FDA considers new drug bar coding rules to cut errors

In an attempt to reduce the number of adverse drug events that occur every year due to medication errors, the US Food and Drug Administration (FDA) is proposing to introduce a requirement for all human drug and biologic products to be labelled with bar codes. The aim is to minimise errors due to drug mix-ups and also to provide crucial information for prescribers.

A report published in 1999 by the Institute of Medicine estimated that there were 770,000 adverse drug events leading to injury or death every year in US hospitals, of which anything between 28% and 95% arose from preventable errors. According to the FDA, at least 30% of medical errors resulting in death involve FDA-regulated drugs, devices, blood products or vaccines.

FDA officials believe barcode technology, used in conjunction with other information technology, will increase patient safety. The bar codes would identify the drug, strength and manufacturer, as well as lot number and expiry date, and could be compared with a specific patient's drug regimen to ensure that the correct drug is administered.

The FDA move is being supported by the international Patient Safety Officer Society (PSOS), a non profit-making organisation devoted to helping patient safety officers succeed in their efforts to reduce preventable medical errors and enhance overall patient care safety.

In the meantime, Abbott Laboratories in the US is to put unit-of-use bar codes on all of its 1,000+ hospital injectable pharmaceuticals and IV solutions product lines by early 2003. The company has already bar coded around 45% of its injectable pharmaceuticals and IV solutions products and expects to increase this to 70% by the end of the year.

Approximately a quarter of Abbott's injectables and IV solutions will use a new technology - Reduced Space Symbology (RSS) - which allows for a miniaturised bar code to be applied to single-unit containers as small as a pen cap. Previous technologies did not allow for smaller or odd-shaped containers to be effectively bar coded.

Abbott is believed to be the first company to introduce RSS bar code technology commercially on its injectable pharmaceuticals and IV products. It has worked for several years on this initiative, most notably through its role in partnering with the Uniform Code Council (UCC) to test the effectiveness of RSS in a hospital setting.

Michael Di Yeso, chief operating officer of the UCC, said: 'Reduced Space Symbology is a breakthrough bar code solution that will improve the identification of small health care items and bring greater speed, accuracy, and efficiency to the business processes that support patient care.'