Friday, June 06, 2008

tracking prescription drug, device safety

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The Department of Health & Human Services recently announced a plan called the Sentinel System, under which the FDA will monitor prescription drug and medical device safety by reviewing existing databases for information about side effects.

The FDA would also have the authority to access the claims data from private insurance companies and the databases of federal programs, such as Medicare.

US Unveils Plan to Track Safety of Drugs & Devices

Secretary Mike Leavitt said the program is a shift from a reactive approach to concerns to a system of surveillance intended to prevent harm.

Questions remaining include funding for the program, precisely what information the FDA will have access to and whether the information will be made public.

I personally have concerns about this improving consumer safety if the information will not be made public. Public access to this information is key in helping consumers make informed choices.

In related news, a new study found that 1 of every 9 visits to emergency departments are related to medication use errors.

Incidence, Severity and Preventability of Medication-Related Visits to the Emergency Department

Sixty-eight percent of the errors were considered preventable. The study's authors suggested these errors could be prevented by improved doctor patient communication and increased monitoring of risk high patients.

Always ask your doctor and pharmacists any questions you have about medication you have been prescribed. If you're in doubt about something, err on the side of caution and make a call to clarify the way your medications are to be used.

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