FDA Issues Guidance to Reduce Medication Errors


A pair of FDA final guidance documents may help drug manufacturers reduce the risk of deadly medication errors.

A pair of FDA final guidance documents may help drug manufacturers reduce the risk of deadly medication errors.

Medication errors are a leading cause of preventable death in the United States, and data from the Institute of Medicine suggest that as many as 7000 Americans die each year from medication-related causes.

Both guidance documents are part of the FDA’s efforts to meet the goals of the 2007 Prescription Drug User Fee Act, which include establishing “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.”

In its first guidance document, the FDA recommended that submissions from applicants or sponsors include the following components to help the agency more thoroughly review the proprietary name appropriately:

· Primary or alternative proposed proprietary name

· Intended pronunciation of that name

· Derivation of the name

· Intended meaning of the name’s modifiers

· Pharmacologic/therapeutic category

· Proposed label and labeling, and what should be included when a product does not yet have a proposed label and labeling

· Information about product dispensing and delivery

According to the Institute of Safe Medication Practices, brand names that look and sound alike play a large role in medication errors.

While the FDA’s guidance may help reduce instances of medications error, pharmacists can also take steps to reduce the risk for their own patients. When accepting new phone prescriptions or prescription transfers, for example, pharmacy staff should write down the prescription and then read back the medication name, strength, dose, and frequency of administration for verification.

In its second guidance document, the FDA detailed how applicants and sponsors can improve a drug’s container closure system and overall “user interface.”

“How a user locates and interprets the information necessary to use the product is critical to the product’s safe and effective use,” the agency stated 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.”

The FDA recommends that applicants and sponsors start considering a product’s final dosage form earlier in the design process because “certain product modifications based on manufacturing constraints or clinical issues may inadvertently create the opportunity for medication error.”

Additionally, the FDA said drug makers should consider the different types of settings where their finished product may be used, such as hospitals, outpatient facilities, retail pharmacies, and patients’ home. That way, they may be able to more accurately assess whether design elements should be altered to fit the needs of those settings.

Pharmacists should make a point to counsel patients each and every time they fill their prescriptions about the potential for medication error—especially during transitions of care.

The FDA’s recommendations for appropriate labels and labeling will be published in a separate guidance document.

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