressions of violence, was identified as one of the major concerns of healthcare professionals and users of services, due to its intense occurrence and the severity of its consequences on health. Its impact on strategies to cope with the violence and the difficulty in making the phenomenon visible are highlighted. It is considered that this type of violence, prevalent in the black territories of the city, is legitimized by structural racism, being the public security policy -- based on the ideal of war on drugs and on the military confrontation with armed groups that operate in the retail trade of illicit drugs -- expressions of state racism and necropolitics. [ABSTRACT FROM AUTHOR]

All the while, Dick calmly explained the improvements underway at the FDA in more than 50 congressional hearings, many of which were made difficult by harsh but often unfair public criticism of the FDA. Dick will long be remembered by the drug development and drug regulatory communities for his highly influential role as Director of the US Food and Drug Administration (FDA) Bureau of Drugs from 1971-1982, a time during which much of what we now recognize as the essential features of a well-controlled study were identified and incorporated into drug development. Even these regulations had little impact on FDA review practices until the 1970s during Dick's tenure at the FDA. [Extracted from the article]

Cannabis legalization in some U.S.A. states has catapulted the mass production of concentrates, with tetrahydrocannabinol (THC) concentrations ranging from 50-90%. A major public health concern is that these products will increase cannabis-related harms such as use disorders, psychotic symptoms, and accidental poisonings. This paper describes and contextualizes the results of a study requested by the WA State Legislature to understand perspectives of WA stakeholders on the topic. Concept Mapping (CM), a mixed-methods research approach that supports people-centered policy decisions was utilized. The goal of the study was to explore stakeholders' concern levels and support of policies to address the availability of high THC cannabis products. For analysis purposes, stakeholders were categorized into three groups: community, professionals, and cannabis advocates. CM generated an inventory of policy ideas for regulating high-potency cannabis from a variety of stakeholders. Notably, stakeholders from community and professional groups supported environmental policy changes such as such as taxation, increasing minimum age for high concentration cannabis products, and advertising prohibition. Meanwhile, cannabis advocates (mostly industry actors) opposed taxation per THC content, proposed lowering taxes, and supported policies with low population impact such as educating parents, teachers, and youth. Support for regulating high concentration THC products varied by stakeholder group. Consistent with how other health compromising industries have historically acted, cannabis industry stakeholders rejected regulation of their products. Future studies should explore non-cannabis industry stakeholders' willingness to work towards minimizing the influence of the cannabis industry in policy development processes to assure public health regulations prevail. [ABSTRACT FROM AUTHOR]

First, this paper attempts an assessment of recent developments in British drug policies. In the 1980s British drug policies are in a state of transformation in which it appears that medicine is being displaced from a central role, and being replaced by a more extensive and diffuse response involving a broader range of agencies and ideas about drug problems. A more active role is being played by central government, the debate on drugs is becoming politicized, and there is a new emphasis on law enforcement, and legal and penal control It is now questionable whether the British approach to drug problems is as distinctive as it once was. Given that research on contemporary drug policy is negligible, the second task of this paper is to identify a number of areas and issues worthy of policy analysis. [ABSTRACT FROM AUTHOR]

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

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

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

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

The article reports on a discussion paper released by the Patented Medicine Prices Review Board which asks Canadians, physicians, and pharmaceutical companies to review the drug-pricing system in Canada, with the aim of modernizing and simplifying the regulatory framework on patented drug pricing. It highlights statistics which compare the cost of medicines in the country with others. The discussion paper is said to be a part of a consultation process designed to focus drug-pricing problems.

The article reports on the proposal of Health Canada for a new regulatory regime for drugs. Under its paper, "The Progressive Licensing Framework Concept Paper for Discussion," Health Canada proposes to lower the threshold for initial market authorization licenses in exchange for more safety and efficacy studies as a condition for selling a drug. The institution's proposed regime involves the incorporation of post-market surveillance in its oversight of drugs.

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in thewake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard ControlOrganisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of EthicsCommittees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, aswell as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research. [ABSTRACT FROM AUTHOR]

Background: In 2013, Uruguay became the first country in the world to legally regulate cannabis from seed to smoke. A growing body of research addresses drug policy reform in Uruguay. However, existing studies have almost completely elided its international dimension, treating the process as exclusively domestic phenomenon.Methods: To consider the international dimension of drug policy reform in Uruguay, the paper draws on primary and secondary sources such as existing studies, media reports, official documents, parliamentary debates and interviews with stakeholders and policy analysts from Uruguay and elsewhere.Results: The paper shows that, when, and, how international factors and actors contributed to Uruguay's drug policy reform process. Two ways in which the international dimension manifested itself are identified. First, as drug policy debate around the world changed, the context for reforms in Uruguay evolved. This resulted in a rather mixed international reaction to Uruguay's reform proposal. Second, international actors became directly involved in the process. Drug policy experts informed and legitimated cannabis reform and transnational advocates supported campaigning and mobilisation in Uruguay.Conclusion: By unearthing the international dimension of Uruguay's drug policy reform, the paper adds a novel perspective to the study of drug policy reform in the Uruguay. [ABSTRACT FROM AUTHOR]

Prison systems throughout Latin America are plagued with overcrowding. This phenomenon is due in part to the proliferation of harsh drug laws and policies, which spread throughout the region beginning in the 1980s. However, studies have shown that the imprisonment of low-level, non-violent offenders hardly makes a dent on the drug trade, increasing the call for a reconceptualization of the predominant prohibitionist model. This has led international organizations involved in rule of law reform to prescribe Latin American governments a potent cocktail of reforms aimed at reducing prison overcrowding by decreasing drug-related incarcerations. This paper, through a study of existing drug law in Bolivia, Colombia, and Peru and a comparison to Costa Rica's "new model" of prison systems, argues that before judicial and legislative reforms of any kind can be successfully undertaken, there must be a paradigmatic shift in the way Latin American government's view the role of the penitentiary system and prison populations. Depriving a person of his or her liberty is one of the most formidable powers of any State. The way in which States exercise this power, striking a balance between the duty to guarantee public safety and the obligation to respect fundamental human rights, is of the utmost importance. The operation of the justice system has repercussions for society as a whole. [ABSTRACT FROM AUTHOR]

Background: A central policy research question concerns the extent to which specific policies produce certain effects - and cross-national (or between state/province) comparisons appear to be an ideal way to answer such a question. This paper explores the current state of comparative policy analysis (CPA) with respect to alcohol and drugs policies.Methods: We created a database of journal articles published between 2010 and 2014 as the body of CPA work for analysis. We used this database of 57 articles to clarify, extract and analyse the ways in which CPA has been defined. Quantitative and qualitative analysis of the CPA methods employed, the policy areas that have been studied, and differences between alcohol CPA and drug CPA are explored.Results: There is a lack of clear definition as to what counts as a CPA. The two criteria for a CPA (explicit study of a policy, and comparison across two or more geographic locations), exclude descriptive epidemiology and single state comparisons. With the strict definition, most CPAs were with reference to alcohol (42%), although the most common policy to be analysed was medical cannabis (23%). The vast majority of papers undertook quantitative data analysis, with a variety of advanced statistical methods. We identified five approaches to the policy specification: classification or categorical coding of policy as present or absent; the use of an index; implied policy differences; described policy difference and data-driven policy coding. Each of these has limitations, but perhaps the most common limitation was the inability for the method to account for the differences between policy-as-stated versus policy-as-implemented.Conclusion: There is significant diversity in CPA methods for analysis of alcohol and drugs policy, and some substantial challenges with the currently employed methods. The absence of clear boundaries to a definition of what counts as a 'comparative policy analysis' may account for the methodological plurality but also appears to stand in the way of advancing the techniques. [ABSTRACT FROM AUTHOR]

Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programme (EAP).The regulations regarding EAPs is not the same all over the world. For example, the recommendation of the European Medicines Agency (EMA) in EU countries also includes within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment. Nevertheless, the patients treated in a clinical trial could have the option of continuing treatment for an extended period in an Open-label Extension study, aimed to generate long-term data on efficacy, safety, tolerability and administration.The aims of this paper - based on the difficulties and incoherence encountered by an Italian Ethic Committee (EC) during the authorisation process of EAPs - are: understanding the origin of this misclassification by analysing differences and similarities among USA, European and Italian regulations concerning EAPs; and showing difficulties in classifying international study protocols as a consequence of the lack of harmonisation of definitions.We performed a critical review of the current USA, European and Italian regulations and we analysed some practical cases by retrieving protocols from Clinicaltrials.gov and the Italian Clinical Trials Registry (OsSC) containing in the title the keywords 'Expanded Access Programme', "'Expanded Access', 'Open-label Extension study' or 'Early Access'.We observed that the Food and Drug Administration ( FDA) definition of EAP is very clear while the EMA definition is similar to that of an Open-label Extension study. This lack of a clear definition generates misclassification and it is possible to find an EAP with an efficacy or safety endpoint; or an EAP managed as a clinical trial; or an EAP classified in Clinical Trials Registries as a phase II, III or IV clinical trial.The internationalisation of the studies requires a harmonisation on a global level of legislation and definitions to eliminate misclassification of protocols. For this reason, the authors suggest that: a) the EMA definition should be harmonised with the FDA definition of EAPs, b) European regulation, even if optional, should be adopted in a compulsory way by national regulations. Moreover, separate registries for both EAPs and clinical trials should be organised. [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]

In their paper, Istvan and colleagues hint at the similarities between the regulation policies of flunitrazepam and zolpidem to draw conclusions about zolpidem's use. Indeed, of the about 1400 cases of hospitalization for addiction to high doses of benzodiazepines and the like in our institution, none were due to flunitrazepam, while more than half of them were due to lormetazepam. Https://doi.org/10.1007/s11739-020-02538-2 5 Lugoboni F, Bertoldi A, Casari R, Mantovani E, Morbioli L, Tamburin S. Adult attention-deficit/hyperactivity disorder and quality of life in high-dose benzodiazepine and related Z-drug users. [Extracted from the article]

Recent studies have shown that the punitive drug laws enacted in the mid-1970s led to a sharp increase in incarceration only in the mid-1980s, when city police departments started policing street-level drug markets much more intensively. The case study of New York City in the wake of the Rockefeller Drug Laws of 1973 presents an explanation. Only when new policing ideas, popular dissatisfaction with street crime, and the revival of the city's fiscal capacity coalesced as part of a larger project to rebuild urban governance in the aftermath of the fiscal crisis of the 1970s did New York turn toward street-level drug enforcement. An examination of the political history of street-level drug enforcement offers a better understanding of the history of New York's war on drugs, as well as a new chronology of the political dynamics of state rebuilding in the 1980s. [ABSTRACT FROM AUTHOR]

Pharmaceutical residues can harm the environment. Therefore any Marketing Authorisation Application (MAA) for a medicinal product for human use shall be accompanied by an "indication of any potential risks presented by the medicinal product for the environment" according to Article 8(3)(g) of the Directive 2001/83/EC. Since 2006 a guideline document from the European Medicines Agency (EMA, formerly EMEA) is available for this task, which is now called the "Environmental Risk Assessment" (ERA). Recently the EMA released a draft revision of an updated ERA guideline. The present paper provides a summary of the intended innovation. A number of options have been discontinued, but some of them cannot be easily recognised, even though they are potentially affecting the MAA and its costs in a relevant way. A new specifically tailored experimental testing course for antibiotics and a secondary poisoning assessment is introduced. The selection of required study types is altered and the environmental fate evaluation is adapted to the scientific progress. In the recent situation it is suggested that marketing authorisation applicants may reconsider the conduct of water/sediment studies for substances not requiring these according to the guideline revision. The new tailored testing approach for antibiotics avoids any vertebrate use, because it demands no fish study, therefore it may be applied henceforth. If the new prescriptions are not yet in force at the point in time of the MAA submission, appropriate waivers should be stated in the ERA. No further HPLC-study types and acute earthworm toxicity tests should be performed, since the guideline update draft does not accept them. In preclinical toxicity and pharmacokinetic studies, additional data gathering on metabolites should be considered in order to avoid unnecessary leaflet warnings. The cost for ERA may change significantly, with a tendency to increase for generic pharmaceutical MAA, but with a possible reduction for substances of low environmental concern. Earlier consideration of ERA in the drug development process is recommended. [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]

The term 'off-label drug use' refers to drugs that have not yet acquired 'approved' status or drugs that have acquired 'approved' status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996 and the common law, which require that off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions. [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]

Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana ('soft drugs') and other drugs ('hard drugs'). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow the sale of soft drugs at 'coffee shops'. However, they did little to control the activities of coffee shop operators, whereas the supply of soft drugs to the shops remained illegal. In this paper, we review the ongoing debate on the soft drug policy in the Netherlands and analyze it from the perspective of the regulation of illegal markets. [ABSTRACT FROM AUTHOR]

Copyright of Hospital Pharmacology: International Multidisciplinary Journal is the property of Serbian Medical Society, Section for Clinical Pharmacology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Hospital Pharmacology: International Multidisciplinary Journal is the property of Serbian Medical Society, Section for Clinical Pharmacology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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

To what extent has the right to access generic HIV medication been implemented in Kenya for the 1.6 million people living with HIV? How does this relate to the right to health under international and national law? This paper examines a constitutional challenge brought to the High Court of Kenya in 2009 (the “Anti-Counterfeit Case”) against the Anti-Counterfeit Act of 2008, which the petitioners, all of whom were living with HIV, argued would affect their ability to access affordable and generic antiretroviral medication. They argued that this would amount to a violation of their right to life, dignity, and health. This case is particularly interesting because the new Kenyan Constitution came into force in 2010, after the case had been filed, and specifically provided for the right to health for all of Kenya’s citizens, as well as giving direct effect to all international laws ratified by the Kenyan government. This paper follows the Anti-Counterfeit Case, which includes amendments filed by the petitioners following the new constitutional changes, the arguments by the different parties in the case, and the inappropriateness of counterfeit laws as measures to control substandard and falsified medicine. The case has resulted in the suspension of significant parts of the Anti-Counterfeit Act that would pose a challenge to parallel importation, and to the court issuing a directive that the sections be amended. The judgment is examined in detail, as are the broader implications of this case for other countries in Eastern Africa. [ABSTRACT FROM AUTHOR]

New European Union (EU) pharmacovigilance legislation, effective from July 2012, introduced new concepts and procedures to optimise the way medicines are regulated within the Union and provided new channels for public health interventions. Triggered by the EU legislation, the work done by the International Conference on Harmonisation (ICH) has provided a common standard for periodic benefit-risk evaluation reporting within the ICH regions. The present paper provides a review of the concepts behind the use of periodic benefit-risk evaluation reports (PBRER) in supporting safety evaluation and assessment of benefit-risk balance and covers essential points in the documentation of safety information, risk evaluation and benefit-risk assessment. The review incorporates the experience to-date with the PBRER at EU level led by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. The scope of the PBRER, the main content topics and the challenges relevant to the different stakeholders are highlighted together with key success factors for the report to deliver its objectives and maximise the use of the regulatory assessment procedure. It is clear that the PBRER extends beyond new ways of data presentation and analysis and reflects a further shift in pharmacovigilance in the EU towards more integrated benefit-risk assessment of marketed medicines. [ABSTRACT FROM AUTHOR]

Background New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances ( NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale. Aims and method This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market. Findings A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit. Conclusions The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study. [ABSTRACT FROM AUTHOR]

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access. [ABSTRACT FROM AUTHOR]

Research on values is gaining in popularity within drug policy scholarship. To date, research has focused on analysing values within policy, through documentary analysis and interviews with key stakeholders. We extend this research enquiry to investigate the values that emerge from drug policy debate with those who have lived and/or living experience of using drugs. We used workshop data collected from the ESRC-funded Drug Policy Voices project as the basis for our analysis. Within the workshops, participants were given a range of drug policy scenarios to discuss. We selected three scenarios for this paper which discussed policies related to cannabis, heroin, and MDMA/ecstasy. We coded the workshop data using Schwartz's ten basic values, which is a framework that perceives values as the core 'motivators of action' that underpin choices, attitudes and behaviours. We found that the values of 'self-direction', 'security' and 'conformity' were prominent across this participant group, when discussing these policy topics. Yet the drug policy preferences discussed in the workshops revealed that it is the combinations of values that nuance preferences. Security combined with self-direction supports policies that enhance personal responsibility for change; self-direction combined with hedonism supports freedom to use drugs, whereas self-direction combined with conformity and achievement supports recovery policies; and conformity combined with tradition and power supports abstinence-based drug prevention. Schwartz's ten basic values provided a useful framework for surfacing values that underpin drug policy preferences. These exploratory findings demonstrate that identifying values within dialogue is a complex process and reinforces opposing values can explain policy preference differences. More importantly, policy preferences were underpinned by combinations of values including those that are apparently opposing in Schwartz's circumplex. [ABSTRACT FROM AUTHOR]

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

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 concept of governance is applied in a wide range of contexts, but this paper focuses on governance in relation to public administration, i.e. states and how they take action, and specifically governance of particular policy areas. In the current context of financial austerity and an era of globalisation, policy-makers face pressures and challenges from a growing range of interests and local, national and supranational actors. Drug policy is an example of a particularly contentious and polarised area in which governance-related challenges abound. In response to these challenges, interest has grown in developing agreed policy governance standards and processes and articulating policy-making guidelines, including the use of available evidence to inform policy-making. Attempts have been made to identify ‘policy fundamentals’ – factors or aspects of policy-making apparently associated with successful policy development and implementation ( Hallsworth & Rutter, 2011; Laughrin, 2011 ) and, in the drug policy field, Hughes et al. (2010) reflecting on the co-ordination of Australian drug policy highlighted some of what they considered principles of good governance. But how useful is the concept of ‘good governance’; how well can it be defined, and to what purpose? As part of a wider project considering the governance of drug policy, RAND Europe and the UK Drug Policy Commission undertook a targeted review of other research and sought expert views, from within and beyond drug policy, on principles, processes, structures and stakeholders associated with good drug policy governance. From this emerged some perceived characteristics of good governance that were then used by the UK Drug Policy Commission to assess the extent to which drug policy making in the UK fits with these perceived good governance characteristics, and to suggest possible improvements. Particular consideration was given to the range of interests at stake, the overarching aims of drug policy and the development and inclusion of an evidence base where possible. This paper draws on findings of the study to highlight challenges associated with defining good governance, provides an example of a framework for assessing drug policy governance and discusses the feasibility, transferability and potential benefits of such an undertaking. [ABSTRACT FROM AUTHOR]

This paper considers the variation in entry, stay, and residence travel restrictions for people living with HIV/AIDS in the World Health Organization's Eastern Mediterranean region and the wider Muslim world. If these travel restrictions are associated with human rights violations, why do some countries maintain restrictions while others repeal them? In particular, why do countries with a secular governmental regime like Egypt maintain restrictions, while non-secular countries like Iran do not? We argue that in the Eastern Mediterranean region this variation is explained not by the characteristics of a country's particular form of Islam, its level of development, or its adherence to human rights norms, but by the characteristics of the epidemic in a given country. Countries in which the main mode of transmission is sex maintain restrictions because of stigma associated with sex outside marriage in Islam. Countries in which the main mode of transmission is injecting drug use are less likely to maintain restrictions because of Islam's more lenient approach towards drugs. Using firth logistic regression, we show that this holds for countries in the Eastern Mediterranean, but not for Muslim countries globally. We discuss possible reasons for this and the implications for future research. [ABSTRACT FROM AUTHOR]

Drugs that are powerful enough to cure disease are powerful enough to do potential harm. This common saying among physicians is the central point of this paper. When harm to a patient does occur, the sense of society requires that where and when appropriate the patient should be adequately compensated. We present the proposition that there are three actors in such cases that must in some way be held to account: the pharmaceutical manufacturer, the physician, and the patient. In addition, there is the question as to the proper role of the Food and Drug administration that has the duty mandated by law to oversee the efficacy of the drugs and to evaluate the warnings that the manufacturer must give as to any possible adverse effects. The theme of the paper is how to legally allocate the responsibility for the adverse outcome. In the United States there is a very well developed, and still evolving, body of law that attempts to do so in a socially responsible manner. The heart of American law is that the manufacturer must be held accountable under the law of "strict products liability." Essentially, the manufacturer will be liable regardless of any "fault" or intentional wrongdoing in developing or manufacturing the drug. Another key element in the American law is the application of the "learned intermediary rule". This rule holds that the manufacture has performed its duty to warn of adverse reactions if it warns the medical community at large. Underpinning the American law is evaluating the role of the FDA, and whether DFA approval of the drug and the warning will relieve the manufacturer, but not the physician, of any liability for adverse reactions. We believe that the adoption of some aspects of American pharmaceutical products liability law would be most effective in Thailand and other nations that will inevitably deal with this issue. However, we present arguments that some of the American law should be modified placing more responsibility on the manufacturer. We believe that placing the manufacturer, who after all has the most expertise regarding the drug, in a position of a having a heightened legal duty to assure that the drugs are effective and that the warnings are adequate, is a socially responsible resolution of allocating accountability for adverse reactions. Finally, we believe judges in Thailand, after learning from American judges, should likewise balance the responsibility of the pharmaceutical industry, the doctors, and the patients by applying the legal principle of comparative negligence when they decide cases before them. [ABSTRACT FROM AUTHOR]

This paper draws on theories of nodal governance and discursive framing to investigate the rhetorical strategies adopted by campaigners in the ongoing contest over access to medicines and the protection of intellectual property rights in Kenya. It focuses specifically on debates surrounding the implementation of the WTO's TRIPs Agreement in 2001 and the passage of anti‐counterfeit legislation in 2008. A survey of parliamentary debates and media sources, as well as interviews conducted with key participants, indicates that “the nation” provided a common overarching frame for arguments made by opposing sides to these debates. The salience of specifically national considerations confirms our view that studies of framing and health governance need to extend their focus beyond developments in international and developed country fora. It also highlights the continued purchase of the national interest as a means of mobilizing the key state institutions needed to implement global legal regimes in Africa. [ABSTRACT FROM AUTHOR]

Supplementary protection certificates for medicinal products for human use (SPC) and data exclusivity are legal instruments that provide protection for pharmaceuticals. They differ, however, with respect to the rationale, requirements and scope of their protection. An SPC does not prolong the basic patent, but extends protection conferred by the basic patent, within the limits prescribed by the marketing authorization for a given medicinal product, which is usually different from the scope of protection granted by the basic patent. The aim is to provide an additional period of protection in the case where a pharmaceutical marketing authorization process was particularly long. This is to allow a pharmaceutical company that holds the basic patent to recoup the investment made in research and development of the pharmaceutical. An SPC rewards a product - a patented active ingredient or a combination of active ingredients, as opposed to the first submitted regulatory dataas in the case of data exclusivity. Data exclusivity is a "quasi" - intellectual property right which prevents health authorities responsible for granting marketing authorizations from relying on the original data submitted by the first market entrant as well as preventing subsequent applicants from cross-referring to the original data. Data exclusivity should be distinguished from market exclusivity. Market exclusivity means that a subsequent market entrant may not market a particular product on which a marketing authorization has been issued, irrespective of the fact whether he refers to data submitted by the first market entrant or he has generated the data himself. Data exclusivity should neither be confused with data protection, as there are other legal instruments, such as trade secrets, which serve to protect undisclosed, confidential know-how. Complex relationships between SPCs, data exclusivity and market exclusivity may occur i.e. the scope and period of protection conferred by them may overlap or complement each other. In the latter case they enhance the overall protection for a given medicinal product. They are even more important during the period when no other type of protection is available, and there is only data exclusivity or SPC protection. Due to the interesting interrelations between SPCs and data exclusivity they are both worth a profound analysis. The paper aims to touch upon the importance of data exclusivity in the light of other legal protection instruments available, such as an SPC. [ABSTRACT FROM AUTHOR]

Evaluation of the effectiveness of drug risk-minimisation measures is mandatory for both risk evaluation and mitigation strategies (REMS) in the United States and risk management plans in the European Union (EU-RMPs). Such evaluations aim to assess the impact of risk-minimisation measures on the knowledge, attitudes or behaviours of healthcare professionals or patients, the incidence of safety concerns, and their impact on the overall benefit-risk balance. Although many effectiveness evaluation models and methods are available, regulatory guidance and policy are still evolving. This paper considers evaluation strategies, challenges in evaluating risk minimisation post-authorisation, possible outcome measures and their interpretation, and potential emerging regulatory policy issues. Particular challenges include appropriate data collection, perceived and real burdens of performing evaluation on clinical practice, lack of comparators and benchmarking, and uncertainty about the best outcome measures. [ABSTRACT FROM AUTHOR]

I read with interest the excellent paper by Powell I et al i .1 entitled "Drug Dosing Recommendations for All Patients: A Roadmap for Change", wherein they discuss "adjusting drug development and regulation to enable effective dosing for all." If drug developers studied wide dose ranges throughout drug development, and regulators subsequently approved wide dose ranges, we would have a pragmatic framework for delivering personalized dosing based on dose titration for each patient. Personalized Dosing = Approved Wide Dose Ranges + Dose Titration. [Extracted from the article]

An increase in new drugs first launched in the U.S. and shorter lags between first global drug launch and U.S. approval indicate that the U.S. drug lag has declined. This paper examines the impact of these changes on drug safety using adverse drug reaction data for FDA-approved drugs in 1990 to 2004. Results show two different effects. First, drugs having longer U.S. launch lags (more foreign market experience) have fewer post approval drug risks compared to drugs with shorter launch lags. This result implies that foreign market experience prior to U.S. entry provides information to help alleviate drug-related risks for U.S. patients. Second, drugs that are first launched in the U.S. have fewer serious drug reactions compared to those that were first launched abroad. This result is surprising, and may suggest that first U.S. drug launch signals information about unobserved application quality, which translates into lower post approval drug risks. [ABSTRACT FROM AUTHOR]

Copyright of Revista Científica General José María Córdova is the property of Escuela Militar de Cadetes General Jose Maria Cordova and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The uncertainties associated with the precise nature of legalization regimes and with their expected outcomes sometimes are used to justify the maintenance of drug prohibition. This paper details the role that buyer licensing and exclusion might play in implementing a low-risk, post-prohibition drug regulatory regime. Buyer licensing and exclusion provide assistance to those who exhibit or are worried about self-control problems with drugs, while not being significantly constraining upon those who are informed and satisfied drug consumers. Relative to prohibition, licensing and self-exclusion can be part of a drug regulatory structure that is much more finely tuned to the risks of harms stemming from drug use. [ABSTRACT FROM AUTHOR]