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Key Drug Warnings Falling Through the Cracks

No Federal Monitoring of Drug Labels; What Consumers Can Do to Stay Safe 
Consumer ReportsYonkers, 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, NY: 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:

  • Four of the five pharmacies failed to provide a federally mandated medication guide that is required for certain drugs, including warfarin.
  • The prescription filled by Target included four warnings printed directly on the label and a directive to “read the medication guide that comes with this medicine.” Walgreens also had four warnings printed on the label; CVS had three warnings printed on the label; Costco had two warning stickers positioned sideways on the bottle; and Walmart had no warnings of any kind on the bottle.  However, a second trip to Walmart did yield three warning stickers on the bottle, as did a third trip to another Walmart in the area.
  • All of the pharmacies provided their own patient materials, known as consumer medication information (CMI).  However, they differed from the FDA-approved guide for warfarin and they contained conflicting warnings about alcohol.  While Costco and CVS advised patients to “limit or avoid alcohol,” the FDA approved guide recommends abstaining from alcohol all together.
  • Target’s bottle design and labels stood out from the pack, thanks to the chain’s triangular containers which provide ample space for detailed instructions.  The drug information is in large type, the pharmacy details are small and at the bottom of the label, and there’s space for multiple warnings and instructions on the back of the bottles.

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:

  • Understand the basics of your medication.  Talk to your doctor about how much you should take, when, and how often.  Take time at the pharmacy counter to talk to the pharmacist.  Even if he or she seems busy, don’t feel reluctant to ask.
  • Ask about food, medications, supplements, and vitamins that should be avoided.  And what about alcohol and other beverages?  
  • Ask about possible side effects, both common and rare.
  • Read the patient information sheets that accompany your prescription. 
  • Determine when you can stop taking the medication.  Some drugs, like antibiotics, should be taken until they’re finished. You might be able to discontinue other medication as you feel better.

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