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FDA push for medication bar coding and adverse drug event reporting to improve patient safety

Accreditation Connection, March 14, 2003

Get ready to report possible medication side effects and drug errors to the government. And ensuring that patients don't receive the wrong medication may be a lot easier in the near future.

The Food and Drug Administration (FDA) last week issued the following two proposed rules to help reduce medication mistakes and more quickly identify potential drug errors:

1. To improve how health care organizations and drug manufacturers report adverse drug events-including both side effects and errors-to uncover preventable problems.

2. To require bar codes similar to supermarket scanners on all prescription drugs and some over-the-counter medications and vaccines, a system that contains the drug name, dosage form, and strength. Note: This regulation does not require including the medication's lot number and expiration date in the bar code.

The following are some highlights to the first rule:

_ Organizations must report within 15 days actual and potential (i.e., "near miss") medical errors, such as when a pharmacist selects the wrong medication because of similar names but catches the error prior to dispensing it. Currently, organizations must promptly report such problems if they cause serious injury.

_ Blood banks must report serious adverse reactions to blood transfusions or use of blood products. Currently, companies must only report fatalities.

The proposed rules pertain to drug and biological products used during clinical trials and once the product hits the market.

The FDA also hopes to improve the quality of reporting by requiring the use of internationally agreed upon definitions and reporting formats. If the reporting rule is approved, organizations must prepare a single, high-quality report to submit to all major regulatory agencies around the world, according to a FDA press release.

Additionally, the proposal refines and clarifies how much data to include in safety reports to lessen some of the industry's reporting burdens.

For example, a safety report of a suspected drug reaction would contain "a minimum data set" of the patient's name, reporter, suspect product, and the reaction. More serious reports must contain more details.

The American Society of Health-System Pharmacists lauds the bar code proposal since it would significantly improve patient safety. However, the lot number and expiration date are critical to protect patients from recalled or expired medications.

Hospital patient safety advocates also applauded the proposals, but expressed concerns about the cost of adopting bar coding systems. The FDA estimates it will cost drug manufacturers about $53 million to change their labels and comply and hospitals may face an additional $7.2 billion in order to use the technology.

But advocates say patient safety comes first, including the ability to better guarantee the correct medication, dose, time, route, and patient.

"We are supposed to check those every time," says Sandy Patterson, quality resources officer and legal compliance officer at North Oaks Health System in Hammond, LA. "But when you look at medication errors in facilities it turns out that one of those [systems] was violated."

The FDA's two proposals are open for public comment-90 days on the bar code plan and 120 days on changes to the adverse reactions reporting system-before the new rules take effect. Send written comments to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockland, MD, 20852.

Read about the two proposals at www.fda.gov/oc/initiatives/barcode-sadr

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