Pediatrics
- Introduction
- Patient safety
- Device/product safety
- Federal legislation and activity
- Product identification
- Medication safety
- Perinatal safety
Introduction
Children are not just little adults. Physical size is just one of the many differences. Children’s body surface area, organ and system maturity and function, as well as cognitive and emotional development can result in differences in response to illness, diagnosis, treatment, medications and medical devices. Often medications, products and devices are developed and tested only on adults and then scaled down in size, dose or application for use with pediatric patients, creating a potential patient safety risk.
All stages of pediatric growth and development from pre-term newborn through adolescence must be considered in providing safe and high quality care, including medications, treatments and medical devices that are appropriate for patients in each stage of development.
Government, professional, manufacturing and pharmaceutical organizations are working together to address this situation— but there is still more work to be done.
The purpose of this Web site is to provide key information on selected topics related to pediatric patient safety, including resources, tools, and recent national and legislative activity.
Patient safety
There are five key differences between children and adults that present patient care challenges and potential safety issues unique to children. These include:
- Variability in size – differences in patient size, requiring different sized devices and potential for technical difficulties because of smaller sizes, such as insertion of intravenous catheter.
- Developmental changes – unique susceptibility to certain infections at different stages of development, such as neonates susceptibility related to immunity from mother, and toddlers and children’s immunity related to immunization.
- Dependence on adults – unable to administer their own medications, identify potential mistakes, and be primary historians for reports of pain or illness.
- Disease epidemiology – unique risks and diseases, such as birth trauma, spina bifida and cystic fibrosis.
- Demographics – higher rates of poverty leading to poor access to medical care.
The release of the first Institute of Medicine (IOM) report on patient safety, To Err is Human: Building a Safer Health System (IOM-1), in November 1999 was responsible for an unprecedented number of new publications, process improvement initiatives, research studies and educational programs that focus on preventing medical errors in hospitals. However, both the IOM report and most of the early work in patient safety focused on adult populations. Recently, several pediatric organizations have collaborated to improve general understanding, reporting, process improvement methodologies, and quality of pediatric inpatient care. A selection of resources from these organizations is being made available on this Web site.
Device/product safety
The vast majority of products used with pediatric patients are developed for adults and adapted for use in children. These products may lack the durability required to withstand the more active lifestyles of children and may fail as a result of material fatigue. Additionally, biocompatibility of materials with tissue in children of different ages may differ from adults. Unique needs, coupled with ongoing growth and development, also make medical and surgical device safety a particular challenge in pediatric patients.
Devices developed for adult populations, even when made smaller to accommodate children, may not account for the anatomical and functional differences. While there are devices designed specifically for the needs of the pediatric population and not used in adults (infant incubators, bilirubin lights, bili blankets, etc.), the challenges of designing devices in a small size with smaller market potential, make the development of devices exclusively for children less attractive to manufacturers. Although people under age 20 make up approximately 30% of the population, it is estimated that they only account for 2% of deaths and 11% of hospital discharges (excluding newborns), resulting in a small market for pediatric medical devices
There have been a number of legislative, regulatory and scientific community responses to the issue of safety of pediatric devices, each with a different emphasis. There is general agreement that we still need a coordinated public-private partnership to develop a central clearinghouse for pediatric devices to enhance communication with all stakeholders, including pediatric clinicians.
Federal legislation and activity
In an effort to address this issue, the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250) called for the Institute of Medicine to assess whether the current system for the postmarket surveillance of medical devices provided adequate safeguards regarding the use of devices in pediatric populations.
In its report, Safe Medical Devices for Children, released in 2005, the Institute of Medicine made numerous recommendations, including:
- The FDA should develop additional guidance on the identification and evaluation of pediatric questions or concerns at all stages in the design and evaluation of medical devices used with children.
- Congress should amend the Federal Food, Drug, and Cosmetic Act allowing the FDA to change the duration of Section 522 studies beyond the three-year limit for devices likely to have significant pediatric use so that studies can take into account children’s growth and development.
Download the executive summary of the IOM report in the resources section of this Web site.
Food and Drug Administration (FDA)
- Medical Device Technical Corrections Act of 2004 – directions to the FDA
While the IOM tackled postmarket issues related to medical devices used in pediatrics, the Medical Devices Technical Corrections Act of 2004 (P. L. 108-214) required the FDA to “report on the barriers to the availability of devices intended for the treatment or diagnosis of diseases and conditions that affect children.” - FDA Report: Barriers to the Availability of Medical Devices Intended for the Treatment/Diagnosis of Diseases that Affect Children, 2004.
In response to the Technical Corrections Act of 2004, the FDA issued a report to Congress in October 2004, Barriers to the Availability of Medical Devices Intended for the Treatment/Diagnosis of Diseases that Affect Children. This report focused on identifying unmet medical device needs in the pediatric population and barriers to the development of new pediatric medical devices. Download a copy of this FDA report in the resources section of this Web site. - FDA Amendments Act of 2007 – Title III: Pediatric Medical Device Safety and Improvement Act
On September 27, 2007, President George W. Bush signed into law the FDA Amendments Act of 2007, which included Title III: Pediatric Medical Device Safety and Improvement Act. The Pediatric Medical Device Safety and Improvement Act is designed to improve the research, manufacture, safety and approval processes for pediatric medical devices. The legislation requires that new device applications submitted to the FDA include a description and the size of any pediatric subpopulations that suffer from the condition the device will treat, diagnose or cure.
Additional changes provided by the legislation include:- Improvement in tracking of pediatric device approvals;
- Incentivizing device development through modification of humanitarian device exemption;
- Establishing nonprofit consortia to stimulate device development;
- Enhancement of postmarket surveillance, including the ability to extend studies beyond the three-year limit for devices likely to have significant pediatric use; and
- Coordination of a plan across multiple federal agencies expanding research and efforts related to pediatric device development.
The Pediatric Medical Device Safety and Improvement Act also requires that the Secretary of Health and Human Services submit a plan to Congress related to expanding research and efforts toward development of pediatric devices. A stakeholders workshop was held in July 2008 to gather feedback and information from the research community and the public to help inform the secretary’s plan. Completion of the Pediatric Device Development Plan is an important next step in improving the availability of medical devices designed for children.
Identification of products for pediatric patients
One of the challenges for clinicians caring for children is finding medical devices that are specifically designed for children, as well as those that are appropriate for use in pediatric care. Premier has developed several resources to help members and other pediatric healthcare providers identify these products.
Medication safety
Adverse drug events are among the most frequently reported medical errors for both adult and pediatric patients. Adverse drug events as defined by the IOM include injuries related to a drug, which can be attributable to preventable and non-preventable causes. Non-preventable causes typically involve adverse reactions to medications, such as unexpected allergic responses or toxic reactions related to the inherent pharmacologic properties of the drug.
Adverse drug events, both medication errors and adverse reactions, occur far more often in pediatric patients than in adult patients. Because the majority of drugs used in pediatric medicine have not been appropriately tested for use in children, pediatricians often prescribe drugs for "off-label" use, which means there have not been FDA-approved pediatric clinical trials with such medications. Since children differ from adults in many ways beyond size, simply adjusting the dose for a smaller size person will not necessarily produce the same response and can lead to adverse drug reactions.
In contrast, preventable adverse drug events, typically called medication errors, are any preventable event that may lead to inappropriate medication use or patient harm. Research has shown that medication errors occur across the entire spectrum of medication delivery, including prescribing; order communications; product labeling, packaging, and nomenclature; dispensing; distribution; administration; monitoring; and documentation. Medication errors are also a significant source of concern for pediatric patients across all settings of care, including within the home.
Some medication errors have a greater potential for harm in pediatric patients. For example, dosing errors can easily occur with pediatric dosing that requires weight-based calculations, fractional dosing and use of decimal points. Many medications are formulated and packaged primarily for adults and must be prepared and re-packaged within the hospital prior to administration to children. Because dosages are small and weight-based, a small error may have much larger consequences. Additionally, due to size and developmental differences, young children may be less able, physiologically, to tolerate a medication error, such as an overdose.
Several organizations have published guidelines and strategies aimed at reducing pediatric medication errors.
- The Institute for Safe Medication Practices and the Pediatric Pharmacy Advocacy Group. In 2001, The Institute for Safe Medication Practices (ISMP) and the Pediatric Pharmacy Advocacy Group (PPAG) released the first national guidelines developed to reduce pediatric medication errors. Guidelines for Preventing Medication Errors in Pediatrics identifies medication errors common to pediatrics facilities, and recommends strategies aimed at reducing medication errors in those settings.
- American Academy of Pediatrics. In August 2003, the American Academy of Pediatrics (AAP) released a policy statement, Prevention of Medication Errors in the Pediatric Inpatient Setting. This policy statement recommends specific actions and guidelines for policy, education and communication to decrease the rate of pediatric medication errors.
- The Joint Commission. In April 2008, The Joint Commission (TJC) released Sentinel Event Alert # 39, Preventing Pediatric Medication Errors. The Alert provides an overview regarding pediatric medication error rates and discusses pediatric-specific strategies to reduce medication errors.
Additional information, including copies of these documents is available in the resources section.
Perinatal safety
Pediatric safety begins at birth. There are nearly three birth-related injuries for every 1,000 babies born in the United States each year. Many of these are preventable. Five recurring clinical issues are commonly cited for the majority of perinatal harm. These issues include:
- failure to recognize an infant in distress;
- failure to initiate a timely cesarean birth;
- failure to properly resuscitate a depressed baby;
- inappropriate use of labor-inducing drugs; and
- inappropriate use of vacuum or forceps.
Premier is currently leading 16 of its member hospitals in the Perinatal Safety Initiative, a national collaborative designed to achieve the consistent delivery of evidence-based care with the goal of eliminating preventable birth-related injuries and deaths. More information about the Premier Perinatal Safety Initiative