Pharmacovigilance in Perspective
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information needed for the evaluation of the benefits and risks of drugs is in the first place a scientific challenge. In addition, there are important ethical, logistical, legal, financial and commercial constraints. Good pharmacovigilance practice needs to be developed to ensure that data are collected and used in the right way and for the right purpose.
Pharmacovigilance, and more generally the study of the benefits and risks of drugs, plays a major role in pharmacotherapeutic decision-making, be it individual, regional, national or international. In addition, pharmacovigilance is becoming a scientific discipline in its own right.
A variety of changes are taking place in the complex system of drug development, regulation and distribution. Pharmacovigilance should be proactive in monitoring their possible consequences.
- Pharmacovigilance in Perspective
Volume 21, Issue 6 , pp 429-447
- Cover Date
- Print ISSN
- Online ISSN
- Springer International Publishing
- Additional Links
- Industry Sectors
- Author Affiliations
- 1. Netherlands Pharmacovigilance Foundation LAREB, ’s-Hertogenbosch, The Netherlands
- 2. Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, The Netherlands
- 5. TweeSteden Ziekenhuis, Tilburg, The Netherlands
- 3. Department of Clinical Pharmacology, Nijmegen University Hospital St Radboud, Nijmegen, The Netherlands
- 4. Department of Clinical Pharmacy, Nijmegen University Hospital St Radboud, Nijmegen, The Netherlands