EU's EMA Balances Medication Approvals with Health Care Data Management
Email
Print
title=Dealing with Global Pharmaceutical Standards}
And similarly controlled terminology in medical information systems is there
to control the quality of input. If a doctor puts in a reaction that is
suspected to have been caused by a drug, the doctor will select the description
of this adverse event from a drop-down list he or she has access to.
We have in total now something like 4,000 organizations registered in one of
our systems, and we have 8,000 individual users in that system. We have 21,000
users of our systems, of which 20,000 are external users.
Historical developments have actually led to de facto technology standards.
The European institution selected many years ago following an open call for
tender Oracle as the database management system. As a result, we have Oracle as
the database standard. There are a few exceptions, but mostly it's Oracle.
This is one of these interesting discussions that is being had within the
network, how to make sure these various national systems work with the European
systems and with the European databases.
What are the leading health care IT issues for the EMA?
The most urgent and challenging one is how to go outside the EU today.
Pharmaceutical really is global. It is necessary but not sufficient to have
EU-wide standards. We need to have our standards aligned with worldwide standards.
And we're working very closely with colleagues at the FDA and within ISO and HL7 to create worldwide technical standards-for
example, to describe a medicinal product, to describe the minimal information
and the way it's structured about an adverse drug reaction so that we can
understand, for example, if the FDA sends us information about something that
happened to a drug which is also sold in Europe.
And they tell us about some real insufficiency or reaction so that a patient
or a specialist here in Europe can actually see that
information and understand it, and also use it in his or her data analysis. So
that's by far the biggest challenge ... to align ourselves with worldwide
standards.
Changing a standard has a massive impact on the existing information
systems. You have to change processing logic, and this causes big problems
through Europe because people don't have the money to do
that.
