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Feature Article

Pharmacy researchers work toward patient-friendly drug labels

Do you understand the information on the labels of the prescription drugs you take? Many people do not. Throughout the nation, the look and content of prescription drug labels varies widely from pharmacy to pharmacy.

"Standardizing the look and content of labels is a safety issue," Joanne Schwartzberg, MD, co-chair of the U.S. Pharmacopeial Convention's Health Literacy and prescription Container Labeling Advisory Panel, recently told the magazine Drug Topics.

In VA, prescription labels vary in terms of content, readability, and layout. Even VA's seven consolidated mail outpatient pharmacies (CMOPs) use different label styles.

VA investigators and colleagues are working on improving this aspect of VA care.

"Studies have shown that when Veterans understand how to take their medications correctly, they have improved medical outcomes, and their total health costs decrease," says Keith Trettin, RPh, MBA, program manager for VA's National Center for Patient Safety (NCPS). As part of their quality-improvement efforts, NCPS has tracked instances in which Veterans misinterpreted their prescription labels and had poor clinical outcomes as a result.

Trettin and his team created a national study to evaluate Veterans' understanding of current VA prescription labels, with the goal of using their feedback and input and that of VA pharmacy staff to create a new, safer label. Results of the study, titled " Improving Veteran health-literacy and safety through implementation of a novel, evidence-based, patient-centered outpatient prescription label," were presented on July 23, 2012, at the Applied Human Factors and Ergonomics Conference in San Francisco, Calif.

As part of the study, the team evaluated Veterans' understanding of current VA prescription labels, and asked them and pharmacy staff to evaluate a proposed new label. Nearly 450 Veterans and 700 VA pharmacy staff members participated in the study at 11 survey sites.

Veterans, the survey showed, thought the most important information on the pharmacy label was the patient's name, the directions explaining how to use the medication, the number of refills remaining before a new prescription needed to be written, and the name of the drug itself. Pharmacy staff agreed that the patient's name, directions for use, and the drug name were important—but also thought that the prescription number and the quantity of drugs in the container were significant.

Armed with that information, the team designed a sample "VA Patient Centric Prescription Label," in which the patient's name is at the top, bold-faced and highlighted. Directly underneath the patient's name are simple, plain-English directions for how the medication should be used (such as "take 1 tablet by mouth twice daily"). Below that is the name of the drug and its dosage level, followed on the next line by a prescription number and the number of refills the patient has left.

A black border separates the above information from the name of the prescriber, the quantity of medications in the container, the issuing pharmacy's name and phone number, and any cautions the federal or state government has offered related to the medication. Next to a border on the right side of the label is any other important information related to the medication (such as "take with food," or "may cause dizziness"). Below that is the date the prescription was filled, the last date that refills can be ordered without a new prescription, the date by which the medication must be used, and a short description of what the medication looks like.

Information of special importance to the patient, such as the patient and drug name, is both highlighted and bolded for easy reference. The team found that 64 percent of the Veterans they surveyed and 62 percent of VA pharmacy staff preferred this new design to others they were shown.

The team also identified a number of other issues that, if corrected, could reduce errors in taking medications. The NCPS database includes 1229 cases involving patients who took a whole tablet of medication when they were supposed to split the tablet in half and take only the reduced dose. Researchers found that the best way to present that information was to present both the fraction of the pill to be taken and the words one-half on the label, as in "take � (one-half) tablet by mouth".

Jargon on the labels also confused patients, and will be eliminated. Trettin cited one label for the drug digoxin, used to treat heart failure, which read, "Take one tablet by mouth every day for heart give x 2 doses only (start 8 hours after the initial 250 mcg now dose is given"). When the Veteran was asked how he was supposed to be taking his digoxin, he incorrectly responded, "Twice daily, just as the label says." In actuality, the intent of the instructions was that the drug be taken once a day, and discontinued after two days.

In addition, many Veterans could not identify the correct number of pills to take when the word "meals" was used in the directions. Seventy percent of pharmacy staff preferred the word "food."

"Our study will be used to develop a standardized VA prescription label," concludes Trettin. Testing of the standardized label began in July 2012 at pharmacies throughout Veterans Integrated Service Networks (VISNs) 6, 7, and 8, and at VA's Charleston, S.C., CMOP. The testing is expected to conclude in a few months. After the pilot concludes and the results are evaluated, if the test is successful all VA pharmacies will begin using the new labels early next year.

"We hope to see an improvement, not only in Veteran satisfaction, but also in their understanding and comprehension of the medications they are taking," says Jeanne Tuttle, pharmacy program manager for VA's Pharmacy Benefits Management Program. "Ultimately, if Veterans are able to understand medication labels better, it should increase their adherence to their drug regimen—and keep them healthier."

Tuttle, like Schwartzberg, is a member of the Pharmacopeial Convention, a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. She expects that the convention will come out with worldwide standards for medication labeling sometime this fall. "VA is ahead of the curve," she says. "And that's appropriate."

In Fiscal Year 2010, 4.6 million Veterans used the VA pharmacy for one or more prescription medications. Approximately 136 million prescriptions were filled by VA pharmacies in that year, 77 percent of which were filled by VA's consolidated mail outpatient pharmacies (CMOPs). VA employs approximately 7,300 pharmacists, and more than 4,100 pharmacy technicians—and spent nearly $3.3 billion on drugs in 2010.

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