In the guidelines the FDA cites examples of how improper packaging can lead to medication error. The agency warns that oral and topical drugs contained in vials can be mistaken for intravenous medications, that oral inhalation products packaged in capsules can lead to the medication being swallowed instead of inhaled and that topical products packaged in containers that look similar to ingestible drug containers can lead to application of the topical product in the eye, ear, nose and mouth.
The FDA writes, “The best container closure designs are those that do not require extensive end-user training and that make sense for the dose, route and method of administration.”
These guidelines are the first of a planned threefold series of recommendations created to reduce medication errors with alterations at the level of product design and labeling — the other guidelines will focus on risks associated with the design of drug product container labels and minimizing risks when developing and selecting proposed proprietary names.
The guidelines state that active ingredients, strength of the medication, the product’s size and shape and proper storage should all be considered when labeling and packaging drug products.
“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 FDA writes.
The guidance documents are part of FDA’s efforts to meet goals established by the 2007 Prescription Drug User Fee Act.
More articles on medication issues:
Treatment & medication approval: The arduous process
Pain meds like Tylenol may impede brain’s ability to detect error, according to new study
25 things to know about e-prescribing
