NACDS urges flexibility on USP container labeling recommendations

April 12, 2011

NACDS has raised several concerns with the U.S. Pharmacopeia on prescription container labeling.

The National Association of Chain Drug Stores (NACDS) has raised several concerns with the U.S. Pharmacopeia (USP) on prescription container labeling.

In a letter to USP on its recent prescription container labeling recommendations, NACDS said that the language requirements of the proposed labels, technological issues, legal restrictions, and container and label size limitations will cause problems for pharmacist and patients.

For example, USP is proposing that prescription labels should be provided in the patient’s preferred language using a high-quality translation process or that the label be printed in English with translation by a trained interpreter whenever possible.

“…[T]he pharmacist is required to review the label to assure that it complies with the prescriber’s prescription. To do this, the prescription label must be readable by the pharmacist. This means that the label must be in English, the standard language for which U.S. licensed pharmacists must demonstrate competency,” wrote Diane Darvey, PharmD, JD, director of federal and state public policy for NACDS, in the letter.

NACDS is also requesting that pharmacists have more flexibility regarding the USP’s recommendations on “patient-centered labeling” and emphasis of instructions that are important to patients.

“We are supportive of the general concept of a patient-centered label and agree with USP that only the most important patient information should be on the label. However, we believe that this standard must specifically state that pharmacies have flexibility in how this is achieved,” Darvey wrote.

USP’s current prescription label recommendations could lead to further medication adherence problems, according to NACDS. “Poor medication adherences cost the U.S. approximately $290 billion annually - 13% of total healthcare expenditures. Providing concise, understandable prescription container labeling can further assist patients in adhering to their medication regimens,” NACDS said in a statement.