July 20,2006

Chairman Grassley Comments on the Institute of Medicine Report on Medication Errors

M E M O R A N D U M

TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
RE: Institute of Medicine Report Preventing Medication Errors
DA: Thursday, July 20, 2006

Sen. Chuck Grassley made the comment below in response to a report released today by
the Institute of Medicine (IOM), Preventing Medication Errors. The IOM study, which examined
the incidence and costs of medication errors, was mandated by the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA), which Sen. Grassley sponsored as
Chairman of the Senate Committee on Finance.

The IOM found that hospital patients are subjected to at least one medication error per
day and at least 1.5 million preventable adverse drug events occur each year as a result of
medication errors. While IOM found that data on the costs associated with medication errors is
limited, one study estimates the cost in the hospital setting alone at $3.5 billion. Another study
estimates the cost for Medicare beneficiaries in an outpatient setting at $887 million.

To reduce medication errors, IOM recommends improving communication between
patients and providers, enhancing the resources to support consumer-oriented drug information
and medication self-management, increasing access to patient information by clinicians and
consumers, improving drug product naming, labeling, and packaging, establishing standards for
drug-related health information technologies, and incentivizing the adoption of practices and
technologies that reduce medication errors.

Statement by Sen. Grassley:

“I appreciate this comprehensive report from the Institute of Medicine. While our
healthcare system is the envy of the world in many ways, clearly there is room for improvement.
This report outlines an ambitious agenda for increasing the safety of the medication use process.
While some of the recommendations will take longer and require more resources to implement,
there are others on which immediate action can be taken. For example, the Institute of Medicine
attributed many medication errors to confusion about a drug’s name, label and package. Drug
names look and sound alike, labels are cluttered, and warnings are given inadequate prominence.
To address this confusion, the Institute of Medicine suggests that the Food and Drug
Administration and others develop guidance documents for industry by the end of 2006. I hope
the FDA will act on this recommendation as soon as possible.

“Of particular interest to me as the chair of the Finance Committee, which has
jurisdiction over Medicare, is the Institute of Medicine’s assertion that almost nothing is known
about the benefits and risks of medications for people over age 80 and those taking medications
for multiple conditions. To address this, the new report calls for an increase in clinical trial
studies as well as giving access to trial data to patients, providers, health insurers, researchers,
and regulators. This recommendation is consistent with the provisions contained in the “Fair
Access to Clinical Trials Act of 2005” or “FACT Act” (S. 470) which I co-sponsored with Sen.
Dodd. The purpose of the FACT Act is to foster transparency and accountability in
health-related research and development, and to ensure that physicians, the scientific community,
patients, and the general public have access to basic information about clinical trials.”