European Patients Academy on Therapeutic Innovation Eudra Vigilance

European Patients’ Academy on Therapeutic Innovation Eudra. Vigilance

The Eudra. Vigilance Database European Patients’ Academy on Therapeutic Innovation Eudra. Vigilance is a European (EU) web-based information system. § It is designed to manage safety report data. § It contains adverse reaction (ADR) reports for medicines that have been authorised in the EU. 2

Access European Patients’ Academy on Therapeutic Innovation § Stakeholders including marketing authorisation holders, regulatory authorities, academia, healthcare professionals and patients can access data held in the Eudra. Vigilance database, based on the European Medicines Agency’s (EMA) Eudra. Vigilance access policy. 3

Access for healthcare professionals, patients and the general public European Patients’ Academy on Therapeutic Innovation Public access is granted to § a restricted set of data (approx. 25%) for spontaneous reports and is provided alongside detailed guidance on the nature and interpretation of the data, whilst respecting data privacy. • It includes advice to patients not to change their medication without consulting a healthcare professional. Access tools Publicly accessible European database of suspected adverse drug reaction reports are available at http: //www. adrreports. eu 4

Data Collection European Patients’ Academy on Therapeutic Innovation There are two modules for the collection of data within the Eudra. Vigilance database. The pre-authorisation module collects: § Suspected unexpected serious adverse reactions (SUSARs) reported by sponsors of clinical trials § Data from interventional clinical trials 5

Data Collection European Patients’ Academy on Therapeutic Innovation The post-authorisation module collects data from: § Suspected serious adverse reactions § Healthcare professionals’ spontaneous reporting § Post-authorisation studies (non-interventional) § Worldwide scientific literature (spontaneous, noninterventional) § Transmission of an infectious agent via a medicine 6

Safety Signals European Patients’ Academy on Therapeutic Innovation § The reporting of suspected ADRs in a consistent way across the European Economic Area (EEA) is very important. § This helps to monitor the benefits and risks of medicines and to detect emerging safety signals. 7

Safety Signals European Patients’ Academy on Therapeutic Innovation § Safety signals are identified within Eudra. Vigilance by performing a regular analysis of reports on such events. § A safety signal can be defined as new information related to known ADRs or any other event § These can be adverse or beneficial, that is, potentially causally related to the use of a medicinal product and requiring further investigation. 8

Data Collected European Patients’ Academy on Therapeutic Innovation § ADR reports are received from the National Competent Authorities (NCAs), marketing authorisation holders (MAHs), sponsors of clinical trials, patients, and healthcare professionals. § Eudra. Vigilance is a repository of both EU and non-EU ADRs for ‘investigational’ and authorised medicines. § Eudra. Vigilance also incorporates the ‘Medical Dictionary for Regulatory Activities’ (Med. DRA), which contains international medical terminology. 9

Signal Detection European Patients’ Academy on Therapeutic Innovation § The EMA has been operating a signal-detection process for centrally authorised medicines since July 2012. § It also supports the EU member states in their signaldetection processes for nationally authorised medicines. § The Eudra. Vigilance database is the main source of signals that may trigger regulatory action. 10

Interpreting the data on European databases European Patients’ Academy on Therapeutic Innovation § The information on the databases relate to suspected adverse reactions, for example, the effects that have been observed following the administration of, or treatment with, a medicine. However these suspected adverse reactions may not be related to, or caused by, the medicine. § The information on the website cannot be used to determine the likelihood of experiencing an adverse reaction. § Other information, such as how many people take the medicine and how long it has been on the market, must be considered when interpreting the data. 11

European Patients’ Academy on Therapeutic Innovation § Users of the database are given clear guidance on the interpretation of data. § Access will be granted to approximately 25% of any report. § Summaries or individual reports comply with personal data protection legislation. 12

References European Patients’ Academy on Therapeutic Innovation Ø The European database of suspected adverse drug reaction reports is available in 24 European languages from http: //www. adrreports. eu Ø More information on Eudra. Vigilance is available from https: //eudravigilance. ema. europa. eu/highres. htm 13