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A dozen or more regulatory frameworks have been proposed for legal cannabis but many of the "not-for-profit" options have yet to be developed in any detail, reducing the likelihood they will be seriously considered by policy makers. New Zealand's innovative "not-for-profit" regulatory regime for gaming machine gambling (i.e. "slot machines") has reversed the previous increase in gambling expenditure, empowered local councils to cap the number of gambling venues, and is unique in requiring the societies operating gaming machines to distribution 40% of the gross expenditure from machines (i.e. $NZ 262 million in 2015) to community purposes (e.g. sports). However, the regime has been criticised for not addressing the concentration of gaming outlets in poorer communities, and not requiring grants to be allocated in the disadvantaged communities where outlets are located. There have also been cases of gaming societies providing community grants in exchange for direct or indirect benefits. In this paper we adapt this regulatory approach to a legal cannabis market. Under the proposed regime, licensed "not-for-profit" cannabis societies will be required to distribute 20% of cannabis sales to drug treatment and 20% to community purposes, including drug prevention. Grants must be allocated in the regions where cannabis sales are made and grant committees must be independent from cannabis societies. A 20% levy will be used to cover the wider health costs of cannabis use. A further 10% levy will be used to fund the regulator and evaluate the new regime. Local councils will have the power to decide how many, and where, cannabis retail outlets are located. Other important elements include a minimum price for cannabis, effective taxation of cannabis products, regulating CBD in cannabis products, higher taxation of traditional smoking products, advertising restricted to place-of-sale, no internet sales, and restrictions on industry involvement in regulation making and research., (Copyright © 2017. Published by Elsevier B.V.)

Objectives: To analyze how value-based pricing (VBP), which grounds the price paid for pharmaceuticals in their value, can manage "affordability" challenges, defined as drugs that meet cost-effectiveness thresholds but are "unaffordable" within the short-run budget., Methods: Three specific contexts are examined, drawing on recent experience. First, an effective new treatment for a chronic, progressive disease, such as hepatitis C, creates a budget spike that is transitory because initial prevalence is high, relative to current incidence. Second, "cures" that potentially provide lifetime benefits may claim abnormally high VBP prices, with high immediate budget impact potentially/partially offset by deferred cost savings. Third, although orphan drugs in principle target rare diseases, in aggregate they pose affordability concerns because of the growing number of orphan indications and increasingly high prices., Results: For mass diseases, the transitory budget impact of treating the accumulated patient stock can be managed by stratified rollout that delays treatment of stable patients and prioritizes patients at high risk of deterioration. Delay spreads the budget impact and permits potential savings from launch of competing treatments. For cures, installment payments contingent on outcomes could align payment flows and appropriately shift risk to producers. This approach, however, entails high administrative and incentive costs, especially if applied across multiple payers in the United States. For orphan drugs, the available evidence on research and development trends and returns argues against the need for a higher VBP threshold to incentivize research and development in orphan drugs, given existing statutory benefits under orphan drug legislation., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

This review illustrates some brief considerations of the medical use of cannabis recently issued in Italy. History and uses of cannabis throughout centuries and different countries are illustrated together with a description of botany and active phytocannabinoids. Then, medical use of cannabis anti-pain treatment for patients resistant to conventional therapies is described in case of chronic neuropathic pain, spasticity, for anticinetosic and antiemetic effect in nausea and vomiting caused by chemotherapy, for appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, hypotensive effect in glaucoma resistant to conventional therapies and for reduction of involuntary body and facial movements in Gilles de la Tourette syndrome. Italian most recent legislation on medical cannabis is detailed with some law proposals, also showing the inconsistent legislation within European Union. Some final considerations of future studies are also reported.

According to the Organization for Economic Co-operation and Development (OECD), drug expenditures account for about 20 % of all health expenditures in high-income countries. The increase of these drug expenditures which has been observed in all these countries over a long period is due to the combination of aging populations, changes in medical practices and the dynamics of the pharmaceutical market, in particular the hospital market. France is no exception. Its consumption of drugs (which accounted for 17.5 % of health expenditures in 2014), historically among the highest in volume, has grown slower in the last decade than in other OECD countries. However, the particularly rapid and wide adoption of pharmaceutical innovations, which has always characterized France, has had in recent years a very significant effect on the soaring drug expenditures covered by the social protection system (plus 1.1 billion in 2014, a year marked by the introduction of new therapies against hepatitis C). This significant effect should continue with the introduction of new and very expensive therapies, particularly in oncology., (© 2018 médecine/sciences – Inserm.)

Background: The United Nations Convention against Illicit Traffic in Narcotic Drugs 1988 ("1988 Convention") expresses a strong normative preference for criminalising drug possession. Historically, the United Nations offices responsible for overseeing the treaties have held that decriminalisation of drug possession is contrary to the treaties. Leading up to and during UNGASS 2016, however, rather than emphasise criminalisation, the high-ranking officials from the drug control offices emphasised the treaties' allowance of alternatives to punishment for drug possession offences., Methods: This paper applies transnational social movement theory to analyse the political opportunity structure for drug law reform at the UN. Data was collected from documents created by important United Nations agencies in the lead up to UNGASS 2016. By analysing the statements of prominent UN officials within a social movement theory framework, we can assess whether those responsible for administering global drug policy are offering concession to drug law reform social movement and whether a political opportunity structure is opening up for drug law reformers to pursue further reforms., Results: from the United Nations documents demonstrated significant reference to local drug law reforms and the benefits of non-punitive treatment of drug users. However, given the strong normative preference and mandatory language ("shall") in the 1988 Convention, policy leaders at the UN can only offer very moderate concessions to drug law reformers - primarily the advocacy of alternatives to incarceration. Such policies still suffer many problems caused by using the criminal justice system to funnel people into treatment. Indeed, many other offices at the UN explicitly drew attention to the problem of pre-trial punishment in their contributions to UNGASS 2016., Conclusion: A schism is developing at the UN as other UN offices are pointing out that advocating for alternatives to punishment is inadequate due to the many problems of "pre-trial punishment". Social movement theory suggests that this schism represents an opening of the political opportunity structure as advocates for drug law reform can now more forcefully criticise, and even breach, the treaties and will have high-level support at the UN., (Copyright © 2017 Elsevier B.V. All rights reserved.)

After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.

Purpose: To evaluate the safety-related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012., Methods: We analyzed serious safety issues appended to drug package inserts (PIs) in Japan in 2012. The issues were characterized according to drug class, adverse event, years since drug approval, initiator of regulatory actions, revised section of PI, and evidence source. We also quantified the durations from signal detection to tentative decision and from tentative decision to regulatory action., Results: We identified 144 serious safety issues during the study period, and the majority of evidence originated from spontaneous reports (83.5%). The PMDA initiated regulatory actions for half of all safety issues, and the median duration from drug approval to regulatory action was 8 years (interquartile range [IQR], 3-26.5 years). The median duration was 49 days (IQR, 0-362 days) from signal detection to tentative decision and 84 days (IQR, 63-136 days) from tentative decision to regulatory action. Several safety issues involving older drugs and multiple products had protracted decision-making durations., Conclusions: Most safety issues led to prompt regulatory actions predominantly based on spontaneous reports. Some safety issues that were not easily detected by the spontaneous reporting system were identified years after approval. In addition, several safety issues required assessments of multiple drug products, which prolonged the decision-making process., (Copyright © 2017 John Wiley & Sons, Ltd.)

Purpose: Evaluate changes in use of erythropoiesis-stimulating agents (ESAs) and red blood cell transfusion in cancer patients receiving myelosuppressive chemotherapy following regulatory and reimbursement actions., Methods: Calendar year patient cohorts (2005-2013) with breast, colorectal, lung, multiple myeloma, non-Hodgkin lymphoma, ovarian, or prostate cancer and receiving myelosuppressive chemotherapy were identified within the Marketscan database. Incidence of ESA treatment and transfusion were estimated in each year, as was median number of ESA administrations. Clinical characteristics associated with ESA administration and transfusions were evaluated by using multivariable logistic regression. Additionally, annual new ESA user cohorts within the Oncology Services Comprehensive Electronic Records database (2011-2014) were examined to assess hemoglobin levels at ESA initiation., Results: Across all tumor types, ESA use decreased substantially (breast cancer: 53.7 to 3.2%; lung cancer: 66.0 to 13.3%, non-Hodgkin lymphoma: 39.8 to 3.8%), transfusion use increased (2 to 5.5%, 5.5 to 18.2%, and 4.5 to 9.1%, respectively), and median number of ESA administrations declined. Across all tumor types, proportion of patients initiating an ESA with hemoglobin >10 g/dL was <10% from 2011 onward. In recent years, cancer patients who are older, female, and have chronic kidney disease or moderate or severe liver disease were most likely to receive ESAs., Conclusion: Subsequent to important regulatory and reimbursement ESA-related actions, total ESA exposure among cancer patients receiving myelosuppressive chemotherapy declined substantially. Today, fewer patients receive ESA therapy, and among those treated, more are initiated at hemoglobin levels <10 g/dL and are exposed for a shorter duration, consistent with current product labeling., (Copyright © 2017 John Wiley & Sons, Ltd.)

Several jurisdictions around the world have introduced policies and laws allowing for the legal use of cannabis for therapeutic purposes. However, there has been little critical discussion of how the object of 'medicinal cannabis' is enacted in policy and practice. Informed by Carol Bacchi's poststructuralist approach to policy analysis and the work of science and technology studies scholars, this paper seeks to problematise the object of 'medicinal cannabis' and examine how it is constituted through governing practices. In particular, we consider how the making of the object of 'medicinal cannabis' might constrain or enact discourses of pleasure. As a case example, we take the Victorian Law Reform Commission's review of law reform options to allow people in the Australian state of Victoria to be treated with medicinal cannabis. Through analysis of this case example, we find that although 'medicinal cannabis' is constituted as a thoroughly medical object, it is also constituted as unique. We argue that medicinal cannabis is enacted in part through the production of another object (so-called 'recreational cannabis') and the social and political meanings attached to both. Although both 'substances' are constituted as distinct, 'medicinal cannabis' relies on the 'absent presence' of 'recreational cannabis' to define and shape what it is. However, we find that contained within this rendering of 'medicinal cannabis' are complex enactments of health and wellbeing, which open up discourses of pleasure. 'Medicinal cannabis' appears to challenge the idea that the effects of 'medicine' cannot be understood in terms of pleasure. As such, the making of 'medicinal cannabis' as a medical object, and its invocation of broad notions of health and wellbeing, expand the ways in which drug effects can be acknowledged, including pleasurable and desirable effects, helping us to think differently about both medicine and other forms of drug use., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Purpose: Cardiovascular safety alerts about rosiglitazone resulted in regulatory actions in several countries in 2010, but the Food and Drug Administration eliminated access restrictions in 2013, reflecting new evidence concerning the drug safety. We investigated the effects of safety signals and regulation shifts concerning rosiglitazone on prescribing of antidiabetic drugs (ADs)., Methods: Patient data were extracted from the Korean health insurance claims database for 2007 to 2015. Linear regression and interrupted time series analyses were performed to examine drug utilization trends and the impact of 5 milestone events regarding rosiglitazone safety on AD utilization., Results: A steady growth was observed in the AD consumption, with metformin preserving its dominant market share throughout the period. Pioglitazone use has increased since 2008 in response to safety issues surrounding rosiglitazone. A significant decline in rosiglitazone use was observed after Nissen's meta-analysis and safety warnings (2007) and after restriction/suspension of access to rosiglitazone (2010), associated with a drop in prevalence by 29.5%/year and 99.5%/year, respectively. The most common AD newly started among users who discontinued rosiglitazone in 2010 was pioglitazone, followed by dipeptidyl peptidase-4 (DPP-4) inhibitors. Our concomitancy analysis showed that DPP-4 inhibitors have overtaken sulfonylureas since 2014 as the most common add-on to metformin., Conclusions: The most frequently added AD in diabetes patients who had switched off rosiglitazone in 2010 was pioglitazone, followed by DPP-4 inhibitors. Despite new evidence from a long-term clinical trial and the Food and Drug Administration's subsequent decision to eliminate access restrictions on rosiglitazone in 2013, domestic regulations were left intact; hence, its use remained negligible in Korea., (Copyright © 2017 John Wiley & Sons, Ltd.)

Background: Alternative methods for consuming cannabis (e.g., vaping and edibles) have become more popular in the wake of U.S. cannabis legalization. Specific provisions of legal cannabis laws (LCL) (e.g., dispensary regulations) may impact the likelihood that youth will use alternative methods and the age at which they first try the method - potentially magnifying or mitigating the developmental harms of cannabis use., Methods: This study examined associations between LCL provisions and how youth consume cannabis. An online cannabis use survey was distributed using Facebook advertising, and data were collected from 2630 cannabis-using youth (ages 14-18). U.S. states were coded for LCL status and various LCL provisions. Regression analyses tested associations among lifetime use and age of onset of cannabis vaping and edibles and LCL provisions., Results: Longer LCL duration (OR vaping : 2.82, 95% CI: 2.24, 3.55; OR edibles : 3.82, 95% CI: 2.96, 4.94), and higher dispensary density (OR vaping : 2.68, 95% CI: 2.12, 3.38; OR edibles : 3.31, 95% CI: 2.56, 4.26), were related to higher likelihood of trying vaping and edibles. Permitting home cultivation was related to higher likelihood (OR: 1.93, 95% CI: 1.50, 2.48) and younger age of onset (β: -0.30, 95% CI: -0.45, -0.15) of edibles., Conclusion: Specific provisions of LCL appear to impact the likelihood, and age at which, youth use alternative methods to consume cannabis. These methods may carry differential risks for initiation and escalation of cannabis use. Understanding associations between LCL provisions and methods of administration can inform the design of effective cannabis regulatory strategies., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Importance: Over the last 25 years, illicit cannabis use and cannabis use disorders have increased among US adults, and 28 states have passed medical marijuana laws (MML). Little is known about MML and adult illicit cannabis use or cannabis use disorders considered over time., Objective: To present national data on state MML and degree of change in the prevalence of cannabis use and disorders., Design, Participants, and Setting: Differences in the degree of change between those living in MML states and other states were examined using 3 cross-sectional US adult surveys: the National Longitudinal Alcohol Epidemiologic Survey (NLAES; 1991-1992), the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC; 2001-2002), and the National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III; 2012-2013). Early-MML states passed MML between NLAES and NESARC ("earlier period"). Late-MML states passed MML between NESARC and NESARC-III ("later period")., Main Outcomes and Measures: Past-year illicit cannabis use and DSM-IV cannabis use disorder., Results: Overall, from 1991-1992 to 2012-2013, illicit cannabis use increased significantly more in states that passed MML than in other states (1.4-percentage point more; SE, 0.5; P = .004), as did cannabis use disorders (0.7-percentage point more; SE, 0.3; P = .03). In the earlier period, illicit cannabis use and disorders decreased similarly in non-MML states and in California (where prevalence was much higher to start with). In contrast, in remaining early-MML states, the prevalence of use and disorders increased. Remaining early-MML and non-MML states differed significantly for use (by 2.5 percentage points; SE, 0.9; P = .004) and disorder (1.1 percentage points; SE, 0.5; P = .02). In the later period, illicit use increased by the following percentage points: never-MML states, 3.5 (SE, 0.5); California, 5.3 (SE, 1.0); Colorado, 7.0 (SE, 1.6); other early-MML states, 2.6 (SE, 0.9); and late-MML states, 5.1 (SE, 0.8). Compared with never-MML states, increases in use were significantly greater in late-MML states (1.6-percentage point more; SE, 0.6; P = .01), California (1.8-percentage point more; SE, 0.9; P = .04), and Colorado (3.5-percentage point more; SE, 1.5; P = .03). Increases in cannabis use disorder, which was less prevalent, were smaller but followed similar patterns descriptively, with change greater than never-MML states in California (1.0-percentage point more; SE, 0.5; P = .06) and Colorado (1.6-percentage point more; SE, 0.8; P = .04)., Conclusions and Relevance: Medical marijuana laws appear to have contributed to increased prevalence of illicit cannabis use and cannabis use disorders. State-specific policy changes may also have played a role. While medical marijuana may help some, cannabis-related health consequences associated with changes in state marijuana laws should receive consideration by health care professionals and the public.

Background: Support for the legalization of recreational marijuana continues to increase across the United States and globally. In 2016, recreational marijuana was legalized in the most populous US state of California, as well as three other states. The primary aim of this study was to examine trends in support for recreational marijuana legalization in Washington, a state which has had legal recreational marijuana for almost four years, using data collected over the four years post-legalization. A secondary aim was to examine trends in support for the cultivation of marijuana for personal use., Methods: Data come from geographically representative general population samples of adult (aged 18 and over) Washington residents collected over five timepoints (every six months) between January 2014 and April 2016 (N=4101). Random Digit Dial was used for recruitment. Statistical analyses involved bivariate comparisons of proportions across timepoints and subgroups (defined by age, gender, and marijuana user status), and multivariable logistic regression controlling for timepoint (time) to formally test for trend while controlling for demographic and substance use covariates. All analyses adjusted for probability of selection., Results: Support for legalization in Washington has significantly increased: support was 64.0% (95% CI: 61.2%-67.8%) at timepoint 1 and 77.9% (95% CI: 73.2%-81.9%) at timepoint 5. With each six months' passing, support increased 19% on average. We found no statistically significant change in support for home-growing., Conclusions: Support for marijuana legalization has continued to significantly increase in a state that has experienced the policy change for almost four years., (Copyright © 2017. Published by Elsevier B.V.)

Brazilian public policy on drugs has been permeated by two diametrically opposing approaches: one focusing on prohibition and the other on non- prohibition. Similarly, there have been two opposing approaches to mental healthcare, one centered on hospitalization and the other psychosocial care and development. In the context of these different paradigms, this article presents an analysis of twenty-two documents sourced by the legislative rules over the last sixteen years. After the year 2000, a renewed focus by healthcare community on drugs was noticeable as was the immersion of a harm reducing approach. Following international trends, although there are still considerable divergencies between (a) psychosocial care and(b) residential care in the therapeutic communities there seems to be an alignment to anti- prohibition approaches.

This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the United States has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System to define when waivers for bioequivalence studies can be supported by in vitro dissolution. However, a challenge is that in vitro models should adequately mimic the physiology of different pediatric age-groups and dose definition is another critical aspect. There is a tendency for off-label use of established adult medicines, resulting in increased adverse events and decreased efficacy in the target population. Recent advances in physiologically based pharmacokinetic modelling may be used to provide valuable input into these discussions, but there are currently still many knowledge gaps. It is encouraging that there is a global recognition of these deficiencies and substantial funding in the field of basic research is being provided, for example, within Europe the Innovative Medicines Initiative consortium., (Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Historically, neonatal therapeutic interventions were derived from adult therapeutics, and tragedies resulting from this approach have demonstrated differences in the pathophysiologic and developmental processes between neonates and older patients. Over the past 3 decades, researchers and collaborative research networks have made progress in the systematic evaluation of neonatal therapies, yet most neonatal therapeutic products have been incompletely assessed for safety and efficacy, and remain unlabeled and unapproved., Approach: This work describes the legislative initiatives that have stimulated an increase in pediatric and neonatal studies. It highlights examples of successful neonatal drug studies that have resulted in informative neonatal labeling changes, as well as studies that have produced incomplete information. Strategies that support the design of successful studies, including targeting specific subpopulations, modeling and simulation to inform dose selection, innovative design strategies, biomarkers, and endpoints are discussed. Multi-stakeholder consortia such as the International Neonatal Consortium (INC), are working to improve the tools needed for the development of neonatal therapies. These research tools may be used by trial networks to inform consistent and efficient multicenter studies., Conclusion: More data are needed to support safe and effective use of drugs in neonates, and to obtain these data, a thorough understanding of pathophysiology, drug disposition, biomarkers, and clinically-meaningful endpoints is required. This information will be derived from clinical trials, registries, real-world evidence, and the medical literature. Collaboration of consortia and the development of research networks are essential to achieving these goals., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

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

Background: Medical marijuana legalization is associated with a higher prevalence of marijuana use which may affect cigarette use and nicotine dependence in co-users. In the present study, we examined relationships between statewide legalization of medical marijuana and prevalence of cigarette and marijuana co-use and nicotine dependence in co-using adolescents and adults., Methods: Data were analyzed from the 2013 National Survey on Drug Use and Health. We compared cigarette and marijuana co-use in the past 30days across age categories (12-64 years) by statewide medical marijuana legalization. Logistic regression models were used to estimate the odds of having nicotine dependence among current cigarette smokers who also reported past 30-day marijuana use and "ever but not current" marijuana use (vs. "never" use) adjusting for covariates including statewide legalization of medical marijuana., Results: Overall, 5.1% of the sample reported past 30-day cigarette and marijuana co-use and a higher proportion of co-users resided in states where medical marijuana was legal compared to illegal (5.8% vs. 4.8%; p=0.0011). Co-use was associated with greater odds of having nicotine dependence compared to cigarette-only use across age categories. Odds were highest and up to 3-times higher in adolescents aged 12-17 years (OR=3.54; 95%CI: 1.81-6.92) and adults aged 50-64 years (OR=3.08; CI: 1.45-6.55)., Conclusion: Marijuana policy could inadvertently affect cigarette and marijuana co-use and pose challenges to tobacco cessation., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Recently momentum has been building behind pharmacist prescriptive authority for certain products such as oral contraceptives or naloxone. To some, prescriptive authority by pharmacists represents a departure from the traditional role of pharmacists in dispensing medications. Nearly all states, however, currently enable pharmacist prescriptive authority in some form or fashion. The variety of different state approaches makes it difficult for pharmacists to ascertain the pros and cons of different models. We leverage data available from the National Alliance of State Pharmacy Associations (NASPA), a trade association that tracks pharmacy legislation and regulations across all states, to characterize models of pharmacist prescriptive authority along a continuum from most restrictive to least restrictive. We identify 2 primary categories of current pharmacist prescriptive authority: (1) collaborative prescribing and (2) autonomous prescribing. Collaborative prescribing models provide a broad framework for the treatment of acute or chronic disease. Current autonomous prescribing models have focused on a limited range of medications for which a specific diagnosis is not needed. Approaches to pharmacist prescriptive authority are not mutually exclusive. We anticipate that more states will pursue the less-restrictive approaches in the years ahead., (© The Author(s) 2016.)

The 114th Congress (2014-2016) has received recent attention for the high number of legislative bills directed to the public health crisis in prescription opioid abuse. The US government does not have a single source for determining public policy; however, the people expect that there will be some level of efficiency and coordination between federal and state leaders to improve the nation's health. A search of the National Library of Congress database to analyze legislative bills introduced between 1973 and 2016 and which contain the term "opioid" identified 127 bills that characterize consistency and coordination with other governmental efforts in prescription opioid abuse. Despite the recent number of introduced bills, there does not appear to be a close coordination between Congress and Federal Administrative agencies regarding this crisis.

Rising mortality rates, increased opioid prescription abuse, and a perceived need to provide practitioners with structured guidance in opioid prescribing have prompted the Washington State Legislature to establish new legal standards of practice regarding chronic non-cancer pain management. Clinicians are required to conduct a detailed physical examination and health history prior to treatment. Risk assessments for abuse and detailed periodic reviews of treatment are required at least every 6 months. Those considered "high risk" or who have significant psychiatric comorbidities will be required to sign and follow a written agreement or pain contract, obtain their pain prescriptions from a single provider, and submit to biological drug screening. Unless an exemption exists, patients prescribed > 120 mg of morphine-equivalents daily, considered severe pain nonresponders, necessitating dosage escalation, diagnosed with multifaceted mental health-related comorbidities, demonstrating diagnostic ambiguity, and/or requiring significant treatment individualization are referred to a pain specialist. Episodic care settings should refrain from supplying opioids to chronic pain patients whenever possible. The ER is for Emergencies coalition instituted the Seven Best Practices program throughout the state to reduce unnecessary visits, coordinate prescribing practice, reduce Medicaid expenditures, and improve overall patient care. The state reported approximately $33.65 million in savings in 2013 through the use of these practices and converting Medicaid participants from fee-for-service to managed care plans. Similar legislation to complement clinical practice guidelines is expected to be enacted in other states. It is vital that practitioners comprehend the new guidelines and make appropriate adjustments in their opioid prescribing habits., (© 2015 World Institute of Pain.)

The main objective of this study was to assess the practice at retail pharmacies in Pakistan and to compare the same in rural and urban areas. The maintenance of pharmacy and drug inspectors' visit was also assessed. This cross sectional study was conducted in Abbottabad, Pakistan during October-November, 2012. A sample of 215 drug sellers or drug stores was selected by employing convenient sampling method. With a response rate of 91.6%, 197 drug sellers participated in this study. All the drug sellers were male. Overall, 35% (n = 197) of the drug sellers did not have any professional qualification. A majority of the drug sellers were involved in various malpractices like selling of medicines without prescription (80.7%), prescribing practice (60.9%), prescription intervention (62.4%) and selling of controlled substances (66%) without a license for selling it. These malpractices were significantly higher in rural area than that in urban area.

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

Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

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

Background: In 2010, Mississippi became the second state to require a prescription to purchase pseudoephedrine-based medications. Proponents of "prescription-only" laws argue that they are necessary to disrupt methamphetamine markets, but critics note the costs to legal consumers of cold medications may offset some of the laws' intended benefits., Objective: We evaluated the effect of prescription-only restrictions for methamphetamine precursors on state-level methamphetamine lab seizures and methamphetamine prices., Methods: We used a synthetic control approach to create a control state comparable to Mississippi and then used permutation testing to determine if the resulting difference was statistically significant., Results: We found that Mississippi's prescription-only law removed 2637 small methamphetamine labs in the two years after the law became effective, which represents a 77% reduction in small labs relative to the synthetic counterfactual. We found no evidence that the law impacted methamphetamine prices., Conclusion: We conclude that while prescription-only laws can reduce the number of domestic small methamphetamine labs in operation, methamphetamine availability is unlikely to be materially impacted., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Objectives: To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled "House Bill 1" (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012., Design: A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame., Results: The incidence of intraspinal abscess increased 1.56-fold in 2011 (n = 26) and 2012 (n = 25) relative to 2010 (n = 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold (n = 38) and then 4.19-fold (n = 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 (n = 3) and 2012 (n = 3). However, it increased twofold (n = 7) in 2013 and then ninefold (n = 27) in 2014. A correlation coefficient (rSAD ) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse., Conclusions: The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account., (Wiley Periodicals, Inc.)

An analysis of US Food and Drug Administration (FDA)-approved new molecular entities (NMEs) reveals dynamism in terms of new innovation. An assessment of the first patent for each drug shows that the pharmaceutical industry, particularly large, established companies in North America, tend to dominate the field. Over the past 10-15 years, European and Asian organizations have begun to close the gap. A dynamic inventive environment in drug discovery is suggested by the fact that NMEs for biologics or awarded to biotechnology companies often have inventors from the pharmaceutical and academic sectors. Whereas inventors continue to found biotechnology companies at a steady rate, recent trends suggest these inventors more often come from the private sector., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

The characterisation of new psychoactive drugs which were identified in the last years in continuously increasing numbers is a challenge for different academic institutions. This paper gives an overview on new psychoactive drugs in regard of their chemistry, pharmacology, metabolism, analytics and legal aspects in Germany.

According to the European Medicine Agency, a "biosimilar" is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference or innovative medicinal product) that has been authorized in the European Economic Area. The similarity to the reference medicinal product in terms of quality, biological activity, safety and efficacy needs to be set on a comprehensive comparability basis. The generic standard approach (demonstration of bioequivalence with a reference medicinal product by appropriate bioavailability studies), which is applicable to a wide range of chemically derived medicinal products, is not sufficient to prove the similarity of biotechnology derived products due to their structural complexity. Furthermore, these biopharmaceuticals products, in comparison with the conventional ones, show a greater ability to activate the immune response. The evaluation of biosimilar medicines for authorisation purposes by the European Medicine Agency does not include recommendations on whether a biosimilar should be used interchangeably with its reference medicine. Substitution policies are, therefore, within the remit of the EU member states. In order to support pharmacovigilance monitoring, all appropriate measures should be taken to clearly identify any biological medicinal product with due regard to its brand name and batch number. The situation of the European Community and the regulatory framework have been developed since the first applications (growth hormone), almost a decade ago, until the recent advent (monoclonal antibodies). The introduction to the market of biosimilars have positive effects on competition by improving access to biological therapies., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation., (© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.)

In June, 2012 the United States Food and Drug Administration (FDA) developed a "blueprint" for prescriber education as a means of directing Certified Medical Education (CME) activities that included content which would meet the regulatory requirements of the class-wide, longacting/ extended-release (LA-ER) opioid Risk Evaluation Mitigation Strategies (REMS). Within the blueprint is the suggested adoption of Patient-Provider Agreements (PPAs) to be used in association with opioid prescribing, but, to our knowledge, there have been no reported evaluations of the role played by opioid-agent PPAs in clinical practice, or of the perceptions of this regulatory mandate by clinicians. Therefore, we conducted a survey regarding PPA perceptions by opioid prescribers that was posted for five weeks on a well-trafficked online CME service provider (Medscape). Of the 1,232 respondents (reflecting a 99.5% completion rate), 52.4% treat acute or chronic pain with opioids. The survey identified an improvement of opioid safe-use education (21% of respondents) as the most frequently selected beneficial element of PPAs. Conversely, the challenges to adoption included time constraints (21% of physicians) as well as lack of evidence that PPAs will reduce drug misuse, and the lack of a uniform, patient-friendly PPA. Based on our survey, clinicians consider the PPA of potential value, but data regarding the utility of such an instrument are lacking.

On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

Importance: Opioid analgesic overdose mortality continues to rise in the United States, driven by increases in prescribing for chronic pain. Because chronic pain is a major indication for medical cannabis, laws that establish access to medical cannabis may change overdose mortality related to opioid analgesics in states that have enacted them., Objective: To determine the association between the presence of state medical cannabis laws and opioid analgesic overdose mortality., Design, Setting, and Participants: A time-series analysis was conducted of medical cannabis laws and state-level death certificate data in the United States from 1999 to 2010; all 50 states were included., Exposures: Presence of a law establishing a medical cannabis program in the state., Main Outcomes and Measures: Age-adjusted opioid analgesic overdose death rate per 100 000 population in each state. Regression models were developed including state and year fixed effects, the presence of 3 different policies regarding opioid analgesics, and the state-specific unemployment rate., Results: Three states (California, Oregon, and Washington) had medical cannabis laws effective prior to 1999. Ten states (Alaska, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, Rhode Island, and Vermont) enacted medical cannabis laws between 1999 and 2010. States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate (95% CI, -37.5% to -9.5%; P = .003) compared with states without medical cannabis laws. Examination of the association between medical cannabis laws and opioid analgesic overdose mortality in each year after implementation of the law showed that such laws were associated with a lower rate of overdose mortality that generally strengthened over time: year 1 (-19.9%; 95% CI, -30.6% to -7.7%; P = .002), year 2 (-25.2%; 95% CI, -40.6% to -5.9%; P = .01), year 3 (-23.6%; 95% CI, -41.1% to -1.0%; P = .04), year 4 (-20.2%; 95% CI, -33.6% to -4.0%; P = .02), year 5 (-33.7%; 95% CI, -50.9% to -10.4%; P = .008), and year 6 (-33.3%; 95% CI, -44.7% to -19.6%; P < .001). In secondary analyses, the findings remained similar., Conclusions and Relevance: Medical cannabis laws are associated with significantly lower state-level opioid overdose mortality rates. Further investigation is required to determine how medical cannabis laws may interact with policies aimed at preventing opioid analgesic overdose.