White paper provided by Sciformix. Click here for more information
21st century technologies will create significant opportunities and challenges for all health care stakeholders. Pharmacovigilance too is in transition, with new sources of medical information and methods for its analysis that will transform today’s largely reactive system into proactive benefit-risk management for all medication users.
The discipline of pharmacovigilance (PV) largely originated in reaction to public health disasters caused by medications, e.g. tetanus toxoid (1912), sulfanilamide (1938), thalidomide (1962), etc. The detection of significant, previously unrecognized hazards of medications following their introduction into clinical use was traditionally based on collation and evaluation of essentially anecdotal reports of suspected adverse drug reactions (ADRs). Subsets of these reports were communicated to regulators, individually and/or in the aggregate, within specific timeframes; however, these regulations were established at a time when modern communication tools and databases did not exist and all communication was on paper, greatly limiting the analysis and evaluation of potential safety signals.
Furthermore, regulatory oversight of company safety activities for approved medical products was, until very recently, largely limited to assessing the adequacy of and compliance with the procedures license holders established to meet their legal obligations, rather than on any identifiable public health benefit.
In recent years, the combination of greater public awareness of drug safety issues and emerging informatics-based methods for acquiring and analyzing medical information has sparked global research initiatives for transforming the present largely reactive system into one that is proactive, robust, and more useful clinically.
Download to learn:
- A new model for the 21st centuary
- Why do we need a new PV model?
- What might effective PV look like in 2038?
- New data sources
- Better clinical decision making
- Broad accessibility of appropriate information
- Cost benefit considerations