BETHESDA, MD 30 November 2012—The United States Pharmacopeial Convention (USP) recently unveiled universal standards for prescription drug container labels that are intended to make it easier for patients to take their medications as prescribed.
The two-page document was unveiled in October and is officially known as United States Pharmacopeia (USP) chapter 17, "Prescription Container Labeling."
"The whole approach was to focus on what was most important for the patient," said Gerald K. McEvoy, ASHP's assistant vice president for drug information. McEvoy is cochair of the USP Health Literacy and Prescription Container Labeling Advisory Panel, a group of independent experts who developed the new standards.
According to USP, the standards provide, for the first time, "a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists."
The standards emphasize patient-friendly elements such as prominent placement of the most important information and the use of clear, simplified language and explicit instructions. The standards also address legibility by requiring high-contrast print, a large font size for critical information, and prudent use of white space.
These elements are illustrated in example labels released along with the new standards.
McEvoy said much of the chapter addresses such issues as stating "Take 1 tablet in the morning and 1 tablet at bedtime" instead of "Take twice daily."
"Spell it out more clearly so patients are less likely to misinterpret the instructions," he said.
The standards state that a drug's full generic and brand names should appear at the top of the label along with the strength and dosage instructions.
McEvoy said stakeholders' concerns that there might be insufficient space on container labels for a drug's full generic name have not been borne out. He said that the lengthy names of commonly used combination drugs such as "acetaminophen–hydrocodone" and "acetaminophen–oxycodone" have been shown to fit on labels.
"I don't think that there are real technical issues" posed by following the standards, he said. "It's just going to be reorganizing the information and making sure that the instructions that are provided to the patient are more understandable."
According to the standards, "less critical but important content," such as the pharmacy's name and phone number and fill and refill dates, should be placed away from dosing instructions and should never supersede critical patient information.
The standards also encourage physicians to include a drug's prescribed indication on the prescription so that it can be included on the container label, unless doing so would cause privacy concerns for patients.
McEvoy said including the indication on container labels makes it easier for patients to associate each medication they take with the reason they take it.
USP started its work on the standards more than five years ago in response to an Institute of Medicine (IOM) initiative to improve health literacy in the United States.
Experts convened by IOM to study health literacy had cited prescription drug container labels as an important target for improvement. IOM estimates that 77 million Americans have limited health literacy, which is defined as "the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions."
State boards of pharmacy determine what information is required on container labels and, in some cases, where and how specific information appears on the label. State boards of pharmacy are not required to adopt the new container labeling standards.
"USP can establish the standard but they can't really enforce it," McEvoy said. "It's up to the state boards of pharmacy whether or not they will enforce the standard."
The National Association of Boards of Pharmacy this past May passed a resolution to assist state pharmacy boards in efforts to adopt uniform prescription drug container labeling elements. These elements, which are similar to USP's standards, are described in the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy.
McEvoy said the advisory panel remains in effect and will address additional label concerns as they arise.
"The purpose of the original chapter was to get information out there that we felt could move practice forward in terms of universal standards. But we recognized there will likely be additional details that would be added to the chapter as more evidence became available," McEvoy said.
He mentioned the standardization of auxiliary labels as one area the committee may study.
"Auxiliary labels have been a major issue of confusion for patients," McEvoy said. "Right now, we just simply say that they should be evidence based and that they should be essential, but it's certainly within the realm of possibility that moving forward there might be some more specific recommendations" about these labels.