to Reduce Medication Errors
the FDA is working to improve medication safety and what
do to help
When Jacquelyn Ley shattered her elbow on
the soccer field two years ago, her parents set out to find
her the best care in Minneapolis. "We drove past five other
hospitals to get to the one we wanted," says Carol Ley,
M.D., an occupational health physician. Her husband, an
orthopedic surgeon, made sure Jacquelyn got the right surgeon.
After a successful three-hour surgery to repair the broken
bones, Jacquelyn, who was 9 at the time, received the pain
medicine morphine through a pump and was hooked up to a
heart monitor, breathing monitor, and blood oxygen monitor.
Her recovery was going so well that doctors decided to turn
off the morphine pump and to forgo regular checks of her
Carol Ley slept in her daughter's hospital
room that night. When she woke up in the middle of the night
and checked on her, Jacquelyn was barely breathing. "I called
her name, but she wouldn't respond," she says. "I shook
her and called for help." The morphine pump hadn't been
shut down, but had accidentally been turned up high. The
narcotic flooded Jacquelyn's body. She survived the overdose,
but it was a close call. "If three more hours had gone by,
I don't think Jacquelyn would have survived," Ley says.
"Fortunately, I woke up."
Ley was pleased with the way the hospital
handled the error. "They came right out and said the morphine
pump was incorrectly programmed, they told me the steps
they were going to take to make sure Jacquelyn was OK, and
they also told me what they were going to do to make sure
this kind of mistake won't happen again. And that's very
important to me." The hospital began using pumps that are
easier to use and revamped nurse's training. Ley believes
there were many contributors to the error, including the
fact that it was Labor Day weekend and there were staff
shortages. "It goes to show that this can happen to anyone,
anywhere," says Ley, who now chairs the board of the National
Patient Safety Foundation.
Since 1992, the Food and Drug Administration
has received about 20,000 reports of medication errors.
These are voluntary reports, so the number of medication
errors that actually occur is thought to be much higher.
There is no "typical" medication error, and health professionals,
patients, and their families are all involved. Some examples:
A physician ordered a 260-milligram preparation
of Taxol for a patient, but the pharmacist prepared 260
milligrams of Taxotere instead. Both are chemotherapy drugs
used for different types of cancer and with different recommended
doses. The patient died several days later, though the death
couldn't be linked to the error because the patient was
already severely ill.
An elderly patient with rheumatoid arthritis
died after receiving an overdose of methotrexate--a 10-milligram
daily dose of the drug rather than the intended 10-milligram
weekly dose. Some dosing mix-ups have occurred because daily
dosing of methotrexate is typically used to treat people
with cancer, while low weekly doses of the drug have been
prescribed for other conditions, such as arthritis, asthma,
and inflammatory bowel disease.
One patient died because 20 units of insulin
was abbreviated as "20 U," but the "U" was mistaken for
a "zero." As a result, a dose of 200 units of insulin was
A man died after his wife mistakenly applied
six transdermal patches to his skin at one time. The multiple
patches delivered an overdose of the narcotic pain medicine
fentanyl through his skin.
A patient developed a fatal hemorrhage when
given another patient's prescription for the blood thinner
These and other medication errors reported
to the FDA may stem from poor communication, misinterpreted
handwriting, drug name confusion, lack of employee knowledge,
and lack of patient understanding about a drug's directions.
"But it's important to recognize that such errors are due
to multiple factors in a complex medical system," says Paul
Seligman, M.D., director of the FDA's Office of Pharmacoepidemiology
and Statistical Science. "In most cases, medication errors
can't be blamed on a single person."
A medication error is "any preventable event
that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the
health care professional, patient, or consumer," according
to the National Coordinating Council for Medication Error
Reporting and Prevention. The council, a group of more than
20 national organizations, including the FDA, examines and
evaluates medication errors and recommends strategies for
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. 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
"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
- 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
- Zantac (ranitidine) for heartburn, Zyrtec (cetirizine)
for allergies, and Zyprexa (olanzapine) for mental conditions
� Celebrex (celecoxib) for arthritis and Celexa (citalopram)
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
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:
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
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,
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
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
- 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
- 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.
Robert Krawisz of the National Patient Safety Foundation
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."
Patient Safety Proposals
In March 2003, Health and Human Services
Secretary Tommy G. Thompson announced two proposed rules
from the FDA that will use state-of-the-art technology to
improve patient safety. Here is a snapshot of each rule:
- Bar codes: Just as the technology
is used in retail and other industries, required bar
codes would contain unique identifying information about
drugs. When used with bar code scanners and computerized
patient information systems, bar code technology can
prevent many medication errors, including administering
the wrong drug or dose, or administering a drug to a
patient with a known allergy.
- Safety Reporting: The proposed revamping
of safety reporting requirements aims to enhance the
FDA's ability to monitor and improve the safe use of
drugs and biologics. The rule would improve the quality
and consistency of safety reports, require the submission
of all suspected serious reactions for blood and blood
products, and require reports on important potential
Hospitals and other health care organizations
work to reduce medication errors by using technology, improving
processes, zeroing in on errors that cause harm, and building
a culture of safety. Here are a couple of examples.
Pharmacy intervention: It
was a challenge for health care providers, especially surgeons,
at Fairview Southdale Hospital in Edina, Minn., to ensure
that patients continued taking their regularly prescribed
medicines when they entered the hospital, says Steven Meisel,
Pharm.D., director of medication safety at Fairview Health
Services. "Surgeons are not typically the original prescribers,"
he says. The solution was to have pharmacy technicians record
complete medication histories on a form. In a pilot program,
the technicians called most patients on the phone a couple
of days before surgery. A pharmacist reviewed the information
and then the surgeon decided which medications should be
continued. After three months, the number of order errors
per patient dropped by 84 percent, and the pilot program
Computerized Physician Order Entry
(CPOE): Studies have shown that CPOE is effective
in reducing medication errors. It involves entering medication
orders directly into a computer system rather than on paper
or verbally. The Institute for Safe Medication Practices
conducted a survey of 1,500 hospitals in 2001 and found
that about 3 percent of hospitals were using CPOE, and the
number is rising. Eugene Wiener, M.D., medical director
at the Children's Hospital of Pittsburgh, says, "There is
no misinterpretation of handwriting, decimal points, or
abbreviations. This puts everything in a digital world."
The Pittsburgh hospital unveiled its CPOE
system in October 2002. Developed by the hospital and the
Cerner Corporation in Kansas City, Mo., Children'sNet has
replaced most paper forms and prescription pads. Wiener
says that, unlike with adults, most drug orders for children
are generally based on weight. "The computer won't let you
put an order in if the child's weight isn't in the system,"
he says, "and if the weight changes, the computer notices."
The system also provides all kinds of information about
potential drug complications that the doctor might not have
thought about. "Doctors always have a choice in dealing
with the alerts," Wiener says. "They can choose to move
past an alert, but the alert makes them stop and think based
on the specific patient indications."