A new Institute of Medicine (IOM) report about how the Food and Drug Administration (FDA) can strengthen post-market surveillance of new medications mentions the use of electronic health records data to aid in tracking drug effects.
Explaining why the report was commissioned, the IOM says, "Changes in federal law, especially passage of the Food and Drug Administration Amendments Act in 2007, along with advances in information technology, have provided an opportunity for the Food and Drug Administration (FDA) to improve its system for ensuring that drugs are safe and effective after they are approved for sale."
The IOM committee that wrote the report stressed the need to make sure that the post-market research is conducted in an ethically and scientifically sound way. "Continuing advances in electronic health record systems and analytic techniques likely will mean that observational approaches using large data sets will become more important over time, and these approaches could create new ethical challenges," according to the IOM announcement.
The committee recommends that the FDA emphasize a "life cycle" approach to drug safety oversight. This method requires the agency to anticipate and plan surveillance of particular medications during their entire market lifetime.
Because randomized clinical trials may be impractical once a medication is on the market, the report says, post-marketing research may require observational studies. While the report summary doesn't say so, observers have pointed out that EHRs can be used to collect data in observational trials conducted in medical practices. In fact, EHRs can harvest data on the kind of surrogate endpoints--such as lowered blood pressure--that may predict clinical outcomes, according to the report.
It's unclear, however, whether the pharmaceutical companies that conduct these studies would pay physicians to gather the clinical data from their EHRs. Also, as the IOM report points out, patient privacy issues would have to be addressed.
To learn more:
- read the IOM announcement
- see the report summary