FDA's Woodcock To Testify At Adverse Drug Events Hearing Feb. 1

FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, will testify before a Senate Health, Education, Labor & Pensions Committee hearing on adverse drug events Feb. 1.

The hearing will be the second of a planned series of medical errors hearings by the Health Committee, the first of which was held Jan. 26.

General Accounting Office Health Financing & Public Health Issues Associate Director Janet Heinrich is also scheduled to testify. She will discuss a GAO report analyzing the magnitude of adverse drug events. The report was requested by the Health Committee and by the House Commerce Committee in October 1998.

Other witnesses scheduled to testify are Institute for Safe Medication Practices President Michael Cohen, Harvard Medical School professor and Harvard Pilgrim Healthcare Director-Research Richard Platt, MD, National Patient Safety Foundation Senior Fellow Eleanor Vogt, PhD, and Georgetown University Department of Pharmacology Chairman Raymond Woosley, MD/PhD.

The Feb. 1 hearing will come only a week after two medical errors hearings were held to discuss the issues raised in a November Institute of Medicine report (¹ (Also see "Medical Error Mandatory Reporting System Recommended By IoM" - Pink Sheet, 6 Dec, 1999.)).

The Senate Appropriations/HHS Subcommittee held its second hearing on medical errors Jan. 25 in a joint session with the Veterans Affairs Committee. Sen. Specter (R-Penn.), chairman of both the HHS Subcommittee and the VA Committee, held the first hearing on the subject in December (² (Also see "Medical Error Reduction Effort Will Be Led Initially By AHRQ (Formerly AHCPR)" - Pink Sheet, 20 Dec, 1999.)).

Specter was the only senator to attend the hearing; the Senate was closed Jan. 25 because of a snowstorm in Washington.

Specter discussed medical errors legislation he and Senate Appropriations/HHS Subcommittee Ranking Member Harkin (D-Iowa) are developing for introduction in the first or second week of February.

The legislation would establish 15 demonstration projects at health care institutions across the country to develop models for reducing the frequency and seriousness of errors.

"On five of the demonstration projects, there will be mandatory reporting, with the errors to be held confidential," Specter said. "On five of the other demonstration projects, there will be voluntary reporting, with the information to be confidential."

"And five other demonstration projects will call for mandatory reporting and will mandate that the hospital physician who made the mistake must report that to the patient," the chairman added.

Specter favors mandatory reporting of medical errors and mandatory disclosure of errors to patients.

"There is a professional responsibility on the part of a hospital or a doctor where an error is made which affects the patient, that the patient ought to be notified," he stated.

The bill would also "provide for an analysis as to how to solve the problems of federal funding."

Specter added that, as chairman of the subcommittee overseeing funding of HHS, he intends "to see to it that adequate resources are devoted to identify the problems and to move ahead with the solutions."

Harkin said in a written statement that the bill would offer grants to states to establish reporting systems.

"As a condition of these grants, a state must set up its reporting system along the guidelines of a public-private task force established to determine the best way for providers to submit error data," Harkin said. "The state must send the data they collect to the Agency for Healthcare Research & Quality for analysis and evaluation."

The legislation would also provide for the development of patient safety information for public dissemination and offer grants to professional health associations for training providers in ways to reduce medical errors through curriculum development, technology training and continuing medical education.

Another medical errors bill focusing on major federal health care programs is being drafted by a bipartisan coalition of senators including Lieberman (D-Conn.), Grassley (R-Iowa), Kerrey (D-Neb.), Snowe (R-Maine), Bryan (D-Nev.), Collins (R-Maine) and Robb (D-Va.).

The bill will call for "broad reform" in the administration of Medicare, Medicaid, the Federal Employees Health Benefits Program, the Veterans Administration health care system and the Department of Defense's TriCare program, the coalition announced Jan. 24.

VA Committee Ranking Member Rockefeller (D-W.Va.) said Jan. 25 he opposes legislating patient safety measures for the VA.

"Generally, I question the need for taking legislative action to force VA to comply with IoM recommendations, which they are already doing," Rockefeller said. Part of the Subcommittee hearing focused on VA's efforts to reduce medical errors.

Specter indicated that he will hold more hearings on medical errors.

While both Specter and Jeffords are pursuing medical errors hearings and legislation, each seems to be tackling the issue independently. There has been little or no contact between Jeffords' staff and Specter's staff to discuss their interest in the issue.

Specter's Jan. 25 hearing was originally scheduled to coincide with Jeffords' hearing, which was postponed to Jan. 26 because of the snow.

Harvard School of Public Health professor Lucian Leape, MD, who was scheduled to testify at the HELP Committee hearing, testified at Specter's hearing, then again for Jeffords the next day.

Leape told the Jan. 26 hearing that the Agency for Healthcare Research & Quality currently has the resources to serve the functions of a national center for patient safety, but a separate center should be established to serve as a physical statement of the commitment to improving patient safety.

"What we're really talking about here is saying that this is an important thing for this country and therefore we have a national focal point that we can look to that is clearly defined and specific and everybody knows what it is," Leape, a co-author of the IoM report, said. Of a patient safety center, Leape said, "certainly the ability to do that is already there."

The IoM report, released Nov. 29, recommends that Congress establish and fund a Center for Patient Safety, to be coordinated by AHRQ. The hearing was called in part to determine whether the recent reauthorization of AHRQ (formerly the Agency for Health Care Policy & Research) had addressed the need for a new center.

In his statement to the committee, Sen. Hagel (R-Neb.) noted that the committee plans to "examine what existing agencies and programs are currently available to monitor and disseminate medical error information."

"In doing so," Hagel continued, "it is important to determine whether it is necessary to establish a new layer of federal bureaucracy, or if by expanding the responsibilities of existing agencies we can adequately improve patient safety."

Senate Health Committee Ranking Member Kennedy (D-Mass.) is considering legislation that would establish a center for patient safety and set up a mandatory reporting system for serious and deadly medical errors.

Kennedy originally planned to introduce the bill Jan. 27, but says now that he will wait until the series of Health Committee hearings has been completed and the GAO report has been released. Jeffords plans to hold additional hearings after the Feb. 1 hearing.

During the Jan. 26 hearing, Jeffords suggested that he will be working with Kennedy and other committee members to author medical errors legislation.

"Once the committee has gained a better understanding of the problems associated with medical errors and the recommended solution, I anticipate the development of bipartisan legislation creating a healthcare system quality improvement framework to address this problem," Jeffords said.

Jeffords added that Kennedy and Sens. Frist (R-Tenn.) and Dodd (D-Conn.) have expressed interest in sponsoring legislation.

Kennedy urged that the issue of patient safety not be used to cloud the issue of patient protection and the passage of a Patient's Bill of Rights. "Preventing mistakes by doctors and hospitals is important, but it is no substitute for enacting strong protections for patients against abuses by HMOs and other insurance companies," he said.