The PROTECT project on pharmacovigilance achieves key objectives

12 February 2013

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project, a public-private partnership for innovative methodologies in pharmacovigilance and pharmacoepidemiology coordinated by the European Medicines Agency, has reached a crucial stage with the delivery of two databases that will offer access to important data resources for pharmacovigilance activities and pharmacoepidemiological studies.

The first of these two databases, the Drug Consumption Database, is a comprehensive and structured source of information on drug consumption in Europe. It is the result of reviewing, compiling and updating knowledge about European sources of data on drug utilisation in the out- and in-patient healthcare settings. Information is currently available for 17 European Union (EU) countries (Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Norway, Poland, Portugal, Spain, Sweden, the Netherlands, and the United Kingdom) up to October 2012. Work is in progress to expand the data available.

The second database, the PROTECT ADR database, is a listing of all adverse drug reactions (ADRs) contained in the section 4.8 of the summary of product characteristics (SmPC) of medicinal products centrally authorised in the EU. It is based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The goal of this database is to improve the efficiency of the detection process of ADRs by allowing quick identification and filtering or flagging of listed and unlisted ADRs. This database is updated every 6 months and currently contains information up to 30 June 2012.

About PROTECT

The goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe by developing innovative methods. These methods aim to:

• enhance early detection and assessment of ADRs from different data sources (clinical trials, spontaneous reporting and observational studies);
• enable the integration and presentation of data on benefits and risks.

PROTECT is receiving funding from the European Community's Seventh Framework Programme (FP7/2007-2013) through the Innovative Medicine Initiative. The Agency coordinates the project and manages a multinational consortium of 33 partners including academics, regulators and companies.

Note:

• The PROTECT ADR database is different to the European database of suspected adverse drug reaction reports, which relates to suspected side effects.