Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors

Regulatory NewsRegulatory News | 11 April 2016 |  By 

The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors.

Medical errors, which include medication errors, are one of the leading causes of preventable death in the US. A report published by the Institute of Medicine (IOM) in 1999 found that between 44,000 and 98,000 Americans die each year due to medical errors, though other estimates place that figure as much as four times higher. According to the IOM report, roughly 7,000 of those deaths are linked to errors with patients' medicine.


The final guidance, which is applicable to a wide range of products, including new drugs, biologics, generics and over-the-counter drugs, follows up on draft guidance originally published in 2012. In terms of differences between the draft and final guidance, FDA said it made revisions to address public comments requesting clarifications and implement formatting changes for improved readability. FDA also moved recommendations appropriate for labels and labeling to a separate guidance.

The document is part of a broader effort by FDA to improve drug safety by reducing the risk of medication errors.

Last week, FDA finalized a guidance on reducing errors related to proprietary drug names, and the agency is working on a third guidance which will focus on drug container and carton labeling.

The guidance documents are part of FDA's efforts to meet goals established by the 2007 Prescription Drug User Fee Act (PDUFA IV), including "measures to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone labeling and packaging designs."

Design Considerations and User Interface

FDA says that sponsors should weigh all aspects of a product's "user interface," which includes everything from its active ingredient and strength to the product's size, shape and how it should be stored.

"How a user locates and interprets the information necessary to use the product is critical to the product's safe and effective use. 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," the agency says.

Because of this, FDA says sponsors should also consider the environment and scope of a product's use. For instance, the agency says drugmakers should consider differences in the types of settings a drug might be used in, such as hospitals, outpatient facilities, retail pharmacies and patients' homes and determine if design elements should be changed to suit the needs of those settings.

Sponsors should start thinking about a product's finished dosage form earlier in the design process, FDA says, particularly as "certain product modifications based on manufacturing constraints or clinical issues may inadvertently create the opportunity for medication error."

Proactive Risk Assessment

In order to effectively consider these factors, FDA says that sponsors should conduct proactive risk assessments from the earliest stages of designing a drug.

These assessments, the agency writes, should "employ analytical approaches" and cover end user needs as well as the environment and how a product will be used.

In its guidance, FDA lays out two types of risk assessments sponsors should employ: failure mode and effects analysis (FMEA) and simulated use testing.

FMEA involves analyzing a product in relation to its use in order to determine "the relative impact of different types of system failures that may affect use-related medication error and prioritization of risk."

On the other hand, simulated use testing "involves systematic collection of data from representative end users' realistic use of early, interim, or final product designs." According to FDA, this type of assessment can help a sponsor evaluate individual design elements to determine whether they might contribute to or reduce the likelihood of medication errors occurring.



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