Standardized Prescription Labeling Could Save Lives


An effort is underway by the US Pharmacopeia (USP) to standardize prescription medication labels to make them easier for patients to understand. Such modifications of prescription labels will hopefully help the 90 million adults who have limited health literacy avoid medication errors, and it could also save lives.

Noting that limited health literacy is a major problem in the United States, the Institutes of Medicine (IOM) recently requested that the USP develop consistent labeling of dispensed prescription packaging. Poor health literacy is associated with patient noncompliance and misuse of medications. The Institute of Medicine of the National Academies reports that at least 1.5 million people are harmed by medication errors each year in the United States, and that the extra medical costs of treating these injuries occurring in hospital alone costs about $3.5 billion per year.

Several studies have examined medication-related errors associated with physicians and the health care system, but few have looked at medication errors initiated by patients. In a study published in the Annals of Internal Medicine in December 2006, the researchers tested 395 patients in indigent communities to determine how well they understood prescription label instructions.


Patients who had lower literacy levels and those who were taking more medications were less able to understand the instructions on the labels. Even among patients who understood the labels, only a few could demonstrate how to take the medication correctly. For example, although 70.7 percent of patients with poor literacy could correctly state the instructions “Take two tablets by mouth twice daily,” only 34.7 percent were able to show how many pills they should take according to these instructions.

The USP, a nonprofit scientific organization that establishes legally enforceable standards for medications in the United States, formed an advisory panel for the purpose of improving prescription drug labeling to enhance patient understanding and minimize medication errors. Joanne G. Schwartzberg, MD, co-chair of the USP Health Literacy and Prescription Container Labeling Advisory Panel, noted that “by standardizing labels of medications so that they provide reliable, simple and concise information, I think we can significantly advance patient health and safety.”

Some of the panel’s recommendations include the following:

  1. Organize the information on the label so that it features only what the patient must know to safely and effectively use the medication
  2. Use simple, clear, standardized language, utilizing only common terms and sentences. Unclear medical jargon and unfamiliar terms, including Latin, should be avoided. Ambiguous directions such as “take as directed” should not be used unless the patient also receives unambiguous instructions and counseling
  3. Dosage, usage, and administration instructions must be clearly distinguished and explained. For example, “Take 4 capsules daily. Take 2 capsules with breakfast and 2 capsules with dinner” is much clearer than “Take two capsules by mouth twice daily.”
  4. Prescription labeling should be provided in a patient’s preferred language whenever possible.
  5. All critical information for patients must appear on the label in a minimum of 12-point, sans serif font and punctuated like a normal English sentence.
  6. Include the purpose for which the medication was prescribed in clear, simple terms (e.g., “for rash”).
  7. Include auxiliary information on the label, but limit it to critical information and present it in a standardized manner.
  8. Prescribing directions should be presented in a standardized manner.

These recommendations will be used to develop a new USP general chapter on prescription container labeling, which is projected to be done within a few months. At that time, consumer and health care organizations, as well as the public, can give their comments and suggestions. The eventual goal is a standardized prescription labeling model that will reduce medication errors, improve patient compliance, and in the process, save lives.

Davis TC et al. Annals of Internal Medicine 2006 Dec; 145(12): 887-94
US Pharmacopeia press release