Productos de tabaco y relacionados: Portal europeo eu-ceg

Background: The Tobacco Products Directive (2014/40/EU) obliges manufacturers and importers of tobacco products and related to notify Member States the commercialization of these products through the EU Common Entry Portal (EU-CEG). The objective of this study is to describe the main data available in EU-CEG in Spain and analyze its implications for smoking control policies. Methods: Cross-sectional analysis of the data obtained in EU-CEG for Spain. The access is done through .xml or .pdf files, downloaded from the portal or consulted through its interface. It describes the distribution of products, manufacturers, presence of priority ingredients, Slim cigarettes and concentration of nicotine in liquids. Results: In the EU-CEG portal for Spain there are currently 42,736 records. 83.7% corresponds to the devices susceptible to nicotine release (67% of refill liquids, mainly with concentrations of 3, 6, 12 and 18 mg). In tobacco products, cigarettes (5%), cigars (5.9%) and water pipe tobacco (2.8%) stand out. Herbal products for smoking account for 0.1%. 5 of the priority ingredients for surveillance are present in more than 75% of cigarettes and rolling tobacco. There are 44 records of Slim cigarettes and 9 novel tobacco products. Conclusions: The EU-CEG portal has become a powerful tool in tobacco control. We highlight challenges that require a joint and comprehensive approach in aspects such as labeling and ingredients, Slim cigarettes and new forms of consumption.Fundamentos: La Directiva de Productos del Tabaco (2014/40/EU) obliga a los fabricantes e importadores de productos de tabaco y relacionados a notificar a los Estados miembros la comercialización de estos productos, a través del Portal de Entrada Común de la UE (EU-CEG). El objetivo del estudio fue describir los principales datos disponibles en el EU-CEG en España, así como analizar sus implicaciones para las políticas de control del tabaquismo. Material y métodos: Se realizó un análisis transversal de los datos obtenidos en el EU-CEG para España. El acceso se realizó a través de archivos en formato xml o pdf, descargados del portal o consultados mediante su interfaz. Se describió la distribución de productos, de fabricantes, la presencia de aditivos prioritarios, y la concentración de nicotina en los líquidos. Resultados: En el portal EU-CEG para España existen actualmente 42.736 registros. El 83,7% correspondía a los dispositivos susceptibles de liberación de nicotina (67% de líquidos de recarga, principalmente con concentraciones de 3, 6, 12 y 18 mg). En productos de tabaco destacaron los cigarrillos (5%), los puros (5,9%) y el tabaco para pipa de agua (2,8%). Los productos de hierbas para fumar supusieron el 0,1%. Cinco de los aditivos prioritarios para su vigilancia estaban presentes en más del 75% de los cigarrillos y del tabaco de liar. Existían 44 registros de cigarrillos Slim y 9 de productos novedosos de tabaco. Conclusiones: El portal EU-CEG se ha convertido en una potente herramienta en el control del tabaco. Destacan los retos que requieren un abordaje conjunto e integral en aspectos como el etiquetado y los ingredientes, los cigarrillos Slim y las nuevas formas de consumo

A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study

© 2023Background: The benefit of pharmacogenetic testing before starting drug therapy has been well documented for several single gene–drug combinations. However, the clinical utility of a pre-emptive genotyping strategy using a pharmacogenetic panel has not been rigorously assessed. Methods: We conducted an open-label, multicentre, controlled, cluster-randomised, crossover implementation study of a 12-gene pharmacogenetic panel in 18 hospitals, nine community health centres, and 28 community pharmacies in seven European countries (Austria, Greece, Italy, the Netherlands, Slovenia, Spain, and the UK). Patients aged 18 years or older receiving a first prescription for a drug clinically recommended in the guidelines of the Dutch Pharmacogenetics Working Group (ie, the index drug) as part of routine care were eligible for inclusion. Exclusion criteria included previous genetic testing for a gene relevant to the index drug, a planned duration of treatment of less than 7 consecutive days, and severe renal or liver insufficiency. All patients gave written informed consent before taking part in the study. Participants were genotyped for 50 germline variants in 12 genes, and those with an actionable variant (ie, a drug–gene interaction test result for which the Dutch Pharmacogenetics Working Group [DPWG] recommended a change to standard-of-care drug treatment) were treated according to DPWG recommendations. Patients in the control group received standard treatment. To prepare clinicians for pre-emptive pharmacogenetic testing, local teams were educated during a site-initiation visit and online educational material was made available. The primary outcome was the occurrence of clinically relevant adverse drug reactions within the 12-week follow-up period. Analyses were irrespective of patient adherence to the DPWG guidelines. The primary analysis was done using a gatekeeping analysis, in which outcomes in people with an actionable drug–gene interaction in the study group versus the control group were compared, and only if the difference was statistically significant was an analysis done that included all of the patients in the study. Outcomes were compared between the study and control groups, both for patients with an actionable drug–gene interaction test result (ie, a result for which the DPWG recommended a change to standard-of-care drug treatment) and for all patients who received at least one dose of index drug. The safety analysis included all participants who received at least one dose of a study drug. This study is registered with ClinicalTrials.gov, NCT03093818 and is closed to new participants. Findings: Between March 7, 2017, and June 30, 2020, 41 696 patients were assessed for eligibility and 6944 (51·4 % female, 48·6% male; 97·7% self-reported European, Mediterranean, or Middle Eastern ethnicity) were enrolled and assigned to receive genotype-guided drug treatment (n=3342) or standard care (n=3602). 99 patients (52 [1·6%] of the study group and 47 [1·3%] of the control group) withdrew consent after group assignment. 652 participants (367 [11·0%] in the study group and 285 [7·9%] in the control group) were lost to follow-up. In patients with an actionable test result for the index drug (n=1558), a clinically relevant adverse drug reaction occurred in 152 (21·0%) of 725 patients in the study group and 231 (27·7%) of 833 patients in the control group (odds ratio [OR] 0·70 [95% CI 0·54–0·91]; p=0·0075), whereas for all patients, the incidence was 628 (21·5%) of 2923 patients in the study group and 934 (28·6%) of 3270 patients in the control group (OR 0·70 [95% CI 0·61–0·79]; p <0·0001). Interpretation: Genotype-guided treatment using a 12-gene pharmacogenetic panel significantly reduced the incidence of clinically relevant adverse drug reactions and was feasible across diverse European health-care system organisations and settings. Large-scale implementation could help to make drug therapy increasingly safe. Funding: European Union Horizon 2020