From the November 2008 issue

Health literacy has increasingly been viewed as a patient safety issue. A recent study demonstrated the relationship between lower literacy and a greater volume of prescription medications being taken without patients fully understanding the instructions on the prescription medication labels.1 The ability to understand prescription container label instructions is critical for safe medication use. This is especially true since other sources of patient medication information may be insufficient. For example, supplementary medication information such as consumer medication information leaflets printed for each new prescription may be too complex, too long, and written at a reading level unsuitable for many patients to comprehend. As a result, these materials are often ignored, making the prescription label the patient’s primary, if not only, source of information about how to take their medication.

The Institute of Medicine 2006 report, Preventing Medication Errors, stated that problems with prescription drug labeling were the cause of a large proportion of out-patient medication errors and adverse drug events, as patients may unintentionally misuse a prescribed medicine due to improper understanding of instructions.3 In response to this report, the American College of Physicians Foundation released a white paper, Improving Prescription Drug Container Labeling in the United States, A Health Literacy and Medication Safety Initiative which set standards for an enhanced prescription container label.4

Based on analysis of actual medication errors, pharmacy-generated labels, and the studies mentioned above, ISMP has developed a draft set of guidelines for community and mail order pharmacy prescription packages as a basic approach toward the prevention of errors related to label misinterpretation. The draft guidelines are available and open for public comment on our website at: www.ismp.org/Tools/guidelines/labelFormats/comments/default.asp. We encourage your feedback. After review of the comments, ISMP will post the final guidelines on our website and share them with The National Association of Boards of Pharmacy. (Note: These guidelines, if followed, may not always provide complete understanding of instructions to patients. Therefore, drug labeling is only one part of an overall strategy to improve medication adherence and reduce medication errors.)

References: 1) Davis TC, Wolf MS, Bass PF, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145(12):887-894. 2) International Pharmaceutical Federation. FIP statement of professional standards: medication errors associated with prescribed medication.  1999. Available on the Internet at: http://www.fip.org/www/uploads/database_file.php?id=229&table_id=. Accessed 11 Nov 2008. 3) Institute of Medicine. Preventing medication errors. Aspden P, Wolcott J, Bootman L, et al, Eds. 2006; Washington, DC: National Academies Press. 4) American College of Physicians Foundation. Improving prescription drug container labeling in the United States: a health literacy and medication safety initiative. 2007. Available on the Internet at: http://foundation.acponline.org/files/medlabel/acpfwhitepaper.pdf. Accessed 11 Nov