Increasing access to ADR reports on the Web PCWP Wednesday 26 - PowerPoint PPT Presentation

Increasing access to ADR reports on the Web PCWP – Wednesday 26 November 2014 Presented by Steven Le Meur Data Collection and Management Service An agency of the European Union

Agenda • Background • Website usage • Products & Substances available – what is new ? • ADR Website – web reports and patient guidance • Spontaneous reporting in the EEA • What’s next ? 1

Background The EudraVigilance Access Policy was created to define the level and mean of access to EudraVigilance data by the multiple stakeholders – Member States, Marketing Authorisation Holders & Sponsors, Healthcare professionals and the general public. The access to EudraVigilance data for Healthcare professionals and the general public was implemented with the creation of the www.adrreports.eu website that provides aggregated data for suspected adverse drug reactions for Centrally Authorised Products (CAP) and is available online since May 2012. Since 06 October 2014, information on suspected adverse drug reactions is available for an additional 1,700 active substances contained in medicines approved in the European Union (EU). 2

Website usage Average of 4 ,4 0 0 unique visitors & 7 ,7 0 0 visits per m onth 3

Products & Substances available – what is new ? Num ber of Num ber of W eb Centrally reports for Authorised Centrally Details Products Authorised ( Authorised, Products W ithdraw n, Suspended) No data received in EudraVigilance for 190 Centrally Authorised Products -> no web 910 720 reports created (122 authorised products & 68 withdrawn products) W eb reports for Centrally Authorised Products are autom atically added w hen data are received in EudraVigilance 4

Products & Substances available – what is new ? Substance Num ber of Details classification Substances belongs to Centrally Corresponding to the Centrally Authorised 527 Authorised Products Products 965 monitored by Member States belongs to Nationally 1,724 Authorised Products 759 from the Periodic Safety Update Reports & Union Reference Date (EURD) Total 2 ,2 5 1 Addition of over 1 ,7 0 0 nationally authorised substances 5

ADR Website http: / / www.adrreports.eu 6

Spontaneous reporting in EEA * 295,043 281,357 226,513 300,000 250,000 200,000 150,000 100,000 50,000 0 Pre Legislation After Legislation After Legislation 02/07/11 - 01/07/12 02/07/12 - 01/07/13 02/07/13 - 01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication 7

Spontaneous reporting by patients in EEA * 35,642 33,292 40,000 35,000 20,560 30,000 25,000 20,000 15,000 10,000 5,000 0 Pre Legislation After Legislation After Legislation 02/07/11 - 01/07/12 02/07/12 - 01/07/13 02/07/13 - 01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication 8

What’s next ? Revision of the EudraVigilance Access Policy • Public consultation ongoing -> comments until 15 September 2014 • Currently the policy foresees for the public and the healthcare professionals • Increased level of transparency and volume of information published online • Inclusion of Line Listings and access to a set of data fields from the safety report ⇒ More detailed information available online for more substances 9

What’s next ? Dependencies • Validation of the medicinal product information submitted by the pharmaceutical industry ⇒ Improve data quality and the addition of more substances overtime • Implementation of the new ISO data standard for the reporting of safety information ⇒ Few changes to be expected in the web reports layout (e.g. seriousness, origin,… ) 10

Thank you for your attention Further information steven.lem eur@em a.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone + 44 (0)20 3660 6000 Facsim ile + 44 (0)20 3660 5555 Send a question via our w ebsite www.ema.europa.eu/ contact Follow us on @EMA_ New s