Abstract
The main objective of pharmacovigilance is the early detection of new adverse drug reactions. Health care professionals play a key role in safety surveillance, as they are frontline observers if serious and unexpected adverse effects occur. They are obliged to report their observations and suspicions to the regulatory authorities, thereby enabling the authorities to react in an appropriate and timely manner.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Definitions: Adverse reaction. A response to a medicinal product which is noxious and unintended, Unexpected adverse reaction. An adverse reaction, the nature, severity, or outcome of which is not consistent with the summary of product characteristics.
References
Dukes G (1985) The effects of drug regulation. A survey based on European studies of drug regulation. MTP Press Limited, Lancaster
Finney DJ (1965) The design and logic of a monitor of drug use. J Chronic Dis 18:77–98
Grobner T (2006) Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermatopathy and nephrogenic systemic fibrosis? Nephrol Dial Transpl 21:1104–1108
Lenz W (1966) Malformations caused by drugs in pregnancy. Am J Dis Child 112:99–106
Regulation (EU) no. 1235/2010 amending Regulation (EC) 726/2004 and Directive 2010/84/EU amending Directive 2001/83/EC
Stenver DI (2008) Pharmacovigilance: what to do if you see an adverse reaction and the consequences. Eur J Radiol 66:184–186
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Stenver, D.I. (2014). Pharmacovigilance: When to Report Adverse Reactions to Contrast Media . In: Thomsen, H., Webb, J. (eds) Contrast Media. Medical Radiology(). Springer, Berlin, Heidelberg. https://doi.org/10.1007/174_2013_868
Download citation
DOI: https://doi.org/10.1007/174_2013_868
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-36723-6
Online ISBN: 978-3-642-36724-3
eBook Packages: MedicineMedicine (R0)