Drug Warnings Are Slipping Through the Cracks

Kate H. Gamble, Senior Editor
Published Online: Wednesday, June 29, 2011
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Prescription drug labels are missing the mark, according to a study by Consumer Reports, which found that drug labels sometimes lack key safety warnings, and that some pharmacies fail to include medication guides.

As part of an investigation, Consumer Reports Health staffers filled prescriptions for 5 mg of warfarin at 5 chain pharmacies located in the Yonkers, New York area. Warfarin—known under the brand name Coumadin and also available in generic form—is a blood thinner used to prevent strokes. It is one of the 20 most commonly prescribed drugs in the United States, according to IMS Health.

What the staffers found was that 4 of the 5 pharmacies failed to provide the federally mandated medication guide that is required for certain drugs—one of which is warfarin. And although all of the pharmacies provided consumer medication information (CMI), the guides differed from the FDA-approved guide for warfarin and contained conflicting warnings about alcohol. These findings are particularly alarming, as warfarin is the second most common drug implicated in emergency room visits in the United States.

The report found that CMIs were “confusing, loaded with medical jargon, and sometimes unreadable due to tiny print,” according to Marvin M. Lipman, MD, chief medical adviser at Consumer Reports Health. “We were shocked by what we unearthed. It’s very worrisome to think of consumers taking dangerous drugs without adequate warnings.”

The Institute of Medicine estimates that there are approximately 1.5 million preventable medication errors each year, and that roughly one-third of those mistakes occur outside of hospitals, where patients must rely upon their own ability to follow the instructions on medication containers. The problem is that instructions can often be misunderstood or misinterpreted. For example, a 2007 study in the journal Patient Education and Counseling found that one-third of patients did not realize that "2 tablets by mouth twice daily" meant taking 4 pills in a 24-hour period.

"Health literacy is a big issue," said Allen Vaida, PharmD, executive vice president of the Institute for Safe Medication Practices (ISMP) in Pennsylvania. "Even college grads can have trouble when it comes to understanding terms that health-care workers use."

Patients, the report found, tend to fare better when given more specific directions. Language like, "1 tablet in the morning and 1 tablet at night, 12 hours apart" helps patients understand when they should take their medication, rather than the vague "twice a day," which isn't associated with any time frame.

Part of the problem, according to Consumer Reports, stems from the lack of a nationwide standard similar to the Nutrition Facts labels on food packages or the Drug Facts labels on OTC medications. Although the Federal Food, Drug, and Cosmetic Act requires certain details to appear on bottle labels—including the patient's name and dosage instructions—other details can vary by state.

To help facilitate more uniformity among labels, which in turn can improve patient safety, US Pharmacopeia, the authority that sets voluntary standards for prescription medication, and the ISMP suggest that labels should contain:
  • Words typed in easy-to-read 12-point type, with the patient's name, drug name, and drug instructions in the largest letters
  • Warnings typed directly onto patient labels in a large typeface
  • The generic and brand name of a drug
  • Images or physical descriptions of the pills in the container
  • No extra zeroes (like 5.0 mg)
  • The pharmacy's information—name, address, and phone number—at the bottom of the label
For more information on the Consumer Reports investigation, view the video below.



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