Risk Communication

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Chapter: Pharmacovigilance: Spontaneous Reporting in Germany

‘Risk communication’ has become an important tool not only to inform patients or their caregivers about the properties of the drugs actually used.


RISK COMMUNICATION

‘Risk communication’ has become an important tool not only to inform patients or their caregivers about the properties of the drugs actually used. Risk commu-nication also contributes to a better understanding of drug therapy, its principle benefits and risks. Also, the enormous change in the public availability of infor-mation on drugs through the internet or print media is a challenge. Drug agencies have a lot of information and data from unpublished, pre-clinical and clinical, studies that are not accessible to people in the outside world. They also have easy access to worldwide liter-ature and exchange information with drug agencies worldwide. Presently, major changes in the commu-nication policy are taking place, and the EU-revised Regulations and Directives specify what should and can be communicated to interested parties and the public in the near future.

BfArM has the policy of sharing information from the ADR database with people who ask for it. They must not have any specific reasons for their request, i.e. having experienced an ADR themselves. Informa-tion is given strictly in line with the existing confiden-tiality rules. BfArM regularly explains the origin of the reports, their validity with regard to causality and that any frequency calculations cannot be made using report numbers from SRSs. A respective caveat paper, very similar to that used by the Uppsala Monitoring Centre (UMC), is sent out.

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