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Marsha Regenstein, et. al.

Marsha Regenstein, Ellie Andres, Dylan Nelson, Stephanie David, Ruth Lopert and Richard Katz, Medication Information for Patients with Limited English Proficiency: Lessons from the European Union, 40 Journal of Law, Medicine & Ethics 1025 (Winter 2012) (66 Footnotes)


Access to clear and concise medication information is essential to support safe and effective use of prescription drugs. Patient misunderstanding of medication information is a common reason for non-adherence to medication regimens and a leading cause of outpatient medication errors and adverse drug events in the U.S. Medication errors are the most common source of risk to patient safety, leading to poor health outcomes, hospitalizations, and deaths. Over half a million adverse drug events occur in the outpatient setting each year at a cost of approximately $1 billion annually.

Nearly half of adults in the U.S. experience difficulty understanding and acting upon health information. Even individuals with high levels of general literacy may find medication information difficult to understand or use. The risk of misunderstanding medication information is compounded for patients with limited English proficiency (LEP) who may not have access to this information in their own language. Several studies underscore the particular challenges that misunderstanding of medication information creates for patients with LEP and demonstrate that language barriers may be a significant cause of medication errors. Examples of patients with LEP who have experienced medication errors as a result of language barriers abound, such as the common and treacherous example of “once daily” in English being easily confused with “eleven times” in Spanish.

Given the high incidence, significant risks, and substantial costs of medication errors, the Institute of Medicine has dedicated considerable attention to the issue as a quality concern. For medicines to be effective, patients must understand and comply with dosage, timing, and other instructions--an expectation that cannot be met if the necessary information is not understandable to the patient. Likewise, the safe use of medicines requires patients to understand information about side effects, warnings, contraindications, and interactions with other medications or foods. For reasons of equity, the language spoken by the patient should not serve as a barrier to accessible and accurate medication information.

In its 2006 report, Preventing Medication Errors, the Institute of Medicine drew attention to the issue of language barriers related to medication information and offered recommendations for improvements, including necessary accommodations for patients with LEP, such as translations of prescription labels and information leaflets. Similarly the Joint Commission, the National Quality Forum, and the National Committee on Quality Assurance each have standards that include broad requirements or recommendations for translating essential documents.

The United States lags behind the European Union (E.U.) in terms of practices related to the delivery of medication information in multiple languages. Since 1995, the centralized drug approval procedure in the E.U. has required pharmaceutical manufacturers to make medication information available in the official languages of E.U. member states. U.S. regulatory frameworks do not impose any obligations regarding the translation of medication information into multiple languages, and consequently, this information is rarely available in the U.S. in languages other than English.

This paper describes regulations and practices related to the delivery of medication information to U.S. consumers, and examines practices in the E.U. that may serve as a model for future U.S. policy efforts to improve the quality and availability of medication information for individuals with limited English proficiency.

Vernellia R. Randall
Founder and Editor
Professor Emerita of Law
The University of Dayton School of Law

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