U.S. Pharmacopeia's Proposed Revisions to General Chapter 17 – Prescription Container Labeling

Have you ever looked at the label on your prescription bottle and thought how readable and understandable these labels are for most patients? I am sure most of us have not given that much thought. Instead, we have been focused on what information is required on the label, what are the key messages we need to deliver on the label, and what are the auxiliary labels we are going to affix to the side of the prescription bottle. And, occasionally, there is also the thought of how are we going to get all this “sig” to fit on that label.

Some of us don't spend a lot of time thinking about how to phrase the “sig” on the label. Instead, if the prescriber writes “Take one BID” on the prescription, this is transferred to the label as “Take one tablet twice daily” or a similar phrasing. Would it be better if the instructions read “Take one tablet in the morning and one tablet in the evening,” “Take one tablet with breakfast and one tablet with dinner,” or “Take one tablet every 12 hours”? These examples provide the patients with the number of tablets they should take and some guidance as to the time of day the medication should be taken, whereas the twice daily reference provides no guidance as to when the medication should be taken during the day. So which one is better for optimal patient care?

These types of questions have been the subject of research studies for years and the focus of the U.S. Pharmacopeia's Health Literacy and Prescription Container Labeling Advisory Panel during 2005-2010. This U.S. Pharmacopeia advisory panel has proposed revisions to General Chapter 17 – Prescription Container Labeling that could be used by regulatory boards to determine what is required on a prescription label and how it should be formatted. The revisions recommended by this advisory panel include label formatting, appearance, content, and sentence structure that are designed to improve patient understanding.

All pharmacists should take a look at these recommendations (http://www.usp.org/pdf/EN/USPNF/M5531.pdf) and consider how they will influence their practice and how they can adopt the recommendations to improve the information that is placed on the prescription label to improve patient care. However, if you disagree with these recommendations, it is imperative that you make your opinion known to the U.S. Pharmacopeia by sending them an e-mail message (17PrescriptionContainerLabeling@usp.org) before the end of March 2011.

The U.S. Pharmacopeia and the members of this advisory panel should be thanked for looking at this issue and bringing it to the attention of all health professionals. Those individuals who comment on these recommendations should also be thanked for taking the time and energy to help improve patient care.