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

An agency of the European Union

Increasing access to ADR reports on the Web

PCWP – Wednesday 26 November 2014

Presented by Steven Le Meur Data Collection and Management Service

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

3

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

Products & Substances available – what is new ?

4

Num ber of Centrally Authorised Products

( Authorised, W ithdraw n, Suspended)

Num ber of W eb reports for Centrally Authorised Products Details 910 720 No data received in EudraVigilance for 190 Centrally Authorised Products -> no web 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(122 authorised products & 68 withdrawn products)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

Products & Substances available – what is new ?

5

Substance classification Num ber of Substances Details

belongs to Centrally Authorised Products 527 Corresponding to the Centrally Authorised Products belongs to Nationally Authorised Products 1,724 965 monitored by Member States 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

ADR Website

http: / / www.adrreports.eu

6

7

Spontaneous reporting in EEA*

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

8

Spontaneous reporting by patients in EEA*

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

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

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

Further information

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