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A doctor ordered 650 mg of buffered aspirin three times a day for a patient with arthritis. When the nurse on afternoon medication rounds checked the patient's bin of the medication cart, she saw two 2-tablet unit-dose packages of this product. She compared the drug order with the package label, which listed the dose as "aspirin, 325 mg .... "
The nurse assumed that the label on a unit -dose package described the total package contents. Because the label didn't state "325 mg per single tablet" or "each tablet contains 325 mg," she assumed the entire package contained 325 mg. So she administered two entire packages (4 tablets) to the patient, thinking she was giving 650 mg.
After completing rounds, the nurse told the pharmacist she'd need more packages for the evening dose. The pharmacist was sure he'd put enough medication for the day in the patient's bin, so he asked her how many packages she'd given the patient. When she told him, he explained that each tablet in the package contains 325 mg, so a 2-tablet package contains 650 mg.
Luckily, the patient wasn't harmed by this double dose of aspirin. But he could have developed aspirin toxicity if the error had been repeated indefinitely.
Although the nurse knew that most aspirin tablets contain 325 mg, she interpreted the package label literally and didn't ask the pharmacist to confirm her interpretation. And she didn't ask herself why she was giving two packages for one dose-often a clue that something is wrong. Nevertheless, the package label was misleading.
The nurse, upset by her error, decided to take action. She wrote to the drug manufacturer, explained what had happened, and pointed out that the label on a 2-tablet package of a similar product states "each tablet contains 325 mg." A few months later, the manufacturer agreed to revise the label.
If you have a similar problem with a package label, report it in a detailed letter to the manufacturer.
Also, you can notify either the United States Pharmacopeia (USP) Drug Product Problem-Reporting Program or the FDA. The USP will investigate the complaint and contact the manufacturer. Call the Drug Product Problem-Reporting Program toll-free at (800) 638-6725 between 9 a.m. and 4:30 p.m. on weekdays. (At other times, a recording device takes your complaint.) In Maryland, Hawaii, and Alaska, call collect (301) 881-0256 between 9 a.m. and 4:40 p.m. weekdays.