The first of what is guaranteed to be a flurry of bills aimed at reducing medical errors falls short of requiring providers to report errors.
Under a draft proposal by Sens. Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa), 15 healthcare providers would participate in a demonstration project to help Congress determine the best way for providers to report errors: voluntarily or by a requirement of federal law.
The demonstration project would also look at whether providers should tell patients and their families about the errors.
The bill, which has not been formally introduced, is a response to the Institute of Medicine report on medical errors released late last year. MODERN HEALTHCARE obtained a draft copy of the bill last week.
Two other bills aimed at reducing the number of medical errors are in the works (Jan. 31, p. 8).
Feeding the bill-writing frenzy last week were two congressional hearings, at which witnesses called on Congress to institute a better system for reporting hospital and doctor errors and for sharing information about risky treatments with patients.
Providing emotionally charged testimony to the Senate Subcommittee on Public Health was Paul Gelsinger, the father of a Tuscon, Ariz., teen-ager who died in September after participating in a University of Pennsylvania gene therapy study.
Gelsinger said he learned just two months ago that the researchers had withheld and falsified information to persuade him to let his son Jesse participate in the study.
In a Jan. 31 letter to subcommittee Chairman Bill Frist (R-Tenn.), University of Pennsylvania President Judith Rodin said the school is taking the matter very seriously and has begun two independent reviews to determine what happened.
Testifying before the Senate Health and Education Committee during a separate hearing, an FDA official called adverse drug events "a very serious public health problem" and asked Congress for additional resources to document and reduce such incidents. Adverse drug events include medication errors and unexpected reactions to drugs.
"The problems with drugs are national," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, told the committee. "We need to draw information from everywhere. We've had to pull drugs off the market that would be safe if safeguards were in place and the healthcare system (were) managing the risks properly."
The General Accounting Office, Congress' investigative arm, also released a report last week saying that relatively little is known about the frequency or cost of adverse drug reactions, because the current reporting system is fragmented.