Preventing Medication Errors in Pediatric and Neonatal Patients

Learning ObjectivesDiscuss common medication errors that occur in pediatric and neonatal patient careDescribe error reduction strategies for the pediatric and neonatal populationsExplain limitations of automated medication error reduction devices in these populationsDescribe the role of the interdisciplinary team in preventing medication errors

Adverse Drug EventsADEs are injuries that result from drug useMay be preventable or nonpreventablePotential ADEs result from medication errors with potential for harm but:Are intercepted before reaching patient, orReach patient but do not cause harm.

Incidence of Adverse Drug EventsMedication error rate: pediatric error rates approximately equal to adult error ratesErrors in pediatrics are 3 times more likely to be associated with a potential ADENeonatal ICU: patient group with highest error and potential ADE rate74% of errors and 79% of potential ADEs occur in ordering phaseFortescue E, et al. Pediatrics. 2003;111(4 pt 1):7229.Kaushal R, et al. JAMA. 2001;285:211420.

Reasons for Increased RiskDifferent and changing pharmacokinetic parametersLack of pediatric formulations, dosage forms, guidelinesCalculation errorsInconsistent measurement of preparationsProblems with drug delivery systems

Pediatric and Neonatal PharmacokineticsOne size doesnt fit allPreterm neonates (12 years)

Pediatric and Neonatal PharmacokineticsDo not use the terms interchangeablyDiscuss patients in terms of age and weight to provide more accurate kinetic profileDifference between adolescent and preterm neonate drug dose: potentially 100-fold

Reasons for Increased RiskDifferent and changing pharmacokinetic parametersLack of pediatric formulations, dosage forms, guidelinesCalculation errorsInconsistent measurement of preparationsProblems with drug delivery systems

Lack of Pediatric FormulationsMay lead to:Crushing tabletsOpening capsules and adding to food or beverageUtilizing IV formulations for oral useUsing ophthalmic preparations in the earGiving oral anticonvulsants rectallyCompounding extemporaneous products

Lack of Pediatric FormulationsPitfalls of altering adult formulationsInsufficient data to support practiceExpiration dating of compounded formulationUnknown bioavailabilityExtemporaneous compounding errors

Lack of Pediatric FormulationsBarriers to commercial availabilityComplications of testing in pediatric patientsConcerns involving informed consentRecruitment problems (e.g., too few patients)Determining which pediatric subset to testMarket limitationsCost of testing may outweigh expected marketMarket share typically less than in adult marketLess financial incentive to manufacturers for most disease states

Attempts to Overcome BarriersAmerican Academy of PediatricsShared responsibility to conduct research in children to support rational drug therapy in childrenAmendments to the Food, Drug, and Cosmetics Act Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act 2003, 2007Manufacturers of drugs or biologics that submit an application to market a new active ingredient, indication, dosage form, dosing regimen, route of administration must include a pediatric data assessment Provided 6-month exclusivity extensionProvided funding for research of orphan therapies

Sources of ErrorsConfusion between adult and pediatric formulationsConfusion among oral liquid concentrationsLook-alike and sound-alike packaging and namesMultiple dosing styles

Adult Versus Pediatric FormulationsDifferent concentrationsDifferent volumesShould be stored in separate locations to avoid errorsWithin the pharmacyOn nursing units

Oral Liquid ConcentrationsMultiple concentrations of same productFatal overdoses occur annuallyExample of dangerous situationAvailable liquid acetaminophen products:100 mg/mL Infant drops160 mg/5 mL Childrens liquid167 mg/5 mL Adult extra strengthAsk parent to give a child 5 mL of TylenolChild is 4 years oldParents only have drops; give 5 mL of drops (500 mg)Correct dose should have been 160 mg

Look-Alike, Sound-AlikeMedication namesMedication packagingConfusion between IV and oral productsThis problem has increased in pediatrics as practice of using IV medication for oral administration has increased

Additional Information on Look-Alike and Sound-Alike Medications and Packaging Available in Slide Deck for Chapters 6 and 7

Multiple Dosing StylesDaily dosing versus every 6 hoursAcetaminophen 1015 mg/kg/dose q 68 hrAmpicillin 100200 mg/kg/24 hr divided q 6hrPractitioners must read the fine printWatch your units!mcg/kg/min versus mg/hr versus mcg/kg/hrElectrolyte dosagemEq versus mg versus grams

Reasons for Increased RiskDifferent and changing pharmacokinetic parametersLack of pediatric formulations, dosage forms, guidelinesCalculation errorsInconsistent measurement of preparationsProblems with drug delivery systems

Calculation ErrorsMisuse of decimals Wrong Right .1 mg0.1 mg1.0 mg 1 mgWay to remember: if the decimal is not seen, 10-fold error might be madeOrdering a dose in volumeCreates ambiguity if medication is available in several different concentrations

Calculation ErrorsSingle dose divided by frequency3 mg/kg every 8 hours Example: 10 kg patient Correct: 30 mg every 8 hoursIncorrect: 30 mg daily divided every 8 hours (10 mg every 8 hours)Not dividing daily dose by frequency6 mg /kg/day divided every 8 hours Example: 10 kg patient Correct: 20 mg every 8 hours (60 mg total daily dose)Incorrect: 60 mg every 8 hours

Calculation ErrorsErrors in unit conversionMiscalculation of body surface areaMisplaced decimalsCompounded errors: 10-fold errorsErrors calculating drip ratesWeight-based errorsUsing wrong weight or old weightExpressing weight as lb (wrong) instead of kg (right)

Insulin DilutionFor insulin doses 5 unitsMay use the 100 units/mL concentrationFor insulin doses

Reasons for Increased RiskDifferent and changing pharmacokinetic parametersLack of pediatric formulations, dosage forms, guidelinesCalculation errorsInconsistent measurement of preparationsProblems with drug delivery systems

Oral Measuring DevicesOral medications more likely to be dispensed in bulk and not in unit of use3 out of 4 households still use kitchen teaspoons for measuring*Pre-packaged dispensing cups or droppersMistaken for whole doses versus graduated dosingVarious calibration units on syringesVaries on different syringe sizes

*Institute for Safe Medication Practices. Safety briefs. ISMP Medication Safety Alert! February 26, 1997;2:1.

Rule of 6The Rule of 6 is an equation used to calculate the amount of drug to add to 100 mL of IV fluid so that an infusion rate of 1 mL/hr will deliver 1 mcg/kg/min

6 x weight (kg) = amount of drug (mg) 100 mL of solution

Concerns With Rule of 6Not consistently usedCalculations and mixing may be completed at bedside without pharmacy double checkTypically done with critical care, high-risk drugsDosage adjustments can result in fluid overloadError risk compounded when double or triple concentrating infusionsDrug waste

The Joint Commission and the Rule of 62002: National Patient Safety Goal (NPSG) requiring standardization and limitation of concentrations of high-alert medications in all patientsHospitals were allowed to apply for exemption for Rule of 6By December 31, 2008, all hospitals must comply with standardization

Reasons for Increased RiskDifferent and changing pharmacokinetic parametersLack of pediatric formulations, dosage forms, guidelinesCalculation errorsInconsistent measurement of preparationsProblems with drug delivery systems

Administration of Enteral FluidsEnteral pumps may not be able to deliver small enough volumes to neonatesParenteral syringe pumps have been used insteadIncreases risk for accidental IV administrationTo prevent accidental IV administration of enteral productsTrace tubing to point of origin prior to connecting tubingLabel tubing, administration sets, pumpsUse non-Luer feeding tubesWill connect only with oral syringes

Strategies for Medication Error Reduction

Strategies With Highest Error Prevention Potential in Pediatric PatientsImproved communication among physicians, nurses, and pharmacistsUnit-based clinical pharmacists making rounds with the health care teamUse of computerized prescriber order entry (CPOE) with decision supportFortescue E, et al. Pediatrics. 2003;111(4 pt 1):7229.

Staff CompetenciesRequire math competencies for all staff Develop competencies for entire team before new service is implementedProvide resources for maintaining competency for pediatric and neonatal pharmacologyEnsure competency on all staffing shifts

Patient InformationProvide patient age and date of birthDecreases risk of confusing age in years versus monthsWeight and height in metric measures onlyPatients medication historyInclude concentration of all medicationsRecord doses in milligrams, not in volumeSpecifically ask about common OTCsAcetaminophen, ibuprofen, vitamins

Know Your Own Height and WeightProvides a frame of referenceKnow your height in centimetersKnow your weight in kilograms

Reduction of Calculation ErrorsEstablish reliable method of providing current patient weight in kg to the health care teamRequire calculated dose and dose per weight (i.e., mg/kg) on each orderAcetaminophen 100 mg (10 mg/kg) every 6 hours by mouthExceptionsVitamins, topicals, other medications not requiring weight-based dosingRequire independent double check of dosing calculations

Reduction of Calculation ErrorsUse pre-calculated dose sheetsEmergency medication sheetsCommonly used medicationsStandardize dosing and concentrationsIV drip rates or concentrationsRecipes and strengths for extemporaneous compoundsProvide pediatric references in ordering, dispensing, and administration locationsEncourage rounding to whole numbers when possible

Reduction of Calculation ErrorsInclude warnings for potentially low or high doses in the pharmacy and CPOE systemsAppropriately use decimal pointsUtilize leading zeros: 0.1 (right) .1 (wrong) Do not use trailing zeros: 1 (right) 1.0 (wrong)

Reduction of Prescribing ErrorsVerbal orders Only for emergent/urgent situationsAlways write down order and read backNot allowed when the prescriber and chart are availableNot accepted by pharmacy without written confirmation (prescription faxed/sent prior to dispensing)Limit to formulary drugsReceived only by those authorized by the hospital to do soSpell drug names and pronounce numeral digitsFifty, Five ZeroNever accept verbal chemotherapy ordersHave order signed by prescriber as soon as possible

Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 11.111.16.

Reduction of Prescribing ErrorsWrite directly into patients chartAvoid abbreviationsDo not use u for unit; spell out unitU can be misread as a zero10u can be misread as 100Do not use cc; use mLcc can be misread as 001cc has been interpreted as 100Include patient weight in each order

Reduction of Dispensing ErrorsStandardize concentrationsUse one consistent formula or standard concentrationUse commercially available unit of use preparations whenever feasibleHave pharmacy prepare all IV admixtures and oral liquid preparationsIndependently double check prior to dispensing

Reduction of Administration ErrorsOral liquidsDispense in unit of useOral syringesDispensing bottlesDo not administer oral liquids with IV syringesSyringe tips are a choking hazardOnly utilize dosing graduated cups or oral syringes Oral syringes have caps that are harder to remove

Reduction of At-Home Administration ErrorsDispense appropriate measuring device with each prescription and refillReview dosing instructions with caregiversSuggest a 1 caregiver administration policyPrevents overdoses by well-meaning multiple caregivers administering dosesAsk caregiver to demonstrate administration techniqueIncluding measuring doses

Medication Safety in Pediatric EmergenciesBroselow tapeMeasuring tape placed next to a supine childBased on childs length, tape estimates childs weightBroselow tape and code medication concentrations must match within a facilityEducate staff on proper use and limitations of using tapeUtilize most recent tape versionLimitations for Broselow tapeIncorrect positioning next to childDoses may be expressed in volumeProvides directions to make infusions with non-standard concentrations

Section of Broselow Tape

Medication Safety in Pediatric EmergenciesProvide age-appropriate code traysAdult, pediatric, neonatalSet appropriate par levels Provide pre-printed code sheetsWeight-based dosing algorithmsIdeally, print individualized code sheets for each patientEstablish verbal order proceduresInvolve a pharmacist in ED medication use

Reducing Errors in the Pediatric ORWithin therapeutic classesReduce number of drugs and concentrations Label all medications placed on and off sterile field including:Drug nameConcentration/strengthDate and initials of person preparingThe Joint Commission NPSG Segregate neuromuscular blocking agents from other medications

Reducing Errors in the Pediatric ORAdd required medications to surgeons preference cards or pre-printed order forms Avoids verbal orders or faxes from ORStandardize medications and concentrations for same proceduresAdvocate for weight-based preparation of anesthesia suppliesProvide standardized trays Communicate information about perioperative medication use to postoperative care team

Pre-Procedure SedationOften prescribed for administration at home prior to arrival at physicians officeChloral hydrate and benzodiazepines most commonAmerican Academy of PediatricsChildren should not receive sedatives without supervision and monitoring by skilled medical personnel with appropriate resuscitation equipment

AutomationAutomated Dispensing Cabinets (ADC)Bar Code Point of Care (BPOC)Computerized Prescriber Order Entry (CPOE)Smart Infusion Pumps

Role of Automation in Pediatric and Neonatal ServicesSafetyCPOE: Ability to check prescribed doses against patient weightADCs make dosages available for emergent or after hours useBar coding checks for correct patient, drug, dose, dosage form, and time at point of drug administrationSmart infusion pumps allow for safety checks on standard concentrations prior to infusion

Pitfalls of Automation in Pediatric and Neonatal ServicesCPOEData are only as accurate as information enteredCorrect patient weight may not be in systemLabels may not be appropriate for pediatric dosage formsBar code reading Difficult on pediatric dosagesDifficult on pediatric and neonatal arm/leg bands

Pitfalls of Automation in Pediatric and Neonatal ServicesADCsMedications requiring further preparation or measurement by the nurse may be stored in ADCDrugs may be obtained before pharmacist review (override)When accessing one particular drug, nurse may have access to other drugsSmart infusion pumps (use a drug library to provide alerts if pump is potentially misprogrammed)Systems may not allow for hundredths decimal placeDoses in small total volumes may not account for volume needed to fill tubingInfusion rates can be checked only if IV drug is a standard concentration

Additional Information on Automation Available in Slide Deck for Chapter 15

ReferencesCohen MR. Medication Errors. Causes, Prevention, and Risk Management; 11.111.16.Fortescue E, Kaushal R, Landrigan CP, et al. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics. 2003;111(4 pt 1):7229.Institute for Safe Medication Practices. Safety briefs. ISMP Medication Safety Alert! February 26, 1997;2:1.Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285:211420.

*Referring to a patient as being a child is open to interpretation. Be specific (i.e., a 4 year old weighing x kg). This provides a more accurate picture of the child in terms of their pharmacokinetic profile.*Often times, people will turn to investigational studies when they have no other options for treating a disease state. *These acts are meant to increase pediatric testing and data for drugs. Waivers are allowed to the PREA, however, the 2007 version added documentation requirements as to why a pediatric formulation could not be manufactured*Broselow tape utilizes height or length to determine doses in an emergency. Realizing that weight and age may not be available during an emergency situation in a pediatric patient.Color coded