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Continuous Literature Research and Assessment

The “4. Bekanntmachung der Bundesoberbehörde zur Anzeige von Nebenwirkungen und Arzneimittelmissbrauch” of April 2005 delineates the requirements for literature research for pharmacovigilance purposes in germany.

Section 3.1.2 states the following:

  • Screening of literature for cases of adverse reactions should be based on a specific substance (not product).
  • At least one relevant database must be screened.
  • The 15-day deadline for reporting relevant cases to the competent authorities begins with the day the marketing authorisation gains knowledge of the case.

The Pooling Project Pharmacovigilance of the BPI Service helps pharmaceutical firms to comply with the regulatory requirements for literature research on a continuous basis without draining company resources.

The Literature Research and Assessment function within the Pooling Project Pharmacovigilance is based on the use of a joint literature database. Because the research, assessment and database access is collaborative, the costs of these activities per firm become less as more participants take advantage of the service.

The Pooling Project screens more than 12 relevant databases (including Medline and Toxline) The literature found in these screenings is assessed for relevance and then saved to the database. CIOMS forms are generated and filled out for cases which are assessed as “Potential Cases”, including a “Recommended assessment of drug relation to adverse reaction”. These can be accessed as digital files to be downloaded and edited.

A line listing is available for all cases that appear relevant to a Periodic Safety Update Report (PSUR). As with the CIOMS form, these may also be downloaded for a small fee. Studies which are considered relevant for a PSUR have no line listing attached, but are posted in the database to facilitate future PSUR-writing.