New USP Standards for Prescription Container Labels

Jennifer Markarian

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US.

Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US.  It seems that, despite the efforts of regulators, industry, and medical professionals, patients continue to misunderstand dosage instructions.

The USP Nomenclature, Safety, and Labeling Expert Committee, which developed the new standards, said in an Oct. 9 press release that a lack of universal standards for labeling caused patient misunderstanding. The USP standard aims to solve this problem by creating a “patient-centered” label that is organized, readable, and explicit. A

provides examples of such labels. The standard eliminates language such as “Take 2 tablets twice daily” and replaces it with language that separates the dose from the timing of each dose, such as, “Take 2 tablets in the morning and 2 in the evening”. The standard also takes language barriers into account and suggests that directions should be provided in the patient’s preferred language, along with the drug name in English.  The standard also recommends large font size and alternative systems for visually impaired patients, such as “tactile, auditory, or enhanced visual systems that may employ advanced mechanics or assistive technology,” according to the press release.

Tactile systems could include Braille. The European 2004/27/CE directive in 2006 made Braille labeling mandatory on pharmaceutical packaging in Europe. Braille is not mandatory in the US and Canada, but the International Association of Diecutting and Diemaking (IADD) developed a Can-Am Braille standard for North America several years ago.  Other systems include labels that could be read audibly by a computer. It would be interesting to hear more about such systems and how they are being used commercially. Is there an app for that?