Signal selection and follow-up in pharmacovigilance.
The detection of unknown and unexpected connections between drug exposure and adverse events is one of the major challenges of pharmacovigilance. For the identification of possible connections in large databases, automated statistical systems have been introduced with promising results. From the large numbers of associations so produced, the human mind has to identify signals that are likely to be important, in need of further assessment and follow-up and that may require regulatory action. Such decisions are based on a variety of clinical, epidemiological, pharmacological and regulatory criteria. Likewise, there are a number of criteria that underlie the subsequent evaluation of such signals. A good understanding of the logic underlying these processes fosters rational pharmacovigilance and efficient drug regulation. In the future a combination of quantitative and qualitative criteria may be incorporated in automated signal detection.
Meyboom
Ronald H B
RH
The Uppsala Monitoring Centre, Uppsala, Sweden. r.meyboom@who-umc.org
Lindquist
Marie
M
Egberts
Antoine C G
AC
Edwards
I Ralph
IR
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005500:Follow-Up Studies; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000706:statistics & numerical data*; D014944:World Health Organization