Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 29 n° 299

Posts Tagged ‘patients’

Boehringer Ingelheim: Advancing anticoagulation care with new data at ESC Congress 2017

Posted by fidest press agency su giovedì, 24 agosto 2017

Boehringer IngelheimBoehringer Ingelheim today announced that it will present important new data on the treatment of patients with atrial fibrillation (AF) at the ESC Congress in Barcelona, Spain, 26-30 August 2017. In total, four abstracts have been accepted, investigating different aspects of AF patient treatment. The results of the RE-DUAL PCI™ trial have been selected for one of the Late Breaking Science sessions of the congress.The RE-DUAL PCI™ trial compared dual therapy with triple therapy after percutaneous coronary intervention (PCI) with stent placement in approximately 2,500 adults with atrial fibrillation. Patients were either treated with dabigatran etexilate (Pradaxa®) and a single antiplatelet agent or with the vitamin K antagonist (VKA) warfarin and two antiplatelets. The dabigatran doses investigated in this trial are the same doses which have already demonstrated effective stroke prevention in atrial fibrillation and are therefore approved around the world in this indication. “The presentation of the results of our RE-DUAL PCI™ trial at ESC is particularly timely as the focus of the 2017 congress is ‘40 years of PCI’”, commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “We are honoured that the results will be included in the congress Spotlight Session and hope that the findings from the trial will provide a valuable contribution to patient management in the PCI setting.” (photo: Boehringer Ingelheim)

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Stroke history higher in asymptomatic versus symptomatic atrial fibrillation patients

Posted by fidest press agency su giovedì, 22 giugno 2017

fibrillazione atrialeVienna, Austria Newly diagnosed asymptomatic atrial fibrillation patients have a higher rate of previous stroke than those with symptoms, according to results from the GLORIA-AF Registry presented today at EHRA EUROPACE – CARDIOSTIM 2017.1 The findings highlight the need for screening to identify atrial fibrillation patients with no symptoms so that stroke prevention treatment can be given.“Patients with non-valvular atrial fibrillation have a five-fold increased risk of stroke compared to those without atrial fibrillation,” said lead author Dr Steffen Christow, a cardiologist at Hospital Ingolstadt GmbH, Ingolstadt, Germany. “Strokes in patients with non-valvular atrial fibrillation tend to be particularly severe and disabling, with about half of patients dying within one year.”“Appropriate anticoagulant therapy substantially reduces the risk of stroke, but in many cases non-valvular atrial fibrillation is only diagnosed after a patient has had a stroke,” he continued. “When patients are unaware of their atrial fibrillation they remain untreated and unprotected from stroke.”GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a large, multinational, prospective registry programme involving patients with newly diagnosed non-valvular atrial fibrillation. This sub-analysis compared characteristics between symptomatic and asymptomatic patients in Western Europe.The study included 6 011 consecutively enrolled patients with non-valvular atrial fibrillation in Western Europe.2 Symptom status was defined by the European Heart Rhythm Association (EHRA) score: I-II asymptomatic/minimally symptomatic; III-IV symptomatic.
A total of 4 119 patients (two-thirds) were asymptomatic/minimally symptomatic (hereafter referred to as ’asymptomatic‘) and one-third (1 892) were symptomatic at the time of diagnosis. A number of differences were observed between the two groups.In terms of medical history, asymptomatic patients were twice as likely to have permanent atrial fibrillation (15.8% versus 8.3%) and more than twice as likely to have had a previous stroke (14.7% versus 6.0%) than patients in the symptomatic group. Asymptomatic and symptomatic patients had a similar number of stroke risk factors, as indicated by a CHA2DS2-VASc score of 3.3 in each group.Dr Christow said: “The finding of a higher rate of previous stroke in the asymptomatic patients despite no differences in the number of stroke risk factors may be explained by a longer but undiagnosed history of atrial fibrillation.”“Our study found that in Western Europe, two-thirds of patients newly diagnosed with atrial fibrillation were asymptomatic,” he continued. “Without detection, patients may not receive appropriate preventive therapy and remain at increased risk of stroke.”Dr Christow concluded: “These results underline the urgent need for public programmes to detect atrial fibrillation in the general population.”

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International Forum on Cancer Patients Empowerment “Shared decisions, one policy”

Posted by fidest press agency su giovedì, 11 maggio 2017

università studi milanoMilano, 16 al 17 maggio 2017 presso l’Università degli Studi. Nella sessione di apertura dalle 9.30 alle 10.15 sono attesi gli interventi del Ministro della Salute, Beatrice Lorenzin, e del Ministro dell’Istruzione, dell’Università e della Ricerca, Valeria Fedeli. L’equilibrio tra innovazione e sostenibilità, in uno scenario caratterizzato dai nuovi trend dell’oncologia di precisione e della medicina genica e personalizzata, sarà al centro di una
successiva sessione dedicata (dalle 11.45 alle 13.30), dove interverranno tra gli altri, Mario Melazzini, Presidente dell’Agenzia Italiana del Farmaco, Massimo Scaccabarozzi, Presidente di Farmindustria, e Nathalie Moll, EFPIA General Director. Nella giornata del 17 maggio, Gianluca Vago, Rettore dell’Università degli Studi di Milano introdurrà la sessione di apertura, in cui Paolo Corradini, Direttore del Dipartimento di Oncologia ed Onco-ematologia dell’Ateneo milanese, illustrerà l’esperienza maturata negli anni da quello che oggi, con oltre 60 addetti, si propone come un centro di eccellenza, tra i più grandi a livello europeo, dedicato alla ricerca e cura oncologica. Il Forum avrà luogo presso l’Università degli Studi di Milano, sede di importanti gruppi di ricerca operanti nel contesto e partecipe di molti dei più rilevanti programmi di ricerca nazionali e internazionali sul fronte della ricerca scientifica e su quello del trasferimento tecnologico e di sviluppo applicativo dei risultati della ricerca scientifica. La partecipazione dei cittadini ai processi decisionali rappresenta uno dei valori fondamentali su cui si basa la strategia comunitaria europea, anche nella pianificazione dei nuovi programmi sanitari. “Shared decisions, one policy” è il primo Forum internazionale dedicato ai diritti dei pazienti e al loro attivo coinvolgimento nel processo decisionale clinico e nelle politiche di sanità pubblica nell’era dell’oncologia personalizzata, con particolare riferimento alle esigenze di omogeneizzazione e riequilibrio tra i diversi standard assistenziali europei.
Il Forum propone una sintesi multidisciplinare e multidimensionale, offrendo il contributo di tutte le categorie a vario titolo interessate e coinvolte su questo tema in Italia e in Europa: rappresentanti dei pazienti, operatori sanitari, politici, legislatori e regolatori, organizzazioni internazionali, organismi governativi e aziende farmaceutiche. Il Forum contribuisce al dialogo internazionale sul diritto umano ad uno stato ottimale di salute, collocandosi a pieno titolo all’interno del contesto dell’azione comune europea sul controllo del cancro.
La partecipazione al Forum non prevede costi di iscrizione ed è aperta a tutti gli interessati, previa registrazione sul sito: http://www.forumcpe.it (foto: università studi milano)

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Unemployment associated with 50% higher risk of death in heart failure patients

Posted by fidest press agency su martedì, 2 maggio 2017

infarto-miocardico-acutoParis, France. Unemployment is associated with a 50% higher risk of death in patients with heart failure, according to research presented today at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure. The observational study in more than 20 000 heart failure patients found that not being employed was linked with a greater likelihood of death than history of diabetes or stroke.“The ability to hold a job brings valuable information on wellbeing and performance status,” said lead author Dr Rasmus Roerth, a physician at Copenhagen University Hospital, Denmark. “And workforce exclusion has been associated with increased risk of depression, mental health problems and even suicide.”“In younger patients with heart failure, employment status could be a potential predictor of morbidity and mortality,” he continued. “If that was the case, employment status could help to risk stratify young heart failure patients and identify those needing more intensive rehabilitation.”This study compared the risks of all-cause death and recurrent heart failure hospitalisation in patients with heart failure, according to whether they were employed at baseline or not. Using the unique personal identification number assigned to all residents in Denmark, individual data was linked from nationwide registries on hospitalisation, prescribed medication, education level, public welfare payments, and death.The study included all patients of working age (18 to 60 years) with a first hospitalisation for heart failure in Denmark between 1997 and 2012. Of the 21 455 patients with a first hospitalisation for heart failure, 11 880 (55%) were part of the workforce at baseline.During an average follow-up of 1005 days, 16% of employed and 31% of unemployed patients died, while 40% of employed and 42% of unemployed patients were rehospitalised for heart failure.After adjusting for age, sex, education level and comorbidities, heart failure patients unemployed at baseline had a 50% increased risk of death and 12% increased risk of rehospitalisation for heart failure compared to those who were employed. Not being part of the workforce was associated with a higher likelihood of death than history of diabetes or stroke.Dr Roerth said: “We found that heart failure patients out of the workforce at baseline had a higher risk of death. Not being part of the workforce was associated with a risk of death comparable to that of having diabetes or stroke. Those without a job also had an increased risk of recurrent heart failure hospitalisation.”Dr Roerth said the exact mechanism on how employment status may affect mortality is complex and most likely multifactorial. “The ability to work can be seen as a measure of performance status and be interpreted as whether patients meet the physical requirements of a full time job or not,” he said.But he added: “Employment status is more than just a physical measurement as it also has an influence on quality of life, and has been shown to be important for mental health and wellbeing. Thus, both from a physical and psychological point of view it makes sense to include employment status in the evaluation of young heart failure patients’ prognosis.”Dr Roerth said it was perhaps not surprising that employment status has importance for prognosis. “But the observation that employment status is associated with an increased risk of death comparable to that of many other comorbidities such as diabetes and stroke is notable,” he said.In terms of implications of the findings, Dr Roerth said workforce exclusion could be used to identify heart failure patients at risk of poor outcomes and that efforts to get patients back into work might be beneficial.He said: “It could be highly valuable to assess employment status and actually think of workforce exclusion as a prognostic marker in line with suffering from serious chronic diseases. Knowledge on why workforce exclusion has happened for the individual patient might lead to ideas on how it can be prevented – for example with more intensive rehabilitation, physical activity, psychological treatment, or a different job.” Authors: ESC Press Office.

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International Forum on Cancer Patients Empowerment

Posted by fidest press agency su venerdì, 21 aprile 2017

porta nuova milanoMilano 16 e 17 maggio a Milano l’International Forum on Cancer Patients Empowerment, primo appuntamento promosso su questo tema a livello europeo.
Nella sessione di apertura il 16 maggio dalle 9.30 alle 10.15 sono attesi gli interventi del Ministro della Salute, Beatrice Lorenzin, e del Ministro dell’Istruzione, dell’Università e della Ricerca, Valeria Fedeli. L’equilibrio tra innovazione e sostenibilità, in uno scenario caratterizzato dai nuovi trend dell’oncologia di precisione e della medicina genica e personalizzata, sarà al centro di una successiva sessione dedicata (dalle 11.45 alle 13.30), dove interverranno tra gli altri, Mario Melazzini, Presidente dell’Agenzia Italiana del Farmaco, Massimo Scaccabarozzi, Presidente di Farmindustria, e Nathalie Moll, EFPIA General Director. Nella giornata del 17 maggio, Gianluca Vago, Rettore dell’Università degli Studi di Milano introdurrà la sessione di apertura, in cui Paolo Corradini, Direttore del Dipartimento di Oncologia ed Onco-ematologia dell’Ateneo milanese, illustrerà l’esperienza maturata negli anni da quello che oggi, con oltre 60 addetti, si propone come un centro di eccellenza, tra i più grandi a livello europeo, dedicato alla ricerca e cura oncologica.
Il concetto di patient empowerment, coniato e sviluppatosi negli Stati Uniti a partire dagli anni ’70, ha segnato una vera e propria rivoluzione nel mondo della salute. Un cambiamento culturale, che ha posto il paziente al centro del processo di cura, con la sua storia personale, il suo vissuto, il suo ambiente, la sua rete di relazioni. E’ stato dimostrato, infatti, che la consapevolezza del paziente rispetto alle proprie condizioni di salute e al proprio percorso di cura incida positivamente sull’esito delle terapie e porti benefici alla collettività in termini di risparmio e maggiore efficienza del Sistema. Per questo, l’empowerment del paziente oncologico si pone oggi come riferimento imprescindibile e unificante delle politiche a livello globale: la partecipazione dei pazienti ai processi decisionali è uno dei valori fondamentali su cui si basa la pianificazione delle nuove strategie sanitarie dell’UE. I pazienti europei sono chiamati ad essere più coinvolti in ogni aspetto della loro salute, dal rimodellamento della sperimentazione clinica alla legislazione e in tutte le questioni che li riguardano in prima persona, compresa quella della gestione dei dati genetici, al centro dei nuovi protocolli della medicina personalizzata.
Troppo spesso, tuttavia, il “patient empowerment” resta ancora relegato a una dichiarazione di intenti e raramente tradotto nella prassi medica e sanitaria quotidiana. “Shared decisions, one policy” è il titolo scelto per questo primo Forum, che affronterà la sfida di tradurre in azioni concrete e buone pratiche la centralità del paziente oncologico, grazie al ruolo chiave che può essere giocato dalla sinergia tra scienza e formazione. Con questo obiettivo, l’evento vedrà il contributo di tutti gli attori coinvolti nel Sistema (rappresentanti dei pazienti, operatori sanitari, politici, legislatori, regolatori, organizzazioni internazionali, organismi governativi e aziende farmaceutiche) per fare il punto sui traguardi raggiunti e tracciare una roadmap per affrontare esigenze e sfide future.

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Clinical trial rules should protect patients and results not operational details

Posted by fidest press agency su giovedì, 9 marzo 2017

Sophia Antipolis. Rules governing the conduct of clinical trials are failing to produce the intended benefits for patients and should be rewritten through a transparent process that involves academic clinical trialists and patient advocates as well as regulators and industry representatives, according to recommendations published today in European Heart Journal. The call comes from the Cardiovascular Round Table (CRT), an independent forum of the European Society of Cardiology (ESC), which convened regulators, drug companies, academic clinical trialists and patients to discuss the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. “Well conducted randomised clinical trials are the bedrock of safe and effective, evidence-based treatment of cardiovascular disease. However, the cost and complexity of clinical trials has risen out of all proportion,” said lead author Professor Martin Landray, Professor of Medicine and Epidemiology, Clinical Trial Service Unit, University of Oxford, UK. “It means that many potential new treatments are abandoned before their efficacy has been thoroughly assessed. Furthermore, some ineffective or harmful treatments may continue to be used widely because of a lack of robust clinical trial data.” The paper argues that GCP requirements for randomised clinical trials should be based on the overarching principle of minimising issues that may materially impact the well-being of trial participants or the reliability of the results.Professor Landray said: “The emphasis on reliable results is not just for academic reasons. It’s the results that impact on the care of future patients. If a treatment really works but your trial fails to prove it then you’ve missed an opportunity. If a treatment is not safe and you miss that because your trial is too small or is badly conducted then that’s also bad for patients.” “The rules should be based on the principles, not on the operational details which will, and should change over time,” said Professor Barbara Casadei, ESC President-Elect and co-chair of the CRT. “We have no idea what technology and healthcare systems will look like in ten years. What we do know is that protecting patients and obtaining reliable results will remain a priority.” “Even today, innovative approaches to trial design, such as randomisation within the context of a large cardiovascular registry, are often thwarted by concerns about how to adhere to current GCP requirements that were written before the advent of smartphones or the widespread use of electronic healthcare records,” said Professor Landray.The current rules are determined by the ICH (www.ich.org) which includes a select group of regulators, for instance, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and pharmaceutical companies. It does not involve patients, scientific organisations, or academic clinical trialists. The CRT asserts that these groups have a major role to play in improving clinical trial guidelines. Indeed, previous experience, particularly in the US but also in Europe, has demonstrated the importance of effective engagement of all those involved in clinical trials, including academic and patient communities. The CRT meeting was the catalyst for MoreTrials, a public campaign “for more, better, randomised trials”, of which the ESC is an active supporter. These efforts have had some success, including signs of positive engagement from the ICH. For example, ICH has already made some helpful changes to GCP. In June 2016, Professor Landray and colleagues were invited to present the CRT’s concerns to the ICH meeting and as a result, in January 2017, the ICH launched a consultation on a proposal for more widespread revisions to its key guidelines.Professor Landray said: “We are delighted that the ICH is starting to listen but there is still a way to go. The ICH has proposed only limited academic engagement in the development of new GCP guidelines (largely confining our input to studies that are observational or based on existing databases).”Professor Casadei concluded: “The ESC will continue to campaign for much greater engagement between regulators, pharmaceutical companies, patients, scientific organisations and academic organisations in the development and application of clinical trials regulations. Such work is critical to advances in care and improvements in outcomes for patients with cardiovascular disease”

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One-third of heart failure patients do not return to work

Posted by fidest press agency su lunedì, 23 maggio 2016

ospedaleOne-third of patients hospitalised with heart failure for the first time have not returned to work one year later, reveals a study in nearly 12 000 patients presented today at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure by Dr Rasmus Roerth, a physician at Copenhagen University Hospital in Copenhagen, Denmark.1. “Employment is crucial for self esteem and quality of life, as well as being of financial importance, in patients with all kinds of chronic illness,” said Dr Roerth.He continued: “Inability to maintain a full time job is an indirect consequence of heart failure beyond the usual clinical parameters of hospitalisation and death. Most information on heart failure is derived from studies in older patients since they are the majority. This has led to a knowledge gap regarding the impact of living with heart failure among younger patients, who perhaps have the most to lose from the condition.”The study included 11 880 heart failure patients of working age (18 to 60 years) who were employed prior to being hospitalised for heart failure. Information on age, length of hospital stay, gender, education level, income, comorbidities and working status was obtained from Danish nationwide registries.2 All Danish residents are included in the registries and have a unique personal identification number making it possible to link information on an individual level.The researchers found that one year after being hospitalised for heart failure for the first time, 68% of patients had returned to work, 25% had not, and 7% had died.Dr Roerth said: “Among patients who are alive one year after their first heart failure hospitalisation, 37% did not return to work, which is a substantial proportion. It confirms that heart failure significantly reduces a patient’s capacity to maintain a normal life and live independently.” Younger patients (18 to 30 years) were over three times more likely to return to work than older patients (51 to 60 years). “This is perhaps not that surprising because younger patients have fewer comorbidities and may have a greater determination to stay employed,” said Dr Roerth. Patients with a higher level of education were twice as likely to return to work as those with basic schooling. Dr Roerth said: “This could be because higher education is associated with less physically demanding jobs. In addition, it may be more possible for highly educated patients to arrange a flexible work life.”Men were 24% more likely to return to work than women. “We do not think that this is primarily explained by men having a better recovery than women,” said Dr Roerth. “It could be that men are more often forced to return to work, for economical and other reasons. Having a work identify may be more important to men.” Conversely, patients were less likely to return to work if they had stayed in hospital for more than 7 days, or had a history of stroke, chronic kidney disease, chronic obstructive pulmonary disease, diabetes or cancer. Dr Roerth said: “It’s important to highlight that our findings are associations and not necessarily causal connections. The associations might help to identify which patients are at the greatest risk of becoming unemployed after being in hospital with heart failure for the first time.” He continued: “More research is needed to better understand why this loss of employment occurs among those who were working before they went into hospital. It could be that physicians are afraid to advise returning to work because they have unfounded concerns about the risks. Some patients may have been wrongly told they were at high risk of death but could safely return to the workforce.” Dr Roerth concluded: “Removal from the labour market and dependence on public benefits has great economic consequences which go beyond the already significant financial burden that these patients place on the healthcare system. More knowledge on what stops patients going back to work will put us in a better position to find ways of preventing it, for example with more intensive rehabilitation, psychological support, or education.”

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Earlier treatment would cut spending on migrant healthcare in the EU: FRA study

Posted by fidest press agency su giovedì, 3 settembre 2015

african_migrants.jpg.crop_displayWhile the issue of migrants at the EU’s borders is currently at the top of the European agenda, once in the EU irregular migrants often find themselves cut off from health screening and preventive treatment. However, new research by the EU Agency for Fundamental Rights (FRA) suggests that Member States would spend less on migrant health by treating them earlier, rather than waiting until they require emergency treatment.Access The cost of exclusion from healthcare – the case of migrants in an irregular situation summary and full report >> In the first such research to investigate the cost-effectiveness of providing access to healthcare for irregular migrants, FRA used economic analysis based on a decision tree model to estimate the expenditure necessary for timely access to screening and medical care for irregular migrants, compared with the cost of emergency treatment. The research examined the situation in Germany, Greece and Sweden for two of the most common healthcare issues in the EU: hypertension and prenatal care.Based on available data, providing regular healthcare to hypertensive patients could: generate savings of approximately 9% over the space of one year, rising to 13% after five years and 16% over a lifetime help prevent more than 300 strokes and more than 200 heart attacks per 1,000 migrants in each country
Improved prenatal care could generate savings of up to 48% in Germany and Greece and as much as 69% in Sweden over the space of two years.
As documented by FRA’s earlier report on access to healthcare for migrants in an irregular situation, varying legal frameworks and practical barriers lead to substantial differences in healthcare services provided to irregular migrants around the EU. With many countries reducing their spending on social welfare in the wake of the financial crisis, FRA’s findings are particularly relevant. Combined with the fact that adequate healthcare is necessary in order to meet EU Member States’ fundamental rights obligations, this is a powerful argument to improve healthcare provision for irregular migrants throughout the EU. The three countries covered by this research project were chosen because of their geographical spread, the very different financing models for healthcare funding and public authority involvement in healthcare provisions, and the fact that all three have sizeable communities of migrants in an irregular situation. The medical issues selected are common health needs among irregular migrants. However, broader research covering a greater number of countries and health issues is needed for more conclusive analysis.

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Food allergy: a burden carried by more than 17 million Europeans

Posted by fidest press agency su sabato, 14 marzo 2015

zurichZurich With more than 17 million of Europeans suffering from allergies1, food allergy is one of the most common allergic diseases. As the prevalence of food allergy is greater among children than adults2, food allergy has been recognised as a major paediatric health problem in western countries. The number of hospital admissions for severe allergic reaction3 in children has increased 7-fold in the past 10 years in Europe4. No cure has been found yet and the disease is so unpredictable that it often causes anxiety in patients and caregivers, leading to social exclusion because of the fear of eating dangerous foods by mistake. Only clear information on ingredients and disease management can help food allergy patients”, says Breda Flood, EFA President. Food allergy is a major public health problem: governments and the general public are expected to face increasing direct and indirect costs, due to its major effects on lifestyle and quality of life4,5.The Beware of Allergy campaign highlights the increasing incidence and burden of food allergy and of severe allergic reactions such as anaphylaxis and calls on patients, healthcare professionals and pharmacists to familiarise themselves how to recognise early and manage these diseases.“By focusing on education for food allergy prevention, early diagnosis and correct management, EAACI hopes to help patients and their families to better control their food allergy and improve their quality of life and to increase the resources allocated by the society to manage the allergy epidemic”, says Antonella Muraro, EAACI Secretary General and President Elect. Prof. Muraro has also coordinated the publication of the Food Allergy and Anaphylaxis Guidelines, to translate best science into best practice.Prompt recognition and management of severe allergic reactions are of utmost importance as such reactions can be fatal. Caregivers, teachers and parents should be provided with information on how to manage severe allergic reactions, including adrenaline auto-injectors and instructions on how and when to use it6. It is crucial to better inform schools and restaurants staff so they can help patients avoid accidental exposure and make appropriate food choice

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Ensuring Access to Medicines for Patients: Pharmaceutical industry associations

Posted by fidest press agency su mercoledì, 21 gennaio 2015

BruxellesBrussels, AESGP, EFPIA, EGA, and PPTA are pleased to announce today’s release of the joint principles for “Communication of information on quality and manufacturing potential supply disruption”. This document forms part of the industry response to the EMA (European Medicines Agency) call for voluntary and proactive action, to provide European patients with continuous access to medicines.
There can be multiple causes to medicines shortages, including issues relating to quality and manufacturing. In cases where a disruption to the manufacturing process of a medicine arises, Marketing Authorisation Holders (MAHs) are obligated to timeously notify Competent Authorities (CAs). This document addresses such communications, and complements the output from the professional organisations ISPE & PDA on the prevention of such supply disruptions – see enclosed summary report.
This ‘Principles’ document introduces a harmonised approach to the communication of information by MAHs, meeting the complex and divergent data requirements across national CAs and EMA. This is expected to facilitate coordinated action between CAs; it will further enable CAs to gather standardised data for the identification and analysis of the causes, while considering mitigation strategies. This ‘Principles’ document constitutes a first and concrete step in the right direction and was warmly welcomed by the EMA and national CAs.AESGP, EFPIA, EGA, and PPTA believe that more can be achieved within the EMA initiative, particularly on reporting and notification mechanisms beyond manufacturers, which should form the next key milestone of the EMA initiative for 2015. This necessitates an integrated solution involving all stakeholders in the supply chain, illustrated in the recent report commissioned by DG Sanco1.The pharmaceutical industry is fully committed to working with these stakeholders, to mitigate factors that could contribute to supply disruptions, and to provide European patients with continuous access to the medicines they need.

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Faster and accurate identification of drugs causing allergic reactions: a great relief for patients

Posted by fidest press agency su venerdì, 19 settembre 2014

A new diagnostic set to become the regular method for the diagnosis of cutaneous adverse drug reactions is faster, safe and easy to perform Allergic skin diseases are among the most frequently misunderstood diseases that allergists have to deal with
Experts confirm that better and faster diagnosis will help improve the quality of life of patients with allergic skin diseases
Krakow (Poland), Medication is a major pillar in the management of many diseases. But for some patients, their use can have detrimental effects including cutaneous adverse drug reactions (CADR), a common form of allergic skin disease, what can seriously impact on their quality of life. For allergists, CADR can prove time-consuming, especially with regard to diagnosis, since they often require the use of more than one analytic system to find the drug causing the allergy.Until recently, no universal method has been available, despite allergic reactionsintensive research in this field over the preceding decades. However, the diagnosis of CADR could now improve significantly thanks to a new method developed by a group of researchers led by Dr Grzegorz Porebski, Jagiellonian University, Department of Clinical and Environmental Allergology (Krakow, Poland). Faster, safer, more accurate and widely availableThe new technique is faster and more accurate than existing methods as it allows the accurate identification of the drug causing the reaction:“People usually take more than one drug together and it’s impossible to withdraw all this medication immediately. Patients would like to know which drug they can continue using and which one not, and this is a big challenge. Now they have a new tool that can improve the causality diagnosis to exclude the drug which has caused the allergy and it can be used in quite a large group of people affected by these reactions,” explains Dr Porebski.In addition, the method is safer because it doesn’t require exposure of the patient to the drug, as it is performed in vitro with a blood sample. Another advantage is that the technique is easy to perform and could be easily available in health centres, as opposed to other methods which are more expensive and therefore not accessible to all patients.This new diagnostic method has been studied in a drug whose use is widespread among Europeans – carbamazepine – which is prescribed in cases of epilepsy, psychiatric disorders or neurophatic pain. However, the study is also to confirm the method’s efficiency in the use of antibiotics and new phases will be extended to other drugs.Dr Porebski will present the implications of this new method at the Third Skin Allergy Meeting (SAM) organised by the European Academy of Allergy and Clinical Immunology (EAACI). The meeting is being held in Krakow, Poland, starting today until Saturday. Europe’s leading researchers and clinicians in the field of skin allergy are gathering at SAM to share their expertise with participants on a wide range of topics from contact dermatitis, atopic eczema, urticaria and angioedema, to mastocytosis and anaphylaxis, drug and food allergies and the skin, diagnostics in skin allergy and hand eczema.
Allergies can be seen in almost every organ. Most commonly, however, it is the skin and the mucous membranes that are involved since they represent the frontier between the individual and their environment. Despite being so common, allergic skin diseases are among the least understood, and most frequently misunderstood, diseases the allergists have to deal with.The umbrella term for a local inflammation of the skin should be dermatitis. What is generally known as “atopic eczema/dermatitis” is not one, single disease but rather an aggregation of several diseases with certain characteristics in common.According to Professor Radoslaw Spiewak, Professor and Head of the Department of Experimental Dermatology and Cosmetology of the Jagiellonian University Medical College and President of the Local Organising Committee for the EAACI SAM, one of the common mistakes that allergists make is to consider all forms of eczema as atopic dermatitis. Another frequent error is to blame food allergy as the major cause of allergic skin diseases. Moreover, various types of eczema may co-exist in a patient, overlapping, and being replaced by one another. Sometimes, this situation occurs without being noticed by patient or doctor. Despite a similar appearance, the diversity of mechanisms underlying allergic skin diseases requires diverse and complex approaches.

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Patients with Phenylketonuria (PKU) Across Europe at the European Parliament

Posted by fidest press agency su giovedì, 1 marzo 2012

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Brussels (PRNewswire)Today, on World Rare Disease Day, the European Society for Phenylketonuria and Allied Disorders (E.S.PKU) urged policy makers to bridge significant gaps in Phenylketonuria (PKU) care across Europe during a lunch debate at the European Parliament. The E.S.PKU presented a set of recommendations based on the first PKU benchmark report “Closing the Gaps in Care”, launched on this occasion. The event was hosted by Members of the European Parliament (MEP) Esther de Lange and Antonyia Parvanova.Esther de Lange, MEP, said: “Unfortunately, for many diseases, as for PKU, vast differences exist between European Union (EU) countries. Therefore the EU Council Recommendation on the implementation of rare disease plans is a welcome signal. I invite national governments to include PKU as an example in these plans, including strong guidance on high standards of screening, care and treatment.””The level of health inequalities faced by patients suffering from PKU in Europe is unacceptable. Debating these with members of the Parliament in Brussels is a crucial step to draw attention to the condition which is one of the most common rare diseases in Europe,” said Eric Lange, President of E.S.PKU. “Through this initiative, we call on European policy makers and other decision-makers to help us give our PKU patients an equal chance of living a healthy and productive life, no matter where they live.”Maria Gizewska, Paediatrician, Poland, stressed: “The medical community is well aware of their responsibility and role in finding broader consensus on therapeutic threshold, treatment targets and advice. Despite recent advances in many aspects of PKU, there is however still a lack of baseline data on the condition globally, and more clinical evidence is needed to overcome this knowledge gap.”Eric Lange, E.S.PKU, concluded: “I call on those here in the room today to include PKU in activities undertaken at EU level such as the upcoming initiatives on Newborn Screening, and the Implementation Report on National Plans. Further, I would like to encourage healthcare professionals in particular to continue their endeavours in developing much-needed clinical guidance to ensure that all PKU patients receive the optimal care they deserve.”The debate is the first of a series of E.S.PKU initiatives to prioritize PKU as a rare disease on national health agendas, address unequal access to treatment and gaps in reimbursement. These initiatives are supported by an unrestricted grant from Merck Serono.A full version of the release can be downloaded at http://www.espku.org. We further invite you to watch and download the full launch debate at http://www.blastmedia.eu/espku (webcast available on the 29th February from 4pm CET onwards).

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Deadly epidemics in Africa

Posted by fidest press agency su martedì, 7 dicembre 2010

Ouagadougou, Burkina Faso,  For more than 100 years, sub-Saharan Africa has suffered from epidemics that exact a terrible and deadly toll. As many as 450 million people are at risk from the disease across Africa. Major group A epidemics occur every 7-14 years and are particularly devastating to children and young adults. The sickest patients typically die within 24 to 48 hours of the onset of symptoms, and of those who survive, 10 to 20 percent suffer brain damage, hearing loss or a learning disability. In 2009, the seasonal outbreak of meningitis across a large swathe of sub-Saharan Africa infected at least 88 000 people and led to more than 5 000 deaths.  Developed by the Meningitis Vaccine Project (MVP)?a partnership between the World Health Organization (WHO) and PATH, with support from the Bill & Melinda Gates Foundation ? the new meningococcal A conjugate vaccine MenAfriVac provides African health authorities, for the first time, with an affordable, long-term solution that protects even young children against meningitis A (group A Neisseria meningitidis).
The new vaccine has several advantages over vaccines currently used to combat meningitis epidemics in Africa: it protects children as young as one; and it is expected to both protect from the disease for significantly longer than the vaccine now used to combat epidemics, and to reduce infection and transmission. Reduced transmission in turn protects the larger community, including family members and others who have not been immunized. The rapid development of the vaccine is in large part due to the commitment of the Serum Institute of India, Ltd., the vaccine manufacturer. Africans have in the past waited as long as 20 years for a vaccine to travel from the industrialized north to the nations of the south. In this case, MenAfriVac will be introduced in Africa before it is distributed anywhere else.The process of developing the new vaccine and planning for its introduction has also helped strengthen systems in Africa for disease surveillance, clinical development, pharmacovigilance and vaccine logistics. Clinical trials, carried out in India, the Gambia, Ghana, Mali, and Senegal, beginning in 2005, have shown the vaccine to be safe and highly effective. Indian regulatory authorities granted marketing authorization for export and use of MenAfriVac in December 2009. In June 2010, the vaccine was prequalified by WHO, which guarantees that the vaccine meets international standards of quality, safety, and efficacy.
If MenAfriVac is introduced throughout sub-Saharan Africa, the resulting reduction in cases of meningitis is expected to free up more than US$ 120 million in the period up to 2015, money from national budgets which would otherwise be spent on medical costs for diagnosis and treatment. These funds can then be brought to bear on other problems of disease and poverty that weigh so heavily on the region. The GAVI Alliance has thus far contributed over US$ 85 million to the effort to eliminate meningococcal A meningitis in Africa. Yet, the full promise of the vaccine, to protect people throughout the African meningitis belt, can only be realized if an additional US$ 475 million is mobilized. The introduction of MenAfriVac in Burkina Faso will be closely followed by introduction in Mali and Niger, two other hyper-endemic countries in the meningitis belt. Vaccine introduction in these three countries has been made possible through the support of a number of funding and technical partners, including the Michael & Susan Dell Foundation, Médecins sans Frontières, and UNICEF. “Having procured the vaccine, UNICEF is working with the Ministry of Health of Burkina Faso and local communities to ensure that this extraordinary campaign is a success,” said Dr Gianfranco Rotigliano, Regional Director of the UNICEF Regional Office for West and Central Africa.
Established in 2001, the Meningitis Vaccine Project is a partnership between PATH and the World Health Organization. Its mission is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa through the development, testing, introduction, and widespread use of conjugate meningococcal vaccines.

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Reproductive health

Posted by fidest press agency su martedì, 5 ottobre 2010

European patients are in many countries, in fact, limited in their individual choice of medically assisted reproduction (MAR) treatment, experts from the European Society of Human Reproduction and Embryology (ESHRE) stressed today at the European Health Forum Gastein (EHFG). The EHFG is the most important conference on health care policy in the EU. This year it has attracted about 600 decision-makers from more than 40 countries in the fields of health care policy, research, science, and business as well as from patients’ organizations. During an ESHRE workshop the political, professional, industrial and patient perspectives highlighted the problems related to the patchwork of MAR regulation in Europe. The regulatory diversity in MAR is attributed to the religious, cultural, social, ethical and moral attitudes prevalent in individual countries towards human life and its origins. In particular, gamete and embryo donation, surrogacy and preimplantation genetic diagnosis are hot spots in MAR regulation in Europe. Demand for infertility treatment on the rise The field of MAR is subject to the EU directive 2004/23/EC on quality and safety of human tissues and cells. “19 Member States have specific legislations in place for MAR, in the remaining eight countries, MAR is covered by the general health legislation,” said Isabel de la Mata from the European Commission. “The organization of health systems is the exclusive competence of the members, meaning the legally allowed forms of treatment, the eligibility criteria and the reimbursement of treatments all vary between the Member States.” And yet demand for MAR treatment is on the rise in Europe. The latest survey by ESHRE – the only one of its kind in Europe – found that 494,599 treatment cycles were performed in Europe in 2006 compared to 203,893 cycles ten years earlier. The number of clinics reporting to the survey increased from 482 to 1,016 during the same period. In several European countries 2-5% of children are born after MAR, with every one in six couples seeking some sort of medical assistance in order to achieve a pregnancy. 30,000 couples seek treatment outside their home countries

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III Foresight Training Course in Krakow

Posted by fidest press agency su mercoledì, 25 agosto 2010

Krakow 1/3 September 2010 Relevant European experts from the European Agency of Medicines (EMA), National Agencies, Pharmaceutical and Patient’s Association Representatives around Europe will meet in Krakow for a high-level course: “Benefit/Risk Assessment of Medicines to achieve shared objectives: from Research to Reality”. Health Authorities have the role of guaranteeing the safety of the patients but have also the responsibility to drive their efforts towards the most important clinical needs… and in the meantime the interests of industry and the interests of patients have to meet each other. The III “Foresight Training Course” is organised by the ‘Gianni Benzi’ Pharmacological Research Foundation, in collaboration with the National Medicines Institute and the Children’s Memorial Health Institute of Warsaw; it takes inspiration from the EMA Road Map and is intended to re-read all the phases of drug development, with the benefit/risk ratio as a compass and primary target of the efforts of all involved in this difficult process. From orphan and paediatric drugs to pharmacovigilance, from the pre-marketing to the post-marketing phase, as well as from the submissions of Clinical Trial applications to a comparative evaluation of the B/R ratio, taking into account also economic elements (HTA), the course will review Benefit/Risk assessment during the entire process of research and development. http://www.benzifoundation.org

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Reproduction under new savings scheme

Posted by fidest press agency su venerdì, 28 maggio 2010

The Danish government until now provided reimbursement for assisted reproduction treatments (ART) with up to three treatment trials for married and unmarried couples, singles and homosexuals. In light of the need to prioritise public expenditure, the Parties agreed this month to implement a legislative amendment, so that Assisted Reproduction Treatment (ART) will no longer be part of the free public health services. ‘This is sad news considering Denmark has always been praised as the benchmark in Europe in terms of access and availability of treatment for patients seeking ART’ said Dr. Søren Ziebe from the University Hospital in Copenhagen, Executive Committee Member of ESHRE and the SIG coordinator of all SIGs at ESHRE. The Danish government has allocated a pool of a mere 50 million Danish Krone (approximately 6.7 million Euros) for groups with special needs only. The cuts in this area will decrease government spending by 200 million Danish Krone (EUR 26.9 million) annually in 2011, 2012, 2013 and thereafter. In 2007, 4.9% of all children born in Denmark were babies conceived with the help of ART, according to the ESHRE European IVF Monitoring Group (EIM). With 2,558 cycles per million inhabitants annually, Denmark has the highest availability of ART in Europe. ‘Every school class in Denmark has two IVF children on average’ said Dr. Ziebe. ‘These changes will have major implications and detrimental effect for childless couples, for fertility clinics and the research environment in Denmark.’:http://www.eshre.eu/page.aspx/1020

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The health of Europe

Posted by fidest press agency su martedì, 25 maggio 2010

The EU should intensify its efforts towards establishing of a common health care system, based on know-how from the countries with the most effective systems. Together with Member States it should implement an equal basic standard of healthcare for each EU-citizen. There should be centralised oversight of provisions and standards. An independent mechanism for EU wide recognition of qualifications for medical and health care professionals should be developed and  implemented.  The EU should recognise patient mobility as a core component of the freedom to avail services  EU wide. Therefore it should develop legal certainty regarding the mobility of patients especially  in the case where services are not provided in a member state or where there are long waiting lists. The European Commission should establish a common database, where patients could obtain information regarding medical treatment in other Member States. For the purposes of disease prevention and the reduction of health risks, the EU should encourage Member States to place greater emphasis on health promotion. Funds should be  earmarked for compulsory examination of the whole population, in accordance with the principle “prevention is less expensive that treatment”. The EU should develop global disease prevention campaigns, particularly for HIV, diabetes, obesity and cardiovascular diseases. The EU should provide guarantees that health services will be offered on a competitive basis,  including that the national health markets will be liberalized.The EU should establish a regulatory framework to set health insurance premium fees at a minimum.  The EU should encourage links between alternative and mainstream medicine. It should regulate research, transfer of good practices, and education in alternative medicine. Treatments in alternative medicines should also be fully reimbursed by health insurance providers. All 27 Member States should become members of the European Organs Bank.

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Citadelle Regional Hospital Liège (CHR)

Posted by fidest press agency su sabato, 15 agosto 2009

Louvain-la-Neuve  The Citadelle Regional Hospital (CHR), an inter-municipal public hospital, operates at three sites in the heart of the city of Liège. Among their many activities, the human resources and nursing departments of the CHR conduct satisfaction surveys among patients, following instructions from the Walloon Region. Generally these surveys consist of forms which, once completed by the patients, are encoded into database systems. This easily amounts to 7,000 pages per survey. The results are then interpreted using statistical tools. Obviously, the manual encoding of the responses represents a heavy workload and offers only little added value, which is why the Citadelle Regional Hospital wished to acquire a solution for the scanning and automatic form recognition. For this project, I.R.I.S. implemented digitisation technologies that collect the images and extract information from the appropriate fields. At the end of the chain, both the images of the scanned forms and the data that was captured from them are exported into the CHR’s systems where the results are interpreted. Yves Alsteens, Sales Manager at I.R.I.S., says: “Since the CHR wanted to end up with full control of the solution, I.R.I.S. organised training for a manager appointed by the CHR: this person will therefore be capable of managing and customising the recognition system with complete autonomy, which will allow the hospital to make optimum use of the solution by automating the processing of other forms.”- http://www.iriscorporate.com

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