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New FDA Guidance on Minimizing Medication Errors

August 21, 2016


In April 2016, The U.S. Food and Drug Administration (FDA) released their new Guidance for Industry, “Safety Considerations for Product Design to Minimize Medication Errors.”

The point of this new guidance is to put an end to the medication errors that have been occurring within the medical industry when it comes to wholesale packaging.

Roughly 82% of U.S. adults take at least one medication and approximately 29% take five or more medications. Errors in packaging or dosage could have serious consequences for patient’s health.

Two of the main points of emphasis on the new guidance are:

1. Dosing Measurements — Dosing devices used for oral liquids should be appropriate to the specific measured dosages.

2. Dosage Solution — Dosing devices should also deliver a solution in a volumetric unit that is consistent with the recommended dosage.

“How a user locates and interprets the information necessary to use the product is critical to the product’s safe and effective use,” FDA officials said in a press release. “Because labeling packaging and nomenclature have been identified as key system elements that have great influence on medication use, any weaknesses or failure in the design of these elements can cause medication errors that lead to patient harm.”

According to Pharmacy Times, errors in the medical field are the leading cause of preventable death in the country. Roughly 7,000 Americans die every year from medication-related errors. The new FDA-implemented guidance is part of the administration’s efforts to achieve the goals of the 2007 Prescription Drug User Free Act (PDUFA). One of the goals of the PDUFA is to reduce the number of medical errors related to names and labeling.

The FDA does plan on publishing another separate guidance document that will reference recommendations for appropriate labeling when it comes to medications.

Custom product packaging manufacturers, wholesale packaging companies, and professionals throughout the medical industry will have to make note of these important changes and hopefully these new guidelines will lead to fewer errors, fewer medication-related deaths, and stricter policies within both the medical field and the wholesale packaging industry.



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