Universal Prescription Drug Label Standards Issued

(FDA.gov)

The U.S. Pharmacopeial Convention (USP), a scientific standards-setting organization, released new standards that the group says for the first time provide a universal labeling format for medicines in containers dispensed by pharmacists. The standards are expected to be published next month.

The standards (free registration required) — known formally as General Chapter <17> Prescription Container Labeling in USP 36–NF 31 — address the format, appearance, content, and language of instructions for medicines in containers provided by pharmacists. USP says the document offers directions to label manufacturers, pharmacies, and prescribers on the layout of prescription labels in a way that reflects how most patients seek out and understand medication instructions.

The organization devised the new labeling standards in response to an Institute of Medicine initiative to improve health literacy, defined as the ability to understand basic health information and services needed to make health care decisions. USP cites an Institute of Medicine report that says some 77 million Americans have limited health literacy, and most Americans have trouble understanding and using health information and services.

The standards call for the prominent display of important information for patients’ safe and effective use of the medicine. At the top of the label, for example, the document calls for specifying the patient’s name, the drug’s nonproprietary and brand names, strength, and clear directions for use in simple language. Typography should should be optimized with high contrast print and adequate white space between lines of text, as well as simple uncondensed and familiar Times Roman or Arial fonts, and large font sizes.

The standards urge the use of explicit instructions removing room for different interpretations and clearly separating the dose itself from the timing of each dose. Instructions, say the document, should take into account lifestyle patterns, such as shift work, thus avoid giving precise times for taking the drug.

The USP standards specify including the purpose of the drug, unless the patient requests it not appear. The purpose should be spelled out in plain language, e.g. “high blood pressure” rather than “hypertension.” The standards also provide guidance on labels for non-English-speaking patients and those with impaired vision.

Enforcement of the standards, says USP, will be the decision of individual state boards of pharmacy that can include the standards in their regulations. At its 2012 annual meeting, the National Association of Boards of Pharmacy voted to support state boards in requiring a standardized prescription container label.

Read more:

• New Standards Released for Drug Impurity Limits, Methods
• Database Reveals Food Ingredient Fraud Hazards
• Standards Proposed for Pharmaceutical Supply Chain Integrity
• Database to Track Substandard, Counterfeit Medicines
• Standards Proposed for Prescription Drug Labels

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