Disparities in Addiction Treatment: Learning from the Past to Forge an Equitable Future.

The Half-Century long problem of addiction treatment disparities. We cannot imagine addressing disparities in addiction treatment without first acknowledging and deconstructing the etiology of this inequity. This article examines the history of addiction treatment disparities beginning with early twentieth-century drug policies. We begin by discussing structural racism, its contribution to treatment disparities, using opioid use disorder as a case study to highlight the importance of a structural competency framework in obtaining care. We conclude by discussing diversity in the workforce as an additional tool to minimizing disparities. Addiction treatment should be aimed at addressing care delivery in the context of the social, economic, and political determinants of health, which require appreciation of their historical origins to move toward equitable treatment.

Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors.

INTRODUCTION: Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature. METHODS: We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration "Drug Alerts and Statements" repository. We categorized reports into errors of "contamination," suprapotency," and "subpotency." Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available. RESULTS: We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. DISCUSSION: Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors. CONCLUSION: In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.

Nurse prescribing in New Zealand-the difference in levels of prescribing explained.

This article discusses the three types of nurse prescriber currently registered in New Zealand (nurse practitioners, registered nurse prescribers (RNP) in primary health and specialty teams and registered nurse prescribers (RNPCH) in community health). It also provides an overview of the evolution of each group, as well as a summary of the current legislation, prescribing restrictions and models of supervision required for each type of prescriber.

Clinical trials and the origins of pharmaceutical fraud: Parke, Davis & Company, virtue epistemology, and the history of the fundamental antagonism.

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. This new framework fundamentally altered the set of epistemic virtues-a phrase we draw from the philosophical field of virtue epistemology-considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place.

[40 years of medicines policy in the Netherlands: from financial constraints to medicines shortages?] / 40 jaar geneesmiddelenbeleid.

On a near daily basis, medicines make the news. Abstract topics such as international pricing policy or medicines patents, and concrete topics such as medicines shortages are regularly reported on. In this article, we summarise a 40-year-history of medicines policy in the Netherlands. Furthermore, we briefly touch upon future directions in this area.

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

Importance: US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks. Objective: To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018. Evidence: Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018). Findings: From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period. Conclusions and Relevance: Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.

A History of United States Cannabis Law.

Perhaps the best way to understand early-Twenty-First Century state and federal cannabis law in the United States is to examine the relevant history. Justice Oliver Wendell Holmes, Jr.'s statement is apropos: "[A] page of history is worth a volume of logic." This article begins by discussing the early history of cannabis and its uses. Next, the article examines the first state and federal marijuana laws. After a brief comparison of alcohol prohibition to cannabis prohibition, this article addresses cannabis laws from the 1920s to the early 1950s. Then, the article takes up the reorganization of the federal drug regulatory bureaucracy since its inception. Addressing the current era of cannabis laws and regulations, this article recounts how marijuana became a Schedule I drug. The discussion then turns to changing social attitudes towards cannabis as reflected in presidential politics and popular culture. Starting with the late-1990s, this article describes the development of state and federal cannabis laws and policies up to the present day.

The evolution of addiction treatment and harm reduction programs in Iran: a chaotic response or a synergistic diversity?

BACKGROUNDS AND AIMS: Iran has 2.1 and 1.8% of its 15-64-year-old population living with illicit substance and opioid use disorders, respectively. To address these problems, Iran has been developing a large and multi-modality addiction treatment system, spanning the time before and after the Islamic Revolution. METHODS: Iran's current drug treatment scene is a combination of services, ranging from medical/harm reduction services to punitive/criminal justice programs. Included in this array of services are drop-in centers providing low-threshold harm reduction services, such as distribution of sterile needles and syringes; opioid maintenance treatment clinics providing methadone, buprenorphine and opium tincture; and abstinence-based residential centers. We will review the evolution of this system in four phases. RESULTS: In 1980, Iran's revolutionary government shut down all voluntary treatment programs and replaced them with residential correctional programs. The first shift in the addiction treatment policies came 15 years later after facing the negative consequences. Addiction is viewed as a disease, and new voluntary treatment centers offering non-agonist medications and psychosocial services were established. With an increased number of people who inject drugs and HIV/AIDS epidemics, in the second shift an extensive move towards harm reduction strategies and opioid-maintenance programs has been implemented to reduce HIV-related high-risk behavior. The emergence of a methamphetamine use crisis creating an increased number of socially marginalized addicted people resulted in public and political demands for stricter policies and ended in the third shift starting in 2010, with extended compulsory court-based residential programs. Currently, there is a new shift towards reducing the severity of criminal penalties for drug use/sales and promoting proposals for opium legalization. CONCLUSION: Iran's evolutionary experience in developing a large addiction treatment program in a complex combination of medical/harm reduction and punitive/criminal justice addiction treatment can be examined in its political, clinical and pragmatic context.

The Use of Nonnutritive Sweeteners in Children.

The prevalence of nonnutritive sweeteners (NNSs) in the food supply has increased over time. Not only are more children and adolescents consuming NNSs, but they are also consuming a larger quantity of NNSs in the absence of strong scientific evidence to refute or support the safety of these agents. This policy statement from the American Academy of Pediatrics is intended to provide the pediatric provider with a review of (1) previous steps taken for approved use of NNSs, (2) existing data regarding the safety of NNS use in the general pediatric population, (3) what is known regarding the potential benefits and/or adverse effects of NNS use in children and adolescents, (4) identified gaps in existing knowledge and potential areas of future research, and (5) suggested talking points that pediatricians may use when discussing NNS use with families.

[A brief history of marijuana in the western world]. / Breve historia sobre la marihuana en Occidente.

Marijuana is a substance with a long and controversial history. At different times in its history, which goes back over 5,000 years, this plant has been used for different purposes, ranging from recreational and leisure to its use in the treatment of several diseases or to offer relief in processes that entail a certain type of malaise, and including its consideration as a means of relaxation and meditation. Although it was supposed that the roots of marijuana lay in Central America, it is now known that this is but an urban legend with little credibility and that its origins can be found recorded in Chinese medical references dating back to the year 2737 BC. Although this plant was not originally from Central America, it has aroused interest around the world, and above all in Mexico. It is in this country where the use of cannabis has gone from applications in textiles and medicine to its free sale, the bans on its use due to political and social pressures, its tolerance and, recently, its decriminalisation for recreational and medicinal use. Unfortunately there are few references on the history of this plant in Mexico, and thus we have considered it interesting to present some data about the generalities of marijuana, a brief history in the world, the development of decriminalisation in North America, its medicinal uses and its course through Mexico to the present day.

TITLE: Breve historia sobre la marihuana en Occidente.La marihuana es una sustancia con una extensa y controvertida historia. A lo largo del tiempo, esta planta, y desde hace mas de 5.000 años, ha sido utilizada para diferentes fines, que van desde el uso ludico y recreativo, pasando por un medio de relajacion y meditacion, hasta su uso en el tratamiento de varias enfermedades o el alivio de procesos vinculados a cierto tipo de malestares. Aunque se supuso que la marihuana tenia su origen en Mesoamerica, ahora se sabe que es solo una leyenda urbana de poca credibilidad y que sus origenes los podemos registrar en referencias medicas chinas datadas alrededor del año 2737 a. de C. Si bien esta planta no tiene un origen mesoamericano, si ha generado interes en el mundo, y sobre todo en Mexico. Es en este pais donde el uso del cannabis ha ido desde intereses textiles y medicinales hasta el consumo ludico, pasando por su venta libre, la prohibicion por presiones politicas y sociales, su tolerancia y, recientemente, su despenalizacion para uso ludico y medicinal. Desgraciadamente existen pocas referencias de la historia de esta planta en Mexico, por lo que ha sido de nuestro interes presentar algunos datos sobre las generalidades de la marihuana, una breve historia en el mundo, el desarrollo de la despenalizacion en Norteamerica, sus usos medicinales y su paso por Mexico hasta nuestros dias.