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Canada is in the midst of a public health emergency in drug poisoning (overdose) deaths. In this context parents, and especially mothers, of those who have died from drug poisoning have mobilised to advocate for urgent responses and drug policy reforms. To document this emerging women‐led advocacy, we initiated a community‐academic research partnership with three parent groups representing families in Canada bereaved by drug‐related deaths. In this commentary, we describe four guiding principles we developed during the course of this project, to ensure an ethical and equitable approach to conducting our research partnership. In particular, we emphasise how we navigated parents' roles as vocal advocates for addressing drug stigma and expanding harm reduction while actively working to avoid eclipsing the need to centre the perspectives of people who use drugs. Meaningful and collaborative partnerships between academics and community groups may facilitate greater understandings of how families and communities can be allied in drug policy reforms urgently needed to prevent drug poisoning deaths. [ABSTRACT FROM AUTHOR]

This article compiles and explores most relevant government measures to combat the consumption and trafficking of illicit fentanyl to the United States, in order to reduce the number of opioid overdose deaths and provide medical care and treatment to users with drug addiction problems during administrations of Barack Obama, Donald Trump and Joe Biden. [ABSTRACT FROM AUTHOR]

Common accounts of police and prosecutorial nonenforcement discretion tend to valorize individual declination choices as demonstrations of mercy and resource constraint. Simultaneously, these accounts critique blanket nonenforcement policies as being outside the bounds of executive authority. Both accounts fail to consider the origins and implications of nonenforcement decisions made by police officers and prosecutors in individual cases that, when taken together, amount to significant underenforcement of an otherwise valid law. This Article fills the gap between these differing perspectives by empirically examining the hidden and habitual underenforcement of technically valid drug-free-zone (DFZ) laws in one Southern county. Data matching the locations of felony drug arrests with residential, school, and commercial drug-free zones shows chronic underenforcement of DFZ laws during the first decade of the twenty-first century. Interviews with police and prosecutors in this county expose their reasons for nonenforcement. These reasons predominately include ignorance, benign neglect, institutional mistrust of other system actors' motives and competence, and pessimism about the ability of the laws to effect deterrence. Finally, interviews with active drug offenders within the county reveal their limited understanding of the nature of DFZ laws, the terms of liability, and the consequences of being charged with a violation. While chronic underenforcement of DFZ laws is surely preferable to widespread application of an overly punitive drug policy, these laws can stigmatize the underclass even if not meaningfully enforced. Moreover, if enforcement were to be reinvigorated, the zone locations would likely create considerable disparities in criminal legal processing. Only structural legal change can mitigate these concerns. [ABSTRACT FROM AUTHOR]

This study reviewed and compared fentanyl's potential impact on public health in India and China, two nations linked to its production and distribution. A comparison of China and India's governance structures, historical experiences with opioids, ideologies, and drug policies on the potential for domestic fentanyl use showed that fentanyl will likely become a more significant threat to Indian society. India's relatively weak governance, historical acceptance of opium, and permissive drug culture facilitate an environment conducive to the production and use of fentanyl. In contrast, China's strong central government, the Opium Wars, the historical effects of opium addiction, and adherence to conservative Confucian ethics will likely contribute to opposition to fentanyl use. Understanding these disparities is paramount for policymakers and public health officials in both nations to develop and customise strategies to confront the challenges posed by fentanyl. [ABSTRACT FROM AUTHOR]

This article analyzes alternative development coalitions, their contradictions and complexities, and how they promoted a steeply unequal agrarian change through illicit crop substitution. We zoom into two paramilitary-controlled territories in Colombia. We show that those programs counted with significant support from, and were actually driven by, long coalitions that included regional and national politicians, sectors of the rural rich, paramilitary leaders, Colombian government and United States agencies. [ABSTRACT FROM AUTHOR]

Introduction and Objectives: Treatment of chronic hepatitis B (CHB) with nucelos(t)ide analogues (NA) can improve outcomes, but NA treatment is expensive for insurance plans. Materials and Methods: The Centers for Medicare & Medicaid Services database was assessed from 2012 to 2021 to assess the use of NA for CHB in patients on Medicaid. Data extracted included the number of claims, units, and costs of each agent stratified by originator and generic. Results: Over the study period, 1.9 billion USD was spent on NA, with spending peaking in 2016 at $289 million US, which has subsequently decreased. Lower expenditures since 2016 have been associated with increased use of generics. The use of generic tenofovir or entecavir led to savings of $669 million US over the study period. Conclusions: Increased generic use has significantly reduced expenditures for NA drugs; policy shifts towards generic drug use may help with sustainability. [ABSTRACT FROM AUTHOR]

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

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

Background: In 2018, the National Centralized Drug Procurement (NCDP) policy has been implemented in 11 provinces, and promoted across the country in 2019. The main feature of the policy is "volume for price", therefore, it is necessary to measure the price relationship, not only to reduce the price of drugs, reduce the burden of patients' medical costs, but also facilitate pharmaceutical companies to access enough innovation incentives. The aim of this study was to assess the vacated space effect of the drug centralized procurement by national organizations in exchange of price for quantity. Methods: A difference-in-differences (DID) model was employed to analyze the effect of the 4 + 7 pilot drugs centralized purchasing policy on drug sales volume and selected versus clinically substitutable unselected varieties, using observational data from 2018 to 2019. We compared drug procurement data between secondary and above public hospitals in pilot and non-pilot cities throughout China. Results: The study showed that the average treatment effect (ATE) of sales in the in-hospital market for the selected supply varieties in centralized purchasing is -0.42, and with a sales volume of 0.49. This indicates a volume-price vacated space of 1.16 ~ 1.17 DDD (defined daily dose)/Yuan, implying that for every 1 defined daily dose (DDD) increase in reported volume, the standardized price decreased by 1.16–1.17 Yuan. The ATE of in-hospital market sales for drugs not selected in centralized procurement shows a decrease of 0.13. This finding highlights the presence of the price linkage effect. The ATE of sales volume is 0.57, indicating a volume-price space of 4.38 ~ 4.39 DDD/Yuan for unselected drugs, approximately 3.75 higher relative to that of the selected ones. Conclusions: The ratio of the volume-price space of clinically substitutable unselected and selected drugs may serve as direct evidence for evaluating the shift from centralized purchasing of drug varieties to clinically substitutable other ones. To strengthen the volume-based negotiation approach and maximize the effectiveness of centralized purchasing policies, we recommend the strategic implementation of a three-tiered centralized purchasing system, the expansion of drug coverage, and the introduction of relevant constraints and incentives. [ABSTRACT FROM AUTHOR]

Rare diseases have various types, low incidence rates, complex conditions, and are often difficult to diagnose. Due to China's large population, there is a significant number of rare disease patients, but there is a shortage of orphan drugs. Consequently, these patients often find themselves in a situation where necessary medications are either unavailable or unaffordable. To address this urgent clinical need, China has implemented a series of orphan drug policies aimed at improving drug accessibility and affordability. In terms of drug accessibility, companies are encouraged to expedite drug development through the implementation of tax incentives, guidance for clinical research on rare diseases, and the provision of data protection periods of 6 years, along with market exclusivity periods limited to a maximum of 7 years. Moreover, exemptions for clinical trials, acceptance of overseas clinical trial data, and the creation of a list prioritizing clinically urgent new drugs from overseas have been introduced to expedite the drug registration application, review, inspection, and approval processes. In terms of drug affordability, the import value-added tax on rare disease drugs has been reduced by 3%, and various provinces and cities have established a representative rare disease protection model, which includes special funds, medical assistance programs, and serious disease insurance. The national medical insurance catalog has been adjusted to reduce the financial burden on rare disease patients, resulting in an increase in the number of orphan drugs covered by the catalog to 95 as of March 2024. By comparing orphan drug policies in the United States, the European Union, Japan, Australia, and other countries (or regions), we will provide relevant suggestions to further improve orphan drug policies in China, thus bringing more treatment options and hope to patients with rare diseases. [ABSTRACT FROM AUTHOR]

Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior. This Special Communication examines the Federal Trade Commission's policy and legal actions related to alleged misconduct, consolidation, and anticompetitive behavior in the pharmaceutical market between 2000 and 2022. [ABSTRACT FROM AUTHOR]

Background: Policies to address substance use differ greatly between settings, where goals may range from zero-tolerance to harm reduction. Different approaches impact formats of care, policing, and even interpersonal interactions, and may play a role in the labelling and stigmatization of people who use drugs (PWUD). Where Sweden has a more restrictive policy, aiming to have a society free from drugs, Denmark has embraced harm reduction principles. The aim of this study was to explore PWUDs' experiences of interpersonal interactions, policing, and service formats in the two countries. Methods: The data consists of 17 qualitative semi-structured interviews with Swedish PWUD who have been in both Sweden and Denmark. Recruitment took place at harm reduction sites in both countries, and through snowball sampling. Results: Participants reflected on how they were perceived by those in public spaces, and received by care systems and personnel. In public settings in Sweden, participants felt they were ignored, rendered invisible, and lost their humanity. In Denmark, they were perceived and acknowledged, valued as people. This was simultaneously linked to being embodied by the availability of differing service offerings and policing practices, which solidified their "right to be out" in public. Reflecting on their reception in the treatment system, strict formatting in Sweden caused participants to feel that an identity was projected upon them, limiting their opportunities or growth of new facets of identity. Care relations in Denmark fostered more opportunity for autonomy and trust. Conclusion: A zero-tolerance policy and associated public discourses could solidify and universalize stigmatizing categorizations as a central feature of PWUD identity and reception from those around them, exacerbating social exclusion. Conversely, harm reduction-centered policies fostered positive interactions between individuals with care providers, public, and police, which may promote inclusion, empowerment, and wellbeing. [ABSTRACT FROM AUTHOR]

Influenced by a harm reduction philosophy, the then Victorian Labor Government announced the establishment of the state's first medically supervised injecting room (MSIR) in North Richmond in late 2017. But, public and political opinion remains sharply divided as to the merits of the MSIR. One influence on policy development appears to be media commentary on the MSIR and the wider illicit drugs policy debate. This paper compares the official editorials of the two daily Melbourne newspapers, the Herald Sun and The Age regarding the MSIR, from November 2017 until November 2022. Based on 33 articles (Herald Sun, N = 28; The Age, N = 5), our findings identify philosophical differences between the two newspapers as reflected in their sources of information, language and highlighted issues. The Age was mostly supportive of both the introduction of the North Richmond MSIR and proposals for a second site. The Herald Sun's position was more ambiguous, ranging from qualified support for the North Richmond MSIR to strong opposition to further sites. [ABSTRACT FROM AUTHOR]

Rare diseases have become an increasingly important public health priority due to their collective prevalence and often life-threatening nature. Incentive programs, such as the Orphan Drug Act have been introduced to increase the development of rare disease therapeutics. While the approval of these therapeutics requires supportive data from stringent pre-market studies, these data lack the ability to describe the causes of treatment response heterogeneity, leading to medications often being more harmful or less effective than predicted. If a Goal Line were to be used to describe the multifactorial continuum of phenotypic variations occurring in response to a medication, the 'Goal Posts', or the two defining points of this continuum, would be (1) Super-Response, or an extraordinary therapeutic effect; and (2) Serious Harm. Investigation of the pharmacogenomics behind these two extreme phenotypes can potentially lead to the development of new therapeutics, help inform rational use criteria in drug policy, and improve the understanding of underlying disease pathophysiology. In the context of rare diseases where cohort sizes are smaller than ideal, 'small data' and 'big data' approaches to data collection and analysis should be combined to produce the most robust results. This paper presents the importance of studying drug response in parallel to other research initiatives in rare diseases, as well as the need for international collaboration in the area of rare disease pharmacogenomics. [ABSTRACT FROM AUTHOR]

This article provides a review of four books that offer valuable perspectives on the history and current issues surrounding drug use in the United States. "Whiteout" explores the influence of race and capitalism on the opioid crisis, while "The Prescription-to-Prison Pipeline" examines the impact of medicalization and criminalization of pain on mass incarceration. "Quick Fixes" analyzes the cultural and historical significance of psychoactive substances, and "The Long War on Drugs" delves into the history and concept of prohibition. These interdisciplinary books contribute to our understanding of the enduring significance of drugs in America, but could benefit from further exploration of the links between prohibition, labor relations, racialization, and disability studies. [Extracted from the article]

Alcohol use is a major determinant of health at both an individual and societal level. In New Zealand alcohol is legal and highly commercialized. Its harms are pervasive and are inadequately managed by current alcohol policy. However, contemporary methods for policy reform have also proven ineffective, and so effective alcohol regulation has been repeatedly thwarted. This essay first outlines the current state of regulatory failure and establishes the need for reform, before proposing citizens' assemblies as a solution to this public health conundrum. These are novel democratic institutions designed to secure an informed and representative public voice as the central determinant of policy. This essay contends that an appropriately designed citizens' assembly is likely to lead to alcohol policy which is more informed, evidence-based, and democratically accountable than current methods. Such an assembly would also be consistent with the Treaty of Waitangi principles and may assist in reducing alcohol-related inequities for Māori. Finally, in discussing such an assembly, this essay presents an internationally applicable model which could be employed for a range of other drug policy issues. [ABSTRACT FROM AUTHOR]

Previous research suggests that American drug sentiment is becoming more liberal. However, the absence of a reliable and valid over time measure limits our understanding of changes in drug attitudes. This project utilizes the dyad ratios algorithm and 298 administrations of 66 unique survey indicators to develop a measure of public mood toward drugs from 1969 to 2021. I find that drug mood has trended more liberal since the late 2000s. I then test for the predictors and consequences of drug mood empirically using ARMAX modeling. Results suggest that the violent crime rate, presidential rhetoric on drugs, and college attendance are not significant predictors of drug mood, but punitiveness is significant and negative. Moreover, only drug mood emerges as a significant and negative predictor of punitiveness. Granger causality tests indicate that drug mood Granger causes changes in punitiveness. These results elucidate the socio-political dynamics regarding public opinion toward drug policy. [ABSTRACT FROM AUTHOR]

Copyright of Nordic Studies on Alcohol & Drugs / Nordisk Alkohol- & Narkotikatidskrift is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

According to international research, an increase in the patient share of pharmaceutical expenditure results in a decrease in medicines utilization. In 2010, the Portuguese government reduced the reimbursement rate for certain therapeutic classes. The aim of this study was to evaluate the impact of raising cost to the patient on the utilization of medicines. Between January 1996 and December 2015, medicines utilization and cost to the patient per DDD of antihypertensive, antidyslipidemic, antidiabetic, antiulcer and antidepressant medicines were compared. A segmented linear regression of two time series – before and after the change in reimbursement percentage – was used. During the two time series, there was an increase in the utilization of antidepressants and antiulcer medicines. The consumption growth decelerated following the reduction in reimbursement rate. Cost to the patient decreased for both classes across the two time series, although the trend accelerated during the second. These findings suggest that a decrease in the reimbursement rate had little impact on the utilization of medicines. It is reasonable to assume that the reduction in percentage covered by the Portuguese National Health System was gradually compensated by the decrease in the absolute amount that patients paid for medicines.. [ABSTRACT FROM AUTHOR]

Drug distribution is considered one of the most serious crimes in general and the most serious drug offense in particular. Drug distribution may cover behavior of very different levels of seriousness, ranging from the social supply of small quantities of illicit drugs in friend circles to international drug trafficking organized by powerful global crime syndicates. The article explores the criminological contexts of less serious drug distribution and penal frameworks of the relevant countries in the Baltic region. The article argues for a more nuanced penal approach to such offenses in the Lithuanian penal law. [ABSTRACT FROM AUTHOR]

Abstract Background Since the twenty-first century, the prevalence of diabetes has risen globally year by year. In Gansu Province, an economically underdeveloped province in northwest China, the cost of drugs for diabetes patients accounted for one-third of their total drug costs. To fundamentally reduce national drug expenditures and the burden of medication on the population, the relevant departments of government have continued to reform and improve drug policies. This study aimed to analyse long-term trends in antidiabetic drug use and expenditure in Gansu Province from 2012 to 2021 and to explore the role of pharmaceutical policy. Methods Data were obtained from the provincial centralised bidding and purchasing (CBP) platform. Drug use was quantified using the anatomical therapeutic chemistry/defined daily dose (ATC/DDD) method and standardised by DDD per 1000 inhabitants per day (DID), and drug expenditure was expressed in terms of the total amount and defined daily cost (DDC). Linear regression was used to analyse the trends and magnitude of drug use and expenditure. Results The overall trend in the use and expenditure of antidiabetic drugs was on the rise, with the use increasing from 1.04 in 2012 to 16.02 DID in 2021 and the expenditure increasing from 48.36 in 2012 to 496.42 million yuan in 2021 (from 7.66 to 76.95 million USD). Some new and expensive drugs changed in the use pattern, and their use and expenditure shares (as the percentage of all antidiabetic drugs) increased from 0 to 11.17% and 11.37%, but insulins and analogues and biguanides remained the most used drug class. The DDC of oral drugs all showed a decreasing trend, but essential medicines (EMs) and medical insurance drugs DDC gradually decreased with increasing use. The price reduction of the bid-winning drugs was over 40%, and the top three drugs were glimepiride 2mg/30, acarbose 50mg/30 and acarbose 100mg/30. Conclusions The implementation of pharmaceutical policies has significantly increased drug use and expenditure while reducing drug prices, and the introduction of novel drugs and updated treatment guidelines has led to changes in use patterns.

Background: Methylenedioxymethamphetamine (MDMA) is a popular drug worldwide and use is prevalent in Aotearoa New Zealand. Although associated with some significant harms, including fatalities, MDMA is ultimately less harmful than other commonly consumed drugs. We aimed to expand the understanding of MDMA harm and harm reduction strategies from a consumer perspective so that national harm reduction efforts can be better informed. Methods: We conducted 14 semi-structured focus group discussions including 60 people (aged 18–67, median = 21) who use MDMA in the Southern region of Aotearoa New Zealand to explore their thoughts and experiences regarding MDMA associated harm and harm reduction. Reflexive thematic analysis was conducted from a critical realist perspective. Results: Five themes were generated; (1) Mindset and setting matters; (2) Looking after your body and mind, not overdoing it; (3) Other substances increase risk and harm; (4) Trusted friends and peers are protective; and (5) Valid information is key for healthy self-determination; and one subtheme 5.1) Drug checking is essential harm reduction. Conclusions: We discuss the implications for MDMA consumers and aim to inform national drug policy and the harm reduction practices of consumers and organisations, for the ultimate purpose of reducing MDMA-related harm in Aotearoa New Zealand. [ABSTRACT FROM AUTHOR]

This article introduces an analytic of discursive and material failure, developing a spatial grammar for analysing both the discursive framing of policies as failed and the actually existing processes and effects of failed policy. Using the case of harm reduction drug policy in Budapest, I demonstrate how a successful policy was made to fail at the local and national scales, and how that failure in turn spurred the mobility of harm reduction's implementation across scales and into the European Union's Drugs Strategy. I show how focusing on policy failure exposes the politics of making and mobilizing urban policy, and how an analysis of failure can uncover unforeseen effects of the local politics of policy mobility. Analysing failure as both discursive and material allows scholars to break down policymaking processes into the political and practical elements assembled in policy mobilization. Discursive policy failures take into consideration the framing and accounting of actions, events and processes, while analysis of material failure begins with seemingly fewer political questions because of its focus on the technical. I argue that it is in understanding the relationship between material and discursive failure that the politics of urban policy mobility becomes a central question. [ABSTRACT FROM AUTHOR]

Background & objectives Medication-related harm is known to be the cause for about 1/10th of hospitalizations. Some estimates from India show that about 90 per cent of medicines consumed are inessential or irrational and contribute towards high out-of-pocket expenditure on health. In this context, the Indian Council of Medical Research in 2022 constituted a National Task Force (NTF) to explore possible solutions that could improve safe and rational use of medicines (SRUMs). The objective of this study was to identify research ideas in the field of SRUM through a survey of relevant stakeholders, and further to prioritize the research ideas using a pre-identified set of criteria. Methods The responses from the identified stakeholders were assessed using the Child Health and Nutrition Research Initiative method, which is an established research priority-setting methodology. First, the NTF asked for two to six research ideas from relevant Indian and global stakeholders on solutions to improve SRUM. The ideas were checked for duplicates, re-phrased where necessary and classified into various sub-themes. Subsequently, the research ideas were scored by Indian experts with relevant technical expertise using a pre-defined set of five criteria: innovativeness, effectiveness, translational value, answerability and applicability. Each research idea received from a stakeholder was assigned a score under each of the five criteria. The overall research priority score was calculated as a mean of all five criteria-specific scores and converted into a percentage. Results The final output of the prioritization process was a list of research ideas or questions, ranked by their scores. Total 209 unique ideas were received from 190 respondents, which were scored by 27 experts. The top three research topics on medication safety focused on cost-effective strategies for improving antimicrobial stewardship, safe use of poly-pharmacy in geriatric patients and drug take-back policy interventions. Regarding the rational use of medicine, the top three topics included testing mobile application-based antimicrobial stewardship interventions, development of diagnostics for antimicrobial resistance, and behavioural interventions. Interpretation & conclusions Several priority ideas found in this study also align with those of global priority, e.g., safe disposal practices and enhanced pharmacovigilance, rational use of medicines. Patient engagement, which underlines many of the top scoring ideas found in this study, is also inclined with the top research priorities reported by the WHO priority exercise on research into the safe use of medicines. However, to the best of our knowledge, this is the first such work from a low- and middle- income country on medication safety and rational use of medicines. The findings of this research priority-setting exercise can help to guide research for the development of policy-relevant and novel interventions to improve SRUM in India. [ABSTRACT FROM AUTHOR]

Background: Limited empirical research exists on sustainable supply chain management in underdeveloped nations. This study focuses on pharmaceutical companies in southern Ghana, aiming to address the lack of practical information on environmentally friendly practices in meeting global pharmaceutical demand. Aim: This study examines the degree and form of stakeholder engagement in Ghana's Pharmaceutical Policy for Supply Chain Sustainability. Setting: The study focused on top executives in Ghana s pharmaceutical industry and government institutions overseeing pharmaceutical regulations. Method: This qualitative study explores the policy framework of upstream pharmaceutical sustainable supply chain management in Ghana. Targeting top managers in the pharmaceutical industry, 18 purposively sampled interviewees provided data. Thematic analysis revealed insights through collaboration on the issue of sustainable supply chain management policy framework. Result: The study identified global bodies like World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH shaping global pharmaceutical sustainability policies. In Ghana, implemented policies encompass green procurement, healthcare waste management, and recycling. Challenges include transparency gaps, supplier engagement, regulatory complexity, limited resources, and stakeholder collaboration. Conclusion: The adoption of sustainable supply chain practices is crucial for the pharmaceutical industry in Ghana. Collaboration and inclusion of stakeholders are essential for the adoption of sustainable practices. Pharmaceutical companies in Ghana should collaborate with their suppliers, customers, regulators, and civil society organizations to promote sustainable practices throughout the supply chain. Contribution: The study suggests PMAG fosters robust collaboration and stakeholder involvement to advance sustainable supply chain practices in Ghana s upstream pharmaceutical industry. [ABSTRACT FROM AUTHOR]

Copyright of Medical Management & Health Policy / Meditsinski Menidgmant i Zdravna Politika is the property of Medical University - Sofia, Central Medical Library and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: Under the background of the regular implementation of the National Centralized Drug Procurement (NCDP) policy, this study aimed to assess the impacts of the NCDP policy on drug utilization of county-level medical institutions, and probe into the influencing factors of the changes in drug utilization. Method: A pre-post study was applied using inpatient data from a county-level medical institution in Nanjing. Drug utilization behavior of medical institutions of 88 most commonly used policy-related drugs (by generic name, including bid-winning and bid-non-winning brands) was analyzed, and the substitution of bid-winning brands for brand-name drugs after policy intervention was evaluated. Results: After policy intervention, 43.18% of policy-related drugs realized the substitution of bid-winning brands for bid-non-winning brands (6.82% of complete substitution, 36.36% of partial substitution). Meanwhile, 40.90% of policy-related drugs failed to realize brand substitution. Multiple factors affected brand substitution, including: (1) Policy effect: brand substitution was more obvious after the intervention of the first and third round of NCDP. (2) Drug market competition: the greater the price reduction of bid-non-winning brands, the more the drugs for the same indication, the more likely that medical institutions keep using the same brands as they did before policy intervention. (3) Previous drug utilization of medical institutions: brand substitution was more obvious in drugs with large number of prescriptions and weak preference for brand-name drugs. Conclusion: The NCDP policy promoted the substitution of bid-winning brands for bid-non-winning brands. However, the NCDP policy remained to be further implemented in county-level medical institutions. Policy implememtation efforts, drug market competition and drug utilization of medical institutions would affect the implementation of the NCDP policy. [ABSTRACT FROM AUTHOR]

Antimicrobial resistance was estimated to be associated with 4.95 million deaths worldwide in 2019. It is possible to frame the antimicrobial resistance problem as a feedback-control problem. If we could optimize this feedback-control problem and translate our findings to the clinic, we could slow, prevent, or reverse the development of high-level drug resistance. Prior work on this topic has relied on systems where the exact dynamics and parameters were known a priori. In this study, we extend this work using a reinforcement learning (RL) approach capable of learning effective drug cycling policies in a system defined by empirically measured fitness landscapes. Crucially, we show that it is possible to learn effective drug cycling policies despite the problems of noisy, limited, or delayed measurement. Given access to a panel of 15 β-lactam antibiotics with which to treat the simulated Escherichia coli population, we demonstrate that RL agents outperform two naive treatment paradigms at minimizing the population fitness over time. We also show thatRLagents approach the performance of the optimal drug cycling policy. Even when stochastic noise is introduced to the measurements of population fitness, we show that RL agents are capable of maintaining evolving populations at lower growth rates compared to controls. We further tested our approach in arbitrary fitness landscapes of up to 1,024 genotypes. We show that minimization of population fitness using drug cycles is not limited by increasing genome size. Our work represents a proof-of-concept for using AI to control complex evolutionary processes. [ABSTRACT FROM AUTHOR]

Current malaria elimination targets must withstand a colossal challenge–resistance to the current gold standard antimalarial drug, namely artemisinin derivatives. If artemisinin resistance significantly expands to Africa or India, cases and malaria-related deaths are set to increase substantially. Spatial information on the changing levels of artemisinin resistance in Southeast Asia is therefore critical for health organisations to prioritise malaria control measures, but available data on artemisinin resistance are sparse. We use a comprehensive database from the WorldWide Antimalarial Resistance Network on the prevalence of non-synonymous mutations in the Kelch 13 (K13) gene, which are known to be associated with artemisinin resistance, and a Bayesian geostatistical model to produce spatio-temporal predictions of artemisinin resistance. Our maps of estimated prevalence show an expansion of the K13 mutation across the Greater Mekong Subregion from 2000 to 2022. Moreover, the period between 2010 and 2015 demonstrated the most spatial change across the region. Our model and maps provide important insights into the spatial and temporal trends of artemisinin resistance in a way that is not possible using data alone, thereby enabling improved spatial decision support systems on an unprecedented fine-scale spatial resolution. By predicting for the first time spatio-temporal patterns and extents of artemisinin resistance at the subcontinent level, this study provides critical information for supporting malaria elimination goals in Southeast Asia. Author summary: Resistance to artemisinin derivatives has been confirmed in the Greater Mekong Subregion, with worrying signs of spread in India and more recently emergence in Rwanda and Uganda. This situation is dire given the way that the emergence and spread of resistance to other antimalarial drugs, chloroquine and later sulphadoxine–pyrimethamine, resulted in dramatic increases in malaria-related morbidity and mortality across sub-Saharan Africa in the 1990s. To eliminate malaria, up-to-date maps of artemisinin resistance are urgently needed; predictive models of the spread of drug resistance can make far-reaching, significant, changes in our approach to malaria elimination by informing appropriate changes to drug policy. In this study, we have provided the first data-driven, predictive maps of the changing landscape of resistance to artemisinin derivatives in the Greater Mekong Subregion. These maps provide estimates where no data are available and can be used by health agencies to guide the prioritisation of surveillance for resistance, and policies to improve treatment and prevent the further spread of resistance. [ABSTRACT FROM AUTHOR]

This article provides information on various novel psychoactive substances of abuse, including NBOMe and 2C drugs, psilocybin, synthetic benzodiazepines, desomorphine (krokodil), fentanyl analogues, and xylazine. It discusses their mechanisms of action, formulation, dosage, clinical presentation, diagnosis, and management. The article also covers the management and effects of synthetic benzodiazepines and synthetic opioids, highlighting their potential risks and symptoms. Additionally, it explores the treatment of acute intoxication or overdose, focusing on opioid use disorder and the use of xylazine. Healthcare providers should be aware of these substances to provide appropriate care. [Extracted from the article]

Background: Since the twenty-first century, the prevalence of diabetes has risen globally year by year. In Gansu Province, an economically underdeveloped province in northwest China, the cost of drugs for diabetes patients accounted for one-third of their total drug costs. To fundamentally reduce national drug expenditures and the burden of medication on the population, the relevant departments of government have continued to reform and improve drug policies. This study aimed to analyse long-term trends in antidiabetic drug use and expenditure in Gansu Province from 2012 to 2021 and to explore the role of pharmaceutical policy. Methods: Data were obtained from the provincial centralised bidding and purchasing (CBP) platform. Drug use was quantified using the anatomical therapeutic chemistry/defined daily dose (ATC/DDD) method and standardised by DDD per 1000 inhabitants per day (DID), and drug expenditure was expressed in terms of the total amount and defined daily cost (DDC). Linear regression was used to analyse the trends and magnitude of drug use and expenditure. Results: The overall trend in the use and expenditure of antidiabetic drugs was on the rise, with the use increasing from 1.04 in 2012 to 16.02 DID in 2021 and the expenditure increasing from 48.36 in 2012 to 496.42 million yuan in 2021 (from 7.66 to 76.95 million USD). Some new and expensive drugs changed in the use pattern, and their use and expenditure shares (as the percentage of all antidiabetic drugs) increased from 0 to 11.17% and 11.37%, but insulins and analogues and biguanides remained the most used drug class. The DDC of oral drugs all showed a decreasing trend, but essential medicines (EMs) and medical insurance drugs DDC gradually decreased with increasing use. The price reduction of the bid-winning drugs was over 40%, and the top three drugs were glimepiride 2mg/30, acarbose 50mg/30 and acarbose 100mg/30. Conclusions: The implementation of pharmaceutical policies has significantly increased drug use and expenditure while reducing drug prices, and the introduction of novel drugs and updated treatment guidelines has led to changes in use patterns. [ABSTRACT FROM AUTHOR]

Prescription drug cost-sharing is a barrier to medication adherence, particularly for low-income and minority populations. In this systematic review, we examined the impact of prescription drug cost-sharing and policies to reduce cost-sharing on racial/ethnic and income disparities in medication utilization. We screened 2,145 titles and abstracts and identified 19 peer-reviewed papers that examined the interaction between cost-sharing and racial/ethnic and income disparities in medication adherence or utilization. We found weak but inconsistent evidence that lower cost-sharing is associated with reduced disparities in adherence and utilization, but studies consistently found that significant disparities remained even after adjusting for differences in cost-sharing across individuals. Study designs varied in their ability to measure the causal effect of policy or cost-sharing changes on disparities, and a wide range of policies were examined across studies. Further research is needed to identify the types of policies that are best suited to reduce disparities in medication adherence. [ABSTRACT FROM AUTHOR]

This manuscript offers an overview of 11 disciplinary perspectives on the failed and destructive War on Drugs and the salutary prospects from decriminalizing drug use, including History, African American studies, Journalism, Sociology, Political Science, Cost Accounting, Urban Education, Counseling, Psychology, Nursing, and Public Health. This offers a roadmap for counselor social and political advocacy with drug policy and highlights community collaboration opportunities. [ABSTRACT FROM AUTHOR]

In recent years, policymakers have proposed and implemented regulatory changes promoting the deprioritization, decriminalization, or state-level legalization of one or more psychedelic substances, usually referencing data from clinical trials as reasons to support liberalizing drug control policies. As psychedelic policies continue to be drafted, personal possession limits may be considered for inclusion in those regulations. If "allowable amount" limits are to be written into law to set personal possession limits, then such amounts should be more consistently related to psychedelic doses found to be safe and efficacious in clinical trials, existing data on moderate-high doses commonly used in various naturalistic settings, and the few studies that estimate psychedelic dose equivalence based on the intensity of subjective effects. In this commentary, we provide an evidence-informed table of typical moderate-high doses for seven commonly used psychedelic substances. These estimates of comparable moderate-high doses can be used to inform "allowable amount" values for psychedelic substances. When such limits are written into legislation, the adoption of evidence-informed comparable limits akin to those presented here would be an important first step toward ensuring greater parity and consistency in drug policy, relative to limits that have little or no scientific basis. [ABSTRACT FROM AUTHOR]

Policy debates at the intersection of patent law and pharmaceutical innovation have become increasingly polarized, often ending in a stalemate between seemingly incompatible goals of pharmaceutical innovation and access. Professor Karshtedt’s body of work at this intersection navigates the partisan divide by carefully probing the assumptions and practices of patenting in pharmaceutical markets to identify opportunities for incremental improvement in both innovation and access. His Article The More Things Change: Improvement Patents, Drug Modifications, and the FDA exemplifies this approach, identifying an opportunity to nudge private sector incentives to innovate into closer alignment with public health gains through modest regulatory interventions.1 In doing so, the Article offers a pathway through policy intransigence by offering a market-incentive based rationale for expanded agency authority, focusing on what should be a shared goal of improving the decision making of patients, prescribers and payors. The impact of Professor Karshtedt’s work stems not only from the insights in articles like The More Things Change, but also from the standards he set for himself as a scholar. Professor Karshtedt’s work exemplifies the kind of thoughtfulness, analytical precision, and willingness to pursue a line of inquiry with patience, persistence, and intellectual intensity to which we should all aspire. His approach to patent law draws from both law and science, from experience working in a startup company, a law firm, working for a judge, and within a law school, and from the perspectives of a patent holder, a patent practitioner, and a patent scholar. Perhaps most importantly, both in his work and in his intellectual life Professor Karshtedt was always in thoughtful conversation with people and ideas around him. This essay is both a tribute to Professor Karshtedt’s work and an invitation to draw lessons from his approach to scholarship and to building academic community that may serve well in navigating contested terrains such as the current debates at the intersection of patent law and pharmaceutical policy. [ABSTRACT FROM AUTHOR]

Background: In 2016, an innovative medical pricing reform called zero-markup drug policy (ZMDP) was implemented in selected pilot cities in China, which focuses on curbing the unreasonable growth of medical expenses. This study aimed to evaluate the impacts of ZMDP on medical expenditure of stroke in western China. Methods: The quantitative data of inpatients diagnosed with stroke was extracted from the medical insurance system in 7 tertiary public hospitals. An interrupted time series (ITS) was used to analyze the instantaneous level and long-term trend changes of hospitalization expenses per visit from January 2015 to November 2018. Results: A total of 22,407 stroke inpatients were extracted. The total hospitalization expense per visit had the highest proportion of 20,000 CNY and above (33.66%). After the ZMDP, the median total hospitalization expense and western medicine expense per visit decreased by 631.74 CNY and 966.35 CNY, respectively (P < 0.001). Before the policy, the total hospitalization expense, traditional Chinese medicine (TCM) expense, examination expense, treatment expense, laboratory expense and surgical expense per visit showed upward trends (P< 0.05), while the anesthesia expense per visit showed a downward trend (P< 0.001). When the policy was implemented, the anesthesia expense per visit instantaneously increased by 91.70% (P< 0.001). After the policy, the total hospitalization expense, western medicine expense, TCM expense, treatment expense and surgical expense per visit changed from upward trends to downward trends (P< 0.05). The anesthesia expense per visit changed from a downward trend to an upward trend (P< 0.001), and the examination expense per visit maintained an upward trend (P=0.005). Conclusion: The economic burden of stroke inpatients decreased significantly with the implementation of the ZMDP, especially for the drug expenses. The medical service expenses increased significantly, reflecting the improvement in the value of medical staff's technical labor. However, the unexpected increase in the examination expenses was likely to be associated with the unreasonable medical compensation mechanism. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to conduct a comprehensive cost-effectiveness comparison between novel oral anticoagulants (NOACs) and warfarin in Chinese patients with left ventricular thrombosis (LVT). By incorporating the impact of volume-based procurement (VBP) policy for pharmaceuticals in China, this analysis intends to provide crucial insights for informed healthcare decision-making. Patients and Methods: A Markov model was employed to simulate the disease progression of LVT over a 54-week time horizon, using weekly cycles and six mutually exclusive health states. The model incorporated transition probabilities between health states calculated based on clinical trial data and literature sources. Various cost and utility parameters were also included. Additionally, a series of sensitivity analyses were conducted to address parameter variations and associated uncertainties. Results: The study finding suggest that from the perspective of Chinese healthcare, the majority of brand-name drug (BND) NOACs generally lack cost-effectiveness when compared to warfarin. However, when considered the VBP policy, NOACs, particularly rivaroxaban, prove to be more cost-effective than warfarin. Rivaroxaban provided an additional 0.0304 quality-adjusted life years (QALYs) per patient and reduced overall medical costs by 9095.73 CNY, resulting in an incremental cost-effectiveness ratio (ICER) of − 298,786.20 CNY/QALY. Sensitivity analysis indicated a 78.4% probability of any NOACs being more cost-effective compared to warfarin. However, specifically considering NOACs under the VBP policy, the likelihood of them being more cost-effective approached 90%. Conclusion: Taking into account Chinese pharmaceutical procurement policies, the findings highlight the superior efficacy of NOACs, especially rivaroxaban, in enhancing both the quality of life and economic benefits for Chinese LVT patients. NOACs present a more cost-effective treatment option, improving patient quality of life and healthcare cost efficiency compared to warfarin. [ABSTRACT FROM AUTHOR]

Background: Launched in March 2019, the National Centralized Drug Procurement (NCDP) initiative aimed to optimize the drug utilization framework in public healthcare facilities. Following the integration of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) into the procurement catalog, healthcare establishments in Suining swiftly transitioned to the widespread adoption of NOACs, beginning 1 March 2020. Objective: This study aims to comprehensively assess the impact of the NCDP policy on the efficacy of anticoagulation therapy, patient medication adherence, and the incidence of hemorrhagic events in individuals with non-valvular atrial fibrillation (NVAF) residing in Suining. The analysis seeks to elucidate the broader impacts of the NCDP policy on this patient demographic. Methods: This study analyzed patient hospitalization records from the Department of Cardiology at Suining County People's Hospital, spanning 1 January 2017, to 30 June 2022. The dataset included demographic details (age, sex), type of health insurance, year of admission, hospitalization expenses, and comprehensive information on anticoagulant therapy utilization. The CHA2DS2-VASc scoring system, an established risk assessment tool, was used to evaluate stroke risk in NVAF patients. Patients with a CHA2DS2-VASc score of 2 or higher were categorized as high-risk, while those with scores below 2 were considered medium or low-risk. Results: 1. Treatment Cost Analysis: The study included 3,986 patients diagnosed with NVAF. Following the implementation of the NCDP policy, a significant increase in the average treatment cost for hospitalized patients was observed, rising from 8,900.57 ± 9,023.02 CNY to 9,829.99 ± 10,886.87 CNY (p < 0.001). 2. Oral Anticoagulant Utilization: Overall, oral anticoagulant use increased from 40.02% to 61.33% post-NCDP (p < 0.001). Specifically, NOAC utilization among patients dramatically rose from 15.41% to 90.99% (p < 0.001). 3. Hemorrhagic Events: There was a significant decrease in hemorrhagic events following the NCDP policy, from 1.88% to 0.66% (p = 0.01). Hypertension [OR = 1.979, 95% CI (1.132, 3.462), p = 0.017], history of stroke [OR = 1.375, 95% CI (1.023, 1.847), p = 0.035], age =65 years [OR = 0.339, 95% CI (0.188, 0.612), p < 0.001], combination therapy of anticoagulants and antiplatelets [OR = 3.620, 95% CI (1.752, 7.480), p < 0.001], hepatic and renal insufficiency [OR = 4.294, 95% CI (2.28, 8.084), p < 0.001], and the NCDP policy [OR = 0.295, 95% CI (0.115, 0.753), p = 0.011] are significant risk factors for bleeding in patients with atrial fibrillation. 4. Re-hospitalization and Anticoagulant Use: Among the 219 patients requiring re-hospitalization, there was a notable increase in anticoagulant usage post-NCDP, from 36.07% to 59.82% (p < 0.001). NOACs, in particular, saw a substantial rise in usage among these patients, from 11.39% to 80.92% (p < 0.001). 5. Anticoagulant Type Change: The NCDP policy [OR = 28.223, 95% CI (13.148, 60.585), p < 0.001] and bleeding events [OR = 27.772, 95% CI (3.213, 240.026), p = 0.003] were significant factors influencing the alteration of anticoagulant medications in patients. Conclusion: The NCDP policy has markedly improved anticoagulation management in patients with AF. This policy has played a crucial role in enhancing medication adherence and significantly reducing the incidence of hemorrhagic events among these patients. Additionally, the NCDP policy has proven to be a key factor in guiding the selection and modification of anticoagulant therapies in the AF patient population. [ABSTRACT FROM AUTHOR]

Background: Although harm reduction is highlighted as an effective intervention for alcohol and drug use, a funding gap for harm reduction interventions has been identified, mainly in low- and middle-income countries. In these countries, tensions between abstinence and harm reduction models have impaired the shift from punitive practices to evidence-based interventions committed to guaranteeing the human rights of people who use drugs. Since 2015, the Brazilian government has adopted a more punitive and abstinence-focused drug policy that jeopardizes the care of people who use alcohol and other drugs and the comprehension of the harm reduction workers' perspective in relation to their practice. Therefore, this study aimed to comprehend the meanings constructed by Brazilian harm reduction workers regarding their practices with vulnerable populations amidst a context of political tension. Methods: We conducted 15 in-depth semi-structured qualitative interviews with harm reduction workers employed in public health services for at least 6 months. Data were analyzed using thematic analysis. Results: The thematic axis "The joy and pain of being a harm reduction worker in Brazil" was constructed and divided into four major themes: (1) Invisibility of harm reduction work; (2) Black, poor, and people who use drugs: identification with the service users; (3) Between advocacy and profession: harm reduction as a political act; (4) Small achievements matter. Despite the perceived invisibility of harm reduction workers in the public health and alcohol and drug fields, valuing small achievements and advocacy were important resources to deal with political tension and punitive strategies in Brazil. The findings also highlight the important role of harm reduction workers due to their personal characteristics and understanding of drug use behavior, which bring the target audience closer to actions within the public health system. Conclusion: There is an urgent need to acknowledge harm reduction based on peer support as a professional category that deserves adequate financial support and workplace benefits. Additionally, expanding evidence-based harm reduction interventions and community-based voluntary drug use treatment centers should be prioritized by public policies to address the human rights violations experienced by people who use drugs. [ABSTRACT FROM AUTHOR]