Conclusions

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Chapter: Pharmacovigilance: Spontaneous Reporting in Germany

Spontaneous reporting remains an essential pillar in detecting risks, mainly ADRs, associated with the use of drugs.


CONCLUSIONS

Spontaneous reporting remains an essential pillar in detecting risks, mainly ADRs, associated with the use of drugs. Spontaneous reporting systems have been and will be further refined to overcome, at least partly, the known limitations of SRSs. Electronic tools help to handle the huge amount of data which today can be gathered for one individual case and which can be put together and stored in large databases. Exist-ing statistical methods, which should be developed further, enable drug safety activists to detect signals on drug-related risks earlier. However, it continues to be a major task that information from SRSs inevitably must undergo intellectual assessment by skilled phar-macovigilance experts. It is essential that risk informa-tion from SRSs is brought into the context of overall risk-to-benefit assessments. This is a pre-condition for making reasonable and robust decisions that are to the benefit of the patients and to communicate these properly.

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