EMA boosts EU transparency with online publication of suspected side effect reports




Member States and the Agency release data on medicines in compliance with EudraVigilance access policy

31/05/2012 – The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: http://www.adrreports.eu. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The information published today relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

A side effect (also known as an adverse drug reaction) includes side effects arising from use of a medicine within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

All information on the website relates to suspected side effects. Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.

Medicines are an important part of modern healthcare, providing effective treatments for many diseases and conditions. For a medicine to be authorised for use in the EU the benefits of the medicine must always outweigh the risks.

Today’s launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the EU. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.

In June, the Agency will launch the website in the remaining 22 official EU languages.

Press release issued May 31st, 2012 on the EMA website – http://www.ema.europa.eu

You are responsible for what you share online

A video from Andew Keen on CNN, author of “Digital vertigo”, has been buzzing today and kept popping up on my LinkedIn, Twitter or Facebook with that dramatic title “Opinion: Facebook threatens to ‘Zuck up’ the human race”. Wow. With such a title, you can only click the link, read the article and watch the video (over here)

In my opinion, Andew Keen does have a good point (many actually), particularly when he says that we live in an era of digital narcissism, but also when he says that we all became the products of social platforms. He puts in those words: “Networks like Facebook have turned us into products in which their only economic value is our personal data.”

That’s undeniable. Facebook might be the big bad guy, the devil, blabla, and it’s your right to think that as many of the self-called experts as well as journalists like to think and like you to think. I have no real opinion on that. Facebook is a company and like all businesses it needs some kind of income, a product, other than investors injecting money in it. Since Facebook does not offer any paying membership, which could be a consequent revenue source, they have to “sell” something else. It makes sense in a way, a business has got to earn something to keep existing, right?

So, well, here’s my view on that, something I have in mind constanly when I hear people whining about what a devil facebook is selling our data (yet those are the same people who are all day long on it and sharing everything they do by the minute): you are responsible for what you put online. Nobody forces you to put pictures of you in a bikini on Facebook. Nobody forces you to give your home address and personal phone numbers to Facebook. Just because there’s some not mandatory field to fill, you don’t have to fill it. YOU put that data in there, so if you don’t want it to be used, then don’t put it in the first place.

But here’s the bad news for those who scream that Facebook has their home address (they gave it to facebook themselves, remember?) – you can erase it from your facebook profile, you can even dactivate your account, your data will not show anymore but Facebook does keep it in store. Everything you ever posted, wrote and deleted, remains.

So in my humble opinion, the issue here is not that Facebook sells our personal data to advertisers. Google does it. Many others do it. Did you ever book a flight online, let’s say to London, and noticed in the days afterwards that on any website with ads you’d visit (online dictionaries or whatever), you’d see ads about cheap flights to London? There you go. See, Facebook are not the only ones… and those are in my eyes somehow freakier, because that means The Internet God knows exactly what I do, what I search, when and where without me even knowing nor asking for it. I just booked a flight to London, damn! While on Facebook, again, YOU chose to enter your personal information on your own.

Nope, I think the issue is multiple. Facebook should inform its users about it, clearly and plainly, that’s a first point. Facebook should also inform us plainly and clearly that whet we think we erase from our profile remains stored in the Facebook attics for God knows how long. And the third issue is ourselves, and this is where I agree with Andrew Keen: digital narcissism. We don’t have to share everything we’re doing. We don’t have to post everything we think. We don’t have to. We don’t need to. Nobody forces us to share this and that and everything on Facebook or Twitter or whatever.

So don’t do it. There’s not much more to say to it. Use your common sense. Be a grown-up. We are all responsible for ourselves.

GxP will be attending Hit Paris and Hôpital Expo 2012





We are pleased to announce that we will be travelling to Paris from May 21st to 23rd to attend the Hit Paris and the Hôpital Expo Trade Shows this year again.

Here’s the HIT Paris editorial from Stéphane Pic-Pâris, Event Director

Simultaneously an Exhibition and a Conference, Hit Paris has firmly established its position as the leading event dedicated to technologies and information systems applied to health.
Information systems have become a crucial factor in health organisation strategy. Long limited to management and office automation applications, hospital IT systems have now become routine tools of the trade and decision-making aids.

For 4 unifying and cross-cutting days, from 22 to 25 May, 2012, Hit Paris and HOPITAL EXPO remain the first – and leading – business event bringing together buyers, decision-makers and users, as well as institutional and industrial players around the central themes represented by the implementation of shared information systems hinged around patient care and electronic communication.
Exhibitors will therefore have a wealth of opportunities for direct contact with their core target having gathered for the occasion.

This 6th edition of the event will be an opportunity for participants to understand, learn, debate and share their experiences – in the form of workshops, lectures, business paths – focusing on the challenges posed by digital technologies and services.

2012 objective:
Modernise and simplify exchange.Make HIT Paris more open to community medicine and private-practice health professionals/Reinforce Community-Hospital communication.

In 2012, Hit Paris is further consolidating its image as a showcase for cutting-edge technologies and a catalyst for projects and is proposing a number of events and novelties: Hit.TV, the Hit Cyber Café, new business paths, the Hit Awards, new themed spaces, innovative and dynamic services that you can discover on the pages that follow.

Source http://www.health-it.fr/index.asp

Complete info about the event: http://www.health-it.fr/

The Top 100 Language Lovers 2012 Competition

It’s on again! The bab.la language portal and the Lexiophiles blog announced the start of the Top 100 Language Lovers 2012 competition on May 2nd. The nominations phase is now over and the voting phase starts today and runs until May 28th.

Here are the four categories in the competition:

1. Language Learning Blogs: blogs about the language learning process, both from the learners and teachers perspective.
2. Language Professionals Blogs: blogs by people using languages in their profession, such as translators or interpreters.
3. Language Facebook Pages: Facebook Pages related to language topics, such as dictionaries, translation tools, language lovers’ communities and more.
4. Language Twitter accounts: Twitterers who share content about languages.

All information on the competition is available here
Time to vote ! This way…

Neues Telemedizin-Projekt “Mein Herz” in NRW

Medizinische Betreuung durch elektronische Ferndiagnose. Beim Telemedizin-Projekt “Mein Herz” in NRW ist das Realität. Patienten mit einer “Linksherzinsuffizienz” (Herzschwäche) werden zu Hause über einen täglichen Gesundheitscheck betreut. Sie leiten alle relevanten Daten telefonisch an den Arzt weiter. Die DAK-Gesundheit und das Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) in Bad Oeynhausen haben dazu einen entsprechenden Vertrag abgeschlossen. Die engmaschige Überwachung und schnelle Betreuung durch Spezialisten ergänzt die Behandlung durch den Hausarzt vor Ort.

Beim Projekt “Mein Herz” stehen die Medizinexperten des HDZ NRW und ihre Kooperationspartner den Teilnehmern 18 Monate, 24 Stunden am Tag, mit Rat und Tat zur Seite. Bei einer Linksherzinsuffizienz hängt die Lebensqualität der Betroffenen in erster Linie von der Früherkennung einer Verschlechterung und von der engmaschigen Betreuung durch ein gut vernetztes Team von Ärzten ab. “Mit dem Projekt helfen wir unseren Patienten, nach einer stationären Behandlung mehr über ihre Erkrankung zu lernen und selbstbestimmt und verantwortlich zu leben”, betont Wilhelm Hecker, Geschäftsführer des HDZ NRW. Peter Mager, Vertragschef der DAK-Gesundheit in Nordrhein-Westfalen, ergänzt: “Die telemedizinische Betreuung ermöglicht eine frühere Erkennung der Risikofaktoren und verbessert so spürbar die Lebensqualität von Patienten mit schwerer chronischer Erkrankung. Langfristiges Ziel ist es, die Anzahl stationärer Einweisungen zu reduzieren.”

Home-Check ermöglicht selbstbestimmtes Leben
Kernstück des Angebotes ist der tägliche Gesundheits-Check in den eigenen vier Wänden. Das HDZ NRW hat das Angebot auf die verschiedenen Bedürfnisse seiner Patienten angepasst. Patienten bekommen eine spezielle Körperwaage, die telemedizinisch Daten versenden kann. Bei Bedarf wird die Versorgung um ein Blutdruckmessgerät und gegebenenfalls auch ein EKG-Gerät erweitert. Die Gesundheitsdaten der Teilnehmer gelangen über den Telefonanschluss direkt an die telekardiologische Abteilung des Zentrums. “Wenn wir bei der Auswertung der Daten sehen, dass es den Herzkranken schlechter geht, können wir sofort reagieren. Gleichzeitig erhöhen wir die Lebensqualität der Betroffenen, indem unnötige Krankenhausaufenthalte im Sinne des Patienten vermieden werden”, sagt Privatdozent Dr. Heinrich Körtke, Leiter des Instituts für angewandte Telemedizin (IFAT) im HDZ NRW.

Patientenschulungen als Vorbereitung
Für den sicheren Umgang mit dem Home-Check werden die Patienten intensiv geschult. Nach Zusendung der Geräte werden die Patienten entweder telefonisch oder durch Schwerpunktpraxen vor Ort geschult. “Um den Therapieerfolg nachhaltig zu sichern und die Compliance des Patienten zu erhöhen, erhält der Patient regelmäßig einen Anruf aus dem Telemedizinzentrum”, sagt Mager. Die Teilnahme am Projekt ist für alle Versicherte der DAK-Gesundheit freiwillig und kostenlos. Voraussetzung für die Teilnahme ist, dass die Versicherten zuvor stationär mit der Hauptdiagnose “Linksherzinsuffizienz” behandelt wurden.Nach Schätzungen des Fritz Beske Instituts in Kiel werden die jährlichen Behandlungsfälle von Herz- und Kreislauferkrankungen in Deutschland weiter steigen: von rund 115.000 im Jahr 2000 auf 157.000 im Jahr 2020 und über 190.000 im Jahr 2050.

“Mein Herz” – Telemedizinische Versorgung von Patienten mit chronischer Herzinsuffizienz
Die chronische Herzinsuffizienz betrifft eine große Anzahl von Patienten und ist für ältere Patienten der häufigste Aufnahmegrund für eine stationäre, internistische Behandlung. Eine der wesentlichen Ursachen stellt dabei die Beeinträchtigung der Funktion der linken Herzkammer (Links-Herzinsuffizienz) dar. Dabei haben Studien das Potenzial einer strukturierten Entlassungsplanung, sektorübergreifenden Nachsorge und leitliniengerechten Arzneimittelversorgung aufgezeigt. Einige Studien wiesen nach, dass Überlebensdauer und Lebensqualität, sowohl durch die Früherkennung einer beginnenden Verschlechterung der Herzinsuffizienz, als auch durch Feedback und Schulung erheblich gesteigert werden können.

Quelle: ehealthserver.de

8 common questions about HL7

As recent talks have Health Level Seven International (HL7) moving beyond IT professionals, the standards process is setting the stage to make a significant impact on usability and workflow. And as more communities are embracing HL7, learning the basic ins-and-outs of the standards process is more important than ever. Rob Brull, product manager at Corepoint Health, answers eight common questions about HL7.

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