In order to survey the safety of drugs, which are in use in daily practice, collection
and analysis of reports of possible adverse drug reactions is needed. Collecting reports
from health professionals (and also patients) has shown to be the most efficient way
to do so.
Adverse reactions on psychotropic drugs are the most frequently reported adverse drug
reactions.
The assessment of individual cases is the key activity of pharmacovigilance. Pharmacoepidemiology
has large numbers as its core activity: it studies the spread of diseases (and e.g.
adverse drug reactions) in a population of users of a drug.
In this way a database of ADR reports is a meeting point of pharmacovigilance and
pharmacoepidemiology. The value of individual cases and the contribution of pharmacoepidemiology
to safe drug use will shortly be discussed.
The characteristics of the national databases for adverse drug reactions differ among
the countries in Europe. The value of the database depends in a high degree on the
quality of the information. The individual reports need to contain all the necessary
clinical information for a good assessment of the report.
The history of decision making of regulatory authorities shows that a series of well
documented cases is in most cases the basis of their decisions.
There are also supranational databases that are very useful, both for signal detection
and for reinforcement of suspected ADRs. The WHO database, maintained by the Uppsala
Monitoring Centre is a longer existing database. A new development is the Eudravigilance
database, maintained by the EMEA. What will be the impact of this database on the
national databases in Europe?
