Medication Errors: Congress Gets to the Root of the Problem
The underreporting of adverse events is only a problem when the FDA does not "get any reports about a certain problem," says Woodcock. "It is a question of quality." If the FDA were to receive additional funds to set up satellite reporting centers at various health care settings, that could increase the reporting of adverse events by about fifteenfold, she tells WebMD. But the key to preventing unknown side effects is to catch them early. And in terms of known side effects, the FDA is prepared to take a different approach. "We even might not approve the drug if improper prescribing of that drug could cause death."
Medications are an important means of delivering health care, testified Raymond Woosley, MD, chairman of the department of pharmacology at Georgetown University. But in order not to lose that benefit, "we must teach safe prescribing habits," he said. Those educational programs, though, should include the consumer. "Direct-to-consumer advertising has created an aura around medication that is inappropriate." And in order to balance the benefits of letting a consumer know about the availability of a new drug vs. creating a dangerous desire for that drug, drug makers should be required to also broadcast a public service announcement.
Eleanor Vogt, RPh, PhD, senior fellow at the National Patient Safety Foundation, and one of the last of the panelists to testify before the Senate committee, said, "What it really is all about is practicing good medicine."