Which databases are accessed for research?
At least 12 relevant databases are screened for relevant publications, including
Medline and Toxline
How often are the databases screened?
Databases are screened on a weekly or monthly basis.
Does the BPI Service GmbH send the CIOMS forms to the competent
No. The subscription to the literature research service does not release the
marketing authorisation holder from the responsibility of expedited reporting.
The authorisation holder is responsible for sending the case reports (CIOMS or
ICSR) to the competent authorities.
What reference information is used when evaluating case reports regarding
“expectedness” and “seriousness”?
When a substance has been booked by only one firm, the reference information
used is the SmPC of that firm. Therefore, it is very important to send us
electronic files of the current SmPC of your product. If a substance has been
booked by several firms, the cases are evaluated using the template SmPC for
the substance as published by the BfArM. If there is no such template SmPC
available for the substance, the most incomplete SmPC among the subscribing
firms is used. This is to ensure that each case is always evaluated against the
“worst case” scenario. Each firm must ensure that the cases published in the
database are evaluated against the firm’s own reference information before the
case is filed or reported. If there are neither company SmPCs or template SmPCs
available, the Rote Liste® is used as a reference.
When is an adverse reaction “serious”?
An adverse reaction is serious if:
It is life-threatening
It results in death
It results in a significant and ongoing disability
It results in a congenital anomaly
It results in hospitalisation or a prolongation of hospitalisation
What adverse reactions qualify for expedited reporting within 15 days?
Every serious adverse reaction occurring in Germany qualifies for expedited
reporting. Also, all cases of serious, unexpected adverse reactions from non-EU
countries. Some adverse reactions may not fulfil any of the criteria to be
classified as “serious”, yet may still warrant reporting. These reactions are
classified as “Medically Important Events” and therefore equivalent to
Is the CIOMS form available in an E2B-compliant format for electronic
As the implementation of an E2B-compliant adverse reactions database for
electronic reporting is being pursued in close cooperation between the BPI
Service GmbH and the BPI e.V., the data in the literature research database
will be compliant with the specifications of the E2B-database to allow
electronic reporting of the literature cases. This will be possible once the
E2B-compliant database is made available. This phase of the project is expected
to be implemented the beginning of 2007.