US health insurer WellPoint Inc is developing a system that will use its 35m member database to monitor and more quickly identify potential safety problems of approved medicines.
Launching in mid-2009, the new system is expected to be capable of continually monitoring its 35m member database and identifying increases in health problems among members taking a given drug, indicating a potential for serious adverse events. WellPoint is the largest US health insurer by membership.
The new Safety Sentinel system is being developed in collaboration with US health regulators and other government and academic institutions. In theory, it should be able to uncover health risks that may surface once drugs are being used by the general population.
"When we see a signal within our claims data that suggests there may be an issue, we can very quickly work with our provider community to figure out if in fact it’s real," Marcus Wilson, president of WellPoint’s HealthCore unit, which is developing the system, said in a statement.
In addition to data from its membership, WellPoint will work closely with healthcare providers and hospitals to generate evidence based on its findings.
The Food and Drug Administration has increasingly been requiring companies to conduct post-marketing studies as a condition of approving some drugs.
WellPoint says that data collected and reviewed under its new Safety Sentinel system could enhance understanding of dangers associated with popular medications.
"The discovery of important risks of drugs like Vioxx and Avandia has demonstrated that the health care system currently has no reliable means of quickly measuring the safety of drugs once they’re in widespread use," Dr Jerry Avorn, professor of medicine at Harvard Medical School, said in a press statement.
Heart risks associated with the diabetes treatment Avandia and Vioxx were not discovered until after they had been used by tens of millions of patients
It is still being worked out how information gleaned from the system will be shared with the FDA, physicians, members and drugmakers, Wilson said.
The Safety Sentinel system will be able to examine potentially hazardous combinations of treatments, especially in patients with certain diseases or health conditions, such as diabetes, WellPoint said.
"This critical information will allow health care decision-makers, including federal agencies, physicians, consumers and manufacturers, to move far more quickly than in the past in addressing potential drug risks," said Sam Nussbaum, WellPoint’s chief medical officer.