2,8 As reported in an earlier study, ADE rates in hospitalized children were substantially higher (15.7 per 1000 patient-days) than previously described.9 However, 22% of all ADEs could be preventable, and 17.8% could have been identified earlier.9
In 2001, the ISMP and the Pediatric Pharmacy Advocacy Group (PPAG) collaborated to produce the nation’s first set of guidelines to reduce pediatric medication errors.10 The American Academy of Pediatrics (AAP) has also taken a lead in making recommendations to reduce errors.11
Closure of performance gaps and “getting to zero” medication errors will require the constant vigilance from all healthcare professionals and the commitment of hospitals and healthcare systems to implement action in the form of specific leadership, practice and technology plans. This will lead to a decrease in medication errors and a reduction in the occurrence of preventable ADEs in pediatric patients.
Leadership Plan
The hospital board, executives and other senior administrative leadership (medicine, pharmacy and nursing) must fully understand the performance gaps in reducing pADEs at their own healthcare systems. Commitment from all the leaders and stakeholders is necessary for the successful closure of these performance gaps. Leaders should endorse a comprehensive pADE reduction action plan and ensure implementation across all providers and systems. Strategic and tactical approaches that hospital leadership should endorse include the following:
- Establish pADE reduction as a strategic priority by creating a clear metric and goal that are included on the hospital-wide dashboard reviewed by the board and senior executives.
- Invest and allocate funds to:
- Develop and maintain continuous education programs for healthcare providers with respect to pediatric clinical updates, high alert medications, pADEs monitoring and proper use of drug infusion pumps.12,13,14,15,16
- Support clinical and research programs to develop an educational forum and “Best Practices”model for healthcare providers to expand the body of knowledge in pediatric medicine.
- Encourage and support the use of a simple, real-time pADE reporting system.15
- Review accurate, up-to-date pADE data at least monthly.15
- Charter a committee or task force to review the reported data at the hospital and unit levels, generate and implement strategies for improvement, analyze barriers and regularly report to executive leadership.15
- Expect a comprehensive root cause analysis of all pADEs that involve serious patient harm. The analysis should include the root cause of the medication error, feedback to the individual linked to the error, implementation of time-bound and evidence-based changes to avoid similar pADEs, and widespread sharing of lessons learned.15
- Support the development of a lessons learned program to raise awareness among providers across the spectrum of medication delivery about pADE events, risks and improvement efforts using longitudinal data, individual events and near misses.
- Assess staffing and ensure an adequate number of medical, nursing and pharmacy staff specially trained to prescribe, prepare, dispense, and administer medications to children.11,17.
- Promote and enhance collaborative communication among all disciplines participating in neonatal and pediatric patient care, including pharmacy staff, patients and families.7
- Consider relevant improvement initiatives and opportunities for collaboration in pADE reduction outside of the pediatric hospital system such as ECLIPSE,18FDA-ASHP Standardize for Safety (S4S) Initiatives and OCHSPS.
- Implement and disseminate assistive technologies that support community practitioners as they stabilize, treat and transfer neonates and children in higher levels of care.
Practice Plan
- Standardize pediatric medication treatments and usage, as well as the processes for drug administration in pediatric patients. Some strategies include the following:
- Establish and maintain a functional pediatric formulary system with policies for drug evaluation, selection and therapeutic use.6,11
- Develop and optimize a smart infusion pump drug library with explicit support for intravenous therapy for pediatric patients.19,20
- Prevent timing errors in medication administration by standardizing the number of days considered in all pediatric protocols upon deciding a treatment start date (e.g., Day 0 or Day 1).6
- Weigh all pediatric patients in kilograms at the time of admission or as soon as possible (i.e., within four hours of admission) in an emergency situation since weight is used to calculate most dosing for children.6
- Standardize and limit the number of concentrations and dosage strengths of high alert medications to the minimum needed to reduce potential medication errors.6,21,22,23,24 High alert medications for pediatric patients should be generated by individual hospitals based on their types of pediatric population, infrastructure and unique features.25,26
- Develop age-related treatment algorithms to guide providers to the correct dosing appropriate for the age of the pediatric patient.
- Age- and weight-related developmental changes in pediatric patients affect the medication use process of specific drugs, and should be taken into consideration. The age-related treatment algorithms will be useful in preventing the use of medications outside the intended patient population.
- Use reputable, reliable references and protocols to help standardize pediatric medication therapies.
- Participate and track the progress of the FDA-ASHP Standardize for Safety Initiative.
- Evaluate clinical guidelines and protocols on a routine basis for sustainability and safety, especially when limited safety and/or efficacy data are available in the pediatric population.
- Develop and implement a pediatric trigger toolkit that will electronically identify high risk medications based on the therapeutic levels, dosages and pADEs.
- Alignment of the trigger toolkit with clinical protocols specific for the medication.
- Utilization of an ADE trigger tool method to identify possible adverse events have been shown to ensure more patient safety events compared to voluntary reporting.27,28
- The pediatric trigger toolkit is effective at identifying ADEs and reducing the frequency of sentinel events for hospitalized pediatric populations.9
- Create a pediatric multidisciplinary team. This team’s responsibilities will include the following:
- Achieve hospital-wide pADE reduction goals; ○Monitor accurate, up-to-date pADE metrics;
- Ensure outstanding event reporting systems, root cause analyses, lessons learned processes and improvement strategies for pADE reduction;
- Benchmark the adequacy of the features of the individual hospital’s medication safety practices and clinical information systems against the proven best practices, identify gaps, and make recommendations.
- Collaborate in a multidisciplinary team (e.g., physicians, pharmacists and nurses) to promote and endorse accountability and responsibility in reporting pADEs from all healthcare providers.29,30
- For example, a pharmacy-driven ADE reporting approach, embraced by nurses and physicians, was shown to improve ADE reporting and avoid inconsistency in the information gathered.29
- Develop and ensure comprehensive specialty training for all practitioners involved in the care of pediatric patients, as well as continuous education programs for healthcare providers to stay current and knowledgeable in medications and treatment of pediatric conditions, and be familiar with the ongoing pADE tracking and reporting systems.6,11
- Collaborate with the Informatics Technology team to develop and customize CPOE order sets to help standardize care and medication therapy for specific pediatric disease states.31○Develop a team of experts (e.g., physician, pharmacist and nurse) to train healthcare providers at their hospital on how to use the smart infusion pumps with customized pediatric drug libraries.20
- Develop and standardize a smooth and effective communication process for hand-offs (e.g. using a checklist)32,33 upon patient transfer to a different unit within the hospital, and upon the transitions of care within and outside clinical settings.34,35,36
- Ensure adequate pharmacy services for pediatric patients to reduce medication errors and ADEs.12The strategies proposed by the American College of Clinical Pharmacy (ACCP) and PPAG include:37
- Elevating the minimum expectations for pharmacists entering pediatric practice,
- Standardizing pediatric pharmacy education,
- Expanding the current number of pediatric clinical pharmacists,
- And creating an infrastructure for development of pediatric clinical pharmacists and clinical scientists.
- Develop and implement pharmacist-managed admission medication histories and medication reconciliation process for pediatric patients, which have shown to prevent potentially significant adverse drug reactions and have a positive impact on patient care.38
- Develop and implement a discharge prescription review program, led by a clinical pharmacist (with pediatric training preferred), to ensure the medication doses are equivalent to those prepared in the hospital. This is an effective method for reducing prescribing errors in pediatric patients during transition of care.39
- Implement pharmacist-driven processes, such as developing a double- and triple-check system for high alert medications to ensure the “5 Rights”, appropriate medication selection, and accurate excipients, dose and concentrations of liquid medications prior to compounding and dispensing them.
- Develop an education forum for community healthcare providers (e.g., physicians, pharmacists and nurses) about appropriate prescribing and dispensing medications for pediatric patients.40
- Disseminate pediatric-specific assistive technologies such as eBroselow (or equivalent) to assure that basic capabilities to stabilize and treat acutely ill or injured children are present 24/7 throughout all environments of care.41
Technology Plan
Suggested practices and technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. As other options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org. Technology has significantly advanced in the last decade within the healthcare setting with development of Electronic Health Records (EHR), CPOE, barcode medication administration (BCMA), bar code assisted medication preparation system (BCMP) and smart pump infusion technology. Multiple studies in pediatrics have demonstrated a decrease in both prescribing errors and ADEs after implementing these technologies.12,24,42,43,44,45,46,47,48,49,50However, most of these systems are designed for use in adult patients and customization is often needed to ensure optimal use in pediatric patients.31,51
- Work with the multidisciplinary healthcare team to develop, improve and optimize the pADE reporting systems to identify, target, track and monitor pADEs.
- Embed a pediatric trigger toolkit in the CPOE as an alert system for prescribers when medications are ordered out of range or are duplicate therapies.9,27,28
- Develop and optimize real-time surveillance systems to identify high risk/high alert medications and to optimize pediatric patient outcomes via mitigation of pADEs.
- Standardize equipment and measurement systems throughout the institution, such as smart infusion pumps and accurate weight scales for pediatric patients.11
- Ensure best practices are used for syringe pumps with medications requiring low infusion rates (<5 mL per hour) to prevent medication errors.52,53
- Ensure that the FDA Safety Communication: “Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences” is reviewed and understood by pharmacists who dispense drugs for use in programmable syringe pumps, by clinical engineers and technicians who maintain programmable syringe pumps, and by caregivers who use or who train users on programmable syringe pumps.52
- Promote eLearning modules on this topic,54 prepared by Massachusetts General Hospital, are freely available at syringeinfusionsafety.org as referenced by the FDA in the Safety Communication.
- Implement and optimize bar coded medication process for pediatric medication products (e.g., multi-dose or unit-dose vials, compounded, and/or repackaged).48,55
- Use a bar code assisted medication preparation system (BCMP) for intravenous sterile compounding in pharmacy, such as Baxter’s DoseEdge Pharmacy Workflow Manager, BD’s Cato™ Medication Workflow Solutions, and Omnicell’s i.v.SOFT® Assist.
- Use the eBroselow System (or equivalent) as an electronic aid to assist those who compound drugs extemporaneously, in achieving compliance with standardized concentrations that respect fluid balance considerations for small patients and patients with fluid restriction, and are compatible with the performance envelope of drug infusion pumps.41
- Use the Codonics Safe Label System,56 or the BD Intelliport Medication Management System, to assure correct source vial identification, container preparation, and Joint Commission- compliant labeling of drugs given by IV push or infusion in the perioperative environment.57
- Utilize Continuous Quality Improvement (CQI) software from infusion pump manufacturers to monitor drug library parameters on a routine basis and to report the frequency of command overrides and alerts triggered for unsafe practices.58,59
- Analyze and proactively respond to identified issues from smart pump data to minimize use of basic mode.
- Develop systems to perform gap and root cause analyses to improve patient and medication safety.
- With technology prevalent in healthcare, physicians, pharmacists and nurses should use both synchronous and asynchronous forms of communication to improve medication safety at the transitional points of care.7,34
- Develop and optimize communication technology across healthcare settings, providers and caregivers of the pediatric patients via secured HIPAA-protected lines (e.g., telemedicine and apps).
Essential Criteria to Consider
The system must be:
- Capable of capturing 100% of all hand hygiene events (soap and sanitizer) electronically in real-time.
- Capable of reporting Hand Hygiene Compliance (HHC) based on the WHO 5 Moments for Hand Hygiene at the Group, Unit, Ward or Department Level.\cite{Steed_2011}
- Validated for accuracy in at least one peer reviewed study.\cite{Diller_2014}
- Supported by scientific evidence of efficacy.
- Supported with a behavior and culture change tool kit.
Consider an Electronic Monitoring System for Hand Hygiene Compliance to ensure an accurate and reliable data set from which real improvement can be driven, such as:
- Biovigil Hand Hygiene Compliance & Surveillance System
- DebMed: DebMed GMS (Group Monitoring System)
- GOJO Industries: GOJO SMARTLINK Hand Hygiene Solutions
- HandGieneCorp: HandGiene HHMS (Hand Hygiene Monitoring System
- Hyginex
- Hill Rom
- Hygreen
- IntelligentM: IntelligentM Smartband System
- Proventix: nGage
- Stanley Healthcare: Hygiene compliance monitoring system
- UltraClenz: Patient Safeguard System (PSS)
- Versus: SafeHaven with Versus RTLS and Versus Advantages Hand Hygiene Safety (HHS) software
Metrics
Topic
Observed Hand Hygiene Compliance
Compliance rate of hand hygiene by observation
Outcome Measure Formula
Based on the “My five moments for hand hygiene” method.\cite{Sax_2007,Sax_2009} Moments defined as:
- Before patient contact,
- Before aseptic task,
- After body fluid exposure,
- After patient contact and
- After contacts with patient surroundings.
The formula can be used to calculate hand hygiene compliance during all 5 moments. Moments 1 and 4, before and after patient contact are key calculations.
Numerator: Number of hand hygiene actions performed
Denominator: Number of hand hygiene actions required (hand hygiene opportunities)
*Rate is typically displayed as Events/10,000 Adjusted Patient Days
Metric Recommendations
Direct Impact: All Patients
Lives Spared Harm:
\(Lives\ =\ \left(Compliance\ Rate_{measurement}\ -\ Compliance\ Rate_{baseline}\right)\ x\ Healthcare-associated\ Infection\ Rate\ _{baseline}\)
Data Collection: Direct observation of hand hygiene practices in identified clinical settings with one (or two) trained and validated observers. Observers will watch healthcare workers’ hand hygiene practices at the point-of-care. The observer openly conducts observations but the identities of the healthcare workers are confidential. Based on WHO Guidelines on Hand Hygiene in Healthcare (2009) and “Save lives, Clean Your Hands” campaign.(World Health Organization 2009)