Self-inflicted medication mishaps are on the rise, in part due to confusing labels. WSJ's Informed Patient columnist Laura Landro highlights some new efforts to make medicine labels easier to understand.


As many as three in four Americans say they don't take prescription medicine as directed, according to the National Community Pharmacists Association.

Professor Michael Wolf, who researches drug labeling, holds up a seemingly contradictory warning on a prescription for Nexium given to his brother by a pharmacy in Washington, D.C. Stephen Anzaldi

The Food and Drug Administration is planning to test single-page consumer information sheets that would replace the multi-page package inserts and medication guides widely used in retail pharmacies. And the U.S. Pharmacopeial Convention, which sets quality standards enforced by the FDA for the quality, strength and purity of medicines, is developing a new national standard for prescription labels, which can vary widely from pharmacy to pharmacy and befuddle consumers. The standards, if adopted, would require clear instructions on dose and timing and state in simple terms the purpose of the drug—such as "for high blood pressure"—unless the patient prefers that it not appear.

By the Numbers

  • Nearly 1.9 million people were treated in hospitals for illnesses and injuries from taking medicines, a 52% increase from 2004 to 2008.
  • Another 838,000 people were treated and released from emergency rooms due to harm from medications in 2008.
  • Almost 36% of treat-and-release emergency room visits were patients ages 18 to 44, and 18% were elderly.


With the growing complexity of medication regimens, especially for the elderly and those with multiple, chronic conditions, even highly educated consumers can fail to take their medications correctly, says Karen Weiss, program director of the FDA's Safe Use Initiative. "We need to create better awareness about the gamut of harm that can occur."

Currently, consumers may receive as many as three different types of drug pamphlets with their prescriptions: package inserts written by the manufacturer and approved by the FDA, medication guides for certain classes of drugs and products required by the FDA, and consumer medical information provided by various third-party companies. However, recent studies by the FDA have shown that the information offered is not consistently understandable—and sometimes even conflicting or inaccurate.

Medication mishaps often happen in the hospital, due to clinician error and unexpected allergies or reactions. According to the Agency for Healthcare Research and Quality, the number of people treated in U.S. hospitals for illnesses and injuries from taking medications jumped 52% to 1.9 million between 2004 and 2008, the latest year available, including patients admitted from the emergency room. More than half of the increase was due to corticosteroids, blood thinners, and sedatives and hypnotics.

Another 838,000 patients were also treated and released from the ER with problems related to those and other medications, including painkillers, antibiotics, cardiovascular drugs, insulin and other hormones used to treat common diseases such as asthma, arthritis and ulcerative colitis. FDA officials say inadvertent errors made by patients who misunderstand information are causing significant harm. One reason cited is low literacy skills. A study in 2006 showed that of 70% of patients with low literacy who could correctly state the instructions "take two tablets by mouth twice daily," only 34% could then demonstrate the number to be taken daily.


Bad Reactions

How drugs can cause harm if taken incorrectly

  • Painkillers: Taking with alcohol or other painkillers or sedatives can cause breathing problems or death. Over-the-counter products containing acetaminophen can injure the liver if taken with opioid-acetaminophen combination drugs.
  • Antibiotics: Can cause allergic reaction or fail to fight infection; sun exposure while taking can cause extreme burn.
  • Corticosteroids (for arthritis, asthma, ulcerative colitis, immunosupression in transplant patients): Can worsen high blood pressure, diabetes, bloodsugar problems or ulcers. Suddenly stopping use can cause withdrawal symptoms.
  • Antidepressants/ tranquilizers: Can lead to suicidal actions, panic attacks.
  • Blood-pressure drugs: Insufficient dose can cause spike in blood pressure; overdose can cause dizziness, chest pain, shortness of breath, coma or an unusually slow or fast heartbeat; stopping use too quickly can cause serious heart problems.
  • Cancer drugs: Can exacerbate fatigue, confusion. Can cause fever, shortness of breath, nausea and vomiting, diarrhea, overdose can cause death.
  • Insulin: Can increase or reduce blood-sugar levels and lead to shock and other complications
  • Blood thinners: Too high a dose can cause excessive bleeding, bruising; too low a dose can cause blood clots. Interactions with many medications can reduce effectiveness or cause bleeding.

In another study, his team filled 100 prescriptions across the country and found that important warnings often were not included on labels. For example, only half the time did prescription labels for Fosamax, an osteoporosis drug, carry the warning that patients should not lie down for 30 minutes after taking the drug; doing so can lead to irritation and erosion of the lining of the esophagus.

The FDA is working with the Brookings Institution on the one-page guides that could eventually replace other materials, says Denise Hinton, a senior program manager with the FDA. A pilot test is awaiting funding from the Office of Management and Budget. It could take five to six years for a final rule to go into effect.

There is some concern that a one-page summary printed on only one side isn't adequate, especially for more complex drugs. The Institute for Safe Medication Practices (ISMP), a nonprofit safety group that investigates medication errors, is working with the Agency for Healthcare Research and Quality on a series of medication brochures printed on two sides of a single page for medications with the potential to cause the most harm, such as the cancer drug methotrexate, which has caused deaths when mistakenly taken daily instead of once or twice a week. ISMP President Michael Cohen says the free brochures will be tested in pharmacies this year.

The American Society of Health-System Pharmacists, which creates medication instructions used by the federal National Library of Medicine, cautions that it will be difficult to boil down instructions to a single page without compromising patient safety, says Gerald McEvoy, assistant vice president of the group.

Kaiser Permanente, the large managed-care organization, has started a training program for pharmacists that includes confirming the directions for use and stressing the importance of taking medication as prescribed. "As reluctant as many pharmacists and consumers are to take the extra time, it is worth one last extra check to make sure nothing will go wrong," says Michael Negrete, chief executive of the Pharmacy Foundation of California.

Write to Laura Landro at