Other ways to prevent medical errors
Drug Labeling
Consumers tend to overlook important label information on OTC drugs, according to a Harris Interactive Market Research Poll conducted for the National Council on Patient Information and Education and released in January 2002. In May 2002, an FDA regulation went into effect that aims to help consumers use OTC drugs more wisely.The regulation requires a standardized "Drug Facts" label on more than 100,000 OTC drug products. Modeled after the Nutrition Facts label on foods, the label helps consumers compare and select OTC medicines and follow instructions. The label clearly lists active ingredients, uses, warnings, dosage, directions, other information, such as how to store the medicine, and inactive ingredients.
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
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 (see "Who Tracks Medication Errors?"). 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.
