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 send the CIOMS forms to the competent authorities?

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 “serious”.

Is the CIOMS form available in an E2B-compliant format for electronic reporting?

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.