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Background: A widespread sense of a failing criminal justice system and increased feelings of insecurity changed the response to crime into a culture of control, which is characterized by policies that punish and exclude. In the Netherlands, these influences can be witnessed in the war on drugs where local authorities use their administrative power to close homes involved in drug-related crime. Citizens can invoke judicial review over these administrative interferences by claiming that such closure results in an unfair balance between purposes, means and consequences. This paper assesses whether judicial review functions as a safety net against losing one's home due to drug-related crime., Methods: We used doctrinal legal research methods to examine the "law in the books" and empirical legal research methods to analyse the "law in action". We used a survey to investigate how often the drug-related closure power was used in 2015, and we statistically analysed all published case law of Dutch lower courts between 2007 and 2016., Results: The scope of the closure power broadened over the years and our data show that local authorities fiercely make use of this instrument. In 41.4% of the cases, citizens are successful in fighting the closure. While scholarly literature indicates that judicial courts function as safeguards by questioning the proportionality of administrative action, raising a proportionality defence does not necessarily result in a more favourable outcome for citizens. In fact, raising a proportionality defence makes it more likely to result in dismissal of the appeal., Conclusion: The stretched scope of the drug-related closure power together with the relatively low success rate of citizens who fight the loss of their home and a seemingly meaningless proportionality check show no sign of a safety net against the loss of one's home at the suit of a local authority., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation., (© 2017 American Society for Clinical Pharmacology and Therapeutics.)

Cannabis policies are changing in some countries. This may have consequences that extend beyond cannabis-specific outcomes, such as an impact on the consumption patterns of other substances. Changes in cannabis policies may also influence policy responses to other drugs, as countries re-assess the balance between law enforcement and public health objectives. If this happens, it could have important health and social consequences, especially in those countries where a 'war on drugs' policy perspective has inhibited investment in evidence based responses in areas such as treatment and harm reduction. The burden of disease associated with opioid use for example is large and this is an area in which treatment and harm reduction have been shown to deliver benefits. Thus if the changes in cannabis policies result in a greater willingness to invest in effective interventions for other drugs, the potential net health gains could be considerable. On the other hand, if cannabis policy changes are associated with an increase in health risk behaviours, such as driving under the influence or increased use of harmful substances such as tobacco, then significant increased health costs could result. To date most attention has been focused on recent cannabis sales liberalisation in the Americas, but experiences from elsewhere are also informative. In Europe, for example, moves towards decriminalisation of drug possession are resulting in lower rates of incarceration and arguably have reduced barriers to treatment uptake. Robust monitoring and assessment of the impact of these different policy changes is crucial to evaluating and understanding their results. It is important that such monitoring is international in scope, is not limited to issues around the use of cannabis only, and considers the interactions that may exist between cannabis policies and the approaches taken to other substances., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Using the case of synthetic cathinones (commonly referred to as 'bath salts' in the US context), this paper analyses structural factors surrounding novel psychoactive substances (NPS) as contributing to the unique risk environment surrounding their use. Drawing on interviews with 39 people who use bath salts from four U.S. cities and analysis of the infrastructural, social, economic, and policy contexts, we document the unique harms related to changing contexts for illicit drug regulation, manufacture, and consumption. Findings suggest that NPS and designer drug markets, which are highly reliant upon the internet, share characteristics of the entertainment industry which has come to rely more heavily upon profits derived from the 'long tail' of myriad lesser-known products and the diminished centrality of 'superstars' and 'hits'. Findings point toward increased theoretical and policy attention to changing drug market structures, more rigorous evaluations of drug 'analogues' legislation and greater involvement with NPS education and testing by harm reduction agencies., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework., (© 2017 American Society for Clinical Pharmacology and Therapeutics.)

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)-licensed reference product (Table 1). Here we discuss implementation of the US biosimilar approval pathway and the role of various types of data, including clinical pharmacology data, in biosimilar development., (Published 2017. This article is a US Government work and is in the public domain in the USA.)

This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the series to forewarn consumers, clinicians, corporations, and governments of possible serious adverse events. They may also quicken the response rate during Phase IV post-marketing surveillance, in which governments could then exercise their regulatory powers., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Purpose: Reducing global disease burden requires improving access to medicines, thus the need for efficient and effective supply chain management for medicines. The Nigerian government came up with new policies on Mega Drug Distribution Centres and National Drug Distribution Guidelines to improve access to quality medicines with pharmacists having a key role to play. However, pharmacists in Nigeria seem not to be aware and adequately equipped to handle the medicines supply chain. This article aimed at assessing the awareness and readiness of Nigerian pharmacists on supply chain management practices for improving access to medicines., Methods: Pharmacists in Nigeria's Capital were randomly sampled. Semi-structured questionnaires were administered. Descriptive statistics was used in data analysis. P values less than 0.05 were considered to be significant., Results: 29.3%, 20.7% and 53.7% were not aware of supply chain management, National Drug Distribution Guidelines and Mega Drug Distribution Centres, respectively. 85.46% do not have a copy of the National Drug Distribution Guidelines. 78% were not aware that Mega Drug Distribution Centres are already operational. 35.4% have never been involved in any supply chain management practice. 69.5% often experience stock out of vital and essential medicines, of which 85.2% were in hospitals. 15.9% were successful in managing their facility's supply chains. 84.1% opined that pharmacists in Nigeria are not yet ready to handle the medicines supply chain., Conclusions: Findings showed limited awareness and readiness on supply chain management of medicines. This may be due to inadequate supply chain management skills and infrastructure, poor financing, lack of accountability and poor management. Tackling these as well as pharmacists showing more interest in the country's health policies and obtaining necessary postgraduate certifications will lead to improvements. This will improve access to quality medicines and thus help in the fight to reduce disease burden both locally and globally., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Physiologically based pharmacokinetic (PBPK) modeling is a valuable tool in drug development and regulatory assessment, as it offers the opportunity to simulate the pharmacokinetics of a compound, with a mechanistic understanding, in a variety of populations and situations. This work reviews the use and impact of such modeling in selected regulatory procedures submitted to the European Medicines Agency (EMA) before the end of 2015, together with its subsequent reflection in public documents relating to the assessment of these procedures. It is apparent that the reference to PBPK modeling in regulatory public documents underrepresents its use. A positive trend over time of the number of PBPK models submitted is shown, and in a number of cases the results of these may impact the decision-making process or lead to recommendations in the product labeling. These results confirm the need for regulatory guidance in this field, which is currently under development by the EMA., (© 2016 American Society for Clinical Pharmacology and Therapeutics.)

This paper exploits variations in aerial spraying across time and space in Colombia and employs a panel of individual health records in order to study the causal effects of the aerial spraying of herbicides (glyphosate) on short-term health-related outcomes. Our results show that exposure to the herbicide used in aerial spraying campaigns increases the number of medical consultations related to dermatological and respiratory illnesses, as well as the number of miscarriages. These findings are robust to the inclusion of individual fixed effects, which compare the prevalence of these medical conditions for the same person under different levels of exposure to the herbicide used in the aerial spraying program over a period of 5 years. Also, our results are robust to controlling for the extent of illicit coca cultivation in the municipality of residence., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare that we have no competing interests. Provenance and peer review: Commissioned; externally peer reviewed.

Objectives: In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008. The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs., Methods: Materials supporting this overview were collected using the records in the database of administrative proceedings of SUKL, in-house standard operating procedures, and the legislation in force. Based on these sources as well as the hands-on knowledge of the current practice, a brief description of the general rules of administrative proceedings involving HTA of varying complexity was elaborated. Characteristic features of the individual types of proceedings, basic differences in the complexity of HTA employed, and its most important challenges were summarized., Results: In Czech Republic, HTA in the formal administrative proceedings ensures a transparent process of introduction of new medicinal products into clinical practice and leaves space for restriction of reimbursement conditions to minimize budget impact., Conclusions: As a robust as well as pragmatic HTA methodology has been implemented by SUKL, relevant stakeholders (marketing authorization holders, Health Care Funds, clinical expert groups) are now able to influence reimbursement of new technologies.

Objectives: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA)., Methods: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies., Results: Healthcare law creates conditions that allow implementation of the principle "value for money." The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal., Conclusions: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.

Objectives: The aim of this study was to describe the healthcare system and health financing in Bosnia and Herzegovina and recent trends in health technology assessment (HTA) placement in the system., Methods: A short review of PubMed published literature has been conducted using key words related to reimbursement, HTA, and health policy. We also revised legislation in Bosnia and Herzegovina published in Official Gazettes related to healthcare financing and organization., Results: A deecentralized system in Bosnia and Herzegovina led to high differences in health policy. HTA has been recognized in legislation in Bosnia and Herzegovina, but it still has not been introduced in practice in full capacity. A small number of publications are found in PubMed treating these issues, but generally the problem of introduction of HTA in Bosnia and Herzegovina is lack of experts, as well as the political environment and education in this field., Conclusions: HTA in the Federation of Bosnia and Herzegovina and the Republic of Srpska has a short history because of a huge political impact in the decision-making process, decentralized system, and multiple decision makers in these regions. Challenges remain in assessments, in development of more transparent approaches in different areas of the health system in these regions, and in consistent application of appropriate standards especially in education of professionals who will provide establishment of HTA in the health system of The Federation of Bosnia and Herzegovina and the Republic of Srpska.

Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes., Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis., Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses., Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Objectives: The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania., Methods: Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system., Results: Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients' rights in cross-border health care had to be passed into Romanian law. The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines., Conclusions: In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.

Objectives: The aim of our study was to describe approaches to health technology assessment (HTA) for medicines in the Slovak healthcare system and the related decision-making processes concerning reimbursement for medicines., Methods: Analysis of the Slovak legislative framework related to HTA and the reimbursement process for medicines was performed. Additionally, current practices of the Working Group for Pharmacoeconomics, Clinical Outcomes and Health Technology Assessment of the Slovak Ministry of Health were evaluated., Results: In Slovakia, there is always at least one treatment available in each determined therapeutic class with no co-payment. HTA is becoming an established method for the evaluation of cost-effectiveness of medicines in Slovak healthcare policy. The majority of decision makers within Slovakia support the idea of increased use of and the quality and efficiency of HTA methods. However, it is crucial to overcome several practical barriers to facilitate progress in the field of HTA in the Slovak Republic., Conclusions: It can be seen that participation within the European Network for Health Technology Assessment (EUnetHTA JA 2 and EUnetHTA JA 3 projects) has significantly improved the quality of the process of HTA in Slovakia. Further legislative activities in this field are required due to the approved strategy for European Union cooperation on HTA.

Objectives: The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources., Methods: We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information., Results: The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria., Conclusions: While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the "pragmatic" HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

Amphetamine or methylphenidate are first-line options for treating attention-deficit/hyperactivity disorder (ADHD). Deviations from suggested routes of administration such as crushing, chewing, intravenous administration, or snorting stimulant medication may alter the release rate, absorption, and bioavailability of the active drug. Additionally, the pharmacokinetic (PK) profiles of extended-release formulations of certain medications (e.g., some opioids) are known to be dangerously altered when consumed with alcohol; specifically, there is an unintended, rapid release of a significant portion of the drug (dose dumping). In vitro data suggest some extended-release stimulants dose dump in the presence of alcohol, which is of concern because the ADHD patient population is at risk for alcohol abuse. This article reviews the available scientific literature concerning modifications to routes of administration that may alter PK properties of stimulant-based medication for treating ADHD. These modifications are of clinical interest because they may pose safety hazards and affect efficacy. Electronic databases were searched for appropriate studies using relevant search terms. The misuse and abuse potential for stimulants and the efforts to prevent misuse are also discussed. Future research should be focused on determining the PK ramifications of stimulant misuse, along with developing new formulations with abuse-deterrent properties.

The issues of efficient application of pharmaceuticals by national authorities and supranational institutions are considered as important ones. The WHO recommends implementing twelve key propositions enhancing efficient application of pharmaceuticals. The development of independent information system concerning pharmaceuticals. The WHO recognizes that absence of neatly organized information system concerning pharmaceuticals information is usually spreading through different channels by manufacturers of medicines. The WHO determines admissible sources of information concerning pharmaceuticals and also requirements to content of presented information. The article presents results of survey of opinions of medical professionals about information sources concerning pharmaceuticals regulated in the Russian Federation and the WHO and also about actual information system concerning pharmaceuticals in the Russian Federation and its role in efficient application of medicines.

This article was designed to discuss the issues related to ensuring the methodological uniformity of investigations of the novel psychoactive substances based on the system of the newly established specialized laboratories. The authors propose the methodological approaches to the implementation of comprehensive chemical and pharmacological research including chemical, biological, and sociological studies. The main specific features of these approaches are the use of laboratory animals and the automation of in vivo experiments. Also, we discuss the use of the concrete results of the computational experiments designed to elucidate the parameters responsible for the chemical similarity of psychoactive substances. The mechanisms of their action are considered. The special emphasis is placed on the necessity of close cooperation between scientific and expert communities with a view to accumulation of the data on the newly developed and potentially harmful psychoactive substances as a basis for the efficacious prevention of their illegal trafficking.

The cannabis plant has been known to humanity for centuries as a remedy for pain, diarrhea and inflammation. Current research is inspecting the use of cannabis for many diseases, including multiple sclerosis, epilepsy, dystonia, and chronic pain. In inflammatory conditions cannabinoids improve pain in rheumatoid arthritis and:pain and diarrhea in Crohn's disease. Despite their therapeutic potential, cannabinoids are not free of side effects including psychosis, anxiety, paranoia, dependence and abuse. Controlled clinical studies investigating the therapeutic potential of cannabis are few and small, whereas pressure for expanding cannabis use is increasing. Currently, as long as cannabis is classified as an illicit drug and until further controlled studies are performed, the use of medical cannabis should be limited to patients who failed conventional better established treatment.

The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions., (Copyright © 2014 John Wiley & Sons, Ltd.)

Several types of collaboration are being pursued to identify, validate and apply new biomarkers. Here, we highlight examples of such initiatives and discuss the challenges, approaches to address these challenges and key factors for success.

Background: Prescription drug abuse is a serious health concern and is considered a nationwide epidemic. Patients often fail or refuse to disclose the use of controlled substances, leaving prescribers and pharmacies unaware of the potential for harmful drug interactions and risk of overdose. Psychiatric patients are especially vulnerable to controlled substance misuse., Objectives: To determine hazardous patterns of prescription drug use among psychiatric outpatients and to raise awareness about the importance of reviewing information provided by prescription drug monitoring programs (PDMPs)., Methods: The medical records of 150 patients attending the Adult Outpatient Psychiatric Clinic at the Los Angeles County+University of Southern California (LAC+USC) Medical Center from July 2012 through May 2013 were reviewed. Patient activity reports were generated from California's PDMP. Nondisclosure of controlled substance use was identified by a discrepancy between patient reporting of prescriptions according to the medical records and PDMP reports. A "pattern suggestive of prescription drug abuse" was defined as having one or more of the following: within-class prescriptions from multiple providers and/or within-class early refills or within-class overlapping prescriptions picked up within 10 days of each other., Results: Of the 150 patients, 113 were found in California's PDMP database. Of these 113 patients, 81 had obtained 111 prescriptions for controlled substances in the past 12 months. Of these 111 prescriptions, 52 (47%) were not disclosed to the primary psychiatrist, of which 14 (27%) revealed patterns consistent with prescription drug abuse., Conclusions: Reviewing PDMP databases before prescribing controlled substances should be considered a standard prescribing practice to prevent abuse, diversion, and adverse medical outcomes.

Prescription monitoring programs (PMPs), state-level databases that collect patient-specific prescription information at the time medications are dispensed, have been suggested as tools to address the overdose epidemic. We reviewed all laws in the United States (n = 25) that articulated the purposes PMPs are intended to serve. Attributes related to reducing abuse, misuse, and diversion of prescription medications appeared most commonly. Only 5 purpose statements mentioned the promotion of public health as goals of the PMP, and only 3 listed improving health care. None listed overdose prevention as a goal of the PMP.

In 2000, the United States Congress proclaimed the decade commencing January 1, 2001, as the "Decade of Pain Control and Research." This review examines the progress, setbacks, and controversies in public policy, pain education, advocacy, ethics, and the law through this decade. Critical developments including the rise and fall of the consensus on the doctrine of balance in opioid policies, the respective roles of federal and state bodies, the surge of and response to the diversion and abuse of prescription medication, initiatives in education and advocacy, and reforms to state pain policies and laws shall be examined.