VIGILANCE 2.0
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VIGILANCE 2.0
SocialVigilance ou la place des réseaux sociaux dans la surveillance  et la détection de signaux des produits de santé
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Dr GOOGLE , promu lanceur d'alerte par la FDA - Pharmacovigilance pour tous

Dr GOOGLE , promu lanceur d'alerte par la FDA - Pharmacovigilance pour tous | VIGILANCE 2.0 | Scoop.it
La FDA collabore avec GOOGLE pour l'aider à détecter les effets secondaires sur les réseaux sociaux
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Pharmacovigilance et réseaux sociaux : le projet de l'association Renaloo retenu par l'Agence du Médicament (ANSM)

Pharmacovigilance et réseaux sociaux : le projet de l'association Renaloo retenu par l'Agence du Médicament (ANSM) | VIGILANCE 2.0 | Scoop.it

La possibilité d’utiliser les médias sociaux comme source d’information pour la pharmacovigilanceétant peu évaluée en France, ce projet permettra à l’ANSM d’en mesurer sa pertinence et sa transposabilité à d’autres pathologies, pour les autres communautés de patients ou autres plateformes Web 2.0.

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Big Data Enabling Better Pharmacovigilance - Knowledgent

Big Data Enabling Better Pharmacovigilance - Knowledgent | VIGILANCE 2.0 | Scoop.it
With the proliferation of social media and the release of data from large study endeavors such as the Human Genome Project, data sources are only increasing today and will only continue to increase at a faster rate. Patient registries may be able to get near real-time data from wearable technologies, and Health Information Exchanges will be an increasingly important source of information.
EVELYNE PIERRON's insight:

Intéressant livre blanc à télécharger sur le Big data et la pharmacovigilance : peut il l'améliorer? des pistes.....

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Take & Tell : une application pour noter les effets secondaires - Pharmacovigilance pour tous

Take & Tell : une application pour noter les effets secondaires - Pharmacovigilance pour tous | VIGILANCE 2.0 | Scoop.it
Une application mobile pour noter les effets secondaires et en parler à son médecin traitant Take &Tell lancé par l'UMC
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Comment un selfie de Kim Kardashian fait réagir la FDA? - Pharmacovigilance pour tous

Comment un selfie de Kim Kardashian fait réagir la FDA? - Pharmacovigilance pour tous | VIGILANCE 2.0 | Scoop.it
La FDA est bien entrée dans l’ère du 2.0 même si tout n’est pas encore rose ! Voilà qu’elle a tout simplement demandé à Instagram, réseau social revendiquant plus de 300 millions d’utilisateurs actifs, de retirer un « selfie » de la non moins célèbre Kim Kardashian West (lue dans Guardian). Ne me demandez pas qui est Kim Kardashian (je ne pourrais pas y répondre), néanmoins elle a plus de 42 millions de « followers » sur son compte Instagram.  Mais quel est le lien entre l’agence américaine du m
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#Pharmacovigilance #Google s'associe à l'agence sanitaire FDA pour identifier les effets indésirables des médicaments

#Pharmacovigilance #Google s'associe à l'agence sanitaire FDA pour identifier les effets indésirables des médicaments | VIGILANCE 2.0 | Scoop.it
La FDA a signé un partenariat avec Google afin d'établir un lien de corrélation entre la recherche sur internet d'un médicament et ses potentiels...
EVELYNE PIERRON's insight:

La FDA, l’agence américaine des produits alimentaires et médicamenteux, est actuellement en discussion avec le moteur de recherche Google afin d’identifier les effets indésirables de certains médicaments sur la santé.

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UK - Pharmacovigilance - esanté- Une nouvelle application mobile pour déclarer les effets indésirables

UK - Pharmacovigilance - esanté- Une nouvelle application mobile pour déclarer les effets indésirables | VIGILANCE 2.0 | Scoop.it
Le Yellow Card Scheme anglais lance un application mobile gratuite pour déclarer les effets indésirables des médicaments et des vaccins
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Pharmacovigilance - Twitter, prochaine instance de contrôle des médicaments ?

Des chercheurs ont mis au point un algorithme permettant de détecter des interactions positives ou négatives entre des médicaments grâce à l'analyse de la twittosphère.
EVELYNE PIERRON's insight:
Twitter révèle son potentiel dans le champ médical en aidant à déceler rapidement les interactions médicamenteuses potentiellement dangereux tout comme les effets secondaires néfastes pour la santé
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SocialVigilance or Pharmacovigilance 2.0 New system for detecting adverse effects of medications using social media

SocialVigilance or Pharmacovigilance 2.0  New system for detecting adverse effects of medications using social media | VIGILANCE 2.0 | Scoop.it
Researchers at Carlos III Universidad de Madrid have developed a system for detecting adverse effects of pharmaceutical drugs by tracking information generated by patients on specialized blogs or social networks such as Twitter in real time.
EVELYNE PIERRON's insight:

Researchers at Carlos III Universidad de Madrid have developed a system for detecting adverse effects of pharmaceutical drugs by tracking information generated by patients on specialized blogs or social networks such as Twitter in real time.

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Pharmacovigilance - Monitoring FDA Medwatch reports : A critique of a key drug safety reporting system

EVELYNE PIERRON's insight:

The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.


The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.

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EVELYNE PIERRON's curator insight, February 8, 2015 1:30 PM


The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.


The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.

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Les réseaux sociaux en Santé Publique

EVELYNE PIERRON's insight:

Document intéressant, synthétique à partir d'une revue de la littérature qui définit d'abord les médias sociaux, puis de son usage et de celui qui pourrait en être fait  en Santé Publique.

Des questions sont soulevées: 

- quelle est l'efficacité des médias sociaux?

- Quel est leur impact sur les inégalités en santé?

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EVELYNE PIERRON's curator insight, January 26, 2015 10:21 AM

Document intéressant, synthétique à partir d'une revue de la littérature qui définit d'abord les médias sociaux, puis de son usage et de celui qui pourrait en être fait  en Santé Publique.

Des questions sont soulevées: 

- quelle est l'efficacité des médias sociaux?

- Quel est leur impact sur les inégalités en santé?

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SocialVigilance ou Pharmacovigilance? Searching social networks to detect adverse reactions

SocialVigilance ou Pharmacovigilance? Searching social networks to detect adverse reactions | VIGILANCE 2.0 | Scoop.it
Regulators and pharmaceutical companies are monitoring social media posts for potential adverse drug reaction signals.
EVELYNE PIERRON's insight:

A l'ère du numérique, la pharmacovigilance se frotte aux réseaux sociaux.......cela devient vraiment une réalité avec le développement d'outils et les autorités qui s'y intéressent.

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Lettre Innovation &Prospective de la CNIL- Projet MOBILITICS :Focus sur les smartphones, applications et données personnelles

EVELYNE PIERRON's insight:
La CNIL et Inria travaillent depuis maintenant 3 ans
sur un projet de  recherche et d’innovation ambitieux nommé Mobilitics. Son objectif : mieux connaître les smartphones, ces objets utilisés quotidiennement par des dizaines de millions de français et qui
restent de véritables boîtes noires pour les utilisateurs, les chercheurs et les autorités de régulation. Pourtant, ces « amis qui nous veulent du bien » sont d’extraordinaires producteurs et consommateurs de données personnelles.
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Les réseaux sociaux seraient ils un cadeau empoisonné? Social media during epidemics: a poisoned chalice?

Les réseaux sociaux seraient ils un cadeau empoisonné? Social media during epidemics: a poisoned chalice? | VIGILANCE 2.0 | Scoop.it
Social networking is now the most popular online activity worldwide. Social networking sites account for nearly 1 in every 5 minutes spent online globally, reaching 82 percent of the world’s Internet population.
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Big Data et Pharmacovigilance- Post-marketing data analysis of pharmaceuticals discovers side effects not previously known

Big Data et Pharmacovigilance- Post-marketing data analysis of pharmaceuticals discovers side effects not previously known | VIGILANCE 2.0 | Scoop.it
Big data is delivering many breakthroughs in medicine at a breathtaking pace. One of the latest examples is in post-marketing data analysis of prescription drugs. 
EVELYNE PIERRON's insight:

What this means is that we can find side effects that were not found in pre-marketing testing and FDA approval studies faster so appropriate steps can be taken quicker. It also means that this analysis can be checked by other parties to ensure accuracy.  

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Pharmacovigilance - [3 questions à] Claude Touche : « eVedrug veut restaurer la confiance entre les patients et leur système de santé » | FrenchWeb.fr

Pharmacovigilance - [3 questions à] Claude Touche : « eVedrug veut restaurer la confiance entre les patients et leur système de santé » | FrenchWeb.fr | VIGILANCE 2.0 | Scoop.it
La start-up, positionnée sur le marché de la pharmacovigilance, édite deux applications: My eReport et My eClinical. Interview.

Via Celine Sportisse
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US - FDA - Pharmacovigilange 2.0- Mining Social Media for Adverse Events - Policy and Medicine

US - FDA - Pharmacovigilange 2.0-  Mining Social Media for Adverse Events - Policy and Medicine | VIGILANCE 2.0 | Scoop.it
In February, the FDA released a Request for Proposal asking firms to help the agency monitor social media activity for adverse event reporting, among other content. Many have been critical about the utility of FDA examining user-generated content for adverse...
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Open Access Social Media Guide for Pharma: Let's Crowdsource the New Version!

Open Access Social Media Guide for Pharma: Let's Crowdsource the New Version! | VIGILANCE 2.0 | Scoop.it
In 2011, we published a crowdsourced open access guide for pharmaceutical companies containing practical pieces of advice about how to use and how not to use social media. As there was no guide fro...
EVELYNE PIERRON's insight:

Un appel à contribution pour une nouvelle mise à jour du guideline Social Media pour les industriels donnant des conseils sur l'utilisation des réseaux sociaux a été initié par Bertalan Mesko.

Ce guideline est voulu comme un guide plus pratique que le guideline existant .

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Using Twitter to study pharmaceutical drug side effects

Using Twitter to study pharmaceutical drug side effects | VIGILANCE 2.0 | Scoop.it

Recent data from the CDC has indicated that 50% of Americans are taking one prescription drug, and 10% are on 4 or more prescribed medications as well. Taking into consideration the aging population and the movement towards primary prevention with medications, it is likely a larger shift will occur in the next decade.


Coupled with this is the increasingly large role of social media in the daily lives of the social schema of many Americans — and we may have a new form of Drug Surveillance. It comes as no surprise that many patients report their daily status of health online, and include their experiences with their medications as well. But recent data has come out from researchers at Boston Children’s Hospital that Twitter alone could be a treasure trove of data.


Traditionally, adverse drug effects could be reported to the FDA through their Adverse Event Reporting System (FAERS). From this, monitoring post clinical trials can be conducted for any issues that may arise. Many medications have been adjusted or withdrawn from the market based on unseen side effects on patients.


But Friefield and colleague’s recent study in Drug Safety demonstrated that patients are increasingly reporting their side effects via Twitter. Utilizing a semi-automated process to identify 23 drug products on Twitter,  approximately 7 million tweets were assessed, with 60,000 evaluated, producing 4,400 identified. Many of the events related to side effects from drugs and how they were responding to therapy.


Another recent study by White and colleague’s in JAMIA also highlighted the use of social media in drug safety analysis. The researchers have highlighted the growing use of social media as a low-cost monitoring tool for federal agencies and drug manufacturers to utilize.


While these studies are sure to spark great interest in the use of social media as a new method to collect post-market safety data, there may be some shortcomings to consider.


Via Pharma Guy
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Pharma Guy's curator insight, September 9, 2014 12:19 PM


When FDA announced the 2009 public hearing about regulating the pharma industry use of social media for promoting drugs, the agency asked for specific feedback regarding the use of social media for monitoring drug side effects.


Pharma Marketing News published survey results to see if and how the industry was using social media to monitor adverse events. The chart above shows some results. For more details read Social Media Adverse Event Reporting Safe Harbors, which  includes a detailed summary of responses to the survey "FDA Regulation of Drug & Device Promotion via the Internet & Social Media" regarding social media adverse event monitoring, processing, challenges, and uncertainties.

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Pharmacovigilance - Role for smartphones and social media in medicine safety

Pharmacovigilance - Role for smartphones and social media in medicine safety | VIGILANCE 2.0 | Scoop.it
An app will be developed to make it easy for healthcare professionals and the public to report suspected adverse drug reactions.
EVELYNE PIERRON's insight:


An app will be developed to make it easy for healthcare professionals and the public to report suspected adverse drug reactions (ADRs) to national and European regulators.

An EU initiative wants to widen the use of smartphones and social media for transmitting notifications about drug safety issues directly to patients, clinicians and caregivers. The three-year project, known as WEB-RADR, involves the Medicines and Healthcare products Regulatory Agency (MHRA).

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MHRA- pharmacovigilance UK regulator leads innovative EU project on the use of smartphones and social media for drug safety information

MHRA- pharmacovigilance UK regulator leads innovative EU project on the use of smartphones and social media for drug safety information | VIGILANCE 2.0 | Scoop.it
EVELYNE PIERRON's insight:

The Medicines and Healthcare products Regulatory Agency (MHRA) is leading a consortium of organisations including European medicines regulators, academics and the pharmaceutical industry in a three year project to develop new ways of gathering information on suspected adverse drug reactions (ADRs).

The project, known as WEB-RADR, is in response to the rapid adoption of smartphones, apps, and social media for discussing issues with medicines and health.  

It will work to develop a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators. It will also investigate the potential for publicly available social media data for identifying potential drug safety issues. All social media data used within the project will be appropriately anonymised to protect data privacy.

In addition to reporting suspected ADRs the app could also serve as a platform to send accurate, timely and up to date medicines information to patients, clinicians, and caregivers.

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Identifying Trends in Illegal Drug Use

Identifying Trends in Illegal Drug Use | VIGILANCE 2.0 | Scoop.it
News from JAMA — Warning System Aims to Detect Emerging Trends in Illegal Drug Use
EVELYNE PIERRON's insight:

A national surveillance system is being developed to use both traditional data collection strategies and scans of social media and web platforms to identify emerging designer synthetic drugs and their metabolites (http://1.usa.gov/1mRw1XJ).

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How Can Pharmaceutical Companies Build Closer Relationships With Social Patients?

How Can Pharmaceutical Companies Build Closer Relationships With Social Patients? | VIGILANCE 2.0 | Scoop.it
This year, FDA has final begun to offer some guidance to marketers about social media. Heres what social patient say they want

Via COUCH Medcomms, Lionel Reichardt / le Pharmageek
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Le digital : un traitement à prescrire pour la pharma

Le digital : un traitement à prescrire pour la pharma | VIGILANCE 2.0 | Scoop.it
Si vous êtes un expert de l'industrie pharmaceutique, cet article n'est pas pour vous...vous n'allez rien apprendre. Pour tous les autres, si les défis que représentent l'apport du digital au sein ...
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To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter | Eye on FDA

To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter | Eye on FDA | VIGILANCE 2.0 | Scoop.it
EVELYNE PIERRON's insight:

Note that the agency sent out the tweet announcing the product name and the indication. The generic or chemical name is not included, nor is there any risk information.

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Curated by EVELYNE PIERRON
Médecin, veilleur de sa communauté #pharmacovigilance, passionnée de #sécurité sanitaire, de #santé publique et GEEK à mes temps perdus.