- Michael S. Leonard, MD, MS*
- *Chief Quality & Safety Officer for Children's Services, Associate Professor of Pediatrics, University of Rochester Medical Center, Rochester, NY.
Dr Leonard has disclosed no financial relationships relevant to this article. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
After completing this article, readers should be able to:
Define terms commonly used in patient safety discourse.
Describe the scope of medical errors and adverse events, focusing on medication-related issues.
Identify barriers to improving patient safety.
Address disclosure of medical errors and adverse events.
Review principles and practices that can reduce the risk of harm to patients.
This is the first in a series of articles to review the topics of patient safety and quality improvement in pediatrics.
Patient safety is a subject that traverses all medical specialties and affects every health-care professional. The attention to medical errors and adverse events as well as the resultant literature has grown exponentially over the past decade. A number of practicing physicians, however, remain unaware of the extent of the problem, the impact on patients, and the burden on the health-care system. Many also are unfamiliar with strategies to reduce the risk of harm.
It is important to note that definitions used in patient safety can vary across studies, between organizations, and over time. A medical error, as defined by the Institute of Medicine (IOM), is “the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim.” (1)(2) It is a mistake in action or judgment. A medical error must be distinguished from an adverse event, which is “an injury caused by medical management rather than by the underlying disease or condition of the patient.” An adverse event results in harm to the patient. Not all medical errors lead to adverse events. In fact, most do not.
A medication error is the most common type of medical error (3)(4) and can occur at any point in the medication management process. (5) This chain of events includes ordering, transcribing, preparing, delivering, and administering a drug. Medication errors can be classified as errors of commission or omission. (6) An error of commission occurs when an incorrect action is taken, such as prescribing ceftriaxone for a neonate who has hyperbilirubinemia. An error of omission results when a correct action is not taken, such as not premedicating a patient who has a history of red man syndrome with an antihistamine before administering vancomycin.
An adverse drug event (ADE) is an injury due to a medication. ADEs are the most common type of adverse events. Fortunately, less than 1% of medication errors result in an ADE. (5) A preventable ADE is an ADE that, based on the medical information known at the time, could have been avoided, such as a patient who has a known allergy to macrolides being prescribed azithromycin and developing urticaria. This occurrence is in contrast to a nonpreventable ADE, which could not have been foreseen based on the medical information known at the time. For example, a patient who has no known allergies is given azithromycin and develops urticaria. An adverse drug reaction is synonymous with a nonpreventable ADE. It is an event defined by the World Health Organization as “noxious and unintended, and which occurs at doses used in man for prophylaxis, diagnosis or therapy.” (7)(8)
A potential ADE is a medication error that places a patient at significant risk of injury but does not actually result in harm. (7) Potential ADEs often are referred to as “near misses.” There are two subtypes of potential ADEs: intercepted and nonintercepted. An intercepted ADE is an error that is identified and corrected before it reaches the patient. For example, a patient is prescribed an overdose of ranitidine that is detected by a pharmacist, who does not dispense the drug, but instead refers the prescription back to the prescriber for correction. A nonintercepted ADE is an error that reaches the patient but, by pure happenstance, does not cause harm to the patient. For example, a patient is prescribed and given an overdose of ranitidine without suffering any ill effects. The Figure shows the relationship among medication errors, ADEs, and harm.
A sentinel event is “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.” (9) An ADE or a potential ADE may qualify as a sentinel event. Not all sentinel events are the result of a medical error. A never event, as described by the National Quality Forum, is one of 28 events resulting from an error in medical care that is serious, unambiguous, and usually preventable. (10) Never events, which also are referred to as serious adverse events, serious reportable events, and serious reportable adverse events, never should occur within a health-care institution and generally signal a system safety failure.
Patient safety has become a national health-care focus over the past 10 years, but medical errors and adverse events have been addressed for a far longer time. The investigators for the Harvard Medical Practice Study reviewed more than 30,000 records from patients discharged in 1984 from 51 hospitals across the state of New York. (11) Adverse events occurred in 3.7% of these hospitalizations, most of which were preventable. (12) If generalized to all hospitals in the United States, this incidence translates to more than 1 million people experiencing an adverse event and approximately 180,000 patients dying from an adverse event every year. (7) Medication-related incidents were the most common type of adverse event, at a rate of 0.7 ADEs per 100 admissions. (5)(12)
A study of nearly 15,000 discharges across 28 hospitals in Utah and Colorado in 1992 identified 459 adverse events. (13) Fifty-eight percent of these adverse events were found to be preventable. In a study of more than 4,000 admissions at two large Boston hospitals over a 6-month period in 1993, investigators identified 247 ADEs. (14) This translates to 6.5 ADEs per 100 admissions, a rate greater than nine times that found in the Harvard study. Twenty-eight percent of the ADEs were considered preventable. These investigators also identified 194 potential ADEs, of which 43% were intercepted before they reached the patient.
The IOM released its landmark report To Err is Human at the end of 1999, heralding a new age for the field of patient safety. (1) Extrapolating the results of the Utah-Colorado study and the Harvard study over the 33.6 million admissions to United States hospitals in 1997, the report estimated that 44,000 to 98,000 patients die from medical errors annually. The IOM issued recommendations in four strategic areas to improve patient safety: leadership and knowledge, identifying and learning from errors, setting performance standards and expectations for safety, and implementing safety systems in health-care organizations.
The financial impact of medical errors and adverse events is enormous. Based on the IOM report, the estimated cost of medical errors in the United States is $37.6 billion annually. Preventable adverse events comprise an estimated $17 to $29 billion, more than 50% of which represent direct costs to the health-care system. (1)(2) An ADE extends the length of hospital stay by 1.74 to 2.2 days and increases costs by $2,000 to $3,200. A preventable ADE extends the hospital stay by 4.6 days and increases costs by $5,800. (14)(15)(16) These figures represent dollar values from the 1990s; current estimates are likely even higher.
The financial burden of adverse events is shifting toward health-care institutions. Medicare no longer reimburses the cost of treatment for some events occurring during a hospital admission, and many state Medicaid agencies are considering similar financial disincentives. Private third-party payers may begin pursuing similar practices.
The prevalence of medical errors and adverse events in children is becoming clearer. Investigators analyzed a subset of data from the Utah-Colorado study representing more than 3,700 pediatric hospitalizations, including birth admissions. (17) They found that adverse events occurred in 1% of these hospitalizations, 60% of which were deemed preventable. Extrapolated to the entire United States population, approximately 70,000 hospitalized children experience an adverse event each year, of which 42,000 could be avoided.
Children have been recognized as a high-risk population for medication errors and ADEs. The risk for an ADE is estimated to be three times higher in hospitalized children than in adults. (4)(18) In a prospective study of medication orders in a children's hospital, 23.7% contained errors. (19) In a study of more than 10,000 medication orders representing 1,120 patients across two children's hospitals, the investigators found 5.7% of the orders contained errors, with 1.1% representing potential ADEs. (18) They identified 2.3 ADEs per 100 admissions, 19% of which were preventable. In a more recent study across 12 children's hospitals, investigators reported a rate of 11.1 ADEs per 100 patients, 15.7 ADEs per 1,000 patient-days, and 1.23 ADEs per 1,000 medication doses. (20) Rising ADE rates actually may reflect an improved ability to detect such events over time rather than a true increase in incidence.
For many reasons, children are more vulnerable to medication errors and ADEs. Unlike adults, for whom dosing tends to be a single or limited number of options, dosing for children usually is tailored to the patient based on his or her weight. Proper dosing requires that the prescriber have an accurate weight for the child as well as the proficiency to perform weight-based calculations. Many settings in which children are treated are predominantly adult-oriented, with pediatric patients comprising only a small fraction of admissions. In such venues, staff may not always be trained in safe pediatric medication practices, and if they are, their skills may wane due to the infrequency of providing care to these young patients. Most drugs are packaged commercially for adult use. Such preparations require compounding for pediatric usage, a task that requires a specific skill set. The need for this additional step in the medication delivery process introduces risk of error and, therefore, risk of harm. (4)
Children who experience extended lengths of stay, complex medication regimens, and higher severity of illness are at increased risk of ADEs. (21) Neonates and young infants are at even greater risk due to their immature hepatic, renal, and immune systems. (4)(22) In settings such as the neonatal intensive care unit, where lengths of stays often are measured in months, patients can have significant changes in weight over the course of a hospitalization. This change requires vigilance to assure that medication dosing regimens remain within safe and therapeutic ranges.
Medication errors and ADEs occur in the community as well, although this venue has been less researched. (6)(23) In a prospective study across six outpatient offices, 14% of pediatric patients experienced an ADE. (24) Twenty-three percent of these events were judged to be preventable. Again, complex medication regimens increased the likelihood of preventable ADEs. Of note, parents whose English proficiency was limited were less likely to report an ADE, which may represent a subpopulation of children at even greater risk of harm.
Not all outpatient errors and preventable adverse events are iatrogenic; they also can be caused by well-meaning parents and nonmedical caregivers. Many over-the-counter children's medications are available in a variety of preparations and concentrations, which can contribute to confusion and subsequent dosing errors. Outpatient medication errors and ADEs are not limited to oral drugs. For example, in 2007, a 17-year-old athlete died of salicylate toxicity from excessive use of over-the-counter topical sports ointments. (25) A tragic event such as this underscores the need for pediatricians to take every opportunity to stress to patients and families the importance of using medications only as instructed and the potential hazards of using seemingly benign drugs inappropriately.
Detection of Medical Errors and Adverse Events
Difficulty in identifying medical errors and adverse events creates a significant barrier to assessing risk reduction strategies. Although the data presented in this article are staggering, they are likely to represent considerable underestimates. In the absence of an accurate, reliable methodology to measure errors and events, the ability to assess the impact of patient safety initiatives remains challenging.
Historically, identification of medical errors and adverse events relied on incident reports, a methodology that has many pitfalls. The reporting of incidents presumes that an individual recognizes a medical error or an adverse event when it occurs. If an error or adverse event is identified, staff may assume, mistakenly, that someone else will report it. Incident report forms generally require a large amount of information, which makes them both time-consuming and cumbersome to complete. Personnel who do take the time to report events often receive no feedback. They may not see their efforts resulting in noticeable improvement, which can act as a disincentive for reporting subsequent events. (26)
Staff may have valid apprehensions about reporting errors and adverse events. (27) There is a natural hesitancy to point out one's own mistakes for fear of being labeled incompetent and a reluctance to point out others’ mistakes for fear of being labeled a whistleblower. Although institutions across the country are transitioning to a culture of blameless reporting, staff still may worry about discipline by their institutions or licensing organizations. Fear of litigation also remains a major deterrent.
Chart reviews in search of medical errors and adverse events are time- and labor-intensive. The cost often is prohibitive, and generally only a sampling of records can be evaluated. Trigger methodology can streamline the process and help capture occurrences that otherwise might go undetected. A trigger is an action or indicator that might signal the presence of an adverse event. For example, flumazenil usually is prescribed in response to a benzodiazepine-related ADE. An order for flumazenil, therefore, can serve as a trigger. Groups of triggers have been combined into trigger tools to increase the ability to identify actual and potential ADEs. (28) The resultant focused chart reviews save time and resources by improving efficiency. Trigger methodology has been applied in children's hospitals and has been shown to increase detection of ADEs. (20)
The general public is becoming increasingly aware of issues of patient safety. A study reviewing newspaper articles over a 10-year period found increasing coverage of pediatric medication safety. (29) The United States had the highest absolute number of articles of the five countries included in the study. Nearly two thirds of the articles covered specific adverse events. The good news is that three quarters of the articles were written in a tone characterized as neutral, a positive step as health care transitions from a culture of individual blame to one of system-based improvement.
Patients and families often know when they have experienced an adverse event. They may observe worsening of clinical status, the need to perform additional testing, or adjustments made to treatments. They may perceive a change in the behavior of the physician or other staff. They may overhear conversations between staff members. Patients and families want to be told when an error has occurred. They want to know what happened, why it happened, how it will affect their health, and what is being done to prevent such an error from recurring. (30)
Informing patients and families when medical errors cause harm is the right thing to do, but despite physicians’ best intentions, full disclosure of such events is uncommon. Practitioners often fear that such disclosure may result in litigation, loss of trust by the patient and family, or tarnishing of their professional reputation. Health-care professionals must overcome the instinct to ignore, hide, or worst of all, deny when an adverse event occurs. Disclosure relieves the anxiety of not knowing and reaffirms an open, honest physician-patient-family relationship. Such transparency has been demonstrated to decrease litigation as well as the average settlement amount for claims that are filed. (30)(31)(32)
Patients and families also want an apology. An apology historically has been viewed as an admission of guilt, and for this reason, practitioners often ignore their instincts to say “I’m sorry.” However, this omission is perceived as cold, heartless, and impersonal by patients and families. They correctly feel angry and distanced, which is toxic to the physician-patient-family relationship and actually may increase the likelihood of litigation. The importance of an apology and the reluctance by physicians to provide one due to fear of litigation has resulted in legislative changes. As of January 2008, 35 states have enacted statutes that prevent an apology from being used against a physician in a law suit. (30) Other states have similar legislation in progress. The impact, effectiveness, and protection afforded by these recent statutes have yet to be established. Policies vary across organizations, and legislation varies among states. Health-care professionals should consult risk management experts or legal counsel for guidance with disclosure of adverse events and saying “I’m sorry.”
Although patients are the primary and most visible victims of medical errors and adverse events, it is important to remember the “second victims”: the clinicians. (33) The emotional impact of medical errors on health-care personnel, especially those errors that cause harm to patients, should not be underestimated. In many cases, more than one clinician is involved and may feel responsible. Resultant feelings of guilt, anxiety, or incompetence can be devastating, leading to inappropriate behaviors such as lashing out at patients, families, and colleagues and to unhealthy behaviors such as substance abuse. Health-care professionals must be supportive and nonjudgmental of their colleagues when medical errors occur. Debriefing sessions can provide a therapeutic venue to discuss not only the medical aspects of the event, but also the emotional issues as they relate to the clinicians involved.
Patient safety initiatives can be framed within a public health model of prevention. (27) The disease we are trying to eradicate is medical errors, and specifically for this discussion, medication errors. It is logical for physicians’ efforts to focus on prescribing, the step in the medication management process at which errors most commonly occur. (7)(18)(34)
The goal of primary prevention is to reduce the incidence or risk of disease. For example, the purpose of the influenza vaccine is to prevent or decrease the likelihood that a patient will become ill from the virus. For medication errors, there is no vaccine, but our armamentarium for preventing errors includes a host of strategies. The following is a list of simple practices that can be employed by prescribers in any setting to help prevent errors and adverse drug events (Table):
Obtain a list of your patient's current medications. This is part of a process termed medication reconciliation, one of the National Patient Safety Goals. It helps to prevent inadvertent drug interactions and ensure that patients receive the intended therapy. (35) Include all prescription drugs, over-the-counter medications, vitamins, and supplements.
Obtain an accurate list of allergies and adverse reactions. Include all drugs, foods, and relevant substances. Document the specific symptom(s) the patient experiences when he or she is exposed.
Print legibly. Few settings are completely paperless, and handwriting that is difficult to decipher can be misinterpreted, propagating misinformation. This outcome is true not only for orders and prescriptions, but for other documents as well, such as progress notes, medication lists, and even the self-stick message notes affixed to charts.
Avoid the use of unsafe abbreviations. Many historically used abbreviations have been identified as dangerous, increasing the likelihood of medication errors and ADEs. As part of the National Patient Safety Goals, the Joint Commission has compiled a list of abbreviations that should not be used, (35), such as:
QD, which easily can be mistaken for QID, resulting in fourfold overdosing. Write “daily” instead.
U, which can be misinterpreted as a zero (0), resulting in 10-fold overdosing. Write out the word “units” instead.
A good maxim is: When in doubt, write it out.
Obtain an accurate patient weight. Most pediatric dosing is based on the child's weight, at least until adult size is reached. Weigh the patient in kilograms and include weight-based dosing information on the order or prescription. (4)(36) This practice allows a pharmacist or nurse to double-check your calculations.
Mind your decimals. Dosing errors are the most common type of prescribing errors; children, in particular, are at high risk for 10-fold errors due to misplaced decimals. (18)(34)(37)(38)(39)(40)(41) The adage “Always lead, never follow” can help avoid this type of error. Always precede a decimal with a zero (eg, 0.3 mg, not .3 mg). Never follow a decimal with a zero (eg, 7 mg, not 7.0 mg). (35)
Include the indication for therapy on orders and prescriptions. (36) This practice helps to prevent orthographic, or look-alike, medication errors. Zyprexa® can be mistaken easily for Zyrtec® on a poorly handwritten prescription and has been. (42) Specifying the indication “allergic rhinitis” on a prescription for Zyrtec® drastically reduces the likelihood that Zyprexa® will be dispensed. The indication for therapy also should be included with verbal orders to prevent phonetic, or sound-alike, medication errors. Diamox® and Trimox® may not be mistaken for each other on paper or on a computer screen, but a nurse working on a noisy unit receiving a verbal order from a physician on a cell phone with only “one bar” easily could mistake them. Including the indication for therapy decreases the risk that these two drugs will be interchanged.
Educate patients and families. Review the dosing regimen, indications for therapy, and potential adverse effects for every new prescription. Provide written instructions and information whenever possible. Encourage patients and families to contact you with any questions or concerns.
Institution-based primary prevention strategies also can be implemented. Computerized physician (or provider) order entry (CPOE) refers to a broad spectrum of electronic prescribing systems that have been shown to decrease medication errors and ADEs. (43)(44)(45) CPOE can ascertain that required information is included in an order or prescription using forced format screens and essentially can eliminate the issue of illegibility. Weight-based calculators with pediatric guardrails can ensure that dosing remains within safe parameters. Clinical decision support functionalities embedded in many CPOE systems include checks for allergies and drug interactions, integration of available laboratory data, reminders to monitor serum drug concentrations, and promotion of standardized order sets.
However, CPOE is not a panacea. CPOE may help solve some problems, but it can introduce new sources of error. For example, forced format screens can facilitate incorrect orders in some instances. (46) Implementation of CPOE requires an enormous investment in human and financial resources. The cost of the technology remains prohibitive for many institutions. In a 2002 survey, less than 10% of United States hospitals had CPOE systems completely available. (47) Paper-based order forms with forced formats can provide a temporizing, fiscally friendly solution for ensuring that all necessary information is included in an order, (48) but they cannot resolve poor handwriting or provide the automated safeguards of an electronic system.
Clinical pharmacist participation on inpatient rounds has been shown to be another effective means of primary prevention in various settings. (22)(49)(50)(51) Recommendations, including choice of drug, dosing regimen, and pharmacokinetic monitoring, help reduce errors and preventable ADEs. Unfortunately, the cost in human and financial resources precludes this solution for many organizations.
Secondary prevention aims to detect and intervene early in the course of disease. Antiviral drugs such as oseltamivir are prescribed upon early identification of influenza to minimize symptom severity. Secondary prevention for medication safety is the rapid detection and removal of errors introduced into the medication management system, intercepting them before they have the opportunity to become preventable ADEs. Review of medication orders by pediatric pharmacists has been shown to be an effective means of preventing potential ADEs from reaching the bedside. (37)(52) Pharmacists and nurses should be empowered and encouraged to double-check orders (53) and contact the prescriber when an error is identified. Physicians should be grateful rather than annoyed by these calls; each represents averted harm to a patient.
The goal of tertiary prevention is to minimize sequelae associated with disease. Physical therapy assists patients whose baseline status has been compromised by a severe bout of influenza. For patient safety, having reversal agents readily available such as naloxone for narcotics and having interventional systems in place such as rapid response teams (54) may help reduce the short- and long-term morbidity associated with adverse events when they do occur.
Primordial prevention strives to reduce environmental, societal, cultural, and behavioral factors that increase risk of disease. (55) For influenza, this is accomplished through public health campaigns to promote immunization and measures to reduce disease spread. For patient safety, primordial prevention entails increasing awareness of the problem, an objective of this article; building systems that minimize the risk of error and swiftly intercept them before they have an opportunity to cause harm; and establishing a culture in which safe practices are the standard, error and event reporting is nonpunitive, and continual improvement is the paradigm.
Strides are being made to keep patients safe despite the enormity of the challenge and the inherent difficulties in assessing improvement.
Pediatricians need to be cognizant of general patient safety principles as well as those specific to children.
We must adopt safe practices and remain vigilant in our efforts to reduce the risk of harm to our patients. To err may be human, but to improve is divine.
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- © American Academy Of Pediatrics, 2010. All rights reserved.