Proper Pill-Taking: Reading Drug Labels

The FDA has proposed placing strong warning labels on many over-the-counter painkillers, cautioning patients about the risks of possible liver failure from taking them too often.

More than 200 million Americans take these drugs in combination, and overdoses lead to approximately 450 deaths every year from liver failure. The risks of liver failure are particularly high in people over the age of 60 with a history of ulcers or stomach bleeding.

The proposed warning label, therefore, would be placed on all bottles of aspirin, ibuprofen, naproxen and ketoprofen, drugs known to cause stomach bleeding from overuse, which can lead to liver failure.

Whether the placement of a warning label on these drugs will deter people from overusing them, remains to be seen. But this move does highlight the importance of reading and understanding drug labels on both over-the-counter and prescription medications.

Over-the-Counter Drug Safety
Labels on all over-the-counter medications are carefully regulated by the FDA. In fact, you may have noticed that all of the cold syrups, aspirin bottles and stomach medicines that you purchased at the local drug store have labels in the same format. Prescription medication labels, on the other hand, are not as tightly regulated, so they do not have a standard format and vary from one pharmacy to another.

"Over-the-counter drugs are held to a higher bar," said Dr. Michael S. Wolf, professor of medicine at Northwestern University's Feinberg School of Medicine, "because there is no physician intermediary."

Wolf adds that for a medication to become available over-the-counter, it has to be proven to be safe and effective. But, as the FDA warning shows, just because a drug is safe when taken by itself, doesn't mean it's safe in combination with other drugs.

So, every time you purchase an over-the-counter drug, be sure to check out its label. Here is what you should look for and what it means.

  • Active Ingredient. The active ingredient is the chemical in the medicine that interacts with your body to improve your symptoms. It is always the first thing listed on an over-the-counter drug label.
  • Uses. Sometimes called "indications," this section will list the only symptoms this drug is approved to treat.
  • Warnings. This section tells you what other medications, foods or situations (like driving) you need to avoid when using this mediation. If a medication is listed in this section, its "active ingredient" will be named, not its brand name.
  • Directions. This section will tell you the amount you should take and how often you should take it. Follow this sectioncarefully to avoid overdose.
  • Other Information. This section will let you know if there is any special way you should store the medication. For example, many drugs should be kept out of direct sunlight or away from heat to prevent them frombecoming inactive.

Prescription Label Problems
Reading prescription labels can be even trickier than reading over-the-counter medication labels. In a study, Wolf surveyed 395 English-speaking patients in doctors' waiting rooms about various prescription labels. The results of the study were published in the Annals of Internal Medicine.

Only 34 percent of those surveyed who were determined to have a low degree of literacy were able to correctly demonstrate what was meant by the directions "take two tablets by mouth twice daily." Worse, more than one-third of patients who were judged to have average literacy (at grade level) could not understand at least one of the medication directions given to them.

"This is cause for concern, because patient misunderstanding could be a potential source of medication error," said Wolf.

Often, the cause for misunderstanding prescription labels, says Wolf, is that patients don't take enough time to read the directions carefully and think about what they mean before they start popping the pills.

The potential for a patient to take one drug incorrectly is troubling, but many patients take a variety of drugs, and juggling various prescription schedules can lead to this misunderstanding having an even greater impact.

"It is possible that as patients take more prescription medications, the complexity and possible confusion of managing multiple instructions may be greater," said Wolf.

Wolf recommends that pharmacists and doctors be more explicit when explaining how a drug should be taken. For example, they could ask the patient to describe how they think the drug should be taken based on their instructions.

More importantly, however, is that "patients take responsibility and take the time to talk to their doctor about the drugs they are taking," says Wolf. "Ask questions every time you are at the pharmacy."

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