One primary justification for building large electronic health records systems has been that they will make it easier to detect rare but dangerous side effects of drugs, or to identify previously undetected risks by studying trends in large user populations. In Drug Safety, Thomas Moore of the Institute for Safe Medication Practices and Wake Forest University School of Medicine’s Curt Furberg ask, after years of efforts, “What has been learned about electronic health data as a primary data source for regulatory decisions regarding the harms of drugs?”
“Electronic health data for postmarket surveillance became a key element in the new paradigm for drug regulation, which involved fewer and smaller clinical trials prior to marketing approval,” the authors state in their summary points. They then review what was awry in a slew of attempts to use massive databases of electronic health records to better understand drug risks, including inconsistent practice tendencies and record-keeping among different physicians, difficulty in validating findings, and problems with identifying and adjusting for confounders.
The authors conclude, “There is no credible evidence that electronic health data today has the capacity to provide robust, reliable ‘active surveillance’, meaning identifying new drug risks not previously identified through other means. The results thus far dramatize the difficulties in confirming known adverse effects found using other methods. The high levels of variability in almost every parameter render findings difficult to replicate and vulnerable to substantial bias, either as an accident of data and method selection or through intentional manipulation of study criteria.”
Moore, Thomas J., and Curt D. Furberg. “Electronic Health Data for Postmarket Surveillance: A Vision Not Realized.” Drug Safety, May 30, 2015, 1–10. doi:10.1007/s40264-015-0305-9. (Abstract) (Full text)