Since medication errors account for an estimated 7,000 deaths annually in this nation, the US Food and Drug Administration (FDA) started looking at and addressing safety issues related to product labeling in order to reduce medication errors.
The FDA recently issued a draft guidance on container and carton labels and design in order to reduce medication mistakes that poor label designs have been causing. The rules have not been enforced yet, as the Pharma industry is now providing its comments and input before the new set of principles and recommendations are adopted.
The reason behind this move is to focus on the safety aspects of labeling. A carton’s label is critical to safe dispensing, administration, and the use of the product. This is why the FDA has provided guidance on labeling design, in hopes that medication errors will be reduced. If prescription drug and biologic product manufacturers concentrate on making their container labels according to this new set of recommendations, their efforts may reduce errors that occur when dispensing medication.
The FDA realized that there are many things about labels that cause medication errors including:
- Look-alike and sound-alike medications names
- Unclear label abbreviations
- Error-prone labeling and packaging designs
In order to minimize risks, it was decided that labels should be designed properly allowing people to easily locate and read the safety information. This means that the text and font size or style, color contrast, warnings, and other critical information should be easy to read and designed in a way to keep patients safe. The new draft rules that the FDA is issuing will apply to prescriptions drugs, but it will not apply to over-the-counter (OTC) drugs.
If you have been the victim of pharmacy error, you have rights! Contact the pharmacy error attorneys at Kennedy Hodges, L.L.P., today (888-526-7616) to schedule a free consultation to discuss your case.