USP〈17〉PRESCRIPTION CONTAINER

PRESCRIPTION CONTAINER LABEL STANDARDS TO PROMOTE PATIENT UNDERSTANDING

Organize the Prescription Label in a Patient-Centered Manner

Information shall be organized in a way that best reflects how most patients seek out and understand medication instructions. Prescription container labeling should feature only the most important patient information needed for safe and effective understanding and use.

Emphasize Instructions and Other Information Important to Patients

Prominently display information that is critical for the patient’s safe and effective use of the medicine. At the top of the label, specify the patient’s name, the drug name (spell out full generic and brand name) and drug strength, and explicit clear directions for use in simple language.

The prescription directions should follow a standard format so that the patient can expect that each element will be presented in a specific, predictable order each time a prescription is received. Use of a methodology that simplifies the administration instructions for the patient’s medication should improve the individual’s ability to understand prescription instructions, to take the correct dose, and to organize multidrug regimens. Employing best practices of patient-centered instructions—which utilize the principles of health literacy, medication therapy management, and education, to explicitly describe how to take daily-use, solid dose-form medications—has resulted in improved patient understanding. One such patient-centered method is the universal medication schedule (UMS). The UMS shifts medication-taking into four standardized time periods (morning, noon, evening, bedtime) and uses simplified language and formatting to promote understanding (e.g., “take 1 pill in the morning and 1 pill at bedtime” rather than “take one tablet twice daily”). Such methods may be particularly useful for simplifying daily medication regimens that include multiple oral therapies. [Note—The word “pill” is used in the UMS to enhance health literacy and may not reflect a USP definition for an oral dosage form (see Compendial Nomenclature, USP Nomenclature Guidelines on the USP website at▲https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/nom_guidelines.pdf?_ga=2.122038472.2104491025.1577066358-70347674.1551206442▲ (USP 1-Aug-2021)).]

▲When oral liquid dosage forms are prescribed, the appropriate "dosing tool" (also known as a dosing component; examples include oral syringe or dosing cup) shall be provided to the patient or caregiver to accurately measure and administer the oral medication. Oral syringes are recommended when dosing accuracy is important, particularly for doses of 5 mL or less. The size of the dosing tool should be considered in the context of the recommended dose volume. The dosing tool volume provided should be the smallest one capable of holding the entire dose volume (e.g., for a 2-mL dose, a 5-mL capacity syringe is preferable to a 10-mL capacity syringe; for a 7.5-mL dose, a 10-mL capacity syringe is preferable to a 5-mL capacity syringe). The volume markings on the dosing tool shall be legible, indelible, and also limited to a single measurement scale that corresponds with the dose instructions on the prescription container label, typically volumetric metric units (see Packaging and Storage Requirements 〈659〉).▲ (USP 1-Aug-2021)

Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-46BF6E02-E3E3-492E-A344-8194C8ACC17F_10101_en-US?source=TOC

plastic pharmaceutical packaging

Effervescent tablet packaging

HDPE bottle