If you don't get easy-to-understand information from your prescription drug label, don't expect the lengthier instructions in the patient insert to clarify matters much. With each of the five prescriptions for generic warfarin, we found incomplete or hard-to-read package inserts—and in 4 of 5 cases, a dangerous omission that violated an FDA regulation.
Most chain pharmacies send patients home with pages of complex supplemental instructions and warnings about the drugs they've dispensed, but studies suggest that this literature usually isn't helpful. Some research has found that the majority of people don't read through it because the language is too complex. Small typeface, narrow spacing, and poor design only make matters worse. "By objective measures, current systems for providing high quality, easily accessible prescription medication information to patients have failed," says Sandy Walsh, a spokeswoman for the Food and Drug Administration. She cites an FDA study from 2008 that found that 94 percent of consumers receive informational leaflets with new prescriptions but only 75 percent of the leaflets met even minimum criteria for usefulness.
Our five information sheets with each prescription of warfarin showed similar problems with readability and usability. And, surprisingly, in our local spot check, four of the five pharmacies failed to provide an FDA-approved Medication Guide that is required for certain drugs, including warfarin, that have particularly serious safety problems or other issues. Only Costco got it right. In general, failure to do so is a violation of federal law, and by extension, state law, according to Catizone.
That's a problem, because warfarin is among the most likely prescription drugs to cause serious adverse reactions leading to emergency-room visits, and requires clear guidance. Representatives of Target and CVS told us that their pharmacies automatically print medication guides for patients. But those guides did not make it to our staff members' packages. At press time, Walgreens and Walmart had not responded to our queries.
All of the pharmacies did provide their own patient materials, known as consumer medication information (CMI) - and all the materials included the most important "black box" safety warnings about the risk of bleeding. But, they differed from the FDA-approved guide, and proved confusing even for our health reporters to decipher.
For example, warfarin's possible side effects include life-threatening bleeding problems; skin-tissue damage; "purple-toes syndrome," which can lead to amputation; allergic reactions; liver problems; low blood pressure; swelling; low red blood cells, paleness; fever; and rashes, according to the official FDA guide. But the inserts from Walgreens, Walmart, and Target reported under the heading "possible side effects" that warfarin has "no common side effects (all in capital letters) with the proper use of this medicine." Those inserts instead included a list of serious symptoms and "unusual effects,"—shortness of breath, and bloody stool or urine among them—and followed up with a caveat referring patients to their doctor for information about other possible side effects.
The first side effects listed in the CVS and Costco inserts—nausea, loss of appetite, and stomach or abdominal pain—don't appear in the FDA-required Medication Guide for patients at all. Nausea and pain are listed as infrequent side effects in the FDA's approved drug insert for physicians, and loss of appetite also appears in the medical literature. None of the five inserts list additional side effects that can be caused by warfarin, such as gas, tiredness, hair loss, a change in the way things taste, or chills.
Those mixed messages dealing with risks or serious symptoms on the one hand, and side effects on the other, are confusing for a consumer looking for simple information about side effects. "I'm not sure how [a pharmacy] can provide information below [FDA] requirements, or package it to downplay information that the FDA [has] determined is critical for the patient," Catizone says.
We also found conflicting warnings about alcohol in the inserts. Costco and CVS advised patients to "limit or avoid alcohol." But the FDA-approved Medication Guide and the other pharmacies recommended not drinking at all.
The inserts weren't all bad. All of them included warfarin's important "black box" safety warning that the medicine can cause "severe and sometimes fatal bleeding," and other important cautions. And all had important information on how food, supplements, and other drugs can interact with warfarin. But readability might prevent many consumers from learning about those cautions.
Target, Walgreens, CVS, and Costco printed the inserts in a small type that most patients would have trouble reading. Walgreens' insert is especially hard to read due to very narrow spacing between the lines. And all of the inserts frequently used capital letters for some warnings or headings, which is harder to read, according to FDA guidelines for consumer medical information. Walmart's insert was printed in relatively large type but the information was spread over four pages. Costco's in-house insert was well-designed with clear formatting, but a large red and blue pharmacy graphic over the drug information was a distraction.
Change may be coming. The FDA's Risk Communication Advisory Committee recently recommended that it adopt a standard document for communicating essential information about prescription drugs. Walsh, the FDA spokeswoman, says the "FDA is engaged in a collaborative effort to explore this recommendation." And the 2009 health-reform law asked the FDA to look into implementing a Drug Facts box that would help consumers understand benefits and risks.