European Drug Research Articles

Dexmedetomidine as an Adjuvant in Peripheral Nerve Block.

Peripheral nerve block technology is important to balanced anesthesia technology. It can effectively reduce opioid usage. It is the key to enhance clinical rehabilitation as an important part of the multimodal analgesia scheme. The emergence of ultrasound technology has accelerated peripheral nerve block technology development. It can directly observe the nerve shape, surrounding tissue, and diffusion path of drugs. It can also reduce the dosage of local anesthetics by improving positioning accuracy while enhancing the block's efficacy. Dexmedetomidine is a highly selective drug α2-adrenergic receptor agonist. Dexmedetomidine has the characteristics of sedation, analgesia, anti-anxiety, inhibition of sympathetic activity, mild respiratory inhibition, and stable hemodynamics. Numerous studies have revealed that dexmedetomidine in peripheral nerve blocks can shorten the onset time of anesthesia and prolong the time of sensory and motor nerve blocks. Although dexmedetomidine was approved by the European Drug Administration for sedation and analgesia in 2017, it has not yet been approved by the US Food and Drug Administration (FDA). It is used as a non-label drug as an adjuvant. Therefore, the risk-benefit ratio must be evaluated when using thesedrugs as adjuvants. This review explains the pharmacology and mechanism of dexmedetomidine, the effect of dexmedetomidine on various peripheral nerve block as an adjuvant, and compare it with other types of adjuvants. We summarized and reviewed the application progress of dexmedetomidine as an adjuvant in nerve block and look forward to its future research direction.

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Time to reimbursement (TTR) of new anticancer medicines differs between countries and contributes to unequal access. We aimed to investigate TTR of new anticancer medicines and explore factors influencing the reimbursement process in seven high-income European countries. We carried out a retrospective case study of anticancer medicines with European Union Market Access (EU-MA) and a positive Committee for Medicinal Products for Human Use opinion from 2016 until 2021 with subsequent national reimbursement approval (NRA). The National Health Technology Assessment (HTA) and reimbursement websites of Germany, France, UK, the Netherlands, Belgium, Norway and Switzerland were used to identify TTR, defined as time from EU-MA to NRA. Additionally, we investigated medication-, country-, indication- and pharma-related factors potentially influencing TTR. Thirty-five medicines were identified for which TTR ranged from -81 days to 2320 days (median 407 days). At data cut-off, 16 (46%) were reimbursed in all seven countries. Overall, the shortest TTR was in Germany (median 3 days, all medicines reimbursed <5 days). The time limit for reimbursement of 180 days stated by the Council of European Communities after the EU-MA (EU Transparency Directive) was met for 100% of included medicines in Germany, 51% in France, 29% in the UK and the Netherlands, 14% in Switzerland, 6% in Norway and 3% in Belgium. The TTR was significantly different between countries (P < 0.001). In multivariate analysis, factors associated with shorter TTR were higher gross domestic product (GDP), absence of a pre-assessment procedure and submission by a big pharmaceutical company. TTR of anticancer medicines varies significantly between seven high-income European countries and leads to inequality in access. Among explored medication-, country-, indication- and pharma-related factors we found that a high GDP, the absence of a pre-assessment procedure and submission by big pharmaceutical companies were associated with shorter TTR.

Selective serotonin reuptake inhibitors and suicidality in children and young adults: analyses of pharmacovigilance databases

BackgroundSince the warnings by the United States (US) and European regulatory authorities in 2004 and 2005 it had been discussed whether there is some link between selective serotonin reuptake inhibitors (SSRIs) and suicidality in the pediatric population. The aim of our study was to describe trends and patterns in spontaneous reporting data referring to suicidality in children, adolescents and young adults treated with SSRI after the warnings.MethodsDescriptive analyses of reports for 0–24 year olds referring to suicide/suicidal ideations, self-harms and overdoses with SSRIs reported as suspected submitted to the US (FAERS) and the European (EudraVigilance) adverse drug reaction databases until 2019 were performed. The causal relationship was assessed in accordance with the WHO criteria for the European reports. For Germany, prescription data for SSRIs were provided and reporting rates (number of reports/number of prescriptions) were calculated for the reports with possible causal relationship (so called “confirmed reports”).ResultsSince 2004, the number of reports referring to suicide/suicidal ideations, self-harm and overdoses increased steadily in the US and EU. However, only a slight increase was seen for the confirmed EU reports. After 2008, the proportion of reports informing about suicidal ideations increased, while the proportion of fatal suicide attempts decreased. Reporting rates were higher for females and adolescents (12-18 years).ConclusionsOur results demonstrate the importance of further monitoring suicidality in 0–24 year olds treated with SSRI in order to recognize suicidality early avoiding fatal suicide attempts. The higher reporting rates for females and adolescents should be further investigated.

Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe

ObjectiveTo evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in...

A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania.

The quality of drug products may be affected from manufacture to dispensing, particularly at high temperature and humidity as in Mauritania. This country is not included in the World Health Organization reports on poor quality products due to the lack of a qualified laboratory and monitoring system. Ensuring the quality of medicine is even more relevant in the case of diseases such as Tuberculosis, due to its high prevalence, complex treatment and continuous bacterial resistance. The aim was to develop a monitoring system to assess the quality of antituberculosis drugs products, by the substandard detection based on European and United States Pharmacopeial recommendations regarding quality control. In addition to studying the influence of accelerated storage conditions (40 ± 2°C/75 ± 5% relative humidity) on their qualities and comparing the dissolution profiles to contrast the quality. 18 antituberculosis drug products were taken from Europe and Mauritania, and quality was studied through visual inspection and according to the compliance of the mass uniformity, uniformity of dosage units, dissolution, disintegration and friability pharmacopeial tests. Furthermore, a dissolution profile comparison was carried out to examine quality. A stability study was conducted to assess the influence of climatic conditions on the content and the dissolved amount of the active pharmaceutical ingredients, which were determined by an ultra-performance liquid chromatography system. As result, 69.3% of 13 Mauritanian formulations had a substandard quality mainly due to non-compliance with the test for friability or content uniformity of these medicines. All European drug products complied with pharmacopeia specifications. In addition, storage conditions affected the dissolution rate of ethambutol and the uniformity of the 4 antituberculosis combination drug products.

Prescription drug abuse in migrants from Middle Eastern and North African countries: a review

IntroductionIn recent years, there has been a rise in misuse of low-cost prescription pills across Middle Eastern and North African (MENA) countries. In Algeria, Tunisia and Morocco, for example, the consumption of prescription medications has dramatically increased, particularly amongst young and marginalized groups. Drugs such as clonazepam and pregabalin are extremely popular in these regions, as they are relatively inexpensive and perceived as safe. With the migration of MENA citizens to Europe, it is likely that mental health services will come across substance use disorders related to these medications.ObjectivesThe authors aim to analyse prescription medication misuse reports from MENA countries, specifically pregabalin and clonazepam, and review the pharmacological, neurobiological and social factors that contribute to their potential for abuse.MethodsNarrative review of articles referenced on PubMed and Google Scholar.ResultsPregabalin and clonazepam are widely used in psychiatry and neurology. Pregabalin is an alpha 2 omega ligand with supposed GABA-mimetic properties. Anecdotal reports suggest that pregabalin, used recreationally in amounts up to 3-20 times the therapeutic doses, possesses both sedative and psychedelic effects. Experimenters are mainly individuals with a history of recreational polydrug use, who are aware that pregabalin is not included in standard drug monitoring tests, with this molecule being used in some instances as a legal substitute of common illegal drugs. Clonazepam is a benzodiazepine that combines high potency and a long duration of action and is said to cause euphoria at doses over 8mg. It is very popular and affordable, placing consistently in the top three of benzodiazepines sales across the globe. Clonazepam has potential for tolerance build up and severe withdrawal symptoms. These medications are frequently used together and in combination with other substances such as alcohol and opiates, increasing the risk for respiratory failure and death.ConclusionsPrescription medications such as pregabalin and clonazepam are extremely accessible, inexpensive and highly addictive substances, whose abuse is well disseminated across MENA countries. With migratory flows from this region, the prevalence of misuse of these drugs in Europe is expected to increase. Therefore, physicians should be aware of their potential for abuse and carefully evaluate patients’ previous history before prescribing these medications.Disclosure of InterestNone Declared

A proposed framework to evaluate the quality and reliability of targeted metabolomics assays from the UK Consortium on Metabolic Phenotyping (MAP/UK).

Targeted metabolite assays that measure tens or hundreds of pre-selected metabolites, typically using liquid chromatography-mass spectrometry, are increasingly being developed and applied to metabolic phenotyping studies. These are used both as standalone phenotyping methods and for the validation of putative metabolic biomarkers obtained from untargeted metabolomics studies. However, there are no widely accepted standards in the scientific community for ensuring reliability of the development and validation of targeted metabolite assays (referred to here as 'targeted metabolomics'). Most current practices attempt to adopt, with modifications, the strict guidance provided by drug regulatory authorities for analytical methods designed largely for measuring drugs and other xenobiotic analytes. Here, the regulatory guidance provided by the European Medicines Agency, US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use are summarized. In this Perspective, we have adapted these guidelines and propose a less onerous 'tiered' approach to evaluate the reliability of a wide range of metabolomics analyses, addressing the need for community-accepted, harmonized guidelines for tiers other than full validation. This 'fit-for-purpose' tiered approach comprises four levels-discovery, screening, qualification and validation-and is discussed in the context of a range of targeted and untargeted metabolomics assays. Issues arising with targeted multiplexed metabolomics assays, and how these might be addressed, are considered. Furthermore, guidance is provided to assist the community with selecting the appropriate degree of reliability for a series of well-defined applications of metabolomics.

Impact on the Availability of Food Supplements and Medicines in the Russian Federation during Legislative Changes in 2010: A Case Study

Until the change in drug legislation in 2010, the Russian Federation (RF) tried to follow the world-recognised guidelines of the US and European food supplement and drug registration legislation. After introducing the new pharmaceutical law (NPL), a unique legal system was created that did not correspond to international practice. At the same time, legislation on food supplements (FSs) remained the same corresponding to worldwide accepted practice. Consequently, restructuring of regulatory authorities was implemented. There was no pathway or authority restructuring for FSs in the same period. The present study aimed to analyse the legislative change burden on the availability of food supplements and medicines in the RF during the most turbulent period from 2010 to 2012. Before the NPL, 20,836 drugs and 5000 food supplements (FSs) were registered. After the NPL, the number of registered drugs significantly fell, while the number of registered FSs grew, showing a 90% increase. During the observational period, the number of registered FSs grew, and the registration process was stable. Meanwhile, a reduced quantity of registered medicines was observed, and the decline was −21.25%. Moreover, decreased productivity of regulatory authorities was noted, and the drug MAs issued per year fell by −64.11%.

SARS-CoV-2 Infection in San Patrignano, the Largest European Drug Rehabilitation Community.

Studies on SARS-CoV-2 conducted in confined settings for prolonged times allow researchers to assess how the coronavirus spreads. San Patrignano (SP), Italy, is the largest European drug rehabilitation facility. Between 15 October and 31 December 2020, all SP residents were tested for SARS-CoV-2. We analyzed the relationships between individual characteristics and being SARS-CoV-2-positive. Three selected predictive models were used to calculate the number of expected hospitalizations. For each model, we summed the estimated individual risks to obtain the expected number of hospitalizations in our sample, and we tested whether the observed and expected numbers differed. Of 807 residents, 529 (65.6%) were SARS-CoV-2-positive. Of these 323 (61.1%) were symptomatic. A strong relationship was found between being positive and living connections (p-value < 0.001). No statistically significant relationship was found with age, sex, smoking history, or comorbidities. Although 9 to 17 hospitalizations were expected, no hospitalizations were observed (p-value < 0.001). No one died of COVID-19. The peculiar characteristics of SP residents or the SP environment might at least partially explain the null hospitalization rates. Despite the extreme uniqueness of our population and despite the protected environment and all precautions that were taken, the fact that the virus was able to circulate and infect a large portion of the population highlights the fundamental role of social interactions in the spread of the disease.

The COVID-19 pandemic and the right to health of people who use drugs

Context: According to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) people who inject drugs (PWID) make up a significant part of the population that needs to be looked after to eliminate infectious diseases such as those caused by HIV and HCV. This situation has been exacerbated by the COVID-19 pandemic. As COVID-19 rapidly spread across the globe, governments implemented various prevention measures which not only caused an increase in problem drug use (PDU) because of their negative impact on mental health and socioeconomic conditions but also prompted a decrease in drug services provided. Therefore, new challenges appeared, such as increased demand for drugs and diversification of clients, and new needs. Nevertheless, in clear contradiction to what was needed, the EMCDDA’s initial reports suggested that there was a decline in European drug services both in providing treatment and harm reduction interventions. COVID-19 increased the need to access drug services, healthcare, and support services creating an increased demand for opioid substitution therapy and other medication. Thus, comprehensive, and sustainable policies are needed to combat the public health threats associated with these challenges and to ensure the continuity of care. Policy Options: The challenging circumstances brought by the COVID-19 pandemic require policymakers need to take action to build capacity and resiliency for those facing drug-related health and social problems. These should include the adoption of integrated strategies that combine drug consumption rooms, substance-specific therapies, provision of free needles and naloxone, primary healthcare, and social support. Recommendations: The creation of an integrated drug policy framework addressed to European Union member states is necessary to create robust drug services capable of surviving a crisis. This is guided by a relevant policy design and implementation framework, alongside tangible action principles in line with low-threshold service provision.

Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature

The world bank has classified 80 economies based on their Gross National Income (GNI) per capita as High-Income. European Medicines Agency (EMA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA) are the major regulatory stakeholders driving global pharmacovigilance regulations. The purpose of this article is to describe pharmacovigilance systems and processes in high-income countries, particularly those that are also members of the International Conference on Harmonization (ICH). All high-income countries are members of the WHO PIDM. The income level of a country has a direct relationship with medicine safety measures. All ten pioneering members of the Uppsala monitoring centre are from high-income countries and were the first responders after the thalidomide tragedy by making drug evaluation committees, introducing the ADR reporting forms and taking safety measures. Despite access to the VigiBase, some countries have separate databases for managing and analyzing data like Canada Vigilance online database, FDA Adverse Event Reporting System, the French pharmacovigilance database and European Union's system Eudravigilance. All high-income countries have robust pharmacovigilance systems. USFDA and EMA are the world leaders in the field of pharmacovigilance. Most high-income countries follow EMA guidelines. Medicine safety is directly influenced by a country's income level.

THC and THC-COOH hair concentrations: Influence of age, gender, consumption habits, cosmetics treatment, and hair features

Evaluation of Cannabis consumption is required for many purposes (i.e., workplace drug testing and driving license renewal). Hair analysis represents the most adopted and reliable approach for the investigation of repeated or chronic exposure to Cannabis. The main markers are the Δ9-tetrahydrocannabinol (THC) and its main metabolite, 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH), as stated by the Society of Hair Testing (SoHT) and the European Workplace Drug Testing Society (EWDTS). In this paper we presented an observational study on the hair concentrations of THC and THC-COOH and influences due to age, gender, consumption habits, and hair features. Data were collected from analysis of scalp hair samples (3-cm proximal segment) provided by subjects tested for THC consumption for personal purposes (i.e., workplace drug testing, personal use proving). The subjects provided an informed consent and a short questionnaire. A new analytical method was previously developed and then adopted. It consisted in a hydrolysis (1 mL of 1 M NaOH at 65 °C, 20 min) and a liquid-liquid extraction (with hexane/ethyl acetate,90/10, v/v in presence of 1.5 mL of H2SO4 1 M) of 25 mg of hair. A liquid chromatograph – tandem mass spectrometer (LC-MS/MS) equipped with a C18 column was used. The acquisition was in multiple reaction monitoring for the following transitions: 315→259, 193 m/z, for THC; 318→196, 123 m/z, for THC-d3; 345→299, 193 m/z for THC-COOH; 348→196, 302 m/z for THC-COOH-d3. Correlation between THC and THC-COOH hair concentrations was analyzed by Spearman’s rank correlation coefficient. In order to study the influences of several variables, a new value, Sqrt(THC*THCCOOH), was adopted. Its effectiveness and reliability were proved by the Principal Component Analysis. Relationships between the Sqrt(THC*THCCOOH) and the variables were studied through the Stepwise regression (p = 0.05). The normality of data distribution was tested by the Shapiro-Wilk test. The Lower limits of quantification were 10.0 (THC) and 0.2 (THC-COOH) pg/mg. Accuracy and precision always met the acceptable criteria. Recoveries were > 78% and ion suppression was observed for both the compounds. Data from 126 hair samples were included in this study: 54 subjects(42.9%) were positive both for THC and THC-COOH; none of the samples was positive for a single substance. Concentrations ranged from 0.18 to 1.75 ng/mg (median: 0.78 ng/mg) for THC and from 0.04 to 0.85 ng/mg (median: 0.31 ng/mg) for THC-COOH. Cannabinoids levels seemed to decrease with the age, with lower amounts in the subjects aged > 40 years (p < 0.05). Also years of consumption seemed to have a significant impact on hair concentrations, as higher levels were observed in consumers from > 10 years (p = 0.013). Moreover, this study further provided evidences of a significant reduction of THC and THC-COOH in bleached hair (p = 0.042).

Effects on secondary outcomes of the Brazilian version of the European unplugged drug use prevention program: drug knowledge, intention predictors, and life skill competencies

The drug use prevention program #Tamojunto2.0, a Brazilian version of the European Unplugged, showed effectiveness in preventing the alcohol use onset at short term. However, we aimed to evaluate the program effects on its secondary outcomes, such as drug knowledge, behavioral beliefs, attitudes, decision-making skills, and refusal skills. A cluster-randomized controlled trial (registration: RBR-8cnkwq) was conducted in 73 public middle schools in three Brazilian cities (N = 5,208 students; 49.4% girls; M age= 13.2 years). The intervention group attended twelve #Tamojunto2.0 lessons conducted by their own teachers previously trained. The control group received no intervention. Data were collected pre-intervention (February/March 2019) and at nine-month follow-up (November/December 2019). We used multiple imputation to handle missing data and performed multilevel mixed-effect regression models, adjusted for sex, age, socioeconomic status, and city. The #Tamojunto2.0 program seems to have increased drug knowledge (Coef.= 0.26, 95%CI = 0.17–0.36), and negative and non-positive alcohol beliefs (Coef.= 0.24, 95%CI= 0.05–0.42), according to its logical framework. Nevertheless, it was found no evidence regarding the program’s effect on marijuana beliefs, attitudes, decision-making skills, and refusal skills. These findings could explain the effectiveness of the program in preventing the onset of alcohol consumption in adolescent participants. More research is needed to observe the long-term effects of the program on primary and secondary outcomes.

Negotiating Drug Prices in the US—Lessons From Europe

This Viewpoint describes European drug price negotiation practices and compares them with practices in the US.

From JWH-018 to OXIZIDS: Structural evolution of synthetic cannabinoids in the European Union from 2008 to present day.

With new synthetic cannabinoids (SCs) appearing on the European drug market every year, early warning systems are key to detect, monitor, and respond to threats posed by them. The European Union Early Warning System (EU EWS) implemented by the European Monitoring Centre for Drugs and Drug Addiction has monitored these substances since their first European detection in 2008. Since then, national and international responses have been implemented, aimed at tackling risks posed by SCs. Throughout this time, new SCs have emerged on the European market containing diverse structural moieties, appearing to be designed in a way that circumvents existing legal controls, contributing to a complex public health scenario. This study provides an inventory of the SCs detected in the EU from 2008 to 2022, describing their structural evolution by analysing separately four structural features: their core, tail, linker, and linked groups. The range of structural changes is analysed considering key milestones, including the year of first report by the European Union Early Warning System to the key legislative changes that have occurred since. The analysis shows that from June 2021 to July 2022, 20 out of 23 newly emerged SCs evade the generic SC legislation introduced in China in May 2021. This supports the hypothesis that the protection of public health benefits from timely information exchange and careful assessment of the risks associated with these substances. Additionally, the introduction of legal responses, albeit an important instrument to reduce the availability of dangerous substances on the market, may also be accompanied by unintended consequences.

HTA204 HTA Assessment of Adaptive Trials for Oncology Drugs in Europe

Adaptive trials allow modifications to the trial design following initiation of the trial, and are of particular interest for research in oncology, increasing trial flexibility, efficiency, and the speed at which novel therapies can be evaluated. This study aimed to identify the likelihood for oncology therapies, investigated via adaptive trial designs, to obtain regulatory approval and positive HTA recommendations.

SA13 The Impact of the COVID-19 Pandemic on Collaboration and Innovation in Antiviral Drug Development: A Multi-Stakeholder Systems Dynamics Analysis

The COVID-19 pandemic has sent shock waves through our health systems and will potentially leave a long-lasting impact on the drug development process. The emergency pressure has encouraged unprecedented speed, innovation, and collaboration in antiviral drug development, and highlighted the shortcomings of traditional development. This research aims to: (1) explore qualitative stakeholder perspectives, in the context of IMI CARE (a European public-private antiviral drug development consortium) on how the drug development process is impacted by the time pressure caused by COVID-19 and by the steep learning curve that comes with a new disease, (2) translate these insights into a qualitative model, and (3) generate learnings from this model to improve future drug development. Conceptual model building workshops and semi-structured interviews have been conducted with stakeholders across the drug life cycle, including developers, regulators, HTA bodies/payers, HCPs and patients, to build an end-to-end conceptual model of the health system. The systems model represents the combined mental models of stakeholders across the drug life cycle and shows the overall perceived impact of the pandemic on collaboration, governance and patient-centredness of drug development, in a public-private-academic consortium. The conceptual modeling process confirmed that pandemic pressure promoted successful collaboration and positive momentum in drug development. The model has identified important variables and mechanisms that facilitated collaboration and innovation during the pandemic such as; an influx in availability of budget, more willingness to share information and resources the establishment of parallel validation tracks in development. Challenges were identified related to the uncertainty of project planning and intermediate results with effect on the progress and allocation of work packages to consortium partners. This model can be used to facilitate better informed and strategic decision making throughout the drug life cycle, contributing to more sustained responsiveness to emergencies in drug development going forward.

Size matters: comparing the MDMA content and weight of ecstasy tablets submitted to European drug checking services in 2012–2021

Purpose The 3,4-methylenedioxymetamphetamine (MDMA) content in ecstasy tablets has increased enormously throughout Europe across the past decade. This study aims to determine whether this is caused by the production of “stronger” tablets (more mg MDMA per mg of tablet), or if tablets have simply been getting larger and heavier (more mg of tablet in total). Design/methodology/approach A data set of 31,716 ecstasy tablets obtained in 2012–2021 by 10 members of the Trans European Drug Information (TEDI) network was analysed. Findings The MDMA mass fraction in ecstasy tablets has remained virtually unchanged over the past 10 years, with increased MDMA contents being attributed almost exclusively to increased tablet weight. These trends seem to be uniform across Europe, despite varying sampling and analytical techniques being used by the TEDI participants. The study also shows that while tablet weight correlates perfectly with MDMA content on a yearly basis, wide variations in the MDMA mass fraction make such relations irrelevant for determining the MDMA content of individual tablets. Research limitations/implications These results provide new opportunities for harm reduction, given that size is a tangible and apparently accurate characteristic to emphasise that one tablet does not simply equate to one dose. This is particularly useful for harm reduction services without the resources for in-house quantification of large numbers of ecstasy tablets, although the results of this study also show that chemical analysis remains crucial for accurate personalised harm reduction. Originality/value The findings are both new and pertinent, providing a novel insight into the market dynamics of ecstasy tablet production at a transnational level.

Novel psychoactive substances-related presentations to the emergency departments of the European drug emergencies network plus (Euro-DEN plus) over the six-year period 2014–2019

Introduction Novel psychoactive substances (NPS) have been increasingly reported in the last 15–20 years. We aimed to describe presentations to the emergency department (ED) with acute recreational drug toxicity involving NPS. Methods Data were extracted from the European Drug Emergencies Network (Euro-DEN) Plus database for all presentations to ED (36 EDs in 24 European countries) with acute toxicity between January 2014 and December 2019. Patient demographics, agents involved, and clinical outcomes were described and the subgroup of presentations involving NPS was compared with the rest of the cohort. Results Out of 43,633 Euro-DEN Plus presentations, 3304 (7.6%) involved at least one NPS. Agents were identified mainly based on self-report or clinical presentation, with analytical confirmation being performed only in 17.9% of NPS presentations. The proportion of NPS presentations varied by centre (0–48.8%). For centres where data were available for all 6 years, NPS-related presentations peaked in 2015 (11.9%). In 2014, 78.4% of NPS agents reported were cathinones, while only 3.4% were synthetic cannabinoids (SCs); conversely, in 2019 only 11.6% of NPS agents reported were cathinones, while 72.2% were SCs. NPS-related presentations involved younger patients (median 30 (23–37) vs. 32 (25–40) years, p < 0.001) and more males (84.8 vs. 75.8%, p < 0.001) compared with the rest of the cohort. Patients presenting to ED after using NPS were more likely to self-discharge (22.8 vs. 15.1%), less likely to be admitted to critical care (3.6 vs. 6.1%) but had a longer length of stay in hospital (median 5.1 (2.7–18.7) vs. 4.7 (2.5–9.2) h, p < 0.001). Death occurred in 0.5% of all presentations involving NPS and in 0.4% of non-NPS presentations. Conclusions This large multicentre series of NPS presentations to European EDs showed marked geographical variation and changes over time in the proportion of presentations to ED involving NPS, as well as the proportion of NPS subgroups.

Sales of Iodine-Containing Drugs in Europe Following the Beginning of the War Between Russia and Ukraine

This cross-sectional study investigates sales of over-the-counter iodine-containing drugs in 20 European countries between January 2021 and March 2022.