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.

Continue reading

bvitg e.V. veröffentlicht Branchenbarometer 2012

Niedergelassene Ärzte sind in Summe um ein Vielfaches zufriedener mit Ihrer Software als ihre Kollegen aus der Klinik. So geben 92 Prozent an, mit den meist genutzten Funktionen ihrer IT-Systeme zufrieden zu sein; bei den Klinikärzten sind das lediglich 52 Prozent. Die gleiche Tendenz zeigt sich bei der Bedienbarkeit: Nur 19 Prozent der Klinikärzte finden, dass die Bedienbarkeit effizientes Arbeiten unterstütze, während es bei den Niedergelassenen rund 50 Prozent sind.

Dies sind einige Ergebnisse einer Anwenderstudie unter Niedergelassenen und Klinikärzten, die der Bundesverband Gesundheits-IT – bvitg e.V. auf einer Pressekonferenz im Rahmen der conhIT 2012 (24. bis 26. April auf dem Messegelände Berlin) vorgestellt hat.

Ziel der Studie war es, herauszufinden, was Ärzte von ihrer Software erwarten und wo sie den Nutzen von IT-Systemen auch im Hinblick auf die Zukunft sehen. Neben Ergebnissen der Anwenderstudie enthält das Branchenbarometer Aussagen zum Markt der Healthcare IT sowie den Trends und Themen, die der Bundesverband für dieses Jahr identifiziert hat.

  • Voranschreiten einrichtungsübergreifender Kommunikation,
  • Mobil IT ist mehr als nur cool,
  • Arzneimitteltherapiesicherheit wird digital erzeugt,
  • Managed Services / Cloud-Technologie reduziert IT-Kosten,
  • Fachlösungen und Standards setzen sich durch.

Das sind die zentralen Aussagen der Publikation, die Matthias Meierhofer, stellvertretender Vorstandsvorsitzender des bvitg e.V. und Sprecher der AG Marktforschung, auf der Messe vorstellte.

„Der Markt für Healthcare IT in Deutschland zeichnet sich durch sehr geringes Wachstum aus”, so Meierhofer. „Anders als in den USA, wo die Politik klare Anreize für die Investition in IT-Lösungen für das Gesundheitswesen setzt, ist die Bereitschaft deutscher Gesundheitsversorger in IT zu investieren nach wie vor gering. Mit gut einem Prozent Marktwachstum und einem Investitionsvolumen von knapp 700 Millionen Euro kann die Digitalisierung des deutschen Gesundheitssystem nur langsam voran schreiten. Gleichwohl gibt es viele innovative Produkte am Markt. Das haben die Anbieter auf der conhIT eindrucksvoll bewiesen.“

Das Branchenbarometer wird jedes Jahr innerhalb der AG Marktforschung erarbeitet und enthält neben Trendaussagen zu Primär- und Sekundärlösungen im KIS- und AIS-Bereich auch Ergebnisse aus extern beauftragten Studien unter den Anwendern der IT.

Das bvitg-Branchenbarometer steht ab sofort zum kostenlosen Download auf der bvitg-Website bereit.

Bundesverband Gesundheits-IT – bvitg e.V.
Der Bundesverband Gesundheits-IT vertritt in Deutschland die führenden IT-Anbieter im Gesundheitswesen und repräsentiert mit seinen Mitgliedern 90 Prozent des stationären, des ambulanten sowie des zahnmedizinischen IT-Marktes. Der Bundesverband ist im Frühjahr 2011 aus dem Zusammenschluss von VDAP e.V. mit dem 1996 gegründeten VHitG e.V. hervorgegangen, dem der VDDS e.V. als Verband beigetreten ist. Der VDDS e.V. vertritt in der bvitg-AG VDDS Dental die Belange der Dentalsoftwarehersteller, welche rund 80 Prozent aller Installationen bei Zahnärzten betreuen.

Quelle: bvitg e.V., Pressemitteilungen, “bvitg e.V. veröffentlicht Branchenbarometer 2012″, 27/04/2012 – www.bvitg.de

Gmail now features Automatic Translation

After Google Translate passed the bar of 200 million monthly users last week (see here), it surely is no coincidence that Gmail announced 3 new features today, including… automatic message translation.

This feature originally comes from Gmail Labs (for those not familiar with the concept, Gmail Labs allow users to test gadget features on their own Gmail before they become standard features or disappear) and has been such a hit among users (particularly Business Apps users) that it is now an official, standard add-on on Gmail.

Below is the official announcement from Jeff Chin, Product Manager at Google Translate

Say hello (or olá or halo or salam) to automatic message translation in Gmail

“We’re excited to announce three Gmail Labs graduations today: Automatic Message Translation, Smart Mute and Title Tweaks.

Automatic Message Translation
Did you ever dream about a future where your communications device could transcend language with ease? Well, that day is a lot closer. Back when we launched automatic message translation in Gmail Labs, we were curious to see how people would use it.

We heard immediately from Google Apps for Business users that this was a killer feature for working with local teams across the world. Some people just wanted to easily read newsletters from abroad. Another person wrote in telling us how he set up his mom’s Gmail to translate everything into her native language, thus saving countless explanatory phone calls (he thanked us profusely). I continue to use it to participate in discussions with the global Google offices I often visit.

Since message translation was one of the most popular labs, we decided it was time to graduate from Gmail Labs and move into the real world. Over the next few days, everyone who uses Gmail will be getting the convenience of translation added to their email. The next time you receive a message in a language other than your own, just click on Translate message in the header at the top of the message, and it will be instantly translated into your language.”

Read more on the Official Gmail blog here.

The Translation and Localization conference 2012, Warsaw, Poland

After a rich week in Berlin at conhIT 2012, off to Warsaw for the weekend where I was a guest speaker at the Translation and Localization Conference 2012 (“Konferencja Tłumaczy”- don’t ask me to pronounce it in Polish! ;))

It has been around a year and half since my last Translation industry event and it was truly a pleasure to see familiar faces again and meet new ones.  The event had the good idea of offering bilingual tracks: throughout the weekend, we had one room with English presentations only, while the other room featured only Polish contents. Given my non-existent Polish, this was very welcome!

The general subject areas of the conference were Computer-Aided Translation (how far can we stretch CATs, how do we manage CAT resources, segmentation, data formats, consistence and cohesion, virtualisation, dictation instead of typing and other pivotal issues in the area of computer-aided translation),  audio-visual translation and localization (computer games, dubbing, subtitling, copyright and related rights, going rates, audio-description, accessibility of films and theatrical performances and other cutting-edge developments on the audio-visual translation market), legal and specialist translation  (from fascinating case studies to popular debates on certified translation (and sworn translators): new strategies, food for thought and the big picture,  the business of translation and interpretation (hard data on freelancing, VAT and flat rate tax, as well as translation and localisation agencies. Expert insights on marketing translation services. (Down-to-earth, tried and true advice and fresh perspectives).

I made some interesting contacts and above all, we had very interesting discussions around a cup of coffee at breaks – discussions about the Polish market but also about the way the industry is going, particularly about machine translation (MT). The overall  shared opinion was the fact that MT was now inevitable and that it could be a translator’s best tool in terms of quality and productivity – when used wisely and with a strict quality-control procedure as well as the need to implement confidentiality measures. In short, the consensus was that MT was not completely mature yet – but will be very soon and that the industry should get ready to embrace it.

Entitled “Social Media Marketing for Translators: a must or a should?”, my presentation took place on Sunday morning with a small and lively group of translators with a broad background. There were many “young translators” (beginning in the industry) and experienced ones, curious about finding out whether this new marketing trend could apply to them and could work for them.  I hope that the colleagues who attended left the conference room with their own answer “Yes, Social Media marketing may be something for me, I want to know more” or “Nope, not for me.” At least that was the goal of this presentation, my aim was to give them some keys to help them decide. At the end of the day, as I specified many times during that hour with them, every translator is unique, every business is unique, and they all should see this presentation as a buffet where they just pick up what suits them, their needs and their goals. The presentation went well, there were quite a few questions and I had some very good feedback, so I guess the buffet formula worked for those colleagues!

It was also a fantastic opportunity to discover Warsaw and its gorgeous Old Town – a very enjoyable tour with two locals who know the history of their city by heart.

It was an excellent weekend, informational, interesting, fun (and incredibly hot, 30°C in Warsaw!) – thank you Agenor and Jacek of Localize.pl ;) , Maria Szpor and Anna Konieczna-Purchała of TexteM and their teams for organizing this great conference!

Visit the conference website and the Facebook Page with the photos and feedback – and hopefully see you next year for the 2013 Conference! :)