Making Prescription Labels More ‘Patient-centered’
By Jennifer Larson, contributor
November 8, 2012 - Have you read a good prescription medicine label lately? If you have one nearby, take a closer look: do the instructions seem clear to you, or is there any information that is hard to read or might seem confusing?
If you are a healthcare executive or clinical professional, you undoubtedly are familiar with dosing instructions and perhaps even the details of the medication in the bottle--the benefits, the side effects, etc. Even if you were unclear about some aspect of the medicine, you would know to inquire.
But health literacy is a stumbling block for millions of people. The Institute of Medicine reports that around 77 million adults in the United States have limited health literacy, and the National Patient Safety Foundation estimates as many as 90 million people in the United States have some difficulty understanding and acting upon health information. As one result of low health literacy levels, only about 50 percent of patients take their medications as directed.
In fact, medication misuse could cause as many as 1 million adverse events each year, according to U.S. Pharmacopeial Convention, or USP.
With the goal of promoting better patient understanding and reducing medication errors, the USP recently released a new set of standards for more “patient-centered” medicine labels for containers dispensed by pharmacists.
Many older adults are taking multiple medications for several chronic conditions, and it can be easy to get them confused. Additionally, there are patients with limited English proficiency, visual impairments and other conditions that may make it difficult for them to understand exactly how to take their medications correctly.
“We have to find a way to make this safer for them, and that's really the emphasis for this whole effort,” said Joanne Schwartzberg, MD, a member of the USP Nomenclature, Safety and Labeling Expert Committee, which is the group of experts that put together the new standards.
The new USP standards are contained in the General Chapter 17 “Prescription Container Labeling” in the U.S. Pharmacopeia and the National Formulary.
These recommendations reflect the most current research, she said. “This is state of the art at the moment,” Schwartzberg said, noting that as more research is completed, the standards will likely be revised even more for the future.
Some of the elements included in the new standards include giving explicit instructions, emphasizing the instructions and other information that's relevant to the patients, improving readability, and including purpose for use. The standards also call for adding instructions in the patient's preferred language, if English is not his or her primary language; the standards note that a high-quality translation program will be needed to achieve this. And pharmacies should provide options to help patients with visual impairments, too.
Dosing intervals is an area rife with potential misunderstanding. There's a significant amount of research that shows that people often don't understand what might seem like simple instructions, like “take twice per day,” noted Cindy Brach, senior health policy researcher with the Agency for Healthcare Research and Quality.
“People don't necessarily interpret that the same way the prescriber meant it,” she said.
Schwartzberg agreed. “The words that we use that we think are very simple aren't always clear,” she said.
The prescriber may have intended for the patient to take one pill in the morning and one pill in the evening, but that isn't necessarily what the patient understands. After all, the patient doesn't have the understanding of how medication gets metabolized to help them decipher the intended meaning. It would be better if the prescriber included more explicit instructions, perhaps “Take one pill in the morning, and take one pill in the evening.”
What does the patient really need to know? That is the information that needs to be the most visible, the most readable.
The standards call for the information that is most important for patients' safe use of the medicine to be prominently displayed on the label. At the label's top should be the patient's name, the drug name (including the generic and the brand name), the strength and the clear instructions in simple language.
The less critical information, such as the pharmacy name and the amount of medication contained in the package, can be placed further down on the label or elsewhere.
As more and more information has gotten added to the prescription bottle label, the typeface on the label has gotten smaller and smaller. And for many people, that means it's gotten progressively harder to read.
“The real estate of a label is really small, and there are a lot of things that they're trying to put on there,” said Brach. “But there's not a lot of room there.”
The USP standards call for labels to be designed and formatted for easy readability. For example, “simple uncondensed familiar fonts,” such as Arial or Times Roman, should be used, and the point size should allow for adequate white space in between lines of text.
This is especially important when you consider that many people don't (or can't) read the inserts that come with a prescription bottle--or they lose them and can't refer back to them later.
Purpose of use
The standards suggest that the label include the purpose for which the medication was prescribed. However, it notes there may be instances in which the patient may not want that purpose spelled out so clearly, where other people might see it. (For example, they may not want others to know they're taking an antipsychotic or HIV medication.) So the standards allow for the patient to request the purpose be left off; otherwise, the purpose should be included.
“Our feeling is that this is the right of the patient,” said Schwartzberg.
A step in the right direction
Supporters of the standards believe the effort to make labels more patient-centered can definitely make a difference.
“This is only one piece to helping people take their medicines correctly. There are other pieces that will need to be put in place,” said Brach.
Schwartzberg agreed, saying, “I don't think we are going to wipe out all the medication errors by having better labels, but I think that this is the first step.”
It will be up to each state's board of pharmacy to decide whether to adopt the standards. The USP noted recently that the National Association of Boards of Pharmacy passed a resolution in support of state boards requiring a standardized prescription container label.
For more information:
U.S. Pharmacopeial Convention - Key Issue: USP-NF General Chapter <17> Prescription Container Labeling
UPS Fact Sheet - Examples of Prescription Container Labels that Comply with the New Standards (PDF)