Designing a safer medication label

Abstract

Health literacy is being increasingly viewed as a patient safety issue. A 2006 study in the Annals of Internal Medicine demonstrated the relationship between lower literacy and a greater volume of prescription medications being taken without patients fully understanding the instructions on the medication labels. Health literacy is being increasingly viewed as a patient safety issue. A 2006 study in the Annals of Internal Medicine demonstrated the relationship between lower literacy and a greater volume of prescription medications being taken without patients fully understanding the instructions on the medication labels. The ability to understand prescription container label instructions is critical for safe medication use. 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.■Clear prescription labeling is critical to a patient's understanding of medication use and adherence.■ISMP developed a set of guidelines for prescription packages to help prevent label misinterpretation. ■Clear prescription labeling is critical to a patient's understanding of medication use and adherence.■ISMP developed a set of guidelines for prescription packages to help prevent label misinterpretation. In 1999, the International Pharmaceutical Federation released its Statement of Professional Standards on Medication Errors Associated with Prescribed Medication, which stated that the packaging and labeling of prescribed medicines should be designed with a view to minimizing errors in selection and use. This statement contained a number of recommendations regarding how patient labels should be displayed. The 2006 Institute of Medicine report Preventing Medication Errors stated that problems with prescription drug labeling were the cause of a large proportion of outpatient medication errors and adverse drug events because patients may unintentionally misuse a prescribed medicine due to improper understanding of instructions. 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. Standardized and thoughtful drug labeling practices need to be a part of an overall strategy to improve medication adherence and reduce inadvertent medication errors in community pharmacy practice. The Institute for Safe Medication Practices (ISMP) developed a set of guidelines for community and mail order pharmacy prescription packages to help prevent errors related to label misinterpretation. ISMP based its guidelines on an analysis of medication errors, pharmacy-generated labels, and the materials mentioned above. The packaging and labeling of prescribed medicines should be designed with a view to minimizing errors in selection and use. Highlights of ISMP's Principles of Designing a Medication Label for Community and Mail Order Pharmacy Prescription Packages include the following:■Never abbreviate drug names. Each drug field should contain a sufficient number of characters to prevent truncating drug names, whether single entity or multi-ingredient product. For example, patients may be unaware that prescription labels indicating the drug abbreviation APAP is actually acetaminophen.■Do not include the salt of the chemical when expressing a generic name unless there are multiple salts available (e.g., hydroxyzine hydrochloride and hydroxyzine pamoate). If the salt is listed as part of the name (e.g., U.S. Pharmacopeia-approved abbreviations such as K, Na, HBr, and HCl), then it should follow the drug name, not precede it (e.g., hydroxyzine HCl not HCl hydroxyzine).■Include both the brand name and the generic name on the label. If state law prohibits printing the brand name when the specific brand is not dispensed, then "used for" may be inserted before the brand name.■Include the condition for which the drug was prescribed if requested by the patient and if the condition is indicated on the prescription.■Include on the label a clearly visible second patient identifier, such as date of birth or current address.■Provide a written description of medication and a picture of medication, if possible. These guidelines may not always provide complete understanding of instructions to patients. Therefore, prescription labeling is only one part of an overall strategy to improve medication adherence and reduce medication errors. For more information, visit www.ismp.org/tools/guidelines/labelFormats/comments/default.asp. Institute for Safe Medication PracticesISMP’s National Medication Errors Reporting Program receives reports of errors,close calls, and hazardous conditions at www.ismp.org, [email protected], or 800-324-5723. ISMP’s President is Michael R. Cohen, BSPharm, MS, ScD, author of Medication Errors, 2nd edition, published by APhA and available for purchase on pharmacist.comor by calling 800-878-0729