PROTECT project on pharmacovigilance achieves key objectives, says EMA

The 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 which will offer access to important data resources for pharmacovigilance activities and pharmacoepidemiological studies, the Agency says.

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 utilization in the out- and in-patient healthcare settings. Information is currently available for 17 European Union countries (Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Norway, Poland, Portugal, Spain, Sweden, the Netherlands, and the UK) up to October 2012. Work is in progress to expand 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 authorized 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 ADR. This database is updated every six months and currently contains information up to June 30, 2012.