Pharmacovigilance

Online patient community PatientsLikeMe has found another partner for its massive repository of patient-generated data on health conditions and treatments, but it’s not another pharma company or retail pharmacy. PatientsLikeMe has announced a research partnership with the FDA: The agency will assess the platform’s feasibility as a way to generate adverse event reports, which the FDA uses to regulate drugs after their release into the market. To read the article by mobihealthnews

Years behind USA, Europe starts to grow in its awareness on the potential use of social media analytics as source of hints for detecting unexpected drug effects after market approval. Independent activities have been launched in 2013-2014 from different founding bodies and with different stakeholders, with strong EU footprint, of which hereafter just few are reported. EU IMI Project WEB-RADR ( web-radr.eu), amining at mobile application and automatic text mining for identification of potential adverse drug events. French-founded ADR-Prism ( adr-prism.com), with initial findings not yet published however first year report to be appearing soon. To read the article by …

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. The prototype, created by these scientists within the framework of the European research Project TrendMiner, makes it possible to analyze the comments on social media by using natural language processing techniques (NLP). Thanks to these techniques, patients’ colloquial descriptions are “translated” into manageable data in comparatives studies which allow us to identify patterns and trends.” This data may also be combined with data from …

Regulators and pharmaceutical companies are monitoring social media posts for potential adverse drug reaction signals. Up to 90% of side effects to drugs are not reported, according to some estimates. “Adverse drug reactions (ADRs) are grossly under reported by everyone, including healthcare professionals, but particularly so by patients,” says David Lewis, head of global safety at Novartis, who is co-ordinating the involvement of pharmaceutical companies in a €2.3m three-year public-private project called Web-RADR (Recognising Adverse Drug Reactions). Data from the European Medicines Agency (EMA) indicate that patients are not reporting side effects adequately through official channels and several regulators are …

Ce texte, qui vise à renforcer le système de pharmacovigilance, transpose la directive 2012/26/UE du Parlement européen et du Conseil du 25 octobre 2012 modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain. Il modifie, en premier lieu, les procédures européennes de réévaluation des médicaments à usage humain. Il procède, en deuxième lieu, à un renforcement des obligations pesant sur les entreprises exportant des médicaments vers des pays tiers à l’Union européenne et sur les entreprises important des médicaments en provenance de ces pays. Il modifie, en troisième lieu, …