Rockville, Md., January 3, 2011 For the first time, universal standards to guide the content, language, format and appearance of prescription medication labels to reflect how patients read and understand medication instructions are being proposed on a national level. These labels can vary significantly from pharmacy to pharmacy, even though they are intended to convey critical information for the safe use of medications. The new standards, developed by the U.S. Pharmacopeial Convention (USP)the nonprofit scientific organization that sets FDA-enforceable standards for the quality, purity and strength of medicines in the United Statesare the result of a broad effort led by the Institute of Medicine (IOM) to improve health literacy in the United States by bringing together government, industry, associations and other groups to advance practical strategies that can be implemented to maximize patient comprehension of health information. The new USP standards are being proposed for a 90-day public comment period, during which the organization will accept feedback from healthcare professionals, consumers and all other interested parties.
"As more patients enter the healthcare system, and as the nation becomes increasingly diverse, more patients will have difficulty understanding and using important healthcare information provided to them," said Roger L. Williams, M.D., chief executive officer of USP. "One key component of healthcare information is prescription container labels, which are a patient's bestand often onlysource of instruction and background necessary for safely and appropriately using a medication. Many studies have shown that patient misunderstanding is widespread, and lack of universal standards is a cause of this problem. These new standards were designed with the patient in mind, to bring clarity and consistency to the prescription labels they rely upon."
Developed by a multi-disciplinary group of independent experts convened by USP across the fields of pharmacy, medicine, health literacy, patient safety, human factors research, drug database software and chain drug retail operations, the standards could be adopted by state boards of pharmacy, other governmental authorities, or conformity assessment bodies into state laws, regulations, guidelines or other documents. Adoption of USP's standards at the state level is common, such as in the cases of USP's widely recognized standards for sterile and nonsterile pharmaceutical compounding to help ensure safe preparation of these customized medications. A few states, including California and New York, recently developed their own regulations for prescription container labeling.
Generally, the new standards propose that prescription container labels generated by pharmacies:
Other recommendations include simplifying language, and eliminating Latin terms.
|Contact: Theresa Laranang-Mutlu|