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Release date 06/28/2011
Yonkers, NY — It’s comparable to driving a car without a seatbelt—a new investigation from Consumer Reports Health finds that drug labels sometimes lack key safety warnings and some pharmacies fail to include the medication guides required by the federal government.
For its investigative “spot check,” Consumer Reports Health sent staffers to five individual drugstores in Yonkers, N.Y.: Costco, CVS, Target, Walgreens, and Walmart, to fill prescriptions for warfarin. Warfarin (Coumadin and generics) is a blood thinner used to prevent strokes and one of the 20 most commonly prescribed drugs in the U.S., according to IMS Health. Most alarmingly, four of the five pharmacies failed to provide a federally mandated medication guide that is required for certain drugs, including warfarin. And while all of the pharmacies provided their own patient materials, known as consumer medication information (CMI), they differed from the FDA-approved guide for warfarin and contained conflicting warnings about alcohol. Warfarin can cause severe internal bleeding that can be life threatening and is the second most common drug implicated in emergency room visits in the U.S.
Consumer Reports Health also wanted to see how drug labels, warning stickers, and consumer drug information sheets varied from pharmacy to pharmacy. A certain level of variation was expected due to the use of different software at the various chains to print labels and instructions. While the findings are not nationally representative for each chain, they raise significant concern. “We were shocked by what we unearthed,” said Marvin M. Lipman, M.D., chief medical adviser, Consumer Reports Health. “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. It’s very worrisome to think of consumers taking dangerous drugs without adequate warnings,” added Lipman. Lipman urges consumers who take warfarin to check with their doctor when starting a new medication or discontinuing an old one because some drugs can either decrease or augment its effect.
Part of the problem, according to Lisa Gill, prescription drug editor, Consumer Reports Health, is that there’s no nationwide standard like “Nutrition Facts” on food packages or the “Drug Facts” on over-the-counter medication. “Consumers probably know more about their Cheerios than their prescriptions drugs,” said Gill. While the U.S. Food and Drug Administration (FDA) requires certain details on labels such as a patient’s name and dosage instructions, it does not monitor drug labels; rather, each state’s board of pharmacy is responsible for their overall content. And whether or not there are warnings on the bottles is left up to the individual pharmacist. “It’s my opinion that the inconsistencies and omissions on drug labels really cry out for uniformity and federal oversight. FDA regulation could solve this,” said Lipman.
According to the report, available online at www.ConsumerReportsHealth.org, there are approximately 1.5 million preventable medication errors each year, one third of which take place outside of hospitals where consumers must fend for themselves and rely on their own ability to follow instructions. Research suggests that consumers are confused by the printouts that accompany their prescriptions and rely heavily on the label that’s affixed directly on 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,” said Gill.
Some highlights from the report:
The Consumer Reports Health investigation suggests that consumers need to be on their guard, particularly when starting a new medicine. Consumer Reports Health recommends the following steps to stay safe:
Consumer Reports is a nonprofit membership organization that works side by side with consumers to create a fairer, safer, and healthier world. For 80 years, CR has provided evidence-based product testing and ratings, rigorous research, hard-hitting investigative journalism, public education, and steadfast policy action on behalf of consumers’ interests. Unconstrained by advertising or other commercial influences, CR has exposed landmark public health and safety issues and strives to be a catalyst for pro-consumer changes in the marketplace. From championing responsible auto safety standards, to winning food and water protections, to enhancing healthcare quality, to fighting back against predatory lenders in the financial markets, Consumer Reports has always been on the front lines, raising the voices of consumers.
© 2011 Consumer Reports. The material above is intended for legitimate news entities only; it may not be used for advertising or promotional purposes. Consumer Reports® is an expert, independent, nonprofit organization whose mission is to work side by side with consumers to create a fairer, safer, and healthier world. We accept no advertising and pay for all the products we test. We are not beholden to any commercial interest. Our income is derived from the sale of Consumer Reports® magazine, ConsumerReports.org® and our other publications and information products, services, fees, and noncommercial contributions and grants. Our Ratings and reports are intended solely for the use of our readers. Neither the Ratings nor the reports may be used in advertising or for any other commercial purpose without our prior written permission. Consumer Reports will take all steps open to it to prevent unauthorized commercial use of its content and trademarks.
Consumer Reports is a nonprofit membership organization that works side by side with consumers to create a fairer, safer, and healthier world. For 80 years, CR has provided evidence-based product testing and ratings, rigorous research, hard-hitting investigative journalism, public education, and steadfast policy action on behalf of consumers’ interests. Unconstrained by advertising or other commercial influences, CR has exposed landmark public health and safety issues and strives to be a catalyst for pro-consumer changes in the marketplace. From championing responsible auto safety standards, to winning food and water protections, to enhancing healthcare quality, to fighting back against predatory lenders in the financial markets, Consumer Reports has always been on the front lines, raising the voices of consumers.
© 2011 Consumer Reports. The material above is intended for legitimate news entities only; it may not be used for advertising or promotional purposes. Consumer Reports® is an expert, independent, nonprofit organization whose mission is to work side by side with consumers to create a fairer, safer, and healthier world. We accept no advertising and pay for all the products we test. We are not beholden to any commercial interest. Our income is derived from the sale of Consumer Reports® magazine, ConsumerReports.org® and our other publications and information products, services, fees, and noncommercial contributions and grants. Our Ratings and reports are intended solely for the use of our readers. Neither the Ratings nor the reports may be used in advertising or for any other commercial purpose without our prior written permission. Consumer Reports will take all steps open to it to prevent unauthorized commercial use of its content and trademarks.