Medication safety
Since the Institutes of Medicine published its 2006 report on the perilous nature of oversight when it comes to prescription drugs, the government has gotten busy.
Last week the Food and Drug Administration and Medicare announced a computerized collaboration that will allow medical detectives to mine vast databases of information to ensure the safety of medications that have made it to market.
The program, called Sentinel, is a much more aggressive approach than the current system, which relies on voluntary reports of adverse effects that trickle in from health care providers and patients.
Drug companies perform clinical drug trials before seeking the FDA’s approval, but those tests are conducted on a limited number of people and often do not include the elderly, who are the highest-volume consumers of drugs. Because information from Medicare Part D will be at inspectors’ disposal, they’ll have a much clearer picture on the safety of drugs for seniors.
Even clinical trials can raise nagging doubts that aren’t resolved before drugs hit the market. Sentinel can follow up on those concerns.
Another plus is that consumers and health care providers won’t be as reliant on manufacturers for information. Unfortunately, that arrangement has led to drug companies downplaying negative results and ghost-writing articles for medical journals.
The profit motive has a way of eroding objectivity.
When IOM released its report on drug safety, the Pharmaceutical Research and Manufacturers of America highlighted one way to improve oversight, recommending, among other things, “maximizing use of large health care data base.” So it would appear that drug companies are on board.
About the only opposition to Sentinel comes from groups worried about private medical information being divulged. But the Centers for Medicare and Medicaid say the records will be stripped of information that could be connected to specific patients.
In the United States there are an estimated 1.5 million preventable adverse drug events each year, and IOM says the number could be higher.
An early warning system could help bring that number down.