Statement of the American Academy of Pediatrics

The American Academy of Pediatrics is pleased to provide a statement to the Subcommittee on Health of the Committee on Ways and Means on issues of great importance to pediatricians – Health Quality and Medical Errors.

Pediatricians provide the highest quality care to infants, children, and adolescents but the Academy acknowledges that there are opportunities for improvement. Our goal is to minimize errors and maximize quality. The June 2001 policy of the Academy "Principles of Patient Safety in Pediatrics" provides direction on setting up processes to identify and learn from errors, developing performance standards and expectations for safety, and promoting leadership and knowledge (attached).

Patient safety may be broadly defined as including medication use (medication errors and adverse drug events [ADEs]), wrong or delayed diagnosis, surgical errors, birth injury or nosocomial infection. Infants and children are at increased risk for harm because of their limited reserves and the increased opportunities for error entailed by weight-based dosing for virtually all pediatric medications. Because there is very little published research about pediatric patient safety issues, it is imperative that the Agency establishes a specific research agenda focusing on patient safety issues in the pediatric population.

An important component of patient safety is medication error. The Institute of Medicine report, "To Err is Human," suggests that medication errors are the most frequent type of patient safety error. Little research has addressed the problem of medication errors and adverse drug events in pediatric settings. The lack of pediatric studies is unfortunate because children pose unique challenges, including increased opportunities for error entailed by weight-based dosing for virtually all medications, and the potential for more serious consequences of drug errors due to the limited reserves of smaller children.

In a study of complex errors in hospital prescribing, one researcher demonstrated that the likelihood of drug error is an exponential function of the number of drugs administered. A hospitalized pediatric patient receives an average of seven medications. The errors most frequently recognized in association with hospital pediatric drug therapy include computation errors of dosage and dosing interval, errors in drug orders (including written instructions and interpretation), and errors in drug preparation or conflicts with prescribed dosages. Children are at particular risk for these types of errors, as the broad range of patient age and size requires dosage individualization, most often using dosage equations.

Drug dosages for children are calculated on a per weight basis that is significantly different from calculating dosages for adults. A computation error can result in a significant under or over-dosage. One medication safety issue especially harmful in pediatrics is commonly referred to as the ‘ten-fold’ error (e.g., a misplaced decimal point can mean a ten-fold change in the appropriate dosage of medication). One example dramatically illustrates this type of error. Jose Eric Martinez was an ill two-month-old who exhibited early signs of congestive heart failure. In order to ameliorate his condition, the physician ordered intravenous Digoxin over aseveral day stay. However, because of a decimal point error in determining the appropriate dosage, the infant was given a dose that was 10 times what was intended and died.

In order to better structure appropriate interventions, it is critical to understand which pediatric age groups experience adverse events most frequently. The Harvard Risk Management Foundation, with significant experience in children’s hospital settings, suggests that there may be particular drug distribution and administration challenges in patients weighing less than 5 kilograms (personal communication, Frank Federico). Research is needed to confirm these findings and to support the development of interventions that focus on clinical decision-making and the use of alternate medications to improve care and decrease errors.

In the only study documenting the epidemiology of medication errors in a children's hospital setting, Rainu Kaushal, MD and her colleagues found that serious pediatric medication errors (potential adverse drug events and preventable adverse drug events) occurred at a three-fold higher rate than in adults. This study provided important confirmation of the unique epidemiology of medication errors in pediatric inpatient populations and suggests that hospitalized children are at a greater risk of serious medication errors than adults are. This finding gives additional emphasis to the need for study of appropriate interventions in the pediatric population.

In a review characterizing the nature and potential consequences of actual prescribing errors involving dosage equations at a tertiary care hospital, Timothy Lesar, PharmD, discovered that errors most commonly involved children (69.5%) and antibiotics (53.5%). Forty-two percent of errors were considered to put the patient at risk for serious or preventable adverse outcome. Errors in decimal point placement, mathematical calculation, or expression of dosage regimen accounted for 59.5% of dosage errors. Moreover, the dosage equation was wrong in 29.5% of dosage errors. The study analyzed the characteristics of 200 consecutive prescribing errors with potentially adverse outcomes involving dosage equations.

In addition, research is needed to ensure the safe administration of intravenous medications in the inpatient setting. Because the administration of intravenous medications in a pediatric patient often necessitates the use of a precise delivery system (e.g., an electronic pump), this technology presents both an additional opportunity for error as well as a potential safety check. Research could help determine whether partnership with industry to improve pediatric medication usage (e.g. explicit labeling for pediatric safety/dosing, small volume infusion devices, etc.) can help reduce the rate of medication errors for infants and children.

Because children depend on others to advocate for them, research on the role families play in reducing medical errors in inpatient settings would also be useful.

In the only published evaluation of an intervention to improve safety in hospitalized children, Folli and colleagues demonstrated that a pharmacy review of medication orders could prevent erroneous orders from being implemented at a rate of 14-18 per 1000 patients days. Dr. Kaushal and his colleagues are presently evaluating two other interventions to reduce serious medication errors in pediatrics: computerized physician order entry and clinical ward-based pharmacists with continuous quality improvement teams.

With ambulatory settings providing an increasing proportion of care, patients in inpatient care settings represent only a small part of the population at risk for ADEs. It is estimated that 70 percent of pediatric care takes places in ambulatory settings. This involves well-child, acute, and chronic illness care. Furthermore, although prior studies in adult outpatient populations have demonstrated that ADEs are common, costly, expensive and often serious or fatal, what is known about the prevalence and type of medication errors in pediatric ambulatory settings is extremely limited.

Pediatricians in ambulatory settings prescribe medications in more than half of patient encounters. In a recent survey of a random sample of 1,600 of its members, researchers at the American Academy of Pediatrics found that prescriptions are written for 52.9% of the patients a pediatrician sees during an average workweek. Among those prescriptions, 73.2% are for short-term acute illnesses and 29.2% are for chronic long-term illnesses. Data from National Ambulatory Care Medical Surveys (NACMS) also support this claim. Between 1993 and 1998 the number of office visits where a medication was ordered or provided increased 13.8%, from 109.1 million to 124. 3 million. These data illustrate the opportunity for medication error in children seen in ambulatory settings, yet no research has been conducted to identify common errors, develop a feasible system to report errors, or better understand practices to decrease error in these settings.

Home health care settings also pose additional challenges. Not only are there opportunities for errors in the intravenous administration of medications (e.g., prepackaged medications, preparing and disposing of syringes) but also in the management of children on ventilators and other forms of medical equipment. As in other ambulatory settings, little or no research has been conducted to identify and analyze the types of medical errors in pediatric home care settings. This is critical research given the interest in containing healthcare costs through early discharge to the home.

Types of errors occurring in pediatric ambulatory or home health care settings may include errors in physician drug prescribing (e.g. wrong dose, wrong medication, wrong route, prescribing a medication despite a known allergy, etc), pharmacy dispensing, and parental administration. Outpatient drug complications, which can be a result of a medication error, are not well studied in either adults or children. In a study by Tejal Gandhi, MD and colleagues of adult patients followed in urban clinics, drug complications in the ambulatory setting were common, although most were not documented in the medical record. No studies have been done to evaluate adverse drug events in pediatric ambulatory settings. It is imperative that epidemiologic studies document the type, frequency, and severity of errors in pediatric ambulatory settings.

Significant numbers of medications are given to children every day in schools, pre-schools and many child daycare settings. In fact, after the home, schools and preschools are the most common locations for medication administration to children to occur. Systems of medication delivery at such institutions are too often sub-optimal or do not exist at all. The presence of school nurses increases the likelihood that a school district has a medication-delivery and recording protocol; however, the presence of school nurses is highly variable. In addition, childcare settings for infants and toddlers rarely have any support for health matters and little monitoring by the state agencies. Research on errors in these settings should be a priority. In addition, research is needed to design, promote, and implement standardized protocols for medication delivery in schools, preschools, child care centers, and family-based child day care homes.

Information technology has great potential to minimize medication errors. Computerized order entry has been shown to decrease errors. In addition, this technology offers the opportunity to coordinate care given by multiple individuals to a single pediatric patient. It is imperative that research examine the many uses of information technology in improving patient safety as well as how to influence clinician acceptance of information technology in both the ambulatory and inpatient settings.

The safety of medication use in the pediatric population represents an important area of research need. This knowledge could minimize the risk and maximize the quality of care that children receive. The following are important topics for research:

To determine the prevalence of psychotropic medication use in preschool-aged children, JM Zito, MD and colleagues analyzed ambulatory care prescription records from two state Medicaid programs and a salaried group model health maintenance organization (HMO). It was discovered that the number of psychotropic medications prescribed for preschoolers increased dramatically from 1991 to 1995. The use of stimulants, the most common class of drugs prescribed, increased three-fold in this age group during the early 1990s. These findings are especially remarkable due to the limited data on the efficacy and safety of psychotropic medication use in children. Epidemiologic studies are needed to evaluate clinical and treatment outcomes. Clinical trials are necessary to evaluate dosages, efficacy, and safety of certain drugs not approved for a pediatric age group.

Antimicrobials are the second leading therapeutic category of drugs prescribed by office-based physicians in the United States each year. According to the 1996 NACMS, antibiotic prescriptions reached 128 millions doses compared to 86 million in 1980. From 1990 to 1992, almost one in six physician office visits resulted in antimicrobial prescription. In 1992, more than 6.5 million prescriptions were written for children with a cold or upper respiratory infection.

Otitis media is the leading indication for outpatient antimicrobial use in the United States. Overdiagnosis of and unnecessary prescribing for otitis media has contributed to the spread of antimicrobial resistance. In a recent prospective study, antimicrobial treatment of otitis media accounted for more than 90% of all antimicrobial use during the first two years of life. These data again underscore the increased risk children’s health and safety when they are needlessly exposed to drugs.Research is needed to help physicians better identify which children need antimicrobials, and how to most effectively change clinicians’ prescribing behavior for otitis media. Studies also have demonstrated that parents influence the physician's decision to prescribe antimicrobials. Based on this fact, it is essential that research identify effective approaches to change parents’ expectations about the indications for antibiotics as well as how to improve physician-parent communication on this topic.

Based on the recommendations in the IOM report, state and national policy makers have begun to examine the role reporting systems play in reducing medical errors. However, there are significant external barriers to implementing effective reporting systems. The blame and punish philosophy and the search for individual culpability still persists. This is an obstacle to openly discussing or reporting errors. Reporting programs should be aimed at ensuring that health systems are safe for children. To do so, the reporting systems should be non-punitive, ensure anonymity, focus on system failures, recognize that adverse events may or may not be caused by errors, and support the key role that organizational leadership plays in systems improvement.

To promote effective reporting systems that are designed to maximize patient safety, the Academy recommends AHRQ support research that will provide information to guide decision-making on the following issues:

• Understanding the relationship between organizational culture and reductions in medical error, specifically contrasting punitive versus non-punitive environments and different institutional approaches to creating cultures of safety in pediatrics.
• Determining the effectiveness of interdisciplinary safety teams with leadership sanctions in improving either rates of medical error reporting or changes in patient care systems.
• Examining the effectiveness of state reporting systems on reducing medical errors in pediatrics, including determining whether states that require mandatory board reports with disciplinary action have lower rates of medical error reporting.
• Exploring whether active error identification systems improve the yield of reported medication errors
• Ascertaining whether signal/trigger systems are as effective as spontaneous reporting systems for medication error.
• Exploring best ways to encourage reporting.
• Defining the impact of the error debate on families’ satisfaction with health services.

In summary, the American Academy of Pediatrics urges the Congress to work with the medical community to address the following patient safety issues in the pediatric community:

• Testing and refining the methods for determining medication error, potential adverse drug effects, potential adverse drug effects, and adverse drug detection and analysis in both in-patient and ambulatory settings.
• Documenting the epidemiology of pediatric medication errors in both inpatient and ambulatory settings as a major step towards designing interventions to intercept errors and prevent ADEs in children.
• Documenting the epidemiology of pediatric medication errors in childcare and school settings.
• Developing and testing interventions to improve medication systems in both inpatient and ambulatory settings.
• Designing, promoting, and implementing standardized protocols for medication delivery in schools, preschools, childcare centers, and family-based child day care homes.
• Developing and testing effective reporting systems.
• Researching how to influence clinician acceptance of computerized order entry systems in both the ambulatory and inpatient settings.
• Studying the use of computer technologies as tools to minimize drug errors or as aids in coordinating care provided by multiple individuals.

REFERENCES AVAILABLE UPON REQUEST.

Attachment: Principles of Patient Safety in Pediatrics, AAP Policy statement:

Policy Statement

Pediatrics
Volume 107, Number 6
June 2001, pp. 1473-1475

Principles of Patient Safety in Pediatrics (RE060027)

AMERICAN ACADEMY OF PEDIATRICS

National Initiative for Children's Health Care Quality Project Advisory Committee

ABSTRACT. The American Academy of Pediatrics and its members are committed to improving the health care system to provide the best and safest health care for infants, children, adolescents, and young adults. In response to a 1999 Institute of Medicine report on building a safer health system, a set of principles was established to guide the profession in designing a health care system that maximizes quality of care and minimizes medical errors through identification and resolution. This set of principles provides direction on setting up processes to identify and learn from errors, developing performance standards and expectations for safety, and promoting leadership and knowledge.

INTRODUCTION

The 1999 report of the Institute of Medicine, To Err Is Human: Building a Safer Health System, notes that errors in health care are a leading cause of death and injury.¹ Between 3% and 4% of hospitalized patients are harmed by the care that is supposed to help them. On average, of 100 hospitalized patients, 7 are exposed to a serious medication error that harms or could have harmed them. It is estimated that between 44 000 and 98 000 Americans die in hospitals each year as a result of errors in their care.² Although these figures have been challenged, there is no disagreement as to the importance of the topic or the existence of substantial safety concerns in health care. In response to the report, Congress and various states are proposing legislation and programs to improve patient safety.

The increasing complexity in patient care in addition to the public's increased scrutiny of the health care system underscores the need to make patient safety an issue of high priority. The American Academy of Pediatrics and its members are committed to improving the health care system to ensure that infants, children, adolescents, and young adults receive the best and safest health care.

All health care systems should be designed to prevent errors. The first step in designing these systems is to identify errors and study their pattern of occurrence within delivery systems to reduce the likelihood of adverse events. A specific concern in pediatrics is the lack of information on errors in the pediatric population and the strategies needed to minimize errors and maximize care in both the ambulatory (including schools and child care settings) and inpatient sectors. If the Academy is going to implement an effective and far-reaching agenda to address the public policy and research components of the patient safety debate, the set of principles listed below should serve as its guide.

RECOMMENDATIONS FOR IDENTIFYING AND LEARNING FROM ERRORS

1. Pediatricians are committed to bringing about the best possible health outcomes for children and their families. Because all medical interventions involve known and unknown risks, pediatricians should work with health care teams to create safe patient care environments and prevent medical errors.
2. Efforts to improve patient safety and prevent errors should focus on a systems approach. Existing research on hospital-based care reveals that medical errors rarely represent the failure of an individual caregiver. Most errors in medical care are systems errors related to equipment, complex processes, fragmented care, and lack of standardized procedures.
3. Systems should be developed to identify and learn from errors. These error learning systems should be open, promote discussion of errors without blame, and provide contextual data about the error. The Institute of Medicine has called for a 50% decrease in the rate of medical errors over the next 5 years, which can be realized only by researching the underlying causes of medical errors, creating effective interventions, and addressing future prevention.¹ These efforts must be completely separate from punitive strategies. Peer review protections should be extended to encourage participation in efforts to decrease the rate of medical errors. Currently, state and federal laws provide legal protection so health professionals can be candid during peer review without fear of legal action. This should also apply to situations in which a medical error occurs.

Error reporting systems are one part of an error learning system. We can identify and learn from errors through reporting programs aimed at ensuring the systems are safe for patients. To do so, reporting systems should:

• Be nonpunitive;
• Require that only the most critical events be subject to mandatory reporting;
• Require that information reported to internal and external patient safety review groups should not be discoverable in civil or criminal legal action;
• Allow individuals involved in the events to remain anonymous whether or not error is involved;
• Recognize that adverse events may or may not be caused by errors;
• Focus on systems failures; and
• Support the key role that organizational leadership plays in systems improvement.

4. Most research on medical errors is hospital based. It may not be appropriate to extrapolate the number or types of errors found in hospitals to the number or types of errors that might be found in ambulatory health care settings. Because most health care is delivered in ambulatory care settings, and in pediatrics, many medications are taken outside of the home (in schools and child care settings), research on errors in ambulatory care settings should be a priority, particularly for unique patient populations, such as infants, children, adolescents, young adults, and children with special needs. The problem of drug dose calculation errors for pediatric patients, in particular, should be explored.

RECOMMENDATIONS FOR DEVELOPING PERFORMANCE STANDARDS AND EXPECTATIONS FOR SAFETY

1. Patient safety guidelines should be developed through the coordinated actions of oversight organizations, group purchasers, and professional groups. These guidelines should be reasonable and based on a true assessment of the risk level associated with the specific patient safety intervention. In addition, recommended safety strategies should be flexible enough to allow health care providers to adapt them to varied delivery settings and to pediatric patients' needs.
2. Health care organizations should take into account unique pediatric safety issues. These include particular attention to the potential for errors in care attributable to changes in patient weight and physiologic maturation, limited capacity for cooperation in young children and high levels of dependency on others, and the relative rarity of most pediatric illnesses and accordant lack of widespread familiarity with their care. As uniform regulations and guidelines are developed, they should encompass the service delivery systems and their variations. The goal of pediatric patient safety systems inside health care organizations should be the implementation of safe practices.
3. Information technology has great potential to minimize medication errors. Computerized order entry has been shown to decrease errors and coordinate care given by many individuals to a single pediatric patient.³ It is imperative that research examine the many uses of information technology to improve patient safety and ways to facilitate clinician acceptance of information technology in ambulatory and inpatient settings.
4. All individuals involved in providing health care to children should work together to:
• Develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use;
• Require pharmaceutical companies to test proposed drug names to identify and remedy potential "sound-alike" and "look-alike" confusions with existing drug names;
• Establish appropriate responses to problems identified through postmarketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients; and
• Support expanded efforts to include children in new drug trials.

RECOMMENDATIONS FOR LEADERSHIP AND KNOWLEDGE

1. The Academy supports the creation of a Research Center for Patient Safety within the Agency for Healthcare Research and Quality. The Academy urges that this center be adequately funded to address the protection of all patients.
2. Health care organizations should demonstrate their commitment to pediatric patient safety by establishing patient safety programs with defined executive responsibility in all settings where medications are delivered or care is provided to children and by developing a culture of improvement. Patient safety programs should:
• Provide strong, clear, and visible attention to safety;
• Represent a collaborative effort of physicians, nurses, allied health personnel, and administrative staff who have experience with and knowledge of patient safety;
• Incorporate well-understood safety principles, such as standardizing and simplifying equipment, supplies, and processes;
• Implement proven medication safety practices;
• Establish interdisciplinary learning programs; and
• Address the special needs of inpatient and ambulatory care environments.
3. Research that explores the effect the error debate has on families' satisfaction with health care services should be conducted.

Promoting safety requires changing the culture of medicine to recognize that the potential for errors exists and that teamwork and communication are the basis to guarantee change. The promotion of patient safety and the decrease in the rate of errors should become one of the major goals of the Academy. Safety should be viewed as one component of a broader commitment to providing optimal health care for children—a goal that the membership embraces and that unites pediatricians with the families they serve.

NATIONAL INITIATIVE FOR CHILDREN'S HEALTH CARE QUALITY PROJECT ADVISORY COMMITTEE 
(NICHQ PAC), 2000-2001

Carole M. Lannon, MD, MPH, Chairperson
Barbara Jane Coven, MD
F. Lane France, MD
Gerald B. Hickson, MD
Paul V. Miles, MD
Jack T. Swanson, MD
John Ichiro Takayama, MD, MPH
David L. Wood, MD, MPH
Loren Yamamoto, MD, MPH

REFERENCES

1. Committee on Quality Health Care in America, Institute of Medicine. In: Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: Institute of Medicine; 1999
2. Hearings before the Subcommittee on Health Care of the House Committee on Veterans' Affairs and the Subcommittee on Health and the Environment and the Subcommittee on Oversight and Investigations of the House Committee on Commerce, 106th Cong, 1st Sess (2000) (testimony of Donald Berwick, MD, member Committee on Quality of Health Care in America, Institute of Medicine)
3. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events. Pediatr Res. 2000;47:201. Abstract 1188

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The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.

Copyright © 2001 by the American Academy of Pediatrics. No part of this statement may be reproduced in any form or by any means without prior written permission from the American Academy of Pediatrics except for one copy for personal use.