FDA packaging guidance gets bad 'wrap' (sidebar)

Safer institutional drug packaging?

Drug packaging has never been a political hot potato. But there may be some mashing in store on Capitol Hill as Democrats and Republicans dig into a fertile new healthcare issue: medication errors.

The issue budded late last year when a 20-member committee appointed by the National Academy of Sciences issued a report on medical errors. The report contained the inflammatory estimate that between 44ꯠ and 98ꯠ people died unnecessarily each year in U.S. hospitals because of medical errors that could have been prevented. A high proportion of those deaths involved patients receiving the incorrect drug or dosage.

The committee felt that improved packaging was one way to reduce the number of those errors. It noted the value of unit-dose packaging and went on to observe that: “As a cost-cutting measure, unfortunately, some hospitals have recently returned to bulk dosing, which means that an increase in dosing errors is bound to occur.”

But the report went well beyond simply patting unit-dose packaging on the back. It recommended that the FDA “develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use.” Currently, the FDA only requires packaging to maintain the identity, strength, quality, purity or potency of a product.

See the main story that goes with this sidebar: FDA packaging guidance gets bad ‘wrap’

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