DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-9

FDA Web site: www.fda.gov

Revised: February 2002

“To Err is Human,” acknowledged

the title of an Institute of Medicine

report in November 1999. Its message, however, was an urgent call on

our nation to minimize the exorbitant

toll of medical errors by building a

safer health-care system.

The consequences of misused or

unsafe medical products are shocking: According to recent studies, adverse events associated with drugs

are the single leading contributor to

preventable patient injury, and may

cost the lives of up to 100,000

Americans, account for more than 3

million hospital admissions, and increase the nation’s hospitalization

bill by up to $17 billion each year.

Drug-linked injuries outside the hospital are estimated to inflate the annual health-care bill by an additional

$76.6 billion.

The FDA, which each year receives hundreds of thousands of reports about adverse events associated

with the products it regulates, makes

major efforts to reduce this enormous toll. Here are some of the actions the agency is taking to improve

the management of medical risks:

• Enhancing the collection and

analysis of adverse event reports

involving drugs, vaccines, medical

devices and food products. Serious

problems prompt corrective measures, including warnings and alerts

for consumers, physicians and patients; limitations on the products’

use; and, if necessary, call for their

withdrawal from

the market.

• Implementing a

new regulation requiring all manufacturers of blood

and blood components to report to

the FDA any event

associated with the

testing, processing,

packing, labeling,

storage, or holding

for distribution of a

blood or blood

The Challenge to Improve Patient Safety:

FDA Logs Over 350,000 Reports of Adverse Events Annually

component in which the safety, purity, or potency of a distributed product may be affected.

• Proposing to reorganize and clarify

the scientific information in drug

labeling to make it more easily accessible by physicians, and thereby

help prevent errors in prescribing.

• Working with industry to reduce

medication errors caused by lookalike or sound-alike product names

and confusing packaging configurations.

• Expanding outreach to healthcare providers and the public on safe

use of products.

For more information, please call

301-827-3219 or visit the FDA Web

site at www.fda.gov/medwatch.

Adverse Events Reporting

Goes Global

The FDA’s analysts frequently

consult with their counterparts

abroad about drugs that cause serious

side effects. This exchange of

information will soon become global.

As part of the FDA-pioneered

international harmonization of drug

standards, regulators and the

pharmaceutical industries in the

United States, European Union and

Japan have created a special medical

dictionary for adverse event reporting, and are developing electronic

standards for secure transmission of

all regulatory information.

100,000

150,000

200,000

250,000

300,000

1993 1994 1995 1996 1997 1998 1999 2000 2001

136,095 141,467

155,201

189,077

218,324

256,054

279,306

269,262

278,003

Adverse Events Associated with Drug and Biologic

Products Reported to FDA — 1993-2001