PRINCIPLES OF DESIGNING A MEDICATION LABEL FOR COMMUNITY AND MAIL ORDER PHARMACY PRESCRIPTION PACKAGES
m (lower case) = meter|
kg = kilogram
g = gram
mg = milligram
mcg = microgram
(do not use the Greek letter μ as as µg which has been misread as mg)
L (upper case) = liter
mL (lower/upper case) = milliliter
(do not use cc which has been misread as U or the number 4)
mEq = milliequivalent
mmol = millimole
- List all generic names using lower-case letters as the primary drug nomenclature (unless employing tall man letters as a safety strategy), ensuring that each matches FDA-approved nomenclature. As appropriate, list associated brand names in a requisite field using all upper case letters (e,g., LASIX) to differentiate them from generic names. Trademark symbols (e.g., ™ or ®) should not be used.
- When the drug name, strength, dosage form, and dosage units appear together, avoid confusion by providing a space between them (e.g., propranolol20 mg has been misread as 120 mg and 10Units has been misread as 100 Units).
- 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., USP approved abbreviations such as K, Na, HBr, and HCl), 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 the term “used for” may be inserted before the BRAND name.
- All combination products should include the BRAND name on the label. If a product contains two ingredients they should both appear in the generic name field. If the product contains greater than two generic ingredients then the two primary ingredients should be placed in the generic field accompanied by the phrase “and others” at the end of the 2 generic names. If one of the ingredients is acetaminophen, consider applying an auxiliary label that states; ’This product contains acetaminophen.’
- Do not include an abbreviation of the manufacturer’s name as part of the drug name on the same line of text (e.g., tramadol hcl acetaminophen par, where PAR is the name of the manufacturer, not an additional ingredient or drug-name suffix)
- Should be written as:
tramadol 37.5 mg acetaminophen 325 mg
manuf: Par used for ULTRACET
ISMP additional/future recommendations
- Use a standard icon system for signaling and organizing auxiliary warnings and instructions.
- Consider well placed sparing use of easily understood pictograms to increase likelihood of reading.
- Ensure that warnings and alerts are applied consistently and not practitioner dependent.
- The purchase receipt should include the second patient identifier, preferably date of birth, and/or patient address.
- When affixing labels to a manufacturer-supplied bottle, do not cover medication name and strength on original label.
- If a picture of medication can not be included on the label, refer patient to Web sites that provide pictures of medications, such as: www.mypillbox.org/mypillbox.php; www.healthline.com; www.webmd.com.
- Use the largest font size label will allow, minimum of 18-point type for people with low vision.7 Most standard prescription label size will not accommodate the required labeling information in 18-point type. Therefore, the American Foundation for the Blind recommends that pharmacies:7
- Provide "duplicate labels" (prescription and auxiliary) printed in a minimum of 18-point type on paper stock.
- If pictograms are used, these should also be provided in "large print" format and high contrast (saturated black on white background).
- The "duplicate labels" should be matched in some way to the prescription container, such as by using a large-print number or colored sticker on both the duplicate label and the corresponding medication container.
- Use sans serif, standard font (not narrow or condensed), such as Arial, Verdana, or obtain APHont™ (pronounced Ay'-font). APHont™ was developed specifically for low vision readers and embodies characteristics that have been shown to enhance reading speed, comprehension, and comfort for large print users. Available free at: www.aph.org/products/aphont.html.
- If the pharmacy offers prescription label information in large print, this should be prominently posted at the prescription counter or communicated directly to each patient.
- Use “tall man” letters (e.g., hydrOXYzine and hydrALAZINE) to help distinguish look-alike products on screens to minimize the risk of selecting the wrong product when medication names appear alphabetically in drug profiles. Establish and disseminate a list of products for which tall man letters are used, specifying which letters are affected, to ensure standard application for all uses. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm.
- Shrank W, Avorn J, Rolon C, et al. Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review. Ann Pharmacother. 2007;41:783-801.
- Shrank WH, Agnew-Blais J, Choudhry NK, et al. The variability and quality of medication container labels. Arch Intern Med. 2007;167:1760-1765.
- Wogalter M., Vigilante W. Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics. 2003;46(4):327-344.
- Cohen MR, ed. Medication Errors. 2nd ed. Washington DC: American Pharmacists Association. 2007. 222-223.
- Wolf M, Davis T, Shrank W, et al. To err is human: Patient misinterpretations of prescription drug label instructions. Patient Education and Counseling. 2007;67(3):293-300.
- Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42:1364-1372. Available on the Intranet at: http://www3.interscience.wiley.com/cgi-bin/fulltext/112161379/HTMLSTART. Accessed 24 Nov 2008.
- American Society of Consultant Pharmacists Foundation/American Foundation for the Blind. Guidelines for prescription labeling and consumer medication information for people with vision loss. 2008. Available on the Intranet at: http://www.afb.org/Section.asp?SectionID=3&TopicID=329&DocumentID=4064. Accessed 24 Nov 2008.
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