Executive Summary Checklist

An effective program to reduce the incidence of pediatric adverse drug events (pADEs) and harm should be instituted and combine leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education) in protecting pediatric patients by focusing on the following key tasks:

The Performance Gap

As reported by the Institute for Safe Medication Practices (ISMP), during a 5-year span between 2008 and 2012, there were over 45,000 adverse drug events (ADEs) reported to the US Food and Drug Administration (FDA) in children aged less than 18 years old. Of these, approximately 64% of ADEs (29,298) involved reports of a serious injury, which included 2,935 (6%) deaths, 10,032 (22%) cases that required hospitalization, 1,430 (3%) cases considered life threatening, and 816 (2%) cases of disability \cite{5}(Quarter Watch 2014).
Preventing medication errors in pediatric patients poses unique challenges as children are particularly vulnerable to adverse outcomes from medication errors because of the need for weight-based drug dosing involving multiple calculations, dilution of stock drug solutions, immature renal and hepatic functions, and limited ability to communicate side effects \cite{Kaushal_2001},\cite{2011},\cite{23055866}. In addition, drugs may be not have an FDA specific indicationfor children. Greater than 70% of the drugs used in pediatrics have not been studied scientifically in age-specific populations to assess patient safety \cite{23055866},\cite{Lindell_Osuagwu_2009}. Most medications used in the care of children are formulated and packaged primarily for adults. The available dosage forms and concentrations appropriate for administration to neonates, infants and children are limited. Therefore, medications often must be prepared in different volumes or concentrations to accommodate delivery modalities that take into account fluid balance for small patients andpatients with fluid restriction, and, if an infusion pump is required, provide an infusion rate that is acceptable and within pump capabilities. When drugs are not prepared centrally in the pharmacy (i.e., extemporaneous compounding by frontline caregivers), computational errors and admixtures that do not account stability, compatibility, or bioavailability data may represent additional challenges \cite{6}.
Studies showed that medication errors in pediatrics are up to three times more likely to be associated with a potential ADE compared to those reported in adults (Kaushal 2001),\cite{Fortescue_2003}. Compared to other pediatric patient groups, the neonatal ICU patient group has the highest error and potential ADE rate. Prioritizing strategies for preventing medication errors and adversedrug events in pediatric inpatients \cite{Kaushal_2001},\cite{Le_2006}. As reported in an earlier study, ADE rates in hospitalized children were substantially higher (15.7 per 1000 patient-days) than previously described \cite{Takata_2008}. However, 22% of all ADEs could be preventable, and 17.8% could have been identified earlier \cite{Takata_2008}.
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 \cite{7}. The American Academy of Pediatrics (AAP) has also taken a lead in making recommendations to reduce errors \cite{2003}.
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:

Practice Plan

  • 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.

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 (Manias 2014, Larsen 2005, Morriss 2009, Tourel 2012, Mason 2014, Morriss 2011, Hardmeier 2014, King 2003, Leung 2015, Manrique-Rodriguez 2016, Rinke 2014). However, most of these systems are designed for use in adult patients and customization is often needed to  ensure optimal use in pediatric patients (Ruano 2016).