More evidence of the importance of pharmacovigilance and risk assessment: A study by the U.K. Medical and Healthcare Products Regulatory Agency (MHRA) has found that the number of deaths reported in the U.K., from adverse reactions to prescription medications, more than doubled between 1996 and last year, moving from 382 to 983. Commentators in a Telegraph article noted that physicians may need more basic training in pharmacology, while Agency officials called on the industry to perform more risk analysis.
Few things scare Big Pharma more than the public reporting of adverse events. At a September healthcare blogging summit in Chicago, leading pharma P.R. executives noted that this fear continued to hold companies back from more proactive communications and the use of new media (including Web 2.0 formats) to communicate with healthcare providers and consumers. (All things that could help restore the industry's reputation and public trust)
In the U.S., efforts to establish easier ways for consumers to report adverse reactions appear to be lurching forward. The Agency still lacks a database for monitoring reactions. As Pharmalot and FDA Law blogs recently reported, a consumer 800-number hotline that was to be set up as part of the Best Pharmaceuticals for Children Act, has yet to appear and Congress has given FDA until January to get one going...
Is this data being overblown? For a dissenting point of view, read the next post.
-AMS
