New US Standards Proposed for Prescription Pharmaceutical Container Labels

Posted on by kginter

In recent weeks a new standard for prescription labels has been proposed to help consumers better understand medication instructions be put in place. The standards are aimed at preventing dosing errors by guiding pharmaceutical label content, language, format and appearance of prescription medication labels, for the first time ever on a national level.

Medication labels should essentially “fulfill the professional obligations of the prescriber and pharmacist” because patients rely on the labels as a trustworthy source. In an interview with, USP Director of Health Care Quality Standards, Shawn Becker said, “Each state has different things that they allow on their labels. We want them to be similar. We are here for the public health. That’s our goal.”

According to the USP, studies show that patients often misunderstand label instructions, especially in the areas of dosage and auxiliary warnings, not because of levels of literacy, but because of lack of consistency between subscribers and between medications.

Who is proposing these standards?

The new standards that are being proposed were developed by the U.S. Pharmacopeial Convention (USP). The USP is a non-profit scientific organization that can set FDA-enforceable standards in terms of quality, purity, and strengths of medicines in the US. This effort has been led by the Institute of Medicine (IOM) who has been working rigorously to improve health literacy in the US.

In 2010, the USP welcomed public comment and feedback from healthcare professionals and consumers during a 90-day public comment period. Suggestions included simplifying label language and increasing drug identification cues through label color codes, which will fix errors caused by drug labels that look similar but are for different strengths.

Roger Williams, M.D., Chief Executive Officer of the USP, commented on prescription label issues, saying, “As more patients enter the healthcare system, and as the nation becomes increasingly diverse, more patients will have difficulty understanding and using important healthcare information provided to them,” said Williams.

“One key component of healthcare information is prescription container labels, which are a patient’s best—and often only—source of instruction and background necessary for safely and appropriately using a medication. Many studies have shown that patient misunderstanding is widespread, and lack of standards is a cause of this problem,” said Williams.

What are the standards being proposed?

The USP proposes 8 highlighted standards for prescription labels. “These new standards were designed with the patient in mind, to bring clarity and consistency to the prescription labels they rely upon,” said Williams.

1.) Organize the prescription label in a patient-centered manner. Information such as patient name, drug name, and strength should be placed at the top of the label, so it appears more prominent to the patient. Less important information such as pharmacy name and prescriber name should be placed away from important information so that it isn’t a distraction to the patient.

2.) Emphasize instructions and other information important to patients. Give clear and concise information on drug name and strength and avoid placing less crucial information in the same vicinity.

3.) Simplify language. Languages should be “clear, simplified, concise, and familiar,” avoiding Latin terms, and words that are unfamiliar and unexplained to the patient.

4.) Give explicit instructions. Instructions should precisely name time periods in which doses must be taken for example, “morning” or “evening” instead of “twice daily.”

5.) Include Purpose for Use. The medication should have a “purpose for use” listed on the label unless requested otherwise by the patient. It is recommended that simple terms be used to cause less confusion for patients, for example printing “for high blood pressure” on the label rather than “for hypertension.”

6.) Limit auxiliary information. Warnings and administration alerts should only be used when they are clear or if they improve patient understanding.

7.) Address limited English proficiency. Use label statements that will be easy to understand for someone with limited English language skills.

8.) Improve readability. It is being requested that labels be produced in high-contrast print (white background with black print) with simple fonts sized appropriately (minimum 12-point Times New Roman or 11-point Arial.) Also text can only be printed horizontally. In reference to readability, let me trace you back to the year 2007. Actor Dennis Quaid and his wife had just welcomed premature twins into the world when they were mistakenly overdosed with the drug heparin. A report from ABC’s Good Mornning America shared that Quaid’s children were prescribed a 10 unit dose of heplock, a diluted version of heparin, but received 1,000 times more than that – 10,000 units of heparin. In the Quaid’s lawsuit they blame the overdose on the products packaging because the two product’s bottles share remarkably similar blue labels and a common shape.

What if the labeling standards aren’t adopted on a national level?

Although the goal is to make a standard label regulation nationally there is no assurance that this will happen. If these new standards fail to be adopted on a national level they may still be adopted on a state level. This is a common practice among states. For instance, New York and California already have their own label regulations for prescription medications.

What if new prescription labels are approved?

If a new prescription labeling standard is passed, QuickLabel Systems will work with you to help you ease your way into the new labeling process. We offer a line of digital label printers that allow you to print your own pharmaceutical labels on the fly, with color codes for each prescription strength. With your own QuickLabel color label printer, you can make adjustments to your label content and color at any time and comply with new prescription label standards as they come into effect. We can also help you print your prescription medication labels using our QuickPrint custom label printing services.

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