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It's time to think hard about the unthinkable: medical errors. But there are strategies that you can implement to reduce the risk of a harmful, even lethal, mistake.
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It's time to think hard about the unthinkable: Medical errors, a much publicized problem in recent years, are believed to be a common occurrence in the care of children. But there are strategies that you can implement to reduce the risk of a harmful, even lethal, mistake.
A discomforting truth is that you are likely to make mistakes during your medical career. More often than not, the consequences of medical errors are limitedmissteps that may slip by unnoticed. Nonetheless, the same circumstances that contribute to relatively minor incidents may also spur dreadful events.
A misplaced decimal point, for example, proved fatal for 2-month-old José Eric Martinez, who received 10 times the intended dosage of IV digoxin after being admitted to the hospital with congestive heart failure.1 A similar tragedy occurred when five times the recommended dose of imipramine suspension was accidentally administered to a 5-year-old boy to treat his enuresis.2 And tiny Cal Sheridan suffered severe, permanent neurologic damage when neonatal jaundice progressed unchecked to kernicterus.3 Nobody likes to contemplate the prospect of disaster, but experts are now dissecting medical mishaps, pondering ways to prevent them, and suggesting that you do the same.
The potential for error seems boundless. Consider the havoc that wrong or delayed diagnoses could cause, the outcomes that might follow incorrect use of tests, misinterpretation of results, or failure to act on available information.4 Treatment pitfalls include surgical or other procedural mistakes, errors in dosage or administration of drugs, unnecessary delays, and selection of an inappropriate therapeutic plan. Slip-ups also occur when opportunities for prophylaxis or patient follow-up are missed, when equipment does not perform as required, and when health-care professionals fail to communicate effectively with each other or the patient.
Not much is known about the epidemiology of medical errors in children, according to pediatrician Carol Lannon, MD, codirector of the Children's Primary Care Research Group at the University of North Carolina (UNC) at Chapel Hill and a member of the Committee on Quality Improvement at the American Academy of Pediatrics (AAP). "There really has been very little research done on this issue," Lannon points out.
In a recent study, researchers sifted through 10,778 orders written at two pediatric teaching hospitals.5 They found 616 medication errors55 mistakes for every 100 admissions. They uncovered 26 adverse drug events (ADEs) and 115 potential ADEs (10 for every 100 admissions). Of potential ADEs, 18 (16%) were deemed possibly life-threatening, 52 (45%) were judged serious, and 45 (39%) were considered significant.
"Potential ADEs were defined as medication errors that can cause harm but don't, either because they are intercepted before they reach the patient or because the error reaches a patient who is able to buffer possible negative effects," says lead investigator Rainu Kaushal, MD, MPH, an instructor in medicine at Harvard Medical School. "We compared the results of this study to a previous study in two adult hospitals with very similar methodology. While the medication error rate was the same in both settings, the rate of potential ADEs was three times higher among pediatric patients." A 1998 study of errors in dosage calculation at a tertiary care teaching hospital found that 69.5% of miscalculations occurred when prescribing for children.6
If data on hospitalized children are negligible, then information on office-based errors is virtually nonexistent, a situation researchers are planning to change.
"This research is particularly important, because it is estimated that approximately 70% of children's health care takes place in outpatient settings," says Lannon.
"There is absolutely no reason to think that medical errors are any less prevalent in children than in adults," says pediatric surgeon Lucian L. Leape, MD, adjunct professor of health policy at the Harvard School of Public Health. "Certainly, they might be more of a problem."
A major contributor to missteps is that medication dosages depend on the size of a growing child. "You have to calculate doses for individual patients, and that means an opportunity to make mistakes each time," Leape points out. Children, particularly infants, also have limited physiologic reserves compared with adults, so an error may be less likely to be neutralized by the body, Lannon adds.
Existing error-related statistics are largely derived from populations of hospitalized adults, and they suggest that medical mistakes are pervasive. Perhaps the most shocking estimate is that 44,000 to 98,000 people die in US hospitals each year as a result of medical errors, an approximation released late in 1999 when the Institute of Medicine (IOM) introduced its 2000 report, To Err is Human: Building a Safer Health System. As with children, research in ambulatory adults is limited, according to Leape, who serves on the IOM's Quality of Care in America Committee, the group that compiled the report.
"We've done a couple of studies, including one on prescribing that we will be reporting soon," Leape says. "We find that physicians make the same kinds of errors when writing prescriptions in their offices as they do in hospitals, which is not too surprising."
Undoubtedly, drug errors are a major source of trouble. Many of these are cataloged by the Food and Drug Administration's (FDA's) MedWatch reporting system and the Medication Error Reporting Program, a cooperative effort of the United States Pharmacopoeia (USP) and the Institute for Safe Medication Practices (ISMP). But here, too, children get lost in the numbers.
"You would expect errors and adverse events to be proportional to the use of drugs in [different] populations," says Bill Campbell, PhD, dean of the UNC School of Pharmacy and principal investigator for the UNCbased Centers for Education and Research on Therapeutics (CERT). "That isn't the case, because we know that childrenespecially those between 0 and 5 years of age and 6 and 10 yearshave very high rates of medication use, but there are almost no reports of adverse events or errors that pop up either in the FDA reporting or the USP program." CERTled focus groups disclose that pediatricians believe that errors occur but are not readily evident or reported.
According to the IOM report, more than 7,000 peopleinpatients and outpatients alikedie of medication errors annually. Outpatient deaths caused by medication errors rose 8.48-fold between 1983 and 1993; inpatient medication-related deaths more than doubled. In a landmark study of adverse events among more than 30,000 hospitalized patients, Leape and his colleagues found that injuries tied to medication, whether related to an error or an unpreventable reaction, represented 20% of all adverse events, forming the largest single category of detrimental occurrences.7 Yet, these were only a small part of the total picture, Leape says.
A fair amount of research has also been directed at what the IOM calls the overuse, underuse, and misuse of care, according to Charles J. Homer, MD, MPH, executive director of the National Initiative for Children's Health Care Quality and Chair of the AAP's Committee on Quality Improvement.
"There have been studies looking at specific surgical procedures, like ear tube placement, showing very high rates of inappropriate use, and studies of underuse of appropriate therapies, such as oral rehydration therapy," Homer says. "We overuse complicated antibiotics, and underuse first-line antibiotics." He also points to a recent study indicating that inadequate attention is given to pain control in children dying of cancer and that parents do not really understand when therapy is being administered for palliation, rather than cure.8
Like a rumble of long, low thunder after a first startling crash, reaction to the IOM report has been powerful and persistent. Findings provoked debate on Capitol Hill, fueling introduction of bills that were designed, at least in part, to ensure formation of medical error reporting systems.911 Then-President Bill Clinton announced new plans, supported by financing, for improving the situation. Organizations swept into the fray with further commentary, and some researchers stepped forward to refute the numbers. As might be expected, news stories used the report to fan consumers' worst fears.
An enduring campaign. While the public clamor was somewhat novel, interest in patient safety has been longstanding among all health professionals.
"Many of us in the field predated the IOM report," Homer says. "The Committee on Quality Improvement was established about 10 years ago at the AAP. For us, the report was a very positive call to arms in support of activities that we had already begun. Now, because of public interest, there is needed attention to an area that we've been committed to addressing, and recognition that it is an important issue for children as well as adults. Of course, there is always concern that the easy news stories are adversarial, and we don't think that's the helpful approach."
Other established public and private agencies devoted to safe medical care include the ISMP, the American Medical Association's National Patient Safety Foundation, and the federal government's Agency for Healthcare Research and Quality (AHRQ). All provide comprehensive information on their Web sites, which can be visited at the addresses listed on the right.
Additional efforts have been ongoing at seven CERTs, each charged with performing research and disseminating information that will promote optimal use of drugs, biologic products, and medical devices. Funded by the AHRQ and administered by both the AHRQ and the FDA, the CERTssix of which are at academic medical centersbegan as a demonstration project authorized by the FDA Modernization Act of 1997. Congress gave the go-ahead to permanent centers in its December 1999 Health Quality and Research Act. The UNC site is dedicated exclusively to pediatric research.
"Our work ranges from developing evidence-based guidelines for specific uses of drugs in children, to developing residency programs in pediatric pharmacology and investigating under-studied questions of clinical care," Campbell explains. For example, researchers from the UNC CERT discovered 30 cases of nutritional rickets among breastfed, African-American children at two North Carolina centers between 1990 and 1999an unexpected finding in a developed nation.
"We went back and did a bit of shoe-leather epidemiology and found, in fact, that vitamin D supplementation was not being recommended," Campbell says. This should be a routine practice because breast milk usually doesn't contain adequate vitamin D, particularly in women with darker skin, who convert vitamin D at a lower rate than their light-skinned counterparts.
The oversight tended to occur among younger pediatricians, possibly because they had no clinical exposure to an ailment thought to be of another era. Guidelines were developed, and the CERT began looking for ways to get the message to patients without turning them off to breastfeeding; counseling might be combined with a visual reminder to patients, such as a refrigerator magnet.
"Research has to be converted into practice for it to be useful," Campbell said. "This is a sensitive issue because, in the desire to encourage breastfeeding, one doesn't want to send a mixed messagethat breast milk is a perfect milk but it needs to be supplemented. There's some resistance among breastfeeding advocacy groups to crafting that message."
Still, the findings of the UNC CERT inspired North Carolina's public health department to make vitamin D available immediately and at no cost statewide to all breastfeeding women and their infants.
Homer predicts that the IOM report will probably galvanize support for efforts like these.
"One major recommendation that Congress did act on last session was to appropriate $50 million to fund a new Center for Patient Safety within the AHRQprobably the most important thing it could do," Leape says. "It is in operation now, convening panels to establish best safety practices; working on criteria for reporting programs; and launching requests for a wide range of research and development programs to improve patient safety. Researchers are doing some excellent work that will pay off in the next few years."
Scrapping the blame. The IOM report did not fault practitioners, instead citing the "decentralized and fragmented nature of the health-care delivery system" and stressing the need for a culture of safety. Embedded in IOM's recommendation that organizations take part in error-reporting programs was the opinion that this effort should be nonpunitive, so that everyone involved in care can concentrate on maintaining a safe environment rather than shielding themselves from rebuke.
This notion is essential because open discussion of mishaps can help prevent similar episodes, whether in a large hospital or a small private practice.
"When we're dealing with patients, there is such a desire to do the right thing, to be perfect," Lannon says, "that I think it's hard for us to talk about where there are gaps and where it didn't work. How can we engender a culture where we say 'Let's look at what happened so it won't happen again'?"
Rejuvenating the system. On March 1, 2000, the IOM's Quality of Care in America Committee released a follow-up report, Crossing the Quality Chasm: A New Health System for the 21st Century, that recommends a drastic overhaul of the entire health-care system. The goal of the much needed renovation is a system that is safe, effective, patient-centered, timely, efficient, and equitable. Among its broad new rules for redesigning and improving care is a mandate for safety as a system property.
"Some things are straightforward from a theoretical standpoint, but difficult to do in health care from a political standpoint," Leape notes. "For example, no other industry allows people to work more than 12 hours, and very few allow them to work more than eight. Yet routinely, residents are on duty for 24 to 30 hours. Similarly, ward nurses often have to work a double shift. There's something bizarre about a society in which it's illegal for an airline hostess to work more than eight hours, but it's okay for an intensive care nurse to work for 16."
Stuart Levine, PharmD, director of pharmacy at Alfred I. Du Pont Hospital for Children in Wilmington, Del., agrees. He distinguishes "active failures" from "latent failures."
"Latent failures are all those little minefields that we put in place when we construct a system," Levine says; an example is the penny-wise decision to hire a less experienced employee. "If someone steps on a mine, that's an active failure. You have all those places where things can break down."
"All good peoplebut a bad outcome," describes a particularly dramatic breakdown involving latent and active failures.
A specific target of the new IOM report is handwritten clinical data, which the committee says should be abolished within the next 10 years.
"We recommended that all orders be entered on computers rather than written out by hand on prescription pads," Leape says. "Very good evidence shows that this substantially reduces errors, but it requires a significant up-front investment. There's a movement to see if Congress will help subsidize that in one way or another."
In fact, a start has been made on this effort, although the activity is still a distance from the physician's office. On May 3 this year, Senators Bob Graham (D-Fla.) and Olympia J. Snowe (R-Maine) introduced a bill asking Congress to establish an informatics grant program for hospitals and skilled nursing facilities to help cover such endeavors.12
The technology to computerize medical orders is also finding its way into physicians' offices. Hand-held devices are helpful for prescribing medication, but a desktop model would probably be needed for more complicated checks and reminders, says Harvard's Kaushal, who is studying the effect these instruments have on safety. Computerized order entry circumvents illegibility, ensures that all fields are complete before the order can be accepted, and forces all orders to be written in a standardized way, she adds. Clinical decision support is available, too, with the most sophisticated products offering features such as suggestions based on best medical practices or the cost of drugs.
Your practice can benefit from lessons learned in larger health-care settings. In particular:
Adopt a team approach to patient safety by defining the responsibilities of each employee. Frank communication among staff members is essential.
"Nurses or medical assistants might be reluctant to challenge the judgment or authority of the physician when a decision is made," Dr. Homer says. "The staff needs to be trained to speak up in a way that's clear. Similarly, physicians need to be trained to be able to hear what they say."
Keep close tabs on your office system. Levine recommends regularly scheduled staff meetings at which mistakes, along with preventive strategies, can be discussed. You can also take cases from the literature, talk about them, and consider ways that your team can avoid a similar circumstance.
Maintain a blame-free environment. If job evaluations or salary increases are tied to errors, you can be sure you won't hear about them.
"The normal response of those who feel threatened by discovery of an error is, 'Nothing really happened so we'll forget about it,'" Levine says. "Maybe you were lucky that time; next time you might not be."
Remember that errors need not be gross to expose patients to potential harm. Not prescribing inhaled steroids for the child with persistent asthma or using a suboptimal dosage can lead to more frequent attacks. Or vaccinations may be given at too young an age or too close together, or may be missed entirely.
Sometimes an immunization is withheld because a child has a minor illnesseven though it is perfectly acceptable to administer it under such circumstances, Dr. Homer notes. Then, when no follow-up visit is scheduled, he points out, what results is the perfect example of a system failure.
"By the time kids hit the fifth grade, they all tend to be appropriately immunized," he says, "but in 1- to 2-year-olds, only 60% to 70% have received the indicated injections."
Write a safer prescription. Much emphasis is on medication errors because these are perhaps the easiest to identify and prevent. A rule to remember: The greatest potential for adverse events is found in the youngest patients; newborns are least able to withstand mistakes. Make sure your prescriptions are legible, complete, and unambiguous, Levine says. For example, pediatricians often order ophthalmic drops for treating ear infections; if that is the case, write your intention on the script and explain to the patient or parent what you're doing, as well.
"Sometimes patients are too good at doing what they think needs to be done," Levine adds. "They may think they are supposed to put the drops in their eye even though they know the problem is in their ear."
Include the patient's age, weight, and the mg/kg dose on the prescription when appropriate, particularly when ordering a drug that has a narrow therapeutic index. That way, the pharmacist can quickly recheck your calculation of the dosage. Consider the 12-month-old seen in the emergency department for a gastrointestinal virus who incurred permanent anoxic brain injury after receiving two 2.5-fold overdoses of belladonna alkaloids with phenobarbital elixir plus two doses of a 12.5-mg promethazine suppository, which is contraindicated in children younger than 2 years.2
For that matter, make sure you know what the patient weighs at the time you are prescribingnot only when writing a new prescription but when refilling over the telephone. If you have not seen a child in, say, three, four, or six months, he (or she) may have grown enough to warrant a new dosage.
"A common cause of patients coming into the ED is fever unrelieved by acetaminophen," Levine says. "The reason is that nobody has adjusted the dosage in several months. The same thing happens with patients who have seizures or asthma." Just three weeks is sufficient to encompass a growth spurt in infants. When the prescribed drug has a wide therapeutic index and is dosed on a per-kilogram basis, weight can be estimated within 10% of the patient's true weight without greatly influencing the final dosage.
Another common error is to use a mg/kg dosage in a child who weighs more than 40 kg. At that point, it is time to consider an adult dosage. Always give your calculations a second look. If your weight-based dosage surpasses that given to an adult, check your numbers and the recommended dosage again. Remember that, with some drugs (notably, phenytoin), children require a higher dosage than adults do.
Take care with dosages that are specified as a total daily dosage to be divided over a day. Levine notes that directives such as "mg/kg/d divided q 6" have resulted in a daily dosage being divided by six, and then smaller than intended doses are administered four times a day.
Specify which strength and formulation of a drug you want if more than one is available. Caution is warranted, for example, when writing a prescription for different compounds of iron, magnesium, or calcium, Levine says. These agents are available as a salt (calcium gluconate, for example) or an elemental product, and dosages are not interchangeable: 400 mg of calcium gluconate is not equivalent to 400 mg of elemental calcium.
Likewise, if you are converting a patient from a parenteral product to an oral formulation, make sure the dosages are comparable. Write out the precise size of each dose. For example, instead of "take 12 teaspoonful twice a day" write "take 2.5 mL twice a day." Remind parents to use a dosing tool instead of household spoons, which are notoriously inaccurate.
Never use "as directed" as an instruction, even when you've told the patient or parent how to take the medication. Clear directions should be on the package. The more information you include, the more likely it is that the patient gets what you wanted.
Do not use Latin abbreviations, which can contribute to errors. Consider that the abbreviation "OD" can be interpreted as "daily," "right eye," or, depending on how it is written, "qid." "QOD," or "every other day," is also dangerous and should never be used. The abbreviation "U" (for "units") can be mistaken for "4" or "0." Similarly, symbols for "more than" (">") and "less than" ("<") should not be used because they are easily misinterpreted.
Never place a decimal point and a zero after a whole number, because the decimal point can get lost on a line or otherwise overlooked, causing the patient to receive 10 times the intended dosage. On the other hand, if you are ordering a dosage that involves a fraction, such as 0.125 mg, do include a leading zero in front of the decimal point; in one case, a newborn died when a pharmacist misread an order for ".5 mg" of morphine as "5 mg."13
Don't play telephone. The principles involved in a written prescription hold true for a verbal order. If anything, the chance of an error increases when a drug is ordered by telephone, particularly as it gets transmitted from person to person. Minimize the number of people between you and the pharmacist.
When asking a member of the office staff to call a prescription into a pharmacy, ask the employee to repeat the order back to you to make certain that you were heard correctly. Better yet, write the order down so that it cannot be misremembered by the time the employee gets to the phone. The ISMP reports that a 5-month-old experienced uncontrollable shaking and a pulse that ranged from 140 to 200 after an office nurse ordered 1.5 teaspoonsful of albuterol syrup, 2 mg/mL, three times a day rather than the desired 0.5 teaspoonsful three times a day.2 The child recovered completely.
Sound-alike names pose a particularly serious problem over the phone. Frequent mix-ups occur with Zantac (ranitidine) syrup and Zyrtec (cetirizine) syrup, especially among children 7 to 15 months old, according to the ISMP.14 Other examples of sound-alike drugs include:
Set limits. Restrict the number of drugs you prescribe so that you are familiar with all the medications you use, Levine suggests. Consider putting together a formulary, adding new drugs only after you have had time to get good information about them.
"Many times you find errors when people bring nonformulary medications to a hospital," he says, "and I think the same thing applies to a practice when physicians start using drugs they are not familiar with."
In the same way, consider what procedures you are comfortable doing in your office. Some pediatricians administer IV fluids or chemotherapy and others do not, Levine says. If you do these things on rare occasions, consider not doing them at all. If staff members have little practical experience with a procedure, they are more likely to make mistakes.
Limit the kinds of samples that come into the office. Arrange what you do have so that products of different strengths are not confused. If offering samples to patients, write down instructions and provide only enough of the medication for a day or two. You can then write a prescription if it appears to be working well.
Be sure that your telephone triage system is in order, Homer advises, noting that this system can be shaped into a routine. "This is another area where people have begun to use computer-driven algorithms and trained personnel," he says. "For example, over the last five or 10 years, there's been an evolution toward use of trained nurse triage, especially on night call. It's not a field that I am close to, but my understanding is that a number of malpractice [insurers] have lowered their premiums for doctors who use formal triage services because they find a reduction in errors, more consistency in judgment, and improved documentation of what happens."
Involve families in care. Teach parents to be smart advocates for their children, Leape says. Older children should be encouraged to do the same for themselves. (See the Guide for Parents, "Tips on how you can help prevent medical errors".) Be sure that parents understand what is wrong with their child, what treatment is planned, and what part they are supposed to play in the care plan. Advise them of the risks and benefits of a therapeutic plan so they can make an informed decision. Invite questions and write down the regimen you want parents to follow for their childit's often difficult for them to remember all they've been told in an office visit.
"The decision for all treatments should rest with the patient [or parents]," Leape says. "It can only be a good decision if they really understand everything." Certainly patients [or parents] should know why they are taking every medicine they take, what it's called, what it looks like, and the dose."
Encourage parents and, when appropriate, patients to seek more information as they consider treatment for a chronic condition. Provide written materials or guide them to reliable Web sites.
"Any one doctor, nurse, or patient can make a mistake, but the more people who know how it's supposed to be, the less likely it is for an error to go undetected," Leape says. "Patients can be their own last line of defense." The same is true of their parents.
Take advantage of resources. Of course, try to keep abreast of the latest developments in areas where you often provide treatment. Sources of continuing medical education are burgeoning. Make sure you have current reference books in your office. Don't hesitate to ask colleagues for advice, whether they are physicians or other health professionalssuch as the community pharmacist, who can be helpful and is easily accessible. Remember that their knowledge and experience supports your own.
Instead of relying on memory, use preprinted forms and agreed-upon methods of documentation, Homer suggests. "If travel agents acted like a physician, you would ask for airline tickets and they would say 'Let me see if I can remember when those flights are'," he says. "Use automation or written documentation whenever possible."
"If the half-life of medical knowledge is less than two years, it's impossible for any one person to carry all the necessary knowledge and experience they need," says Julie Morath, chief operating officer of Children's Hospitals and Clinics of Minneapolis and St. Paul. "The interesting thing about this work is, the more you do, the more you see there is to do, so it's never really done. Just when you figure out how to address today's issues, new technology or new pharmaceutical agents are introduced, new knowledge becomes available, and other risks and variables are set in motion."
1. American Academy of Pediatrics: Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. Available at: http://www.aap.org/advocacy/washing/patientsafety.htm . Accessed April 15, 2001
2. Institute for Safe Medication Practices: Oral liquid medications may be more vulnerable to errors than previously recognized. ISMP Medication Safety Alert [Institute for Safe Medication Practices Web site]. June 28, 2000. Available at: http://www.smp.org/MSAarticles/OralLiquids.html . Accessed May 2, 2001
3. Testimony by Susan E. Sheridan, Panel 1: Consumers and Purchasers. Written Statement. Quality Interagency Coordination Task Force. National Summit on Medical Errors and Patient Safety Research. September 11, 2000. Available at: http://www.quic.gov/summit/wsheridan.htm . Accessed May 1, 2001
4. Leape LL, Lawthers AG, Brennan TA, et al: Preventing medical injury. QRB Qual Rev Bull 1993;19:144
5. Kaushal R, Bates DW, Landrigan C, et al: Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114
6. Lesar TS: Errors in the use of medication dosage equations. Arch Pediatr Adolesc Med 1998;152:340
7. Leape LL, Brennan TA, Laird N, et al: The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324:377
8. Wolfe J, Grier HE, Klar N, et al: Symptoms and suffering at the end of life in children with cancer. N Engl J Med 2000;342:326
9. US Senate: Medical Error Reduction Act of 2000. 106th Congress, 2nd session, S2038. February 8, 2000. Available at: http://thomas.loc.gov. Accessed May 12, 2001
10. US Senate: Voluntary Error Reduction and Improvement in Patient Safety Act. 106th Congress, 2nd session, S2743. June 15, 2000. Available at: http:// thomas.loc.gov. Accessed May 12, 2001.
11. US Senate: Patient Safety and Errors Reduction Act. 106th Congress, 2nd session, S2738. June 15, 2000. Available at: http://thomas.loc.gov. Accessed May 12, 2001
12. US Senate: Medication Errors Reduction Act of 2001. 107th Congress, 1st session, S824. May 2, 2001. Available at: http://thomas.loc.gov. Accessed May 10, 2001
13. Institute for Safe Medication Practices: ISMP Medication Safety Alert [Institute for Safe Medication Practices Web site]. November 15, 2000. Available at: http://www.ismp.org/MSAarticles/Calendar/Nov00.htm . Accessed May 2, 2001
14. Institute for Safe Medication Practices: ISMP Medication Safety Alert [Institute for Safe Medication Practices Web site]. November 1, 2000. Available at: http://www.ismp.org/MSAarticles/Zantac-Zyrtec.html . Accessed May 8, 2001
Physicians and medical staff aren't the only ones on the front lines of combating medical error: There is much to recommend to the parents of your patients for their consideration and action. See the "Guide for Parents", which contains many recommendations for parents and patients and which you can photocopy for them.
Agency for Healthcare Research and Quality
American Academy of Pediatrics
Food and Drug Administration
Institute for Healthcare Improvement
Institute of Medicine reports
Institute for Safe Medication Practices
National Coordinating Council for Medication Error Reporting and Prevention www.nccmerp.org
National Initiative for Children's Healthcare Quality
National Patient Safety Foundation
Pediatric Pharmacy Advocacy Group, Inc.
Testimony of the first National Summit on Medical Errors and Patient Safety Research Quality Interagency Coordination Task Force
United States Pharmacopeia
Sometimes the health-care system fails in a staggering way. That was the case at a Denver hospital in October 1996, when a newborn infant died after receiving an IV injection of penicillin G benzathine, an insoluble suspension meant strictly for IM use. As a result, three nurses involved with the case were charged with criminally negligent homicide. In detailing the case, however, members of the Institute for Safe Medication Practices, who donated time to help defend the nurses, discovered a blueprint for disaster. More than 50 different failures contributed to the tragedy, offering "clear evidence that medication errors are almost never caused by the failure of a single element in the system or the fault of a single practitioner."1
"If things don't seem right, you need to question it," says Stuart Levine, PharmD, Director of Pharmacy at Alfred I. DuPont Hospital for Children in Wilmington, Delaware, who uses the catastrophic example when talking to pediatricians about medication errors. "It involved the prescriber, the pharmacist, the nursesif anybody had said 'this doesn't make sense' and checked, it might have been prevented."
Essentially, it was thought the baby might have congenital syphilis, because the mother had a history of the disease. Nobody at the hospital was sure whether she had been treated, so it was decided to treat the child as a precaution. Here are just a few of the contributing snares:
The parents did not speak English, making it difficult to determine the mother's treatment history. Laboratory tests performed during the pregnancy by the primary obstetrician indicated she was disease free, but the baby's physicians did not have this information.
The hospital staff was unfamiliar with the treatment of congenital syphilis.
After discussing treatment with an infectious disease specialist, the neonatologist did not document the recommendation until after the baby died. At the same time, a nurse practitioner seeking advice from the health department recorded incomplete informationpenicillin G 50,000 units/kg rather than penicillin G benzathine 50,000 units/kg. No route of administration was documented.
The pharmacist, also unfamiliar with treatment for congenital syphilis, checked the health department's recommendation, as well as a reference book. However, she misread the order for "Benzathine penicillin G 150,000 U IM" and prepared a 10-fold overdose. It is believed she may have mistaken the abbreviation "U" for an extra zero. Capitalization of benzathine also suggested a brand name to those unfamiliar with the drug. This conclusion was enhanced by the fact that "Benzathine" was written on the line above "penicillin G." Further, it appeared that IM had been written over IV.
Two pre-filled syringes were sent to the floor with directions to administer 2.5 mL IM; the pharmacist did not know that no more than 0.5 mL per IM injection could be administered to an infant.
Concerned that the baby would require five separate injections, a painful experience, the nurses investigated the possibility of administering the drug IV. The nurse's reference did not mention penicillin G benzathineonly aqueous crystalline penicillin G and penicillin G procaine. Assuming Benzathine was a brand name, they believed aqueous crystalline penicillin G and penicillin G benzathine were the same thing.
The infant became unresponsive after receiving 1.8 mL of the preparation and could not be revived.
"People don't go out of their way to do things to hurt patients," Levine says. "These are all good people trying to do good things. You have all those latent failures out thereall those places where things can break downand then you have people who fall into those weaknesses and end up being involved in the active failure, the error itself."
1. Smetzer JL, Cohen MR: Lesson from the Denver medication error/criminal negligence case: Look beyond blaming individuals. Hospital Pharmacy 1998;33:640
The parent guide on how to prevent medical errors may be photocopied and distributed to families in your practice without permission of the publisher.
Government agencies, purchasers of group health care, pediatricians, and other health-care providers are working together to make the health-care system in the United States safer for patients and the public. As parents of a child who requires the attention of the pediatrician or other provider from time to time, and as patients yourselves, you can support and boost this nationwide effort at making medical care more reliably safe. This Parent Guide tells what you can do.
First, though, what are medical errors? They happen when something that was planned as part of medical care doesn't work out, or when the wrong plan was used. Medical errors can occur anywhere in the health-care systemthe hospital, doctor's office, pharmacy, even your home. Errors can involve medicines, surgery, and lab reports, to name a few situations. They can happen during the most routine tasks.
Most errors result from problems created by today's complex health-care system. But errors also happen when doctors and their patients, or their patients' parents, have problems communicating. A recent study found that doctors often do not do enough to help patients make informed decisions. Uninvolved and uninformed parents are less likely to accept the doctor's choice of treatment and less likely to do what they need to do to make the treatment work.
Here are a number of ways to make a difference. Even though the emphasis here is on your child's safety and health, these steps extend to what you can do in your own medical care:
The single most important way you can help prevent errors? Be an active member of your child's health-care team. Take part in every decision about his (or her) health care. Some specific tips, based on the latest scientific evidence about what works best, follow.
Make sure the pediatrician knows about everything your child is taking: prescription and over-the-counter medicines, and dietary supplements such as vitamins and herbs. At least once a year, bring all of your child's medicines and supplements with you to the doctor's office. "Brown bagging" medicines can help you and the doctor talk about them and find out if there are any problems. It can also help the doctor keep your child's records up to date, which can help him get better quality care.
Make sure the pediatrician knows about any allergies and adverse reactions to medicines your child has had.
When the pediatrician writes a prescription for your child, make sure you can read it; if you can't, the pharmacist might not be able to either.
Ask for information about your child's medicines in terms you understandwhen the medicine is prescribed and again when you receive it. For example: What is the medicine for? How is my child supposed to take it, and for how long? What side effects are likely? What do I do if they occur? Is the medicine safe to take with other medicines or dietary supplements that my child is taking? What food, drink, or activities should my child avoid while taking this medicine?
When you pick up the medicine at the pharmacy, ask: Is this the medicine that the pediatrician prescribed?
If you have any questions about directions on medicine labels, ask. Labels can be hard to understand; for example, does "four doses daily" means your child is supposed to take a dose every 6 hours around the clock, or just during regular waking hours?
Ask the pharmacist for the best device to measure liquid medicines. Also, ask questions if you're not sure how to use that best device. Many people use household teaspoons to measure medicines, for example, but these often don't hold a true teaspoon of liquid.
If you have a choice, choose a hospital for your child at which many patients have had the procedure or surgery he needs. Patients tend to have better results when they are treated in a hospital that has a great deal of experience with their condition.
When your child is in the hospital and you are present, consider asking all health-care workers who have direct contact with him whether they have washed their hands. This is not always practical, of course, because you are not likely to be at your child's side at all times. But it is worth working at because, even though hand washing is an important way to prevent the spread of infection, it is not done regularly or thoroughly enough.
When your child is being discharged from the hospital, ask the pediatrician or other responsible doctor to explain the treatment plan that you will provide for your child at homeincluding learning about medicines and finding out when your child can get back to your regular activities.
Speak upin the office or at the hospitalfor your child if you have questions or concerns.
Be sure that someone, such as your child's pediatrician, is clearly in charge of his care.
Make sure that all the health professionals involved in your child's care have important health information about him. Don't assume that everyone knows everything they need to know.
If you have any doubts about your ability to be an advocate for your ill child, especially when he is in the hospital (or, in stressful times, even if you don't have any doubts), ask a family member or friend to be there with you to help you be that advocate.
Keep in mind that "more" is not always better. It's a good idea to find out why a test or treatment is needed and how it can help your child. He could be as well off or better off without it.
If your child has had a test, don't assume that no news is good news: Ask what the results show.
Learn about your child's condition and treatments by asking the pediatrician and nurses and by using other reliable sources. For example, treatment recommendations based on the latest scientific evidence are available from the National Guidelines Clearinghouse at www.guideline.gov . Ask the pediatrician if the treatment proposed is based on the latest evidence.
A report issued by the federal government on medical errors (Publication No. OM 00-0004) is available on the World Wide Web at www.quic.gov/report/ or from the Agency for Healthcare Research and Quality (AHRQ) Publications Clearinghouse: phone, 800-358-9295 (outside the United States, please call 410-381-3150) or e-mail, firstname.lastname@example.org.
This Guide for Parents may be photocopied and distributed without permission to give to parents of your patients. It is adapted here from the AHRQ's "20 Tips to Help Prevent Medical Errors. Patient Fact Sheet" (AHRQ Publication No. 00-PO38, February 2000, AHRQ, Rockville, Md.) and available at http://www.ahrq.gov/consumer/20tips.htm .
Cynthia Starr. Protecting your patients from medical errors. Contemporary Pediatrics 2001;11:86.