Risk assessment of drugs, biologics and therapeutic devices: present and future issues.
OBJECTIVE
The current US system for detecting adverse effects of therapeutics (drugs, devices and biological products) is suboptimal. This report presents the results of an expert workshop on assessing therapeutic risks. This is the second of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) to address the management of therapeutic risks relative to potential benefits.


METHODS
The workshop included academic, industry, government and constituency-based leaders. The focus was on the post-approval phase and procedures in the US, but relevant international issues and attendees were included.


RESULTS
Substantial deficiencies in the current US system for risk assessment were delineated. Improving the system will involve research into methods to improve risk assessment, enhancement and consolidation of data-handling systems, education of healthcare workers, allocation of financial resources and building of constituencies.


CONCLUSIONS
We need leadership on multiple levels for global coordination of risk assessment. We can then begin to fill gaps and produce benefits for industry, health authorities, government agencies, healthcare providers, and most important, the public.
D016907:Adverse Drug Reaction Reporting Systems; D001691:Biological Therapy / Q000009:adverse effects*; D003245:Consensus Statements as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects*; D006291:Health Policy; D006801:Humans; D007857:Leadership; D017891:Pharmacoepidemiology; D018570:Risk Assessment / Q000379:methods*; D014481:United States; D016270:United States Agency for Healthcare Research and Quality