International pharmacovigilance: developing cooperation to meet the challenges of the 21st century.
Much has been accomplished internationally in the past decade to harmonise the much of the process of post-marketing drug risk detection. However, formidable challenges exist in harmonising analytical approaches to such data and in leveraging international database resources to improve the quality of such data. In addition, international challenges continue in the arena of drug risk management once a specific risk has been detected. Especially problematic are the questions of appropriate methodology and metrics to assess the public health impact of our risk management techniques. Finally, international challenges remain in the world of drug risk communication to practitioners, dispensers, and patients. The primary challenge confronting us is that of providing easily accessible, understandable, unbiased information on drug risk to these communities so that truly informed decisions about medicines can be made at the individual patient level. Only by meeting internationally these challenges in drug risk detection, management, and communication can our citizens know how to best use these wonderful pharmacological gifts to which we now have access.
Lumpkin
M M
MM
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857 USA. lumpkin@cder.fda.gov
D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007391:International Cooperation; D011634:Public Health; D018570:Risk Assessment