Drug Monitoring Is Inadequate, Physicians ReportBy Stacy Lawrence | Posted 07-27-2005
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 Accenture's health and life sciences practice, Philip George.
"What doesn't currently exist is a national safety and epidemiology database that we can reference to see what's 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.
Still, despite drug safety concerns, consumers seem to trust the pharmaceutical industry.
Virtually all consumers surveyed said they believe that prescription drugs can have a positive impact on their health, and 87 percent said that pharmaceutical companies provide an extremely or very valuable service to society.
But inadequate post-marketing data and further recalls could erode that trust.
"We weren't that surprised consumers didn't have that much confidence in the regulatory agency because of their bombardment by recent press coverage of drug recalls," said George.
"But the fact that physicians didn't, given their knowledge and involvement in the process, was a little shocking."
Conducted in April, this study was of more than 100 U.S. physicians and 500 U.S. consumers.
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