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System of simplified, standardized dosing instructions for prescription drug labels proposed

PHILADELPHIA, November 28, 2007 - You have just been prescribed a new medication by your doctor and the container label says: "take one tablet by mouth twice daily for 7 days." How much and how often should you take your medicine" This might be easy for you to answer, but 46 percent of adults misunderstand at least one prescription container label, according to a 2006 study published in Annals of Internal Medicine.

Ninety million Americans about half of the adult population suffer from low health literacy. The Institute of Medicine (IOM) defines health literacy as the degree to which individuals can obtain, process, and understand basic health information and services they need to make appropriate health decisions.

At todays Sixth Annual National Health Communication Conference co-sponsored by the American College of Physicians Foundation (ACPF) and IOM, Alastair J.J. Wood, MD, FACP, proposed an evidence-based system of simplified, standardized dosing instructions for prescription medication container labels.

Dr. Wood, a member of the ACPF Medication Labeling Technical Advisory Board, called for a Universal Medication Schedule (UMS) that standardizes prescription medication dosing times on drug container labels so that patients are told to take their medicine at the same four times per day, such as breakfast, lunch, dinner, and bedtime. The UMS would replace the current practice which either instructs patients to take the medicine a specific number of times per day or at specific time intervals.

The benefits of the UMS include use of the same dosing schedule by patients, physicians, and pharmacists; reduced variability in how the medication is prescribed; reduced variability in how the prescription is interpreted by the pharmacist; improved ability of patients to understand how to correctly take their medications; and improved therapeutic outcome, Dr. Wood said.

According to Michael Wolf, PhD, MPH, co-chair of the ACPFs Medication Labeling Technical Advisory Board, a randomized trial of 500 patients found that understanding of the UMS label was five times greater compared to a typical label.

Prescription medication container labels need a radical change, said Ruth Parker, MD, FACP, co-chair of the ACPFs Medication Labeling Technical Advisory Board. Improving drug labels is an issue that sits at the intersection of health literacy and patient safety. The variability of dosing instructions on labels is a source of confusion among patients, which could lead to adverse drug events.

The UMS idea comes in response to a recently released evidence-based ACPF white paper, Improving Prescription Drug Container Labeling in the United States: A Health Literacy and Medication Safety Initiative, that describes problems with current medication labels and notes that poor patient understanding of labels is prevalent and a significant safety concern.

The white paper, presented to the IOM Roundtable on Health Literacy on October 12, 2007, recommends the following standards for improving patient understanding of prescription medication container labels:

  • Use a UMS to convey and simplify dosage/use instructions.
  • Use explicit text to describe dosage/interval in instructions.
  • Organize label in a patient-centered manner.
  • Include distinguishable front and back sides to the label.
  • When possible, include indication for use.
  • Simplify language, avoiding unfamiliar words/medical jargon.
  • Improve typography, use larger, sans serif font.
  • When applicable, use numeric vs. alphabet characters.
  • Use typographic cues (bolding and highlighting) for patient content only.
  • Use horizontal text only.
  • Use a standard icon system for signaling and organizing auxiliary warnings and instructions.

As the ACP Foundation white paper notes, the lack of universal standards and regulations for drug labels is a root cause of medication error, Dr. Parker said.


Contact: Steve Majewski
American College of Physicians

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