An investigation by Consumer Reports found that prescription drug labels sometimes lack key safety warnings and some pharmacies failed to include federally required medication guides.

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Prescription drug information under scrutiny

June 28th, 2011

NEW YORK – An investigation by Consumer Reports found that prescription drug labels sometimes lack key safety warnings and some pharmacies failed to include federally required medication guides.

And on the same day the consumer advocacy organization unveiled its findings, the National Association of Chain Drug Stores announced that it has sent a letter to the Food and Drug Administration urging the adoption of a "one-document solution" for prescription medications as a way to improve patient medication information (PMI).

Consumer Reports said Tuesday that for its investigative "spot check," it sent staffers to five drug stores in Yonkers, N.Y. — Costco, CVS, Target, Walgreens and Walmart — to fill prescriptions for the blood thinner warfarin, one of the nation's most commonly prescribed drugs. Four of the five pharmacies didn't provide a federally mandated medication guide that is required for certain drugs, including warfarin, the investigation found.

All of the pharmacies provided their own patient materials, yet they differed from the FDA-approved guide for warfarin and contained conflicting warnings about alcohol, according to Consumer Reports, which said that warfarin can cause severe internal bleeding and is the second most-common drug implicated in emergency room visits. The guide from two of the chains advised patients taking warfarin to "limit or avoid alcohol," whereas the FDA-approved guide recommended abstaining from alcohol.

The spot check also examined how prescription labels, warning stickers, and consumer drug information sheets varied from pharmacy to pharmacy. Consumer Reports said that its findings, while not nationally representative for each chain, "raise significant concern." The advocacy group also noted that it expected some variation because pharmacy chains use different software to print labels and instructions.

"We found that critical warnings were absent from some drug labels and information sheets were confusing, loaded with medical jargon, and sometimes unreadable due to tiny print," Marvin Lipman, M.D., chief medical adviser for Consumer Reports Health, said in a statement. "It's very worrisome to think of consumers taking dangerous drugs without adequate warnings," he added.

One factor may be that there's no national standard like "Nutrition Facts" on food packages or the "Drug Facts" on over-the-counter medication, according to Lisa Gill, prescription drug editor for Consumer Reports Health. "Consumers probably know more about their Cheerios than their prescription drugs," she commented.

And although the FDA requires certain details on prescription labels such as a patient's name and dosage instructions, the agency doesn't monitor drug labels, the content of which falls under the responsibility of state boards of pharmacy, Consumer Reports said, adding that whether there are warnings on the bottles is left up to the individual pharmacist.

"The inconsistencies and omissions on drug labels really cry out for uniformity and federal oversight. FDA regulation could solve this," Lipman stated.

About 1.5 million preventable medication errors occur each year, and a third of them happen outside of hospitals, where consumers must rely on their own ability to follow instructions, Consumer Reports said, adding that research suggests consumers are confused by the printouts that come with their prescriptions and rely heavily on the label affixed to the bottle.

"From a consumer safety point of view, it all comes down to the label on the bottle, though we still urge consumers to read all materials that come with their prescriptions," Gill stated.

Also on Tuesday, NACDS said that its letter calls for the FDA "to expeditiously develop, adopt and implement" a single-document system for prescription medications dispensed at pharmacies so patients have information that's "designed and written for them." The letter came in response to the Obama administration's request for ideas to streamline federal regulations, according to the association.

Currently, the FDA requires that pharmacies provide patients several types of information on prescriptions, including Medication Guides (MedGuides), Patient Package Inserts (PPI) and Consumer Medication Information (CMI) among other documentation, NACDS explained. However, the retail pharmacy group noted that such information is generated from various authors and sources and can be too complex and incomprehensible for patients.

"As FDA has recognized, various FDA regulations require pharmacies to provide patients several different types of written information, developed by different sources that may be duplicative, incomplete or difficult for patients to read and understand. This current system is not adequate to ensure that patients receive essential information about the medications they are taking," the NACDS letter stated.

"We urge FDA to elevate the transition from Medication Guides (MedGuides), Patient Package Inserts (PPI) and other Consumer Medication Information (CMI) to the 'one-document solution' PMI to be among FDA's highest priorities," the letter said.

NACDS noted that it first proposed the development of a one-document solution in 2007 along with other patient and industry stakeholders. The solution would give patients useful and focused information on their medications and enable pharmacies to advise and counsel patients on adhering to their prescriptions.

"NACDS remains committed to working with the Food and Drug Administration to advance a one-document solution," Steve Anderson, president and chief executive officer of NACDS, said in a statement. "The development and implementation of a one-document solution is an important patient safety recommendation and should be a top priority."

Last fall, NACDS also had sent a letter to the FDA reiterating the urgency for a one-document solution for prescription drug information for patients. The letter supplemented testimony that NACDS offered to agency at a public hearing on the issue in September.

And last August, NACDS responded to a critical Los Angeles Times report suggesting that the printed information provided with prescriptions is confusing for customers and that pharmacists could be more proactive in helping patients understand that information.