New EU countries struggle with drug safety
Countries that recently joined the European Union are struggling to keep up with the demands of medicines safety issues.
A recent survey carried out by the European Medicines Agency (EMEA) found
that the 10 new EU member states had the equivalent of only 36 full-time
pharmacovigilance staff between them.
The survey also found that the 10 countries predominantly rely on spontaneous
paper-based adverse drug reaction reporting and received just 2,800 reports
during 2004. Their cumulative total of ADR reports was 47,000, with 46,000
of these being held by just one of the 10 accession countries.
This contrasts with the cumulative total of one million ADR reports held
by the 15 pre-accession EU countries. As a result, the 10 new EU members
have little awareness of developing medicines safety issues. The survey,
coupled with two earlier surveys — one in 2002 and the other in
2004 before the new members joined the EU — reveal the limited
nature of European pharmacovigilance
resources.
The 2002 survey found that the 15 EU member states then had 300 staff
between them monitoring mainly the safety of nationally licensed products.
Only half of these staff were actually involved with assessing risk,
with the others having only data entry responsibilities.
A working group set up by the EMEA to implement an EU-wide medicines
risk management strategy concludes: “The results of the questionnaire
underline first and foremost the limited nature of resources dedicated
to pharmacovigilance in the EU network.” |
The
Pharmaceutical Journal
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