CR secret shoppers find dangers with prescription labels and inserts

It seemed like a straightforward "spot check." We sent Consumer Reports Health staffers to five pharmacies—Costco, CVS, Target, Walgreens, and Walmart—near our Yonkers, N.Y. office to fill prescriptions for the blood-thinner warfarin to see what kinds of instructions and warnings we'd find on the prescription bottles and patient-information sheets. But what we found was troubling.

We expected clear and consistent label information for two reasons. First, if not taken correctly warfarin, the generic version of Coumadin, can cause bleeding problems, which can be fatal. In fact, it's the second most commonly implicated drug in emergency room visits in the U.S. In addition, it's taken so often that it ranked among the top 20 most prescribed medications in the country last year, according to figures from IMS Health.

But some important warnings on the five prescription bottles we purchased locally were either missing entirely or potentially misleading. And the additional patient leaflets were confounding. Small type and medical jargon made them difficult to read, even for our health reporters. And while all the stores' leaflets did include the drug's most important information about the risk of bleeding, we found other side-effect information that was potentially misleading or unclear.

Also problematic: While all the stores gave us their own patient-information sheets, four out of the five pharmacies failed to provide a required FDA Medication Guide—something that is mandated with many drugs that have serious safety issues or other problems, including warfarin. In our spot-check, only Costco got that one right.

Another eye-brow-raising issue: While the New York State Board of Pharmacy requires that pharmacists provide actual counseling—not just the offer of counseling—to all patients filling a new prescription, only two pharmacists talked with our secret shoppers about the drug and double-checked that it was indeed what the physician had prescribed.

Although our findings are not nationally representative for these drugstore chains, what we discovered is a glimpse of the worrisome variation that a consumer might face when filling a prescription for a very common medication.

Part of the problem with bottle labels is that there are no national standards, unlike the Nutrition Facts labels on food packages or the Drug Facts labels on over-the-counter medication. The Federal Food, Drug, and Cosmetic Act requires certain details to appear on bottle labels (such as the patient's name and dosage instructions), but other details can vary by state. The labels aren't monitored by the Food and Drug Administration; rather, each state's board of pharmacy is responsible for their content.

And for bottle warnings, while each state's board of pharmacy can set prescription bottle warning guidelines, they haven't. This leaves it up to the store, the pharmacist, or both to decide on which warnings go on which bottles.

For details, including tips on how to read drug labels and what questions to ask your pharmacist, see our full report.

—Lisa Gill