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Petitioning Food and Drug Administration and 1 other

Improve mandatory national Standards for Drug packaging in the United States of America

There is currently a multitude of similarly packaged drugs with very different clinical effects available in the United States of America. This increases the risk of significant drug error and the potential for serious patient harm.  This, coupled with long work hours make the likelihood of medication error increase substantially over time.   

Whilst clinician vigilance and pharmacy purchasing practices are important strategies, they are not able to provide a robust, permanent solution to these issues.  Purchasing the same drugs from different distributors may supply the department with the same drugs packaged differently.     

Incorporation of human factors strategies into manufacturer drug packaging & labeling to maximize distinctiveness of different medications and consistency between similar medications, could help to reduce this risk. While work has been done in this area in both labeling and naming, there are no mandatory national standards to prevent pharmaceutical manufacturers producing medications with dangerously similar packaging. 

Manufacturer drug packaging including the external box, labels, ampules, vials, caps, stoppers, blister packs & other elements should be subject to mandatory standards. In addition to previously proposed/implemented strategies this could include color coding of these packaging elements according to the class of drug, based on the list of confused drug names in place for medications, especially intravenous & fluid therapy. This list could be used to target the first implementation of the EZDrugID proposal.

Standardization of the type of packaging (vials, glass or plastic ampules) for different classes of intravenous drugs should also be considered where practical.

The implementation of this proposal may only work if every manufacturer participated. This is not meant to be a replacement for a double check. With an ever-shrinking nursing staff combined with high-stress, high-intensity emergent situations, this supports emergency staff by allowing them to recognize the correct drug first, check, and double-check for right-drug-right-patient, and avoid fumbling with multiple vials where time is critical. A study conducted in a small community hospital demonstrates the potential power of EZDrugID by showing a statistically significant decrease in task completion time, a significant reduction from 25.6% of incorrectly converted medications to 2.5% (23% improvement 95% confidence interval [CI], 13-33; P < 0.001), a significant reduction in incorrectly diluted medications (a 35% improvement, 95% CI, 26-44; P < 0.001), and a significant reduction in incorrectly administered medications (51% improvement, 95% CI, 39-61; P < 0.001).

Irrespective of the manufacturer, the type, design & color of pharmaceutical packaging should be subject to a mandatory national standard, so that its appearance maximizes consistency between similar drug types and distinctiveness between different classes of drug. This needs to be done in a way which does not compromise the ability to distinguish between individual medications.

The ultimate goal is to reduce the risk of drug error and minimize patient harm.

More information on the campaign is available at EZDrugID.org

 

 

http://www.ncbi.nlm.nih.gov/pubmed/19920446

 

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