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Background: We previously reported that the 2018 Canadian Cannabis Act, allowing youth to possess up to 5 g dried cannabis or equivalent for personal use/sharing, was associated with short-term (76 days) post-legalization reduction in police-reported cannabis-related crimes among youth. To establish whether the change might be sustained, we now estimate this association during a much longer time period by including an additional three years of post-legalization data., Methods: Using national daily police-reported criminal incident data from January 1, 2015-December 31, 2021 from the Canadian Uniform Crime Reporting Survey (UCR-2), the study employed Seasonal Autoregressive Integrated Moving Average (SARIMA) time series models to assess the associations between legalization and youth (12-17 years) cannabis-related offenses (male, n = 34,508; female, n = 9529)., Results: Legalization was associated with significant reductions in both male and female police-reported cannabis-related offenses: females, 4.04 daily incidents [95% confidence interval (CI), 3.08; 5.01], a 62.1% decrease [standard error (se), 34.3%]; males, 12.42 daily offenses (95% CI, 8.99; 15.86), a reduction of 53.0% (se, 22.7%). There was no evidence of associations between cannabis legalization and patterns of property or violent crimes., Conclusions: Results suggest that the impact of the Cannabis Act on reducing cannabis-related youth crimes is sustained, supporting the Act's objectives to reduce cannabis-related criminalization among youth and associated effects on the Canadian criminal justice system., Competing Interests: Declaration of Competing Interest This research was supported in part by a Canadian Institutes of Health Research (CIHR) Project Grant (PJT 180292) awarded to the first author (RCC). In relation to the manuscript, the authors have no competing interests to declare., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Introduction: There is concern that recreational marijuana legalization (RML) may lead to increased cannabis use disorder (CUD) among youth due to increased marijuana use. This study investigates whether adolescent substance use disorder treatment admissions for marijuana use increased in Colorado and Washington following RML., Methods: Annual data on 2008-2017 treatment admissions for marijuana use from the SAMHSA TEDS-A dataset for adolescents age 12-17 were used to model state treatment admissions trends. Difference-in-differences models were used to investigate whether treatment admissions increased following RML in Colorado/Washington compared to non-RML states, after adjusting for socioeconomic characteristics and treatment availability., Results: Over all states in the analysis, the rate of adolescent treatment admissions for marijuana use declined significantly over the study period (β=-3.375, 95 % CI=-4.842, -1.907), with the mean rate falling nearly in half. The decline in admissions rate was greater in Colorado and Washington compared to non-RML states following RML, though this difference was not significant (β=-7.671, 95 % CI=-38.798, 23.456)., Conclusion: Adolescent treatment admissions for marijuana use did not increase in Colorado and Washington following RML. This may be because youth marijuana use did not increase, CUD did not increase (even if use did increase), or treatment seeking behaviors changed due to shifts in attitudes and perceptions of risk towards marijuana use., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: The continued toll of opioid-related overdoses has motivated efforts to expand availability of naloxone to persons at high risk of overdose, with 2016 federal guidance encouraging clinicians to co-prescribe naloxone to patients with increased overdose risk. Some states have pursued analogous or stricter legal requirements that could more heavily influence prescriber behavior., Methods: We conducted a systematic legal review of state laws that mandate or recommend that healthcare providers prescribe naloxone to patients with indicators for opioid overdose risk. We coded relevant statutes and regulations for: applicable populations, patient criteria, educational requirements, and exemptions., Results: As of September 2019, 17 states had enacted naloxone co-prescribing laws, the earliest of which was implemented by Louisiana in January 2016. If patient overdose risk criteria are met, over half of these states mandate that providers prescribe naloxone (7 states, 41.1 %) or offer a naloxone prescription (2 states, 11.8 %); the remainder encourage prescribers to consider prescribing naloxone (8 states). Most states (58.8 %) define patient overdose risk based on opioid dosages prescribed, although the threshold varies substantially; other common overdose risk criteria include concomitant opioid and benzodiazepine prescriptions and patient history of substance use disorder or mental illness., Conclusions: A growing minority of states has adopted a naloxone prescribing law, although these policies remain less prevalent than other naloxone access laws. By targeting higher-risk patients during clinical encounters, naloxone prescribing requirements could increase naloxone prescribed, destigmatize naloxone use, and reduce overdose harms. Further investigation into policy effectiveness, unintended consequences, and appropriate parameters is warranted., Competing Interests: Declaration of Competing Interest None., (Published by Elsevier B.V.)

Background and Purpose: MyDispense is an innovative, web-based program which simulates a community pharmacy. Use of this software may assist students' comprehension of validating controlled substance prescriptions by determining if prescriptions contain errors or omissions., Educational Activity and Setting: Fourteen MyDispense practice exercises were created and implemented into a required second-year pharmacy law course. Completion of the MyDispense exercises and performance on the pharmacy law midterm exam were recorded. A questionnaire was administered to students to receive feedback on the exercises., Findings: There were complete data on all 94 student pharmacists enrolled in the didactic course. Thirty-five students (37%) completed all MyDispense exercises, 15 students (16%) completed some of the exercises, and 44 (47%) did not complete any of the exercises. Linear regression results indicate that students who completed more MyDispense exercises were significantly more likely to score higher on the midterm than those who completed fewer exercises (β = 0.28, p = 0.02). Students reported moderate to high exercise value and a willingness to use the software in preparation for future pharmacy law examinations., Summary: MyDispense provided a platform for students to apply controlled substance laws to the prescription validation process in the community pharmacy setting. Completion of practice exercises in MyDispense was shown to positively impact student performance on a pharmacy law midterm. Students valued the innovative simulation tool and were willing to access the tool again to prepare for future examinations., Competing Interests: Declaration of competing interest None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: Medical marijuana use may substitute prescription opioid use, whereas nonmedical marijuana use may be a risk factor of prescription opioid misuse. This study examined the associations between recreational marijuana legalization and prescription opioids received by Medicaid enrollees., Methods: State-level quarterly prescription drug utilization records for Medicaid enrollees during 2010-2017 were obtained from Medicaid State Drug Utilization Data. The primary outcome, opioid prescriptions received, was measured in three population-adjusted variables: number of opioid prescriptions, total doses of opioid prescriptions in morphine milligram equivalents, and related Medicaid spending, per quarter per 100 enrollees. Two difference-in-difference models were used to test the associations: eight states and DC that legalized recreational marijuana during the study period were first compared among themselves, then compared to six states with medical marijuana legalized before the study period. Schedule II and III opioids were analyzed separately., Results: In models comparing eight states and DC, legalization was not associated with Schedule II opioid outcomes; having recreational marijuana legalization effective in 2015 was associated with reductions in number of prescriptions, total doses, and spending of Schedule III opioids by 32% (95% CI: (-49%, -15%), p = 0.003), 30% ((-55%, -4.4%), p = 0.027), and 31% ((-59%, -3.6%), p = 0.031), respectively. In models comparing eight states and DC to six states with medical marijuana legalization, recreational marijuana legalization was not associated with any opioid outcome., Conclusions: No evidence suggested that recreational marijuana legalization increased prescription opioids received by Medicaid enrollees. There was some evidence in some states for reduced Schedule III opioids following the legalization., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: This study compared young adults with and without a medical marijuana (MM) recommendation from a provider ("MM card") on their developmental trajectories of frequent marijuana use and marijuana-related problems in young adulthood., Methods: The analytic sample consists of young adult past month marijuana users (N = 671) who were part of a larger, diverse, and predominantly California cohort. Analyses are based on data from seven surveys completed from ages 13-19., Results: At age 19, 28% of participants reported having an MM card to legally purchase marijuana from an MM dispensary. A multiple group latent growth model indicated that young adults who had an MM card showed steeper increases in frequent marijuana use (i.e., 20-30 days of use in the past month) from ages 13-19 compared to young adults who did not have an MM card. Logistic regression models that matched MM cardholders and non-MM cardholders on individual sociodemographic characteristics found that MM cardholders were more likely to report marijuana negative consequences, selling marijuana/hashish, and driving under the influence of marijuana in the past year. In addition, MM cardholders were more likely to have tried cutting down or quitting in the past 3-months., Conclusions: Among young adult marijuana users, those with an MM card had a higher risk profile for marijuana use and related problems compared to those without an MM card. Given expanding state legalization of MM, this issue warrants further attention., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background and Purpose: The purpose of this project was to impact pharmacy students' personal and professional development through simulation of a board of pharmacy disciplinary hearing regarding addiction., Educational Activity and Setting: The mock board hearing was conducted as part of the required curriculum. Faculty obtained materials from a prior board hearing. The actual respondent, lawyer, former executive director, and a board agent participated. Students served as board members and president, asked questions of the witnesses, and deliberated per board procedure. After the event, student learning and perceptions were assessed through knowledge-based, opinion-based questions, and open-ended questions., Findings: Of the 141 students who attended the event, 97% completed the assessment. The average score on the knowledge-based questions was 95%. Ratings of perceptions and reflections of the experience were used in tandem to understand the experience. In general, students indicated the experience was positive and impactful towards their education. Students indicated they felt that the experience allowed them to better understand addiction and empathize with someone called before the board. In fact, there were fundamental differences in perceptions regarding the "addicted person," going from a penalizing and stigmatized perspective to one of caring and compassion., Summary: Students were knowledgeable about the board and its regulatory process after the event. More than knowledge, students indicated fundamental changes in their views of addiction. Other institutions may consider implementing similar exercises to engender empathy and professionalism regarding drug addiction and regulatory compliance., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Marijuana use during adolescence is associated with neurocognitive deficits and poorer functioning across several domains. It is likely that more states will pass both medical and recreational marijuana legalization laws in the coming elections; therefore, we must begin to look more closely at the longitudinal effects of medical marijuana (MM) advertising on marijuana use among adolescents so that we can better understand effects that this advertising may have on their subsequent marijuana use and related outcomes., Methods: We followed two cohorts of 7th and 8th graders (mean age 13) recruited from school districts in Southern California from 2010 until 2017 (mean age 19) to examine effects of MM advertising on adolescents' marijuana use, cognitions, and consequences over seven years. Latent growth models examined trajectories of self-reported exposure to medical marijuana ads in the past three months and trajectories of use, cognitions, and consequences., Results: Higher average exposure to MM advertising was associated with higher average use, intentions to use, positive expectancies, and negative consequences. Similarly, higher rates of change in MM advertising exposure were associated with higher rates of change in use, intentions, expectancies, and consequences over seven years., Conclusions: Results suggest that exposure to MM advertising may not only play a significant role in shaping attitudes about marijuana, but may also contribute to increased marijuana use and related negative consequences throughout adolescence. This highlights the importance of considering regulations for marijuana advertising, similar to regulations in place for the promotion of tobacco and alcohol in the U.S., (Copyright © 2018. Published by Elsevier B.V.)

While cannabis has been widely used in the UK for over 50 years, it is only in recent decades that domestic cultivation has become established. Public concern, media reporting and policing policy has emphasised the role of profit motivated criminal organisations often working on a large scale and with coerced labour. However, increasingly, another population are growing for medical reasons, to help themselves and others treat or manage difficult, poorly understood, or incurable conditions. Our study sought to further understand the motives, techniques and interactions of cannabis cultivators through interviews with 48 growers and supplementary ethnographic work. As well as those motivated to grow for personal use, social and commercial supply purposes we identified a cohort growing to provide themselves and others with cannabis used for therapeutic purposes. This paper draws primarily on interviews with a sub-group of sixteen medically-motivated growers who were not only involved in treatment, but also embraced the label "activist". Rather than develop techniques of deception they were organising to effect a change in legislation. Rejecting the image of criminal perpetrators, they presented themselves as victims of unjust government policy, an indifferent medical establishment, and brutal and immoral criminal markets. Through cultivation, association, self-healing and apomedication, they have found voice and are shifting the debate over the status of growers and of cannabis itself. The ambiguity of their position as both producers and patients challenges the assumptions underlying legal distinctions between suppliers and users, with potentially profound implications for policy., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Several countries and many U.S. states have allowed, for cannabis to be used as therapy to treat chronic conditions or pain., This has increased the use of cannabis, particularly among older people.Because cannabis has been linked to adverse cardiac events in the medical literature, there may be unintended consequences on increased use among older people., Methods: We analyze cardiac-related mortality data from the U.S. National Vital Statistics System for 1990-2014. We use difference-in-difference fixed-effects models to assess whether there are increased rates of cardiac-related mortality following passage of medical cannabis programs. We also analyze whether states with more liberal rules on dispensing cannabis show higher mortality rates., Results: For men, there is a statistically significant 2.3% increase in the rate of cardiac death following passage. For women, there is a 1.3% increase that is also statistically significant. he effects increase or both men and women with age. The effects are also stronger in states with more a lax approach to cannabis dispensing., Conclusion: Policymakers should be aware of a potential unintended consequence of allowing broader use of cannabis, specifically for those more at risk of cardiovascular events., (Copyright © 2017. Published by Elsevier B.V.)

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.)

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.)

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.)

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.)

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.)

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: 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.)

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.)

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.)

Background: Legal medical marijuana has been commercially available on a widespread basis in Colorado since mid-2009; however, there is a dearth of information about the impact of marijuana commercialization on impaired driving. This study examined if the proportions of drivers in a fatal motor vehicle crash who were marijuana-positive and alcohol-impaired, respectively, have changed in Colorado before and after mid-2009 and then compared changes in Colorado with 34 non-medical marijuana states (NMMS)., Methods: Thirty-six 6-month intervals (1994-2011) from the Fatality Analysis Reporting System were used to examine temporal changes in the proportions of drivers in a fatal motor vehicle crash who were alcohol-impaired (≥0.08 g/dl) and marijuana-positive, respectively. The pre-commercial marijuana time period in Colorado was defined as 1994-June 2009 while July 2009-2011 represented the post-commercialization period., Results: In Colorado, since mid-2009 when medical marijuana became commercially available and prevalent, the trend became positive in the proportion of drivers in a fatal motor vehicle crash who were marijuana-positive (change in trend, 2.16 (0.45), p<0.0001); in contrast, no significant changes were seen in NMMS. For both Colorado and NMMS, no significant changes were seen in the proportion of drivers in a fatal motor vehicle crash who were alcohol-impaired., Conclusions: Prevention efforts and policy changes in Colorado are needed to address this concerning trend in marijuana-positive drivers. In addition, education on the risks of marijuana-positive driving needs to be implemented., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Hormonal and antimicrobial therapies are essential to regulate and maintain healthy reproduction in domestic animals. The appropriate and legal use of these compounds is ultimately the responsibility of the veterinarian and other users, with a primary mission to directly protect and promote the health of animals, and indirectly the health of people. The appropriate use of these products is defined by the Federal Food, Drug, and Cosmetic Act, 21 United States of America § 301 et seq and implementing regulations in the Code of Federal Regulations. In the past, use of a drug in an animal for an unapproved use violated this Act. However, passage of the Animal Medicinal Drug Use Clarification Act 1994 legalized the extra-label use of certain animal and human drugs in veterinary practice for treating diseases. This manuscript reviews currently approved hormonal and antimicrobial drugs for use in theriogenology. Considering the ever increasing knowledge in the area of veterinary reproduction, particularly in the treatment and control of reproduction using antimicrobials and hormones, it would be beneficial to widen the therapeutic options in these categories. The potential for widening the therapeutic options is also discussed in this review, by providing a non-exhaustive but essential list of potential new drugs for use in clinical animal reproduction (theriogenology)., (Copyright © 2011 Elsevier Inc. All rights reserved.)

This paper is a sociological examination of policies and practices in Health Canada's Marihuana Medical Access Division (MMAD) that presume the illicit intentions and inherent "guilt" of medical cannabis users, hampering safe access to a medicine to which many are legally entitled, and raising doubts about this federal programme's overall effectiveness and constitutional legitimacy. Beginning with a brief historical overview of Canada's federal medical cannabis programme, this paper examines the failure of the MMAD to meet the needs of many sick and suffering Canadians through Hunt's [Hunt, A. (1999). Governing morals: A social history of moral regulation. Cambridge, UK: Cambridge University Press] work on moral regulation and Wodak's [Wodak, A. (2007). Ethics and drug policy. Psychiatry, 6(2), 59-62] critique of "deontological" drug policy strategies. I then cite Tupper's [Tupper, K. W. (2007). The globalization of ayahuasca: Harm reduction or benefit maximization? International Journal of Drug Policy, doi:10.1016/j.drugpo.2006.11.001] argument that shifting to a generative metaphor that constructs certain entheogenic substances as potentially useful "tools" rather than regulating them through inherently moralistic prohibitionist policies would better serve public health, and incorporate Young's [Young, I. M. (1990). Justice and the politics of difference. Princeton, New Jersey: Princeton University Press] theories of domination and oppression to examine the rise of community-base medical cannabis dispensaries as "new social movements". First-hand accounts by medical cannabis patients, federally funded studies, and internal Health Canada communication and documents suggest that current federal policies and practices are blocking safe access to this herbal medicine. The community-based dispensary model of medical cannabis access is a patient-centered "new social movement" that mitigates the stigmatization and moral regulation of their member-clients by creating opportunities for engagement, empowerment and joint knowledge creation. In light of ongoing Charter challenges and patient criticism, the survival of this federal programme will depend on the government's ability to shift away from policies based on the oppression and moral regulation, and towards consequentialist policies that balance harm reduction and benefit maximization. The effectiveness of such an approach is exemplified by the success of the community-based dispensary model which is currently producing more peer-reviewed research and supplying medical cannabis to a far greater number of patients than Health Canada's Marihuana Medical Access Division.

In India, a million people with cancer and an unknown number of people with other incurable and disabling diseases, need opioids for pain relief. Only about 0.4% of the population in need have access to them. Major barriers to access to opioids are complicated regulations and problems related to attitude and knowledge regarding pain relief and opioids among professionals and the public. The Pain and Policy Studies Group at Madison Wisconsin has been collaborating with many Indian palliative care workers and government officials to improve availability of opioids to those who need them for pain relief. As a result of this collaborative effort, the Government of India asked all state governments to modify the narcotic regulations following a model given to them. To facilitate the process, the collaboration has conducted workshops in 13 states in association with local champions. Currently, 13 states in India and one union territory have simplified regulations, but opioid availability has improved only in a minority of these states. Establishment of simple standard operating procedures to implement the simplified regulations, advocacy, and improved education of professionals are essential for further improvement of the situation. The past decade has demonstrated that government policy can be changed if palliative care enthusiasts work in tandem with the government. The progress has been slow, but real and encouraging.

Access to the necessary medications for palliative care, especially opioids, is an essential part in the development of a national palliative care program. In November 2005, Romania's Parliament adopted new legislation concerning the medical use of opioids and psychotropic substances to replace the old and restrictive legislation of 1969. The new law and regulations are the result of a four-year project in which governmental authorities collaborated with health care professionals and international experts. The World Health Organization "Achieving Balance in National Opioids Control Policy--Guidelines for Assessment" was used to propose balanced legislation that would facilitate modern pain management and provide adequate control of these substances with the potential for abuse. A national education program to facilitate the implementation of the new legislation has been organized. The training started in November 2006 and will continue throughout 2007. It is anticipated that at least 3,000 doctors and 500 pharmacists will attend these courses.

The 1970 Controlled Substances Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy. While the legislation provided additional resources for law enforcement and a systematic means for regulating the use of most psychoactive drugs, it also did away with mandatory minimum sentences and provided more support for treatment and research. Over the next three decades, and in response to public alarm about drug abuse, the US Congress continuously amended the law to produce a more punitive system of drug control. The amendments, which gave the Drug Enforcement Administration greater control over scheduling and maintenance and which substantially increased penalties for illicit trafficking, transformed the law into the legal foundation of America's "drug war," as the stricter criminal approach came to be known. By the 1980s, the flexibility and innovative spirit of the original Controlled Substances Act (and that of Nixon-era drug strategy generally) had largely disappeared from American drug policy.

Objectives: To examine the problem of counterfeit drugs and its effects around the world, to consider the likely directions the problem will take, and to propose options for controlling or mitigating the problem., Data Sources: Recently published clinical literature identified through review of articles abstracted at MEDLINE. Search terms were counterfeiting, counterfeit drugs, substandard drugs, fake drugs, world counterfeiting, and counterfeit pharmaceuticals. Further information was abstracted from an array of informational sources, including magazines such as Business Week, newspapers such as the International Herald Tribune, National Public Radio news reports, pharmaceutical company press releases, and information from the World Health Organization., Study Selection: Multiple reviewers were used to retrieve relevant and current data., Data Extraction: Relevant data were extracted independently by multiple reviewers., Data Synthesis: Traditionally, the problem of counterfeit pharmaceuticals has been limited to developing nations in Asia and Africa. Now, drug counterfeiting is rapidly becoming a worldwide concern, and counterfeit drugs are reaching the U.S. market. This article defines the problem of counterfeit drugs in its many forms and discusses the extent of the problem, with particular attention to the respective rates of counterfeiting across the globe and the origins of counterfeit drugs., Conclusion: Technologic advances have worsened the counterfeit drug problem. Because drug counterfeiting is a worldwide concern, worldwide action is needed to combat the problem.

Objectives: To determine the current status and features of states' laws on pharmacist collaborative practice, barriers and facilitators to the passage of such laws, pharmacists' satisfaction with present regulations, and pharmacy leaders' perceptions regarding the impact of collaborative practice on pharmacist-physician relationships and on patients' perceptions of pharmacists., Design: Cross-sectional survey., Setting: United States., Participants: Executives of state pharmacy organizations and officers of state pharmacy boards., Main Outcome Measures: Presence and features of collaborative practice law, perceptions regarding effects of collaborative practice on pharmacist-physician relationships, and patients' perceptions of pharmacists., Results: Of 48 states responding to the survey, 32 (66%) had existing pharmacist collaborative practice laws; 23 states (48%) allowed pharmacists to initiate and modify therapy, whereas 9 (19%) allowed only modification of therapy. Dependent collaborative practice was permitted in 31 states (65%). Most state laws applied to hospital, long-term care, and community settings. Five of the 32 states with pharmacist collaborative practice laws had made changes to broaden the provisions since the original laws were enacted. Nine states out of 16 that did not have collaborative practice laws indicated plans to pursue passage of such laws. Overall, collaborative practice was viewed as having a positive effect on pharmacist-physician relationships and a slightly positive effect on patients' perceptions of pharmacists. Respondents believed that pharmacists currently involved in collaborative practice were mostly satisfied with present laws, although some respondents mentioned the need for further revisions to the laws., Conclusion: Significant progress has been made in passing and implementing laws on pharmacist collaborative practice. As positive experience is gained, good opportunities exist to broaden current laws and increase pharmacists' involvement in collaborative practice.

Korea has a great diversity in resources of medicinal plants. The traditional herbal medicines and their preparations have been widely used in Korea as well as in China and Japan for thousands of years. One of the characteristics of Korean herbal medicine preparations is that all the herbal medicines are incorporated into an extractor at the same time and extracted with boiling water during the decoction process. In this process, a variety of interactions between the active components of several herbal medicines may occur. This is the main reason why quality control of oriental herbal drug is more difficult than that of western herbal drug. In this paper, we would like to present an overview of the characteristics of regulation and quality control of herbal medicines in Korea.

Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity.

An overview of regulatory classification systems on carcinogens in the Organization for Economic Cooperation and Development (OECD) countries is presented based on a questionnaire study. Most OECD countries have implemented legislation including classification systems and lists of carcinogens. Basically, there are two types of classifications systems. The major difference between the two is that in one system carcinogens are classified according to the weight of evidence for carcinogenic effects in humans, whereas in the other carcinogens are allocated to various groups according to potency. Even if the classification systems may differ, the substances classified as carcinogens are to a large extent the same. Classification of carcinogens will in many countries require hazard labeling. This labeling, i.e., the limit for labeling of substances and preparations, and risk phrases show considerable similarities, but differ in certain aspects. Several countries have restrictions on sale and/or use of carcinogens. There is a trend toward introducing more mechanistic considerations in the classification of carcinogens.

CHEMEST is an interactive on-line system for estimating chemical properties important in environmental fate assessment. In 1988 we described an extensive validation study of CHEMEST. That study showed that for existing chemicals, most properties could be estimated with accuracy sufficient for screening-level assessment. Reported here are the results of a study of system performance with "new" chemicals, for which Premanufacture Notices (PMNs) must be submitted under the Toxic Substances Control Act. Measured values of key properties were retrieved for more than 300 PMN chemicals having discrete structures, which represented the majority of notices with submitted data that were received by the U.S. Environmental Protection Agency during the period 1979-1990. The measured values were compared to estimates from AUTOCHEM, an automated version of CHEMEST. Errors were generally greater than those for existing chemicals, as expected. Water solubility and the octanol/water partition coefficient (Kow) were estimated with acceptable accuracy, but the results for melting point and boiling point indicate that additional effort is needed to improve the estimation methods.

An analysis of several agencies' risk assessments reveals that the present conservative approach through several stages of estimates of amounts of regulated substances, the exposure levels, and cancer risks often tends to distort the actual final regulation. Changes in this process are desirable and possible and would reduce overestimation of cancer risk assessments. These possible changes are discussed.

In reaching a regulatory decision on the use of pesticides with carcinogenic potential, it is of great importance to investigate the extent of dermal exposure and absorption of a pesticide to users and field workers. By applying this information, along with the appropriate carcinogenicity categorization of a pesticide, a reasonably sound regulatory decision can be derived. Seven pesticides were selected, based on adequacy of tumor data, and were taken through the tumor evaluation system as reported in Part I 1984, Regul. Toxicol. Pharmacol. 4, 355-360). A step-by-step analysis on how a regulatory decision is reached on each pesticide by the EPA and CDFA was discussed.