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A Warning About Prescription Drug Warning Labels

Heidi Ault, PharmD Candidate 2007
Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA
Prepared during Consumer Health Information Corporation Clerkship
McLean, VA

After waiting in line at the pharmacy for your prescription, you are at the register ready to purchase your medication. The technician asks: “Do you have any questions about the medication?” You may answer “no” without thinking of any questions because you have been taking the medication regularly or you have received counseling information from your physician.

Before you answer “no” the next time, ask yourself:

  • Do I understand all the information in the patient pamphlet given by the pharmacy?
  • Do I understand the instructions on the prescription label?
  • Do I understand the warning labels attached to the vial?

A startling statistic states that nearly half of the adult population in the United States do not have the reading skills necessary to understand and use health information.1 If you do not have a clear understanding of the medication instructions, you could be putting yourself at an increased risk of developing adverse drug effects. You could make a mistake in how you take the medicine or miss the early signs of a possible side effect.

Prescription Drug Warning Labels

A prescription drug warning label is a sticker placed on your prescription vial that contains important information about your medication. It is meant to serve as a quick reminder each time you take the medicine.

However, a speed bump to understanding the warning labels on the prescription vial is that the label may look different depending on the manufacture. Each company designs their labels according to their own format, symbol, and color. The Food and Drug Administration (FDA) does not standardize the warning labels.2

The prescription drug warning labels were originally developed as a quick reminder to highlight the most important instructions for the safe use of the medication. However, patients are tending to use the warning labels as the only source of information about the medication. This is because they do not understand the patient pamphlet, do not read the pamphlet, and do not ask questions. In one study, most of the patients did not pay attention to the warning labels and those persons with low reading levels ignored the labels.3

What are some of the problems with the warning labels?

Many patients have problems understanding the messages on warning labels. In one study, the warning labels were not understood by the patients and could have led to unintentional adverse effect, overdosing or underdosing on their medication. Another problem is that patients do not read the warning labels carefully or cannot understand some of the words on the label. For example, when patients received a prescription with the warning label that stated “For external use only,” many did not understand the word “external”. They interpreted the warning to mean “Use extreme caution”. They recognized the first few letters of “external” and then guessed on the meaning.4

Often people who do not clearly understand may find that the use of certain colors and icons will help them better understand the meaning of the warning label. This was shown in one study in which the participants had different descriptions of the icon and used the color to show the severity of the label’s message.5

  • Patients tend to code the label color with the colors of traffic lights:
    • Red – most severe
    • Green – recommendation that is less severe than red
  • White and blue labels were viewed the same as green labels

All of the information on warning labels is important. However, some information may involve several steps. The warning label “Do not take dairy products, antacids, or iron preparations within one hour of this medication” is one example. The word “dairy” creates confusion for some people. What are all the dairy products that need to be avoided? Patients who are allergic to dairy products may think they cannot take the medication.

The text of warning labels must be large enough for people to read it. However, the space on a warning label is very small. To keep the text in the large enough type size to read, the manufacture must decrease the number of words on the label. It is also easier for people to read labels if some of the words are bolded

How can warning labels be improved to better protect the patient’s health?

There are several options:

  • The wording on the warning label must be understandable
  • Another option would be to add icons or pictures that are easy to understand. The label icons help the patient understand visually important information relating to taking the medication. These icons should also be included in the medicine instruction sheets pharmacies give to patients. This will help the patient find more detailed information on the warning label message.
  • A third option would be different colors for each warning label. This helps the text stand out to the patient.

As a patient, you need to understand the information relating to your prescription. This means asking questions before leaving the pharmacy or calling the pharmacy to verify any unsure information. Pharmacists are available to answer your questions and they are an easily accessible resource of information.

So, the next time you are in the pharmacy picking up your prescription, make sure you understand all of the information. Ask to speak to a pharmacist if you have any questions and write down the answers. It could help you from making an unnecessary mistake and suffering an adverse effect.

Endnotes

  1. Wolf, Michael S, Terry C Davis, Hugh T Tilson, Pat F Bass III, and Ruth M Parker. “Misunderstanding of prescription drug warning labels among patients with low literacy.” American Journal of Health-System Pharmacists. June 1, 2006; 63:1048-1055.
  2. Franklin, Deborah. “The Consumer: And Now, a Warning About Labels.” The New York Times online: October 25, 2005. www.nytimes.com. Accessed January 18, 2007.
  3. Davis, Terry C, Michael S Wolf, Pat F Bass III, Jason A Thompson, Hugh H Tilson, Marolee Neuberger, and Ruth M Parker. “Literacy and Misunderstanding Prescription Drug Labels.” Annals of Internal Medicine. December 19, 2006;145(12): 887-894.
  4. Ibid
  5. Ibid

References

  1. Davis, Terry C, Michael S Wolf, Pat F Bass III, Jason A Thompson, Hugh H Tilson, Marolee Neuberger, and Ruth M Parker. “Literacy and Misunderstanding Prescription Drug Labels.” Annals of Internal Medicine. December 19, 2006;145(12): 887-894.
  2. Franklin, Deborah. “The Consumer: And Now, a Warning About Labels.” The New York Times online: October 25, 2005. www.nytimes.com. Accessed January 18, 2007.
  3. Wolf, Michael S, Terry C Davis, Hugh T Tilson, Pat F Bass III, and Ruth M Parker. “Misunderstanding of prescription drug warning labels among patients with low literacy.” American Journal of Health-System Pharmacists. June 1, 2006; 63:1048-1055.

© 2007 Consumer Health Information Corporation. All rights reserved.