Abstract
The importance of pharmacovigilance — the ongoing assessment of the safety of a marketed medicine — has been increasingly appreciated in recent years, owing in part to high-profile safety issues with widely used drugs. In response, strategies to improve the collection, integration and analysis of data related to post-marketing drug safety are being initiated or enhanced. In this article, we summarize the key tools that are available for pharmacovigilance, discuss which might be the most appropriate to use in different situations and consider the future directions of the field.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on SpringerLink
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Evans, S. in Pharmacovigilance 2nd edn Ch. 19 (eds Mann, R. & Andrews, E.) 249–255 (John Wiley, Chichester, 2007).
Medicines and Healthcare products Regulatory Agency. Drug Safety Update: Volume 1, Issue 12 [online] (2008).
Ransohoff, R. M. et al. Natalizumab for multiple sclerosis. N. Engl. J. Med. 356, 2622–2629 (2007).
Silman, A., Symmonds, D., Scott, D. G. I. & Griffiths, I. British Society for Rheumatology Biologics Register. Ann. Rheum. Dis. 62, S28 (2003).
Morrow, J. et al. Malformation risks of antiepileptiform drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register. J. Neurol. Neurosurg. Psychiatr. 77, 193–198 (2006).
del Toro-Riera, M. et al. Follow up of patients with Hunter syndrome: the Hunter Outcome Survey (HOS) registry. Rev. Neurol. 44, S513–S517 (2007).
Biederbeck-Noll, A. B. et al. Verapamil is associated with an increased risk of cancer in the elderly: the Rotterdam study. Eur. J. Cancer. 39, 98–105 (2003).
Harrison-Woolrych, M. et al. Safety and usage of atypical antipsychotic medicines in children: a nationwide prospective cohort study. Drug Safety 7, 569–573 (2007).
Lesko, S. M. and Mitchell, A. A. The safety of acetaminophen and ibuprofen among children younger than two years old. Paediatrics 104, 39–51 (1999).
Friis-Moller, N. et al. Combination antiretroviral therapy and the risk of myocardial infarction. N. Engl. J. Med. 349, 1993–2003 (2003).
Segal, E. S. et al. Risk management strategies in the postmarketing period: safety experience with the US and European bosentan surveillance programmes. Drug Safety 28, 971–980 (2005).
Mallal, S. et al. HLA-B*5701 screening for hypersensitivity to abacavir. N. Engl. J. Med. 358, 568–570 (2008).
Hughes, D. A., Bayoumi, A. M. & Pirmohamed, M. Current assessment of risk–benefit by regulators: is it time to introduce decision analyses? Clin. Pharmacol. Ther. 82, 123–127 (2007).
van Staa. T. P., Smeeth, L., Persson, I., Parkinson, J. & Leufkens, H. G. What is the harm–benefit ratio of Cox-2 inhibitors? Int. J. Epidemiol. 37, 405–413 (2008).
van Staa, T. P., Barlow, D., Cooper, C. & Leufkens, H. G. M. Individualising risks and benefits of hormone therapy. Menopause 15, 374–381 (2008).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Wise, L., Parkinson, J., Raine, J. et al. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov 8, 779–782 (2009). https://doi.org/10.1038/nrd3002
Published:
Issue Date:
DOI: https://doi.org/10.1038/nrd3002
This article is cited by
-
The role of antipsychotics and other drugs on the development and progression of neuroleptic malignant syndrome
Scientific Reports (2023)
-
Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
Drug Safety (2019)
-
Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland
BioDrugs (2018)
-
Factors that affect adverse drug reaction reporting among hospital pharmacists in Western China
International Journal of Clinical Pharmacy (2015)
-
Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database
BMC Complementary and Alternative Medicine (2014)