A Regulatory Approach
The public took notice in 1999 when the Institute of Medicine (IOM) released a report, "To Err is Human: Building a Safer Health System." According to the report, between 44,000 and 98,000 deaths may result each year from medical errors in hospitals alone. And more than 7,000 deaths each year are related to medications.
The purpose of the IOM was to examine public health policy. The IOM operates free of governmental control and is one of the most respected groups in medicine.
In response to the IOM's report, all parts of the U.S. health system put error reduction strategies into high gear by re-evaluating and strengthening checks and balances to prevent errors.
In addition, the U.S. Department of Health and Human Services (HHS) and other federal agencies formed the Quality Interagency Coordination Task Force in 2000 and issued an action plan for reducing medical errors. In 2001, HHS Secretary Tommy G. Thompson announced a Patient Safety Task Force to coordinate a joint effort to improve data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality.
The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which included forming a new division on medication errors at the agency last year. "We work to prevent medication errors before a drug reaches the market and to also monitor any errors that may occur after that," says Jerry Phillips, R.Ph., director of the FDA's new Division of Medication Errors and Technical Support.
Here's a look at key areas in which the FDA is working to reduce medication errors.
Bar code label rule
After a public meeting in July 2002, the FDA decided to propose a new rule requiring bar codes on certain drug and biological product labels. Health care professionals would use bar code scanning equipment, similar to that used in supermarkets, to make sure that the right drug in the right dose and route of administration is given to the right patient at the right time.
"It's a promising way to automate aspects of medication administration," says Robert Krawisz, executive director of the National Patient Safety Foundation. "The technology's impact at VA hospitals so far has been amazing." The Department of Veterans Affairs (VA) already uses bar codes nationwide in its hospitals, and the result has been a drastic reduction in medication errors. For example, the VA medical center in Topeka, Kan., has reported that bar coding reduced its medication error rate by 86 percent over a nine-year period.
Here's how it works
When patients enter the hospital, they get a bar-coded identification wristband that can transmit information to the hospital's computer, says Lottie Lockett, R.N., a nursing administrator at the Houston VA Medical Center. Nurses have laptop computers and scanners on top of medication carts that they bring to patients' rooms. Nurses use the scanners to scan the patient's wristband and the medications to be given. The bar codes provide unique, identifying information about drugs given at the patient's bedside. "Before giving medications, nurses use the scanner to pull up a patient's full name and social security number on the laptops, along with the medications," Lockett says. "If there is not a match between the patient and the medication or some other problem, a warning box pops up on the screen."
The FDA's proposed rule on bar code labeling was published on March 14, 2003. The rule, which would take effect in 2006, applies to prescription drugs, biological products such as vaccines, blood and blood components, and over-the-counter (OTC) drugs that are commonly used in hospitals. Manufacturers, repackers, relabelers, and private label distributors of prescription and OTC drugs would be subject to the bar code requirements. The agency continues to study whether it also should develop a rule requiring bar code labeling on medical devices.
Drug name confusion
To minimize confusion between drug names that look or sound alike, the FDA reviews about 300 drug names a year before they are marketed. "We reject about one-third of the names that drug companies propose," says Phillips. The agency tests drug names with the help of about 120 FDA health professionals who volunteer to simulate real-life drug order situations. "We're also creating a computerized program that will assist in detecting similar names and that will help us take a more scientific approach to comparing names," Phillips says.
After drugs are approved, the FDA tracks reports of errors due to drug name confusion and spreads the word to health professionals, along with recommendations for avoiding future problems. For example, the FDA has reported errors involving the inadvertent administration of methadone, a drug used to treat opiate dependence, rather than the intended Metadate ER (methylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD). One report involved the death of an 8-year-old boy after a possible medication error at the dispensing pharmacy. The child, who was being treated for ADHD, was found dead at home. Methadone substitution was the suspected cause of death. Some FDA recommendations regarding drug name confusion have encouraged pharmacists to separate similar drug products on pharmacy shelves and have encouraged physicians to indicate both brand and generic drug names on prescription orders, as well as what the drug is intended to treat.
The last time the FDA changed a drug name after it was approved was in 1994 when the thyroid medicine Levoxine was being confused with the heart medicine Lanoxin (digoxin), and some people were hospitalized as a result. Now the thyroid medicine is called Levoxyl, and the agency hasn't received reports of errors since the name change. Other examples of drug name confusion reported to the FDA include:
* Serzone (nefazodone) for depression and Seroquel (quetiapine) for schizophrenia
* Lamictal (lamotrigine) for epilepsy, Lamisil (terbinafine) for nail infections, Ludiomil (maprotiline) for depression, and Lomotil (diphenoxylate) for diarrhea
* Taxotere (docetaxel) and Taxol (paclitaxel), both for chemotherapy
* Zantac (ranitidine) for heartburn, Zyrtec (cetirizine) for allergies, and Zyprexa (olanzapine) for mental conditions € Celebrex (celecoxib) for arthritis and Celexa (citalopram) for depression.
