Washington Editor

WASHINGTON - The FDA believes that a simple bar code containing pertinent information about dose and usage of a drug or medical device could help heath care professions reduce the climbing rate of medical errors that often lead to death and injury.

It has not been decided whether the proposed regulation requiring bar codes would include all drugs, biologics and medical devices.

The stunning rate of mistakes occurring in U.S. hospitals became front-page news in 1999 when the Institute of Medicine released its now-famous report, "To Err is Human: Building a Safer Health System," estimating that 100,000 people die every year because of preventable medical errors. Approximately 770,000 adverse drug events leading to injury or death also were documented in the report.

The FDA says 30 percent to 50 percent of the 100,000 deaths likely are associated with agency-regulated products such as drugs, devices, blood and blood products or vaccines.

Upon release of the report, the agency began looking at creative ways to cut down on errors, and came up with the idea of attaching informative bar codes to drug packages and possibly medical device boxes.

Indeed, the FDA released a prepared statement saying, "If a health professional could use a bar code scanner to compare the bar code on a human drug to a specific patient's drug regimen, the health professional would be able to verify that the right patient is receiving the right drug, at the right dose and at the right time."

Exactly what type of information would be included remains unclear. According to the agency, bar code advocates are recommending that the code contain a unique numerical code that is dose-specific to identify the manufacturer, product and package size or type, lot number and expiration date.

The availability of bar codes for pharmaceuticals also would facilitate other patient safety initiatives, the agency said - for example, automated drug prescribing or ordering, automated monitoring for drug toxicities in hospitals and as a component of the automated medical records.

In the medical device arena, the FDA is considering whether all such products need coding. While tongue depressors, syringes and crutches are medical devices, coding them may not be necessary, the agency said.

Friday the FDA will take comments on issues surrounding bar coding at a meeting at the National Institutes of Health in Bethesda, Md. For additional information, call the FDA at 301-827-3360 or visit the web site at http://www.fda.gov/oc/meetings/barcodemtg.html.

NIH Poised For Major Budget Increase

A Senate subcommittee last week approved a $3.7 billion increase to the NIH's budget, bringing the total to $27.3 billion for fiscal year 2003. This approval represents the fifth and final installment of an NIH budget-doubling effort initiated by the Clinton administration in 1998.

The Senate Appropriations Committee is expected to consider the measure Thursday, while the House version is expected in September. The fiscal year begins Oct. 1.