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Preventing Medication Errors in Pediatric and Neonatal Patients Learning Objectives • Discuss common medication errors that occur in pediatric and neonatal patient care • Describe error reduction strategies for the pediatric and neonatal populations • Explain limitations of automated medication error reduction devices in these populations • Describe the role of the interdisciplinary team in preventing medication errors Adverse Drug Events • ADEs are injuries that result from drug use – May be preventable or nonpreventable • Potential ADEs result from medication errors with potential for harm but: – Are intercepted before reaching patient, or – Reach patient but do not cause harm . Incidence of Adverse Drug Events • Medication error rate: pediatric error rates approximately equal to adult error rates • Errors in pediatrics are 3 times more likely to be associated with a potential ADE • Neonatal ICU: patient group with highest error and potential ADE rate • 74% of errors and 79% of potential ADEs occur in ordering phase Fortescue E, et al. Pediatrics. 2003;111(4 pt 1):722–9. Kaushal R, et al. JAMA. 2001;285:2114–20. Reasons for Increased Risk • Different and changing pharmacokinetic parameters • Lack of pediatric formulations, dosage forms, guidelines • Calculation errors • Inconsistent measurement of preparations • Problems with drug delivery systems Pediatric and Neonatal Pharmacokinetics • One size doesn’t fit all – Preterm neonates (<36 weeks’ gestation) – Full-term neonates (birth to 30 days) – Infants (1–12 months) – Toddlers (1–4 years) – Children (5–12 years) – Adolescents (>12 years) Pediatric and Neonatal Pharmacokinetics • Do not use the terms interchangeably • Discuss patients in terms of age and weight to provide more accurate kinetic profile • Difference between adolescent and preterm neonate drug dose: potentially 100-fold Reasons for Increased Risk • Different and changing pharmacokinetic parameters • Lack of pediatric formulations, dosage forms, guidelines • Calculation errors • Inconsistent measurement of preparations • Problems with drug delivery systems Lack of Pediatric Formulations • May lead to: – Crushing tablets – Opening capsules and adding to food or beverage – Utilizing IV formulations for oral use – Using ophthalmic preparations in the ear – Giving oral anticonvulsants rectally – Compounding extemporaneous products Lack of Pediatric Formulations • Pitfalls of altering adult formulations – Insufficient data to support practice – Expiration dating of compounded formulation – Unknown bioavailability – Extemporaneous compounding errors Lack of Pediatric Formulations • Barriers to commercial availability – Complications of testing in pediatric patients • Concerns involving informed consent • Recruitment problems (e.g., too few patients) • Determining which pediatric subset to test – Market limitations • Cost of testing may outweigh expected market • Market share typically less than in adult market • Less financial incentive to manufacturers for most disease states Attempts to Overcome Barriers • American Academy of Pediatrics – Shared responsibility to conduct research in children to support rational drug therapy in children • Amendments to the Food, Drug, and Cosmetics Act Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act – 2003, 2007 • Manufacturers 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 extension • Provided funding for research of “orphan” therapies Sources of Errors • Confusion between adult and pediatric formulations • Confusion among oral liquid concentrations • “Look-alike” and “sound-alike” packaging and names • Multiple dosing styles Adult Versus Pediatric Formulations • Different concentrations • Different volumes • Should be stored in separate locations to avoid errors – Within the pharmacy – On nursing units Oral Liquid Concentrations • Multiple concentrations of same product • Fatal overdoses occur annually • Example of dangerous situation – Available liquid acetaminophen products: • 100 mg/mL Infant drops • 160 mg/5 mL Children’s liquid • 167 mg/5 mL Adult extra strength – Ask parent to give a child 5 mL of Tylenol • Child is 4 years old • Parents only have drops; give 5 mL of drops (500 mg) • Correct dose should have been 160 mg Look-Alike, Sound-Alike • Medication names • Medication packaging • Confusion between IV and oral products – This 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 Styles • Daily dosing versus every 6 hours – Acetaminophen 10–15 mg/kg/dose q 6–8 hr – Ampicillin 100–200 mg/kg/24 hr divided q 6hr – Practitioners must read the fine print • Watch your units! – mcg/kg/min versus mg/hr versus mcg/kg/hr – Electrolyte dosage • mEq versus mg versus grams Reasons for Increased Risk • Different and changing pharmacokinetic parameters • Lack of pediatric formulations, dosage forms, guidelines • Calculation errors • Inconsistent measurement of preparations • Problems with drug delivery systems Calculation Errors • Misuse of decimals Wrong Right .1 mg 0.1 mg 1.0 mg 1 mg Way to remember: if the decimal is not seen, 10-fold error might be made • Ordering a dose in volume – Creates ambiguity if medication is available in several different concentrations Calculation Errors • Single dose divided by frequency – 3 mg/kg every 8 hours • Example: 10 kg patient – Correct: 30 mg every 8 hours – Incorrect: 30 mg daily divided every 8 hours » (10 mg every 8 hours) • Not dividing daily dose by frequency – 6 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 Errors • Errors in unit conversion • Miscalculation of body surface area • Misplaced decimals – Compounded errors: 10-fold errors • Errors calculating drip rates • Weight-based errors – Using wrong weight or old weight – Expressing weight as lb (wrong) instead of kg (right) Insulin Dilution • For insulin doses ≥5 units – May use the 100 units/mL concentration • For insulin doses <5 units – Dilute insulin in pharmacy to 10 units / mL – Only send individual, patient-specific doses to nursing unit – Vials of diluted insulin should not leave pharmacy – A 1 mL tuberculin syringe is used to administer Reasons for Increased Risk • Different and changing pharmacokinetic parameters • Lack of pediatric formulations, dosage forms, guidelines • Calculation errors • Inconsistent measurement of preparations • Problems with drug delivery systems Oral Measuring Devices • Oral medications more likely to be dispensed in bulk and not in unit of use • 3 out of 4 households still use kitchen teaspoons for measuring* • Pre-packaged dispensing cups or droppers – Mistaken for whole doses versus graduated dosing • Various calibration units on syringes – Varies on different syringe sizes *Institute for Safe Medication Practices. Safety briefs. ISMP Medication Safety Alert! February 26, 1997;2:1. Rule of 6 • The “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 6 • Not consistently used • Calculations and mixing may be completed at bedside without pharmacy double check • Typically done with critical care, high-risk drugs • Dosage adjustments can result in fluid overload – Error risk compounded when double or triple concentrating infusions • Drug waste The Joint Commission and the Rule of 6 • 2002: National Patient Safety Goal (NPSG) requiring standardization and limitation of concentrations of high-alert medications in all patients • Hospitals were allowed to apply for exemption for Rule of 6 • By December 31, 2008, all hospitals must comply with standardization Reasons for Increased Risk • Different and changing pharmacokinetic parameters • Lack of pediatric formulations, dosage forms, guidelines • Calculation errors • Inconsistent measurement of preparations • Problems with drug delivery systems Administration of Enteral Fluids • Enteral pumps may not be able to deliver small enough volumes to neonates – Parenteral syringe pumps have been used instead • Increases risk for accidental IV administration • To prevent accidental IV administration of enteral products – Trace tubing to point of origin prior to connecting tubing – Label tubing, administration sets, pumps – Use non-Luer feeding tubes • Will connect only with oral syringes Strategies for Medication Error Reduction Strategies With Highest Error Prevention Potential in Pediatric Patients • Improved communication among physicians, nurses, and pharmacists • Unit-based clinical pharmacists making rounds with the health care team • Use of computerized prescriber order entry (CPOE) with decision support Fortescue E, et al. Pediatrics. 2003;111(4 pt 1):722–9. Staff Competencies • Require math competencies for all staff • Develop competencies for entire team before new service is implemented • Provide resources for maintaining competency for pediatric and neonatal pharmacology • Ensure competency on all staffing shifts Patient Information • Provide patient age and date of birth – Decreases risk of confusing age in years versus months • Weight and height in metric measures only • Patient’s medication history – Include concentration of all medications – Record doses in milligrams, not in volume – Specifically ask about common OTCs • Acetaminophen, ibuprofen, vitamins Know Your Own Height and Weight • Provides a frame of reference • Know your height in centimeters • Know your weight in kilograms Reduction of Calculation Errors • Establish reliable method of providing current patient weight in kg to the health care team • Require calculated dose and dose per weight (i.e., mg/kg) on each order – Acetaminophen 100 mg (10 mg/kg) every 6 hours by mouth – Exceptions • Vitamins, topicals, other medications not requiring weightbased dosing • Require independent double check of dosing calculations Reduction of Calculation Errors • Use pre-calculated dose sheets – Emergency medication sheets – Commonly used medications • Standardize dosing and concentrations – IV drip rates or concentrations – Recipes and strengths for extemporaneous compounds • Provide pediatric references in ordering, dispensing, and administration locations • Encourage rounding to whole numbers when possible Reduction of Calculation Errors • Include warnings for potentially low or high doses in the pharmacy and CPOE systems • Appropriately use decimal points – Utilize leading zeros: – Do not use trailing zeros: 0.1 (right) 1 (right) .1 (wrong) 1.0 (wrong) Reduction of Prescribing Errors • Verbal orders – Only for emergent/urgent situations • Always write down order and read back – Not allowed when the prescriber and chart are available – Not accepted by pharmacy without written confirmation (prescription faxed/sent prior to dispensing) – Limit to formulary drugs – Received only by those authorized by the hospital to do so – Spell drug names and pronounce numeral digits • Fifty, Five Zero – Never accept verbal chemotherapy orders – Have order signed by prescriber as soon as possible Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 11.1–11.16. Reduction of Prescribing Errors • Write directly into patient’s chart • Avoid abbreviations – Do not use u for unit; spell out “unit” • U can be misread as a zero • 10u can be misread as 100 – Do not use cc; use mL • cc can be misread as 00 • 1cc has been interpreted as 100 • Include patient weight in each order Reduction of Dispensing Errors • Standardize concentrations • Use one consistent formula or standard concentration • Use commercially available unit of use preparations whenever feasible • Have pharmacy prepare all IV admixtures and oral liquid preparations • Independently double check prior to dispensing Reduction of Administration Errors • Oral liquids – Dispense in unit of use • Oral syringes • Dispensing bottles – Do not administer oral liquids with IV syringes • Syringe tips are a choking hazard – Only utilize dosing graduated cups or oral syringes • Oral syringes have caps that are harder to remove Reduction of At-Home Administration Errors • Dispense appropriate measuring device with each prescription and refill • Review dosing instructions with caregivers • Suggest a “1 caregiver” administration policy – Prevents overdoses by well-meaning multiple caregivers administering doses • Ask caregiver to demonstrate administration technique – Including measuring doses Medication Safety in Pediatric Emergencies • Broselow tape – “Measuring tape” placed next to a supine child – Based on child’s length, tape estimates child’s weight • Broselow tape and code medication concentrations must match within a facility • Educate staff on proper use and limitations of using tape • Utilize most recent tape version • Limitations for Broselow tape – Incorrect positioning next to child – Doses may be expressed in volume – Provides directions to make infusions with non-standard concentrations Section of Broselow Tape Medication Safety in Pediatric Emergencies • Provide age-appropriate code trays – Adult, pediatric, neonatal – Set appropriate par levels • Provide pre-printed “code sheets” – Weight-based dosing algorithms – Ideally, print individualized code sheets for each patient • Establish verbal order procedures • Involve a pharmacist in ED medication use Reducing Errors in the Pediatric OR • Within therapeutic classes – Reduce number of drugs and concentrations • Label all medications placed on and off sterile field including: – Drug name – Concentration/strength – Date and initials of person preparing • The Joint Commission NPSG • Segregate neuromuscular blocking agents from other medications Reducing Errors in the Pediatric OR • Add required medications to surgeon’s preference cards or pre-printed order forms – Avoids verbal orders or faxes from OR • Standardize medications and concentrations for same procedures • Advocate for weight-based preparation of anesthesia supplies – Provide standardized trays • Communicate information about perioperative medication use to postoperative care team Pre-Procedure Sedation • Often prescribed for administration at home prior to arrival at physician’s office – Chloral hydrate and benzodiazepines most common • American Academy of Pediatrics – Children should not receive sedatives without supervision and monitoring by skilled medical personnel with appropriate resuscitation equipment Automation • Automated Dispensing Cabinets (ADC) • Bar Code Point of Care (BPOC) • Computerized Prescriber Order Entry (CPOE) • “Smart” Infusion Pumps Role of Automation in Pediatric and Neonatal Services • Safety – CPOE: Ability to check prescribed doses against patient weight – ADCs make dosages available for emergent or after hours use – Bar coding checks for correct patient, drug, dose, dosage form, and time at point of drug administration – Smart infusion pumps allow for safety checks on standard concentrations prior to infusion Pitfalls of Automation in Pediatric and Neonatal Services • CPOE – Data are only as accurate as information entered – Correct patient weight may not be in system – Labels may not be appropriate for pediatric dosage forms • Bar code reading – Difficult on pediatric dosages – Difficult on pediatric and neonatal arm/leg bands Pitfalls of Automation in Pediatric and Neonatal Services • ADCs – Medications requiring further preparation or measurement by the nurse may be stored in ADC – Drugs may be obtained before pharmacist review (override) – When accessing one particular drug, nurse may have access to other drugs • “Smart” infusion pumps (use a drug library to provide alerts if pump is potentially misprogrammed) – Systems may not allow for hundredths decimal place – Doses in small total volumes may not account for volume needed to fill tubing – Infusion rates can be checked only if IV drug is a standard concentration Additional Information on Automation Available in Slide Deck for Chapter 15 References Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 11.1–11.16. 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):722–9. 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;285:2114–20.