Naming, labeling, and packaging of pharmaceuticals

Area of Science:

• Pharmaceutical Sciences
• Human Factors Engineering
• Patient Safety

Background:

• Medication errors frequently occur due to similar-sounding or looking drug names and packaging.
• The current medication-use system's reliance on human perfection makes it inherently flawed and susceptible to errors.
• Established commercial and bureaucratic processes, rather than human factors principles, often dictate drug naming, labeling, and packaging.

Purpose of the Study:

• To discuss the significant problem of medical errors linked to pharmaceutical naming, labeling, and packaging.
• To highlight the inadequacy of current drug naming and packaging standards in preventing medication errors.
• To emphasize the need for incorporating human factors principles into the drug development and approval process.

Main Methods:

• Analysis of the pharmaceutical naming, labeling, and packaging process.
• Review of human factors concepts relevant to medication safety.
• Examination of commercial and regulatory influences on drug product design.
• Assessment of the impact of 'trade dress' on drug interchangeability.

Main Results:

• Sound-alike and look-alike drug names/packages lead to unintended drug interchanges, causing patient harm or death.
• Human factors principles such as simplicity, standardization, and clear communication are often overlooked.
• The drug industry's resistance to change and the FDA's lack of mandatory human factors standards contribute to the persistence of the problem.

Conclusions:

• Current pharmaceutical naming, labeling, and packaging practices are not designed with human factors principles, increasing the risk of medical errors.
• Reforms proposed by private organizations and the limited success of industry changes indicate an ongoing challenge.
• Patient safety is compromised by a system that prioritizes commercial considerations over human factors in drug product design.