A recent study by industry consultancy Accenture found that about two-thirds of doctors and one-third of consumers have become more concerned about the safety of prescription medications since the recent removal from the market of popular pain relievers known as COX-2 inhibitors.
The survey also found that the vast majority of physicians and consumers believe that more should be done to monitor the safety of drugs after they are on the market.
Eight in 10 physicians said regulatory agencies should increase monitoring after drugs are approved for use, and more than three-quarters said regulatory agencies should improve monitoring feedback capabilities.
Only one-third of physicians said they were extremely or very confident in the current post-market monitoring system.
Beyond simply increasing the requirements for extended post-marketing clinical trials, information technology may provide a useful solution to this dilemma.
Doctors participating in the study expressed confidence that new medical IT has the potential to help improve the existing system of drug-safety monitoring.
In fact, two-thirds of physicians surveyed said they believe that electronic medical records could help address post-market drug surveillance.
National or regional EMR (electronic medical record) networks could allow for the real-time reporting and analysis of symptoms, diagnoses and treatments, according to the managing partner of Accentures health and life sciences practice, Philip George.
“What doesnt currently exist is a national safety and epidemiology database that we can reference to see whats out of the norm,” George said. “Now patients report what they think is an adverse reaction to the physician and the physician reports back to the pharmaceutical company.”
George expects to see state and regional electronic medical records emerging in the next two to three years and a national one in about a decade.
Before that can come about, though, “we need common standards so that all the information can be put into a single system in a readable, usable format, and you need analysis tools to mine the database,” George said.
A more intermediate solution is to query the databases of the big health plans.
