When the FDA introduced SPL (structured product labeling), the idea was to help inform consumers and improve patient safety. This regulation requires manufacturers to submit prescribing and product information (i.e., the package insert or label) using standardized medical terminology in a readable, accessible format.
The European equivalent of the FDA – European Agency for the Evaluation of Medicinal Products introduced its Product Information Management (PIM) standard, which is aimed at creating consistent labeling across the region. Multinational companies have incorporated both standards into their business processes.
But problems still exist. 33% of medication error reports to the Institute of Safe Medication Practices (ISMP) Medication Error Reporting Program may be attributed to the packaging and labeling of drug products.
What are some of the attributes for these errors?
- Small font size and illegible information making it difficult to read
- Prominent placement of branding and logos, instead of important information
- Too much clutter on labels
The number of errors can be reduced by making some changes to these labels, such as:
- Raising the minimum font size
- Color coding to help differentiate products
- Electronic technology
- Bar coding
There is technology available to reduce the number of errors, such as validated medical labeling solutions including auditable security protocols and lifecycle documentation. Labeling printing programs and barcode software allows users to include variable data, such as product codes and descriptions, barcode, logos and images in labels.
Do you think the FDA should be doing more to regulate pharmaceutical labels? What steps are you taking to reduce these errors from occurring?
