Preventing Medication Errors : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

As for health professionals, the FDA proposed a new format in 2000 to improve prescription drug labeling for physicians, also known as the package insert. One FDA study showed that practitioners found the labeling to be lengthy, complex, and hard to use. The proposed redesign would feature a user-friendly format and would highlight critical information more clearly. The FDA is still reviewing public comments on this proposed rule. The agency has also been working on a project called DailyMed, a computer system that will be available without cost from the National Library of Medicine next year. DailyMed will have new information added daily, and will allow health professionals to pull up drug warnings and label changes electronically.

Error tracking and public education: On March 13, 2003, the FDA announced a proposed rule that would revamp safety reporting requirements. For example, the proposal would require that reports on actual and potential medication errors be submitted to the agency within 15 calendar days. FDA's Seligman says, "This rule is part of FDA's overall effort to understand the sources of medication errors and prevent them."

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 ISMP, one reason may be health professionals' limited knowledge about external reporting programs.

The FDA receives and reviews about 250 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.

ISMP reports medication errors through various newsletters that target health professionals in acute care, nursing, and community/ambulatory care. Recently, ISMP launched a newsletter for consumers called Safe Medicine.

In December 2002, USP released an analysis of medication errors captured in 2001 by its anonymous national reporting database, MedMARX. Of 105,603 errors, 3,361 errors (3.2 percent) involved children. Most of the errors were corrected before causing harm, but 190 caused patient injury and of those, two resulted in death. As a result of this analysis, USP released recommendations for preventing drug errors in children in January 2003.

What Consumers Can Do

In one case reported to 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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.