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Objective To describe the widespread use of compounded bioidentical hormone therapies (cBHT). To define the term clinical utility and present why there is insufficient evidence to support the overall clinical utility of cBHT products. To recommend actions that pharmacists and regulators can take to promote safer cBHT use. Summary Nationwide, millions of men and women use cBHT products. Use of these products appears to be increasing year-to-year, according to the limited data reported by the 503 A and 503 B pharmacies that formulate and dispense these products. Although use appears to be widespread, the safety, efficacy, and clinical utility of these products remains unproven. This commentary provides examples of what draws consumers to these products, comparative costs, and formulation challenges. Actions to promote the safe use of cBHT and approaches to begin the study of these products are provided. Conclusion While significant progress was made via the Drug Supply Chain Security Act in 2013 to improve the safety of compounding practice in general, efforts to further improve the safety and transparency of cBHT dispensing and use must continue, at both the local and national level.

Objective The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. We also address the challenges that 503B outsourcing facilities are facing that limit their utilization and offer possible solutions. Summary Section 503B outsourcing facilities are emerging contributors in compounding owing to their ability to compound large quantities of medication without requiring patient-specific prescriptions. As such, they play a valuable role in the U.S. drug supply chain. The use of outsourcing facilities to compound ready-to-use drug products is gaining traction in hospitals and other health care systems. Outsourcing facilities help hospitals that are facing time and cost constraints owing to the evolving regulatory landscape around compounding. Although outsourcing facilities are assets to the drug supply chain, there are several challenges to their use. The lack of a finalized 503B Bulks List has led to outsourcing facilities being overly cautious in compounding products using bulk drug substances. In addition, the time between Food and Drug Administration (FDA) inspections is undefined, and a lack of follow-up information regarding concerns identified during an inspection may result in uncertainties about the current state of the outsourcing facility. Conclusions Health care providers, outsourcing facilities, and FDA need to work together to ensure that patients are provided the drugs they need in a safe and effective way.

Instruct clinicians on counterfeit drugs and their implications for patient health. Counterfeit drugs imperil patients around the globe, and their penetration into the United States, Canada, and Western Europe is only increasing over time. In addition to inserting counterfeit drugs in the legitimate drug supply, rogue Internet pharmacies and consumer purchases while traveling abroad allow counterfeit drugs to endanger patients. Pharmacists need to understand the nature and severity of the issue and directly counter it through personal actions to secure a legitimate drug supply, such as by using verified distributors and examining the shipment packaging, product packaging, the bottle, and the label for evidence to determine if it is counterfeit or has been tampered with. They can also indirectly counter it through patient education and by working with other key stakeholders in the health care system. Given the risk to patients, pharmacists have an important role to play in limiting patient use of counterfeit drugs.

During the past decade, 'alcohol's harm to others' (AHTO) has emerged as an international approach to studying alcohol problems and informing policy. The AHTO approach seeks to increase political will for alcohol policy by mapping, measuring and often costing harms beyond the person who drinks (e.g. family members, co-workers). In this paper we consider the implications of a 'harm to others' approach for illicit drugs. We ask whether it could and should be used as a policy tool, given the high risks of further stigmatizing people who use drugs. We consider the ways in which the concept and measurement of 'harm to others' may be either productive or potentially harmful, depending on the extent to which the AHTO is replicated for illicit drugs. Shifting the language may assist: the term 'harm from others' appears to carry less risk of stigma. In addition, all harms inclusive of drug supply and drug consumption need to be included if a full picture of harms that accrue to other people from illicit drugs is to be achieved.

Objective To evaluate the current pharmaceutical supply chain, from both a regulatory and market perspective, to identify instabilities as well as propose methods to ensure consistent drug quality and access. Data sources Data sources include publicly available Food and Drug Administration (FDA) databases. Summary Recent recalls of important drugs such as angiotensin receptor blockers, heparin, epinephrine, and acyclovir highlight the importance of ensuring access to essential medications. However, the current drug supply chain has multiple weaknesses from both regulatory and market perspectives. A lack of adequate inspection and quality standards means that quality issues often go unfound, but when they are found, disruptions to the supply chain are amplified by a dependence on India and China for active pharmaceutical ingredients. The mutual recognition agreement, India Pilot Program, and increased number of FDA foreign inspectors were steps in the right direction, but more must be done to ensure access. Conclusion Ensuring drug quality and access is not possible without first providing greater transparency into the drug supply chain. This allows both health care consumers and the FDA to respond to drug quality issues. Additionally, extra steps including broadening the scope of the mutual recognition agreement, encouraging increased self-regulation in China and India, and mandating unannounced inspections of foreign manufacturers may help in providing a more stable supply chain.

Insulin prescription prices have been a barometer of the complexities and concerns in the United States drug supply chain. The influence of free samples of medications have not been explored in this context.To examine the trends in insulin prescription prices among sample users and non-users.Medical Expenditure Panel Survey (MEPS) data from the years 2009-2015 were used. Insulin users were identified and grouped according to self-reported sample use and as new users based on year of treatment initiation variables. Prevalence of sample use was discerned using Cochran-Armitage Trend tests. Per prescription costs were summed as both the total costs and the patient out-of-pocket costs (OOP) and compared between users and non-users of samples. MEPS weights were used to create a nationally representative analytic sample.The weighted analytic sample included 5.3 million insulin users in 2009, which increased to 7.7 million insulin users in 2015. Among these, 5.6% reported sample use in 2009, which peaked in 2014 (8.1%), and was 6.2% in 2015 (p 0.001). In 2015, the average OOP and overall costs were higher for sample users vs. non-users ($232 vs. $108, P 0.001). This pattern was consistent each year. Per prescription costs per insulin prescription increased by 62% between 2009 and 2015 for sample users ($232 vs. $143, p 0.001) and increased 35% for non-users ($108 vs. $80, p 0.001).Sample use has increased among insulin users and is associated with higher per prescription costs. Patients and prescribers should consider the implications of sample use in the long-term.

Objective The aim of this study was to assess status of early warning indicators (EWIs) for HIV drug resistance in Ethiopia. Methods A retrospective cohort study was conducted among 90 health facilities (HFs) in 2015. Data were abstracted for ‘on time pill pickup’ (EWI-I), ‘Retention in care’ (EWI-II), ‘drug supply continuity’(EWI-III) and ‘dispensing practices’ (EWI-IV). Data analysis was conducted using WHO Excel tool and SPSS V20. Results EWI-IV was excellent across all of the six rounds of EWI surveys conducted between 2008 and 2015. There were improvements in EWI-II over time from 55.6% to 81%. However, EWI-I and EWI-III declined from 86.7% to 31% and 100% to 41%, respectively. During 2015, half of the HFs in Gambella, Amhara and Southern Nation, Nationalities and people regional (SNNPR) states achieved excellent performance for EWI-I. Similarly, all HFs in Afar, Amhara, Dire Dawa, Harari and Tigray regions achieved excellent performance for EWI-II. There were also differences by level of HFs for EWI-III; 62% of hospitals and 28% of health centers were out of stock of one or more ARV drugs by 2015. Conclusion Excellent performance of EWI-IV and improvement of EWI-II over time shall be maintained. The program shall further work to ensure medication adherence and supply continuity.

Pharmacy benefit managers (PBMs) are thoroughly integrated into the drug supply chain as administrators of prescription drug benefits for private insurers, self-insuring business, and government health plans. As the role of PBMs has expanded, their opaque business practices and impact on drug prices have come under increasing scrutiny. PBMs are particularly influential in oncology care because prescription drugs play a major role in the treatment of most cancers and an increasing number of patients with cancer are treated with oral oncology agents managed by PBMs. There is concern that some PBM practices may threaten access to high-quality cancer care and may increase the financial and administrative burden on patients and practices. In this article, we review the role of PBMs in prescription drug coverage and reimbursement, discuss the impact of PBMs on oncology care, and present data from the 2018 ASCO Practice Survey assessing the knowledge and attitude of oncology practices toward PBMs.

Background The North American opioid overdose crisis is driven in large part by the presence of unknown psychoactive adulterants in the dynamic, unregulated drug supply. We herein report the first detection of the psychoactive veterinary compound xylazine in Toronto, the largest urban center in Canada, by the city’s drug checking service. Methods Toronto’s Drug Checking Service launched in October 2019. Between then and February 2021, 2263 samples were submitted for analysis. The service is offered voluntarily at harm reduction agencies that include supervised consumption services. Samples were analyzed using gas chromatography–mass spectrometry or liquid chromatography-high resolution mass spectrometry. Targeted and/or untargeted screens for psychoactive substances were undertaken. Results In September 2020, xylazine was first detected by Toronto’s Drug Checking Service. Among samples analyzed from September 2020 to February 2021 expected to contain fentanyl in isolation (610) or in combination with methamphetamine (16), xylazine was detected in 46 samples (7.2% and 12.5% of samples, respectively). Samples were predominantly drawn from used drug equipment. Three of the samples containing xylazine (6.5%) were associated with an overdose. Conclusion We present the first detection of xylazine in Toronto, North America’s fourth-largest metropolitan area. The increased risk of overdose associated with use of xylazine and its detection within our setting highlights the importance of drug checking services in supporting rapid responses to the emergence of potentially harmful adulterants. These data also highlight the clinical challenges presented by the dynamic nature of unregulated drug markets and the concomitant need to establish regulatory structures to reduce their contribution to overdose morbidity and mortality.

The development of health system in Nepal dates back from ancient period to the modern period starting from ayurvedic medicine to today's modern allopathic treatment. With regard to the different rulers in different time period, the number of improvements and changes in the health system of Nepal has been made. Moreover, the health system is further strengthened by the involvement of people and better management of health information and drug supply. Keywords: Bir Hospital; Community health; Health; Nepal.

Locally administrable drugs with controllable release on external cues hold great promise for antitumor therapy. Here, we report an injectable, supramolecular hydrogel (SHG), where the drug release can be controllably driven by near infrared (NIR) irradiation. The SHGs are formed by electrostatic interactions with LAPONITE® (XLG), in which upconverting nanoparticles (UCNPs) modified with α-cyclodextrin (α-CD) are used as the core, and azobenzene quaternary ammonium salts (E-azo) are further assembled through host-guest interactions. The hydrogel demonstrates reversible phase transition between gel and sol states and photothermal conversion capability. In detailed in vitro and vivo trials, drug-loaded SHGs successfully suppressed invasion by cancer cells. Phase transitions that are regulated by NIR light and promote drug release using photothermal effects, highlighting the considerable potential of supramolecular hydrogels in anticancer therapies, especially for treatments requiring long-term, on-demand drug supply in clinics.

A pharmacopoeia's core mission is to protect public health by creating and making available public standards to help ensure the quality of drugs. In recent years, pharmacopoeias around the world have harmonized their standards in the present context of globalized drug supply chains and markets. For example, the Pharmacopoeial Discussion Group has worked to harmonize excipient monographs and general chapters. In addition, the International Meeting of World Pharmacopoeias has been held by the WHO to discuss information exchange and international collaboration, among other topics. To contribute further to the protection of public health in the globalized drug market, we conducted a comparative study of the pharmacopoeias in Japan, Europe, and the United States. We aimed to examine current differences among the Japanese Pharmacopoeia, the European Pharmacopoeia, and the United States Pharmacopeia-National Formulary and to identify areas that require further collaboration among the three pharmacopoeias. In this study, we analyzed monographs and general chapters listed in the three pharmacopoeias. We identified the features of the monographs and general chapters listed in each pharmacopoeia, as well as differences across the pharmacopoeias. Moreover, on the basis of our findings, we suggest standards that require further collaboration among the pharmacopoeias in certain preferred areas. The comparison data produced by this study are expected to be used to develop strategies for future revisions of pharmacopoeias around the world.

Central venous access poses a risk for the development of catheter-related infections (CRIs). The aim of this study was to evaluate prophylactic use of taurolidine-citrate (T-C) solution on the number of CRIs. Ninety-seven catheters, used in 86 children, were divided at random into two groups: Group T(-) (N=49) underwent standard aseptic procedures, and Group T(+) (N=48) received additional filling of the lines with T-C solution during intervals in cycles of parenteral nutrition or drug supply. Sixteen CRIs occurred in Group T(-) and one CRI occurred in Group T(+); this difference was significant (P

A good drug inventory planning system is important for an efficient budgeting, procurement, and cost control of drugs. When stagnant drugs in the inventory are too much, wastage due to expired and spoiled drugs could occur. These will not only cause loss of income but could also jeopardize healthcare service delivery.This study aimed to determine the most efficient and effective management of stagnant and shortage drugs by comparing three pharmacy logistic methods; the economic order quantity (EOQ), minimum-maximum stock level (MMSL), and the traditional consumption of drug inventory, at RA Basoeni Hospital, Mojokerto. Drug inventory was analyzed to calculate the opportunity loss, opportunity cost, and proportions of both stagnant and shortage drugs.We found that EOQ and MMSL performed best for control of stagnant drugs and shortage drugs, respectively. Both methods had proved as effective pharmacy logistic planning. In addition, EOQ produced the lowest opportunity cost for stagnant drugs besides the lowest opportunity loss for shortage drugs.The study concluded that EOQ is the most effective and efficient method to manage stagnant and shortage drugs at hospital pharmacy.

BACKGROUND: Fatal overdoses involving cocaine (powdered or crack) and fentanyl have increased nationally and in Massachusetts. It is unclear how overdose risk and preparedness to respond to an overdose differs by patterns of cocaine and opioid use. METHODS: From 2017 to 2019, we conducted a nine-community mixed-methods study of Massachusetts residents who use drugs. Using survey data from 465 participants with past-month cocaine and/or opioid use, we examined global differences (p < 0.05) in overdose risk and response preparedness by patterns of cocaine and opioid use. Qualitative interviews (n = 172) contextualized survey findings. RESULTS: The majority of the sample (66%) used cocaine and opioids in the past month; 18.9% used opioids alone; 9.2% used cocaine and had no opioid use history; and 6.2% used cocaine and had an opioid use history. Relative to those with a current/past history of opioid use, significantly fewer of those with no opioid use history were aware of fentanyl in the drug supply, carried naloxone, and had received naloxone training. Qualitative interviews documented how people who use cocaine and have no history of opioid use are largely unprepared to recognize and respond to an overdose. CONCLUSIONS: Public health efforts are needed to increase fentanyl awareness and overdose prevention preparedness among people primarily using cocaine.

Highlights L’épidémie de SARS-CoV-2 a contraint les établissements hospitaliers à augmenter le nombre d’unités de soins critiques Les pharmacies hospitalières ont dû répondre dans des délais très courts aux besoins en médicaments et dispositifs médicaux. La présence de préparateurs affectés dans les unités de soins critiques à la gestion des produits pharmaceutiques en étroite collaboration avec les médecins et le personnel infirmier depuis plusieurs années a été un facteur déterminant dans la conduite des opérations. Le calcul quotidien des quantités notamment de curares consommées par patient a constitué un élément clé pour ajuster les commandes et les livraisons et préparer les changements de spécialités imposés par les ruptures d’approvisionnement. Cet épisode de crise légitime la question de l’extension de l’ouverture de la pharmacie d’un centre hospitalo-universitaire en équipe complète 365 jours par an., Le circuit du médicament hospitalier le plus sûr est la dispensation journalière individuelle nominative automatisée assurée par la pharmacie. Depuis plusieurs années nous essayons de convaincre les décideurs hospitaliers de l’implanter dans notre établissement. En attendant, pour pallier les risques d’erreurs médicamenteuses encourus par les patients et les soignants, nous avons constitué plusieurs équipes de travail au sein des unités de soins. Ces équipes sont constituées d’un pharmacien et d’un ou deux préparateurs en pharmacie hospitalière qui assurent notamment la gestion des armoires à pharmacie des unités de soins. La collaboration étroite avec médecins et personnel infirmier développée au fil des années a été un élément favorable déterminant lorsqu’il a fallu doter en médicaments et en dispositifs médicaux stériles (DMS) les nouvelles unités de soins critiques face à l’afflux de patients contaminés par le SARS-CoV2. Le suivi quotidien des médicaments consommés par patient, particulièrement les curares, et des DMS en rupture d’approvisionnement a été un élément clé de la gestion des stocks et des changements de principes actifs, de conditionnements et/ou de références de matériel. Les faits relatés donnent du poids au rapport Claris qui souligne les effets positifs en termes de qualité et de sécurité de prise en charge des patients du travail des PPH et pharmaciens dans les unités de soins. Ils soulignent par ailleurs les dangers auxquels sont exposés patients et soignants samedi, dimanche et jours fériés quand la pharmacie est fermée. Ils légitiment la question de l’extension de l’ouverture de la pharmacie en équipe complète 365 jours par an.

KEY POINTS The COVID-19 pandemic has revealed weaknesses in global manufacturing and distribution of medications, exacerbating many pre-existing limitations and inequities in drug supply and creating new shortages.[1][1]–[3][2] Supply chains have been disrupted[4][3] as many were designed for “

The pharmaceutical or drug supply chain is the means through which prescription medicines are manufactured, stocked, and delivered to consumers. How the complexity and fragmentation of this supply chain shape or reshape the decisions and courses of action as well as risk aversions of its actors (stakeholders) is the question we address in reviewing recent literature presented at the 2021 AEA-ASSA economics convention. In doing so, we identify key aspects or dimensions of the supply chain that remain unexplored or under-explored in the empirical literature.All original research relevant to the pharmaceutical supply chain were selected from the AEA-ASSA convention panel sessions. Empirical evidence was thematically identified, and the theoretical and practical implications of findings on firm and stakeholder decision-making were analyzed.Stakeholder choices and risks in the action steps or stages of the supply chain are conditioned or framed by variables that are less prominent and seldom documented in the empirical literature. These include firm ownership and marketing, the provider's IT system, pricing and discounts negotiated by pharmacy benefit managers (PBMs), health insurance coverage, employer plan sponsorship, and hassle costs of drug prescribing and monitoring. On the other hand, prominent and well documented policy initiatives, like international reference pricing and renationalization or "decoupling" from global value chains, can have unintended effects on supply chain actors and end-users, including reverse redistribution. The continuing and changing multi-dimensional character of the supply chain adds to its complexity and fragmentation.Organizational, operational, and value-adding measures to overhaul the drug supply chain and make it perform better have been proposed in the surveyed literature and elsewhere. Yet, aspects of the supply chain that bear a direct impact on firm short-term financial success typically assume precedence in evaluations of performance and effectiveness. Whether and to what extent the drug supply chain will change to cope and adapt to the major challenges and upheavals it currently faces are lingering questions.

In July 2020, the Massachusetts Drug Supply Data Stream (MADDS) encountered two drug samples sold in a community as cocaine (one as “crack” and one as “white rock”) that contained bupropion as the ...

The drug supply chain is global and at risk of disruption and subsequent drug shortages, especially during unanticipated events.Our objective was to determine the impact of coronavirus disease 2019 (COVID-19) on drug purchases overall, by class, and for specific countries.A cross-sectional time series analysis of country-level drug purchase data from August 2014 to August 2020 from IQVIA MIDAS was conducted. Standardized units per 100 population and percentage increase in units purchased were assessed from 68 countries and jurisdictions in March 2020 (when the World Health Organization declared COVID-19 a pandemic). Analyses were compared by United Nations development status and drug class. Autoregressive integrated moving average models tested the significance of changes in purchasing trends.Before COVID-19, standardized medication units per 100 population ranged from 3990 to 4760 monthly. In March 2020, there was a global 15% increase in units of drugs purchased to 5309.3 units per 100 population compared with the previous year; the increase was greater in developed countries (18.5%; P0.001) than in developing countries (12.8%; P 0.0001). After the increase in March 2020, there was a correction in the global purchase rate decreasing by 4.7% (April to August 2020 rate, 21,334.6/100 population; P0.001). Globally, we observed high purchasing rates and large changes for respiratory medicines such as inhalers and systemic adrenergic drugs (March 2020 rate, 892.7/100 population; change from 2019, 28.5%; P0.001). Purchases for topical dermatologic products also increased substantially (42.2%), although at lower absolute rates (610.0/100 population in March 2020; P 0.0001). Interestingly, purchases for systemic anti-infective agents (including antiviral drugs) increased in developing countries (11.3%; P0.001), but decreased in developed countries (1.0%; P = 0.06).We observed evidence of global drug stockpiling in the early months of the COVID-19 pandemic, especially among developed countries. Actions toward equitable distribution of medicines through a resilient drug supply chain should be taken to increase global response to future unanticipated events, such as pandemics.

COVID-19 pandemic has rapidly spread worldwide causing a serious challenge to the global medical community. Italy was struck hard during the first wave earlier this year and several weaknesses as well as general unpreparedness of the national healthcare system were acknowledged. Learning essential lessons from the past, we realized how implementing contingency response measures, human resources and social dynamics could have changed the outcome if promptly adopted. This review translates the previous experience into strategic actions that has to be considered when developing appropriate national and regional operational plans to respond to a pandemic.

Introduction Novel psychoactive substances (NPS) are increasingly being consumed worldwide, with synthetic cannabinoids and synthetic opioids being the second and third most commonly used NPS, respectively. Certain synthetic cannabinoids can produce significant harms, particularly when used with opioids. The objective of this study was to characterise the presence of synthetic cannabinoids in the unregulated drug supply in three Canadian settings METHODS: In the British Columbia setting, all samples were first analysed at point-of-care using combination Fourier-transform infrared (FTIR) spectroscopy and fentanyl immunoassay strips prior to confirmatory testing using quantitative nuclear magnetic resonance spectroscopy, gas chromatography/mass spectrometry (GC/MS) and/or liquid chromatography/mass spectrometry (LC/MS). In the Toronto, Ontario setting, the samples were analysed directly by GC/MS, LC/MS liquid chromatography-high resolution/mass spectrometry. Results Between January 2018 and December 2019, 38 (2.8%) synthetic cannabinoid samples were detected in the unregulated drug supply (25/909 in British Columbia and 13/440 in Ontario). In British Columbia and Ontario, 76% and 85% of samples, respectively, were expected by individuals to be an opioid. Synthetic cannabinoids detected included AMB-FUBINACA, AB-FUBINACA, 5-fluoro-MDMB-PINACA, and 5-fluoro-MDMB-PICA, and largely co-occurred with fentanyl. In the British Columbia context, Fourier-transform infrared spectroscopy failed to detect synthetic cannabinoid compounds in almost half (48%) of the samples at point-of-care. Discussion and conclusions As point-of-care technologies failed to detect these compounds in many occasions, our findings demonstrate the importance of laboratory confirmatory analysis to identify NPS. Given the high risk of harm associated with the consumption of synthetic cannabinoids, further research should investigate the reasons for adulteration.

Evaluate the cost-effectiveness of various options for the supply of direct antiviral agents for patients with chronic viral hepatitis C. An analysis of the data of Moscow Department of Health on the drug supply of patients with chronic hepatitis C antiviral drugs at the expense of budgetary funds in Moscow was carried out. The direct medical costs of the urban healthcare system for the use of direct antiviral action drugs for the period from 2017 to 2019 were calculated. For the period from 2017 to 2019, 6,936 patients with chronic hepatitis C received medication with antiviral drugs at the expense of budget funds in Moscow. An increase in the number of patients compared to the base (2017) year was noted by 76%, as well as an increase in the volume of interferon-free antiviral therapy sets against the background of an increase in budget expenditures by 212%. The average level of cost for all sets with direct antiviral drugs amounted to 689,844 rub. The most commonly used set is Dac + Asu. The average cost of this set per patient treated as part of the first-line antiviral therapy was 58,899 rub. cheaper than a set of 3D, and 58,861 rub. more expensive than the Grz/Elb set, while the need for retreatment for the Dac + Asu set was 8.4%, and for the 3D, Grz/Elb and Gle/Pib sets, 0.58%, 0% and 0%, respectively. An even greater excess of the average was recorded for the Sof + Dac, Sof + Sim sets: which naturally entailed the excess of the costs of treating one patient with this distribution of treatment sets and financial resources by 253,236 rub. and 189,173 rub., respectively, which is 1.36 and 1, 27 times the average cost of all prices for antiviral treatment sets. Most often, re-medication was provided to patients who were initially provided with Sof set (33%), followed by Sim + Dac set (18.6%), 8.4% of re-medication cases were registered in patients who received Dac + Asu set as the first line of therapy. Budget costs for the second and subsequent sets of therapy increased by 92,739,115.30 rub.

Aim: to estimate the quality and availability of medical care for patients with ulcerative colitis (UC) and Crohn’s disease (CD), to assess the impact of the economic burden of these diseases on the healthcare budget of Russia and to systematize the main problems in the organization of medical care and drug supply for patients with inflammatory bowel diseases (IBD).Regional IBD databases (2016-2018), official statistical databases, costs of treatment and results of expert interviews with specialists in IBD were used in the study.The analyzed databases showed 104,668 patients with UC in Russia in 2018 (prevalence rate 71 per 100,000 people) and 66,647 patients with CD (prevalence rate of 45 per 100,000 people). The economic burden including agents for biologic therapy (ABT) for the UC was 39.54 billion rubles a year (495 rubles per capita), and CD - 32.98 billion rubles a year (378 rubles per capita). It requires an additional 9.87 billion rubles annually for UC and 9.20 billion rubles annually for CD patients to provide the complete supply with ABT.The annual burden of IBD is 72.52 billion rubles, which is comparable to the costs of other socially significant diseases, including malignant tumors. It shows the high social and economic value of IBD for the country. The main problems of medical care and drug supply for IBD patients are the mismatch of official statistical data and real IBD prevalence in Russia due to absence of comprehensive register and the insufficient supply with ABT due to limited funding. A federal center for IBD should be founded for better quality of registration, for the precise monitoring and for the active management of personal drug supply.

Background: This study provides insight into the impact of methamphetamine precursor regulation, which is considered to be one of the most important tools of supply reduction and a tool with potential public health impact. Methods: It is based on a longitudinal and quasi-experimental design and it investigates the changes of methamphetamine precursor regulation in Czech Republic, which is treated as a natural experiment. The statistical analysis uses features from the generalized fluctuation test framework as well as from the F test framework to estimate structural changes in the methamphetamine-related arrests and nonfatal intoxications time series. Results: The analysis identified structural breaks in the majority of the methamphetamine drug market-related time series in the period related to the tightening of regulation. The results of this study show that methamphetamine precursor regulation was associated with the proliferation of international and organized crime groups and with no change in the overall number of arrests and nonfatal intoxications. Conclusions: The precursor regulation ceteris paribus plausibly leads to the change in drug supply towards more organized groups and to an increasing involvement of foreign nationals at the drug market and is not effective in suppressing the methamphetamine market and in reducing the public health indicator of nonfatal methamphetamine intoxications.

International audience; Substance abuse (SA) among children is a recognized challenge for policymakers and law enforcement and has life-threatening consequences owing to the impact on the children's development and the consequent increase in vulnerability. This work outlines several important issues related to SA among children: (1) SA prevalence including onset, common examples, extent, and spectrum of SA; (2) the presence of new psychoactive substances, which are rapidly spreading worldwide with limitations regarding their prevalence, detection, and interventions; (3) street children and their recruitment in drug supply; (4) SA and substance use disorder pathways, risk and protective factors for the development of SA; (5) SA consequences in the case of early initiation, including deaths; and (6) current preventive interventions for the pediatric population. In conclusion, this challenge requires consistent and unremitting attention in order to execute effective prevention programs with continuous re-evaluation of the situation.

Despite awareness of the role of drug use in shaping sex worker/client interactions, these dynamics remain poorly understood in the context of illicit fentanyl-driven overdose epidemics. This study examined sex workers' experiences negotiating client interactions amidst a toxic drug supply in Vancouver, Canada. Findings draw from two ethnographic studies. The first, conducted between December 2016 and May 2017, examined the rapid implementation of several low-threshold supervised consumption sites. The second investigated experiences of women accessing a women-only site from May 2017 to June 2018. Data included 200 hours of fieldwork and in-depth semi-structured interviews with 34 street-based sex workers who use illicit drugs. Data were analysed thematically with attention to the risk environment. Participants described providing harm reduction services to clients as a means to reduce overdose-related risks, thus increasing sex workers' hidden labour. Participants, comments regarding criminalisation and stigma surrounding drug use and sex work indicated a reticence to report overdoses, thereby potentially increasing the risks of overdose-related harms, including death. There is an urgent need for sex worker-led overdose prevention strategies that prioritise health and safety of sex workers and their clients with specific attention to how the criminalisation of particular drugs, practices and people contributes to overdose-related risks.

Background Pharmacists as the trustee of pharmacy services must adhere to ethical principles and evaluate their professionalism. Pharmacists may sometimes show different unethical behaviors in their interactions, so it is essential to understand these behaviors. The present study aimed to determine the challenges of ethical behaviors based on a principles-based approach in the area of drug supply in pharmacies. Methods This qualitative content analysis was conducted in Kerman in 2018. A number of key players in the field of medication supply were selected using snowball sampling to interview. An effort was made to select samples with maximum variation. Exclusion criteria include having less than 3 years of work experience in pharmacy and supervision, not willing to participate in the interview, and not participating in the interview for 3 times. The participants in this study consisted of pharmacy technicians (n = 5), patients (n = 6), pharmacists (n = 8), inspectors of insurance companies (n = 4), and inspectors of food and drug administration (n = 3). Data were analyzed using directed content analysis by Maxqda software version 10 (VERBI Software, Berlin, Germany). The principles of “Beauchamp and Childress Ethics” theory including autonomy, beneficence, non-maleficence, and justice were selected as the main principles. Results After data analysis, 8 main categories and 26 subcategories were obtained. The main categories include patient privacy, patient independence, communication principles, patient-centered services, drug supplier, patient harm avoidance, supervision, and distributive, procedural, and interactional justice. The subcategories include increasing patient awareness, culturizing prescription, and rational drug use, confidentiality and privacy, and pharmacist-patient relationship/communication, which were the main ethical challenges in the area of drug supply at pharmacies. Conclusions According to a principle-based approach, the greatest challenges were related to two principles of autonomy and beneficence. The policymakers in the healthcare system should emphasize patient independence, patient privacy, and patient-centered services. The results of this study can be used as a tool to introduce ethical challenges to policymakers and develop educational contents, the chart of professional ethics in pharmacies, and accreditation measures of pharmacies.

Background: While antiretroviral therapy (ART) has markedly increased survival in people living with human immunodeficiency virus (PLHIV), emerging trends of co-existence of non-communicable diseases (NCDs) and HIV could negate the gains already achieved in controlling HIV. Aim: The study aimed to determine the prevalence of hypertension and diabetes mellitus in PLHIV on ART in Gweru district. Setting: Six high-volume ART sites in Gweru district under Midlands province in Zimbabwe. Methods: This was a cross-sectional study. Screening and data collection occurred over a 3-month cycle when all patients were expected to have visited the ART sites for their monthly ART drug supply. The process also allowed the identification of health system challenges regarding data management for HIV-NCD comorbidity. Poisson regression analysis was used to calculate NCD prevalence ratio (PR) in PLHIV. Results: Nearly 18 000 PLHIV registered for ART were identified. Hypertension (19.5%) and diabetes mellitus (8.4%) were the most common NCDs identified with a high proportion of those who did not know their diagnosis (over 50%). The prevalence of hypertension and/or diabetes mellitus among women was 74.9% compared to 25.1% in men (PR 3.22; 95% CI: 3.07–5.51, p = 0.0000). Other factors associated with increased prevalence of hypertension and/or diabetes mellitus were age group of ≥ 60 years (PR 2.5; 95% CI: 1.42–3.22, p = 0.00023), and duration of ≥ 5 years on ART (PR 6.4; 95% CI: 4.70–8.01, p = 0.0011). Separate data collection for NCDs and HIV was a key challenge affecting quantification of magnitude of HIV-NCDs comorbidity and subsequently management of NCDs in PLHIV. Conclusions: Indications of increasing prevalence of NCDs in PLHIV call for integrated electronic data management for HIV, TB and NCDs. This will allow active NCD case finding, and eventually improve prevalence data and treatment for HIV-NCD comorbidity. Future studies should focus on the health experiences and access to treatment in PLHIV diagnosed with NCDs; and to establish the accurate manner in which HIV status, ART and NCDs might be associated, through conducting a case control or cohort study.

Background U.S. research examining the illicit drug supply remains rare even though the information could help reduce overdoses. Relatively little is known regarding how often opioids are found in stimulants and whether temporal and geographic trends exist. We examined trends in fentanyl-cocaine and fentanyl-methamphetamine combinations in the national illicit drug supply. Methods We analysed serial cross-sectional data from the National Forensic Laboratory Information System (NFLIS) collected between January 2011 and December 2016. We restricted the analysis to cocaine (N = 1,389,968) and methamphetamine (n = 1,407,474) samples and calculated proportions containing fentanyl (including 23 related analogs) over time. Results The combined presence of fentanyl and cocaine steadily increased nationally between 2012–2016 (p = 0.01), and the number of such samples tripled from 2015 to 2016 (n = 423 to n = 1,325). Similarly, the combined presence of fentanyl and methamphetamine increased 179 % from 2015 to 2016 (n = 82–n = 272). Patterns varied widely by state; in 2016, fentanyl-cocaine samples were most common in New Hampshire (7.2 %), Connecticut (5.4 %), Ohio (2.6 %) and Massachusetts (2.1 %), whereas fentanyl-methamphetamine samples were most often in New Hampshire (6.1 %), Massachusetts (5.6 %), Vermont (2.4 %) and Maine (1.2 %). Conclusions Although relatively uncommon, the presence of fentanyl in the stimulant supply increased significantly between 2011 and 2016, with the greatest increases occuring between 2015–2016; the presence of these products was concentrated in the U.S. Northeast. Given these trends, strengthening community-based drug checking programs and surveillance within the public health infrastructure could help promote timely responses to novel threats posed by rapid shifts in the drug supply that may lead to inadvertent exposures.

Coincident with the opioid epidemic in the United States has been a dramatic increase in the number of children born with neonatal abstinence syndrome (NAS), a form of withdrawal resulting from opioid exposure during pregnancy. Many research efforts on NAS have focused on short-term care, including acute symptom treatment and weaning of the infants off their drug dependency prior to authorizing their release. However, investigations into the long-term effects of prenatal opioid exposure (POE) on brain development, from the cellular to the behavioral level, have not been as frequent. Given the importance of the perinatal period for human brain development, opioid-induced disturbances in the formation and function of nascent synaptic networks and glia have the potential to impact brain connectivity and cognition long after the drug supply is cutoff shortly after birth. In this review, we will summarize the current state of NAS research, bringing together findings from human studies and preclinical animal models to highlight what is known about how POE can induce significant, prolonged deficits in brain structure and function. With rates of NAS continuing to rise, particularly in regions that already face substantial socioeconomic challenges, we speculate as to the most promising avenues for future research to alleviate this growing multigenerational threat.

This article explores recent developments within the U.K. drug market: that is, the commuting of gang members from major cities to small rural urban areas for the purpose of enhancing their profit from drug distribution. Such practice has come to be known as working “County Lines.” We present findings drawn from qualitative research with practitioners working to address serious and organized crime and participants involved in street gangs and illicit drug supply in both Glasgow and Merseyside, United Kingdom. We find evidence of Child Criminal Exploitation (CCE) in County Lines activity, often as a result of debt bondage; but also, cases of young people working the lines of their own volition to obtain financial and status rewards. In conclusion, we put forward a series of recommendations which are aimed at informing police strategy, practitioner intervention, and wider governmental policy to effectively address this growing, and highly problematic, phenomenon.

“Import-from-Canada” strategies to address high prices for patented pharmaceuticals are gaining momentum in the United States. In the first two months of 2019 alone, five congressional bills incorporating such strategies were introduced; these bills have attracted bipartisan support across the fractious American political divide. At the same time, Canadian lawmakers continue their long-standing failure to take action in response to the looming threat of having Canada’s drug supply siphoned off by its more powerful neighbour. Unregulated bulk importation of pharmaceuticals originally intended for the Canadian market into the USA would lead to severe drug shortages that would undermine the Canadian health system, while also halting emerging moves towards universal Canadian pharmacare in their tracks. At the same time, this short-term approach to tackling American pricing woes would fail to heal the deep systemic issues that underpin unaffordable drug prices in the USA. This article underscores the need for Canada to take action to protect its supply of patented medicines, and suggests possible forms such action might take.

Background Opioid overdose deaths in the United States continue to rise, with the majority of deaths involving fentanyl. Drug checking has been used in Europe and Canada to assess adulteration of the illegal drug supply, but faces legal barriers in the United States. We are presenting information from a pilot mobile program offering drug checking services to participants of a harm reduction program in Chicago, Illinois, USA. Methods Drug checking services were provided at five mobile outreach and one fixed-point drop-in location in Chicago, IL, between March 2019 and August 2020. Three technologies were used: a Fourier transform infrared spectroscopy (FTIR) spectrometer, a handheld high-pressure mass spectrometer (HPMS), and immunoassay fentanyl test strips (FTS). We report on results generated by this combination of technology during the study period. Results During the study period, 422 total samples were tested, the majority of which were sold as dope/heroin (66.7 %). Of the 282 samples sold as dope/heroin, 12.8 % matched to fentanyl on the FTIR, 47.5 % had fentanyl identified on the HPMS, and 57.8 % produced a positive FTS. Conclusions This pilot program demonstrated the feasibility of using three technologies to assess for the presence of fentanyl in user-submitted samples, revealed discordant results from the technologies, and provided information on the local drug market.

Background Fentanyl test strip (FTS) programs are designed to promote fentanyl awareness and reduce overdose risk by providing people who use drugs (PWUD) with a method of testing drugs for the presence of fentanyl prior to use. In 2018, two large syringe services programs (SSP) in the U.S. Mid-Atlantic—one in Baltimore City, Maryland and one in the state of Delaware—began distributing FTS. We evaluated the implementation of these programs. Methods A convenience sample of SSP clients was surveyed in Baltimore City (urban) and Delaware (urban, suburban and rural) to assess FTS utilization patterns and drug use behaviors. Data were collected and analyzed in 2019. Results We surveyed N = 123 PWUD in Baltimore and N = 102 in Delaware. Collectively, 20,000 strips were distributed over six months. In both locations, high FTS utilization was reported (70% in Baltimore; 77% in Delaware) and clients reported testing a range of drugs including heroin, fentanyl and cocaine. Following utilization, 23% and 69% of respondents in Baltimore and Delaware adopted risk reduction behaviors (e.g., using less than intended, going slower, doing tester shot, asking someone to check on them). When asked about their level of interest in future FTS use, 49% and 74% reported being interested or very interested, respectively. Conclusion Our findings demonstrate that FTS programs could be helpful in promoting fentanyl awareness and risk reduction among PWUD and in monitoring the evolving drug supply in areas where comprehensive community-based drug checking programs have not been established.

Drug stock-outs are an unfortunate yet common reality for patients living in low and middle income countries, particularly in sub-Saharan Africa where trouble with consistent stock of antiretroviral medications (ARVs) continues. Our study takes a snapshot of this problem in Ghana. Although the country launched its antiretroviral therapy (ART) programme in 2003, progress toward realising the full benefit of ART for treated individuals has been limited, in part, because of stock-outs. In Ghana’s Greater Accra region, we conducted semi-structured interviews with 40 women living with HIV (WLHIV) and 15 individuals with a history of HIV-related work in government or non-governmental organisations, or healthcare facilities. We used repeated review with coding and mapping techniques to analyse the transcripts and identify common themes. Stock-outs of ARVs result in inconsistent administration of therapy, increased indirect medical costs for WLHIV, and negative labelling of patients. Inefficiencies in drug supply, poor coordination with port authorities, inadequate government funding and dependence on international aid contribute to the stock-outs experienced in Ghana. Although using ARVs produced in-country could reduce supply problems, the domestically-manufactured product currently does not meet World Health Organization (WHO) standards. We recommend focused efforts to produce WHO standard ARVs in Ghana, and a review of current supply chain management to identify and mend pitfalls in the system.Keywords: antiretroviral therapy, healthcare funding, HIV/AIDS, pharmaceutical supply, reagent shortage, West Africa

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

Implantable drug delivery systems, such as drug pumps and polymeric drug depots, have emerged as means of providing predetermined drug release profiles at the desired site of action. While initial implants aimed at providing an enduring drug supply, developments in polymer chemistry and pharmaceutical technology and the growing need for refined drug delivery patterns have prompted the design of sophisticated drug delivery implants such as on-demand drug-eluting implants and personalized 3D printed implants. The types of cargo loaded into these implants range from small drug molecules to hormones and even therapeutic cells. This review will shed light upon recent advances in materials and composites used for polymeric implant fabrication, highlight select approaches employed in polymeric implant fabrication, feature medical applications where polymeric implants have a significant impact, and report recent advances made in these areas.

Botulinum toxin (BT) drugs were introduced in the late 1980s. They are now used worldwide in a large number of indications. This huge market and its future opportunities have attracted a number of companies about to enter the competition with projects to develop new BT drugs. We want to outline features of BT drugs that are relevant for their therapeutic use and - with that - are also relevant to compare and to evaluate new BT drugs and to guide their further development. BT drugs may vary in their content of botulinum neurotoxin, complexing proteins and excipients. Their manufacturing is complex and directly influences core features of the final drug. It includes breeding, purification, botulinum neurotoxin activation, stabilisation, potency control, labelling and testing, specific biological activity and packaging. The manufacturer's support concerning product documentation and support, reliability of drug supply, counterfeit protection and - last but not least - competitive pricing is also important. Further developments include the indication spectrum, the market penetration, the drug's duration of action, liquid preparations, transdermal applications, improving antigenicity and a bio-similarity registration process. Most projects, however, will try to produce Botox® analogs at reduced sale prices.

With the breadth of new psychoactive substances and international policy changes, an analysis of specific responses in all areas of drug supply and demand is beyond the resources of a single country. The Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction calls for a strengthening of global monitoring and evidence synthesis and a renewed vigour in collaborative efforts to expand training, research and the quality and comparability of data across Europe and beyond.

Comparative analysis of dynamics of cardiovascular mortality in Russia and foreign countries as well as main directions of development of cardiological service in Russia are presented in this review article. Plan of measures for reduction of mortality from ischemic heart disease (IHD) was created in 2015. This plan comprises 4 blocks of assessment of the following measures: directed at improvement of primary IHD prevention (1), directed at secondary prevention of complications of IHD (2); directed at improvement of efficacy of medical care of patients with IHD (3), and directed at monitoring of some demographic parameters (4). The article also contains results of monitoring of realization of the plan of IHD reduction in republics of North Caucasus. Realization of the program on healthy life style (HLS) lacks coordination between ministries. Mass information media are not sufficiently involved in propaganda of HLS. Mean achievement of target levels of main risk factors does not exceed 30-35%. First stage of prophylactic medical examination (dispanserization) has been fulfilled in 65%. High technology care is available both in federal and regional centers. Organization of effective urgent medical service, drug supply, and rehabilitation of patients with IHD are important aspects of improvement of secondary prevention in the region.

Tyndall’s CMAJ commentary regarding safer supply, namely pharmaceutical alternatives to the poisoned drug supply fueling the overdose crisis, describes the roots of the overdose crisis and calls for a clear strategy to scale up safer supply prescribing.[1][1] Addressing barriers to prescribing

The present market for herbal drugs is estimated about ₹40 billion, which is expected to increase by 16% in next 3–4 years. The current production of many Ayurvedic herbs is less than their market demand, which incentivizes adulteration in the Ayurvedic drug supply chain. The present work aims to highlight the most used Ayurvedic plants that have been listed in the International Union for Conservation of Nature’s “red list” of endangered or vulnerable plants. The future of Ayurvedic medicines from these listed plants is uncertain, as the collection of herbs from their natural habitat is prohibited and their cultivation does not meet market demands. Many of these plants, such as Taxus baccata and T. wallichiana, are endangered and are only grown in their natural habitats; their cultivation in other areas is impractical. This is the present state, and will worsen as demand continues to grow, with increasing populations and increasing adoption of this system of medicine. It is possible that in coming years most of the Ayurvedic drugs will be adulterated, and will cause only side effects rather than the therapeutic effects. The Ayurvedic fundamentals are under-explored areas where the Ayurvedic practitioners and research scientists can work together. The scientific work on the basic principles will unravel many unknown or little-known facts of this ancient science. Hence, the present review emphasizes the conservation of Ayurvedic herbs, minimization of the use of medicinal plants and the promotion of the research based on Ayurvedic fundamentals.

Summary After 15 years of global scale-up of antiretroviral therapy (ART), rising prevalence of HIV drug resistance in many low-income and middle-income countries (LMICs) poses a growing threat to the HIV response, with the potential to drive an increase in mortality, HIV incidence, and costs. To achieve UNAIDS global targets, enhanced strategies are needed to improve quality of ART services and durability of available ART regimens, and to curb resistance. These strategies include roll out of drugs with greater efficacy and higher genetic barriers to resistance than those that are currently widely used, universal access to and improved effectiveness of viral load monitoring, patient-centred care delivery models, and reliable drug supply chains, in conjunction with frameworks for resistance monitoring and prevention. In this Review, we assess contemporary data on HIV drug resistance in LMICs and their implications for the HIV response, highlighting the potential impact and resistance risks of novel ART strategies and knowledge gaps.