Error tracking and public education: The FDA reviews medication error reports that come from drug manufacturers and through MedWatch, the agency's safety information and adverse event reporting program. The agency also receives reports from the Institute for Safe Medication Practices (ISMP) and the U.S. Pharmacopeia, or USP.
A recent ISMP survey on medication error reporting practices showed that health professionals submit reports more often to internal reporting programs such as hospitals than to external programs such as the FDA. According to the ISMP, one reason may be health professionals' limited knowledge about external reporting programs.
The FDA receives and reviews about 300 medication error reports each month and classifies them to determine the cause and type of error. Depending on the findings, the FDA can change the way it labels, names, or packages a drug product. In addition, once a problem is discovered, the FDA educates the public on an ongoing basis to prevent repeat errors.
In 2001, the agency released a public health advisory to hospitals, nursing homes, and other health care facilities about the hazards of mix-ups between medical gases, which are prescription drugs. In one case, a nursing home in Ohio reported four deaths after an employee mistakenly connected nitrogen to the oxygen system.
The ISMP reports medication errors through various newsletters that target health professionals in acute care, nursing, and community/ambulatory care. The ISMP also has launched a newsletter for consumers called Safe Medicine.
In December 2003, the USP released an analysis of medication errors captured in 2002 by its anonymous national reporting database, MedMARX. Of the errors reported to MedMARX, slightly more than one-third reached the patient and involved a geriatric patient. Many of these medication errors were found to be harmful.
What Consumers Can Do
In one case reported to the ISMP, a doctor called in a prescription for the antibiotic Noroxin (norfloxacin) for a patient with a bladder infection. But the pharmacist thought the order was for Neurontin (gabapentin), a medication used to treat seizures. The good news is that the patient read the medication leaflet stapled to his medication bag, noticed the drug he received is used to treat seizures, and then asked about it. ISMP president Michael Cohen, R.Ph., Sc.D., says, "You should expect to count on the health system to keep you safe, but there are also steps you can take to look out for yourself and your family."
* Know what kind of errors occur. The FDA evaluated reports of fatal medication errors that it received from 1993 to 1998 and found that the most common types of errors involved administering an improper dose (41 percent), giving the wrong drug (16 percent), and using the wrong route of administration (16 percent). The most common causes of the medication errors were performance and knowledge deficits (44 percent) and communication errors (16 percent). Almost half of the fatal medication errors occurred in people over 60. Older people are especially at risk for errors because they often take multiple medications. Children are also a vulnerable population because drugs are often dosed based on their weight, and accurate calculations are critical.
* Find out what drug you're taking and what it's for. Rather than simply letting the doctor write you a prescription and send you on your way, be sure to ask the name of the drug. Cohen says, "I would also ask the doctor to put the purpose of the prescription on the order." This serves as a check in case there is some confusion about the drug name. If you're in the hospital, ask (or have a friend or family member ask) what drugs you are being given and why.
* Find out how to take the drug and make sure you understand the directions. If you are told to take a medicine three times a day, does that mean eight hours apart exactly or at mealtimes? Should the medicine be stored at room temperature or in the refrigerator? Are there any medications, beverages, or foods you should avoid? Also, ask about what medication side effects you might expect and what you should do about them. And read the bottle's label every time you take a drug to avoid mistakes. In the middle of the night, you could mistake ear drops for eye drops, or accidentally give your older child's medication to the baby if you're not careful. Use the measuring device that comes with the medicine, not spoons from the kitchen drawer. If you take multiple medications and have trouble keeping them straight, ask your doctor or pharmacist about compliance aids, such as containers with sections for daily doses. Family members can help by reminding you to take your medicine.
* Keep a list of all medications, including OTC drugs, as well as dietary supplements, medicinal herbs, and other substances you take for health reasons, and report it to your health care providers. The often-forgotten things that you should tell your doctor about include vitamins, laxatives, sleeping aids, and birth control pills. One National Institutes of Health study showed a significant drug interaction between the herbal product St. John's wort and indinavir, a protease inhibitor used to treat HIV infection. Some antibiotics can lower the effectiveness of birth control pills. If you see different doctors, it's important that they all know what you are taking. If possible, get all your prescriptions filled at the same pharmacy so that all of your records are in one place. Also, make sure your doctors and pharmacy know about your medication allergies or other unpleasant drug reactions you may have experienced.
* If in doubt, ask, ask, ask. Be on the lookout for clues of a problem, such as if your pills look different than normal or if you notice a different drug name or different directions than what you thought. Krawisz says it's best to be cautious and ask questions if you're unsure about anything. "If you forget, don't hesitate to call your doctor or pharmacist when you get home," he says. "It can't hurt to ask."
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