6. Signal detection and evaluation
Based on the analysis of data collected on ARs, particularly in terms of severity, novelty and frequency, ANSM must be alerted to a potential signal that could modify the benefit/risk ratio of the drug. If the signal is confirmed, thus becoming an alert, precautionary measures and/or preventive or corrective actions must be implemented.
6.1 Signal detection
Signal detection in pharmacovigilance involves highlighting any potential association between a drug and the AEs it is likely to cause, where this relationship is unknown or insufficiently documented. The signal may reveal a new iatrogenic effect of the drug, but also risk factors for its occurrence, drug interactions and so on.
Signals can be detected manually, by analyzing notifications...
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Signal detection and evaluation
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Bibliography
- (1) - BLAYAC (J.P.) - Regard historique sur la mise en place de la première vigilance française : la pharmacovigilance. - Académie des Sciences et Lettres de Montpellier, 8 fév. 2010 http://www.ac-sciences-lettres-montpellier.fr/academie_edition/fichiers_conf/BLAYAC-2010.pdf ...
Websites
http://ansm.sante.fr/ (page consulted on November 26, 2015)
https://ansm.sante.fr/documents/reference/declarer-un-effet-indesirable
Regulations
Laws
Law no. 2011-2012 of December 29, 2011 on reinforcing the safety of medicines and health products
Law no. 98-535 of July 1 1998 on the reinforcement of health monitoring and control of the safety of products intended for human use.
Law no. 95-116 of February 4, 1995 on various social provisions
...
Appendix: Adverse reaction reporting form
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